Pharmaceutical Manufacturing (PME) Program
-- Course Descriptions -Spring 2010
PME 530 Introduction to Pharmaceutical Manufacturing
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
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
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 537 Sustainable Design for Bio-Pharma Facilities
Course addresses the sustainable design of a fully-compliant bio-pharmaceutical facility. It defines ways to reduce waste,
eliminate unnecessary packaging, save on energy consumption, cut costs and be environmentally sensitive. It provides
technical tools and knowledge of sustainable means and methods of approaching a current Good Manufacturing Practice
(cGMP) facility, whether in planning, design, construction or operation phase. BioPharma buildings types have
particularities in their design, which require special knowledge to mitigate safety and regulatory issues, while saving
energy and protecting the environment. Current sustainability requirements are optional; however, the sustainable design
standards are becoming mandatory once endorsed by International Building Codes and other national and international
regulatory aiming on lowering carbon emission and eliminating the ozone depletion chemicals.
Topics include: global trends (ecosystem decline, greenhouse gases, and climate change), 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 and pharmaceutical 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 may be of interest to
individuals who are in or entering a bio-pharma technical career, either in manufacturing or facility operations, or project
or design engineering.
(Prerequisite: PME 535.)
PME 538 Chemical Technology Processes in API Manufacturing
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 diafiltration. 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 noncatalytic reactions.
1
PME 539 Bioprocess Technology in API Manufacturing
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
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
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
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
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.
2
PME 580 Medical Device Design and Technology
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.
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
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 640 Contemporary Concepts in Pharmaceutical Validation
Current and evolving validation concepts and standards in pharmaceutical manufacturing, including FDA’s 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, PME 540.)
3
PME 643 Design and Management of Aseptic Pharmaceutical 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
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 647 Environmental Systems (HVAC) in Healthcare Manufacturing
Proven techniques and creative tools presented for design, development, and delivery of Environmental Systems
necessary for the control and monitoring of classified spaces to manufacture drugs, medical devices, and research labs
with potent or biologic compounds. Obtain knowledge of pharmaceutical environmental requirements, understanding of
theories and principles of operation for Heating, Ventilating, and Air Conditioning (HVAC) equipment and system
configurations to satisfy regulatory acceptance criteria, gaining practical knowledge of environmental system design and
implementation including validation that supports drug production. Course also includes Building Automation Systems
conceptual design and application for controlling and monitoring a regulated production environment. Exploring new
trends and technologies of HVAC systems and design for sterile and aseptic manufacturing, barrier and isolation
technologies, containment of potent compounds, specific extraction, flammable solvent handling, and using HVAC
system as secondary protection of products and operators. (Prerequisites: PME 530, PME 535.)
PME 649 Design of Water, Steam, and CIP Utility Systems for Pharmaceutical Manufacturing
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 bioburden 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
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.)
4
PME 660 Medical Devices Manufacturing
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
patient’s 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, PME 535.)
5