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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.

and compliance with good manufacturing practice (GMP) whether the equipment is of traditional design or is single use. As a biopharmaceutical company moves a new drug molecule candidate through the clinical development process, a position on the drug candidate and manufacturing process is developed and filed with regulatory agencies.

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