Overview
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.
Key feature
Through completion of the Graduate Certificate Sterile Process Manufacturing program at Temple University, 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.
Programme Structure
Courses include
- Production of Sterile Parenterals
- Sterilization Processes
- Microbiological Concepts in Pharmaceutical Manufacturing
- Development of Sterile Products
- Vaccines: Regulatory Affairs and Quality Assurance Issues
Key information
Duration
- Full-time
- 36 months
Start dates & application deadlines
- StartingApply anytime.
- StartingApply anytime.
Fall and Spring admissions are on a rolling basis.
Language
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Credits
Delivered
Campus Location
- Philadelphia, United States
Disciplines
Pharmacy Health Sciences Production and Manufacturing Engineering View 73 other Masters in Production and Manufacturing Engineering in United StatesWhat students do after studying
Academic requirements
We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.
English requirements
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- 98 accuracy using real exam data
- 4.9/5 student rating
Other requirements
General requirements
- Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a BS degree in Biochemistry, Biology, Chemistry, Physics or a health-related discipline.
- Application form
Photocopies of all undergraduate and graduate transcripts from any schools previously attended, including Temple's RA and QA program (copies of transcripts are acceptable; official transcripts are not required)
Notice of Completion
Tuition Fees
-
International Applies to you
Applies to youNon-residents5900 USD / year≈ 5900 USD / year - Out-of-State5900 USD / year≈ 5900 USD / year
-
Domestic
Applies to youIn-State4744 USD / year≈ 4744 USD / year
Living costs
Philadelphia
The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.
Financing
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- Free visa & career support through our Path2Success program
Funding
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Scholarships Information
Below you will find Master's scholarship opportunities for Graduate Certificate Sterile Process Manufacturing.
Available Scholarships
You are eligible to apply for these scholarships but a selection process will still be applied by the provider.
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