BPOG extractables testing of AdvantaPure®’s key silicone and TPE tubing products complete
Test results help drug manufacturers compare tubing.
BPOG testing has been completed on AdvantaPure’s primary product lines. The full BPOG (BioPhorum Operations Group) standardised 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.
“It’s important because, ultimately, lives are at risk.”
Tested AdvantaPure products include:
- AdvantaSil® 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® 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 here.
For more information on AdvantaPure’s BPOG-tested fluid transfer products, visit the website or contact the team by phone at 888-755-4370 or 215-526-2151; e-mail; fax: 888-258-4293 or 215-526-2167 or at 145 James Way, Southampton, PA 18966.