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Single-use bag extractable case study: Lessons learned
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
  • Jayanthi Grebin, Entegris
  • Mike Johnson, Entegris
Publication Date
10-20-2015
Conference Dates
October 18-21, 2015
Abstract

A supplier's ability to furnish extractable data from single-use components and systems to end users is of extreme importance. The data allows an end user to effectively assess the risk these extractables have on process fluids and final drug products. The protocols followed to produce such data are currently a point of discussion between suppliers and end users. In this case study, single-use bags were subjected to a portion of the BioPhorum Operations Group (BPOG) extractable protocol. This poster documents the testing process and lessons learned when executing such an evaluation, along with suggestions to improve the uniformity of the process.

Citation Information
Jayanthi Grebin and Mike Johnson. "Single-use bag extractable case study: Lessons learned" (2015)
Available at: http://works.bepress.com/mike-johnson/11/