@article {Kirk89, author = {B. Kirk and R. Hambleton and H. T. Hoskins}, title = {A Model for Predicting the Stability of Autoclaved Pharmaceuticals Using Real Time Computer Integration Techniques}, volume = {39}, number = {2}, pages = {89--98}, year = {1985}, publisher = {Parenteral Drug Association (PDA)}, abstract = {The various national Phamacopoeias describe a number of sterile products, the majority of which are sterilized by {\textquotedblleft}heating in an autoclave{\textquotedblright}. Many of the products described are heat stable, however some are heat labile and therefore degrade to a certain extent during processing. This paper describes a method which makes it possible to predict to what extent a product has degraded during processing by the computerized integration of the time-temperature profile. The proposed hypothesis was verified by using as a model the decarboxylation of 2,4-dihydroxybenzoic acid in aqueous phosphate buffer, pH 7. A significant (p - 0.05) difference between the amount of degradation occurring in DHBA samples incorporated in bottles situated at the corners of a standard load matrix (28.9\% degradation) and those situated in the center (24.1\% degradation) was observed. Using autoclave cycles delivering a standard process lethality. F0 = 8, by means of different holding temperatures it was observed that {\textquotedblleft}high temperature, short time{\textquotedblright} cycles (121 {\textdegree}C/F0 = 8) produced a smaller degree of degradation (12\%) than one which employed prolonged exposure at a relatively low temperature (112 {\textdegree}C/F0 = 8; 30\% degradation). This point was further emphasized when, using computer modeling of the autoclave process techniques, it was found that only 5.8\% degradation would occur when the standard load was exposed to a chamber temperature of 150 {\textdegree}C and the cycle allowed to continue until a process lethality, F0 = 8 had been accrued.}, issn = {0006-3363}, URL = {https://journal.pda.org/content/39/2/89}, eprint = {https://journal.pda.org/content/39/2/89.full.pdf}, journal = {PDA Journal of Pharmaceutical Science and Technology} }