If there have been changes to the product but the changes are judged not to be significant, a reduced requalification consisting of a minimum of a single half cycle should be performed to verify that the process still yields a sterility assurance level
Look for a product that is sterile and validated to a Sterility Assurance Level
For a product to have a sterile label claim, it usually needs to have a Sterility Assurance Level
(SAL) of [10.sup.6].
 Proper cleaning prolongs the life of the instruments, keeps them in optimal condition and allows the Sterility Assurance Level
(SAL) to be reached more easily by reducing the bacterial load by 3[log.sub.10] and by shortening the time required to reach SAL.
In accordance with EN13060:2004+A2 2010 Section 7.1, STATIM sterilizers are tested on a microbiological basis and have proven to consistently achieve a sterility assurance level
of 10-6 (or a 6-log reduction in microorganisms) for a variety of loads (solid, hollow, hinged, etc.).