GRADUATE CERTIFICATE PROGRAMS
In addition to the degree programs, the Department also offers graduate certificate programs. In most cases, the courses may be used toward the Master’s degree. Each graduate certificate program is a self-contained and highly focused collection of courses carrying nine or more graduate credits. The selection of courses is adapted to the professional interests of the student.
Pharmaceutical Manufacturing Practices Graduate Certificate
The Graduate Certificate in Pharmaceutical Manufacturing Practices is an interdisciplinary School of Engineering certificate developed by the Department of Mechanical Engineering and the Department of Chemical Engineering and Materials Science. This certificate is intended to provide professionals with skills required to work in the pharmaceutical industry. The focus is on engineering aspects of manufacturing and the design of facilities for pharmaceutical manufacturing, within the framework of the regulatory requirements in the pharmaceutical industry.
The certificate is designed for technologists in primary manufacturers, including pharmaceutical, biotechnology, medical device, diagnostic, and cosmetic companies, as well as in related companies and organizations, including architect/engineer/construction firms, equipment manufacturers and suppliers, government agencies, and universities.
Pharmaceutical Manufacturing Practices Courses
- PME 530 Introduction to Pharmaceutical Manufacturing
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.
- PME 535 Good Manufacturing Practice in Pharmaceutical Facilities Design
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.
- PME 640 Contemporary Concepts in Pharmaceutical Validation
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.
and one of the following electives:
- PME 531 Process Safety Management
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.
- PME 538 Chemical Technology Processes in API Manufacturing
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.
- PME 628 Manufacturing and Packaging of Pharmaceutical Oral Solid Dosage Products
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.
- PME 649 Design of Water, Steam and CIP Utility Systems for Pharma Manufacturing
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.
Pharmaceutical Process Engineering Graduate Certificate
The Graduate Certificate Program in Pharmaceutical Process Engineering is a 4-course program comprising: Pharmaceutical Reaction Engineering, Separation Processes in Pharmaceutical Industry, Pharmaceutical Mixing, and Design of Control Systems. The program provides practical up-to-date information and skills needed by the pharmaceutical industry process engineers and other professionals in the biopharmaceutical, food and beverage, and specialty chemical industries in their everyday work. Course content and curriculum were developed by Stevens’ faculty in collaboration with industry practitioners with expertise in the field.
This program will provide an overview and understanding of the chemical engineering principles involved in process development. Courses cover current and emerging technologies used for mixing, reaction, separation and process control. The program benefits professionals in the Pharmaceutical/Life Sciences industry including: chemical engineers, chemists, process engineers, and compliance and quality directors and managers. The credits earned can also be applied toward a Master’s Degree in Chemical Engineering or Interdisciplinary Studies.
Pharmaceutical Process Engineering Courses
- CHE 615 Separation Processes in Pharmaceutical Industry
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.
- CHE 621 Pharmaceutical Mixing
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.
- CHE 661 Design of Control Systems
This course is aimed at the application of advanced process control techniques in industry with a focus on pharmaceutical, petrochemical and power distribution applications. Topics considered include: reactor and system modeling; data collection for data regression and predictive control modeling for control systems design and operations decision support are discussed and demonstrated. State and parameter estimation techniques, optimization of reactor productivity for batch, fed-batch and continuous operations and expert systems approaches to monitoring and control are taught using standard control system programming languages. Distribution of control application functions is discussed. An overview of a complete automation project - from design to startup - of a pharmaceutical plant will be discussed.
- CHE 681 Pharmaceutical Reaction Engineering
This course will provide a fundamental understanding, and the application of emerging and current approaches to reaction engineering and catalysis in the pharmaceutical and fine chemical industries. The course will focus on promising technologies such as enzymatic catalysis and bioreactor design, chiral synthesis and kinetics, multiphase reactions, and microreactor technology with emphasis throughout on industrially relevant reactions.
