is the part of industrial microbiology
Industrial microbiology or microbial biotechnology encompasses the use of microorganisms in the manufacture of food or industrial products. The use of microorganisms for the production of food, either human or animal, is often considered a branch of food microbiology...
that is responsible for ensuring medications do not contain harmful levels of microbes- such as bacteria
Bacteria are a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria have a wide range of shapes, ranging from spheres to rods and spirals...
, yeasts and moulds.
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.
Another major focus of pharmaceutical microbiology is to determine how a product will react in cases of contamination
Contamination is the presence of a minor and unwanted constituent in material, physical body, natural environment, at a workplace, etc.-Specifics:"Contamination" also has more specific meanings in science:...
. For example: You have a bottle of cough medicine
A cough medicine is a medicinal drug used in an attempt to treat coughing and related conditions. For dry coughs, treatment with cough suppressants may be attempted to suppress the body's urge to cough...
. 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.
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
The United States Pharmacopeia is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year...
is used; in Japan there is the Japanese Pharmacopeia; in the United Kingdom there is the British Pharmacopoeia
The British Pharmacopoeia is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organizations involved in pharmaceutical research, development, manufacture and testing....
and in Europe the European Pharmacopeia.These contain a test method which is to be follwed when testing, along with defined specifications for the amount of microorganisms allowed in a given amount of product.
The specifications change depending on the product type and method in which it is introduced to the body.