A Proof of Principle Study of the Terminal Sterilization of Prefilled Syringes Using A Water Cascade Process

Abstract

A new development in drug compounding is the production of ready-to-administer sterilized prefilled syringes. A challenge with these syringes is the method of terminal sterilization. There is no information available whether water cascade sterilization is a suitable method. We investigated the effect of this sterilization method on cyclic olefin (co)polymer (CCP/COC) syringes.

Keywords

• ready-to-administer
• compounding
• sterilization
• water cascade sterilization
• prefilled syringe