Dry Heat Sterilization of Parenteral Oil Vehicles
Author(s): Kupiec Thomas C, Matthews Parrish, Ahmad Riaz
Issue: May/Jun 2000 - Compounding for the Ear, Nose and Throat
View All Articles in Issue
Page(s): 223-224
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Abstract: The purpose of this study was to evaluate the effect of temperature
and time on the dry-heat sterilization conditions of
cottonseed, peanut and sesame-seed oils used as vehicles for parenteral
drugs. The three oils were individually spiked with
Bacillus subtilis spores and exposed to dry heat at four different
temperatures (150, 160, 170, and 180°C) for three different
time intervals (one, 1.5 and two hours). Following inoculation
and dry-heat sterilization, samples were placed in a
laminar airflow hood and processed according to <71>, “Sterility
Tests” of the USP XXIV/NF 19 using thioglycolate broth
and fluid D.1 The specimens were then placed into an incubator
at 30° C and observed for three, five and seven days for bacterial
growth. All tests were performed in triplicate. Positive
and negative controls were conducted with each group. All
three oils were found to be free of viable Bacillus subtilis following
dry-heat sterilization at 150, 160, 170 and 180°C for one,
1.5 and two hours after incubation for seven days. The positive
controls were positive for observed growth and the negative
controls had no observed bacterial growth. Dry-heat sterilization
of the three oils at 150°C for one hour appeared to be
sufficient for time and temperature conditions. However, the
authors recommend dry-heat sterilization procedures be validated
for each product.
Related Keywords:
bacillus subtilis, cottonseed oil, dry-heat, edible oils, endospores, fluid d, heat treatment, high-temperature, microbial, oil, oil vehicles, parenteral oil, peanut oil, sesame-seed oil, stability, sterilization, thioglycolate medium
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