Risk Assessment for extractables/leachables for Single-use technologies implementation in the wake of USP <665>

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Thurs, 2 Sep, 2021 |

11:00 AM - 12:30 PM IST

The growing industry trend is to utilize single-use technologies throughout the biopharma manufacturing process. However, challenges to adoption remain to be addressed.

Pre-sterilized single-use systems can reduce setup and changeover times and eliminate the costs associated with cleaning and cleaning validation. These benefits have been demonstrated in the development setting and are increasingly being realized for clinical and commercial manufacturing, particularly in new hybrid and modular facility layouts that allow users to better optimize these system benefits.

Concerns remain, however, regarding assurance of quality and compliance with GMP manufacturing across the supply chain and with the potential impact of extractables on patient safety. There has been a shift to shared responsibility for quality—and therefore risk—between the end user and supplier. Addressing these concerns requires close collaboration between SU suppliers and drug product manufacturers, with clear communication regarding the requirements and expectations of both parties. Suppliers must be able to demonstrate control of their supply chains and provide assurance that SU assemblies and their components will not affect the drug product’s quality.

To understand recent advancements and regulatory expectations associated with the use of single-use technologies, Express Pharma in association with Pall Corporation will organize a webinar with the latest insights from industry experts followed by a panel discussion.

Why Attend?

Get insights about the USP <665> standardized extraction solution protocol for manufacturing components and systems
Understand how to apply USP <665> data sets to support risk assessment and qualification of single-use systems