Terminal Sterilization Of Prefilled Syringes

By Thomas Ofenboeck and Christian Dallner, Syntegon

For many parenteral products, terminal sterilization is the last step in the pharmaceutical fill-finish process. The more sensitive the drugs and their primary packaging materials are, the more important this process is. This applies in particular to pre-sterilized syringes.

Due to the complex interaction between drugs, packaging material and physical laws, terminal sterilization of prefilled syringes is very demanding for the product as well as the sterilization process – and presents pharmaceutical manufacturers with numerous challenges.

Many factors need to be taken into account when terminally sterilizing liquid pharmaceuticals. This whitepaper describes which requirements must be considered regarding products and methods, and how risks can be avoided effectively.