The Role of PUPSIT within the Assurance in Sterilizing Filtration

Since 1998, the EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use, Annex 1 (Manufacture of Sterile Medicinal Products) or “Annex 1” has contained the requirement for verifying the integrity of a sterilizing grade filter before use and after its sterilization. The requirement remained in the 2008 revision and in the 2017 and 2020 draft revisions to Annex 1. Concerns by European and other Health Authorities over the risk of filtration failure resulted in an increase in enforcement of this requirement. This enforcement started a discussion within the industry of the of the challenges, benefit, and aseptic process related risk of PUPSIT. The resulting debate has exposed a need for scientific evidence to support and effective risk based approach to PUPSIT use. To help meet that need, BioPhorum and the PDA formed the Sterile Filtration Quality Risk Management (SFQRM) Consortium, which has been working to provide objective, unbiased, scientific data to help guide informed decisions about sterile filtration control measures.

This will be a 90-minute Webinar to ensure ample time for questions.

This webinar will be the first in a series presenting the background of, reasons for, challenges to, and approach for mitigating the risk of sterilizing filtration, that has prompted the use of PUPSIT. Subsequent webinars will present the scientific findings resulting from these efforts and a plan for using that information to make better filtration and PUPSIT related decisions. Learn more about the three-part webinar series, The Science, Implementation, and Implications of PUPSIT in Terminal Sterilizing Filtration.