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�

Pharmaceutical microbiologists focus heavily on quality control to ensure a supply of life-saving drugs and vaccines that are free from contamination by micro-organisms.


When a positive culture is detected in a sample from a production environment, identification of the cultured microbe is required. The MALDI Biotyper is a revolutionary new Rapid Microbiological Method for microbial identification based on microbial protein fingerprints. The MALDI Biotyper ready-to-use reference library comprises thousands of individual strains and covers explicitly industrial quality control. Thus, even demanding microorganisms like anaerobic and non-fermenting bacteria as well as multicellular fungi can be identified with one approach. No expertise in mass spectrometry is required and the identification can be obtained in-house within minutes. These time savings can directly translate into enormous cost savings in terms of saving lost product shipments and production line up time. Already in use in a number of pharmaceutical microbiology labs, the MALDI Biotyper provides a very rapid and specific microbial identification comparable to molecular sequencing resolution but with significantly less effort, time and cost. The implementation and validation of the MALDI Biotyper is assisted by IQ/PV documentation and 21 CFR Part 11 supporting software. For daily routine documentation requirements the MALDI Biotyper solution offers complete workflow traceability.

Clinical Microbiology

The MALDI Biotyper identifies microorganisms using MALDI-TOF (Matrix Assisted Laser Desorption Ionization-Time of Flight) Mass Spectrometry to measure a unique molecular fingerprint of an organism. Specifically, the MALDI Biotyper measures highly abundant proteins that are found in all microorganisms.


The characteristic patterns of these highly abundant proteins are used to reliably and accurately identify a particular microorganism by matching the respective pattern with an extensive open database to determine the identity of the microorganism down to the species level.

The MALDI Biotyper System:

  • Highly Accurate
  • Applicable to a Wide Range of Microorganisms
  • Much Faster than Traditional Methods
  • Cost Effective
  • Robust and Easy to Use