Optimization of autoclave cycles and selection of formulation for parenteral products, Part III: Effect of formulation variables on sporicidal kinetics
Wang, Y.J.; Leesman, G.D.; Lipstein, M.E.; Basch, H.I.; Monkhouse, D.C.
Journal of parenteral science and technology a publication of the Parenteral Drug Association 38(2): 78-82
1984
ISSN/ISBN: 0279-7976 PMID: 6726544 Document Number: 225737
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.