Applications and scope of pharmaceutical microbiology

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Pharmaceutical microbiology is one of the branch of applied microbiology and has special applications in the pharmaceutical field.

 Applications of microbiology in the pharmaceutical area are described as follows:


Production of antibiotics

Pharmaceutical or industrial microbiology concerns itself with the isolation of antibiotic producing microorganisms from natural environments such as soil or water. Many antibiotics are isolated from natural microorganisms by the process of fermentation. e.g. Penicillin from Penicillium species, Streptomycin from Streptomyces griseus, Tetracycline from Streptomyces aureofaciens, Chloramphenicol from Streptomyces venezuelae etc.

Production of enzymes, vaccines, biosurfactants, and other pharmaceutical products

The detection and assay of pharmaceutical and chemical products of microbial activity is a part of pharmaceutical microbiology. Many microbial cells convert raw materials or substrates into valuable organic compounds such as butanol, ethanol, acetone etc. Microbial cells also produce intracellular and extracellular enzymes and these enzymes are important for the success of pharmaceutical fermentation processes. They are associated with the microorganisms ability to attack, degrade and utilize components of the medium and to accumulate fermentation products e.g. amylases, proteases, lipases, invertases, oxidase, catalase, cortisone reductase, phospholipases, cellulases, chitinases etc. Biosurfactants have lot of applications in agriculture, food industries, industrial cleaning, leather, paper and metal industries, textiles, cosmetics and the pharmaceutical industry.

 Diagnosis of diseases and treatment

Different tests are used to detect infectious microorganisms e.g. EUSA, Widal test. Antimicrobial susceptibility testing is mainly used for selection of antibiotics for the treatment of microbial infections.

Treatment of industrial waste material

 Most industrial processes produce waste waters, salts, organic matter and spent media and these may be toxic. Many microbial species are used for decomposition of such waste materials and organic components


actinomycetes, fungi, protozoa etc. Anaerobic bacteria in anaerobic digestion tanksare active in the decomposition of organic matter by yielding simple organic molecules such as acids, alcohols, glycerol and amines. Cyanide is produced on an industrial scalefor use in metal extraction, electroplating and steel industry which is degraded by Streptomyces laveridulae.

Plant growth promotion

 Many microbial cells present in soil, play an important role in soil fertility, herbicidal resistance, insect resistance, change in protein/oil content and enhanced quality of plant products e.g. Rhizobium species, Rhodospirillum species, Azotobacter species, Pseudomonas species, Acetobacter species etc. Many nitrogen fixing soil microorganisms are useful for providing nitrogen for the growth of crops and enzymes released from microorganisms are helpful for plant growth, germination of seeds, flavouring and fruiting of medicinal plants. Soil microbial populations are the key element in recycling plant nutrients and thus they play a major role in the maintenance of soil fertility and soil health.

The rhizospheric bacteria may release various plant growth promoting substances as secondary metabolites, which may promote plant growth directly or indirectly. Such beneficial rhizopheric bacteria are often referred to as plant growth promoting rhizobac (PGPR). Pseudomonas is one of the extensively studied PGPR, which promotes growth of plants by protecting plant health from soil borne phytopathogens and their toxins. Azotobacter chroocogcum is a well known free living nitrogen fixing bacterium capable of synthesizing and secreting plant growth promoting substances like thiamine, riboflavin, IAA, gibberellin etc. and is frequently used as a nitrogenous biofertilizer for a number of crops.

Sterile product preparation

 Pharmaceutical microbiology plays a major role in preparation of sterile products. It deals with preparation of sterile rooms, aseptic techniques, and detection of microbes by sampling and sterility testing of different sterile preparations. Sterility testing is carried out to support batch releases of sterile pharmaceuticals and medical devices. Settle plates, contact plates and air sampling techniques are used for detection of microorganisms in sterile rooms.


Different pharmaceutical products are sterilized by killing microorganisms. Methods of sterilization are decided depending on the properties of products and general type of microbes present in the products. All the sterilization processes may be validated by using biological indicators. A biological indicator (BI) is a preparation of microorganisms usually bacterial spores that are contained in filter papers, porcelain cylinders or test tubes which serves as a challenge to the effectiveness of a given sterilization process or cycle e.g. Moist heat sterilization (autoclave) -Bacillus

stearothermophilus, Dry heat sterilization (hot air oven) – Bacillus subtilis, Radiation sterilization – Bacillus pumilis, Membrane filtration – Pseudomonas diminuta etc.

Steroid biotransformation

 Steroids e.g. ergosterol, testosterone, progesterone etc. Important steroids can be produced by microbiological transformations of naturally occurring steroids. Microbial conversions of steroids are brought about by enzymes secreted by selected strains of microorganisms e.g. Streptomyces species, Rhizopus species, Aspergillus species, Penicillium species.

Identification of microorganisms

 Two vital functions of pharmaceutical microbiology and biotechnology are the enumeration and identification of microorganisms found in products and the manufacturing environment. There are many microbial cells present in the environment that are useful for the production of antibiotics, enzymes and other pharmaceutical substances. These microorganisms are isolated and identified by morphological, biochemical, cultural, microscopic characteristics and genetic studies. Testing of pharmaceuticals:

Testing of pharmaceuticals

     a. Microbiological assays of antibiotics

The antibiotic bioassay provides a potency for the overall biological activity of an antibiotic preparation. Activity or potency is quoted in terms of units of a recognized international standard, specifically defined by pharmacopoeias. Agar diffusion (plate assays) and turbidometric assays permit an estimate of antibiotic potency through direct comparison of a test antibiotic with an approved, well-calibrated reference substance.

  B. Evaluation of disinfectants

 Effective cleaning and disinfection of manufacturing facilities are crucial to the achievement and maintenance of high quality standards required for medicine and medical devices. Phenol coefficient test, cup plate method, turbidometric method and Kelsey Sykes test are mainly used for evaluation of different disinfectants.

C. Antimicrobial preservative efficacy testing

 Preservatives are intended to protect a product from spoilage due to microorganisms introduced by the user and those which unavoidably arise during the manufacturing process. There is an extensive range of chemical substances available for potential use in preservative systems. The preservatives should be non-toxic, easily available and have broad spectrum activity. Cup-plate method, turbidometric method and total viable counting techniques are used for determination of antimicrobial efficacy of preservatives.

D. Endotoxin testing

 The bacteriel endotoxins test (BET) is most important in microbiology laboratories involved with quality control of parenterals and medical devices. LAL test, gel-clot method, chromogenic end-point, kinetic turbidometric assay and kinetic chromogenic assay are used for detection of endotoxins.

These are Applications and scope of pharmaceutical microbiology.

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