Resumen de Air microbiological qualityin a cleanareafrom a pharmaceutical industry
María del Carmen de la Rosa Jorge, Carlos Ullán, María Pilar Prieto, María Angeles Mosso Romeo
Microbiological analysis of the air from a clean area used for aseptic packing of raw materials in a pharmaceutical industry has been carried out in order to determine the microbiological levels and to identify those microorganisms present in the air. 569 sam- ples were taken from seven different points of the clean area during 18 months, using gravity and impact (Biotest RCS Plus) methods. The average number of bacteria and fungi obtained when using the gravity method was 2.4 and 2.7 ufc/ 30 min ; 13 and 1.1 ufc/m3 using the impact method. We have obtained more samples with presence of bac- teria (51 %) than fungi (33%) and a prevalence of cocci over rods and molds over yeasts. Gram negative bacteria were not detected. The most frecuently bacterial genera were Staphylococcus (24.7%), Micrococcus (9.7%), Bacillus (8%), Corynebacterium (7.4%) andArthrobacter (6.7%) and the molds were Penicillium (7.2%), Curvularia (6.3%) and Aspergillus (4.4%). There is a good microbiological quality in this clean area and all the samples reached a class C limit and the 32% at the class A as established by the Euro- pean Union.
