Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption

A primary concern limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments. Experimental findings and insights from execution of both the BPOG and USP <665> extractables protocols on multiple single-use components will be shared, including similarities and differences in extraction profiles. Case studies will also be presented illustrating how Pall’s growing portfolio of BPOG extractables datasets can be used to help support component qualification and overall toxicological risk assessment for single-use systems.

Moderator

Hélène Pora, Ph.D.

 

Vice President, Single Use Technology

Pall Corporation

Speakers

James Hathcock, Ph.D.

 

Senior Director, Regulatory and Validation ConsultingTeam

Pall Biotech

Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption

White paper: A risk based approach to validation studies for sterilizing filtration.

More Biotech Webinars
Our webinars keep you informed on the latest products and technologies, current industry topics, the latest trends and a range of innovations and solutions to help continuously improve your processes.
October 2021

Integrity Assurance for Single-Use Systems An End-User’s Perspective

 

What should you consider when building an integrity control strategy for your single-use systems (SUS)? How do you overcome application challenges?

 

Join leading industry experts Charlotte Masy of GSK and Patrick Evrard from Pall Corporation to gain insights and answers in this webinar from BioPharma Asia on integrity Assurance for Single-Use Systems, an End-User’s Perspective. They will present several case studies to show how integrity concerns can be practically addressed for cGMP manufacturing applications and the results observed a few years on. 

 

Attendees will learn about:

 

  • The latest regulatory requirements for integrity assurance of SUS
  • The different technologies available to control integrity of SUS
  • Key parameters that affect integrity measurements

 

Register now for this webinar from industry experts on October 6.

 

Watch