1.0
SCOPE:
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This procedure is applied while checking the Air Flow Pattern in Filling
Rooms of Sterile Area.
3.0 RESPONSIBILITY:
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Production Manager
QC Manager
4.0 PROCEDURE:
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- Take the Smoke Tube from engineering store.
- Take the Smoke and rubber pump (Sucker) into the changing room and mop with disinfectant.
- Enter into the filling room as per relevant SOP.
- Take the Smoke Tube and pump into the filling room.
- Switch “ON” the L.F.H as per routine filling procedure.
- Ensure that only one person should be in filling room at the time of Test.
- Cut the both sides of Smoke Tube with cutter and fix it in the pipe of rubber pump.
- Press the ball of the pump; it will generate smoke in the room.
- Hold the smoke of Tube in the area under examination, 100 – 150 mm below the HEPA Filter.
- Generate smoke sufficient to determine the direction of Airflow within the area.
- Draw the Airflow pattern on paper and compare with Standard Air Flow Pattern. Note any areas where the Airflow exhibits turbulence of unparallel behavior.
- Precautions should be taken that no person are in the immediate area of smoke flow.
- If there is Turbulence of unparallel behavior then ask Engineering department to adjust the filter dampers and blowers.
- After checking the Air Flow Pattern, mop the entire room with disinfectant to remove the traces of smoke pencil chemical.
- Perform the test annually & when required.
5.0
QUALITY FORMS AND RECORD:
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N/A
6.0 DISTRIBUTION
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Chief Executive
Plant Manager
Production Manager
Q.C Manager
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