RT Journal Article
SR Electronic
T1 Optimization of Autoclave Cycles and Selection of Formulation for Parenteral Products, Part III: Effect of Formulation Variables on Sporicidal Kinetics
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 78
OP 82
VO 38
IS 2
A1 Wang, Y. J.
A1 Leesman, G. D.
A1 Lipstein, M. E.
A1 Basch, H. I.
A1 Monkhouse, D. C.
YR 1984
UL http://journal.pda.org/content/38/2/78.abstract
AB 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.