AdvantaPure now offers one of the most comprehensive portfolios of extractables testing for silicone and TPE (thermoplastic elastomer) tubing in the pharmaceutical and clean application industries. The company conducted the tests to address customer needs and to assure potential end users that its products meet or exceed stringent requirements. AdvantaPure’s tubing is used primarily for fluid flow and is available as single use molded manifold assemblies, bulk coil lengths, and assembled with sanitary fittings.
Although there are no regulations naming tests that must be carried out, AdvantaPure chose to conduct analytical extractables testing in order to help end users evaluate their products with as much information as possible. Extractables – substances that can be drawn out of a product under extreme conditions – must be known long before a section of tubing can be used in a pharmaceutical or biopharmaceutical manufacturing process. Testing is costly but necessary to demonstrate a supplier’s commitment to its customers and the purity of its products.
“We’re covering a lot of bases with our tests,” notes John Stover, AdvantaPure’s Director of New Business Development and Product Technical Director. “Customers who view our test portfolios are impressed with the level we’ve gone to, and that substantiates our credibility and reliability as a supplier. Our testing was done with forethought and a chemistry approach that relates to the end users’ conditions.”
AdvantaPure tests its tubing and reinforced hose manufactured from Class VI, platinum-cured silicone, its platinum-cured liquid injection molded silicone, and its AdvantaFlex® biopharmaceutical-grade TPE tubing. Products are tested after autoclave sterilization and gamma irradiation. Testing includes some of the fluids that AdvantaPure’s customers use in their manufacturing processes to better approximate actual conditions. Tests are conducted by outside laboratories and include those for endotoxins, particulate, pH, and polarity.
Test results are available by request through the company’s website or via phone. Customers may order a summary or a comprehensive report, which shows chemical, analytical bracketing of various test parameters. Both are complimentary and available on CD-ROM or as PDF files.