Filter integrity testing is a key operation in manufacturing aseptically produced pharmaceuticals. It verifies that the filters used to sterilize liquids and gases are free from defects and leaks that could compromise sterility, and ensures the quality and safety of the product.
The updated version of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (Annex 1) published in August 2023 includes guidance for filter integrity testing and specifically the need for a pre-use post-sterilization integrity test (PUPSIT).
The BioPhorum Sterilizing Filtration Quality Risk Management Team is trying to understand how the PUPSIT requirement is being implemented across industry following the introduction of the latest version of Annex 1.
To track the implementation of PUPSIT, it has developed a set of questions for an online survey, which can be found at BioPhorum Sterile Filtration Quality Risk Management Team: 2024 PUPSIT Survey.
After gathering some basic information, the survey asks how you perform or are planning to perform PUPSIT, how inspectors review and assess the PUPSIT process, and how you are managing your PUPSIT implementation.
Please take a few minutes to fill out this survey and share your insights with us – we will publish the results on the BioPhorum website in Q2 2024. This will help us understand the challenges users are experiencing when performing filter integrity testing in manufacturing facilities. The more we know, the more we can effect change through our work program.
For more information, contact Deborah Hill, Global Change Facilitator, on firstname.lastname@example.org