CHARACTERIZATION OF THE CLEAN ROOM ENVIRONMENTN.H. DESAI, M. SHRAVAN KUMAR AND H.H. MEHTAAbstract Maintenance of appropriate quality of the pharmaceutical product is considered vital for achieving success in the global trade. Monitoring microbial distribution and identifying the predominant isolates is part of good manufacturing practice. Therefore, Clean rooms are essential in maintaining an aseptic environment in the pharmaceutical Industry. In this study, we have evaluated the dominant/ abundance and occurrence of Environmental micro flora which were identified from clean room over a period of time. Clean room microorganisms were isolated using Soybean Casein Digest Agar Media by various microbiological techniques like Plate (Passive Monitoring), Air Sampling (Active Monitoring) and Contact plate Method, which are used for surface monitoring. Over the period of study around 155 isolates are isolated, out of which 150 were bacterial isolates and 5 were fungal isolates. These isolated microorganisms were identified by applying Vitek 2 identification system and 16S- RDNA ribotyping. The data generated by Vitek 2/16S RDNA ribotyping were analyzed in the following manner. 1. The isolated microorganisms were identified and segregated on the basis of the Gram nature of microorganism. Out of 150 isolates, 137 (91.33%) are Gram positive cocci, 10 (6.67%) are Gram positive rods and remaining 3 (2%) are Gram negative rod. 2. The isolated microorganisms were also analyzed for predominance and it was found that the most predominant isolate is Micrococcus luteus. This study concludes that periodical validation of a clean room is necessary as in pharmaceutical industry long production runs keeps contaminating the production area and surroundings. |