Medical tubing maker AvantaPure has completed its BioPhorum Operations Group standardized extractables testing on three of its silicone and thermoplastic elastomer tubing products.
Testing is complete on the company's AdvantaSil APST silicone tubing, AdvantaSil APHP high pressure silicone tubing, and AdvantaFlex weldable and sealable biopharmaceutical grade TPE tubing. AvantaPure, based in Southampton, Pa. and part of New Age Industries Inc., said applications for these products include bio pharmaceutical and pharmaceutical fluid transfer, virus filtration and inline integrity testing of filtration assemblies, among others.
BPOG's standardized extractables test protocol includes using six extraction solvents, each tested at four different exposure times — 30 minutes, seven days, 21 days and 70 days — using a variety of analytical techniques. The tests measure any compounds extracted from AdvantaPure's tubing. All tests were performed by a fully-accredited, third-party test laboratory.
The firm said the project took several months to complete and the results are now available by request.
"Our customers asked for BPOG extractables testing," AvantaPure Product Manager Gregg Donovan said in a statement. "They need to know what chemicals, if any, may come out of our tubing that could affect their pharmaceutical products. The test results provide critical information to the end user."
In addition to BPOG extractables test results, AvantaPure said all three materials also have full validation guides with other test reports required for use in the bio pharmaceutical market. They meet various ISO and USP standards, including USP Class VI, and are certified free of animal-derived components.
AvantaPure specializes in high purity tubing, hose, single-use process tubing manifolds, BioClosure container closure systems and other molded components for the pharmaceutical, bio pharmaceutical, biomedical, food, beverage and chemical industries. The firm is a division of NewAge Industries, which manufactures rubber and plastic tubing in reinforced and unreinforced styles.