Risk Based Study of Sample Spot Fixing for Conducting Environmental Monitoring Test in Classified Areas of Pharmaceutical Industry.

Environmental monitoring is a study Programme designed to study load of Viable Microorganism as well as Non-Viable Particles present in (controlled and classified area) environment. The use of risk assessment approaches is an important current Good Manufacturing Practice (cGMP) tool in microbiological environmental monitoring Programme. The study was designed to conduct Risk assessment study for fixing sampling point and location for conducting environmental Monitoring in Classified area. Clean rooms were divided into five groups based on different Production activities done in the plant and further the individual rooms were divided in to five different sample spot based on risk of contamination of products during activities to find the Hot spot areas for higher microbial load. Finger dab test was performed to detect the hygiene and sanitization practices in plant. In-house limit of 100 cfu was set for finger dab test as non-sterile formulation was done in plant and result was found satisfactory. The data of non-viable count was taken from third party report performed annualy during rest condition. 0.5 micron and 5.0-micron particle was tested in class D area and result was satisfactory. The obtained data suggests that the worst case location is “Near Return Air Loop” in the classified areas. This location can be selected as “Hot Spot” for regular environmental monitoring of rooms..