PT - JOURNAL ARTICLE AU - Thomas D. Murphy AU - Joanne Hokes AU - Theresa C. Green AU - Anthony M. Cundell TI - The Application of Response Surface Methodology to Sterilization Process Development and Validation of a Water Cascade Autoclave DP - 1999 Mar 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 83--94 VI - 53 IP - 2 4099 - http://journal.pda.org/content/53/2/83.short 4100 - http://journal.pda.org/content/53/2/83.full SO - PDA J Pharm Sci Technol1999 Mar 01; 53 AB - The application of Response Surface Methodology (RSM) to the performance validation of a water cascade sterilizer is described. The methodology was successfully used to 1) identify the cold and hot zones within maximum load configurations through three dimensional thermal mapping, 2) demonstrate the consistency of consecutive sterilization cycles in companion sterilizers, and 3) set target sterilizing values (F0) to achieve a high statistical assurance that any location will be above a minimum F0 (sterility assurance) and below a maximum F0 (for stability considerations).