Recommended

Sarepta’s DMD drug Elevidys issued FDA label update
Rare disease gene therapy granted European first approval
Johnson & Johnson agrees $3bn oncology acquisition
European Commission grants EU first for J&J’s Simponi biosimilar
Researchers validate approach that supports animal-based pyrogen test replacement
ON DEMAND webinar: automating QC testing for radiopharmaceutical production
Insmed secures EU approval for Brinsupri (brensocatib)
Moderna invests over $140m to onshore mRNA medicine manufacturing in US
Advertorial

AdvantaPure® completes full BPOG extractables testing of several silicone and TPE tubing products

3
SHARES

Posted: 22 June 2018 | | No comments yet

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.

 

Reserve your FREE place

 


Address the time-to-result challenge posed by short shelf-life radiopharmaceuticals.

20 November 2025 | 3:00 PM GMT | FREE Virtual Panel Discussion

This webinar showcases the Growth Direct System; an RMM (Rapid Microbial Method) that improves on traditional membrane filtration, delivering increased accuracy, a faster time to result, enhanced data integrity compliance, and more control over the manufacturing process.

Key learning points:

  • Understand the benefits of full workflow microbiology quality control testing automation in radiopharmaceutical production
  • Learn about ITM’s implementation journey and considerations when evaluating the technology
  • Find out how the advanced optics and microcolony detection capabilities of Growth Direct® technology impact time to result (TTR).

Don’t miss your chance to learn from experts in the industry – Register for FREE

 

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/.

Share via
Share via