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Extractables and leachables

Best practices guide for evaluating leachables risk from polymeric single-use systems used in biopharmaceutical manufacturing

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Independent industry surveys have shown that concerns about extractables and leachables are the number one barrier to implementing disposables technologies.There is clear regulatory guidance around what is required by regulatory authorities such as the EMA, yet to date there has been limited or no information (consensus or best practice) on how companies should do this.

BioPhorum Operations Group’s (BPOG) Leachables team is a collaboration of representatives from 17 major biopharmaceutical manufacturers seeking to close this gap. The best practices guide for evaluating leachables risk from polymeric single-use systems used in biopharmaceutical manufacturing represents the consensus position of this team of experts and key opinion leaders. The guide is in 4 sections focusing on risk assessment, leachables study design, analytical methods and lessons learned from experience.

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