Smoke Study in Pharmaceutical Industry
Smoke Study is used to maintain the aseptic conditions when manufacturing sterile products. When we are manufacturing sterile products, we have to maintain aseptic conditions under the laminar airflow. So, how to ensure that the airflow is proper?
We cannot see air, but we can see smoke. Smoke is used as a visual aid, a visual help, so that we can understand that really our airflow is laminar. Under aseptic conditions, the smoke study, the visualization of critical airflow is used to demonstrate unidirectional airflow and sweeping action over and away from the product.
We need to protect our product. So whatever air is coming, it should be Grade A air, and there will be no microbial contamination.
In the filling machine there will be lot many instruments, such as filling assembly, and if it is a vial filling line, we will have a stopper bowl, seal bowl, we have in-feed and out-feed, and the complete setup. How do we ensure that that setup is not disturbing the airflow?
There is a concept called first air, first air is the air directly coming from the LAF and coming into contact with the open product container, empty or filled. That container should receive the first air. That is the air which has not come into any other contact after leaving the HEPA filter from the top.
Read also:
- Rapid Readout Biological Indicator in Sterilization Process
- Particles Counter for Cleanroom and Environmental Monitoring
Resource Person: Ch/Ahmed Mahmoud
