The effect of closure processing on the microbial inactivation of biological indicators at the closure-container interface.

Two biological indicators are routinely used by the Hospital Products Division to demonstrate the sterilization of the closure-container interface. The use of a moist heat (Clostridium sporogenes) and a dry heat (Bacillus subtilis) biological indicator allows a better understanding of the parameters that impact sterilization of the closure-container system. The ability to sterilize a given closure-container interface is defined in large part by closure moisture and product time above 100 degrees C. The data will demonstrate several different means to alter these two key factors, thereby enhancing sterilization of the closure-container interface. A categorization of closure types and processing parameters allows for more efficient cycle development in the R&D facility and a higher success rate for the final subprocess validation in the manufacturing steam vessels.