Abstract
In optimizing the autoclave cycle of a parenteral product, sterilizing temperature and exposure time could both be reduced by enhancing the thermal lethality on bacterial spores through formulation changes. Consequently, less chemical degradation with an assurance of sterility could be expected. Citric acid (0.1 M, pH 2), disodium phosphate (0.1 M, pH 10), 50% propylene glycol and 50% polyethylene glycol 300 effectively enhanced the thermal lethality on Bacillus stearothermophilus spores. Sporicidal kinetic parameters were calculated by non-isothermal kinetic treatment.
- Received October 26, 1983.
- Accepted January 20, 1984.
- Copyright © Parenteral Drug Association. All rights reserved.
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