Books Contact Forms Registration Tuition

Stevens offers the four course (12 credit) Graduate Certificate in Pharmaceutical Manufacturing Practices at Raritan Valley Community College's University Center in North Branch, NJ. All graduate courses are open to qualified individuals with a bachelor's degree, who are accepted into Stevens Institute of Technology. Stevens classes meet once a week for 14 weeks.  


PME 530 Introduction to Pharmaceutical Manufacturing

Quality Assurance and regulatory issues in pharmaceutical manufacturing. Overview of chemical and biotech process technology and equipment, dosage forms and finishing systems, facility engineering, and health, safety, & environment concepts. Regulatory and legal overview. Ensuring that methods, facilities and controls used for the manufacture, processing, and packing or holding of drug products meet requirements for safety, effectiveness, identity, strength, quality and purity.

PME 531 Process Safety Management

In-depth study of 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. Course includes case studies.

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, III and their effect on plant design. Defending products against contamination. Building quality into products.

PME 540 Validation and Regulatory Affairs in Pharmaceutical Manufacturing

Validation concepts for plant, process, cleaning, sterilization,filtration, analytical methods, and computer systems;GAMP (Good Automated Manufacturing Practice), IEEESQAP, and new electronic requirements – 21 CFR Part 11.Master validation plan, IQ, OQ, and PQ protocols, and relationshipsto GMP. National (FDA) and international (EU) regulatory affairs for cGMP (current Good manufacturingPractice) and cGLP (current Good Laboratory Practice)requirements in development, manufacturing, and marketing. Handling the FDA inspection.

And one of the following two courses:

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). Batch and continuous reactors for homogeneous, heterogeneous, catalytic, and non-catalytic reactions.

PME 628 Pharmaceutical Finishing and Packaging System

Finishing and packaging systems in the pharmaceutical and health-related industries for various product and dosage forms. Unit operations, such as blending, granulating, compressing, branding, and coating for tablets, as well as blending and filling for capsules. Packaging equipment for tablet and capsule counting, capping, security sealing and banding, labeling, cartoning, and blister packing. Design tools for selection, specification, line layout, and computer simulation. Project-based design of typical packaging line for either solid dose or liquid products. Project require analysis of material flow, space constraints, operator needs, and equipment selection, resulting in CAD design layout and computer simulation. Also, development of complete documentation, including equipment specifications, capital expenditure request, purchase order, test plan, and validation documents.

New M. Eng. Course:
PME 649* Design of Water, Steam, and CIP Utility Systems for Pharmaceutical 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, reserve omosis, distillation, ultrafiltration, and ozonation systems; process considerations, including pretreatment, storage and distribution, materials of construction, microbial control, pyrogen control, and system maintenance; FDA requirements; cleanin-place systems; steam generation and distribution systems.

* PME 649 does not apply to the Graduate Certificate, but can be used for credit towards a M. Eng. in Interdisciplinary, Chemical or Mechanical Engineering.