Freudenberg Medical, a global contract manufacturer of medical device components and pharmaceutical tubing, has announced the completion of extractables testing on PharmaFocus Premium silicone tubing.
The tubing is used in biopharma fluid processing and single-use applications.
Freudenberg worked with Eurofins Lancaster Laboratories to conduct independent extractables testing according to BPOG and USP 665 protocols. The two protocols included a total of eight solvents, and they were tested to the 21 day exposure timeframe.
Tubing that underwent extractables testing included PharmaFocus Premium Silicone Tubing (ASTC), PharmaFocus Premium Reinforced Tubing (ASTR), and PharmaFocus Premium Peristaltic Pump Tubing (ASTP).
Additionally, PharmaFocus Premium tubing underwent further 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 was also performed on the finished products, as well as to the silicone material.
Rudi Gall, general manager of Freudenberg Medical Kaiserslautern, commented: “We understand that identifying extractable and leachable substances is extremely important for our biopharma customers.
“When specifying tubing into a process, this data will save customers valuable time and cost when bringing a new process into production and will guarantee and safeguard built-in quality.“