PT - JOURNAL ARTICLE AU - Wang, Y. J. AU - Leesman, G. D. AU - Dahl, T. C. AU - Monkhouse, D. C. TI - Optimization of Autoclave Cycles and Selection of Formulation for Parenteral Products, Part I: Identification of Autoclave Conditions by a Nonisothermal Approach DP - 1984 Mar 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 68--72 VI - 38 IP - 2 4099 - http://journal.pda.org/content/38/2/68.short 4100 - http://journal.pda.org/content/38/2/68.full SO - PDA J Pharm Sci Technol1984 Mar 01; 38 AB - This report describes a method to determine optimal autoclave conditions, i.e., exposure time and temperature. Using chemical degradation and spore kill data from each complete cycle, a nonisothermal run, one can determine first-order kinetic parameters from a nonlinear least squares program. By employing these kinetic parameters, contour curves for exposure time and temperature can be constructed to represent the conditions that will produce a predetermined spore kill and degradation. The optimized conditions for autoclave sterilization are to be found in the area enclosed by these contour curves.