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: 2â€“60.
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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: 1â€“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.