ABSTRACT
Candida parapsilosis was detected in environmental swabs and batches of total parenteral nutrition (TPN) products after routine monitoring. The isolates were analysed using randomly amplified polymorphic DNA (RAPD) to determine clonality and establish the most likely source of contamination. Of 20 isolates analysed, 18 were indistinguishable clonally and were found to be associated with particular work stations. The application of regular testing using a system such as the BacT/Alert, and molecular studies for epidemiological analysis, is of benefit to producers of medical products such as TPN to ensure patient safety.
Subject(s)
Candida/isolation & purification , Parenteral Nutrition, Total , Random Amplified Polymorphic DNA Technique/methods , DNA, Fungal/isolation & purification , Humans , Mycological Typing Techniques/methodsABSTRACT
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.
