RT Journal Article
SR Electronic
T1 The Effect of Formulation of Parenteral Solutions on Microbial Growth—Measurement of D- and Z-values
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 32
OP 41
VO 49
IS 1
A1 Thomas J. Berger
A1 Patricia A. Nelson
YR 1995
UL http://journal.pda.org/content/49/1/32.abstract
AB 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