AdvantaPure® completes full BPOG extractables testing of several silicone and TPE tubing products
Provides Drug Manufacturers with Extensive Test Results for Tubing Comparison…
AdvantaPure announces that it has completed BPOG standardised 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) standardised 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 http://www.advantapure.com
More information about the BioPhorum Operations Group can be found at https://www.biophorum.com/.
Related topics
Analytical techniques, Bioprocessing, Bioproduction, Contract Manufacturing, Dissolution Testing, ICH guidelines, Lab Automation, Lab Equipment, Laboratory Information Management Systems (LIMS), Manufacturing, Production, QA/QC, Quality by Design (QbD)
