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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

Related Categories: PEER-REVIEWED, STERILE PREPARATIONS

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