60Co irradiation for sterilization of veterinary mastitis products containing antibiotics and steroids

Abstract

Effects of 60Co irradiation for sterilization of veterinary mastitis products were evaluated. The mastitis products which were examined contained various combinations of antibiotics and steroids suspended in peanut oil vehicle. Bioburden data indicated that the unirradiated products were only occasionally contaminated with microorganisms. The D-values of the nonsterile product and environmental isolates were 0.028, 0.15, 0.017, and 0.018 Mrads for Aspergillus fumigatus, Penicillium oxalicum, Pseudomonas aeruginosa , and Pseudomonas maltophilia , respectively. The D-value of the biological indicator organism, Bacillus pumilus spores, in the vehicle was 0.27 Mrads. Thus, an irradiation dose of 1.6 Mrads would be sufficient to achieve six log cycles of destruction of the biological indicator organism. The minimum absorbed irradiation dose of 2.5 Mrads preferred by many countries for sterilization would achieve 9.3 log cycle destruction of the indicator organism and guarantee a probability of 1 × 10 -15 assurance for the most radio-resistant product isolate, Penicillium oxalicum . In order to examine short and long term chemical stabilities of active components, stability indicating high-performance liquid chromatographic (HPLC) methods for the determination of the following antibiotics and steroids were developed. They were: dihydrostreptomycin, neomycin, novobiocin, penicillin G, hydrocortisone acetate, hydrocortisone sodium succinate, and prednisolone. The rates of degradation and radiolytic degradation schemes for the majority of these compounds were elucidated. Formation of new compounds was not observed in these antibiotics and steroids upon 60Co irradiation. The compounds that increased by irradiation were inherently present in commercially available non-irradiated lots and/or can easily be formed by either acidic, basic, or thermal treatment.