PubMed1986
Sterile pharmaceutical preparations must be supplied to clinical wards; their high degree of safety is given by hospital pharmacists who are responsible for quality control of these preparations. Various considerations on the choice of protocol are suggested. Good manufacturing practice is to carry out quality controls at every stage of production of total parenteral nutrition fluids. However, these controls are made difficult by the poor equipment of hospital pharmacies and by the absence of specific pharmaceutical monographs. The selected protocol involves: preliminary controls, which determine the practicability of the suggested formulation, as well as its expiration date: amino acid determinations using liquid chromatography, electrolyte analysis and concentration, pH, evolution of particle size in fat emulsion according to storage conditions, choice of plastic container; microbiological controls: every two months and every time the pharmaceutical staff changes; moreover, a search for bacterial endotoxins using a chromogenic substrate (LAL technique) with "microstrips" is suggested; a sample from each admixture is kept under refrigeration for 15 days; controls during fabrication to check, at the end of the process, if good manufacturing practices have been realized: microbiological sampling of the working area and elaboration of a written procedure; control after fabrication of each nutrient admixture: determination of various elements such as sodium, potassium and dextrose in a 5 ml sample. These assays enable the checking of high standards of fabrication. Hospital pharmacies, despite their reduced equipment, can answer by these procedures to the physicians' needs and supply sterile TPN meeting pharmaceutical standards.