Studyportals
Postgraduate Certificate On Campus

Graduate Certificate Sterile Process Manufacturing

36 months
Duration
1105 USD/credit 4420 USD/year
1105 USD/credit 4420 USD/year
969 USD/credit 3876 USD/year
Unknown
Tuition fee
Unknown
Apply date
Unknown
Start date

About

The graduate and post-master's certificate in Graduate Certificate Sterile Process Manufacturing at Temple University  is intended to enable Regulatory Affairs and Quality Assurance (RAQA) students to receive formal recognition for studying the techniques and applicable regulations used in the development and manufacture of sterile products.

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.

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.

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

Language

English

Credits

12 alternative credits

Delivered

On Campus

Academic requirements

We are not aware of any academic requirements for this programme.

English requirements

We are not aware of any English requirements for this programme.

Other requirements

General requirements

  • 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.

Tuition Fee

To alway see correct tuition fees
  • International

    4420 USD/year
    Tuition Fee
    Based on the tuition of 1105 USD per credit during 36 months.
  • National

    4420 USD/year
    Tuition Fee
    Based on the tuition of 1105 USD per credit during 36 months.
  • In-State

    3876 USD/year
    Tuition Fee
    Based on the tuition of 969 USD per credit during 36 months.

Living costs for Philadelphia

1313 - 2284 USD /month
Living costs

The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.

Funding

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.

Our partners

Graduate Certificate Sterile Process Manufacturing
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Temple University

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