Sterilization technique and Validation Process for Prefilled Syringes | HCLTech

Sterilization technique and Validation Process for Prefilled Syringes

Sterilization refers to any process that removes, kills, or deactivates all forms of life (in particular referring to microorganisms) and other biological agents like prions present in a specific surface, object, or fluid. Prefilled syringes are now used across a wide array of therapeutics sectors outside of the traditional domains of anticoagulants and vaccines. The use of prefilled syringes is expected to accelerate over the coming decades. For the pharmaceutical manufacturing company, the advantages of prefilled syringes are minimizing drug waste, increasing product life span and enhancing market share. Prefilled syringes are the second largest medical market other than oral medication, because of the increased development of large molecule drugs.

Sterilization of Pre Filled Syringes(PFS) are carried out in multiple ways depending on the manufacturer. This document describes all possible ways of sterilizing a PFS using different Sterilization Techniques which are best suitable for the current markets. Sterility is measured by probability expressed as sterility assurance level (SAL). SAL of 10-6 is required for any medical device for usage. (A SAL of 10-6 means that there is less than or equal to one chance in a million that a particular item is contaminated or unsterile following a sterilization process). Download whitepaper to continue reading.

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