External Preparation SOPs

1.0 OBJECTIVE

To lay down a standard operating procedure for qualification of HEPA filters of AHU, LAF, RLAF, DPB, FBD, FBE, Coating equipment APU, Bin washing and any other equipment where HEPA filter is installed.

2.0 SCOPE:

This SOP is applicable to all the HEPA filters installed in AHU terminals and Plenum, LAF, RLAF, DPB, FBD, FBE, Dynamic pass Box Coating equipment APU, Bin washing stations APU and any other equipment where HEPA filter is installed

6.0 PROCEDURE

6.1 PROCEDURE TO PERFORM AIR VELOCITY

6.1.1 Start the AHU and Ensure the Differential Pressure within the limits.

6.1.2 Ensure that instrument is used for velocity testing is calibrated and is accompanied by calibration certificate (Photocopy to be attached).

6.1.3 Open the grill and take five readings of velocity (FPM) with anemometer in place parallel to 6-12 inch of filter pace. Namely the four corners and centre from filter face

• Note down the reading and calculate the average velocity.
• Carry out the above test for each and every grill/diffuser for each production area.
• If anemometer is not available then use air capture hood (Flow hood) to measure the CFM directly from grill/diffuser.
• The acceptance limit for velocity of RLAF/LAF is 90 FPM ± 20%. (i.e. 72 FPM to 108 FPM)

6.2 AIR CHANGES PER HOURS (ACPH)

6.2.1 Calculate the CFM = Average velocity (Foot per minute) X Filter Area (Sq. ft.)

                  Air changes per hours =    Total CFM of Room X 60

                     Volume of room in Cu. Ft.

6.2.2 Note down the volume of the room in ft3.

6.2.3 Calculate and record the air changes/hour for every clean room of ISO 8 grade.

6.2.4 Acceptance criteria: ACPH Not less than 20 for ISO 8 as per ISO class -8.

6.2.5 If an air change does not meet as per acceptance criteria, take necessary corrective action.

6.2.6 Carry out the test measurement for AHU once in a year for LAF/RLAF six monthly.

6.3 PROCEDURE TO PERFORM HEPA FILTER INTEGRITY TEST

6.3.1 Ensure that the instrument used for HEPA filter integrity test is calibrated and accompanied by calibration certificate.

6.3.2 Ensure no product is exposed in the area where HEPA filter integrity testing is being carried out.

6.3.3 Carry out HEPA filter integrity testing by using the aerosol photometer having the facility to generate the printout of the results.

6.3.4 Ensure that personnel protective equipment is used while carrying out HEPA filter integrity testing.

6.3.5 Provide the compressed air supply to the Aerosol generator and Keep in the Plenum of AHU or provide area aerosol feed directly from port provide in the duct above the terminal filter housing.

6.3.6 Maintain the pressure between 20-23 PSI (1.5 to 2 kg/cm²), or equivalent

6.3.7 Fill the PAO liquid in the reservoir of the generator approximately to the middle level.

6.3.8 Keep the photometer in the in the area for scanning of the filters.

6.3.9 Ensure that the AHU is switched ON and airflow volume is within limits.

6.3.10 Ensure the single-phase power supply to the photometer. Switch on the instrument and allow to clearing any pervious concentration of aerosol.

6.3.11 Turn the photometer Section Knob to upstream position and connect the upstream concentration port on the HEPA filter housing through tube with upstream port of the photometer. The upstream concentration of aerosol is ascertained with the help of photometer.

6.3.12 Once the upstream concentration is ascertained, the photometer is set to 100% reference based on the actual concentration found in the upstream of the filter. It should be between 20-80 µg/Litres

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