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 & 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 & 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
International Journal of Trend in Scientific Research and Development - IJTSRD having
online ISSN 2456-6470. IJTSRD is a leading Open Access, Peer-Reviewed International
Journal which provides rapid publication of your research articles and aims to promote
the theory and practice along with knowledge sharing between researchers, developers,
engineers, students, and practitioners working in and around the world in many areas
like Sciences, Technology, Innovation, Engineering, Agriculture, Management and
many more and it is recommended by all Universities, review articles and short communications
in all subjects. IJTSRD running an International Journal who are proving quality
publication of peer reviewed and refereed international journals from diverse fields
that emphasizes new research, development and their applications. IJTSRD provides
an online access to exchange your research work, technical notes & surveying results
among professionals throughout the world in e-journals. IJTSRD is a fastest growing
and dynamic professional organization. The aim of this organization is to provide
access not only to world class research resources, but through its professionals
aim to bring in a significant transformation in the real of open access journals
and online publishing.