Regulatory Considerations Including Extractables & Leachables For Single-Use Manufacturing
The successful integration of single-use technology in biopharmaceutical processes largely depends on confidence in material selection. Familiarity with regulatory and industry standards is essential for a smooth implementation and approval process.
This presentation will cover regulatory expectations for single-use manufacturing and showcase the advantages of the Emprove® Program, including extractables data generated in line with BioPhorum (BPOG) recommendations and USP <665> guidance. Using a case study, we will explore a risk assessment approach to evaluate the requirements of extractables and leachables in a standard drug manufacturing process.
Watch this webinar to gain insights into regulatory guidance for single-use manufacturing and risk assessment strategies for single-use implementation.
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