Many of you may already know that the FDA has relaxed its sterility test requirements for biologics. Several sites have commentary, including here and here. The most encouraging bit of information is that the FDA cited advances in analysis methods (i.e. Rapid Methods) as a reason for the change.
“..Advances in technology in recent years have allowed the development of new sterility test methods that yield accurate and reliable test results in less time and with less operator intervention than the currently prescribed methods….Manufacturers may benefit from using such sterility test methods with rapid and advanced detection capabilities.”
This change in sterility requirements is an exciting development for those of us in the rapid microbial testing business. With our upcoming 2013 release of the Growth Direct™ System for Sterility, Rapid Micro Biosystems will be able to provide companies with the type of rapid sterility tests that can detect positive results in hours and final results in about half the time. As a growth-based method, the sample will be available at the end of the test for further analysis and identification. Sample capture will mimic the existing, traditional method, simplifying any training.
We are enthusiastic about the relaxed sterility requirements for biologics and look forward to working closely with companies that choose the Growth Direct™ for Sterility.
Rapid Micro Biosystems will be hosting half-day workshops at our offices in Bedford, MA. Participants will have the opportunity to gain hands-on experience with the new technologies. Space is limited, so check available dates here.