Microbiology is the study of microorganisms, e.g., bacteria, fungus and viruses. When microbiological concepts, processes and techniques are applied in pharmaceutical operations, the subject is then called ‘pharmaceuticals microbiology’.
Generally this 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 controlof pharmaceutical products, production environments and people.
Its aim is to ensure the safety and efficacy of pharmaceutical products.
It 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 for the 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. Traditionally, in pharmacy and pharmaceutical sciences curricula, pharmaceutical microbiology is taught at various lengths and depths.
We need to follow the procedures to ensure sterility, determine antimicrobial effectiveness, microbial contamination or bio burden, or to analyze endotoxins.
These days with increasing regulations this has become even more significant and relevant to quality healthcare provisions.
Major microbiological tests included in pharmaceutical industry are
Antimicrobal Efficacy Testing (AET)
Microbial Limits Testing
Bioburden Determination
Endotoxin (LAL) Testing
Environmental Monitoring and Identification
Water Analysis