BPOG and USP 665 tested for single-use biopharmaceutical tubing
Carpinteria, California – Freudenberg Medical, a global contract manufacturer of medical device 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 Lancaster Laboratories 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 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.

About Freudenberg Medical Group:

Freudenberg Medical is a global CMO / CDMO with 11 manufacturing operations and more than 2,000 associates worldwide. Manufacturing capabilities range from high precision molded components and medical tubing to drug coatings, finished devices, catheter shafts and hypotubes for minimally invasive, handheld, and catheter-based devices. ISO 13485 certified quality systems and FDA registered sites are located throughout the Americas, Europe, and Asia. For more information, please visit www.freudenbergmedical.com or email: [email protected]