MICROBIAL-POPULATION BALANCING AS A QUANTITATIVE AID FOR EVALUATING RELEASE FROM A HIGH-PRESSURE HOMOGENIZER

A mass balancing technique has been devised to quantify the number of microorganisms released as an aerosol. Mass balances have been success fully carried out in a 0.36 m(3) containment cabinet and a 8.37 m(3) s oft-film isolation cabinet. Initially an atomizer was used to produce a defined microbial aerosol and an Aerojet-General glass cyclone was u sed to collect dispersed micro-organisms. In this way, cell recoveries of over 50% were achieved for Saccharomyces cerevisiae released into the 0.36 m(3) cabinet. This mass balancing technique was used, togethe r with polymerase chain reaction, to estimate microbial release from a high pressure homogenizer, operated under the conditions of containme nt category B1 inside the soft-film cabinet. The incidental release of the micro-organisms as an aerosol is very small in comparison to the number present in the process fluid.