Description:
Endotoxins are notoriously resistant to destruction by heat, pH extremes and various chemical treatments. Standard autoclaving procedures will not suffice to achieve complete depyrogenation. Dry heat is frequently employed to render glassware or other containers free from pyrogens, as well as viable microbes.
The FDA “Guideliine on Sterile Drug Products Produced by Aseptic Processing” states that “any properly validated process can be acceptable” to demonstrate depyrogenation of containers and closures or glassware used in endotoxin testing is effective.
Charles River Singapore Consultancy Services can help manufacturers develop in-house protocols for depyrogenation. Charles River Singapore is also well equipped to conduct full-scale depyrogenation challenge studies.
Please enquire with us directly for a quote.