Abstract
The various national Phamacopoeias describe a number of sterile products, the majority of which are sterilized by “heating in an autoclave”. 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 “high temperature, short time” cycles (121 °C/F0 = 8) produced a smaller degree of degradation (12%) than one which employed prolonged exposure at a relatively low temperature (112 °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 °C and the cycle allowed to continue until a process lethality, F0 = 8 had been accrued.
- Received January 10, 1985.
- Accepted January 12, 1985.
- Copyright © Parenteral Drug Association. All rights reserved.
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