Eurofins Lancaster Laboratories conducted the independent extractables testing for Freudenberg Medical, drawing on BPOG and USP 665 protocols.
“We understand that identifying extractable and leachable substances is extremely important for our biopharma customers,“ said Jeff Mohror, VP and GM 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 undergoing extractables testing included PharmaFocus Premium Silicone Tubing (ASTC), PharmaFocus Premium Reinforced Tubing (ASTR), and PharmaFocus Premium Peristaltic Pump Tubing (ASTP).
Freudenberg Medical also put the PharmaFocus Premium tubing through additional physical, chemical and biological tests.
Outside laboratories conducted all of the studies. The laboratories have licenses to perform testing and meet all requirements of CGLP, FDA, CFR, Part 58, European Pharmacopoeia, ISO and other special test requirements.
There was also select testing on finished products in addition to the silicone material.