A Brief Overview on Active Air Sampling Procedure for Environment Monitoring
In this paper, we are going to discuss the ‘Active Air Sampling procedure for EM’. EM stands for Environment Monitoring. Environment monitoring is performed in the pharmaceutical manufacturing plants to monitor the contamination of viable and non viable particle count. Viable particle count can be observed through the ‘Settle Plate method, Active Air Sampling, Surface Monitoring contact plate and swab test , and Personnel Monitoring method’. Non viable particles are dust particles and other non living particles. Active Air sampling is performed by microbiologist in the production and manufacturing area using the equipment known as ‘Air Sampler’. A media plate of SCDA Soybean Casein Digest Agar prepared under sterile condition by the microbiologist. The media plate is then allowed to adjust under the ‘Air Sampler hood’ and then it is used for sampling purpose. Air sampler captures 1000L air as per validated time in a 1cubic meter of volume and therefore air sampling is thus performed in the middle of the surrounding area. The sampled plate is then incubated, and after then the required incubation is provided, and the plate is thus analyzed to determine whether our manufacturing area meets the level of expected counts or it crosses the required limit and, on this basis, the reporting is thus generated on regular basis.
Environment Monitoring, Clean Room, Grades and their respective limits, Checkpoints of Media, Air Sampler and its operation, Incubation of the sampled plates, Trend chart analysis
Juhi Rastogi | Faiz Hashmi