Medical device and component manufacturer Freudenberg Medical has announced the availability of full Compendium of material tests and results for the PharmaFocus Premium brand of silicone tubing.
The product is a high purity silicone tubing fabricated using a raw material specifically formulated to meet the demanding requirements of pharmaceutical, bioprocessing, and peristaltic pump applications.
Jeff Hana, national sales manager extrusion at Freudenberg Medical said: "The Compendium tests provide companies with the results they need to confidently use PharmaFocus Premium in their processing. The testing verifies the purity of this tubing and provides the foundation for product specific testing to build upon."
The Compendium is available upon request and covers two products: PharmaFocus Premium Silicone Tubing and PharmaFocus Premium Peristaltic Pump Tubing.
All studies were performed by outside 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, sensitisation, cytotoxicity, genotoxicity, implantation, endotoxins, particulate analysis, and chemical characterisation.