Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy
Sterile Process Manufacturing Certificate (Pre-Master's)
Sterile products must be manufactured in a manner that eliminates or minimizes microbial contamination. Generally, sterile devices are manufactured in clean environments, while sterile drug products are manufactured using aseptic (or free from contamination) process methods where the drug substance, excipients, and vehicle (e.g., saline or water for injection) are combined and filled into a container (such as a syringe). Often times, the final dosage form cannot be sterilized at the end of the manufacturing process, since the drug substance would become degraded; sterility must be assured during the manufacturing process by using microbial controls, sterile filtration, and facility design, all of which must follow regulatory guidelines.
This four-course certificate explores the routes and types of sterile product administration, manufacturing and facility requirements for their design and production, as well as validation and compliance specifications. Attention is also focused on the technical and regulatory aspects of sterilization processes, including thermal, gaseous, radiation, filtration, and aseptic processing methods.
Students must complete two required courses:
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)
- Production of Sterile Products (5492) OR Sterilization Processes (5493)
Students also complete two electives from:
- Statistical Quality Control (5451)
- Production of Sterile Products (5492)
- Sterilization Processes (5493)
- Developmentof Sterile Products (5501)
- Vaccines: RA and QA Issues (5572)
Transfer credits are not accepted towards Temple’s certificate programs.
Brochure - Sterile Process Manufacturing
How to Obtain the Certificate when you've completed the courses:
Submit the following items to the RAQA Office (hard copy only)
2. Photocopies of your undergraduate and graduate transcripts.
3. A transcript from Temple's Banner system of courses taken in the RAQA program.
4. Notice of Completion
All materials must be received by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.
Note: Students may obtain only one certificate before completing the MS program, except for Food RA and QA.