GAMMA RADIATION AS A METHOD FOR STERILIZATION OF ALL-IN-ONE ADMIXTURES BAGS FOR CLINICAL USE: A STUDY OF STABILITY

International Journal of Pharmacy and Pharmaceutical Sciences(2015)

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摘要
Objective: The aim of this work was to evaluate the stability of all-in-one (AIO) admixtures exposed to gamma irradiation sterilization. Methods: The samples were divided into four groups with 10 bags each: a) Group I: control samples (bags without sterilization or inoculation with microorganisms); b) Group II: bags sterilized by gamma irradiation; c) Group III: bags inoculated and then irradiated and, d) Group IV: bags only inoculated. The following studies were performed: macroscopic analysis of admixtures; physicochemical stability; degree of lipoperoxidation (LPO), and microbiological tests. Results: Gamma irradiation sterilization was 100% effective, since no irradiated sample showed growth of microorganisms. All groups exhibited similar particle size distribution, but a longer storage time led to a smaller percentage of large particles. In general, irradiated samples showed reduced LPO. Conclusion: Gamma irradiation sterilization of these admixtures can be extended to clinical practice, as it results in physicochemically stable admixtures.
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