Test Process and Results of Potential Masking of Sterilizing Grade Filters

Abstract

Abstract Pre-use/Post sterilization integrity testing (PUPSIT) has been a widely debated topic for the last several years. To a large extent, the debate is due to the fact that scientific data were not available to provide additional clarity that could inform appropriate risk-based judgements and commensurate actions. To gain clarity, PDA and BioPhorum formed the Sterile Filtration Quality Risk Management (SFQRM) consortium late 2017. The consortium goals have been to fill existing gaps in scientific data as adequately as possible with studies and industry guidance that would provide professionals and license holders with the ability to make informed decisions about appropriate risk management strategies. This paper is one in a series of publications that are the result of the collaboration, and these should be considered together and viewed holistically in order to determine the best course of action with regard to PUPSIT. In total, the four papers cover the following areas • Data-mining to determine the influence of fluid properties on integrity test values • Filter masking studies and results, Part 1 (this publication) • Risk assessment and management from filter production to end-use • Points to consider in the best practice of the use of PUPSIT In total 25 manufacturers and filter suppliers have contributed to the work of the Consortium, deploying their filtration experts, pooling their collective knowledge and applied science experience to address these questions. This effort has also been supported by many independent experts currently available that have contributed to and driven the Filtration Interest Group in PDA for many years. Both PDA and BioPhorum have prioritized this program and combined their approaches to deliver this comprehensive body of work. We hope that collectively the publications aid decision making, create greater certainty and confidence and above all alignment between suppliers, manufacturers and regulators alike on these important questions.