What Is The Position Of Regulatory Authorities On Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)?

A critical step in the aseptic processing of medicinal products is the development of an effective contamination control strategy (CCS). This strategy is essential for reducing or eliminating potential risks to the quality of the drug product. One important component of a CCS is pre-use post-sterilization integrity testing (PUPSIT). PUPSIT is a method by which manufacturers can ensure the sterility of drug products that require aseptic processing. As regulatory bodies continue to update their guidelines for maintaining sterility, manufacturers must adapt to meet the appropriate standards for sterile filter integrity testing. These guidelines vary across different regions and countries, and it is crucial for manufacturers to stay informed about the most current requirements. Developing a robust CCS and adhering to updated regulatory guidelines are vital for maintaining the sterility and quality of medicinal products.

Discover how implementing PUPSIT and other integrity testing methods can help manufacturers significantly reduce the risk of contamination and ensure the safety of their drug products.