BPOG Extractables Testing of AdvantaPure(R)’s Key Silicone and TPE Tubing Products is Complete; Test Results Help Drug Manufacturers Compare Tubing
BioPhorum Operations Group extractables testing was recently completed on several AdvantaPure tubing and hose items. The fluid transfer products are typically used in biopharm and pharmaceutical manufacturing processes. Standardized extractables test protocol was followed and performed by an independent lab. The comprehensive testing was undertaken by AdvantaPure to meet customer requests.
- Philadelphia, PA-NJ (1888PressRelease) May 30, 2019 - BPOG testing has been completed on AdvantaPure's primary product lines. The full BPOG (BioPhorum Operations Group) standardized extractables test protocol, involving six extraction solvents, tested to four different exposure times – 30 minutes, 7 days, 21 days and 70 days – and involving several analytical techniques, was performed by a fully-accredited, independent test lab.
“Some tubing manufacturers aren’t testing to the full 70 day time period,” noted Gregg Donovan, AdvantaPure’s Product Manager. “But many of our customers wanted complete testing, not a truncated and extrapolated version. We made the commitment and investment for full testing to satisfy our customers’ needs.”
Donovan added, “It’s important because, ultimately, lives are at risk.”
Tested AdvantaPure products include:
- AdvantaSil(R) APST unreinforced silicone tubing
- AdvantaSil APSH braid-reinforced silicone hose liner
- AdvantaSil APHP high pressure unreinforced silicone tubing
- AdvantaSil APLT ultra low temperature unreinforced silicone tubing
- AdvantaFlex(R) biopharmaceutical grade, unreinforced TPE tubing
- Silicone for liquid injection molding (used in the manufacture of molded silicone tubing assemblies)
- Ultra low temperature silicone for liquid injection molding
Full BPOG testing on another silicone product, AdvantaSil APSPG pump grade tubing, is underway, and final reports are expected within the next several weeks. Testing and comprehensive reporting typically involves several months.
AdvantaPure products have undergone additional physical, chemical, and biological testing and meet standards for USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.1.9 and NSF (National Sanitation Foundation). The products are also certified free of animal-derived components.
End users and integrators can request a product validation report, which includes full BPOG test results, through AdvantaPure’s website at www.advantapure.com/validation-request.htm.
For more information on AdvantaPure’s BPOG-tested fluid transfer products, visit www.advantapure.com or contact the AdvantaPure team by phone at 888-755-4370 or 215-526-2151; e-mail: info ( @ ) advantapure dot com; fax: 888-258-4293 or 215-526-2167 or at 145 James Way, Southampton, PA 18966 dot
Learn more about the BioPhorum Operations Group at www.biophorum.com/.
About AdvantaPure and NewAge(R) Industries
The AdvantaPure division of NewAge Industries is ISO 9001:2015 certified and specializes in high purity tubing, hose, Single-Use process tubing manifolds, BioClosure(R) 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. The company 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(R) division. BrewSavor(TM) by NewAge Industries provides tubing and hose for craft beer, homebrew and other beverage transfer applications.
In 2006, NewAge initiated an ESOP and became an employee owned company for the benefit of both its employees and customers. NewAge is a solar powered, zero landfill organization committed to continually minimizing its environmental impact.
AdvantaFlex(R), AdvantaSil(R), BioClosure(R), BrewSavor(TM), NewAge Industries AdvantaPure(R), Verigenics(R), and NewAge(R) are trademarks of NewAge(R) Industries, Inc.
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