RT Journal Article SR Electronic T1 Concepts and Issues—Container/Closure Microbial Validation JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 277 OP 285 VO 34 IS 4 A1 M. S. Korczynski YR 1980 UL http://journal.pda.org/content/34/4/277.abstract 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.