NEBBNEBB((National Environmental Balancing BureauNational Environmental Balancing Bureau))

Clean Room Certified by…Clean Room Certified by…

Standard Clean RoomStandard Clean Room

Federal Standard 209E Federal Standard 209E ( ( FS – 209E FS – 209E )) ISO Standard ISO Standard ( ( ISO 14644 – 1ISO 14644 – 1 ) ) Good Manufacturing Practice (GMP)

Federal Standard 209E Federal Standard 209E ((FS-209EFS-209E))

700700100000100000      100000100000

70701000010000      1000010000

7710001000      10001000

  100100300300750750  100100

  1010303075753503501010

  11337.57.5353511

5.0 5.0 μμmm0.5 0.5 μμmm0.3 0.3 μμmm0.20.2 μμmm0.10.1 μμmm  

  CountCount / / ftft33    ClassClass

ISO Standard ISO Standard ( ( ISO 14644 – 1ISO 14644 – 1 ) )

293002930000

83200083200000

3520000352000000      ISO 9ISO 9

293002930083200083200035200003520000      ISO 8ISO 8

293029308320083200352000352000      ISO 7ISO 7

2932938320832035200352001020010200

002370023700

00100000100000

00ISO 6ISO 6

29298328323520352010200102002370023700100000100000ISO 5ISO 5

  838335235210201020237023701000010000ISO 4ISO 4

  88353510210223723710001000ISO 3ISO 3

    4410102424100100ISO 2ISO 2

        221010ISO 1ISO 1

5.05.0 µmµm1.01.0 µmµm0.50.5 µmµm

0.30.3 μμmm

0.20.2 μμmm0.1 0.1 μμm m   

     Count Count / /

mm33    ClassClass

Good Manufacturing Practice Good Manufacturing Practice ((GMPGMP))

In operationIn operationAt restAt rest

Not Not defined defined 

Not Not defined defined   2929 00000033 520520 000000DD

2929 00000033 520520 00000022 900900  352352 000000CC

22 900900352352 000000292933 520520BB

202033 520520202033 520520AA

5.05.0 µµmm0.50.5 µµmm5.05.0 µµmm0.50.5 µµmm  

    CountCount / / mm33GradeGrade

Test DescriptionTest Description

Airborne Particle Count TestAirborne Particle Count Test Airflow Velocity Test UnderAirflow Velocity Test Under Temperature TestTemperature Test Relative Humidity TestRelative Humidity Test Room Pressurization TestRoom Pressurization Test Scan Leak Test HepaScan Leak Test Hepa Scan Leak Test PAOScan Leak Test PAO Light Intensity Level TestLight Intensity Level Test Sound Pressure Level TestSound Pressure Level Test

Type of ConditionType of Condition

AS BUILTAS BUILT The condition where the installation is complete with all The condition where the installation is complete with all

services connected and functioning but with no production services connected and functioning but with no production equipment, materials, or personnel presentequipment, materials, or personnel present

AT RESTAT REST The condition where the installation is complete with The condition where the installation is complete with

equipment installed and operating in a manner agreed equipment installed and operating in a manner agreed between the customer and supplier, but with no personnel between the customer and supplier, but with no personnel presentpresent

OPERATIONALOPERATIONAL The condition where the installation is functioning in the The condition where the installation is functioning in the

specified manner, with the specified number of personnel specified manner, with the specified number of personnel present and working in the manner agreed uponpresent and working in the manner agreed upon

Certify Clean room TestingCertify Clean room Testing

Airborne Particle TestAirborne Particle Test

Airflow Velocity TestAirflow Velocity Test

Temperature & Relative Temperature & Relative Humidity TestHumidity Test

Room Pressurization TestRoom Pressurization Test

Scan Leak TestScan Leak Test

InstrumentInstrument

Test ProceduresTest Procedures

Procedure ForAirborne Particle Count

PurposeTo measure the airborne particulate level in the Cleanroom and to determine the room Cleanliness Classification as per Federal Standard 209E.Instrumentation and EquipmentPMS Lasair II / 310A counter Specification• Test Condition: At Rest / As Built / Operational• Allowable Count Limit for each particle sizeClass 1,000 : < 1,000 count/ft3 @ 0.5 μm & greater

: < 7 count/ft3 @ 5.0 μm & greater

Class 100 : < 300 count/ft3 @ 0.3 μm & greater

: < 100 count/ft3 @ 0.5 μm & greaterProcedureReference: 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 31.6 sq ft3.

Class 100 Grid size not exceeding 25 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.

Procedure For Temperature & Relative Humidity Test

PurposeTo determine the capability of the Cleanroom air handling system to maintain the air temperature and relative humidity within specified limits.

Instrumentation and EquipmentTSI 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 ft 22

•  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.

Procedure ForAirflow Velocity Test

PurposeTo determine the airflow velocity of the filters installed in the Cleanrooms.

Instrumentation And EquipmentAirdata 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 : 0.41 - 0.61 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: 0.36-0.56 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.

Procedure ForRoom Pressurization Test

Purpose To determine the capability of the Cleanroom system to maintain the specified pressure differential . Instrumentation and EquipmentElectronic Micromanometer: ADM-870

SpecificationTest Condition: At Rest / As Built / OperationalDifferential 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.

Procedure ForHEPA 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-870Specification 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.

Procedure ForHEPA 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 EquipmentATI Aerosol Photometer ,Model 2H

Specification

Test Condition: At Rest / As Built / Operational

1 Upstream Concentration: Minimum value 20 µm/litre

Preferred Range 10 - 100 µm/litre2 Maximum allowable penetration < 0.01 % of upstream

Procedure ForHEPA Filter Installation Leak Test

(Photo meter Method)

Procedure

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.

Procedure For Light Intensity Level Test

Purpose To determine the light intensity level at working height level within the Cleanrooms. Instrumentation and EquipmentDigital Lux Meter: LX-50

SpecificationTest Condition: At Rest / As Built / OperationalAverage 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.

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-2c

SpecificationTest Condition: At Rest / As Built / OperationalAverage 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.

Reference CustomerReference Customer

Leader IndustrialLeader Industrial NMBNMB CompartCompart ISCMISCM BeltonBelton NidecNidec CasioCasio Johnson & JohnsonJohnson & Johnson WDWD Epson ToyocomEpson Toyocom Seksun TechnologySeksun Technology

OlicOlic KawasumiKawasumi UrgoUrgo Better PharmaBetter Pharma Bangkok HospitalBangkok Hospital Siriraj HospitalSiriraj Hospital Childen HospitalChilden Hospital NSTDANSTDA GHPGHP Chulabhorn Research InstituteChulabhorn Research Institute

Reference CustomerReference Customer

SeagateSeagate Bumrungrad HospitalBumrungrad Hospital CP MejiCP Meji MEGA LifeMEGA Life Central LabCentral Lab Sema TechnologySema Technology M & HM & H Min AikMin Aik SeikoSeiko Khonkaen HospitalKhonkaen Hospital

NOKNOK JCYJCY NHKNHK Metal FormMetal Form AGCAGC E & TechE & Tech PSCPSC Solar LensSolar Lens HoyaHoya TransitionTransition MTECMTEC Chulalongkorn UniversityChulalongkorn University

Contact Us At :

Tel : 02-536-5316-8, 02-536-5376-8Fax : 02-536-5354

Contact Us At :

Tel : 02-536-5316-8, 02-536-5376-8Fax : 02-536-5354