Graduate Certificate Sterile Process Manufacturing

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.