Clean Room Validation B
Procedure for Clean Room Validation B

Purpose:To reconfirm the wind speed and level for air vent of each room, calculating total ventilation quantity to testify if conform to the design value within clean room.

Range:Areas identified with numbers in the drawing, please refer to the Test Numbered Locations Plan.

Test Procedure:
  • Before verification, first open air conditioning system and confirm system-related hardware facilities work well and are in open-position. After confirmation, leave the air conditioning system stably run for at least 15 minutes before proceeding to measurement.
  • Measure with hot-wire anemometers, confirming wind velocity and volume are conforming to the designed values. Calculate air change rate for such rooms based on air volume converted from measured wind velocity.
  • Measuring method for wind velocity calculation: On measuring, put the sensor rod of anemometer 30mm from vent surface to test at least 10 seconds for each of all 3 points, adding these 3 data up and record the average value to become wind velocity for such a tested location.

Calculation for air volume:Wind velocity(m/s)xvent area(m2)x3600=Air volume CMH

Calculation for air changes:Air volume CMH /Room volume M3=Air changes

Acceptable standard:Based on air changes set for such rooms as approval standard.
In accordance with Global GMP Standard Compliant Forum - 14th July 2010 –Modular GMP Cleanroom Design ISO-14644

PAO Leak Test

PAO Test Procedure:

Test method used Aerosol Photometer has been the earliest method for testing, which is still currently used because of its good efficiency. Aerosol Photometer is a kind of particle counter, also using laser technology; nevertheless, final result provided after sensoring the air sample is rather total strength of particles than particle number. DOP is an oily chemical substance, which would be nebuized to create sub-micrometer particles after being pressurized or heated, and being used to simulate particles in clean room as validated particles.

Leak refers to the leak of 1/10,000 upstream concentration; Aerosol Photometer may directly indicate comparison ratio between upstream and downstream particle concentration which becomes very convenient in scanning filters. Just because of its accuracy and reliability, American Food and Drug Administration (FDA) required all filter leak tests within relevant range (food processing sites and medical device/pharmaceutical manufacturing sites) should use DOP and Aerosol Photometer. Recently DOP has been suspicious to induce cancers, thus mostly swifted to using PAO. Features of PAO are similar to that of DOP, there being not much difference upon applications.

Procedure of leak test for filters generally involves dispersing particles and checking concentration, scanning filters and frames to locate leaks, replacing or repair, retesting, describing the procedure as followed. (In accordane with NEBB operation principles)

Record quantity of filters and number them on the drawing.
Make sure air conditioning system normally operates and is available
for tests, completely adjust the balance between wind velocity and
air volume.
Disperse with a aerosol generator challenging particles at upstream,
inject PAO into filter upstream with a particle concentration of
approximate 10 to 20 microgram od PAO per liter air. The more
particles dispersed the easier to locate leaks, but not much difference exceeding 50 microgram, and not easy to be used when less than 10. Particle concentration may be roughly calculated using air volume, and further confirmed with Aerosol Photometer.
After upstream particle concentration has been confirmed, scanning may be proceeded over filter surface to locate any leak, if required, filter peripherals may be covered with plastic screen to ensure accuracy of the test.
Scan over filter surface with pathway from outside toward inside or circuitously test along long/short edges, procedure as followed:
  • Tests should be performed for each filter and its frame.
  • Place leak detector in the position as shown in (b) of the above figure when scan over filter surface, moving along the short edge and covering the whole filter.
  • When scan filter frames, especially the area between filter and ceiling grid, leak detector may be placed as shown in (a) or (b) of the above figure to cover all seams.
  • Place the regular pyramid-shape (10mmx60mm) sampling probe of particle counter about 25mm under filter to move with a speed of 50mm/sec.
  • Reading on Aerosol Photometer indicates percentage ratio of upstream to downstream, thus, in case of value larger than 0.01(based on designed value) becomes suspicious leak, which is necessary to repeatly retest at backward about 100mm; if there is no any continuous high reading, test may be proceeded, otherwise indicating leaks which would be required to be recorded for further repair or replacement.
Any broken filter shall be repaired or replaced before proceed to retest.
Any broken filter shall be repaired or replaced before proceed to retest.
All scanning results, leak status and treatment shall be specified in the record.

Acceptance Criteria:

Any continuous reading exceeding 0.01(based on designed value) is considered as a leak, no any leak is allowed in tests for each filter and for repaired/replaced ones, neither for edge frames.
Repaired area in each filter may not be larger than 3% of filter area.
Length of any repair area may not be longer than 38mm (1.5inch).
Acceptance standard: Must conform to design conditions listed in appendix.
Cleanliness Test

Purpose:Use instruments such as particle counter to measure if relevant rooms conform to classified regulated values.

Range:Areas identified with numbers in the drawing; please refer to the Filter Test Numbered Locations Plan.

Test Procedure:


  Dynamic Static
Class Maximum allowed particle numbers equal to or larger than the following particle diameters per M3
  0.5μm 5μm 0.5μm 5μm
A 3,520 20 3,520 20
B 3,520 29 352,000 2,900
C 352,000 2,900 3,520,000 29,000
D 3,520,000 29,000 Not defined Not defined

In accordance with Global GMP Standard Compliant Forum - 14th July 2010 – Modular GMP Cleanroom Design & ISO 14644


Dynamic:Facilities have been constructed, operation being performed according to the method agreed by both user and supplier.

  • Air conditioning system stably operates for at least 15 minutes before start to perform mesauring.
  • Before measuring, first specify areas and locations to be measured as baseline for measuring.
  • Use a particle counter that has been calibrated and valid within calibration period to perform measuring. Unit (piece/m3)
    In equation NL = √A:
    NL – Minimum sampling points (round off to integer).
    A – Area of clean room or clean area, indicated with m2.
  • Measure values for all location points, printing out measured data with particle counter.
  • Particle counters acquire a minimum sampling air volume of 100L/min, as well as capability for identifying 0.5μm or even smaller particle diameters.
  • Recommended measuring height: Between 90cm to 120cm above ground, or perform according to the height of current operation platform.
    The lowest point may be not lower than the upper edge of air outlet to avoid creating turbulent flow that affects test result.
Procedure for Temperature and Humidity Tests

Purpose:To make sure if temperature and humidity of relevant rooms in a clean room conform to designed values and are within the regulated ranges.

Range:Areas identified with numbers in the drawing, please refer to the Temperature & Humidity Test Point Location Plan.

Test Procedure:
  • Ice water system and heating system should be confirmed to normally supply before tests stared, allowing air conditioning to operate for at least 15 minutes.
  • Place calibrated temperature/humidity meters in each operation room, testing at 120cm above ground for 30 seconds to get a test value; videorecording to prove the test data changes within standard ranges.

Accetable standard:Interior conditions shall conform to designed values set for such a clean room.

Test Procedure for Airflow Direction

Purpose:To confirm interior pressure differencenform to that in regulations, confirming airflow directions to avoid cross pollution and contaminated cleanliness.

Range:Areas identified with numbers in the drawing, please refer to the Airflow Direction Test Location Plan.

Test Procedure:
  • Make sure all air conditioning/dust collection/exhaust systems have been stably operate, confirming if processing machinery turning on/off would cause variance in room pressure, if yes, the measuring should be performed under turning-off status; while testing relevant rooms in identified areas, all doors ahould be securely closed to avoid any possible leaks.
  • Draw out airflow directions (indicated with arrows) based on pressure difference between operatin room and operation room or aisles, proving airfow directions with smoke testing method and videorecording as evidence.

Ceptable standard:Airflow directions shall conform to the directions set in the following table, i.e. higher cleanliness airflow should move toward rooms with lower cleanliness, supplementing with drawing of room pressures to confirm the accurate airflow directions.

*Note: Upon validation, please draw out actual measuring directions on illustration, checking the blank to specify on the record table.

Test Procedure for Pressure Difference

Purpose:To verify room pressure of clean room kept within the acceptable range for pressure difference in regulations and airflow directions, confirming the requirement for cleanliness.

Range:Validation for various rooms in clean room, please refer to the Room Relative Pressure Difference Test Location Plan.

Test Procedure:
  • Perform measuring with a calibrated differential pressure gage; the calibration date shall conform to requirement, filling the measured pressure values in the following table and make calculations.
Acceptable Standard:
  • Pressure difference between identical-class areas may not be lower than 0.5mmAq.
  • Pressure difference between different-class areas may not be lower than 1.3mmAq.
  • Airflow shall move from locations with higher cleanliness to that with lower cleanliness; i.e. creating positive pressure.
Note: 1mmAq=1mmWG=9.8Pa (Based on Instruction Manual for Sterile Operation Tasks)
Recovery Test Procedure

Purpose:Simulate the time required for a clean room encountered pollution (power failure or other factors) environment recovering to clean class of such an area.

Range:Testing for rooms operating drugs in B, C, and D class areas.

Implementation Method:
  • Simulate pollution with normally operating air conditioning units in clean room, starting the test after simulating environment pollution with smoke generator, almost all industries apply this method. (Under ISO-14644-3)
  • Shutdown for 10 minutes
  • Shutdown for 16 hours
  • Shutdown for 36 hours
Test Procedure:
  • Smoke generator or appropriately alternative
  • Cleanliness: Particle counters acquire a minimum sampling air volume of 28.3L/min(1.0ft3/min), as well as capability for identifying 0.5μm or even smaller particle diameters.
    Temperature/Humidity: Place calibrated temperature/humidity meters in various operation rooms.
Test Procedure:
  • Dust fall concentration and temperature/humidity at measuring point as a baseline required for the recovery of environment from spoil.
  • Pollute the environment over measuring point with smoke generator to 100 times of baseline and record it.
  • a .Concentration change is measured every 10 seconds with particle counter, recording the time required for concentration recovered to baseline.

    b. Temperature/Humidity changes are measured every 3 minutes, recording the time required for temperature/humidity recovered to baseline.
  • Acceptable Standard:
    Cleanliness: Static recovery time shall be less than 15 minutes for B and C class areas, while less than 30 minutes for D class areas.
    Temperature/Humidity: Conditions shall conform to designed values set for such a clean room.

Testing Locations:Areas with larger clean particles indicated in results of cleanliness tests are considered as testing points.

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