Presentation is loading. Please wait.

Presentation is loading. Please wait.

Particle Measuring Technique Co.,Ltd.

Similar presentations


Presentation on theme: "Particle Measuring Technique Co.,Ltd."— Presentation transcript:

1 Particle Measuring Technique Co.,Ltd.
CERTIFIED CLEANROOM

2 Clean Room Certified by…
NEBB (National Environmental Balancing Bureau)

3 Standard Clean Room Federal Standard 209E ( FS – 209E )
ISO Standard ( ISO – 1 ) Good Manufacturing Practice (GMP)

4 Federal Standard 209E (FS-209E)
700 100000 70 10000 7 1000 100 300 750 10 30 75 350 1 3 7.5 35 5.0 μm 0.5 μm 0.3 μm 0.2 μm 0.1 μm Count/ ft3 Class

5 ISO Standard ( ISO 14644 – 1 ) 293000 8320000 35200000 ISO 9 29300
ISO 9 29300 832000 ISO 8 2930 83200 352000 ISO 7 293 8320 35200 102000 237000 ISO 6 29 832 3520 10200 23700 100000 ISO 5 83 352 1020 2370 10000 ISO 4 8 35 102 237 1000 ISO 3 4 10 24 100 ISO 2 2 ISO 1 5.0 µm 1.0 µm 0.5 µm 0.3 μm 0.2 μm 0.1 μm Count / m3 Class

6 Good Manufacturing Practice (GMP)
In operation At rest Not defined   29 000 D 29 000 2 900   C 29 3 520 B 20 A 5.0 µm 0.5 µm  Count/ m3 Grade

7 Test Description Airborne Particle Count Test
Airflow Velocity Test Under Temperature Test Relative Humidity Test Room Pressurization Test Scan Leak Test Hepa Scan Leak Test PAO Light Intensity Level Test Sound 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 present AT REST The condition where the installation is complete with equipment installed and operating in a manner agreed between the customer and supplier, but with no personnel present OPERATIONAL The condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon

9 Certify Clean room Testing

10 Airborne Particle Test

11 Airflow Velocity Test

12 Temperature & Relative Humidity Test

13 Room Pressurization Test

14 Scan Leak Test

15 Instrument

16 Test Procedures

17 Procedure For Airborne Particle Count
Purpose To measure the airborne particulate level in the Cleanroom and to determine the room Cleanliness Classification as per Federal Standard 209E. Instrumentation and Equipment PMS Lasair II / 310A counter  Specification Test Condition: At Rest / As Built / Operational Allowable Count Limit for each particle size Class 1,000 : < 1, μm & greater : < μm & greater Class : < μm & greater : < μm & greater Procedure Reference: Federal Standard 209E NEBB Procedural Standard for Certified Testing Of Cleanroom This 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
Purpose To determine the capability of the Cleanroom air handling system to maintain the air temperature and relative humidity within specified limits. Instrumentation and Equipment TSI Thermal Hygrometer: 8722-M-GB Specification Average Temperature : 20 ~ 24 oC Average Relative Humidity : 40 ~ 70 % Procedure All 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
Purpose To determine the airflow velocity of the filters installed in the Cleanrooms. Instrumentation And Equipment Airdata Electronics Micromanometer, ADM-870 Specification Test Condition: At Rest / As Built / Operational Two (2) velocity values are to be taken for each 2’x4’ HEPA filter at 75 mm. from the filter surface Average : m/s Two (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/s Procedure  Reference: IES Recommended Practice, IES-RP-CC006.2 Testing Cleanrooms NEBB Procedural Standard for Certified Testing of Cleanroom Every 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
Purpose To determine the capability of the Cleanroom system to maintain the specified pressure differential. Instrumentation and Equipment Electronic Micromanometer: ADM-870 Specification Test Condition: At Rest / As Built / Operational Differential Pressure: 0.05”WG wrt adjacent / less stringent room Procedure All 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 confirm that the installed filters are free of defects and small leaks. Instrumentation and Equipment PMS Lasair II / 310A counter Airdata Electronics Micromanometer, AMD-870 Specification Test Condition: At Rest / As Built / Operational Note: 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 systems For each filter, any repair surface must not constitute more than 0.5 sq.inch. Procedure Reference : IEST Recommended Practice, IEST-RP-CC001.3 HEPA and ULPA Filters IEST Recommended Practice, IEST-RP-CC006.3 Testing Cleanrooms NEBB Procedural Standard for Certified Testing Of Cleanroom The 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 taken When 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)
Purpose To insure and confirm that the HEPA filter system is properly installed by verifying the absence of bypass leakage in the installation and the installed filters are free of defects and pinhole leaks.   Instrumentation and Equipment ATI Aerosol Photometer ,Model 2H Specification Test Condition: At Rest / As Built / Operational 1 Upstream Concentration: Minimum value µm/litre Preferred Range µm/litre 2 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 Ed IEST 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 to physical site constraint) ahead of the filter under tests. Appropriate adjustment, if necessary , is made to ensure that the concentration is within the preferred range. 5. Once upstream concentration is satisfied and set, the photometer will be setup for downstream penetration measurement. 6. Rectangular sampling probe will be used to scan the filters. The probe will be held at approximately 1”from the frame 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 the challenge 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
Purpose To determine the light intensity level at working height level within the Cleanrooms. Instrumentation and Equipment Digital Lux Meter: LX-50 Specification Test Condition: At Rest / As Built / Operational Average Light Intensity Level : 700 Lux ~ 880 Lux Procedure All 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
Purpose To measure the airborne sound pressure level within the Cleanroom produced by the basic Cleanroom mechanical and electrical systems. Instrumentation and Equipment Sound Level Meter , Cesva SC-2c Specification Test Condition: At Rest / As Built / Operational Average Sound Pressure Level : 70 dBA. Procedure All 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 the direction 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 it was still within the entrance plane. The average sound pressure level of the Cleanroom was computed form there data.

26 Reference Customer Olic Leader Industrial Kawasumi NMB Urgo Compart
Better Pharma Bangkok Hospital Siriraj Hospital Childen Hospital NSTDA GHP Chulabhorn Research Institute Leader Industrial NMB Compart ISCM Belton Nidec Casio Johnson & Johnson WD Epson Toyocom Seksun Technology

27 Reference Customer Seagate Bumrungrad Hospital CP Meji MEGA Life
NOK JCY NHK Metal Form AGC E & Tech PSC Solar Lens Hoya Transition MTEC Chulalongkorn University Seagate Bumrungrad Hospital CP Meji MEGA Life Central Lab Sema Technology M & H Min Aik Seiko Khonkaen Hospital

28 THANK YOU sales@pmt.co.th www.pmt.co.th Contact Us At :
Tel : , Fax :


Download ppt "Particle Measuring Technique Co.,Ltd."

Similar presentations


Ads by Google