Best Practices Guide For Evaluating Leachables Risk From Polymeric Single-Use Systems

Independent industry surveys consistently highlight extractables and leachables as the primary obstacle to adopting disposable technologies in biopharmaceutical manufacturing. While regulatory bodies like the EMA provide clear guidance on requirements, there's been a notable lack of consensus or best-practice information on how companies should meet these directives.

To bridge this critical gap, BioPhorum's Leachables team, a collaborative effort of representatives from 17 leading biopharmaceutical manufacturers, has developed a critical resource. Their best practices guide for evaluating leachables risk from polymeric single-use systems offers a consensus position from this team of experts and key opinion leaders.

The guide is structured into four comprehensive sections:

• Risk Assessment: Provides a framework for evaluating potential risks associated with leachables.
• Leachables Study Design: Offers guidance on designing effective studies to identify and quantify leachables.
• Analytical Methods: Details appropriate analytical techniques for leachables testing.
• Lessons Learned from Experience: Shares practical insights and experiences from the field.