Microbiological aerosol challenge test

B. Microbiological Aerosol Challenge Tests in. Physical Evaluation of Maintenance of Sterility... 

Gas niters may be evaluated prior to use by the same methods used for liquid filters (see Section 111 below), allowing that they can be effectively dried out and sterilized without loss of the qualities being tested. Alternatively they may be evaluated by exposure to particles in a gas stream, for instance by the sodium name test, which is also used for HEPA filters. Microbiological tests have to be considered in a somewhat different light. Leahy and Gabler 71 describe an aerosol challenge test of 10 Ps. diminuta bacteria per mL over a four-day period as an appropriate manufacturer s validation test. It would not be practical for routine use. 

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