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PRESS RELEASE

Extractables Testing Complete for PharmaFocus® Premium Tubing

BPOG and USP 665 tested for single-use biopharmaceutical tubing

Carpinteria, Calif. – June 2020 – Freudenberg Medical, a global manufacturer of medical components and pharmaceutical tubing, announces the completion of extractables testing on PharmaFocus® Premium silicone tubing used in biopharma fluid processing and single-use applications. Freudenberg contracted with Eurofins to conduct independent extractables testing according to BPOG and USP 665 protocols. The two protocols include a total of 8 solvents and they were tested to the 21-day exposure timeframe.

"We understand that identifying extractable and leachable substances is extremely important for our biopharma customers," said Jeff Mohror, VP & General Manager of Freudenberg Medical Carpinteria. "When specifying tubing into a process, this data will save our customers valuable time and cost when bringing a new process into production."

Tubing that has undergone extractables testing includes PharmaFocus® Premium Silicone Tubing (ASTC), PharmaFocus® Premium Reinforced Tubing (ASTR), and PharmaFocus® Premium Peristaltic Pump Tubing (ASTP).

PharmaFocus® Premium tubing has also undergone additional physical, chemical, and biological tests. All studies were conducted by outside laboratories licensed to perform testing and meet all requirements of CGLP, FDA, CFR, Part 58, European Pharmacopoeia, ISO, and other special test requirements. Select testing has been performed on the finished products in addition to the silicone material.

Learn more about PharmaFocus® Premium biopharmaceutical tubing.

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About Freudenberg Medical

Freudenberg Medical is a global partner for the design, development, and manufacture of medical devices, components, and product solutions. With 11 manufacturing operations and more than 1,500 associates worldwide, Freudenberg Medical offers a wide range of capabilities from high precision silicone and thermoplastics components and tubing to coatings, hypotubes, and subassemblies for catheters and minimally invasive devices. www.freudenbergmedical.com

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For more information or pricing, please call +1-805-576-5375 or email Jeff Hana.

Freudenberg Medical, LLC
1110 Mark Ave.
Carpinteria, CA 93013

www.freudenbergmedical.com

© 2020 Freudenberg Medical, LLC

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