PT  - JOURNAL ARTICLE
AU  - Berger, Thomas J.
AU  - May, Thomas B.
AU  - Nelson, Patricia A.
AU  - Rogers, Gloria B.
AU  - Korczynski, Michael S.
TI  - The Effect of Closure Processing on the Microbial Inactivation of Biological Indicators at the Closure-Container Interface
DP  - 1998 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 70--74
VI  - 52
IP  - 2
4099  - http://journal.pda.org/content/52/2/70.short
4100  - http://journal.pda.org/content/52/2/70.full
SO  - PDA J Pharm Sci Technol1998 Mar 01; 52
AB  - 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.Copyright © Parenteral Drug Association. All rights reserved.