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FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
2.0 PRE-APPROVAL SHEET:
Signing of this approval page of Performance Qualification protocol no. AR/P/HVAC/01 indicates agreement with the performance qualification approach described in this document. Shall modifications to the performance qualification become necessary, on addendum will be prepared and approved.
PREPARED BY SIGNATURE DATE
CHECKED BY SIGNATURE DATE
APPOVED BY SIGNATURE DATE
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
6.0 INTRODUCTION:
The Heating, ventilation & air conditioning system installed at service floor of any company, It consists of following AHU's & configuration of filters
SR.NO.
AIR
HANDLING
UNITS
ROOM NAME HEPA
FILTERS CLASS
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
9.0 HEPA FILTER INTEGRITY TESTING:
9.1 OBJECTIVE: To demonstrate and validate the filter integrity –leak monitoring of the HEPA filters installed in different areas like.
9.2 ACCEPTANCE CRITERIA:
CRITERIA
ACCEPTANCE
HEPA Filter Integrity Test With Using Aerosol
An unacceptable leak is a local reading greater than 0.01%
9.3 PROCEDURE: (FOR GENERATION OF AEROSOL):
STEP ACTION
Start
1 Check the Aerosol oil level in Aerosol generator.
2 Connect Compressed air / Nitrogen gas to aerosol generator & adjust the pressure regulator to 20PSI.
3 Direct the outlet of the aerosol generator to return duct [riser] or fresh air intake of AHU.
4 Start the aerosol generator by switching on the Compressed air / Nitrogen gas to produce the upstream concentration required for leak detection till photometer reads the Photometric concentration of 100%.
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
9.4 CALIBRATION OF THE INSTRUMENT [PHOTOMETER]
STEP ACTION
Start
1 Put the photometer selector switch on upstream mode.
2 Connect the tube of photometer to upstream port of HEPA filter.
3 Wait until the photometer displays 100% upstream concentration.
4 Remove the tube of photometer and close the upstream port of HEPA filter and ensure fir zero leakage.
5 Put the photometer selector switch on down stream mode.
6 Wait until photometer display 0 [ZERO].
On any installation the sealing gasket should be considered as part of the filter and this should be scanned separately from the filter pack.
• Select the sample port; scan the filter pack and the gasket at a distance of 50 to 100 mm.
• For a filter to efficiency 0.001% the range selected should be 0.01% and the alarm set for 0.001%, which is 10% of the full scale, which assumes an efficiency of 99.99% against the challenge aerosol.
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
9.5 TESTING PROCEDURE [TERMINAL HEPA FILTER WITHOUT INDIVIDUAL UPSTREAM
PORT]
STEP ACTION
Start
1 Ensure that before staring activity AHU is operational for 5 to 10 minutes.
2 Ensure that the air velocity, air balancing and flow adjustments are done before proceeding to the Filter integrity testing of HEPA filters.
3 Check that a sampling point is provided and accessible immediately upstream of the filter to be tested.
4 Start the compressed air / nitrogen gas to Aerosol generator to generate the test aerosol at minimum 20 psi and monitor the pressure.
5 Direct the test aerosol to riser of room.
6 Ensure that it is possible to introduce test aerosol so that 100% concentration can be detected at the upstream sampling point.
7 Place the aerosol generator in an accessible position, ideally near the riser, and adjust the aerosol concentration to the specified density.
8 Prior to the generation of the aerosol place the photometer probe down stream of the HEPA filter until the instrument has stabilized.
9 Put photometer selector switch on upstream mode.
10 Check the upstream concentration of Aerosol at port provided for representative HEPA filter for each room ;Until photometer displays 100 % upstream.
11 After getting the upstream conc. & put selector switch to clear position and close upstream Aerosol port.
12 Put photometer selector switch on down stream mode.
13 Wait until photometer displays 0.
14 Measure the down stream concentration by holding the probe approx.1 inch away from the face of filter.
15
The photometer has a sample flow rate of 1 cfm. Hold the probe at a distance between 50 to 100 mm from the filter face and scan the filter and perimeter by passing the probe in slightly overlapping strokes so that the entire area of filter and sealing gasket is sampled. The probe traverse rate should not exceed 10 feet per minute.
16 Observe the percentage of leakage directly on photometer
17 If any leakage observed through the sealing of filter tighten the filter nuts and check again for any leakage.
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
STEP
ACTION
18 If any leakage is more than 0.01% of the upstream aerosol concentration then repair it.
19 Repair the patches on filter s should not exceed maximum of 5% of the total filter face area & maximum width / length of each patch should not be more than 1.5 inches. Total no of patches should not exceed 5 number / filter.
20 If above mentioned limit exceeds then replace the filter & check the integrity of the filter as per above procedure.
21 Record the result [Annexure-II].
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
11.3 PROCEDURE: ESTABLISHMENT OF SAMPLING LOCATION:
STEP ACTION
Start
1 All components of the clean air system affecting air quality must be operating in accordance with the specification and all aspects of the controlled environment, which contribute to the operational integrity, are complete.
2 Measure on a centered grid pattern determined by dividing the total floor area, into approximately equal areas such that:
• The number of sub-areas is as specified in any relevant national standard or as agreed between the client and the contractor sampling positions should be at the intersection of the corners of each sub-area and at a height of 900 mm from the floor, unless agreed otherwise by the client.
• Take the required number of samples at the specified flow rate at each point on the grid. These can be determined from the relevant national standards or agreed by the customer.
3 Calculate the number of sampling locations with the formula
N = Square root of Room in cubic meter made it to approx. [Reference is made to ISO14644-1].
4 The sampling location shall be evenly distributed throughout the area of clean room or clean zone and position at the height of work activity. In case of additional sampling locations their number and position will be specified.
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
11.4 ESTABLISHMENT OF SINGLE SAMPLE VOLUME PER LOCATION:
STEP
ACTION
Start
1
Sample a sufficient volume of air at each location such that minimum of 20 particles would be detected if the particle concentration for the relevant class were at the class limit for the largest considered particle size.
2
The single sample volume Vs per location will be determined by
Vs =20x1000 / Cnm Where
Vs = is the minimum sample volume per location expressed in liters.
Cnm =class limit (number of particles/ m3) for the largest considered particles size specified for the relevant class.
20 = is the defined number of particles that could be counted if particle concentration were at the class limit.
The volume sampled at each location shall be at least 2 liters with a minimum time at each location of 1 minute.
Since particle counter operate at a flow rate of 1CFM, which is equal to 28.3 lits per minute, therefore particle analyzed per cubic feet will need to be multiply with 35.31 to convert to m3.
3
Direct measurement with 1 M3 particle counter,
Specification are: 50 LPM i.e. 1M3 i.e. 1000 liters per 20 minutes.
Sample at each location is taken for 20 minutes, which is equivalent to 50 LPM i.e. 1M3/20 minutes. There fore for grade A/B/C areas [ISO/5/6/7] and for grade D area 1 minute per location. Sampling locations are abased on the criticality of the work zone [Reference is made to AnnexureIV].
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
11.5 SAMPLING AT SPECIFIED LOCATIONS AT WORKING HEIGHT:
STEP ACTION
Start
1 Start the sampling and take minimum of single sample volumes from each location and compute the average particle concentration at specified location.
2 Sampling will be conducted at rest and during operation.
End
11.6 PARTICLE COUNTING AT EACH LOCATION
STEP ACTION
Start
1 Switch on the AHU and let it run for 10-15 minutes.
2 Switch `ON’ the particle counter and set the sampling rate as 1.0 cfm (Approximately 28.0 liters/minute).
3 Hold the particle counter probe to the working height at different locations of control/critical areas and take the print out of the particle counts of mentioned locations of control/critical areas.
4 Take the particle count at different location under HEPA filters covering total area of the control / critical room as mentioned in layout & take printouts of particle count.
6 Switch OFF the particle counter.
7 Get report of the particle count by the external party (Supplier)
8 Such reports should be preserved by the Quality Assurance department.
9 Particle count test of all control /critical rooms under AHUs to be carried out once in six months or earlier immediately after any major change in AHU facility.
10 Record the results and make the trend of particle count [Reference is made to Annexure IV].
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
12.0 RECOVERY STUDY
12.1 OBJECTIVE: To determine the recovery period for the HEPA filters installed in critical areas.
12.2 ACCEPTANCE CRITERIA:
CRITERIA
ACCEPTANCE
Recovery period Not more than 10 minutes/As per Design Specification
12.3 PROCEDURE:
STEP ACTION
Start
1 Measure the clean room or clean zone non-viable particulate counts at rest [before disturbing the area for Recovery test].
2 Shut OFF the AHU of required zone.
3 Allow the required zone to reach next higher grade (i.e. Grade B To Grade C).
4 Measure the non-viable particulate counts when area achieve the next higher grade with help of particle counter for one day.
5 Continue the particle counting for at least 5 counts.
6 Start the AHU and measure the particle counts till it the area achieves the desired level of counts approximately equivalent to the initial counts taken at rest before the test.
7 Measure time taken to recovery the initial grade.
8 Record the results and enclose the particle count printouts and calculate the recovery time as-
• 5 minutes-Initial count after AHU shut OFF
• X minutes-Time taken by the area to recover to initial counts after getting the next grade.
• Recovery time = X minutes.
9 Record the result [Reference is made to Annexure-V].
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
13.0 DIFFERENTIAL PRESSURE TEST
13.1 OBJECTIVE: To demonstrate the capability of the air system to provide pressure gradient among the different room.
13.2 ACCEPTANCE CRITERIA:
CRITERIA
ACCEPTANCE
Differential pressure of rooms As per design sheet + 0.5 mm of water
13.3 PROCEDURE:
STEP
ACTION
Start
1 All HVAC systems of the clean room facility are to be in continuous operation when performing these tests.
2 To avoid unexpected changes in pressure and to establish baseline, all doors in sterile facility must be closed and no traffic is to be allowed through the facility during the test.
3 Adjust the Magnehelic gauge to give a reading of zero in accordance with the manufacturers instructions.
4 Connect one end of the tubes to the higher-pressure side of the Magnehelic gauge(Calibrated) & place the other end of the tube in the area of higher pressure such that it is free from obstruction and directed away from any airflows.
5 Next, connect one end of the second tube to the lower pressure input side of the Magnehelic gauge and place the other end of the tube in the area of lower pressure such that it is free from obstruction and directed away from any airflows. If the tubing passes a surface ensure that any gap surrounding the tube are sealed.
6 Record the pressure displayed on the Magnehelic gauge three times ,for design differential pressure.
7 Record the result [Reference is made to Annexure-VII].
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
15.0 HUMIDITY CONTROL TEST
15.1 OBJECTIVE: To demonstrate the capability of air handling system to control relative humidity at the specified level in each room in critical area and controlled areas.
15.2 ACCEPTANCE CRITERIA:
CRITERIA
ACCEPTANCE
Relative humidity in critical area NMT 50 %
Relative humidity in controlled area NMT 55%
15.3 PROCEDURE:
STEP
ACTION
Start
1 Execute humidity control test after all the air balancing procedure have been concluded and air conditioning system is completely in operation and stable conditions have been achieved
2 Use calibrated Data Logger to record the relative humidity.
3 Record the relative humidity in room as per layout of relative humidity record in each room.
4 Record the result for three consecutive days [Reference is made to Annexure-VI].
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
16.0 LIGHT INTENSITY MEASUREMENT: LUX MEASUREMENT 16.1 OBJECTIVE: To determine the lighting level and its uniformity throughout an area at pre-determined points
16.2 ACCEPTANCE CRITERIA:
CRITERIA ACCEPTANCE
Light level Not less than 300 lux / As per Design Specification
16.3 PROCEDURE
STEP ACTION
Start
1 Record the light levels on a pre-determined grid pattern/ layout of lux level or in the absence of a specification on a 3m x 3m grid pattern.
2 Divide the room into four equal locations.
3 Record the light level at working height or 750 mm above finished floor height.
4 The area under test must have all fitted lights working and the area structure should be complete also if required emergency lighting levels can be recorded.
5 Record the light levels in lux for each position on the grid [Reference is made to AnnexureVII].
6 Note down all variations from the specification if any.
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane
Validation Incharge Validation Head Validation Head
17.0 NOISE LEVEL MEASUREMENT: 17.1 OBJECTIVE: To determine the noise level and its uniformity throughout an area at pre-determined points.
17.2 ACCEPTANCE CRITERIA:
CRITERIA ACCEPTANCE
Noise level Not more than 85 dB / As per Design Secification
17.3 PROCEDURE
STEP ACTION
Start
1 Verify that the air conditioning system is operating in the stable condition and all equipment that is specified is running [In operational condition].
2 Map out the area under test as required by the specification in a 2400 mm x 2400 mm x grid or on a previously agreed location basis i.e divide the area into fur equal parts.
3 Set the instrumentation to work and ensure unauthorized entry and exits from the room are prevented.
4 Measure the sound levels at work surface height or 750 mm from the finished floor level and layout of noise level.
5 Record the data [Reference is made to Annexure- VII].
6 Note down all variations from the specification if any.
End
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN – 401210 Dist : Thane