BPOG Protocol - Consistent and Comprehensive E/L Testing l VR Analytical

Review President Raymond Colton presentation: "Comparison of BPOG and USP Test Matrixes for a Hydrophilic PES Capsule Filter”

Presented at USP Workshop: Material Biocompatibility and Standard for Plastic Manufacturing Systems/Components, June 20-21, 2016

What is the BPOG Protocol?

The Extractables Work Group of the BioPhorum Operations Group (BPOG) has published an article proposing a standard set of extractable tests that each vendor should provide to the end-users.  The BPOG is asking that all product contact materials be tested for extractables by extracting with six solvents for up to 70 days in duplicate, followed by analysis using a minimum of four orthogonal analytical methods.  This extractables data will be used to help the biopharmaceutical manufacturers anticipate the level of leachables that may be present in a drug formulation.  The goal is for all single-use system (SUS) vendors to provide this extractables test data by the first quarter of 2017.

How to Get Started

To a SUS vendor, the BPOG protocol may seem intimidating with the numerous solvents, time points, test temperatures, and analytical methods proposed.  But it’s not…at least not to us. Since 2001, VR Analytical has specialized in extractables and leachables testing, and has successfully completed hundreds of comprehensive extractables studies for its supplier partners.

There are many reasons to choose VR Analytical for your BPOG testing:

  • We have already performed tests using the BPOG recommendations.
  • We have tested all of the SUS component types listed in the BPOG scope.
  • We understand the analytical challenges associated with each of the solvents.
  • We have a proven record of comprehensive and FDA-ready reporting.

Partner with the best in extractables and leachables testing. Contact VR Analytical today.