USA Microbiology Laboratory needed for microbiological analysis:for validation the bacteriostatic properties of filters using microbiological test agents like aerobic mesophilic bacteria, fungi / yeast (Botrytis), and Listeria monocytogenes. 2) ALso, testing for the validation of the application of filters under strict operating conditions and will require proof of the following: a. A hood or container where it can perform a microbiological load, or bioburden natural environment is taken b. That bell or container must be allowed to have 2 rooms separated by the filter and allow re-circulation of air c. measurements should be made of the bioburden of the air before filtering and after filtering d. recirculate air and pass it through the filter, microbiological components go through the filter and are retained and destroyed e. Thus, the comparison of measurements over time, allow to observe the reduction of bioburden. For reference, a test according to DIN 71460-1 conducted in Germany described that instead of a pre-cleaned air, environmental spray test room with natural exposure to bacteria and germs such as spray test is used. With the corresponding samples is performed a selection of specific bacteria in culture media used for the subsequent incubation of the microorganisms collected. The flow rate is in turn 354 m3 / h, but we suggest a rate of 5 m3 / h. In each case six samples are collected in the contaminated side and the filtrate side, for a period of one day. Thus they are determined in each environment (contaminated and filtered) CFU / m3 (colony forming units) and thus reducing the number of germs occurred by the filter or filtration is determined. Taking air samples it is done with the device microbiological air sampling MAS-100 of the Merck brand. The culture medium is subjected to a sample volume of 100 liters or 250 liters. To determine bacterial counts in the culture medium, it is evaluated according to the above method, after 3 days incubation at 30 °C. The detection limit of the sub-search method is 4 to 10 CFU per m3.
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