[1] Other aspects of pharmaceutical microbiology include the research and development of anti-infective agents, the use of microorganisms to detect mutagenic and carcinogenic activity in prospective drugs, and the use of microorganisms in the manufacture of pharmaceutical products like insulin and human growth hormone.
Pathogenic bacteria, fungi (yeasts and moulds) and toxins produced by microorganisms are all possible contaminants of medicines- although stringent, regulated processes are in place to ensure the risk is minimal.
Another major focus of pharmaceutical microbiology is to determine how a product will react in cases of contamination.
The product is "challenged" with a known amount of specific microorganisms, such as E. coli and C. albicans and the anti-microbial activity monitored [2] Pharmaceutical microbiology is additionally involved with the validation of disinfectants, either according to U.S. AOAC or European CEN standards, to evaluate the efficacy of disinfectants in suspension, on surfaces, and through field trials.
Viable monitoring is designed to detect levels of bacteria and fungi present in defined locations /areas during a particular stage in the activity of processing and filling a product.
Active air-samplers generally fall into the following different models: • Slit to Agar • Membrane Filtration • Centrifugal Samplers Monitoring methods will all use either a general purpose culture medium like tryptone soya agar (TSA), which will be used at a dual incubation regime of 30 °C – 35 °C and 20 °C – 25 °C or two different culture media are used at two different temperatures, of which one of the media is selective for fungi (e.g. Sabouraud Dextrose agar, SDA).