Microbial Contamination in Pharmaceutical products
What is Microbes?The microorganism or microbes is a microscopic organism which may exist in single celled form or in a colony. Single celled microorganism were in the first form of life.Microorganism can almost found everywhere on the earth. The science where microorganism are studied called Microbiology.
- At product development stage
- Routine monitoring of pharmaceutical environment & people
- Critical utilities i.e. Water system, compressed air system
- Raw material
- Equipment design
- Facility design
Source of Microbial contamination
In pharmaceutical there are many source of microbial contamination but out of all source people are the main source of microbial contamination who carries lots of microbial loads and knowingly and unknowingly introduce the contamination into drugs products. Rest of the microbial contamination given below;
- Poor Facility Design- No proper segregation for man and material, improper differential pressure between two adjacent room, no temperature or humidity control or inadequately design.
- Poor design of equipment – Common mistake which are generally made in pharmaceutical during procurement of equipment we have not consider hygiene design of equipment. In URS of equipment we generally covered operating requirement, safety requirement, regulatory requirement but we forgot to address hygiene design requirement of equipment which results a lot of batch failure in future. During equipment user requirement finalization we have to covered following hygiene design aspect; No dead leg & crevice, No hard to clean surface, roughness value, considered sanitary valve etc.
- Inadequate Cleaning and sanitation procedure- A validated cleaning and sanitization procedure of equipment and area should be in-place to control microbes and all the disinfectant and their concentration which are use in the area and on equipment should be validate before use. At least one sporocidal disinfectant should be incorporate in the disinfectant and sanitization program to avoid germination of spores inside the processing area.
- Poor gowning- If any gown not covered full body then it microbes can be enter into product from all these uncovered area so proper gowning, gloves , mask and head gear is required before entering into the processing area where product get exposed
- People- Fast movement of people inside the manufacturing area can generate lots of particle/ microbes which can further deteriorate the drug products.
So take care and consider all the above points to avoid microbial contamination in the drug products.
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