Sterile products include a wide range of commonly used products, such as intradermal (ID), intramuscular (IM), intravenous (IV), and subcutaneous (SC) products, vaccines, and products administered directly into different parts of the body, such as arteries (intra-arterial), bones (intrasternal), heart (intracardiac), or the spinal canal (intrathecal). Sterile products must be manufactured using aseptic (or free from contamination) methods wherein the drug substance, excipients, and vehicle (e.g., saline or water for injection) are combined in a container, such as a syringe. Generally, the final dosage form cannot be sterilized at the end of the manufacturing process, since the drug substance would become degraded. Therefore, sterility must be ensured during the manufacturing process by utilizing sterile filtration, microbial controls, and facility design, all of which must follow regulatory guidelines.
About this Program
Through completion of the Graduate Certificate Sterile Process Manufacturing, whether post-baccalaureate or post-master's, students of Temple University understand the following:
- routes and types of administration of sterile products;
- regulations, processes, and unique considerations involved with sterile parenteral products;
- manufacturing and facility requirements for the design and production of sterile products;
- validation and compliance specifications for sterile products; and
- methods used for sterilization, including regulatory requirements for thermal, gaseous, radiation, filtration, and aseptic processing.
- Production of Sterile Parenterals
- Sterilization Processes
- Microbiological Concepts in Pharmaceutical Manufacturing
- Development of Sterile Products
- Vaccines: Regulatory Affairs and Quality Assurance Issues
- 36 months
Start dates & application deadlines
- Apply before
- Apply before
DisciplinesPublic Health Pharmacy Health Sciences View 1913 other Masters in Health Sciences in United States
We are not aware of any academic requirements for this programme.
We are not aware of any English requirements for this programme.
- Master's Degree in Discipline/Related Discipline: Applicants completing the program to earn a post-master's certificate must hold a master's degree in a Pharmacy-related field.
- Bachelor's Degree in Discipline/Related Discipline: Applicants completing the program to earn a post-baccalaureate certificate must hold a B.S. degree in Biochemistry, Biology, Chemistry, Physics, or a health-related discipline.
International4420 USD/yearTuition FeeBased on the tuition of 1105 USD per credit during 36 months.
National4420 USD/yearTuition FeeBased on the tuition of 1105 USD per credit during 36 months.
In-State3876 USD/yearTuition FeeBased on the tuition of 969 USD per credit during 36 months.
Living costs for Philadelphia
The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.
Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.
Apply and win up to €10000 to cover your tuition fees.