September 15, 2018 (Vol. 38, No. 16)
The AdvantaSil™ APST silicone tubing, AdvantaSil APHP high-pressure silicone tubing, and AdvantaFlex® biopharmaceutical-grade TPE tubing recently passed BPOG (BioPhorum Operations Group) standardized extractables test protocols. These protocols included six extraction solvents, tested at four different exposure times—30 minutes, seven days, 21 days, and 70 days—using a variety of analytical techniques. Applications for these products involve biopharma and pharmaceutical fluid transfer, including those related to pumps, TFF, virus filtration, and inline integrity testing of filtration assemblies. In addition to BPOG extractables test results, all three materials also have full validation guides with other test reports required for use in the biopharma market. They meet various ISO and USP standards, including USP Class VI, and are certified free of animal-derived components.