Virtual 2021 PDA Annual Meeting - The Ever Changing-World of Extractables and Leachables, Part 2

Join global industry and regulatory experts as they discuss Extractables and leachables E&L hot topics on pharmaceuticals, biopharmaceuticals and medical devices.  In this Covid 19 world there are urgent testing requirements to help battle this pandemic. This webcast will give you an insight to this ever-changing world of E&L.

Listen to James Hathcock at 11.25 am EST | 4.25 pm GMT | 5.25 pm CET on  Selection and Qualification of Bioprocess Single-Use Systems using Standardized Data.  What to Check and When to Test.

Abstract

Gamma sterilization of single-use systems used in biologics manufacturing, is facing increasing capacity and business continuity constraints driving the need to qualify alternate sterilization approaches within the next 2 to 3 years. With advancements in accelerator technologies, X-ray sterilization is now a mature sterilization technology being used for sterilization of medical devices, with the basic requirements well-described within the tenants of ISO11137. Herein we risk assess similarities and differences in X-ray and gamma irradiation, leading to an industry risk assessment approach supporting qualification of X-ray sterilization for single-use consumables. In addition to sharing the rationale behind the qualification approach, data will be shared evaluating materials attributes of typical single-use components following X-ray and gamma sterilization, including sterility, integrity, extractables, integrity, and performance data. As single-use systems are highly customized to individual drug manufacturing operations, qualification of x-ray sterilization for biotech applications will require strong cross-industry education, cooperation and sharing of results to ensure a comprehensive solution.

What you will learn :

• Urgency needed to evaluate and qualify sterilization modalities to supplement gamma
• Share learnings from current industry efforts to qualify X-ray (BPSA, BPOG, NPPL, etc)
• Socialize material attribute data comparing impact of X-ray to gamma on single-use materials
• Drive industry consensus approach for evaluation and qualification of x-ray