Filter integrity is a fundamental element of sterility assurance during production of biopharmaceutical and vaccine products. Integrity test results are a key foundation for drug lot release, so any external element that could affect their reliability must be viewed as a critical issue. But when should a filter integrity test be performed?
This article highlights the Sartocheck 5 Plus filter integrity tester as a means to address regulatory requirements. Please fill out the form below to read the full article now.
1 Antonsen HR, et al. Technical Report 26: Sterilizing Filtration of Liquids. PDA J. Pharm. Sci. Technol. 62(5S) 2008: 2–60.
2 EU Annex 1: Manufacture of Sterile Medicinal Products. European Commission: Brussels, Belgium, November 2008; https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf.
3 ICH Q9: Quality Risk Management. US Fed. Reg. 71(106) 2006: 32105–32106; https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-3.pdf.
4 “GXP” Data Integrity Guidance and Definitions. Medicines and Healthcare Products Regulatory Agency: London, UK, March 2018; https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/687246/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf.
5 CBER/CVM/ORA. Data Integrity and Compliance with Drug CGMP Questions and Answers: Guidance for Industry. US Food and Drug Administration: Rockville, MD, December 2018; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers-guidance-industry.
6 CBER/CDER/CVM. Data Integrity and Compliance with CGMP: Guidance for Industry. US Food and Drug Administration: Rockville, MD, April 2016; https://www.fda.gov/media/97005/download.
7 Parenteral Drug Association. Points to Consider for Aseptic Processing, Part 2: May 2016. PDA J. Pharm. Sci. Technol. 57(2S) 2003: 1–72; https://store.pda.org/TableOfContents/43527_TOC.pdf.
For more information about the Sartocheck 5 Plus filter integrity tester and regulatory requirements, you can follow this link.
Corresponding author Magnus Stering is senior product and project manager at Sartorius Stedim Biotech in Paris, France; Magnus.firstname.lastname@example.org. Sartocheck is a registered trademark of Sartorius Stedim Biotech SA.