AdvantaPure, the UK-based high purity tubing and moulded components specialist, has completed full BPOG extractables testing of its premier products. The tests are imperative for ensuring patient safety as any chemical from the tubing could have an adverse affect on the treatment passing through.
AdvantaPure has ISO 9001:2015 certification and specialises in components for the pharmaceutical, biopharm, biomedical, food, beverage and chemical industries. Products tested include: AdvantaSil APST silicone tubing, AdvantaSil APHP high pressure silicone tubing, and weldable and sealable AdvantaFlex biopharmaceutical grade TPE tubing.
BioPhorum Operations Group (BPOG), who bring senior leaders of the biopharma industry together to solve key problems around patient risk, was enlisted to perform the tests.
The full BPOG standardised extractables testing took several months to complete. The tests include using six extraction solvents, each tested at four different exposure times – 30 minutes, 7 days, 21 days and 70 days – using a variety of analytical techniques.
The results, that are available on request, were performed by a fully-accredited, third-party test laboratory.
"Our customers asked for BPOG extractables testing," notes Gregg Donovan, AdvantaPure’s Product Manager. "They need to know what chemicals, if any, may come out of our tubing that could affect their pharmaceutical products.
"The BPOG testing data is important. Patients’ lives are at risk," commented Gregg Donovan, AdvantaPure’s Product Manager
Under scrutiny was the company's AdvantaSil APST silicone tubing, AdvantaSil APHP high pressure silicone tubing, and weldable and sealable AdvantaFlex biopharmaceutical grade TPE tubing.
Applications for these products involve biopharm 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 include full validation guides with other test reports required for use in the biopharma market.
The products also meet various ISO and USP standards, including USP Class VI, and are certified free of animal-derived components.
Advantapure has other products in the BPOG extractables testing process: braid-reinforced silicone tubing and liquid silicone for injection moulding, as well as new tubing and LIM products targeted for use in ultra-low temperature storage applications. Final reports are expected later this year.