We have to prove that laminar airflow is maintained in the filling machine while we are doing various activities in the filling machine. What are these activities?
Filling machine assembling
We perform assembling before the filling of product. We have to assemble the sterile filling assembly through which the product is fed into the containers. Assembling requires a lot of aseptic intervention, a lot of activity, and these activities can hamper the airflow. While performing these activities, we have to prove that by these activities there are no turbulence and eddy currents.
During assembling, we have to simulate the same sequence of activities, same process, same number of personnel, and we have to prove that the smoke, in spite of those activities, is not getting disturbed. Even there is a slight disturbance during the activity, the smoke flow, or airflow is restored to the original.
As we know, in the injectable filling we have to do a lot of aseptic interventions during the activity. There are two types of interventions. One is inherent, which we do daily or which is a part and parcel of the process. The second is corrective, the interventions which are not done daily, which are not part and parcel of the process, but we have to do that as an activity. It can be changing something or additional maintenance activity. Such sort of interventions we have to perform in the smoke study also. Whatever intervention you are performing during media fill, during routine operation, all the interventions in the filling setup, filling machine, we have to do in the smoke study also. The only purpose is to prove that with those interventions we are not disturbing the airflow within the filling machine.
Whenever we transfer the material from Grade B to Grade A, before our filling set up, before our filling assembly, we have to do smoke study and demonstrate that while we are transferring the material we are not disturbing the airflow. As we know, we have to open the filling machine door, even if it is an isolator, to transfer the material inside. While transferring materials, it must be ensured that the airflow from filling machine is going outside to the Grade B or Grade C area, and not from outside area to inside. This is another most important part which we have to demonstrate through smoke study that we are not disturbing the airflow.