THE RADIATION ENHANCEMENT OF THE STERILITY ASSURANCE LEVELS OF STERILE FLUIDS - A CASE-STUDY

A study was undertaken to determine the effect of low-dose gamma irrad iation on aseptically admired total parenteral nutrition (TPN) solutio ns to which large inocula of three test bacterial species, recognised as common contaminants of these products, were added. Attainable SALs of TPN solutions containing test bacteria were subsequently calculated . Results showed that a minimum absorbed radiation dose as low as 1.5 kGy improved the SAL of aseptically prepared TPN solutions from a SAL of 10(-3) to a value of less than 10(-8) for the microorganisms invest igated. No measurable changes in amino acid, electrolyte, glucose and lipid components of the solutions were detected up to a dose of 8.3 kG y. Practical experience applying this radiation treatment of TPNs rend ered excellent results leading to the routine application of the proce ss in South Africa.