PT  - JOURNAL ARTICLE
AU  - M. S. Korczynski
TI  - Concepts and Issues—Container/Closure Microbial Validation
DP  - 1980 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 277--285
VI  - 34
IP  - 4
4099  - http://journal.pda.org/content/34/4/277.short
4100  - http://journal.pda.org/content/34/4/277.full
SO  - PDA J Pharm Sci Technol1980 Jul 01; 34
AB  - This presentation describes technical subtleties and complexities associated with validating the sterilization of closure systems. Also presented are areas of misunderstanding and misinterpretations that occur when attempts are made to equate solution and closure sterilization. When developing closure validation studies, the micro-environment at the closure sites must be considered. The F0 value attained by the solution cannot be directly equated to the sterilization kinetics that occur at the closure areas. However, closure validation studies can be designed to evaluate the micro-environment present, and to predict the sterilization assurance afforded by the sterilization cycle.