RT Journal Article
SR Electronic
T1 The Application of Response Surface Methodology to Sterilization Process Development and Validation of a Water Cascade Autoclave
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 83
OP 94
VO 53
IS 2
A1 Thomas D. Murphy
A1 Joanne Hokes
A1 Theresa C. Green
A1 Anthony M. Cundell
YR 1999
UL http://journal.pda.org/content/53/2/83.abstract
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).