Sterility Test

The sterility test need to be assessed by following 21 CFR 610.12 and European Pharmacopeia method (EP 7.0., 2.6.27). Procelltech applies a modified version of the traditional protocol that avoid the test execution in clean room (class B) by using a patented colorimetric technology. This method demonstrates unsurpassed recovery of a wide range of organisms with >95% recovery within 24 hours and >98% within 72 hours detects aerobic, anaerobic, and facultative anaerobic microorganisms, as well as yeast and fungi. Microorganisms multiply in the media, generating CO2. The equipment used in Procelltech detects microorganisms by tracking CO2 production taking readings 144 times a day,. As CO2 increases, the sensor in the bottle turns a lighter color. Algorithms analyze the data to determine positivity, and the laboratory is notified immediately with visual and audible alarms. This sterility method guarantee high sensitivity and affordability.