BPOG 2020 and USP 665 – Extractables Testing of Single-Use Systems

Introduction / Background

This webinar will explore how to conduct effective extractables and leachables (E&L) testing on plastic process materials used during pharmaceutical and biopharmaceutical manufacturing. It will delve into the new BPOG and USP best practices and examine how best to avoid potential risks to the safety, efficacy and stability of pharmaceutical and biopharmaceutical products.

Objective

This presentation will summarize the key elements of E&L studies carried out on plastic process materials used during pharmaceutical and biopharmaceutical manufacturing. It will examine the recently published BioPhorum Operations Group’s 2020 best practices guide on extractables testing of polymeric single-use components used in biopharmaceutical manufacturing. It will also delve into the significant new chapters the US Pharmacopeia (USP) plans on publishing this May as well as analytical considerations associated with the standard extraction protocols recommended by both BPOG and USP. In addition, several case studies on E&L analyses of plastic process materials will be presented.

Agenda

1. Regulatory updates – USP / and BPOG
2. Standard extraction protocol considerations
3. Analytical case studies
4. Q&A

Target Audience

The webinar is aimed at:

• Managers, scientists, and engineers who are involved in the extractables and leachables field
• Manufacturers and bio/pharmaceutical manufacturers that use single-use systems
• Anyone who is interested in subcontracting E&L testing

Presenter

Dr. Dujuan Lu
E&L Manager/Global Lead

Dr. Lu has a Ph.D. in analytical chemistry and is an E&L subject matter expert (SME) with vast contract lab and medical device/pharmaceutical industry experience. Dr. Lu has previously worked on over 500 E&L projects across a broad range of packaging systems.

For more information, please contact:

Josela Renardson
Global Marketing Manager
t: +44 (0) 121 541 4748