Freudenberg Medical, a global manufacturer of medical devices, components, and tubing products for the pharma/biopharma industry, has announced the availability of a full Compendium of material tests and results for the PharmaFocus® Premium brand of silicone tubing.

PharmaFocus® Premium is a high purity silicone tubing fabricated using a premium silicone raw material specifically formulated to meet the demanding requirements of pharmaceutical, bioprocessing, and peristaltic pump applications.

“The Compendium tests provide companies with the results they need to confidently use PharmaFocus® Premium in their processing,” said Jeff Hana, National Sales Manager Extrusion at Freudenberg Medical.  “The testing verifies the purity of this tubing and provides the foundation for product specific testing to build upon.”  The Compendium is available to customers upon request and covers two products: PharmaFocus® Premium Silicone Tubing and PharmaFocus® Premium Peristaltic Pump Tubing.

All studies were performed by outside, non-biased laboratories licensed to perform testing to FDA, 21 CFR Part 58 / cGLP, US Pharmacopoeia (USP), European Pharmacopoeia, ISO and other applicable requirements.  Select testing has been performed on the finished products in addition to the silicone material.  Tests include systemic toxicity, sensitization, cytotoxicity, genotoxicity, implantation, endotoxins, particulate analysis, and chemical characterization