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.
James Hathcock, Ph.D.
Senior Director, Regulatory and Validation ConsultingTeam