Terminal sterilization is the process of sterilizing a product in its final container. It is an important process as it ensures the product remains sterile. ... Any microbial growth that occurs while the products are in storage can affect the quality of the product and must therefore be prevented.

What does Terminal sterilization mean?

In the world of medical devices, “sterilization” is defined as a “validated process used to render product free from viable microorganisms.” Terminal sterilization is defined as the “process whereby product is sterilized within its sterile barrier system.” (10) The terminal sterilization process is considered a ...

What is the difference between terminal sterilization and aseptic processing?

The aseptic process is more carefully monitored all along production and quality is built into the drug product. Terminal sterilisation relies more on the heat treatment procedure carried out at the end of productions.