Provides Drug Manufacturers with Extensive Test Results for Tubing Comparison
Southampton, PA — AdvantaPure announces that it has completed BPOG standardized extractables testing on three of its premier tubing products. The project took several months, from the start of product testing to AdvantaPure’s receipt of finished, comprehensive reports. Test results are now available by request.
The full BPOG (BioPhorum Operations Group) standardized extractables test protocol includes 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 tests measure any compounds extracted from AdvantaPure’s tubing. All tests 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 test results provide critical information to the end user.”
Testing is complete on 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 also have full validation guides with other test reports required for use in the biopharm market. They meet various ISO and USP standards, including USP Class VI, and are certified free of animal-derived components.
The company has other products in the BPOG extractables testing process: braid-reinforced silicone tubing and liquid silicone for injection molding, as well as new tubing and LIM products targeted for use in ultra-low temperature storage applications. Final reports are expected later this year.
“The BPOG testing data is important,” adds Donovan. “Patients’ lives are at risk.”
For more information on AdvantaPure’s BPOG-tested fluid transfer products, visit https://www.advantapure.com, or contact the AdvantaPure team at 145 James Way, Southampton, PA 18966; phone 888-755-4370 or 215-526-2151; fax 888-258-4293 or 215-526-2167; e-mail: info@www.advantapure.com.
About NewAge Industries and AdvantaPure The AdvantaPure division of NewAge Industries is ISO 9001:2015 certified and specializes in high purity tubing, hose, Single-Use process tubing manifolds, BioClosure® container closure systems, and other molded components for the pharmaceutical, biopharm, biomedical, food, beverage and chemical industries. Products are manufactured, stored and shipped using methods that ensure product purity.
In business since 1954, NewAge Industries manufactures plastic and rubber tubing in reinforced and unreinforced styles. NewAge Industries maintains a large inventory of tubing and fittings for its core product lines, provides custom extrusion and fabrication capabilities, and services customers worldwide. Automated product identification systems, including gamma-stable RFID tags and labels, are offered by NewAge’s Verigenics® division. In 2006, NewAge initiated an ESOP (Employee Stock Ownership Plan) for the benefit of both its employees and customers.
