3 Standard Clean Room Federal Standard 209E ( FS – 209E ) ISO Standard ( ISO – 1 )Good Manufacturing Practice (GMP)
4 Federal Standard 209E (FS-209E) 700100000701000071000100300750103075350137.5355.0 μm0.5 μm0.3 μm0.2 μm0.1 μmCount/ ft3Class
5 ISO Standard ( ISO 14644 – 1 ) 293000 8320000 35200000 ISO 9 29300 ISO 929300832000ISO 8293083200352000ISO 7293832035200102000237000ISO 62983235201020023700100000ISO 5833521020237010000ISO 48351022371000ISO 341024100ISO 22ISO 15.0 µm1.0 µm0.5 µm0.3 μm0.2 μm0.1 μmCount / m3Class
6 Good Manufacturing Practice (GMP) In operationAt restNot defined 29 000D29 0002 900C293 520B20A5.0 µm0.5 µm Count/ m3Grade
7 Test Description Airborne Particle Count Test Airflow Velocity Test UnderTemperature TestRelative Humidity TestRoom Pressurization TestScan Leak Test HepaScan Leak Test PAOLight Intensity Level TestSound Pressure Level Test
8 Type of Condition AS BUILT The condition where the installation is complete with all services connected and functioning but with no production equipment, materials, or personnel presentAT RESTThe condition where the installation is complete with equipment installed and operating in a manner agreed between the customer and supplier, but with no personnel presentOPERATIONALThe condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon
17 Procedure For Airborne Particle Count PurposeTo measure the airborne particulate level in the Cleanroom and to determine the room CleanlinessClassification as per Federal Standard 209E.Instrumentation and EquipmentPMS Lasair II / 310A counter SpecificationTest Condition: At Rest / As Built / OperationalAllowable Count Limit for each particle sizeClass 1,000 : < 1, μm & greater: < μm & greaterClass : < μm & greater: < μm & greaterProcedureReference: Federal Standard 209ENEBB Procedural Standard for Certified Testing Of CleanroomThis test was conducted after all the other tests had been completed.The Cleanrooms were purged for at least 12 hours before testing commences.The Cleanrooms were divided into test grids according to their Cleanliness Class as per Federal Standard 209E as follow: -Class 1,000 Grid size not exceeding sq ft3.Class 100 Grid size not exceeding sq ft3. The sample time was set to 1 min per sample with the counters’ sample rate at 1 ft3/min.A minimum of 1 sample was taken at the center of each grid, at a height of 1 meter above the floor. When the count was greater than 75% of the allowable count limit, 3 samples was taken at that sample location.When an obstruction was encountered, the sample was taken at 12” above the obstruction. The average, standard deviation and 95% upper confidence limit were computed from the collected data.
18 Procedure For Temperature & Relative Humidity Test PurposeTo determine the capability of the Cleanroom air handling system to maintain the air temperature and relative humiditywithin specified limits.Instrumentation and EquipmentTSI Thermal Hygrometer: 8722-M-GBSpecificationAverage Temperature : 20 ~ 24 oCAverage Relative Humidity : 40 ~ 70 %ProcedureAll airflow balancing was completed prior to this test. The air conditioning system was operated continuously for at least 24 hours prior to the commencement of the test.The Cleanrooms were divided into test grids of no larger than 100 ft2 The temperature & RH meter was held at the center of the test grid at 1 meter above the floor. When an obstruction was encountered, the measurement was taken at 6” above the obstruction. The readings for all the other grids were taken and recorded. The average temperature and relative humidity of the Cleanroom were computed from these data.
19 Procedure For Airflow Velocity Test PurposeTo determine the airflow velocity of the filters installed in the Cleanrooms.Instrumentation And EquipmentAirdata Electronics Micromanometer, ADM-870SpecificationTest Condition: At Rest / As Built / OperationalTwo (2) velocity values are to be taken for each 2’x4’ HEPA filter at 75 mm. from the filter surfaceAverage : m/sTwo (2) velocity values are to be taken for each 2’x4’ HEPA filter at 150 mm. from the filter surface. (Under Laminar Flow Hood)Average: m/sProcedure Reference: IES Recommended Practice, IES-RP-CC006.2 Testing CleanroomsNEBB Procedural Standard for Certified Testing of CleanroomEvery filter was divided into 2 test grids each.The electronics micromanometer was setup with the Velgrid attachment and the temperature probe for automatic compensation of air density variation.The Velgrid, having a dimension of 14” x 14”, was placed at the center of the grid, with the Velgrid’s standoff spacers just touching the outlet filter surface. The Velgrid’s sides are to maintain parallel to the filter edges.One reading was taken and recorded for each grid.
20 Procedure For Room Pressurization Test PurposeTo determine the capability of the Cleanroom system to maintain the specified pressure differential.Instrumentation and EquipmentElectronic Micromanometer: ADM-870SpecificationTest Condition: At Rest / As Built / OperationalDifferential Pressure: 0.05”WG wrt adjacent / less stringent roomProcedureAll airflow balancing were completed prior to this test.All doors into the Cleanroom and the reference areas were closed throughout the duration of the test.The differential pressure between the Cleanroom and the adjacent room was measured and recorded with Electronic Micromanometer.
21 Procedure For HEPA Filter Installation Leak Test Purpose : To verify the absence of bypass leakage (between filter frame and ceiling grid system) in the installation of the filters and confirmthat the installed filters are free of defects and small leaks.Instrumentation and EquipmentPMS Lasair II / 310A counterAirdata Electronics Micromanometer, AMD-870SpecificationTest Condition: At Rest / As Built / OperationalNote:No additional aerosol challenge will be introduced to the upstream of the filters being tested.Not More than 1 particle at size 0.3 micron and greater must be detected in the downstream of the filter systemsFor each filter, any repair surface must not constitute more than 0.5 sq.inch.ProcedureReference : IEST Recommended Practice, IEST-RP-CC001.3 HEPA and ULPA FiltersIEST Recommended Practice, IEST-RP-CC006.3 Testing CleanroomsNEBB Procedural Standard for Certified Testing Of CleanroomThe filter’s face velocities were determined to ensure that they were within the general design range.The upstream concentration was taken at 0.3 micron and greater. This was taken for information only.Laser Particle Counter with a resolution of 0.3 micron was use for the leak test. The sampling flow rate of the counter was 1 ft3/min.Rectangular particle counter probe was use to scan the filters. The probe dimension was selected to achieve iso-kinetic sampling. The scanning rate used was in accordance to the above reference.The probe was held at 1” from the frame at filter surface during scanning. A count of 1 or more will force a sustained residence time of the probe at the location to assess the source of the detected counts.All confirmed or suspected leaks were identified and recorded. Re-test were conducted after remedial action had been takenWhen filter are beyond repair and replacement was made, record was made to reflect the replacement.
22 Procedure For HEPA Filter Installation Leak Test (Photo meter Method) PurposeTo insure and confirm that the HEPA filter system is properly installed by verifying the absence of bypass leakagein the installation and the installed filters are free of defects and pinhole leaks. Instrumentation and EquipmentATI Aerosol Photometer ,Model 2HSpecificationTest Condition: At Rest / As Built / Operational1 Upstream Concentration:Minimum value µm/litrePreferred Range µm/litre2 Maximum allowable penetration < 0.01 % of upstream
23 Procedure For HEPA Filter Installation Leak Test (Photo meter Method) Reference : NEBB Procedural Standard for Certified Testing Of Cleanroom ,2nd EdIEST Recommended Practice, IEST-RP-CC006.3 Testing Cleanrooms.1. The filters face velocities are first determined to ensure that they are within the general design range.2. The photometer and the aerosol generator are then set-up according to the manufacturer’s instruction.3. Emery 3004 aerosol is then generated with the generator and introduce at the upstream of the filter (s).4. Upstream concentration ,in µm / liter, is then measured. The sampling point should immediately (subject tophysical site constraint) ahead of the filter under tests. Appropriate adjustment, if necessary , is made to ensurethat the concentration is within the preferred range.5. Once upstream concentration is satisfied and set, the photometer will be setup for downstream penetrationmeasurement.6. Rectangular sampling probe will be used to scan the filters. The probe will be held at approximately 1”from theframe and filter surface during scanning. The maximum concentration level will be recorded.7. Upon completion of the tests, the upstream challenge concentration is sampled again to ensure consistency of thechallenge throughout the test.8. Certificate Of Compliance will be issued for each HEPA filter / filter bank that meet the required specification .A sample of the certificate is attached.
24 Procedure For Light Intensity Level Test PurposeTo determine the light intensity level at working height level within the Cleanrooms.Instrumentation and EquipmentDigital Lux Meter: LX-50SpecificationTest Condition: At Rest / As Built / OperationalAverage Light Intensity Level : 700 Lux ~ 880 LuxProcedureAll fluorescent lighting were operated for at least 100 hours to ensure ‘proper seasoning.’The lighting ware operated continuously for least 2 hours to allow for temperature stabilization prior to the actual commencement of the test.The Cleanrooms were divided into test grids of no larger than 100 ft2.One reading was taken at the centre of each grid and at a height of 1 meter above the floor.When an obstruction was encountered, the measurement was taken at 6” above the obstruction.The readings for all the other grids were taken and recorded.The average light intensity level of the Cleanroom were computed from these data.
25 Procedure For Sound Pressure Level Test PurposeTo measure the airborne sound pressure level within the Cleanroom produced by the basic Cleanroommechanical and electrical systems.Instrumentation and EquipmentSound Level Meter , Cesva SC-2cSpecificationTest Condition: At Rest / As Built / OperationalAverage Sound Pressure Level : 70 dBA.ProcedureAll airflow balancing was successfully completed prior to this test.All fan filter modules and air conditioning equipment were switched on before any readings were taken.The Cleanrooms were divided into test grids of no larger than 10’x10’The sound pressure level meter was placed 1 metre above the floor and with the sensor pointing in thedirection of the operating module.The sound pressure level , in dBA, was taken for each location.When an obstruction was encountered, the measurement was taken at 6” above the obstruction, provided itwas still within the entrance plane.The average sound pressure level of the Cleanroom was computed form there data.