Enhancement of microbiological safety levels of aseptically admixed total parenteral nutrition solutions through low-dose gamma irradiation |
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| Authors: | H. J. Koornhof FRCPath,,M. Isaä cson MD,DSc,,J. Saunders MT,,C. J. van,Wyk DSc,A. F. Kotzé BPharm,MSc,I. C. Rosekilly BPharm,&dagger T. A. du,Plessis DSc&Dagger |
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| Affiliation: | Department of Medical Microbiology, The South African Institute for Medical Research, Johannesburg, South Africa;*Department of Pharmaceutics, Potchefstroom University, Potchefstroom;†Isotec Nutrition (Pry) Ltd, Johannesburg;‡Gammatron (Pry) Ltd. Pretoria. |
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| Abstract: | This study was undertaken to determine the effect of low-dose gamma irradiation on aseptically admixed total parenteral nutrition (TPN) solutions to which large inocula of three test bacterial species were added. Microbiological safety levels were quantified in terms of sterility assurance levels (SALs), indicating the probability of contamination occurring expressed as 10-n. The radiation sensitivity (D10 values) of test bacteria in TPN solutions inoculated with a series of bacteria recognized as common contaminants of these products, was determined. Attainable SALs of TPN solutions containing test bacteria were subsequently calculated from the D10 values. Results showed that a minimum absorbed radiation dose as low as 1.5 kGy improved the SAL of aseptically prepared TPN solutions from a probability value of 10-3 to a value of less than 10-8 for the microorganisms investigated. At an absorbed dose as high as 8.3 kGy, no measurable changes in amino acid, electrolyte, glucose and lipid components of the solutions were detected. These findings have important implications for the enhancement of microbiological safety levels of aseptically prepared intravenous fluids in general. |
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