Sterile Process Manufacturing
Available at Pre- and Post-Master's Levels
Pre-Master's Certificate in Sterile Process Manufacturing
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)
Post-Master's Certificate in Sterile Process Manufacturing
Graduates of our MS in RAQA degree are welcome to complete the Post-Master’s Certificate in Sterile Process Manufacturing. Four courses beyond the MS are required to receive this Certificate. Please refer to the brochure for required and elective courses. If one (or more) of those courses were already completed as part of the MS, the student may substitute another course from the list of accepted courses. Courses taken for the completion of the MS degree will not be counted. Students must apply for the Certificate before taking any courses.
Only the following courses may be taken towards completion of the program:
Microbiological Concepts in Pharmaceutical Manufacturing (5512)
Production of Sterile Products (5492) OR Sterilization Processes (5493)
Two electives from:
Statistical Quality Control (5451)
Production of Sterile Products (5492)
Sterilization Processes (5493)
Development of Sterile Products (5501)
Vaccines: RA and QA Issues (5572)
Master’s Students from Other Accredited Schools in the U.S.
If you did not receive the MS in RAQA from Temple University, you are required to complete five courses to receive the Post Master's Certificate in Sterile Process Manufacturing. Please refer to the Brochure regarding course choices. You must have sufficient industry experience and familiarity with basic tenets of RAQA to pursue the Temple University Post Master's Certificate in Sterile Process Manufacturing.
Formal permission to pursue the Post-Master's Certificate in Sterile Process Manufacturing must be received from the Assistant Dean before the student starts any courses in the Advanced Certificate program.