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BIOPHORUM BEST PRACTICES GUIDE FOR EXTRACTABLES …

BIOPHORUM best PRACTICES GUIDE for EXTRACTABLES testing of single-use components 1 CONNECT COLLABORATE ACCELERATETMBIOPHORUM BEST PRACTICES GUIDE FOR EXTRACTABLES TESTING OF POLYMERIC SINGLE-USE COMPONENTS USED IN BIOPHARMACEUTICAL MANUFACTURING TM BIOPHORUM Operations Group Ltd | April 2020 BIOPHORUM best PRACTICES GUIDE for EXTRACTABLES testing of single-use components 2 Contents .. Introduction ..7 Updates to BIOPHORUM EXTRACTABLES Application of EXTRACTABLES data ..9 Scope ..9 Component family and assembly family testing .. EXTRACTABLES studies ..11 Addressing variability ..12 Extraction solvents, exposure times, and exposure temperatures ..12 Analytical methods ..16 Liquid chromatography mass spectrometry ..17 Gas chromatography mass spectrometry with direct injection ..18 Gas chromatography mass spectrometry with headspace injection.

SUS extractables testing data and leachables evaluation are used by end-users to assess and control potential risks to patients that the use of SUS components in product manufacturing may pose10, 11. Extractables testing study data provided …

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RAW MATERIAL RISK ASSESSMENTS - BioPhorum

www.biophorum.com

Table 2: Raw material risk categories, published in Managing Raw Materials in the QbD Paradigm, Part 1: Understanding Risks article, co-authored by Duncan Low in BioPharm International Volume 23, Issue 11, was a foundational inspiration for the development of the qualification categories.

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HPLC Sample Preparation - Sartorius

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removes particles, without adding any extractables or leachables to your sample. The right membranes to filter samples with special properties or low volumes Rely on over 30 years of proven Minisart ® quality for all your sample properties. Minisart® syringe filters l RC membrane for aqueous solutions and solvents

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Guideline on Inhalational medicinal products

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safety testing (e.g., for excipients and leachables) is also addressed. Additional quality aspects (e.g., impurities, process validation, stability testing, specifications) as well as safety and efficacy aspects, are described in other guidance documents, including ICH guidelines.

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