METHOD STATEMENT OF VALIDATION TEST FOR ASPIRE OPERATION ROOMCONTENTS 1. Testing Equipment 2. Air Velocity Test 3. Air Change Rate Calculation cad HEPA Filter Integrity Test 5. Particle Count Test 6. Temperature & Relative Humidity Test 7. Differential Pressure Test (0 Box 60270, Abu Dhabl- United Arab Emirates | o/cmsniobs comTESTING EQUIPMENTS INSTRUMENTS USED The following instrumentation was used for the measurement of the cleanroom facil. Readings taken include Particle Count, Air Velocities, Temperature & Humidity and Leak Test. Air Velocity | Airflow | ACPH Calculation Hot wire Multi-functional Anemometer Make TSI, UK Model: VelociCale 9565P | Serial No. : 9565P1619007 Temperature & Humidity Hot wire Multi-functional Anemometer Make TSI, UK Model: VelociCale 9565P | Serial No. : 9565P1619007 _ Room Classification based on Particle Count Air-bome Particle Counter Make: TSI, UK Model AeroTrak 9350 ‘| Serial No. : 93501438002 _ HEPA Integrity Test _ Aerosol Photometer Make ATI, USA Model 2i |SerialNo. 27992 PAO Generator Make ATI,USA Model TDA4B [Serial No. : 27926 Light intensity Measurement Make = Extech, USA Model : LT300 ‘Sound Measurement — Make Extech, USA Model: 407730 crM (Cubic Feet per Minute fpm Feet per Minute HEPA High Efficiency Particulate Air ACPH Air Changes per Hour PAO : Poly Alpha Olefin AKU : Alr Handling Unit Century itechanical Systems Factory LLC Pro Box 60270, Abu Dhabi United Arab Emirates |ocicmssiobal conAIR VELOCITY TEST Purpose ‘The purpose is to evaluate airflow velocity and supply air volume in clean room/zone. Scope Covers the procedure for testing / evaluating the airflow velocity & volume in clean room or clean zone Details of Test Equipment Hot Wire/ Vane type Anemometer, Accuracy within + 3% of full scale. Velocity Testing Procedure Airflow in Clean Rooms /Zones. 1. The airflow velocity measurement should be carried out for each terminal HEPA or ULPA or Supply air diffuser. 2, Measurement should be made at the approximate centre or user specified locations of each filter area. 3. Hold the probe perpendicular to the velocity flow vector being measured. 4, Measurement should be made at a distance of no more than 150 mm from the filter face, Optimum: 2° depth from diffuser face. 5, Measure the airflow velocity at each test position and allow at least 10 ‘seconds for each measurement and record all the measured values. Special care should be taken to keep the sampled area undisturbed during the test, 2 ‘The arithmetic average of velocities readings taken. Mechanical Systems Factory LLC 5.0 Box: 60270, Abu Drabi- United Arab Emirates | 0 cma) comAIR CHANGE RATE PER HOUR Purpose ‘The purpose is to calculate the number of air changes per hour for after the Airflow velocity & Airflow volume test is completed. Reference Documents ISO ~ 14644: 3 / IEST-RP-CC006.3HEPA FILTER INTEGRITY TEST Purpose ‘This test is performed that the fiter system is properly installed or that leaks have not developed during use. tt covers the installed fiters system leak testing by Aerosol/Photometer challenge Method and Aerosol total penetration method in occupancy state “As Built, r Integrity Test Details of testing equipment used: | merument | | Aerosol Phaiaineter | i \ ! "PAO Generator | | i Materials Equipment & Instruments used ‘+ PAO Aerosol ‘= Aerosol Generator ‘+ Clean & Dry Compressed Air at more than 20 psig + Aerosol Photometer ‘+ Scanning Probe PAO Test Procedure “The fiter under testis challenged with an Aerosol produced by mixing the output of the PAO Generator with Ambient air, resulting in an Up-stream aerosol PAO concentration of minimum 10 g/L. Aerosol blended airs passed through the inlet at top. The Compressed air pressure maintained at 20 psi. The test is conducted at the operating airflow volume ofthe equipment. With the nozzle ofthe probe held not more than 2.0 in (2.5 cm) from the area being tested, scan the entre downstream side of the HEPA fiters, and the perimeter of each fiter pack, by passing the photometer probe in sightly overlapping strokes ata traverse rate of not more than 2 ins (S ems). Separate passes shall be made around the entire periphery of the fier, along the bond between the fiter pack and frame, and around the seal between the filer and the device. The Aerosol Photometer is calibrated and 096 settings are done for the testing forthe relevant aerosol and fiter scanned for leaks. The Maximum allowable leak is 0.01%. Reference Documents; ISO ~ 14644~3 ‘Century Mechanlcal Systems Factory LLC 0 Box 60270, Abu Dhats- Unted rab Emirates info cmssioba combearer ci PARTICLE COUNT TEST Purpose To determine the actual air borne particle count level within the faclty atthe time ofthe test in “as-built, at-rest or “in operation”. ‘Test Equipment Details Air Borne Particle Counter Make: TSI, USA Model No: 9350 Model. : Aero Trak Testing Standard Testing Standard. : Clean Room Classification based on 1SO-14644-1 ‘Testing method ‘The standard of a clean room is defined by the concentration of airborne particles, at a given size or sizes, that is. not to be exceeded in a given occupancy state. To classify an area, it Is necessary to take sufficient samples of alr to have confidence that the airborne particle concentration of the room is within the limits set by the standards. The number of sampling locations must reflect the size of the room and its cleanliness. Larger the room, the more sampling locations that must be used. The air sample must also be of a sufficiently large volume to give confidence in the results, The methods for selection of the number of sampling locations and determining the minimum air volume are laid down in ISO 14644-1, and explained below. The acceptance criteria that must be met for a cleanroom to achieve a given classification are sven in the ISO 14644-1 and described below. Similar methods are used within the Federal Standard 209 E, and where these deviate from the ISO method, it is pointed out. However, anyone wishing to test a cleanroom must purchase the relevant standards, Reference Documents: 1S0 14644-1 & ISO 14644-3 Cantury Mechanical Systems Factory LLC .0 Box 60270, Abu Dhab- United Arab Errirates nfs comGrocet) TEMPERATURE & RELATIVE HUMIDITY Purpose: To demonstrate the capability ofthe installations air handling system to maintain the temperature and humidity level within control limits and over the time period between customer & suppliers: ‘Scope: Covers the General temperature & humidity test of an installation in the “As Built” condition & comprehensive temperature & humidity test for clean room for “At Rest” & “In Operation” state Procedure: Note: General temperature & Humidity tests should be performed after air conditioning system has been operated and the conditions have been stabilized, ‘A. General Temperature test Measure the temperature at a minimum 1 location for each temperature controlled zone. Place the temperature device or a sensor at the designated location at work level height. Allow sulficient time for sensor to stabilize prior to taking the temperature readings. ‘Measure the temperature for at least 1 hour and the temperature should be read and recorded at least every 6 minutes. eRe B. General Humidity Test. ‘Measure the humidity at a minimum 1 location for each humidity (temperature) control zone. 2. Place the humidity device or a sensor at the designated location at work level height [Location should be same as selected for temperature} 3. Measure and record the humidity readings simultaneously with temperature readings. ‘Gantury Mechanical Systoms Factory LLC P.0 Box: 60270, Abu Dhab- Une Arab Emirates | =foP-nensbal com€. Comprehensive temperature & humidity test. [Recommended for areas having strict environmental control specifications) 1. This test should be carried out at least 1 hour after the air conditioning system has been ‘operated and the conditions have been stabilized. Divide the work zone into a equal grid areas. And minimum of three locations should be measured. 3. The temperature & humidity device or sensor should position at work level height simuitaneously and at a distance not less than 300 mm from the ceiling or wall or flor. 4, The device probe selection should be made with due consideration of presence of heat source. 5. Allow sufficient time for sensor to stabilize prior to the testing. 6. Measure the temperature & Humidity simultaneously for atleast 1 hour and the temperature & Humidity should be read and recorded at least every 6 minutes. Acceptance Criteriot ‘Temperature should be 18°C to 25°C (Contiol Point 22 Point 4596) or as specified by the user. |, Humidity should be 35 to 65% (Control Century techanical Systems Factory LLC P.O Box 60270, Abu Dhabi- United Arab Emirates nioPcosniobal oomROOM PRESSURE DIFFERENTIAL TEST Purpose: To verify the capability of the complete installation to maintain the specified prossure difference between the Installation and its surroundings, and between separate spaces within the installation. Covers the alr pressure difference testing between clean room and spaces and to its surrounding, at occupancy state of "As Built’, “At Rest” & "In Operation’ Details of Test Equlpm Calibrated Digital manometer or differential gauges with sensitivity of 1Pa 40.1 Pa, 0 to 100 Pa. Procedure: 41) Alldoors of the clean room or enclosures are closed before resuming the test. 2) Measure and record the pressure differentials [in mm wg or Pa] between innermost clean room or clean ‘space and adjacent spaces or exterior environment. 3) Measure and record the pressure differential between the next adjacent spaces or rooms and other spaces or the exterior environment. 4) Continue the above measurements until the last room has been measured against the extemal environment, ‘Acceptance Criterion: The pressure differential may be greater than or equal to + 2.5 Pa Conclusion: The pressure differential botwoen OR Corridor and OPERATING ROOM ~2 is + ‘Century Mechanlca! Systems Factory LLC 0 Box 60270, Aby Dhabi United Arab Emiates|oPcnsalobal con