BPOG Protocol Testing
The BioPhorum Operations Group (BPOG) is an industry collaboration of the world's leading biopharmaceutical companies. In 2014, BPOG published a protocol titled "Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing". This protocol prescribes standardized extractables testing for all single-use systems, allowing for comparison of profiles amongst various products. It was designed to harmonize extractables testing across vendors. Product types listed in this protocol include Bags, Tubing, Connectors, Filters, Filtration Cassettes, Sensors, Valves, Gaskets, O-rings, Mixer parts, and Filling Needles.
In the second half of 2016, BPOG member companies began sending User Requirement Packs to their vendors. These packs notified vendors of the requirement that all single use systems must be tested per the Standardized Extractables Protocol as of January 1st, 2017. The packet also includes a questionnaire and spreadsheet for capturing the extractables data.
We Can Help
Navigating the testing requirements in this protocol can be difficult. Boston Analytical is working to educate vendors on this protocol, and develop appropriate strategies to respond to these new requirements. Extractables testing (under any protocol) is time consuming, and therefore compliance as of January 1st is not possible for most vendors. We are working with manufacturers and wholesalers to develop test plans for their products. We leverage our experience in the industry to develop test plans that align both the capabilities and expectations of the industry. We have experience working with all types of products and materials, and our state-of-art laboratory capabilities ensure the highest quality data is provided. We offer services ranging from consulting help through full extractables testing per the protocol.
Please contact us today if you have any questions regarding this test protocol, would like help in developing an appropriate test plan, or a quotation to perform extractables testing.