TY - JOUR T1 - Concepts and Issues—Container/Closure Microbial Validation JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 277 LP - 285 VL - 34 IS - 4 AU - M. S. Korczynski Y1 - 1980/07/01 UR - http://journal.pda.org/content/34/4/277.abstract N2 - 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. ER -