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.

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