CERTIFIED CLEAN ROOM

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CERTIFIED CLEANROOM
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Clean Room Certified by
NEBB (National Environmental Balancing Bureau)
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Standard Clean Room

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

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

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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

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Certify Clean room Testing
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Airborne Particle Test
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Airflow Velocity Test
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Temperature Relative Humidity Test
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Room Pressurization Test
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Scan Leak Test
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Instrument
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Test Procedures
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Procedure ForAirborne 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 lt 1,000 count/ft3 _at_ 0.5 µm
  greater
• lt 7 count/ft3 _at_ 5.0
  µm greater
• Class 100 lt 300 count/ft3 _at_
  0.3 µm greater
• lt 100 count/ft3 _at_ 0.5 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
  31.6 sq ft3.

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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.

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Procedure ForAirflow 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
  2x4 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
  2x4 HEPA filter at 150 mm. from the filter
  surface. (Under Laminar Flow Hood)
• Average 0.36-0.56 m/s
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• Procedure 
• Reference IES Recommended Practice,
  IES-RP-CC006.2 Testing Cleanrooms
• NEBB Procedural Standard for Certified Testing
  of Cleanroom
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• 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.

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Procedure ForRoom Pressurization Test

• Purpose
•  
• To determine the capability of the Cleanroom
  system to maintain the specified pressure
  differential.
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• Instrumentation and Equipment
• Electronic Micromanometer ADM-870
• Specification
• Test Condition At Rest / As Built / Operational
• Differential Pressure 0.05WG 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.

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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-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 filters 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.

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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 Equipment
• ATI 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/litre
• 2 Maximum allowable penetration lt 0.01 of
  upstream

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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 manufacturers
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 1from
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.
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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.

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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 10x10
• 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

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Reference Customer

• Olic
• Kawasumi
• Urgo
• 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

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Reference Customer

• 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

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THANK YOU
Contact Us At Tel [phone],
02-536-5376-8 Fax [phone]
sales_at_pmt.co.th www.pmt.co.th