Transcription of BIOPHORUM BEST PRACTICES GUIDE FOR EXTRACTABLES …
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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.
The extractables testing conducted was not consistent between suppliers and was not presented in a way that enabled users to interpret and compare test data from different SUS suppliers or qualify SUS equipment. In response to this, a proposal outlining standardized methods for extractables testing of SUS components was
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