Microbiology – Pharma Guideline

Pharmaceutical Microbiology:

It can be defined as the study of microorganisms that are pertinent to the production of antibiotics, enzymes, vitamins, vaccines, and other pharmaceutical products; it also incorporates the study of microorganisms that cause pharmaceutical contaminations, degradation, deterioration and spoil of pharmaceutical raw materials and finished products.

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 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 and human growth hormone.

Generally, pharmaceutical microbiology provides knowledge and understanding with regards to the significance of the presence of bacteria, yeasts, moulds, viruses and toxins in pharmaceutical raw materials, intermediates, products and pharmaceutical production environments, as well as the microbiological control of pharmaceutical products, production environments and people.

One of the key objectives of pharmaceutical microbiology is to ensure safety and efficacy of pharmaceutical products. It embraces the processes like the validation of disinfectants, evaluation of the efficacy of disinfectants in suspension, on surfaces, and through field trials. Pharmaceutical

microbiology offers protocols and techniques associated with the operation and assurance of clean-room, aseptic-room and controlled environments for preventing any possible microbial contamination, and introduces risk assessment and practical contamination control strategies.

As pharmaceutical microbiology is crucial to the manufacture and production of drugs, biologics and devices, it is absolutely important that people working in these industries have a strong understanding and in depth knowledge of pharmaceutical microbiological principles, techniques, processes and strategies in order to avoid any potentially costly and life-threatening failures and consequences.

The following are some of the procedures to follow in Microbiology Department.