RT Journal Article
SR Electronic
T1 The Effect of Closure Processing on the Microbial Inactivation of Biological Indicators at the Closure-Container Interface
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 70
OP 74
VO 52
IS 2
A1 Berger, Thomas J.
A1 May, Thomas B.
A1 Nelson, Patricia A.
A1 Rogers, Gloria B.
A1 Korczynski, Michael S.
YR 1998
UL http://journal.pda.org/content/52/2/70.abstract
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.