Manufactures of sterile products use extensive means of controlling the envirnment so that these
cricital product can be prepared free form contramination.Nervertheless tests should be performed to
determine level of control actually achived.normally the testes consist of counting viable and non-vible particle suspended in the air or settled on surface in the work space.the tests used generally measure either the particle in a volume of sampled air or the particles that are setting or are present on surfaces.A volume of air mesured by an electronic particle counter will detect all particles but not differentiate between viable and non-vible ones. however,because of the need to control the level of
microbes in the invironment in which sterile products are processed, it is also necessary to detect vible particles. this usually are less in number and are only detectable as colony forming units (CFUs)
after a suitable incubation period in culture media, for examole 30-35c for up to 48hours
to measure the total particle count in air, electronic counters like counter, are available. several air sampling divices are used to obtain a count of microbes in a measured volume of air. A widely used method for micro-biological sampling consists of exposure of nutrient agar culture plates to the settling of microbes from the air.
cricital product can be prepared free form contramination.Nervertheless tests should be performed to
determine level of control actually achived.normally the testes consist of counting viable and non-vible particle suspended in the air or settled on surface in the work space.the tests used generally measure either the particle in a volume of sampled air or the particles that are setting or are present on surfaces.A volume of air mesured by an electronic particle counter will detect all particles but not differentiate between viable and non-vible ones. however,because of the need to control the level of
microbes in the invironment in which sterile products are processed, it is also necessary to detect vible particles. this usually are less in number and are only detectable as colony forming units (CFUs)
after a suitable incubation period in culture media, for examole 30-35c for up to 48hours
to measure the total particle count in air, electronic counters like counter, are available. several air sampling divices are used to obtain a count of microbes in a measured volume of air. A widely used method for micro-biological sampling consists of exposure of nutrient agar culture plates to the settling of microbes from the air.
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