RT Journal Article
SR Electronic
T1 Optimization of Autoclave Cycles and Selection of Formulation for Parenteral Products, Part I: Identification of Autoclave Conditions by a Nonisothermal Approach
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 68
OP 72
VO 38
IS 2
A1 Wang, Y. J.
A1 Leesman, G. D.
A1 Dahl, T. C.
A1 Monkhouse, D. C.
YR 1984
UL http://journal.pda.org/content/38/2/68.abstract
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.