STUDY OF AIR FLOW PATTERN UNDER LFA IN ASEPTIC PROCESSING SOPs

1.0   SCOPE:

           

This procedure is applied while checking the Air Flow Pattern in Filling Rooms of Sterile Area.

3.0   RESPONSIBILITY:

 Production Manager

 QC Manager

4.0    PROCEDURE:

1. Take the Smoke Tube from engineering store.
2. Take the Smoke and rubber pump (Sucker) into the changing room and mop with disinfectant.
3. Enter into the filling room as per relevant SOP.
4. Take the Smoke Tube and pump into the filling room.
5. Switch “ON” the L.F.H as per routine filling procedure.
6. Ensure that only one person should be in filling room at the time of Test.
7. Cut the both sides of Smoke Tube with cutter and fix it in the pipe of rubber pump.
8. Press the ball of the pump; it will generate smoke in the room.
9. Hold the smoke of Tube in the area under examination, 100 – 150 mm below the HEPA Filter.
10. Generate smoke sufficient to determine the direction of Airflow within the area.
11. Draw the Airflow pattern on paper and compare with Standard Air Flow Pattern. Note any areas where the Airflow exhibits turbulence of unparallel behavior.
12. Precautions should be taken that no person are in the immediate area of smoke flow.
13. If there is Turbulence of unparallel behavior then ask Engineering department to adjust the filter dampers and blowers.
14. After checking the Air Flow Pattern, mop the entire room with disinfectant to remove the traces of smoke pencil chemical.
15. Perform the test annually & when required.

5.0    QUALITY FORMS AND RECORD:

 N/A

6.0      DISTRIBUTION

          Chief Executive

         Plant Manager

         Production Manager

         Q.C Manager