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Pharmaceutical Microbiology

Pharmaceutical Microbiology is an applied branch of Microbiology. It involves the study of microorganisms associated with the manufacture of pharmaceuticals e.g. minimizing the number of microorganisms in a process environment, excluding microorganisms and microbial biproducts like exotoxin and endotoxin from water and other starting materials, and ensuring the finished pharmaceutical product is sterile.

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. Another major focus of pharmaceutical microbiology is to determine how a product will react in cases of contamination.

For example: You have a bottle of cough medicine. Imagine you take the lid off, pour yourself a dose and forget to replace the lid. You come back to take your next dose and discover that you will indeed left the lid off for a few hours. Testing of pharmaceutical products is carried out according to a Pharmacopeia of which there are a few types. For example: In America, the United States Pharmacopeia is used; in Japan there is the Japanese Pharmacopeia; in the United Kingdom there is the British Pharmacopoeia and in Europe the European Pharmacopeia. These contain a test method which is to be followed when testing, along with defined specifications for the amount of microorganisms allowed in a given amount of product.