Abstract
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°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.
Footnotes
- Received July 18, 1997.
- Accepted November 20, 1997.
- Copyright © Parenteral Drug Association. All rights reserved.
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