Research ArticleResearch
Test Process and Results of Potential Masking of Sterilizing-Grade Filters
Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph and Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 509-523; DOI: https://doi.org/10.5731/pdajpst.2019.011189
Stephanie Ferrante
1Millipore Sigma Life Science Research, 17 Cherry Hill Drive, Danvers, MA 01923;
Leesa McBurnie
2Meissner Filtration Products, 1001 Flynn Road, Camarillo, CA 93012 USA;
Mandar Dixit
3Sartorius Stedim North America Inc., 5 Orville Dr., Bohemia, NY 11716;
Brian Joseph
4Pall Corporation World Headquarters, 25 Harbor Park Drive, Port Washington, NY 11050; and
Maik Jornitz
5G-CON Manufacturing Inc., 6161 Imperial Loop, College Station, TX 77845

References
- 1.↵PDA Drug Association Inc. Technical Report No. 26: Liquid Sterilizing Filtration; Bethesda, MD, 2008.
- 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.↵International Organization for Standardization, ISO 13408-2:2003(E): Aseptic Processing of Health Care Products—Part 2: Filtration. ISO: Geneva, 2003.
- 4.↵Ministry of Health, Labour and Welfare of Japan, Sterile Drug Products Produced by Aseptic Processing, Tokyo, 2005.
- 5.↵Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S), Recommendation on the Validation of Aseptic Processes (PI 007-2) PIC/S: Geneva, 2004
- 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.↵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.↵Sterilizing Grade Filters and PUPSIT—A Statement From 4 Filter Manufacturers, PDA Letter, April 2018.
- 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.↵Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT). PDA Journal, unpublished work.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
Test Process and Results of Potential Masking of Sterilizing-Grade Filters
Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph, Maik Jornitz
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 509-523; DOI: 10.5731/pdajpst.2019.011189
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