60Co-irradiation as an alternate method for sterilization of penicillin G, neomycin, novobiocin, and dihydrostreptomycin
The effects of the use of 60Co-irradiation to sterilize antibiotics were evaluated. The antibiotic powders were only occasionally contaminated with microorganisms. The D-values of the products and environmental isolates were 0.028, 0.027, 0.015, 0.046, 0.15, 0.018, and 0.19 Mrads for Aspergillus species (UC 7297, 7298), A. fumigatus (UC 7299), Rhodotorula species (UC 7300), Penicillium oxalicum (UC 7269), Pseudomonas maltophilia (UC 6855), and a biological indicator microorganism, Bacillus pumilus spores (ATCC 27142). An irradiation dose of 1.14 Mrads, therefore, was sufficient to achieve a six-log cycle destruction of B. pumilus spores. Based on the bioburden data, a minimum irradiation dose of 1.05 Mrads was calculated to be sufficient to obtain a 10(-6) probability of sterilizing the most radioresistant isolate, Pen. oxalicum. To determine the radiolytic degradation scheme and the stability of the antibiotics following irradiation, high-performance liquid chromatographic (HPLC) methods were developed. The resulting rates of degradation for the antibiotics were 0.6, 1.2, 2.3, and 0.95%/Mrad for penicillin G, neomycin, novobiocin, and dihydrostreptomycin, respectively. Furthermore, radiolytic degradation pathways for the antibiotics were identified and found to be similar to those commonly encountered when antibiotics are subjected to acidic, basic, hydrolytic, or oxidative treatments. No radiolytic compounds unique to 60Co-irradiation were found.
- Research Organization:
- Control Analytical Research and Development, Upjohn Co., Kalamazoo, MI
- OSTI ID:
- 5697451
- Journal Information:
- J. Pharm. Sci.; (United States), Vol. 72:1
- Country of Publication:
- United States
- Language:
- English
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RADIATION STERILIZATION
Related Subjects
60 APPLIED LIFE SCIENCES
ANTIBIOTICS
RADIOSTERILIZATION
ASPERGILLUS
BACILLUS
COBALT 60
ISOTOPE APPLICATIONS
PENICILLIN
PENICILLIUM
PSEUDOMONAS
RADIATION DOSES
RADIOLYSIS
ANTI-INFECTIVE AGENTS
BACTERIA
BETA DECAY RADIOISOTOPES
BETA-MINUS DECAY RADIOISOTOPES
CHEMICAL RADIATION EFFECTS
CHEMICAL REACTIONS
CHEMISTRY
COBALT ISOTOPES
DECOMPOSITION
DOSES
DRUGS
FUNGI
INTERMEDIATE MASS NUCLEI
INTERNAL CONVERSION RADIOISOTOPES
ISOMERIC TRANSITION ISOTOPES
ISOTOPES
MICROORGANISMS
MINUTES LIVING RADIOISOTOPES
NUCLEI
ODD-ODD NUCLEI
PLANTS
RADIATION CHEMISTRY
RADIATION EFFECTS
RADIOISOTOPES
STERILIZATION
YEARS LIVING RADIOISOTOPES
560133* - Radiation Effects on Microorganisms- Radiosterilization of Medical Supplies- (-1987)
070203 - Radiation Sources- Use in Medical Supply Sterilization- (-1987)