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The effect of formulation of parenteral solutions on microbial growth--measurement of D- and z-values

Berger, T.J.; Nelson, P.A.

PDA Journal of Pharmaceutical Science and Technology 49(1): 32-41

1995

ISSN/ISBN: 1079-7440
PMID: 7757457
Document Number: 448148
In order to assess the sterilization conditions for parenteral solutions, the microbial inactivation kinetics of steam resistant spores of Clostridium sporogenes were evaluated. The D-value or death rate kinetics as well as z-values were obtained for several formulation categories of solutions employing a miniature steam retort. Amino acid and heparin solutions provided appreciable microbial resistance as demonstrated by resulting high D- and low z-values. The addition of electrolytes to carbohydrate solutions resulted in increased microbial resistance compared to carbohydrate solutions without electrolytes. A categorization of solutions and their potential impact on microbial thermal resistance will be presented.

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The effect of formulation of parenteral solutions on microbial growth--measurement of D- and z-values

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