Pharmaceutical Manufacturing - A Multidisciplinary Program

Graduate Certificates:
  - Pharmaceutical Manufacturing Practices (PMP)
  - Validation & Regulatory Affairs (VRA)
  - Design of Pharmaceutical Facilities (DPF)
  - Project Engineering in Pharmaceutical Manufacturing (PEPM)
  - Bioprocess Systems in Pharmaceutical Manufacturing (BSPM)

Master’s Degrees:
  - Master of Engineering in Pharmaceutical Manufacturing
  - Master of Science in Pharmaceutical Manufacturing

If you’re an engineer or a healthcare worker in related industries (including biotech, medical devices, personal care, and related GMP-driven industries), this multi-disciplinary online graduate program in pharmaceutical manufacturing engineering provides you with essential skills. Focus on manufacturing and facilities, keeping in mind the industry’s regulatory requirements. Learn about U.S. Food and Drug Administration (FDA) regulatory requirements, including Good Manufacturing Practice (GMP) and Quality Systems Regulations (QSR). Emerge as an expert, ready to meet the major demands that the pharmaceutical industry faces in the twenty-first century.

The Pharmaceutical Manufacturing Engineering (PME) Program at the Stevens Institute of Technology currently offers five Graduate Certificates, in addition to the Master’s Degree in Pharmaceutical Manufacturing, to satisfy specialty needs within the industry.
One Graduate Certificate (GC) is more general, and the others each address specialty areas within the process and equipment engineering aspects of pharmaceutical manufacturing. Each GC has three required courses and a recommended elective course, and is described as follows:

1. Pharmaceutical Mfg. Practices (PMP) 
This GC is an introductory overview of the industry, touching on all basic manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the industry, and one elective dealing with more technical aspects of manufacturing processes in either the chemical or mechanical areas. This is the best sequence for individuals relatively unfamiliar with the industry.
 Required courses: PME 530, 535, 540; recommended elective: PME 538 or 628.

2. Validation & Regulatory Affairs (VRA)
Many individuals work or aspire to work in the validation part of the industry, to test and confirm that equipment and processes meet all specifications. For those individuals, this GC provides more detailed studies of the general concepts, specific applications to computerized systems, compliance issues, and quality aspects of manufacturing. 
 Required courses: PME 540, 541, 542; recommended elective: PME 560.

3. Design of Pharmaceutical Facilities (DPF)
Individuals who work in engineering companies, or who deal with facilities issues, would find this GC of interest. It covers overall facilities design issues, the more detailed design of water systems and HVAC systems, and the challenges required in biopharm facility design.
 Required courses: PME 535, 649, 647; recommended elective: PME 646.

4. Project Engineering in Pharmaceutical Manufacturing (PEPM)
Project engineers and project managers, and those aspiring to these positions in the pharm industry, will find that this GC provides more depth and understanding of these coordination efforts. In addition to the overall discipline view of facilities design, included are a formal introduction to project management concepts, specific implementation concepts for sterile facilities, and the newer PAT concepts. 
 Required courses: PME 535, 609, 643; recommended elective: PME 651.

5. Bioprocess Systems in Pharmaceutical Manufacturing (BSPM)
With the tremendous growth of biopharm facilities, this GC helps individuals address those manufacturing technical issues. It includes the overall facilities issues, biotechnology processes, specific biopharm facilities design concepts, and sterile facilities approaches.
 Required courses: PME 535, 539, 646; recommended elective: PME 643.

All GCs can be credited towards a Master’s Degree in Pharmaceutical Manufacturing.

The Master’s Degree in Pharmaceutical Manufacturing program at the Stevens Institute of Technology - Schaefer School of Engineering is intended to integrate the study of pharmaceutical manufacturing concepts with more advanced engineering design and scientific methodologies.
One of two degrees can be earned in this program, either a Master of Engineering Degree or a Master of Science Degree. The choice of degree is generally defined by the student’s background and the electives taken in the program:

1. A Master of Engineering Degree can be earned if the student has a Bachelor’s Degree in engineering,
 and takes engineering electives; or
2. A Master of Science Degree can be earned if the student has a Bachelor’s Degree in science,  engineering, technology, or other non-technical discipline, and takes technical or management types of
 electives.

A Bachelor’s Degree in Engineering, Technology, or Science is needed for acceptance to this Master’s program. Acceptance with other undergraduate degrees will be considered on an individual basis.
For those students who choose to take non-PME electives, the customization program is designed as follows:

♦ For those individuals who specialize in an Engineering Discipline, such as Mechanical,  Chemical, or
 Biomedical Engineering, electives as a concentration in one of those disciplines would further develop
 technical skills in those disciplines, as complementary to the pharmaceutical studies. 
♦ For those individuals who specialize in Project Engineering and/or Project Management,  electives in Engineering Management, Systems Engineering, Construction Management, or  Technology Management would more strongly develop project and overall management  capabilities in
 those areas. 
♦ Other elective courses are available which are recommended for individuals interested in  Quality, Legal
 Issues, Supply Chain, Logistics, Economics, Sales & Marketing, and Risk Analysis, to name a few.
♦ A wide variety of courses are available at Stevens, which would supplement the Pharmaceutical  Manufacturing studies, and give the individual a closer look at other aspects of corporate operations or
  support. Such a customized program would be developed with each student, according to their needs
 and preferences.
The Master’s Degree in Pharmaceutical Manufacturing requires 30 credits (10 courses), approved by the student’s academic advisor:
♦ Eighteen of the credits (or six courses) are required to be PME courses. These include the three required
 core courses, plus at least three more PME elective courses.
♦ The remaining twelve credits (or four courses) must include either additional PME courses, or at least a
 concentration of three courses in one of the following related programs: Mechanical Engineering,  Chemical Engineering, Biomedical Engineering, Construction Management, Engineering Management,
 Systems Engineering, or Technology Management.

Master’s Degree program in Pharmaceutical Manufacturing, 10 courses (30 credits); includes core courses (PME 540, PME 609) with two options:
 - Master of Engineering Degree, if the student has a Bachelor’s Degree in engineering, and takes engineering electives (plus additional core course PME 639), or
 - Master of Science Degree. if the student has a Bachelor’s Degree in science, engineering, technology, or other non-technical discipline, and takes technical or management types of electives (plus additional core course PME 600).

PME 530 Introduction to Pharmaceutical Manufacturing (Core) 
An overview of Quality Assurance (QA) and how they relate to regulatory issues in pharmaceutical manufacturing. Explore chemical and biotech process technology and equipment, dosage forms, finishing systems, facility engineering, and health, safety, and environment concepts. Study regulatory and legal considerations. Learn how to ensure that methods, facilities and controls meet industry requirements for safety, effectiveness, identity, strength, quality and purity.







PME 531 Process Safety Management (Elective)
Course addresses management and engineering design concepts required for process safety in chemical and biotechnology systems, with pharmaceutical manufacturing applications. Basis is Process Safety Management (PSM) model from OSHA and the Center for Chemical Process Safety of AIChE. Content focuses on sound engineering principles and practices as they apply to industrial situations, project design, risk mitigation, process and equipment integrity, and engineering codes and standards.  Includes calculation of risk assessment scores and cost justification factor; HAZOP study methodology using P&IDs; safety valve, rupture disc, explosion venting, and emergency scrubber design considerations; MSDS uses; overall control, reduction, and prevention of hazardous materials incidents;  case studies.

PME 535 Good Manufacturing Practice in Pharmaceutical Facilities Design (Core)
Become familiar with current Good Manufacturing Practice (GMP) compliance in the design of pharmaceutical and biopharmaceutical facilities. Uncover issues related in process, material, and people flow. Learn about the special needs of the pharmaceutical industry for architecture and engineering, including mechanical, industrial, electrical and computer systems. Study specialized requirements for HVAC, automation, and bio-safety. Develop effective written procedures to document highly complex yet safe processes. Learn about clinical phases I, II, III and their effect on plant design. Find out how to defend products against contamination.

PME 538 Chemical Technology Processes in API Manufacturing (Elective)
A broad overview of bulk active pharmaceutical ingredient manufacturing and unit operations. Covers the basics of process scale-up and transport processes, including mass, heat, and momentum transfer. Explore process synthesis, analysis, and design. Familiarize yourself with traditional separation processes, including distillation, evaporation, extraction, crystallization, and absorption. Find out about new separation processes, including pressure swing adsorption, molecular sieves, ion exchange, and reverse osmosis. Study micro-filtration, nano-filtration, ultra-filtration, and dia-filtration. Gain knowledge of gas permeation, pervaporation, supercritical fluid extraction, and high performance liquid chromatography (HPLC). Review batch and continuous reactors for homogeneous, heterogeneous, catalytic, and non-catalytic reactions.

PME 539  Bioprocess Technology in API Manufacturing (Elective)
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. The course will benefit students majoring in the sciences, engineering, manufacturing technology, and management, who are interested in getting broad knowledge of processes, equipment, and design considerations pertaining to modern biopharmaceutical manufacturing.

PME 540 Validation and Regulatory Affairs in Pharmaceutical Manufacturing (Core)
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).


PME 541  Validation of Computerized Systems  (Elective)
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.

PME 542/ MGT 684 - Regulation & Compliance in the Pharmaceutical Industry (Elective) 
Explores 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.

PME 551 – Process Analytical Technology (PAT) in Pharmaceutical Operations   
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. 
Course is primarily for non-engineers in the M.S. program.    Prerequisite: PME 530. 

PME 560 Quality in Pharmaceutical Manufacturing (Elective) 
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.  Case studies will be used to illustrate the challenges and issues associated with quality system deployment.

PME 600 / EM 600  Engineering Economics and Cost Analysis
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. .

PME 609 / MGT 609  Introduction to Project Management (for the Pharmaceutical Industry)
Basic tools and concepts defined by the Project Management Institute plus other generally accepted practices for project excellence are introduced. The emphasis is on understanding and analyzing the interdependencies among the core processes for initiating, planning, executing, controlling and terminating projects. The dynamics of managing unique, temporary endeavors within the context of routine, permanent organizations are critically evaluated. Industry examples demonstrate and reinforce effective use of learned concepts by course participants.

PME 628 Pharmaceutical Finishing and Packaging Systems – Solid Dosage (Elective)
The course covers finished product manufacturing and packaging systems in the pharmaceutical industry, concentrating on the oral solid dosage forms. Process unit operations include blending, granulating, size reduction, drying, compressing, and coating for tablets, as well as blending and filling for capsules. Design and operation of packaging equipment for tablet and capsule counting, capping, security sealing, labeling, cartoning, and case packing will be considered. Approach for development of project documentation, such as equipment specifications, purchase orders, test plans, and validation documents will be presented. Use of computer simulation tools for system development and improvement will be discussed. Term paper project will require students to collectively design a solid dosage manufacturing and packaging facility, considering selection of processing and packaging equipment, material flow, development of commissioning and qualification plan and protocols.

PME 639  Modeling and Simulation for Pharmaceutical Manufacturing 
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.

PME 643 – Design and Management of Aseptic Pharma. Manufacturing Processes  
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, PME 609.

PME 646  Biopharm Facilities Design       NEW!
Proven techniques and creative tools are 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 overview drug development. Also corporate capital management processes to functionally meet company requirements from pre-clinical to commercial scale of operations, qualifications to pass regulatory inspections, achieving faster “time-to-market,” but not exceeding corporate financial resources.  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: PME 530, 535, 539, 609)

PME 649 Design of Water, Steam, and CIP Utility Systems for Pharmaceutical Manufacturing (Elective) 
Discover industry standards for water and steam systems, including the use of water as an excipient, cleaning agent, and product diluent. Learn about water quality selection criteria, generation, storage and distribution. Cover the basics of bio-burden control, purified water systems (USP PWS) and (USP WFI) systems. Learn how to specify, design, installation, validate, operate, test, and maintain common unit operations. Become expert at deionization, reverse osmosis, distillation, ultrafiltration, and ozonation. Gain knowledge of pretreatment, storage, distribution, construction materials. Grasp advanced concepts of microbial and pyrogen control. Master FDA requirements for clean-in-place, steam generation, and distribution systems.

PME 653  Design of PAT Systems for Pharmaceutical Manufacturing     NEW!
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.  (Prerequisites: PME 530, knowledge of process control and statistics)

Additional courses in development include:
PME 647 - HVAC/Building Automation Systems

Schedule Fall 2008         (Classes start August/Sept. 2008)
PME 530 - Introduction to Pharmaceutical Manufacturing	Hoboken, sections A, B, C, D; or WebCampus, online,  sections WS & W1;	A (Mon. aft.), B (Wed. aft.), C and D (Thurs. eve.) start week of 25 Aug.; WS & W1 start week of 8 Sept.
PME 535 - Good Manufacturing Practice in Pharmaceutical Facilities Design	Hoboken, section A, B, C; or WebCampus, online, sections WS & W1; or Schering-Plough on-site, section SC (employees only)	A (Tues. eve.), B (Thurs. aft.), C (Thurs. eve.) start week of 25 Aug.; WS & W1 start week of 8 Sept.; SC (Tues. eve.) starts 2 Sept.
PME 538 - Chemical Technology Processes in Pharmaceutical Manufacturing	WebCampus, online, section WS	Starts week of 8 Sept.
PME 539 – Bioprocess Technology in Pharmaceutical Manufacturing	Hoboken, sections A & B; or WebCampus, online,  sections WS, W1, W2.	A (Wed. eve.), B (Fri. aft.) start week of 25 Aug.; WS, W1, W2 start week of 8 Sept.
PME 540 - Validation and Regulatory Affairs in Pharmaceutical Manufacturing	Hoboken, sections A, B, C, D; or WebCampus, online,  sections WS & W1	A (Tues. aft.), B (Tues. eve.), C (Thurs. eve.), D (Thurs. aft.)  start week of 25 Aug.; WS & W1 start week of 8 Sept.
PME 541 - Validation of Computerized Systems	WebCampus, online, section WS	Starts week of 8 Sept.
PME 542 – Regulation and Compliance in the Pharmaceutical Industry	Next offered Spring 09
PME 551 – Process Analytic Technology (PAT) in Pharmaceutical Operations	Hoboken, section A.	Starts week of 25 Aug.
PME 560 – Quality in Pharmaceutical Manufacturing	Hoboken, section A; or WebCampus, online, sections WS & W1	A (Mon. aft.) starts week of 25 Aug.; WS & W1 start week of 8 Sept.
PME 600 – Engineering Economics and Cost Analysis	Hoboken, sections A, B, C; or WebCampus, online, sections WS & W1	A (Mon. eve.), B (Thurs. eve.), C (Wed. aft.) start week of 25 Aug.; WS & W1 start week of 8 Sept.;
PME 609 - Introduction to Project Management (Pharmaceutical Industry)	Hoboken, sections B, E, F, H; or WebCampus, online, section WP; all sections specifically for pharm interest	B (Mon. eve.), E (Tues. eve.), F (Wed. aft.), H (Thurs. eve.)  start week of 25 Aug.; WP starts week of 8 Sept.
PME 621 – Pharmaceutical Mixing	WebCampus, online, section WS	Starts week of 8 Sept.
PME 628 - Pharmaceutical Finishing and Packaging Systems – Solid Dosage	Hoboken, sections A, B, C.	A (Mon. eve.), B (Wed. eve.), C (Tues. aft.) start week of 25 Aug.
PME 639 – Modeling & Simulation of Pharmaceutical Manufacturing Systems	WebCampus, online, section WS	Starts week of 8 Sept.
PME 643 – Design and Management of Aseptic Pharmaceutical Manufacturing Processes	Hoboken, section A; or WebCampus, online, section WS.	A (Tues. eve.) starts week of 25 Aug.; WS starts week of 8 Sept.
PME 646 – Biopharm Facilities Design	Hoboken, section A; or WebCampus, online, section WS.	A (Thurs. aft.) starts week of 25 Aug.; WS starts week of 8 Sept.
PME 649 - Design of Water, Steam, & CIP Utility Systems	Next offered Spring 09
PME 653 – Design of Process Analytic Technology Systems for Pharm Mfg.	WebCampus, online, section WS	Starts week of 8 Sept.

Building foundations on sound technologies through applications of practices and procedures

Apply Now! Request Information! Graduate School More Off Campus Information on the PMP Program Graduate Web site Admissions Contact Raritan Valley Community College

For More Information, Please Contact:

Richard S. Berkof, Ph.D., P.E.
Professor of Mechanical Engineering & Director of Pharmaceutical Mfg. Eng. Program
Stevens Institute of Technology
Edwin A. Stevens Hall, Room E-306
Castle Point on Hudson
Hoboken, NJ 07030
Phone: 201-216-5538
rberkof@stevens.edu