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This course is intended to provide an introduction to engineering mechanics. Topics include Static and Dynamics, Strength of Materials, and Systems Modeling. The course will emphasize basic relationships in these areas necessary to the understanding of design and manufacturing principles as covered in ME 503.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Basic concepts and introduction to engineering analysis techniques in mechanical and manufacturing engineering. Topics include: applications of ordinary and partial differential equations, linear algebra and numerical analysis to mechanical and manufacturing engineering system.
Prerequisites:
ME 501 Basic Engineering Mechanics
(0-0-3)(Lec-Lab-Credit Hours)
This course is intended to provide an introduction to engineering mechanics. Topics include Static and Dynamics, Strength of Materials, and Systems Modeling. The course will emphasize basic relationships in these areas necessary to the understanding of design and manufacturing principles as covered in ME 503.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course is intended to provide non-mechanical engineering students with an understanding of the principles of mechanical design. It is given from the viewpoint that design is the central activity of the engineering profession, and it is more concerned with the introduction of mechanical engineering principles pertinent to design of products. This course presents design as an interdisciplinary activity that draws on such diverse subjects as materials selection, modeling and analysis, and manufacturing processes.
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The ballistic regimes, simple piezo ballistics, Corner's analysis,
Frankle-Baer simulation, interior ballistics interactive simulation,
comparison of models, projectile design practice, cannon design practice,
exterior intermediate ballistic regimes, flight trajectories, terminal
ballistics, numerical simulation of impact and fragmentation.
(At Dover, NJ)
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| | (0-0-3) (Lec-Lab-Credit Hours)
A treatment of the physical and chemical theoretical principles which govern the characteristics and performance of propellants and explosives; theories to explain stability, sensitivity, combustion, detonation, initiation, power, shaped charge effect, and flash and smoke formations; thermochemical and thermodynamic calculations to enable performance to be predicted; kinetics of reaction of important systems; modern research instrumentation; test procedures; methods of evaluating propellants and explosives.
Fall and Spring semester. (At Dover, NJ)
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| | (0-0-3) (Lec-Lab-Credit Hours)
A treatment of the physical and chemical theoretical principles which govern the characteristics and performance of propellants and explosives; theories to explain stability, sensitivity, combustion, detonation, initiation, power, shaped charge effect, and flash and smoke formations; thermochemical and thermodynamic calculations to enable performance to be predicted; kinetics of reaction of important systems; modern research instrumentation; test procedures; methods of evaluating propellants and explosives.
Fall and Spring semester. (At Dover, NJ)
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Basic principles of exterior ballistics are introduced. Flight terminology,
vacuum trajectories and flat fire point mass trajectories are discussed.
Siacci Method, Coriolis effect, yaw or repose, wind effects, 6-DOF
trajectories and modified point mass trajectories are covered.
(At Dover, NJ)
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Simplified equations for determination of flight stability and roll resonance are developed. Terminal ballistics are described and nomenclature introduced. Shock and stress wave effects in material are discussed. Penetration and perforation of solids and the governing equations are described. Penetration of armor by shaped charged jets are discussed. Term project focuses on investigation of terminal ballistic effects tailored to a specific job application.
(At Dover, NJ)
Prerequisites:
ME 507 Exterior Ballistics
(0-0-3)(Lec-Lab-Credit Hours)
Basic principles of exterior ballistics are introduced. Flight terminology,
vacuum trajectories and flat fire point mass trajectories are discussed.
Siacci Method, Coriolis effect, yaw or repose, wind effects, 6-DOF
trajectories and modified point mass trajectories are covered.
(At Dover, NJ)
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| | (0-0-3) (Lec-Lab-Credit Hours)
Courses on special topics of current interest in Mechanical Engineering, including but not limited to, the following: Nuclear Power Engineering and Computer-Aided Building Energy Analysis.
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Analysis of thermodynamics, hydraulic, environmental, and economic considerations that affect the design and performance of modern power plants; overview of power generation system and its components, including boilers, turbines, circulating water systems, and condensate-feedwater systems; fuels and combustion; auxiliary pumping and cleanup systems; gas turbine and combined cycles; and introduction to nuclear power plants and alternate energy systems based on geothermal, solar, wind, and ocean energy.
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| | (3-0-3) (Lec-Lab-Credit Hours)
A development of the background necessary for nuclear engineering, beginning with a review of atomic physics and including radioactivity, nuclear reactions, neutron physics and elementary reactor theory, reactor dynamics and control, reactor types.
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Analysis of the automotive vehicle as an entire integrated system under highway and off-road conditions. Significant subject areas include power-train design, control and stability; suspension design, tire-road interface, soil-vehicle interface, four-wheeled, tracked and unconventional vehicles; emphasis is on design theory.
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Composite material characterization; composite mechanics of plates, panels, beams, columns, and rods integrated with design procedures; analysis and design of composite structures, joining methods and procedures, introduction to manufacturing processes of filament winding, braiding, injection, compression and resin transfer molding, machining and drilling, and industrial applications.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course will introduce principles and applications of Nondestructive Evaluation (NDE) techniques which are important in design, manufacturing, and maintenance. Most commonly used methods such as ultrasonics, magnetics, radiography, penetrants, and eddy currents will be discussed. Physical concepts behind each of these methods as well as practical examples of their applications will be emphasized.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course introduces principles of mechatronics to integrate mechanical, electronic/electrical, and control/computer/software components for motion control systems. Electromechanical components and integration concepts include: machine construction and control concepts, control modes (open/closed loop, servo, and process control) and motion profiles, motion drivers and actuators (AC drives, motors, gearing, servo and stepper motors), PLC control and programming (ladder and Boolean and combinatorial logic interfaces), microprocessor/computer based (logic, operating systems, SCADA, and HMI), field devices, signal conditioning, and communication (I/O hardware and management, vision systems, protocols, and programming languages), and introduction to system integration.Course includes hands-on lab work, small design projects, case studies, and industry guest lectures.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course introduces the fundamental principles of mechanics applied to the study of biological systems and relates the design of implants and prosthetics to the biomechanics of the musculoskeletal system. Specific types of tissue covered include bone, ligament, skeletal and cardiac muscle, and articular cartilage. An introduction to the basic concepts of continuum mechanics is provided, including finite-deformation kinematics, stress, constitutive equations, and the governing conservation laws of mass, momentum, and energy applied to deformable continua. Rigid-body kinematics is introduced in the context of applications in biomechanics.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course focuses on the design and manufacture of medical devices in a regulated environment. Current commercially available therapeutic devices are used as illustrations. For each device, the relevant physiology and common pathology is presented from an engineering point of view. This information is translated into user and functional requirements for the design of the therapeutic device. Based on these requirements, we explore how mechanical engineers contribute to the design and manufacture of these devices within a regulated environment.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course blends robotics theory, control theory neural networks theory, and neuroscience to understand in some depth the primate motor system. The goal is to understand how the brain uses vision and other sensory feedback to plan and control movements of the limb.
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The internal combustion engine examined in terms of the four fundamental disciplines that determine its characteristics: 1) fluid mechanics; 2) chemistry of combustion and of exhaust emission; 3) first and second laws of thermodynamics, and 4) mechanics of reciprocating and rotary motion; high output Otto and Diesel engines for terrestrial, maritime and aerospace environments; normal and abnormal combustion; stratified charge and advanced low emission engines; hybrid and multifuel engines; Sterling and other space engines; free-piston and rotary-piston concepts and configurations.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety and environment concepts, and regulatory issues.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course reviews the 12 elements of the Process Safety Management (PSM) model created by the Center for Chemical Process Safety of the American Institute of Chemical Engineers. PSM systems were developed as an expectation/demand of the public, customers, in-plant personnel, stockholders and regulatory agencies because reliance on chemical process technologies were not enough to control, reduce and prevent hazardous materials incidents. PSM systems are comprehensive sets of policies, procedures and practices designed to ensure that barriers to major incidents are in place, in use and effective. The objectives of this course are to: define PSM and why it is important, describe each of the 12 elements and their applicability, identify process safety responsibilities, give real examples and practical applications to help better understand each element, share experiences and lessons learned of all participants, and assess the quality and identify enhancements to student's site PSM program.
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| | (0-0-3) (Lec-Lab-Credit Hours)
An introduction to the principles and control of air pollution, including:
types and measurement of air pollution; air pollution chemistry; atmospheric dispersion modeling; compressible fluid flow; particle dynamics; ventilation systems; inertial devices; electrostatic precipitators; scrubbers; filters; absorption and adsorption; combustion; condensation.
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| | (0-0-3) (Lec-Lab-Credit Hours)
The basis of catalysis and catalytic processes are introduced, such as the production of a broad range of chemicals and reduction of pollutants from mobile and stationary sources.
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Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities. Issues related to process flow, material flow, and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer. Bio-safety levels. Developing effective written procedures, so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do. Levels I, II, and III policies. Clinical phases I, II, III and their effect on plant design. Defending products against contamination. Building quality into products.
Prerequisites:
ME 535 Good Manufacturing Practice in Pharmaceutical Facilities Design
(3-0-3)(Lec-Lab-Credit Hours)
Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities. Issues related to process flow, material flow, and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer. Bio-safety levels. Developing effective written procedures, so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do. Levels I, II, and III policies. Clinical phases I, II, III and their effect on plant design. Defending products against contamination. Building quality into products.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Course addresses the sustainable operation and design of facilities and sites subject to regulatory requirements of US federal agencies such as FDA, NIH, OSHA, EPA, DOE and/or applicable international regulators. Course presents timely issues, challenges and potential benefits of implementing sustainable means and methods to meet new Green Codes and Design Standards that are either in draft review or final version for the regulated facility, whether in planning, design, construction or operation phase. Regulated buildings typically have their own unique requirements in their operation, which require special knowledge to comply and or mitigate safety and regulatory issues, while minimizing impact of rising energy costs to manufacturers, saving scarce resources, and protecting the environment. Furthermore, course introduces the students to resources, survey information of latest sustainable/Green thinking in Green Chemistry, Sustainability and Energy Efficient Design and Products to reduce waste, energy consumption, eliminate unnecessary or optimize manufacturing steps, cut operating costs and be environmentally sensitive.
Topics include: Global trends in Green Regulations and Design Standards, history of “Sustainable Design,” examples of sustainability in large companies, site selection issues, water resource conservation, architectural issues and material selections, energy resource conservation and efficiency design for mechanical, electrical, and plumbing (MEP) systems in regulated facilities, energy performance of buildings, waste and environmental issues, material resource conservation and efficiency (disposables, packaging), construction techniques toward a sustainable certified facility, sustainable design for cGMP facilities and labs, building operations and maintenance. Course will provide useful, current and practical knowledge of Green and Sustainability Design and operation to individuals who are in or entering a technical career in regulated industries such as pharmaceutical, medical devices, and other sectors that have energy-intensive and regulated facilities.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Bulk active pharmaceutical ingredient manufacturing and unit operations. Process scale-up. Transport processes, including mass, heat, and momentum transfer. Process synthesis, analysis, and design. Traditional separation processes, including distillation, evaporation, extraction, crystallization, and absorption. New separation processes, including pressure swing adsorption, molecular sieves, ion exchange, reverse osmosis, microfiltration, nanofiltration, ultrafiltration, diafiltration, gas permeation, pervaporation, supercritical fluid extraction, and high performance liquid chromatography (HPLC). Batch and continuous reactors for homogeneous, heterogeneous, catalytic, and non-catalytic reactions.
Prerequisites:
CHE 530 Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety, & environment concepts, and regulatory issues.
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Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety and environment concepts, and regulatory issues.
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Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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This course provides a broad overview of topics related to the design and operations of modern biopharmaceutical facilities. It covers process, utilities, and facility design issues, and encompasses all major manufacturing areas, such as fermentation, harvest, primary and final purification, media and buffer preparation, equipment cleaning and sterilization, and critical process utilities. Unit operations include cell culture, centrifugation, conventional and tangential flow filtration, chromatography, solution preparation, and bulk filling. Application of current Good Manufacturing Practices and Bioprocessing Equipment Standards (BPE-2002) will be discussed.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Validation of a pharmaceutical manufacturing process is an essential requirement with respect to compliance with Good Manufacturing Practices (GMP) contained within the Code of Federal Regulations (21 CFR). Course covers validation concepts for plant, process, cleaning, sterilization, filtration, analytical methods, and computer systems; GAMP (Good Automated Manufacturing Practice), IEEE SQAP, and new electronic requirements - 21 CFR Part 11. Master validation plan, IQ, OQ, and PQ protocols, and relationships to GMP. National (FDA) and international (EU) regulatory affairs for cGMP (current Good Manufacturing Practice) and cGLP (current Good Laboratory Practice) requirements in development, manufacturing, and marketing. Handling the FDA inspection.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Computers and computerized systems are ubiquitous in pharmaceutical manufacturing. Validation of these systems is essential to assure public safety and compliance with appropriate regulatory issues regarding validation: GMP, GCP, 21CFR Part 11, etc. This course covers validation concepts for various classes of computerized systems and applications used in the pharmaceutical industry; importance of requirements engineering in validation; test protocols and design; organizational maturity considerations.
Prerequisites:
ME 540 Validation and Regulatory Affairs in Pharmeceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Validation of a pharmaceutical manufacturing process is an essential requirement with respect to compliance with Good Manufacturing Practices (GMP) contained within the Code of Federal Regulations (21 CFR). Course covers validation concepts for plant, process, cleaning, sterilization, filtration, analytical methods, and computer systems; GAMP (Good Automated Manufacturing Practice), IEEE SQAP, and new electronic requirements - 21 CFR Part 11. Master validation plan, IQ, OQ, and PQ protocols, and relationships to GMP. National (FDA) and international (EU) regulatory affairs for cGMP (current Good Manufacturing Practice) and cGLP (current Good Laboratory Practice) requirements in development, manufacturing, and marketing. Handling the FDA inspection.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Analysis of refrigeration cycles, properties of refrigerants and coolants; psychrometry; factors affecting human comfort; environmental control requirements in industrial processes; estimation of infiltration and ventilation, heat transmission coefficients, insulation; heating and cooling load on buildings; numerical methods for building energy analysis; selection of air distribution systems, ducting and fans; selection of water and steam distribution systems, piping and pumps.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course lays the foundations in aerospace engineering. Topics include the history of aviation, basic aerodynamics, airfoils, wings and other aerodynamic shapes, aircraft performance, stability and control, aircraft structures (structural analysis and materials), propulsion, flight test, rockets, space flight, and orbits.
Prerequisites:
ME 342 Fluid Mechanics
(3-3-4)(Lec-Lab-Credit Hours)
Properties of a fluid, basic flow analysis techniques, fluid kinematics, hydrostatics, manometry, pressure distribution in rigid body motion of a fluid, control volume analysis, conservation of mass, linear and angular momentum, Bernoulli and energy equations, dimensional analysis, viscous flow in pipes, flow metering devices, external flows, estimation of lift and drag, turbo-machinery, open channel flow.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Aerodynamic and thermodynamic fundamentals applicable to turbomachinery; design configurations and types of turbomachinery; turbine, compressor and ancillary equipment kinematics, thermodynamics and performance; selection and operational problems of turbomachinery.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course presents validation for medical device manufacturers in terms of its objectives, strategies, planning, protocols, and documentation. Validation requirements include producing, collecting, analyzing, and managing data and documentation in support of medical device product design and product performance claims. These, as well as manufacturing processes and test methods, are presented within the context of current Quality System Regulations (QSR) as well as Risk Analysis. Qualification is addressed for equipment and operational systems, software and automated systems, and facilities for manufacturing medical devices. Validation in all life cycle phases is presented, both prior to commercial production and during the operating life of the plant, process, and product. Case studies are included as specific examples. Through this course, students will understand how to implement validation studies for medical device manufacturers and to evaluate existing studies.
Prerequisites:
ME 580 Medical Device Design and Technology
(3-0-3)(Lec-Lab-Credit Hours)
Early history of medical devices and procedures. Minimally invasive and open procedures, techniques and devices, including mechanical and electrosurgical devices. Manufacturing methods for catheters, balloons, plastic and metal components. Design of metal device components including material selection and strength and deformation adequacy using material properties and classical mechanics. Selection of insulation materials for and testing of electrosurgical devices. Selection of medical plastics and design elements. Balloon and catheter burst strength. The Poiseuille flow equation and its use for fluid flow through catheters and vessels. Rapid prototyping techniques, advantages and limitations. Understanding of biocompatibility testing and accelerated age testing using the Arrhenius equation. Device sterilization methods and testing. Developing a project plan from brainstorming to product release for a new device.
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Medical Devices Manufacturing
(3-0-3)(Lec-Lab-Credit Hours)
Technical tools and knowledge required to operate and manage in medical devices manufacturing environment. Current requirements in medical devices regulations, quality systems, and design elements related to manufacturing steps to assure patients health and safety. Requirements concerning selection and supply of raw materials and components for manufacturing; design and qualification of facilities, equipment, and process systems; testing, controls and inspection for compliance. Combination products, validation, external contractors, and case studies. Focus on understanding the principles and methods required in a medical devices manufacturing environment in compliance with GMP regulations.
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Introduction to basic concepts and current state-of-the-art hardware; architecture and elementary programming; instruction sets; fundamental software concepts; interfacing microprocessors to external devices; microprocessors in control systems; hands-on laboratory applications of microprocessors in mechanical engineering systems.
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| | (0-0-3) (Lec-Lab-Credit Hours)
An introduction to using a computer system to aid in engineering design, fundamental components of hardware and software; databases and database management, numerical control and computer-aided manufacturing. Integration of manufacturing system from conceptual design through quality control to final shipping is discussed. Applications include solids modeling, CAD drawing and solution using finite element method.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Course explores the current application of Lean Six Sigma in Pharmaceutical Manufacturing. Topics covered include: Lean Six Sigma Concepts and Techniques, Project and Team Dynamics, Tools of Lean Six Sigma and their Application, and Designing Pharmaceutical Processes for Lean Six Sigma. Emphasis is on DMAIC, including Define, Measure, Analyze, Improve, and Control methodology, with the students’ skill set developed through case studies and project work on actual pharmaceutical processes using statistical software (Minitab). At the conclusion of this course, students will understand the concepts and principles of Lean Six Sigma, be competent with Minitab software and be able to apply these techniques to pharmaceutical processes.
Prerequisites:
PME 555 Lean Six Sigma in the Pharmaceutical Industry
(3-0-3)(Lec-Lab-Credit Hours)
Course explores the current application of Lean Six Sigma in Pharmaceutical Manufacturing. Topics covered include: Lean Six Sigma Concepts and Techniques, Project and Team Dynamics, Tools of Lean Six Sigma and their Application, and Designing Pharmaceutical Processes for Lean Six Sigma. Emphasis is on DMAIC, including Define, Measure, Analyze, Improve, and Control methodology, with the students’ skill set developed through case studies and project work on actual pharmaceutical processes using statistical software (Minitab). At the conclusion of this course, students will understand the concepts and principles of Lean Six Sigma, be competent with Minitab software and be able to apply these techniques to pharmaceutical processes.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course provides project managers with the framework, tools and approaches to meet the quality requirements of their projects and their customers, ensuring project success.
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Application of mathematical optimization techniques, including linear and nonlinear methods, to design and manufacture of devices and systems of interest to mechanical engineers; optimization techniques include: constrained and unconstrained optimization in several variables, problems for structured multi-stage decision, and linear programming; formulation of design and manufacturing problems using computer- based methods; optimum design of parts and assemblies to minimize the cost of manufacture.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course is involved in the design and development of parts and assemblies for manufacturability and functionality; characteristics and capabilities of significant manufacturing processes; principles of design for manufacturability; product planning; conceptual design; embodiment design; dimensional tolerances; optimum design of products to minimize cost of manufacture; materials specifications for ease of manufacturability and good functional results; design for ease of assembly; integrated product development; concurrent engineering practice.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Introduction to microsystem design, modeling and fabrication. Course topics include material properties of Microelectromechanical systems (MEMS), microfabrication technologies, structural behavior, sensing and actuation principles and methods. Emphasis on microsystems design, modeling and simulation including lumped element modeling and finite element analysis. The emerging nano-materials, processes and devices will also be discussed. Student teams design microsystems (sensors, actuators and sensing/control systems) of a variety of types, (optical MEMS, bioMEMS, inertial sensors, etc.) to meet a set of performance specifications using a realistic microfabrication process.
Prerequisites:
ME 345 Modeling and Simulation
(2-3-3)(Lec-Lab-Credit Hours)
Modeling and simulation methodologies including model-block building, logical and data modeling, validation, simulation and trade-off analysis, decision-making, and optimization. Product and assembly modeling; visual simulation; process modeling; production modeling; process plans and resource modeling, entity flow modeling including conveyors, transporters, and guided vehicles; Input and output statistical analysis. Several CAD/CAE simulation software are used.
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Design of Machine Components
(3-0-3)(Lec-Lab-Credit Hours)
Application of the principles of strength of materials to the analysis and design of machine parts. Stress and deflection analysis. Curved bars, multi-support shafts, torsion, cylinders under pressure, thermal stresses, creep, and relaxation, rotating disks, fasteners, springs, bearings, gears, brakes and other machine elements are considered. Failure of structural materials under cyclic stress.
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Microfabrication Techniques
(0-0-3)(Lec-Lab-Credit Hours)
Deals with aspects of the technology of processing procedures involved in the fabrication of microelectronic devices and microelectromechanical systems (MEMS). Students will become familiar with various fabrication techniques used for discrete devices, as well as large-scale integrated thin film circuits. Students will also learn that MEMS are sensors and actuators that are designed using different areas of engineering disciplines, and they are constructed using a microlithographically-based manufacturing process in conjunction with both semiconductor and micro-machining microfabrication technologies.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Early history of medical devices and procedures. Minimally invasive and open procedures, techniques and devices, including mechanical and electrosurgical devices. Manufacturing methods for catheters, balloons, plastic and metal components. Design of metal device components including material selection and strength and deformation adequacy using material properties and classical mechanics. Selection of insulation materials for and testing of electrosurgical devices. Selection of medical plastics and design elements. Balloon and catheter burst strength. The Poiseuille flow equation and its use for fluid flow through catheters and vessels. Rapid prototyping techniques, advantages and limitations. Understanding of biocompatibility testing and accelerated age testing using the Arrhenius equation. Device sterilization methods and testing. Developing a project plan from brainstorming to product release for a new device.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Bringing together the creative talents of electrical, mechanical, optical and chemical engineers, materials specialists, clinical-laboratory scientists, and physicians, the science of biomedical microelectromechanical systems (Bio MEMS) promises to deliver sensitive, selective, fast, low cost, less invasive, and more robust methods for diagnostics, individualized treatment, and novel drug delivery. The goals of this course are to introduce microfabrication, microfluidics, sensors, actuators, drug delivery systems, micro total analysis systems and lab-on-a-chip devices, detection and measurement systems. The main focus is on the fundamental challenges and limitations involved in designing and demonstrating BioMEMS devices.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course offers concurrent design as they apply to quiet product design; vibration and acoustic characteristics in design or products and systems; source-path-receiver model for vibration and acoustics; vibration of single and two degrees of freedom models; features of continuous systems, design for low vibration and vibration control; acoustic plane and spherical waves; acoustical source models; acoustic performance descriptions; design of quiet products and systems; application of computational methods; case studies.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Focus of the course is compliance requirements necessary for Good Manufacturing Practices and Quality Management System. Background includes familiarization of the different categories of medical devices and their manufacturing special requirements. Manufacturing facility requirements are then presented, noting major differences between the various classes of medical devices and also within the classes (e.g. sterility requirements or cleanliness). Included are special requirements for combination products. Regulatory requirements are reviewed. The core of this course is the good engineering practices of facility design. This includes conceptual design, basic engineering, scale up (from lab to manufacturing), procurement, construction, key technologies such as HVAC and utilities requirements, and commissioning, qualification, and validation. Calibration, re-qualification, and maintenance are covered for optimal operational efficiency. Case studies of various manufacturing facilities will be presented.
Prerequisites:
ME 580 Medical Device Design and Technology
(3-0-3)(Lec-Lab-Credit Hours)
Early history of medical devices and procedures. Minimally invasive and open procedures, techniques and devices, including mechanical and electrosurgical devices. Manufacturing methods for catheters, balloons, plastic and metal components. Design of metal device components including material selection and strength and deformation adequacy using material properties and classical mechanics. Selection of insulation materials for and testing of electrosurgical devices. Selection of medical plastics and design elements. Balloon and catheter burst strength. The Poiseuille flow equation and its use for fluid flow through catheters and vessels. Rapid prototyping techniques, advantages and limitations. Understanding of biocompatibility testing and accelerated age testing using the Arrhenius equation. Device sterilization methods and testing. Developing a project plan from brainstorming to product release for a new device.
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Medical Devices Manufacturing
(3-0-3)(Lec-Lab-Credit Hours)
Technical tools and knowledge required to operate and manage in medical devices manufacturing environment. Current requirements in medical devices regulations, quality systems, and design elements related to manufacturing steps to assure patients health and safety. Requirements concerning selection and supply of raw materials and components for manufacturing; design and qualification of facilities, equipment, and process systems; testing, controls and inspection for compliance. Combination products, validation, external contractors, and case studies. Focus on understanding the principles and methods required in a medical devices manufacturing environment in compliance with GMP regulations.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Review of laws regarding air, water and noise pollution. Role of engineering representing a company or public before government agencies. Permit system, implementation plans, and other legal sanction. Site studies and environmental impact statements.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Problems in mechanical engineering illustrating the application of computer methods to solve roots of algebraic and transcendental equations, system of algebraic equations, curve fitting, numerical integration and differentiation, ordinary and partial differential equations.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Basic principles of heat exchanger design; types of heat exchangers, heat exchanger effectiveness; uncertainty analysis of design and operating parameters; fouling factors; heat transfer augmentation in heat exchangers, two-phase flow, boiling and condensation in heat exchangers, second law of thermodynamics for optimization of heat exchanger design; tube vibrations; codes and standards; individually supervised heat exchanger design project.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Introduction to electronic packaging, thermal characteristics and operating environment of electronic components, reliability; fundamental concepts and basic modes of heat transfer; contact and interface thermal resistance; convective cooling of components and systems, modeling of chips, packages, and printed circuit boards; finned array and heat sink analysis; cold plate and heat exchanger design and analysis; computer-aided design; heat pipes; liquid and immersion cooling.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This is a multi-disciplinary course in the analysis and design of electronic systems. Topics include: introduction to conduction, convection and radiation heat transfer as applied to electronic systems; design of heat sinks for small to large frames; structural analysis including shock and vibration modeling; introduction to electromagnetic shielding; integrated product design for manufacturing, reliability and quality control.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Elements of a robotic/flexible automation system; overview of applications; manipulator anatomy; drive systems; end effectors; sensors; computer control: functions, levels of intelligence, motion control, programming and interfacing to sensors and actuators; applications: identification, hardware selection, work cell design, economics, case studies; design of parts and assemblies; advanced topics.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fundamental laws of the thermodynamics of mechanical, thermal and chemical equilibrium systems; thermodynamic properties of materials including multiphase, multicomponent systems with gaseous chemical reactions; analysis of thermodynamic systems (open and closed) based primarily on the first and second laws.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fundamental modes of heat transfer; conduction, thermal resistance, extended surface with variable cross-section area, application of analytical, numerical and analog methods to the steady and unsteady state; convection, fluid flow and elementary boundary layer theory, dimensional analysis, forced convection for internal and external flows, natural convection, laminar and turbulent flow correlation formulas, condensation and boiling; radiation, physical foundations, radiative properties of surfaces, enclosure radiation, view factors, electrical analogy, gas radiation.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Lumped, integral and differential formulation of general laws, statement of particular laws, initial and boundary conditions; steady one-dimensional conduction, principles of superposition; extended surfaces, power series solutions and Bessel functions, approximate solutions; steady two- and three-dimensional conduction, unsteady problems, separation of variables and orthogonal functions; steady periodic problems and complex temperature; finite difference formulation and numerical solutions; introduction to finite element formulation of conduction problems.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Place of convective heat transfer among engineering sciences, concepts related to thermodynamics, mechanics and deformable moving media. General principles: conservation of mass, balance of linear momentum, conservation of total energy, increase of entropy; formulation of parallel flows, buoyancy driven flows, thermal boundary layers, fully developed heat transfer in pipes and channels, heat transfer correlations for turbulent flows.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Courses on advanced topics of current interest in Mechanical Engineering, including but not limited to any of the following: steam turbines, random vibrations, stability of nonlinear mechanical systems, stress waves in solids, lubrication theory, radiative heat transfer, mechanism design, buckling of metal structures.
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| | | (0-0-3) (Lec-Lab-Credit Hours)
Fundamentals of wave motion, acoustical plane waves, spherical waves, transmission of sound through media, radiation of sound, acoustical source mechanisms, absorption of sound, principles of underwater acoustics, ultrasonics.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course will concentrate on a group of current topics in air pollution technology. For example: public health aspects of air pollution, incineration, fugitive emissions, modeling and prediction of near-field dispersion, air quality measurement, aerosols, odor control, current industrial applications and practice. The course will extend coverage of air pollution topics into additional areas not covered in conventional courses and provide flexibility for new, timely subjects.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Introduction to fluid mechanics and heat transfer; design of piping systems; selection of pumps; analysis and design of heat exchangers; modeling and simulation of thermal systems; system optimization and design; case studies.
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| | (0-0-3) (Lec-Lab-Credit Hours)
The structures of flames in a variety of practical combustion devices (e.g., coal and oil burners, reciprocating engines, etc.) are described theoretically and compared to experimental results. Based on this understanding, the basic "tradeoff" between efficiency and pollutant emissions is established.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Introduction to state space concepts; state space description of physical systems such as electrical, mechanical, electromechanical, thermal, hydraulic, pneumatic, aerospace, etc. systems. Eigenvalues, eigenvectors and other topics in linear algebra, modal decomposition and other coordination transformations. Relationship between classical transfer function methods and modern state methods. Analysis of linear continuous and discrete time linear systems, solution by state transition matrix, control ability, observability and stability properties; synthesis of linear feedback control systems via pole assignment and stabilizability and performance index minimization. Brief introduction to optimal control, estimation and identification. Alternate years.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Introduction to vector stochastic processes; response of linear differential systems to white noise, state estimation of linear stochastic systems by Kalman Filtering, combined optimal control and estimation of continuous time Linear Quadratic Gaussian (LQG) regulators; optimization techniques for dynamic systems using nonlinear programming methods and variational calculus; optimal control of linear and nonlinear systems by Pontryagin’s maximum principle and Hamilton-Jacobi-Bellman theory of dynamic programming; computational methods in optimal control and estimation; applications to aerospace, mechanical electrical and other physical systems.
Prerequisites:
ME 621
(0-0-3)(Lec-Lab-Credit Hours)
Introduction to state space concepts; state space description of physical systems such as electrical, mechanical, electromechanical, thermal, hydraulic, pneumatic, aerospace, etc. systems. Eigenvalues, eigenvectors and other topics in linear algebra, modal decomposition and other coordination transformations. Relationship between classical transfer function methods and modern state methods. Analysis of linear continuous and discrete time linear systems, solution by state transition matrix, control ability, observability and stability properties; synthesis of linear feedback control systems via pole assignment and stabilizability and performance index minimization. Brief introduction to optimal control, estimation and identification. Alternate years.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course focuses on the application of advanced process control techniques in pharmaceutical and petrochemical industries. Among the topics considered are bioreactor and polymerization reactor modeling, biosensors, state and parameter estimation techniques, optimization of reactor productivity for batch, fed-batch and continuous operations, and expert systems approaches to monitoring and control. An overview of a complete automation project of a pharmaceutical plant, from design to start-up, will be discussed, including process control issues and coordination of interdisciplinary requirements and regulations. Guest speakers from local industry will present current technological trends. A background in differential equations, biochemical engineering and basic process control is required.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course spans the background, fundamental principles and elements of hardware/software required for design and prototyping intelligent mechatronic systems and fundamentals for developing knowledge-bases, tools and methods that contribute to the intelligent response of system to expected and unexpected stimuli. The course introduces hardware and software development system architectures, interfacing to the analog world with sensors, response synthesis and actuation. Model-based, learning-based and knowledge-based algorithms that enable intelligent response synthesis by the system will be studied. Prerequisite: ME522 Mechatronics I (Preferred but not Required).
Prerequisites:
ME 522
(0-0-3)(Lec-Lab-Credit Hours)
This course introduces principles of mechatronics to integrate mechanical, electronic/electrical, and control/computer/software components for motion control systems. Electromechanical components and integration concepts include: machine construction and control concepts, control modes (open/closed loop, servo, and process control) and motion profiles, motion drivers and actuators (AC drives, motors, gearing, servo and stepper motors), PLC control and programming (ladder and Boolean and combinatorial logic interfaces), microprocessor/computer based (logic, operating systems, SCADA, and HMI), field devices, signal conditioning, and communication (I/O hardware and management, vision systems, protocols, and programming languages), and introduction to system integration.Course includes hands-on lab work, small design projects, case studies, and industry guest lectures.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Gas turbine cycles, theoretical and practical; cycles with intercooling, recuperation and reheat; the closed cycle turbine; cycles on the H-S charts; heat exchangers; intercoolers; compressor and turbine types; turbine cooling; aircraft gas turbines; turboprops and turbojets; afterburners and wet compression for jets; industrial gas turbines; nuclear fuel applications; regulation of gas turbines.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fundamental theory of turbomachines for incompressible fluids; Euler theorem; velocity diagrams; hydraulic turbines and pumps; aerodynamic theory of turbomachines; two-dimensional and three-dimensional flow of compressible fluids; boundary layer considerations in turbomachines, loading limits and design corrections; free vortex, solid rotation, and other types of radical equilibrium; axial, radial and mixed flow machines; transonic and supersonic compressors; similarity laws; characteristic curves; off design conditions and regulation.
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| | (0-0-3) (Lec-Lab-Credit Hours)
The course covers oral solid dosage (OSD) manufacturing and packaging in the pharmaceutical industry. Production unit operations include blending, granulation, size reduction, drying, compressing, and coating for tablets, as well as capsule filling. Packaging aspects reviewed include requirements for primary and secondary containers and labeling, package testing. The course emphasizes design, scale-up, trouble-shooting, validation, and operation of typical OSD manufacturing and packaging facilities, including equipment, material flow, utilities, and quality assurance. Topics related to cGMP, process validation, manufacturing and packaging documentation, QA and QC in OSD manufacturing will be presented. The term project required for this course involves conceptual design of a contract manufacturing and packaging facility for OSD products, including equipment selection, development of the process flow diagrams, room layouts and other design elements, as well as preparation of Standard Operating Procedures for various unit operations.
Prerequisites:
CHE 530
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety, & environment concepts, and regulatory issues.
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(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Vibration of linear system with one degree of freedom; multidegree of freedom systems; vibration control; Lagrange’s equation; theory of small vibrations; matrix methods; normal coordinates; approximate methods of Holzer and Rayleigh-Stodola.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Vibration of continuous systems; theory and application using finite element method; nonlinear systems; transient response, shock and impact phenomena; random vibrations.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course emphasizes the development of modeling and simulation concepts and analysis skills necessary to design, program, implement and use computers to solve complex systems/products analysis problems. The key emphasis is on problem formulation, model building, data analysis, solution techniques and evaluation of alternative designs/processes in complex systems/products. Overview of modeling techniques and methods used in decision analysis, including multi-attribute utility models, decision trees and optimization methods are discussed.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This project-based course exposes students to tools and methodologies useful for forming and managing an effective engineering design team in a business environment. Topis covered will include: personality profiles for creating teams with balanced diversity; computational tools for project coordination and management; real-time electronic documentation as a critical design process variable; and methods for refining project requirements to ensure that the team addresses the right problem with the right solution.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course will introduce students to the modeling and simulation applications in the pharmaceutical manufacturing. Learn the basics of discreet event simulation and use commercially available software to develop models of various manufacturing and service systems. Approaches to the development of conceptual and computer models, data collection and analysis, model verification and validation, simulation output analysis are discussed. Learn how to model chemical, biochemical and separation processes in pharmaceutical manufacturing using process simulation software. Develop material balances, stream reports, operations and equipment Gantt charts, conduct process debottlenecking and cost analysis.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Introduction to the application of engineering analysis techniques and mathematical principles of mechanical engineering. In addition to analytical and computational techniques, case studies and project-based examples will be given.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Topics included are applications of complex variables, linear algebra, ordinary and partial differential equations, numerical analysis and other mathematical methods applied to mechanical engineering.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fundamentals of Computer-Integrated Design and Manufacturing addresses design and manufacturing as a global closed-loop system comprising four major functions: marketing, part design, process specifications and production. The emphasis of this course is on the computer integration of the islands of automation created by isolated computerized systems within these major functions in an enterprise.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Introduction to the design and control of production systems using mathematical, computational and other modern techniques. Topics that will be investigated include forecasting, inventory systems, aggregate production planning, material requirements planning, project planning, job sequencing, operations scheduling and reliability, in addition to capacity, flexibility and economic analysis of flexible manufacturing systems.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Proven techniques and creative tools presented for design,
development, and delivery of biopharmaceutical manufacturing facilities.
Includes skills and knowledge in bioprocessing requirements, equipment and facility requirements, project management as well as regulatory guidelines and big-picture drug development. Also corporate capital management processes to functionally meet corporate requirements from pre-clinical to commercial scale of operations, qualifications to pass regulatory inspections, achieving faster time-to-market, but not breaking the corporate treasury bank. Course also explores trends in new equipment technology such as disposables or single-use product, new design concepts in aseptic manufacturing, barrier and isolation
technologies, new FDA thinking in risk-based compliance approach, process
analytical technology, capital project planning and management.
Prerequisites:
ME 530
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety and environment concepts, and regulatory issues.
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(3-0-3)(Lec-Lab-Credit Hours)
Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities. Issues related to process flow, material flow, and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer. Bio-safety levels. Developing effective written procedures, so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do. Levels I, II, and III policies. Clinical phases I, II, III and their effect on plant design. Defending products against contamination. Building quality into products.
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(0-0-3)(Lec-Lab-Credit Hours)
This course provides a broad overview of topics related to the design and operations of modern biopharmaceutical facilities. It covers process, utilities, and facility design issues, and encompasses all major manufacturing areas, such as fermentation, harvest, primary and final purification, media and buffer preparation, equipment cleaning and sterilization, and critical process utilities. Unit operations include cell culture, centrifugation, conventional and tangential flow filtration, chromatography, solution preparation, and bulk filling. Application of current Good Manufacturing Practices and Bioprocessing Equipment Standards (BPE-2002) will be discussed.
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(3-0-3)(Lec-Lab-Credit Hours)
This course deals with the problems of managing a project, which is defined as a temporary organization of human and non-human resources, within a permanent organization, for the purpose of achieving a specific objective; both operational and conceptual issues will be considered. Operational issues include definition, planning, implementation, control and evaluation of the project. Conceptual issues include project management vs. hierarchical management, matrix organization, project authority, motivation and morale. Cases will be used to illustrate problems in project management and how to resolve them.
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| | (0-0-3) (Lec-Lab-Credit Hours)
A basically physical approach to the study of continuum
mechanics; Cartesian tensor notation, the concepts of stress, deformation and flow in continuous media; conservation equations and constitutive relations developed and used to establish mathematical models for the deformation of elastic, plastic and viscoelastic solids; the flow of Newtonian, and non-Newtonian fluids.
Prerequisites:
ME 658
(0-0-3)(Lec-Lab-Credit Hours)
Torsion, bending and shear of beams with solid or thin-walled sections; curved beams; shrink fits, pressure vessels, spinning discs; experimental techniques, strain rosettes; buckling of bars, beams, rings, boiler tubes; thermal stress problems; introduction to theory of elasticity.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Water and steam systems: water used as excipient, cleaning agent or product dilutent, and water quality selection criteria; generation, storage, and distribution systems; bio-burden control; USP PWS (purified water systems) and USP WFI (water for injection) systems; engineering considerations, including specification, design, installation, validation, operation, testing, and maintenance; common unit operations, including deionization, reverse osmosis, distillation, ultrafiltration, and ozonation systems; process considerations, including pretreatment, storage and distribution, materials of construction, microbial control pyrogen control, and system maintenance; FDA requirements; clean-in-place systems; and steam generation and distribution systems.
Prerequisites:
CHE 530
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety, & environment concepts, and regulatory issues.
Close |
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fundamentals of Newtonian mechanics; principle of virtual work; d’Alembert’s Principle; Hamilton’s Principle; Lagrange’s equations; Hamilton’s equations; motion relative to moving reference frames; rigid-body dynamics; Hamilton-Jacobi equation; applications.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course is intended to give the student an in-depth appreciation of contemporary and emerging manufacturing methods in use in a wide variety of durable and consumable goods industries. The initial emphasis will be on the mechanics of material removal/material flows and processing. Next, contemporary net-shape composite manufacturing processing techniques, equipment and testing methods will be presented and demonstrated whenever possible. The course will conclude with hands-on manufacturing projects accomplished in teams, focusing on the study of the field of manufacturing processes from a mechanical engineering design standpoint. Topics will include optimum mechanical design for cost, weight, stress, energy and tolerances.
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| | (0-0-3) (Lec-Lab-Credit Hours)
The objective of this course is to provide the student
with the engineering tools and knowledge required to design and deploy Process Analytical Technology (PAT) solutions in pharmaceutical drug
substance and drug product manufacturing. This course provides in-depth coverage of current PAT technologies. At the conclusion of this course, students will understand the engineering theory, principles, and mathematics required to design and deploy these technologies in a pharmaceutical manufacturing environment in compliance with FDA and international regulations. Topics covered include: analyzer
types and principals of operation, chemometric techniques
for multivariate analysis, multivariate process models, dynamic process
control, and advanced pattern recognition techniques. In addition, the course will cover the technical aspects of real-time data management and 21 CFR Part 11 compliance.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Robot path control, dynamics of robot systems, mechanical drive systems; microcomputers, computational architectures, digital control of manipulators; sensors, force and compliance control, vision systems, tactile sensing, range finding and navigation; intelligence and task planning.
Prerequisites:
ME 598
(0-0-3)(Lec-Lab-Credit Hours)
Elements of a robotic/flexible automation system; overview of applications; manipulator anatomy; drive systems; end effectors; sensors; computer control: functions, levels of intelligence, motion control, programming and interfacing to sensors and actuators; applications: identification, hardware selection, work cell design, economics, case studies; design of parts and assemblies; advanced topics.
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Close |
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| | (0-0-3) (Lec-Lab-Credit Hours)
Torsion, bending and shear of beams with solid or thin-walled sections; curved beams; shrink fits, pressure vessels, spinning discs; experimental techniques, strain rosettes; buckling of bars, beams, rings, boiler tubes; thermal stress problems; introduction to theory of elasticity.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course deals with methodologies for designing modern structures and other performance-driven products. The course entails aspects of computer-aided engineering (CAE), integration of CAE and design, methodologies for failure and stability analysis, designing with anisotropic materials such as composites, modeling process-material-performance relationships and the use of such models in design, multidisciplinary design optimization and integrated product design automation.
Prerequisites:
ME 641
(0-0-3)(Lec-Lab-Credit Hours)
Introduction to the application of engineering analysis techniques and mathematical principles of mechanical engineering. In addition to analytical and computational techniques, case studies and project-based examples will be given.
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(0-0-3)(Lec-Lab-Credit Hours)
Torsion, bending and shear of beams with solid or thin-walled sections; curved beams; shrink fits, pressure vessels, spinning discs; experimental techniques, strain rosettes; buckling of bars, beams, rings, boiler tubes; thermal stress problems; introduction to theory of elasticity.
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(0-0-3)(Lec-Lab-Credit Hours)
Stress analysis of axisymmetric bodies; beams on elastic foundations; introduction to plate theory and fracture mechanics; plasticity; creep and fatigue of engineering materials.
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(0-0-3)(Lec-Lab-Credit Hours)
Development of the fundamental equations of finite-element theory, using the matrix displacement approach. Detailed case studies of one-dimensional (truss and beam), two-dimensional (plane stress/strain and axisymmetric solid), k and plate-bending elements are explained. Applications include interactive model building and solutions.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Technical tools and knowledge required to operate and manage in medical devices manufacturing environment. Current requirements in medical devices regulations, quality systems, and design elements related to manufacturing steps to assure patients health and safety. Requirements concerning selection and supply of raw materials and components for manufacturing; design and qualification of facilities, equipment, and process systems; testing, controls and inspection for compliance. Combination products, validation, external contractors, and case studies. Focus on understanding the principles and methods required in a medical devices manufacturing environment in compliance with GMP regulations.
Prerequisites:
ME 530
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety and environment concepts, and regulatory issues.
Close |
(3-0-3)(Lec-Lab-Credit Hours)
Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities. Issues related to process flow, material flow, and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer. Bio-safety levels. Developing effective written procedures, so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do. Levels I, II, and III policies. Clinical phases I, II, III and their effect on plant design. Defending products against contamination. Building quality into products.
Close |
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| | (0-0-3) (Lec-Lab-Credit Hours)
Stress analysis of axisymmetric bodies; beams on elastic foundations; introduction to plate theory and fracture mechanics; plasticity; creep and fatigue of engineering materials.
Prerequisites:
ME 641
(0-0-3)(Lec-Lab-Credit Hours)
Introduction to the application of engineering analysis techniques and mathematical principles of mechanical engineering. In addition to analytical and computational techniques, case studies and project-based examples will be given.
Close |
(0-0-3)(Lec-Lab-Credit Hours)
Torsion, bending and shear of beams with solid or thin-walled sections; curved beams; shrink fits, pressure vessels, spinning discs; experimental techniques, strain rosettes; buckling of bars, beams, rings, boiler tubes; thermal stress problems; introduction to theory of elasticity.
Close |
(0-0-3)(Lec-Lab-Credit Hours)
Development of the fundamental equations of finite-element theory, using the matrix displacement approach. Detailed case studies of one-dimensional (truss and beam), two-dimensional (plane stress/strain and axisymmetric solid), k and plate-bending elements are explained. Applications include interactive model building and solutions.
Close |
Close |
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| | (0-0-3) (Lec-Lab-Credit Hours)
Development of the fundamental equations of finite-element theory, using the matrix displacement approach. Detailed case studies of one-dimensional (truss and beam), two-dimensional (plane stress/strain and axisymmetric solid), k and plate-bending elements are explained. Applications include interactive model building and solutions.
Prerequisites:
ME 641
(0-0-3)(Lec-Lab-Credit Hours)
Introduction to the application of engineering analysis techniques and mathematical principles of mechanical engineering. In addition to analytical and computational techniques, case studies and project-based examples will be given.
Close |
(0-0-3)(Lec-Lab-Credit Hours)
Torsion, bending and shear of beams with solid or thin-walled sections; curved beams; shrink fits, pressure vessels, spinning discs; experimental techniques, strain rosettes; buckling of bars, beams, rings, boiler tubes; thermal stress problems; introduction to theory of elasticity.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course covers the development and application of
finite-element theory to (1) fluid structure interaction, (2) large deformations of incompressible material, (3) electromechanical coupling problems, and (4) nonlinear heat transfer with phase change.
Prerequisites:
ME 663
(0-0-3)(Lec-Lab-Credit Hours)
Development of the fundamental equations of finite-element theory, using the matrix displacement approach. Detailed case studies of one-dimensional (truss and beam), two-dimensional (plane stress/strain and axisymmetric solid), k and plate-bending elements are explained. Applications include interactive model building and solutions.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course addresses methodologies and tools to define product development phases and also provides experience working in teams to design high-quality competitive products. Primary goals are to improve ability to reason about design, material and process alternatives and apply modeling techniques appropriate for different development phases, as well as development of competitive product design and plans for its manufacture along with facilities layout simulation, testing and service. Topics covered are: user requirements gathering, quality function deployment (QFD), design for assembly, design for materials and manufacturing processes, optimizing the design for cost and producibility, manufacturing process specifications and planning, process control and optimization, SPC and six sigma process, tolerance analysis, flexible manufacturing, product testing and rapid prototyping.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fracture energy, linear elastic fracture mechanics, stress intensity factor, crack opening displacement (COD), fracture mechanics in design, elastic plastic fracture mechanics, numerical methods in fracture mechanics, introduction to fatigue, fatigue crack initiation, fatigue crack propagation.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fundamentals of elasticity and plasticity, yield criteria, plastic stress-strain relations, theories of work hardening. Extremum principles. Application to problems of bending, torsion, plane stress and plane strain. Slip line and limit analysis.
Prerequisites:
ME 658
(0-0-3)(Lec-Lab-Credit Hours)
Torsion, bending and shear of beams with solid or thin-walled sections; curved beams; shrink fits, pressure vessels, spinning discs; experimental techniques, strain rosettes; buckling of bars, beams, rings, boiler tubes; thermal stress problems; introduction to theory of elasticity.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Review of two-dimensional thin airfoil theory, thin air foils in unsteady motion, transient harmonic time dependence; fundamentals of vibration of continuous and lumped systems; aeroelastic vibrations, single degree of freedom flutter, stall flutter, coupled bending-torsion flutter; multiple degrees of freedom, cascades, turbomachines.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Stress in a continuum; kinematics of fluid motion; rate of strain and vorticity; relation between stress and rate of strain; the Navier-Stokes equations; inviscid flow; stream function, velocity potential and circulation; Kelvin and Helmholtz theorems; two-dimensional incompressible flows; the Kuta-Joukowski theorem; introduction to compressible flows, boundary layers and drag-on bodies.
Prerequisites:
ME 641
(0-0-3)(Lec-Lab-Credit Hours)
Introduction to the application of engineering analysis techniques and mathematical principles of mechanical engineering. In addition to analytical and computational techniques, case studies and project-based examples will be given.
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| | (0-0-2) (Lec-Lab-Credit Hours)
Computational techniques for solving problems in fluid flow and heat transfer; review of governing equations for fluid flow, special topics in numerical analysis, algorithms for incompressible flow, treatment of complicated geometrical constraints.
Prerequisites:
ME 594
(0-0-3)(Lec-Lab-Credit Hours)
Problems in mechanical engineering illustrating the application of computer methods to solve roots of algebraic and transcendental equations, system of algebraic equations, curve fitting, numerical integration and differentiation, ordinary and partial differential equations.
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(0-0-3)(Lec-Lab-Credit Hours)
Stress in a continuum; kinematics of fluid motion; rate of strain and vorticity; relation between stress and rate of strain; the Navier-Stokes equations; inviscid flow; stream function, velocity potential and circulation; Kelvin and Helmholtz theorems; two-dimensional incompressible flows; the Kuta-Joukowski theorem; introduction to compressible flows, boundary layers and drag-on bodies.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fundamental equations of viscous flow; solutions of the Newtonian viscous flow equations; laminar boundary layers; stability of laminar flows; fluid turbulence and approximate solutions.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Pressure wave propagation; one-dimensional flow; isentropic flow, adiabatic flow, diabatic flow, real and ideal flow in nozzles and diffusers; normal shock, Rankine-Hugoniot relation; flow in constant area ducts with friction; flow in ducts with heating and cooling; Fanno, Rayleigh and Busemann lines; generalized one-dimensional continuous flow; unsteady one-dimensional flow; method of characteristics.
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| | (3-0-3) (Lec-Lab-Credit Hours)
As an introduction to micro/nano fluidics, course topics include basic fluid mechanical theories, experimental techniques, fabrication techniques and applications of micro/nano fluidics. The theory part will cover continuum fluid mechanics at micro/nano scales, molecular approaches, capillary effects, electrokinetic flows, acoustofluidics and optofluidics. The experimental part will cover micro/nano rheology and particle image velocimetry. The fabrication part will cover materials and machining techniques for micro/nano fluidic devices. The application part will cover micro/nano fluidic devices for flow control, life sciences and chemistry. As a term project, individual students are required to perform a case study for their own selected topic in micro/nano fluidics, to conduct a literature survey/summary and to propose/analyze their own new design idea of a micro/nano fluidic devices by utilizing the knowledge obtained throughout the course.
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| | (0-0-3) (Lec-Lab-Credit Hours)
The goals of this course are to go beyond the introduction stage in Micro-Electro-Mechanical Systems (MEMS) and Nano-Electro-Mechanical Systems (NEMS) to provide students with a strong background in the design and characterization of micro- and nano-scale sensors and actuators with a broad range of applications in VNT-based sensors, actuators and devices, biomedical systems, micro- and nanoscale manipulation, adaptive optics, and microfluidics. The main focus is on the fundamental challenges and limitations involved in designing and demonstrating micro and nano devices and systems. Prerequisites: ME 573, ME 581 or equivalent.
Prerequisites:
ME 573
(0-0-3)(Lec-Lab-Credit Hours)
Introduction to microsystem design, modeling and fabrication. Course topics include material properties of Microelectromechanical systems (MEMS), microfabrication technologies, structural behavior, sensing and actuation principles and methods. Emphasis on microsystems design, modeling and simulation including lumped element modeling and finite element analysis. The emerging nano-materials, processes and devices will also be discussed. Student teams design microsystems (sensors, actuators and sensing/control systems) of a variety of types, (optical MEMS, bioMEMS, inertial sensors, etc.) to meet a set of performance specifications using a realistic microfabrication process.
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(0-0-3)(Lec-Lab-Credit Hours)
Bringing together the creative talents of electrical, mechanical, optical and chemical engineers, materials specialists, clinical-laboratory scientists, and physicians, the science of biomedical microelectromechanical systems (Bio MEMS) promises to deliver sensitive, selective, fast, low cost, less invasive, and more robust methods for diagnostics, individualized treatment, and novel drug delivery. The goals of this course are to introduce microfabrication, microfluidics, sensors, actuators, drug delivery systems, micro total analysis systems and lab-on-a-chip devices, detection and measurement systems. The main focus is on the fundamental challenges and limitations involved in designing and demonstrating BioMEMS devices.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course will address the basic concepts of nanoelectronics, including fundamental principles, novel electronic materials, novel fabrication techniques and devices. In particular, it will focus on novel nanofabrication techniques including nanolithography, growth and assembly processes, and characterization techniques to validate its fabrication process related to the area of Nanoelectronics. It will also address the technical issues to develop nano-scale elements/devices including single electron devices, carbon nanotubes as interconnects or transistors, nanowires, graphene materials and devices, spintronic applications and eventually complex organic molecules as memory and logic units.
Prerequisites:
ME 573
(0-0-3)(Lec-Lab-Credit Hours)
Introduction to microsystem design, modeling and fabrication. Course topics include material properties of Microelectromechanical systems (MEMS), microfabrication technologies, structural behavior, sensing and actuation principles and methods. Emphasis on microsystems design, modeling and simulation including lumped element modeling and finite element analysis. The emerging nano-materials, processes and devices will also be discussed. Student teams design microsystems (sensors, actuators and sensing/control systems) of a variety of types, (optical MEMS, bioMEMS, inertial sensors, etc.) to meet a set of performance specifications using a realistic microfabrication process.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fundamental principles of two-phase gas-liquid flow and associated heat transfer as applied to power, chemical, petrochemical, and process industries; topics include: flow patterns, homogeneous and separated flow models, two-phase pressure drops, drift-flux model, critical flow, flooding, nucleation theory, pool and flow boiling, critical heat flux, post-critical heat flux, heat transfer, condensation, and thermal-hydraulic instabilities.
Prerequisites:
ME 601
(0-0-3)(Lec-Lab-Credit Hours)
Fundamental laws of the thermodynamics of mechanical, thermal and chemical equilibrium systems; thermodynamic properties of materials including multiphase, multicomponent systems with gaseous chemical reactions; analysis of thermodynamic systems (open and closed) based primarily on the first and second laws.
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(0-0-3)(Lec-Lab-Credit Hours)
Stress in a continuum; kinematics of fluid motion; rate of strain and vorticity; relation between stress and rate of strain; the Navier-Stokes equations; inviscid flow; stream function, velocity potential and circulation; Kelvin and Helmholtz theorems; two-dimensional incompressible flows; the Kuta-Joukowski theorem; introduction to compressible flows, boundary layers and drag-on bodies.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Presentations and discussions by advanced graduate students on selected topics.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Special problem intended for students pursuing Curricular
Practical Training.
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| | (0-0-3) (Lec-Lab-Credit Hours)
3 credits for the degree of Master of Engineering (Mechanical).
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| | (0-0-3) (Lec-Lab-Credit Hours)
3 credits for the degree of Doctor of Philosophy.
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| | (0-0-3) (Lec-Lab-Credit Hours)
3 credits for the degree of Mechanical Engineer.
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| | (0-0-3) (Lec-Lab-Credit Hours)
A participating seminar on topics of current interest and
importance in Mechanical Engineering.
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| | (0-0-6) (Lec-Lab-Credit Hours)
For the degree of Master of Engineering (Mechanical). Six credits with advisor approval.
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| | (0-0-12) (Lec-Lab-Credit Hours)
Design project for the degree of Mechanical Engineer. 12 credits with advisor approval.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Original work, which may serve as the basis for the dissertation, required for the degree of Doctor of Philosophy. Hours and credits to be arranged.
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| Integrated Product Development |
| | (0-0-3) (Lec-Lab-Credit Hours)
The first IPD course addresses methodologies and tools to define product development phases and also provides experience working in teams to design high-quality competitive products. Primary goals are to improve ability to reason about design, material, and process alternatives and apply modeling techniques appropriate for different development phases. Topics covered are: user requirements gathering, quality function deployment (QFD), design for assembly, design for materials and manufacturing processes, and optimizing the design for cost and producibility.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course builds on the product definition and development processes. It focuses on the implementation of competitive product design and plans for its manufacture along with facilities layout simulation, testing, and service. Project deliverables are comprehensive product, process and testing specifications. Topics include: manufacturing process specifications and planning, process control and optimization, SPC and six sigma process, tolerance analysis, flexible manufacturing, product testing, and rapid prototyping.
Prerequisites:
IPD 601 Integrated Product Development I
(0-0-3)(Lec-Lab-Credit Hours)
The first IPD course addresses methodologies and tools to define product development phases and also provides experience working in teams to design high-quality competitive products. Primary goals are to improve ability to reason about design, material, and process alternatives and apply modeling techniques appropriate for different development phases. Topics covered are: user requirements gathering, quality function deployment (QFD), design for assembly, design for materials and manufacturing processes, and optimizing the design for cost and producibility.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course emphasizes the development of modeling and simulation concepts and analysis skills necessary to design, program, implement and use computers to solve complex systems/products analysis problems. The key emphasis is on problem formulation, model building, data analysis, solution techniques and evaluation of alternative designs/processes in complex systems/products. Overview of modeling techniques and methods used in decision analysis, including multi-attribute utility models, decision trees, and optimization methods are discussed.
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| | | (3-0-3) (Lec-Lab-Credit Hours)
This project-based course exposes students to tools and methodologies useful for forming and managing an effective engineering design team in a business environment. Topics covered will include: personality profiles for creating teams with balanced diversity; computational tools for project coordination and management; real time electronic documentation as a critical design process variable; and methods for refining project requirements to ensure that the team addresses the right problem with the right solution.
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| | (0-0-3) (Lec-Lab-Credit Hours)
A participating seminar on topics of current interest and importance in
Integrated Product Development.
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| Product Architecture and Engineering |
| | (0-0-3) (Lec-Lab-Credit Hours)
The study of the Creative Form in the digital environment;
Digitally initiated formal studies (Maya, Rhino, 3D Studio); Reverse Engineering methodologies utilizing 3D Scanning and Touch Probe technologies; Advanced Geometric modeling (Catia, Pro-Engineer, SolidWorks); Design Tables, Parametric Variations; Material Systems Integration; Form Function Integration through simulation methodologies (Catia, Cosmoworks); Visualization and Virtual Reality (Adobe Creative Suite,Eon Studio).
Laboratory Exercises: Digitally initiated formal studies (Maya, Rhino, 3DStudio); Reverse Engineering methodologies utilizing 3D Scanning
and Touch Probe technologies; Advanced Geometric modeling (Catia, Pro-Engineer, SolidWorks);Form Function Integration through simulation methodologies(Catia, Cosmoworks); Visualization and Virtual Reality (Adobe Creative Suite,Eon Studio )
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| | (0-0-3) (Lec-Lab-Credit Hours)
Introduction to the study of expressive form with integrated production methodologies:
Integration of the Production environment methodologies into formal studies Production Methods (Machining, Net-Shape Processes); Computer Controlled Machining Processes Applications(Catia, Master Cam); Net Shape Process Applications; Surface shaping and manipulation (Large Format CNC Laser
Cutting applications); Rapid Prototyping Applications (Z Corp, Stereo
Lithography)
Laboratory exercises: Production Methods (Machining, Net-Shape Processes); Computer Controlled Machining Processes Applications(Catia, Master Cam);Surface shaping and manipulation (Large Format CNC LaserCutting applications); Rapid Prototyping Applications (Z Corp, Stereo
Lithography) Design and
Architecture:
Interactive Design and Scripting (Ceiling mounted cameras,
Macromedia Suite,Projection Systems); Information Visualization (integration of video, photography, scanning, motion and projection);
Non-linear video editing; Physical Computing (studies of scripting languages and its applications)
Laboratory exercises:
Macromedia Suite: Flash, Action Scripting
Final Cut Pro: Non-Linear video editing
3d Laser Scanning: Motion Scanning
3d Laser Scanning: Touch Probe Technologies
Blob Tracking: Projection Systems and its applications
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| | | (0-0-3) (Lec-Lab-Credit Hours)
Performative Environments explores the potentials of interactive digital media as an integral part of architectural spaces. The seminar
examines series of case studies and looks critically into body-centric
interactivity, intelligent environments and narrative spaces. Performative Environments integrates interactivity, physical computing, design and the production environments to develop dynamic media and physical installations. Integration of both Physical and Digital Design
methodologies; Embedded scripting methodologies (sensors, actuators and scripting integration);
Integrated physical production methodologies
Laboratory exercises:
Macromedia Suite: Flash, Action Scripting;
Final Cut Pro: Non-Linear video editing;
3d Laser Scanning: Motion Scanning;
3d Laser Scanning: Touch Probe Technologies;
Blob Tracking: Projection Systems and its applications
Prerequisites:
PAE 630
(0-0-3)(Lec-Lab-Credit Hours)
Introduction to the study of expressive form with integrated production methodologies:
Integration of the Production environment methodologies into formal studies Production Methods (Machining, Net-Shape Processes); Computer Controlled Machining Processes Applications(Catia, Master Cam); Net Shape Process Applications; Surface shaping and manipulation (Large Format CNC Laser
Cutting applications); Rapid Prototyping Applications (Z Corp, Stereo
Lithography)
Laboratory exercises: Production Methods (Machining, Net-Shape Processes); Computer Controlled Machining Processes Applications(Catia, Master Cam);Surface shaping and manipulation (Large Format CNC LaserCutting applications); Rapid Prototyping Applications (Z Corp, Stereo
Lithography) Design and
Architecture:
Interactive Design and Scripting (Ceiling mounted cameras,
Macromedia Suite,Projection Systems); Information Visualization (integration of video, photography, scanning, motion and projection);
Non-linear video editing; Physical Computing (studies of scripting languages and its applications)
Laboratory exercises:
Macromedia Suite: Flash, Action Scripting
Final Cut Pro: Non-Linear video editing
3d Laser Scanning: Motion Scanning
3d Laser Scanning: Touch Probe Technologies
Blob Tracking: Projection Systems and its applications
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| | (0-0-3) (Lec-Lab-Credit Hours)
Issues of context, methodology, program and fabrication are explored for their possible interrelated meanings and influences on the making of expressive form. This design studio, which is required for the Masters degree, is offered by individual instructors to students who have successfully completed the core curriculum.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Under the supervision of a faculty advisor, students are responsible for the preparation and completion of an independent thesis project.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Description of simple physical models which account for electrical conductivity and thermal properties of solids. Basic crystal lattice structures, X-ray diffraction and dispersion curves for phonons and electrons in reciprocal space. Energy bands, Fermi surfaces, metals, insulators, semiconductors, superconductivity and ferromagnetism. Fall semester. Typical text: Kittel, Introduction to Solid State Physics.
Prerequisites:
PEP 242 Modern Physics
(3-0-3)(Lec-Lab-Credit Hours)
Simple harmonic motion, oscillations and pendulums; Fourier analysis; wave properties; wave-particle dualism; the Schrödinger equation and its interpretation; wave functions; the Heisenberg uncertainty principle; quantum mechanical tunneling and application; quantum mechanics of a particle in a "box," the hydrogen atom; electronic spin; properties of many electron atoms; atomic spectra; principles of lasers and applications; electrons in solids; conductors and semiconductors; the n-p junction and the transistor; properties of atomic nuclei; radioactivity; fusion and fission. Spring Semester.
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Electromagnetism
(3-0-3)(Lec-Lab-Credit Hours)
Electrostatics; Coulomb-Gauss law; Poisson-Laplace equations; boundary value problems; image techniques;dielectric media; magnetostatics; multipole expansion; electromagnetic energy; electromagnetic induction; Maxwell’s equations; electromagnetic waves, radiation, waves in bounded regions, wave equations and retarded solutions; simple dipole antenna radiation theory; transformation law of electromagnetic fields. Spring semester. Typical text: Reitz, Milford and Christy, Foundation of Electromagnetic Theory.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Lectures, demonstrations and laboratory experiments, selected from among the following topics, depending on student interest: vacuum technology; thin-film preparation; scanning electron microscopy; infrared spectroscopy, ellipsometry: electron spectroscopies-Auger,
photoelectron, LEED; ion spectroscopies SIMS, IBS, field emission; surface
properties-area, roughness, and surface tension.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course is an introduction to quantum mechanics for students in physics and engineering. Techniques discussed include solutions of the Schrodinger equation in one and three dimensions, and operator and matrix methods. Applications include infinite and finite quantum wells, barrier penetration and scattering in one dimension, the harmonic oscillator, angular momentum, central force problems, including the hydrogen atom, and spin. Fall semester. Typical text: Quantum Physics by Gasiorowicz
Prerequisites:
MA 221 Differential Equations
(4-0-4)(Lec-Lab-Credit Hours)
Ordinary differential equations of first and second order, homogeneous and non-homogeneous equations; improper integrals, Laplace transforms; review of infinite series, series solutions of ordinary differential equations near an ordinary point; boundary-value problems; orthogonal functions; Fourier series; separation of variables for partial differential equations.
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Modern Physics
(3-0-3)(Lec-Lab-Credit Hours)
Simple harmonic motion, oscillations and pendulums; Fourier analysis; wave properties; wave-particle dualism; the Schrödinger equation and its interpretation; wave functions; the Heisenberg uncertainty principle; quantum mechanical tunneling and application; quantum mechanics of a particle in a "box," the hydrogen atom; electronic spin; properties of many electron atoms; atomic spectra; principles of lasers and applications; electrons in solids; conductors and semiconductors; the n-p junction and the transistor; properties of atomic nuclei; radioactivity; fusion and fission. Spring Semester.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course is meant as the first in a two-course sequence on non-relativistic quantum mechanics for physics graduate students, with an emphasis on applications to atomic, molecular, and solid state physics. Undergraduate students may take this course as a Technical Elective. Topics covered include: review of Schrödinger wave mechanics; operator algebra, theory of representation, and matrix mechanics; symmetries in quantum mechanics; spin and formal theory of angular momentum, including addition of angular momentum; and approximation methods for stationary problems, including time independent perturbation theory, WKB approximation, and variational methods. Typical text: Quantum Mechanics by E. Merzbacher.
Prerequisites:
PEP 532 PEP 538 Introduction to Mechanics
(3-0-3)(Lec-Lab-Credit Hours)
Particle motion in one dimension. Simple harmonic oscillators. Motion in two and three dimensions, kinematics, work and energy, conservative forces, central forces, and scattering. Systems of particles, linear and angular momentum theorems, collisions, linear spring systems, and normal modes. Lagrange’s equations and applications to simple systems. Introduction to moment of inertia tensor and to Hamilton’s equations.
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Quantum Mechanics and Engineering Applications
(3-0-3)(Lec-Lab-Credit Hours)
This course is meant to serve as an introduction to formal quantum mechanics as well as to apply the basic formalism to several generic and important applications.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Most processes in petroleum and chemical industries utilize catalytic reactions. Moreover, many emerging technologies in the energy sector and in green chemistry for sustainability rely on catalysis. This course provides the fundamentals of synthesis, characterization and testing of catalytic materials with an emphasis on metal and metal oxide nanoparticles, the most widely used class of catalysts. Methodologies for development of molecular-level reaction mechanisms, material structure-activity relations and kinetic models are described. The course is essential for anyone planning a career in the chemical industry. It is recommended for all professionals working with nanoparticles and also with diverse applications where the solid-gas interface is important.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Principles of environmental reactions with emphasis on aquatic chemistry; reaction and phase equilibria; acid-base and carbonate systems; oxidation-reduction; colloids; organic contaminants classes, sources, and fates; groundwater chemistry; and atmospheric chemistry.
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| | (3-0-3) (Lec-Lab-Credit Hours)
A study of the chemical and physical operation involved in treatment of potable water, industrial process water, and wastewater effluent; topics include chemical precipitation, coagulation, flocculation, sedimentation, filtration, disinfection, ion exchange, oxidation, adsorption, flotation, and membrane processes. A physical-chemical treatment plant design project is an integral part of the course. The approach of unit operations and unit processes is stressed.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Deals with aspects of the technology of processing procedures involved in the fabrication of microelectronic devices and microelectromechanical systems (MEMS). Students will become familiar with various fabrication techniques used for discrete devices as well as large-scale integrated thin-film circuits. Students will also learn that MEMS are sensors and actuators that are designed using different areas of engineering disciplines and they are constructed using a microlithographically-based manufacturing process in conjunction with both semiconductor and micromachining microfabrication technologies
Prerequisites:
PEP 507 Introduction to Microelectronics and Photonics
(3-0-3)(Lec-Lab-Credit Hours)
An overview of Microelectronics and Photonics Science and Technology. It provides the student who wishes to specialize in the application, physics or fabrication with the necessary knowledge of how the different aspects are interrelated. It is taught in three modules: design and applications, taught by EE faculty; operation of electronic and photonic devices, taught by Physics faculty; fabrication and reliability, taught by the
Materials faculty.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course deals with the fundamentals and applications of nanoscience and nanotechnology. Size-dependent phenomena, ways and means of designing and synthesizing nanostructures, and cutting-edging applications will be presented in an integrated and interdisciplinary manner.
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| | (3-0-3) (Lec-Lab-Credit Hours)
The goal of this course is to learn the basic concepts commonly utilized in the processing of advanced materials with specific compositions and microstructures. Solid state diffusion mechanisms are described with emphasis on the role of point defects, the mobility of diffusing atoms, and their interactions. Macroscopic diffusion phenomena are analyzed by formulating partial differential equations and presenting their solutions. The relationships between processing and microstructure are developed on the basis of the rate of nucleation and growth processes that occur during condensation, solidification, and precipitation. Diffusionless phase transformations observed in certain metallic and ceramic materials are discussed.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course covers the environmental and health aspects of nanotechnology. It presents an overview of nanotechnology along with characterization and properties of nanomaterials. The course material covers the biotoxicity and ecotoxicity of nanomaterials. A sizable part of the course is devoted to discussions about the application of nanotechnology for environmental remediation along with discussions about fate and transport of nanomaterials. Special emphasis is given to risk assessment and risk management of nanomaterials, ethical and legal aspects of nanotechnology, and nano-industry and nano-entrepreneurship.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course provides an overview and industrial perspectives regarding downstream separation in drug substance development and manufacturing. Basic principles and practical applications of unit operations most commonly employed in the pharmaceutical industry will be discussed, including extraction, absorption, membrane, distillation, crystallization, filtration, and drying. Examples will be discussed to illustrate the intrinsic relationship between process development, equipment selection, and scale-up success.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Lectures, demonstrations, and laboratory experiments, selected from among the following topics, depending on student interest: vacuum technology; thin-film preparation; scanning electron microscopy; infrared spectroscopy and ellipsometry; electron spectroscopy; Auger, photoelectron, and LEED; ion spectroscopies; SIMS, IBS, and field emission; surface properties-area, roughness, and surface tension.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Upon completion of this course, students will be able to demonstrate an understanding of the major classes of engineering materials, their principal properties, and design requirements that serve as both the basis for materials selection, as well as for the ongoing development of new materials. This course is substantially differentiated from introductory materials courses by its very specific focus on materials whose use puts them in direct contact with physiological systems. Thus, the course begins with brief sections on inflammatory response, thrombosis, infection, and device failure. It then concentrates on developing the fundamental materials science and engineering concepts underlying the structure-property relationships in both synthetic and natural polymers, metals and alloys, and ceramics relevant to in vivo medical device technology.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course follows the introductory course and covers advanced topics in the design, modeling, and fabrication of micro and nano electromechanical systems. The materials will be broad and multidisciplinary including: review of micro and nano electromechanical systems, dimensional analysis and scaling, thermal, transport, fluids, microelectronics, feedback control, noise, and electromagnetism at the micro and nanoscales; the modeling of a variety of new MEMS/NEMS devices; and alternative approaches to the continuum mechanics theory. The goal will be achieved through a combination of lectures, case studies, individual homework assignments, and design projects carried out in teams.
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| | | (3-0-3) (Lec-Lab-Credit Hours)
The course covers recent advances in macromolecular science, including polyelectrolytes and water-soluble polymers, synthetic and biological macromolecules at surfaces, self-assembly of synthetic and biological macromolecules, and polymers for biomedical applications.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Topics at the interface of polymer chemistry and biomedical sciences, focusing on areas where polymers have made a particularly strong contribution, such as in biomedical sciences and pharmaceuticals. Synthesis and properties of biopolymers; biomaterials; nanotechnology smart polymers; functional applications in biotechnology, tissue and cell engineering; and biosensors and drug delivery.
Prerequisites:
CH 244
(3-0-3)(Lec-Lab-Credit Hours)
Continuation of CH 243; reactions of aromatic compounds; infrared and nuclear magnetic resonance spectroscopy.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course will provide a comprehensive introduction to the rapidly developing field of nanomedicine and discuss the application of nanoscience and nanotechnology in medicine such as, in diagnosis, imaging and therapy, surgery, and drug delivery.
Prerequisites:
NANO 600
(3-0-3)(Lec-Lab-Credit Hours)
This course deals with the fundamentals and applications of nanoscience and nanotechnology. Size-dependent phenomena, ways and means of designing and synthesizing nanostructures, and cutting-edging applications will be presented in an integrated and interdisciplinary manner.
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| | (3-0-3) (Lec-Lab-Credit Hours)
As an introduction to micro/nano fluidics, course topics include basic fluid mechanical theories, experimental techniques, fabrication techniques and applications of micro/nano fluidics. The theory part will cover continuum fluid mechanics at micro/nano scales, molecular approaches, capillary effects, electrokinetic flows, acoustofluidics and optofluidics. The experimental part will cover micro/nano rheology and particle image velocimetry. The fabrication part will cover materials and machining techniques for micro/nano fluidic devices. The application part will cover micro/nano fluidic devices for flow control, life sciences and chemistry. As a term project, individual students are required to perform a case study for their own selected topic in micro/nano fluidics, to conduct a literature survey/summary and to propose/analyze their own new design idea of a micro/nano fluidic devices by utilizing the knowledge obtained throughout the course.
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| | (3-0-3) (Lec-Lab-Credit Hours)
A survey course covering the chemical, biological and material science aspects of interfacial phenomena. Applications to adhesion, biomembranes, colloidal stability, detergency, lubrication, coatings, fibers and powders - where surface properties play an important role.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course describes the application of nano- and micro-fabrication methods to build tools for exploring the mysteries of biological systems. It is a graduate-level course that will cover the basics of biology and the principles and practice of nano- and microfabrication techniques, with a focus on applications in biomedical and biological research.
Prerequisites:
NANO 600
(3-0-3)(Lec-Lab-Credit Hours)
This course deals with the fundamentals and applications of nanoscience and nanotechnology. Size-dependent phenomena, ways and means of designing and synthesizing nanostructures, and cutting-edging applications will be presented in an integrated and interdisciplinary manner.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This advanced course covers the mechanism and biological role of signal transduction in mammalian cells. Topics included are extracellular regulatory signals, intracellular signal transduction pathways, role of tissue context in the function of cellular regulation, and examples of biological processes controlled by specific cellular signal transduction pathways.
Prerequisites:
CH 381
(3-3-4)(Lec-Lab-Credit Hours)
The structure and function of the cell and its subcellular organelles is studied. Biological macromolecules, enzymes, biomembranes, biological transport, bioenergetics, DNA replication, protein synthesis and secretion, motility, and cancer are covered. Cell biology experiments and interactive computer simulation exercises are conducted in the laboratory.
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(3-3-4)(Lec-Lab-Credit Hours)
Introduction to the study of molecular basis of inheritance. Starts with classical Mendelian genetics and proceeds to the study and function of DNA, gene expression and regulation in prokaryotes and eukaryotes, genome dynamics and the role of genes in development, and cancer. All topics include discussions of current research advances. Accompanied by laboratory section that explores the lecture topics in standard wet laboratory experiments and in computer simulations.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course is intended to introduce the concept of electronic energy band engineering for device applications. Topics to be covered are electronic energy bands, optical properties, electrical transport properties of multiple quantum wells, superlattices, quantum wires, and quantum dots; mesoscopic systems, applications of such structures in various solid state devices, such as high electron mobility, resonant tunneling diodes, and other negative differential conductance devices, double-heterojunction injection lasers, superlattice-based infrared detectors, electron-wave devices (wave guides, couplers, switching devices), and other novel concepts and ideas made possible by nano-fabrication technology. Fall semester. Typical text: M. Jaros, Physics and Applications of Semiconductor Microstructures; G. Bastard, Wave Mechanics Applied to Semiconductor Heterostructures.
Prerequisites:
PEP 503
(3-0-3)(Lec-Lab-Credit Hours)
Description of simple physical models which account for electrical conductivity and thermal properties of solids. Basic crystal lattice structures, X-ray diffraction and dispersion curves for phonons and electrons in reciprocal space. Energy bands, Fermi surfaces, metals, insulators, semiconductors, superconductivity and ferromagnetism. Fall semester. Typical text: Kittel, Introduction to Solid State Physics.
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(3-0-3)(Lec-Lab-Credit Hours)
This course is meant to serve as an introduction to formal quantum mechanics as well as to apply the basic formalism to several generic and important applications.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course deals with the principles of light interactions with biological and biomedical-relevant systems. The enabling aspects of nanotechnology for advanced biosensing, medical diagnosis, and therapeutic treatment will be discussed.
Prerequisites:
NANO 600
(3-0-3)(Lec-Lab-Credit Hours)
This course deals with the fundamentals and applications of nanoscience and nanotechnology. Size-dependent phenomena, ways and means of designing and synthesizing nanostructures, and cutting-edging applications will be presented in an integrated and interdisciplinary manner.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Lectures by department faculty, guest speakers and doctoral students on recent research.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This graduate course will introduce the applications of multiscale theory and computational techniques in the fields of materials and mechanics. Students will obtain fundamental knowledge on homogenization and heterogeneous materials, and be exposed to various sequential and concurrent multiscale techniques. The first half of the course will be focused on the homogenization theory and its applications in heterogeneous materials. In the second half multiscale computational techniques will be addressed through multiscale finite element methods and atomistic/continuum computing. Students are expected to develop their own course projects based on their research interests and the relevant topics learned from the course.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Progress in the technology of nanostructure growth; space and time scales; quantum confined systems; quantum wells, coupled wells, and superlattices; quantum wires and quantum dots; electronic states; magnetic field effects; electron-phonon interaction; and quantum transport in nanostructures: Kubo formalism and Butikker-Landau formalism; spectroscopy of quantum dots; Coulomb blockade, coupled dots, and artificial molecules; weal localization; universal conductance fluctuations; phase-breaking time; theory of open quantum systems: fluctuation-dissipation theorem; and applications to quantum transport in nanostructures.
Prerequisites:
PEP 554
(3-0-3)(Lec-Lab-Credit Hours)
Basic concepts of quantum mechanics, states, operators; time development of Schrödinger and Heisenberg pictures; representation theory; symmetries; perturbation theory; systems of identical particles, L-S and j-j coupling; fine and hyperfine structure; scattering theory; molecular structure. Spring semester. Typical texts: Gottfried, Quantum Mechanics, Schiff, Quantum Mechanics.
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(3-0-3)(Lec-Lab-Credit Hours)
Crystal symmetry. Space-group-theory analysis of normal modes of lattice vibration, phonon dispersion relations, and Raman and infrared activity. Crystal field splitting of ion energy level and transition selection rules. Bloch theorem and calculation of electronic energy bands through tight binding and pseudopotential methods for metals and semiconductors and Fermi surfaces. Transport theory, electrical conduction, thermal properties, cyclotron resonance, de Haas van Alfen, and Hall effects. Dia-, para-, and ferro-magnetism and magnon spinwaves. Spring semester. Typical texts: Callaway, Quantum Theory of Solid State; Ashcroft and Mermin, Solid State Physics; and Kittel, Quantum Theory of Solids.
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| Pharmaceutical Manufacturing Engineering |
| | (0-0-3) (Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course reviews the 12 elements of the Process Safety Management (PSM) model created by the Center for Chemical Process Safety of the American Institute of Chemical Engineers. PSM systems were developed as an expectation/demand of the public, customers, in-plant personnel, stockholders, and regulatory agencies because reliance on chemical process technologies were not enough to control, reduce, and prevent hazardous materials incidents. PSM systems are comprehensive sets of policies, procedures, and practices designed to ensure that barriers to major incidents are in place, in use, and effective. The objectives of this course are to: define PSM and why it is important, describe each of the 12 elements and their applicability, identify process safety responsibilities, give real examples and practical applications to help better understand each element, share experiences and lessons learned of all participants, and assess the quality and identify enhancements to a student’s site PSM program.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities; issues related to process flow, material flow and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer; bio-safety levels; developing effective written procedures so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do; levels I, II, and III policies; clinical phases I, II, and III, and their effect on plant design; defending products against contamination; and building quality into products.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Course addresses the sustainable operation and design of facilities and sites subject to regulatory requirements of US federal agencies such as FDA, NIH, OSHA, EPA, DOE and/or applicable international regulators. Course presents timely issues, challenges and potential benefits of implementing sustainable means and methods to meet new Green Codes and Design Standards that are either in draft review or final version for the regulated facility, whether in planning, design, construction or operation phase. Regulated buildings typically have their own unique requirements in their operation, which require special knowledge to comply and or mitigate safety and regulatory issues, while minimizing impact of rising energy costs to manufacturers, saving scarce resources, and protecting the environment. Furthermore, course introduces the students to resources, survey information of latest sustainable/Green thinking in Green Chemistry, Sustainability and Energy Efficient Design and Products to reduce waste, energy consumption, eliminate unnecessary or optimize manufacturing steps, cut operating costs and be environmentally sensitive.
Topics include: Global trends in Green Regulations and Design Standards, history of “Sustainable Design,” examples of sustainability in large companies, site selection issues, water resource conservation, architectural issues and material selections, energy resource conservation and efficiency design for mechanical, electrical, and plumbing (MEP) systems in regulated facilities, energy performance of buildings, waste and environmental issues, material resource conservation and efficiency (disposables, packaging), construction techniques toward a sustainable certified facility, sustainable design for cGMP facilities and labs, building operations and maintenance. Course will provide useful, current and practical knowledge of Green and Sustainability Design and operation to individuals who are in or entering a technical career in regulated industries such as pharmaceutical, medical devices, and other sectors that have energy-intensive and regulated facilities.
Prerequisites:
PME 535 Good Manufacturing Practice in Pharmaceutical Facilities Design
(0-0-3)(Lec-Lab-Credit Hours)
Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities; issues related to process flow, material flow and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer; bio-safety levels; developing effective written procedures so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do; levels I, II, and III policies; clinical phases I, II, and III, and their effect on plant design; defending products against contamination; and building quality into products.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Bulk active pharmaceutical ingredient manufacturing and unit operations; process scale-up; transport processes, including mass, heat, and momentum transfer; process synthesis, analysis, and design; traditional separation processes, including distillation, evaporation, extraction, crystallization, and absorption; new separation processes, including pressure swing adsorption, molecular sieves, ion exchange, reverse osmosis, microfiltration, nanofiltration, ultrafiltration, diafiltration, gas permeation, pervaporation, supercritical fluid extraction, and high performance liquid chromatography (HPLC); and batch and continuous reactors for homogeneous, heterogeneous, catalytic, and non-catalytic reactions.
Prerequisites:
CHE 530 Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety, & environment concepts, and regulatory issues.
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Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety and environment concepts, and regulatory issues.
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Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course provides a broad overview of topics related to the design and operations of modern biopharmaceutical facilities. It covers process, utilities, and facility design issues, and encompasses all major manufacturing areas, such as fermentation, harvest, primary and final purification, media and buffer preparation, equipment cleaning and sterilization, and critical process utilities. Unit operations include cell culture, centrifugation, conventional and tangential flow filtration, chromatography, solution preparation, and bulk filling. Application of current Good Manufacturing Practices and Bioprocessing Equipment Standards (BPE-2002) will be discussed.
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| | (0-0-3) (Lec-Lab-Credit Hours)
An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
Prerequisites:
CHE 530 Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety, & environment concepts, and regulatory issues.
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Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety and environment concepts, and regulatory issues.
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Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Computers and computerized systems are ubiquitous in pharmaceutical manufacturing. Validation of these systems is essential to assure public safety and compliance with appropriate regulatory issues regarding validation: GMP, GCP, 21CFR Part 11, etc. This course covers validation concepts for various classes of computerized systems and applications used in the pharmaceutical industry; importance of requirements engineering in validation; test protocols and design; organizational maturity considerations.
Prerequisites:
PME 540 Validation and Regulatory Affairs in Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course explores the economic theory of regulation in general, and the US and international regulatory environments that govern the pharmaceutical and biotechnology industries with particular focus on the US Food and Drug Administration, the European Agency for the Evaluation of Medical Products and the Japanese Ministry of Health, Labor and Welfare. The essential components of Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices regulations will be covered. Students will develop an understanding of the formulation and execution of regulatory strategy and key ethical issues in medical research and production. Where appropriate, case studies will be used to illustrate the challenges and issues associated with compliance as well as the consequences of noncompliance. Ethical issues and the potential consequences of ethical lapses will also be explored. Current events will be used to illustrate key ethical principles and serve as a basis for discussion.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course presents validation for medical device manufacturers in terms of its objectives, strategies, planning, protocols, and documentation. Validation requirements include producing, collecting, analyzing, and managing data and documentation in support of medical device product design and product performance claims. These, as well as manufacturing processes and test methods, are presented within the context of current Quality System Regulations (QSR) as well as Risk Analysis. Qualification is addressed for equipment and operational systems, software and automated systems, and facilities for manufacturing medical devices. Validation in all life cycle phases is presented, both prior to commercial production and during the operating life of the plant, process, and product. Case studies are included as specific examples. Through this course, students will understand how to implement validation studies for medical device manufacturers and to evaluate existing studies.
Prerequisites:
PME 580 Medical Device Design and Technology
(3-0-3)(Lec-Lab-Credit Hours)
Early history of medical devices and procedures. Minimally invasive and open procedures, techniques and devices, including mechanical and electrosurgical devices. Manufacturing methods for catheters, balloons, plastic and metal components. Design of metal device components including material selection and strength and deformation adequacy using material properties and classical mechanics. Selection of insulation materials for and testing of electrosurgical devices. Selection of medical plastics and design elements. Balloon and catheter burst strength. The Poiseuille flow equation and its use for fluid flow through catheters and vessels. Rapid prototyping techniques, advantages and limitations. Understanding of biocompatibility testing and accelerated age testing using the Arrhenius equation. Device sterilization methods and testing. Developing a project plan from brainstorming to product release for a new device.
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Medical Devices Manufacturing
(3-0-3)(Lec-Lab-Credit Hours)
Technical tools and knowledge required to operate and manage in medical devices manufacturing environment. Current requirements in medical devices regulations, quality systems, and design elements related to manufacturing steps to assure patients health and safety. Requirements concerning selection and supply of raw materials and components for manufacturing; design and qualification of facilities, equipment, and process systems; testing, controls and inspection for compliance. Combination products, validation, external contractors, and case studies. Focus on understanding the principles and methods required in a medical devices manufacturing environment in compliance with GMP regulations.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course provides an overview of PAT applications in pharmaceutical operations. At the conclusion of the course, students will understand the PAT life cycle, be able to identify PAT applications likely to yield positive benefit, understand issues of organizing and managing a PAT project and integrating the principles of Quality by Design into the effort (i.e. design control, facility and equipment control, production and process control, and material control). Students will also understand the principles of integrating PAT application projects with the six-sigma approach to process improvement: Define, Measure, Analyze, Improve and Control (DMAIC). Topics covered include: PAT applications, risk analysis/risk management, project management issues (integrating PAT into process and product development, technology transfer to manufacturing, change management, etc.), and the PAT system project life cycle. Examples of PAT impact on workflow, productivity, process variability and product quality will be discussed.
Prerequisites:
PME 530 Introduction to Pharmaceutical Manufacturing
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Course explores the current application of Lean Six Sigma in Pharmaceutical Manufacturing. Topics covered include: Lean Six Sigma Concepts and Techniques, Project and Team Dynamics, Tools of Lean Six Sigma and their Application, and Designing Pharmaceutical Processes for Lean Six Sigma. Emphasis is on DMAIC, including Define, Measure, Analyze, Improve, and Control methodology, with the students’ skill set developed through case studies and project work on actual pharmaceutical processes using statistical software (Minitab). At the conclusion of this course, students will understand the concepts and principles of Lean Six Sigma, be competent with Minitab software and be able to apply these techniques to pharmaceutical processes.
Prerequisites:
ME 555 Lean Six Sigma in the Pharmaceutical Industry
(3-0-3)(Lec-Lab-Credit Hours)
Course explores the current application of Lean Six Sigma in Pharmaceutical Manufacturing. Topics covered include: Lean Six Sigma Concepts and Techniques, Project and Team Dynamics, Tools of Lean Six Sigma and their Application, and Designing Pharmaceutical Processes for Lean Six Sigma. Emphasis is on DMAIC, including Define, Measure, Analyze, Improve, and Control methodology, with the students’ skill set developed through case studies and project work on actual pharmaceutical processes using statistical software (Minitab). At the conclusion of this course, students will understand the concepts and principles of Lean Six Sigma, be competent with Minitab software and be able to apply these techniques to pharmaceutical processes.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course provides a detailed exploration of quality programs with specific application to the particular requirements of the pharmaceutical industry. Students will develop an understanding of the quality philosophy which drives the industry from discovery through manufacturing, and of the systems and tools that are employed to implement and maintain a sustainable and successful quality system. Application of quality strategies in research and development, commercial production, computer systems, post-marketing, and other areas will be included. Where appropriate, case studies will be used to illustrate the challenges and issues associated with quality system deployment.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Course covers the following topics: Structure and physical, chemical and biological attributes of biologics. Product stability, pharmacokinetics, delivery. Critical quality attributes of Pioneer Drugs and Biogenerics. Fundamentals of nucleic acid and protein structure and function. Genetic engineering tools. Modern production vectors and hosts. Cell line and media selection and optimization. Cell-bank characterization and stability. Upstream processes. Culture, fermentation and scale-up. Critical upstream process parameters, regulatory controls and validation. Rapid vaccine manufacturing and monoclonal antibody case studies. Prerequisites: Students must have taken at least one course in organic chemistry and one course in biochemistry, molecular biology, or genetics, or equivalent background as determined by instructor.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Early history of medical devices and procedures. Minimally invasive and open procedures, techniques and devices, including mechanical and electrosurgical devices. Manufacturing methods for catheters, balloons, plastic and metal components. Design of metal device components including material selection and strength and deformation adequacy using material properties and classical mechanics. Selection of insulation materials for and testing of electrosurgical devices. Selection of medical plastics and design elements. Balloon and catheter burst strength. The Poiseuille flow equation and its use for fluid flow through catheters and vessels. Rapid prototyping techniques, advantages and limitations. Understanding of biocompatibility testing and accelerated age testing using the Arrhenius equation. Device sterilization methods and testing. Developing a project plan from brainstorming to product release for a new device.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Focus of the course is compliance requirements necessary for Good Manufacturing Practices and Quality Management System. Background includes familiarization of the different categories of medical devices and their manufacturing special requirements. Manufacturing facility requirements are then presented, noting major differences between the various classes of medical devices and also within the classes (e.g. sterility requirements or cleanliness). Included are special requirements for combination products. Regulatory requirements are reviewed. The core of this course is the good engineering practices of facility design. This includes conceptual design, basic engineering, scale up (from lab to manufacturing), procurement, construction, key technologies such as HVAC and utilities requirements, and commissioning, qualification, and validation. Calibration, re-qualification, and maintenance are covered for optimal operational efficiency. Case studies of various manufacturing facilities will be presented.
Prerequisites:
PME 580 Medical Device Design and Technology
(3-0-3)(Lec-Lab-Credit Hours)
Early history of medical devices and procedures. Minimally invasive and open procedures, techniques and devices, including mechanical and electrosurgical devices. Manufacturing methods for catheters, balloons, plastic and metal components. Design of metal device components including material selection and strength and deformation adequacy using material properties and classical mechanics. Selection of insulation materials for and testing of electrosurgical devices. Selection of medical plastics and design elements. Balloon and catheter burst strength. The Poiseuille flow equation and its use for fluid flow through catheters and vessels. Rapid prototyping techniques, advantages and limitations. Understanding of biocompatibility testing and accelerated age testing using the Arrhenius equation. Device sterilization methods and testing. Developing a project plan from brainstorming to product release for a new device.
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Medical Devices Manufacturing
(3-0-3)(Lec-Lab-Credit Hours)
Technical tools and knowledge required to operate and manage in medical devices manufacturing environment. Current requirements in medical devices regulations, quality systems, and design elements related to manufacturing steps to assure patients health and safety. Requirements concerning selection and supply of raw materials and components for manufacturing; design and qualification of facilities, equipment, and process systems; testing, controls and inspection for compliance. Combination products, validation, external contractors, and case studies. Focus on understanding the principles and methods required in a medical devices manufacturing environment in compliance with GMP regulations.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Course presents Quality Risk Management, including Risk-Based Compliance for Cross Contamination, Occupational Safety, and Environmental Protection. Addresses the issues of occupational exposure to high hazard pharmaceutical compounds, and product-to-product cross contamination in multipurpose facilities. Explores issues that a pharmaceutical professional needs to understand regarding projects that put the workforce or product at risk and, in the case of product exposure, impact product quality and regulatory scrutiny. Included are emission sources and essentials, routes of exposure, toxicology, safety and regulatory limits of exposure, exposure control for facilities and processes, quantitative risk assessment, and mitigation techniques.
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| | | (3-0-3) (Lec-Lab-Credit Hours)
This course presents advanced techniques and analysis designed to permit managers to estimate and use cost information in decision making. Topics include: historical overview of the management accounting process, statistical cost estimation, cost allocation, and uses of cost information in evaluating decisions about pricing, quality, manufacturing processes (e.g., JIT, CIM), investments in new technologies, investment centers, the selection process for capital investments, both tangible and intangible, and how this process is structured and constrained by the time value of money, the source of funds, market demand, and competitive position.
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| | (3-0-3) (Lec-Lab-Credit Hours)
This course deals with the problems of managing a project, which is defined as a temporary organization of human and non-human resources, within a permanent organization, for the purpose of achieving a specific objective; both operational and conceptual issues will be considered. Operational issues include definition, planning, implementation, control and evaluation of the project. Conceptual issues include project management vs. hierarchical management, matrix organization, project authority, motivation and morale. Cases will be used to illustrate problems in project management and how to resolve them.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Fundamentals of mixing relevant to pharmaceutical engineering, flow patterns, dead zones, components of mixers, importance of baffling, determination of flow, power, and shear rates, effect of rheology, “shaken, not stirred”, why viscosity affects more than just Reynolds numbers, continuous processing, heat transfer, suspending solids that sink or float, wetting out solids, concepts of crystallization, catalysis, mass transfer, liquid-liquid dispersions, emulsions, and separations, fermenters, hydrogenators, other gas-liquid applications, pit-falls of scale-up, why scale-down is the better way to design, process intensification and solids-solids mixing.
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| | (0-0-3) (Lec-Lab-Credit Hours)
The course covers oral solid dosage (OSD) manufacturing and packaging in the pharmaceutical industry. Production unit operations include blending, granulation, size reduction, drying, compressing, and coating for tablets, as well as capsule filling. Packaging aspects reviewed include requirements for primary and secondary containers and labeling, package testing. The course emphasizes design, scale-up, trouble-shooting, validation, and operation of typical OSD manufacturing and packaging facilities, including equipment, material flow, utilities, and quality assurance. Topics related to cGMP, process validation, manufacturing and packaging documentation, QA and QC in OSD manufacturing will be presented. The term project required for this course involves conceptual design of a contract manufacturing and packaging facility for OSD products, including equipment selection, development of the process flow diagrams, room layouts and other design elements, as well as preparation of Standard Operating Procedures for various unit operations.
Prerequisites:
CHE 530
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety, & environment concepts, and regulatory issues.
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(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, health, safety and environment concepts, and regulatory issues.
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(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Bulk active pharmaceutical ingredient manufacturing and unit operations. Process scale-up. Transport processes, including mass, heat, and momentum transfer. Process synthesis, analysis, and design. Traditional separation processes, including distillation, evaporation, extraction, crystallization, and absorption. New separation processes, including pressure swing adsorption, molecular sieves, ion exchange, reverse osmosis, microfiltration, nanofiltration, ultrafiltration, diafiltration, gas permeation, pervaporation, supercritical fluid extraction, and high performance liquid chromatography (HPLC). Batch and continuous reactors for homogeneous, heterogeneous, catalytic, and non-catalytic reactions.
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course will introduce students to modeling and simulation applications in pharmaceutical manufacturing. The fundamentals of discrete event simulation and the use of commercially available software to develop models of various manufacturing and service systems will be introduced. Approaches to the development of conceptual and computer models, data collection and analysis, model verification and validation, and simulation output analysis will be discussed. The modeling of chemical, biochemical and separation processes in pharmaceutical manufacturing using process simulation software will be presented. Material balances, stream reports, operations and equipment Gantt charts will be developed and process debottlenecking and cost analysis will be conducted.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Current and evolving validation concepts and standards in pharmaceutical manufacturing, including FDAs GMPs for 21st Century, Risk Assessments (Risk-MaPP, ICH Q7a-Q10, FMEA) and statistics in validation, Commissioning and Qualification (ISPE and ASTM), Computer Systems Validation, Cleaning Validation, Spreadsheet Validation, Lean Manufacturing and Six Sigma, PAT initiative, Equipment Qualification vs. CSV (GAMP and AAPS guidelines). Preparation of draft validation documentation, including master plans, protocols, test procedures and reports. Focus is on concepts and principles required to implement these new qualification and validation approaches in a pharmaceutical manufacturing environment in compliance with FDA and international regulations. Needs knowledge of basic statistics concepts.
Prerequisites:
PME 530
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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(0-0-3)(Lec-Lab-Credit Hours)
An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
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| | (0-0-3) (Lec-Lab-Credit Hours)
This course presents a systematic methodology for the project management of aseptic pharmaceutical manufacturing processes. This includes the associated equipment and the integration of the preliminary design, detailed design, construction, and validation phases of a project to minimize the challenges, and cost and schedule overruns typically associated with implementing these complex processes. The content includes selection of the project team, defining the process requirements the equipment is required to meet, preparation of the equipment user requirements specifications, preparation of the equipment layout, preparation of the equipment budget, preparation of the project schedule, managing the construction of the equipment, managing the testing of the equipment, and installation of the equipment and site acceptance testing. Also addressed will be selection of and dealing with equipment vendors, planning for validation success, and regulatory acceptance.An aseptic manufacturing process case study is used as a basis for the lecture series. The process will be followed from the preparation of the raw data used to determine the process requirements through to final installation and acceptance of the aseptic processing equipment on site.
Prerequisites:
PME 530
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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(3-0-3)(Lec-Lab-Credit Hours)
This course deals with the problems of managing a project, which is defined as a temporary organization of human and non-human resources, within a permanent organization, for the purpose of achieving a specific objective; both operational and conceptual issues will be considered. Operational issues include definition, planning, implementation, control and evaluation of the project. Conceptual issues include project management vs. hierarchical management, matrix organization, project authority, motivation and morale. Cases will be used to illustrate problems in project management and how to resolve them.
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| | (0-0-3) (Lec-Lab-Credit Hours)
Proven techniques and creative tools presented for design, development, and delivery of biopharmaceutical manufacturing facilities. Includes skills and knowledge in bioprocessing requirements, equipment and facility requirements, project management as well as regulatory guidelines and “big-picture” drug development. Also corporate capital management processes to functionally meet corporate requirements from pre-clinical to commercial scale of operations, qualifications to pass regulatory inspections, achieving faster “time-to-market,” but not breaking the corporate treasury bank. Course also explores trends in new equipment technology such as disposables or single-use product, new design concepts in aseptic manufacturing, barrier and isolation technologies, new FDA thinking in risk-based compliance approach, process analytical technology, capital project planning and management.
This course is primarily for engineers in the Master of Engineering program.
Prerequisites:
PME 530
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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(0-0-3)(Lec-Lab-Credit Hours)
Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities; issues related to process flow, material flow and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer; bio-safety levels; developing effective written procedures so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do; levels I, II, and III policies; clinical phases I, II, and III, and their effect on plant design; defending products against contamination; and building quality into products.
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(0-0-3)(Lec-Lab-Credit Hours)
This course provides a broad overview of topics related to the design and operations of modern biopharmaceutical facilities. It covers process, utilities, and facility design issues, and encompasses all major manufacturing areas, such as fermentation, harvest, primary and final purification, media and buffer preparation, equipment cleaning and sterilization, and critical process utilities. Unit operations include cell culture, centrifugation, conventional and tangential flow filtration, chromatography, solution preparation, and bulk filling. Application of current Good Manufacturing Practices and Bioprocessing Equipment Standards (BPE-2002) will be discussed.
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(3-0-3)(Lec-Lab-Credit Hours)
This course deals with the problems of managing a project, which is defined as a temporary organization of human and non-human resources, within a permanent organization, for the purpose of achieving a specific objective; both operational and conceptual issues will be considered. Operational issues include definition, planning, implementation, control and evaluation of the project. Conceptual issues include project management vs. hierarchical management, matrix organization, project authority, motivation and morale. Cases will be used to illustrate problems in project management and how to resolve them.
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Water & steam systems: (water used as excipient, cleaning agent, or product diluent) water quality selection criteria; generation, storage, and distribution systems; bio-burden control; USP PWS (purified water systems) and USP WFI (water for injection) systems; engineering considerations, including specification, design, installation, validation, operation, testing, and maintenance; common unit operations, including deionization, reverse osmosis, distillation, ultrafiltration, and ozonation systems; process considerations, including pretreatment, storage and distribution, materials of construction, microbial control, pyrogen control, and system maintenance; FDA requirements; clean-in-place systems; and steam generation and distribution systems.
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The objective of this course is to provide the student with the engineering tools and knowledge required to design and deploy Process Analytical Technology (PAT) solutions in pharmaceutical drug substance and drug product manufacturing. This course provides in-depth coverage of current PAT technologies. At the conclusion of this course, students will understand the engineering theory, principles, and mathematics required to design and deploy these technologies in a pharmaceutical manufacturing environment in compliance with FDA and international regulations.
Topics covered include: analyzer types and principals of operation, chemometric techniques for multivariate analysis, multivariate process models, dynamic process control, and advanced pattern recognition techniques. In addition, the course will cover the technical aspects of real-time data management and 21 CFR Part 11 compliance. This course is primarily for engineers in the Master of Engineering program.
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| | (3-0-3) (Lec-Lab-Credit Hours)
Technical tools and knowledge required to operate and manage in medical devices manufacturing environment. Current requirements in medical devices regulations, quality systems, and design elements related to manufacturing steps to assure patients health and safety. Requirements concerning selection and supply of raw materials and components for manufacturing; design and qualification of facilities, equipment, and process systems; testing, controls and inspection for compliance. Combination products, validation, external contractors, and case studies. Focus on understanding the principles and methods required in a medical devices manufacturing environment in compliance with GMP regulations.
Prerequisites:
PME 530
(0-0-3)(Lec-Lab-Credit Hours)
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
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(0-0-3)(Lec-Lab-Credit Hours)
Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities; issues related to process flow, material flow and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer; bio-safety levels; developing effective written procedures so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do; levels I, II, and III policies; clinical phases I, II, and III, and their effect on plant design; defending products against contamination; and building quality into products.
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| | (0-0-3) (Lec-Lab-Credit Hours)
A participating seminar on topics of current interest and importance in Pharmaceutical Manufacturing Practices
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Mechanical Engineering Department
Constanin Chassapis, Director |
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