White Paper: Risk-Based E&L Strategies For Bioprocessing Single-Use Systems

The biopharmaceutical industry has widely adopted single-use systems (SUS) for their efficiency, reduced contamination risk, and streamlined validation. SUS applications range from media bags and tubing to connectors, filters, columns, and bioreactors. While these innovations enhance production and minimize risks, leachables from the plastic materials may compromise product quality and end-user safety. Consequently, extractables and leachables studies on process components are mandatory, but navigating the relevant guidance, such as that from USP <655>/<1665> or BioPhorum Operations Group, can be complex.

This white paper delves into the risks due to leachables associated with bioprocessing SUS and explores risk-based strategies for their mitigation. We will navigate the evolving regulatory landscape and explore best practices for extractables and leachables (E&L) testing. 

Download our white paper now to get the knowledge you need to ensure the safety and quality of your biopharmaceutical products in the era of single-use technology