Pharmaceutical Microbiology is an applied branch of Microbiology. It involves the study of microorganisms associated with the manufacture of pharmaceuticals eg. minimizing the number of microorganisms in a process environment, excluding microorganisms and microbial by-products 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 andhuman growth hormone.

Drug safety

Drug safety is a major focus of pharmaceutical microbiology. Pathogenic bacteria, yeasts, 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.

Antimicrobial activity and disinfection

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 have indeed left the lid off for a few hours. What happens if a microorganism "fell in" whilst the lid was off? There are tests that look at that. The product is "challenged" with a known amount of specific microorganisms, such as E. coli and C. albicans and the anti-microbial activity monitored 

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.

Methods and specifications

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