[Control over the bacteriological quality of preparations for TPN by the sequential sampling technic].
A sequential microbiological control was carried out, using a total filtration method, on a sample selected at random from among those prepared on a daily basis and kept at room temperature for twenty-four hours, in order to determine any possible contamination by fungi, bacteria or yeasts. The results obtained were submitted to accumulated sum statistical sampling, the adjustment for which followed a binomial distribution model. For alpha = 0.05, levels of 0.04 and 0.12 respectively were fixed for acceptable quality (NCA) and for rejection (NCR). It was shown that the regulations on work in the unit for the preparation of NPT mixtures is satisfactory, as the latest results obtained are within the NCA established and, as a value, it is sufficiently exacting. The imperative need for routine microbiological control is also made clear, in order to maintain and improve the standard of quality in the section.
Alférez García
I
I
Servicio de Farmacia, Hospital Universitario Clínico, Granada, Spain.
Socías Manzano
M S
MS
D001419:Bacteria / Q000302:isolation & purification; D004340:Drug Contamination; D005658:Fungi / Q000302:isolation & purification; D006801:Humans; D010289:Parenteral Nutrition, Total / Q000592:standards* / Q000706:statistics & numerical data; D011336:Probability; D011786:Quality Control; D011897:Random Allocation; D013997:Time Factors
Control de calidad bacteriológica de preparaciones de NPT por técnica de muestreo secuencial.