Follow
Objective: To establish a standard procedure for particle count monitoring of the classified area catered by Air Handling Unit.
Scope: This SOP is applicable for the area catered by the Air Handling Unit with HEPA filters at (Company Name).
Responsibility:
1. Operator shall be responsible to follow the procedure strictly.
2. Supervisor shall be responsible to ensure that the SOP is followed properly.
Accountability: Head of Engineering.
Precautions: Concerned personnel should be trained on the SOP.
Procedure:
1. Carry out the following pre checks:
2. Ensure that the pre-filters are cleaned and installed properly.
3. Ensure that HEPA filters are installed properly & DOP test is complete after the installation of filters.
4. Ensure that the air handling unit is running.
5. Ensure that the air balancing of the area is proper so that there is no infiltration of outside air.
6. Ensure that the floor, walls & ceilings are free from dust.
7. Ensure that the area to be monitored is free from man & material movements.
8. While monitoring the area for particle counts, ensure that all the machines & utilities are connected and are functional but not in operation, so as to define the class of air at rest.
9. Take the particle location drawing in the area to be monitored & proceed particle counting as per the location drawing.
10. Carry out the following mechanical checks:
>> Ensure the particle count monitoring instrument is calibrated. Check the certificate of calibration to ensure the traceability as per standard in the certificate.
>> Ensure that the thermal paper is positioned properly.
11. Carry out the operation of the particle counter as per SOP NO.: EG081-01.
12. Record the obtained data as per validation protocol.
13. Take photo copy of the printed report and attach it with the validation format for reference.
14. Check the printed report from the Particle Counter for any alarm messages. Compare the readings with the standard for particular class of air.
15. In case the readings exceed the designed class of air, do the following checks:
16. Check the Air balancing.
17. Check & clean the area for free of dust particles.
18. Check the velocity of air & air changes per hour.
19. Check the integrity of HEPA filters & infiltration through filters.
20. Carry out the particle count monitoring as per above procedure.
