Test Process and Results of Potential Masking of Sterilizing-Grade Filters

References

1. 1.↵
   PDA Drug Association Inc. Technical Report No. 26: Liquid Sterilizing Filtration; Bethesda, MD, 2008.
2. 2.↵
   U.S. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Processes. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2004.
3. 3.↵
   International Organization for Standardization, ISO 13408-2:2003(E): Aseptic Processing of Health Care Products—Part 2: Filtration. ISO: Geneva, 2003.
4. 4.↵
   Ministry of Health, Labour and Welfare of Japan, Sterile Drug Products Produced by Aseptic Processing, Tokyo, 2005.
5. 5.↵
   Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S), Recommendation on the Validation of Aseptic Processes (PI 007-2) PIC/S: Geneva, 2004
6. 6.↵
   European Commission, EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. European Commission: Brussels, 2008.
7. 7.↵
   European Medicines Agency, EU GMP Guide Annexes: Supplementary Requirements: Annex 1: Manufacture of Sterile Medicinal Products 1. Question (H+V June 2007): How should the integrity of sterilising filters be verified? https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers (accessed XX).
8. 8.↵
   Sterilizing Grade Filters and PUPSIT—A Statement From 4 Filter Manufacturers, PDA Letter, April 2018.
9. 9.↵
   ASTM International, ASTM F838-15 (Revised 1988, 2005, 2015) Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration, ASTM: West Conshohocken, PA, 1983.
10. 10.↵
    Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT). PDA Journal, unpublished work.