RESUMO
A comparative study was done among available assessment methods to measure airborne viable particles in controlled rooms. Active methods were compared (sieve/nozzle impactor, slit-to-agar, centrifugal, filtration, and impinger). The comparative study was carried out by means of a two-way (factors: day and method) analysis of variance, after to logarithmical transformation of experimental results in order to fulfill the normality test of the variables. Statistically significant differences were found among the results of the five methods (P < 0.0001). In a post hoc study, by means of Tukey's test, no differences were found among centrifugal, filtration, and impinger methods. Differences were found among all the other methods (P < 0.05). It is concluded that centrifugal, filtration, and impinger methods (in which numerical results were higher than in the others) may be the most suitable methods for microbiological monitoring of a clean room. The mean results among the three selected active methods were compared with results on the settle plate (SP) (the passive method). A relationship was established between results of the passive method (CFU/h/plate 90 mmø) and the results of active methods (CFU/m3 air). By means of a lineal regression study, it was obtained a relation factor of 22.7; (95% CI: 19.7, 25.7). This factor is only valid for values between 3 and 16 in CFU/h/plate 90 mmø, and it is put on record that the experimental study took place in a room that fulfills Class D clean room specifications (WHO standards) in microbiological terms.
Assuntos
Microbiologia do Ar , Monitoramento Ambiental/métodos , Tamanho da Partícula , Análise de Variância , Argentina , Monitoramento Ambiental/instrumentação , Desenho de Equipamento/métodos , Fatores de TempoRESUMO
By means of bioluminiscence ATP present in a sample can be quantified. Thus, it would be a method able to evaluate microbiological or organic matter (from vegetal or animal origin) contamination. The present work analyzes the possibility to assess--from the microbiological point of view--the air of pharmaceutical clean rooms by means of bioluminiscence, using the luminomiter HY-LITE 2 [Merck]. It is thought that the use of this methodology versus microbiological classical methods, will allow to obtain results in the working day. Classical methods demand a minimum of 72 hs incubation to read results. But the real conclusion is that with the used technology, it is not possible to evaluate microbiologically the air of pharmaceutical clean rooms.
Assuntos
Ambiente Controlado , Monitoramento Ambiental/métodos , Medições Luminescentes , Bactérias/química , Indústria Farmacêutica , Escherichia coli/química , Staphylococcus aureus/químicaRESUMO
It is done a comparative study between the "Recommended rules for drug products manufacturing and inspection", approved in 1975 by the World Health Organization (and still in force in the MERCOSUR); and the standards published in 1992 by the WHO Expert Committee on Specifications for Pharmaceutical Preparations 32nd Report, named "Good Manufacturing Practices for pharmaceutical products". The correspondence between the regulation in force in the MERCOSUR and the Good Manufacturing Practices Inspection Guide for pharmaceutical industry, used by Health Authorities in the Common Market Member States, is analysed. It is noticed a disagreement between the rule in force and the instrument for verifying its fulfillment. The proposal of this article is the adoption by the Common Market Group, of the rules published by the WHO in 1992, and the establishment of an inspection guide which absolute agrees with it.