Microbiological environmental monitoring during sterile product manufacture: adaptation of methods for a research facility.
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The purpose of this review is to characterize the environmental microbiology, hospital epidemiology, diagnosis and treatment of nosocomial aspergillosis. Appropriate environmental control measures are important in preventing or arresting an outbreak of nosocomial aspergillosis. These include selective environmental microbiological surveillance and floor to ceiling barriers during construction or renovation. These is particularly important for the bone marrow transplant units and units with persistently granulocytopenic patients. We have summarized the point source and cited or formulated the environmental correction measures relating to 25 outbreaks of nosocomial aspergillosis involving a total of more than 100 patients. The most frequent settings of nosocomial invasive aspergillosis occurred in granulocytopenic patients following respiratory infection from an airborne source, associated with hospital construction or contaminated ventilation systems.
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We present, in detail, the (microbiological) environmental monitoring programme for cleanrooms that is in use at the RIVM. The parameters that are measured are: Total airborne particles of 0.5 micron and larger, airborne colony forming units (cfu's), cfu's on surfaces, cfu's on fingertips of gloves and settling cfu's. Most attention is paid to areas where critical handling is performed (class A areas). In these areas sampling is performed continuously during work. The areas surrounding class A areas are seen as a necessary environment to create a class A area and are called supporting areas. Changes in these supporting areas that will adversely effect the quality of the class A area, will be detected in the continuous sampling of the class A area. Sampling the supporting areas should only bring forward whether the measured parameters of these areas are consistent. The frequency of sampling, either weekly, monthly or three monthly, is based on the data obtained in previous sampling. In addition to the programme some data are presented. These data indicate that the values of the earlier mentioned parameters are not particularly dependent upon the lay-out or classification of areas, but rather on the use of the areas, and how the operators behave in them. The results support the concept of our sampling schedule, that relevant information about the production areas can be gathered with relatively little effort. Evaluating the programme, we conclude that the main missing element is a known relation between the results of environmental monitoring and contamination of products. We strongly advocate research that could result in establishing such a relation.
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