Millipore Sigma Life Science Research, 17 Cherry Hill Drive, Danvers, MA 01923.
Meissner Filtration Products, 1001 Flynn Road, Camarillo, CA 93012 USA.
PDA J Pharm Sci Technol. 2020 Sep-Oct;74(5):509-523. doi: 10.5731/pdajpst.2019.011189. Epub 2020 May 28.
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 because of 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, the Parenteral Drug Association (PDA) and BioPhorum Organizations Group (BioPhorum) formed the Sterile Filtration Quality Risk Management (SFQRM) consortium in 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: (1) data mining to determine the influence of fluid properties on integrity test values, (2) filter masking studies and results (this publication), (3) risk assessment and management from filter production to end use, and (4) 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 and pooling their collective knowledge and applied science experience to address these questions. This effort has also been supported by many independent experts currently available who have contributed to and driven the Filtration Interest Group in the 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 and create greater certainty and confidence and above all alignment between suppliers, manufacturers, and regulators alike on these important questions.
预使用/后灭菌完整性测试（PUPSIT）是过去几年中备受争议的话题。在很大程度上，之所以存在争议，是因为缺乏科学数据，无法提供更多的明确信息，以便做出基于风险的适当判断和相应的决策。为了澄清这一问题，2017 年末，美国注射剂协会（PDA）和生物制药工业联合会组织（BioPhorum）成立了无菌过滤质量风险管理（SFQRM）联盟。该联盟的目标是尽可能利用研究和行业指南来填补科学数据中的现有空白，为专业人员和许可证持有者提供能力，使其能够对适当的风险管理策略做出明智的决策。本文是合作成果系列出版物之一，这些出版物应综合考虑，全面看待，以确定 PUPSIT 的最佳行动方案。这四篇论文涵盖了以下四个方面：（1）数据挖掘以确定流体特性对完整性测试值的影响；（2）过滤掩蔽研究和结果（本文）；（3）从过滤生产到最终使用的风险评估和管理；（4）在 PUPSIT 使用的最佳实践中需要考虑的要点。共有 25 家制造商和过滤供应商参与了联盟的工作，他们部署了自己的过滤专家，汇集了他们的集体知识和应用科学经验，以解决这些问题。这项工作还得到了许多独立专家的支持，这些专家多年来一直为 PDA 的过滤兴趣小组做出贡献并推动其发展。PDA 和 BioPhorum 都将这一计划列为优先事项，并结合各自的方法，提供了这一全面的工作成果。我们希望这些出版物能够共同为决策提供帮助，并为这些重要问题创造更大的确定性和信心，最终实现供应商、制造商和监管机构之间的一致。
