Storage of mixtures for total parenteral nutrition. II. Microbiological control of large volume TPN mixtures

Microbiological control of TPN mixtures can be performed either by controlling the aseptic filling procedure using culture medium instead of intravenous solutions, or by an end-product sterility test. A microbiological process control of the filling procedure is described, and it is shown that a hospital pharmacy can prepare 3-litre bags without contamination. The number of 3-litre bags necessary in the process control is discussed, as well as the frequency with which a control should be performed. A possible non-destructive system for testing each 3-litre bag microbiologically is outlined and discussed. This system may be used when TPN mixtures without lipid emulsion are stored for longer periods.