Leachables: Best practices guide for evaluating leachables risk from polymeric single-use systems

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's 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 four sections focusing on risk assessment, leachables study design, analytical methods and lessons learned from experience.

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Technology Strategy
Buffer stock blending system
Knowledge management
Technology adoption
Operations
Change notification
Closure playbook
Extractables and leachables
In-Line Monitoring and Real-Time Release
Raw materials
Regulatory Governance and External Partners
Single-use systems
Annex 1
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Digital plant maturity model
IT for cell and gene therapies
Lab of the future
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