STERILITY ASSURANCE FOR CLEANROOM WIPERS

Procedures specified by the Association for the Advancement of Medical Instrumentation (AAMI) are used by Texwipe and some other wiper manuf acturers to certify the sterility of sterile wipers. The tests assure that there is less than one chance in a million of having a viable par ticle on one of these sterile wipers when the package is first opened. In six of seven sets of wipers tested, the count distribution data su pported the hypothesis that the bioburden (colony-forming units, cfu, per wiper) had a Poisson count distribution, which would come from hav ing a uniform probability of finding a viable particle on each of the 30 wipers tested in the set. No evidence was found for wipers in any s et having a highly unusual level of bioburden.