7.1 Airflow Velocity Measurement & Calculation of Air Changes: Objective

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7.

1 AIRFLOW VELOCITY MEASUREMENT & CALCULATION OF AIR CHANGES:

Objective:
 To demonstrate that the AHU system is balanced and capable of delivering airflow velocities
and providing number of air changes as per requirement when calculated as per respective
room volumes.
 Also calculate the number of air changes considering the air velocities obtained from the
terminal grill filters
Equipment Used:

 Anemometer (Duly calibrated with National / International traceability certificate).

Method of Testing:

 Ensure the Blowers are switched “ON” prior to start of the operation.
 Measure the air velocity at 5 different locations for each HEPA filters (Four corners and
center) with the help of Anemometer at 6-12 inches height below the filter face.

A B
E

D C

 The measure time at each location should be at least 10 seconds.


 Calculate the average velocity of the air coming from supply grill/Terminal filter.

Average velocity = Reading of (A + B + C + D + E)

 Calculate the air flow by multiplying the average velocity with the effective filter area.

Air flow = Average Velocity x Face area of the air inlet grill/Filter

= Ft / Min x Ft ²
= Ft ³ / Min (or) CFM

 Calculate the air flow for the entire supply grill in the room and add values to get the total air
flow in the room (CFM).
 Calculate the number of air changes per hour in the room by using the formula:

Air changes / hour = Total air flow in the room (CFM) x 60


Room Volume (Ft ³)

Acceptance Criteria:
 The variation among the average velocity across the terminal grill supplying to the same
room should not be more than ± 20%.
 Air changes / hour details are mentioned below
S. No. Area Classification No. of air Changes
01 ISO – 8 NLT 20
02 ISO – 7 NLT 60
03 ISO – 6 NLT 80

Evaluation of Test Results:


 The variation among the average velocity across the terminal grill supplying to the same
room should not be more than ± 20%.
 If velocity is not within the specified limit, damper should be regulated and if the minimum
velocity is not achievable, filter should be changed, irrespective to other test complying with
the acceptance criteria
2. NON-VIABLE air borne particle count:

Objective:
 To demonstrate that the AHU system is maintained the clean room classifications as per ISO
14644 standards at operational or rest condition.
Equipment Used:
 Air borne Particle counter (Duly calibrated with National / International traceability certificate).

Method of Testing:

 Number of sampling locations shall be calculated as per ISO 14644


 Ensure that the sampling locations are evenly distributed throughout the area of the clean
room or clean-zone and positioned at the height of the work activity i.e. minimum 1 foot.
 Selection of sampling locations are rationalized based on near the door (where men
movement is more), near the Operator working area, near the equipment, corner of the room
(too long distance from working area) and near the return air raiser (maximum chance of
contamination).
Determination of sampling volume:

 Sampling volume at each location shall be at least 2 Ltrs with the sampling time of 1min

Sampling distance:

 Sampling distance should not more than 1 foot away from the working area.

Sampling Procedure:

 Set up the particle counter in accordance with the manufacturer’s instructions.


 The sampling probe should be positioned pointing into the airflow. If the direction of the
airflow being sampled is not controlled or predictable (e.g. non-unidirectional airflow), the
inlet of the sampling probe shall be directed vertically upward.
 Minimum three sample volumes shall be taken for each sampling location at one time.

Recording of results:

 Record the result of each sample measurement as per concentration of each of the
considered particle size i.e. 0.5µm and 5.0µm diameter. The print out of the particle count
shall be checked and the same shall be duly signed and filed along with a photocopy.

Acceptance Criteria:
 The particle count across the HEPA filter should be within the design specification range to
achieve the clean room classification

Particle count
S. Area Classification
No. At Rest Condition At Operation Condition

0.5 µm 5.0 µm 0.5 µm 5.0 µm

01 ISO – 8 3520000 29300 Not defined Not defined

02 ISO – 7 352000 2930 3520000 29300

03 ISO – 6 35200 293 352000 2930

Evaluation Test Results:


 The particle count across the HEPA filter should be within the design specification range
to achieve the clean room classification at rest or operation conditions.
7.2 HEPA FILTER INTEGRITY TEST:

Objective:
To check the installed HEPA Filter integrity of terminal HEPA Filters.
Equipment Used:
PAO Aerosol Generator, photometer (Duly calibrated with National / International traceability
certificate

Method of Testing:
HEPA Filter integrity shall be monitored as mentioned below.
 Provide the compressed air to aerosol generator at the pressure of about 20 PSI (equivalent
to 1.4 kg/cm2) and visually confirm the generation of aerosol.
 PAO aerosol generator is position to near the return air grill / riser / fresh air damper of the
AHU or at the provided PAO port such that the aerosol is introduced into the upstream of the
subjected HEPA filter(s).
 Switch ON the Aerosol photometer and set the upstream concentration in between 20-80
µg/L of air.
 Measure the aerosol concentration or count at the representative upstream sample port to
ensure that the aerosol source has remain stable.
 The concentration or count shall be within ±10 % of the value obtained at the beginning of
the test. Once the 100 % concentration is established at the upstream side, turn the
instrument knob to downstream scanning mode.
 The photometer probe shall scan the entire filter face and frame at a position of about 5 cm
from the face of the filter and shall be traversed slowly (at a scan rate of not exceeding 5
cm/sec for square probe and about 15cm²/sec for rectangular probe), using slightly
overlapping strokes.
 Similarly scan the entire perimeter of the HEPA filter, along the bond between the filter
medium & frame and along all other joints in the installation through which leakage might
bypass the filter medium.
 The leaks observed can be arrested through silicon sealant.
 If the leakage is equal to or more than 0.03%, re-scan the filter and exactly locate the point of
leakage. The location of the leak should be identified by the position of probe that sustains
the maximum reading on the photometer.
 Aerosol at the downstream of the HEPA filter surface should not be detected more than
0.03% of the upstream concentration (100%).
Acceptance criteria:

 During scanning percentage of the PAO penetration shown by photometer should be less
than 0.03% through the filter media and should be ‘zero’ through mounting joints.
 Any leakage greater than 0.03% of the upstream challenge aerosol concentration is
considered unacceptable and wants repairs and resetting.
 Repair patches on the HEPA Filter should not exceed a maximum of 5% on the total filter
and Maximum width or height of any patch should not exceed 1.5 inches.

Evaluation Test Results:


 Results, complying with the acceptance criteria, shall establish the integrity of the HEPA filter
suitable for clean area.
 If any leakage is observed from the mounting, it has to be rectified through, adjustment and
application of food grade silicone sealant.
 If leakage is observed from the Filter media more than the acceptable limit, filter shall be
replaced with new one and qualified

7.3 VIABLE PARTICLE COUNT TEST:

Settle Plate / Air sampler Method:

 Settle plate or Air sampler method shall be used for viable particle count test.

7.4 RECOVERY TEST

Objective:
To establish the recovery of particles to its original conditions often resuming the AHU.
Equipment Used:
Air borne Particle counter (Duly calibrated with National / International traceability certificate

Method of Testing:

 Calibrated air borne particle counter shall be used and calibrated certificates should be

attached to the report.

 Ensure that area is cleaned and Air Handling Unit (AHU) is switched ON.

 Ensure that instrument is having a calibrated certificate.


 Set up the particle counter at the location where the maximum count is observed during

airborne particle study.

 Set the sampling rate as 1 CFM, take the particle count and check that particle count meets

the area classification design.

 Switch OFF the Air Handling Unit (AHU) and generate the area with aerosol so that particle

count shall become greater than design.

 Switch ON Air Handling Unit (AHU) and continue particle count study till the particle count

readings are nearer to the initial count taken before Air Handling Unit (AHU) switching OFF.

 Check the printout of the particle count, sign it and attached with the report along with a

photocopy.

 All the particle count test results shall comply the above acceptance criteria with clean room

classifications. If observe out of clean room classification and investigated for the source of

contamination and decision on the HVAC System qualification shall be taken.

Acceptance criteria: The clean room or clean zone shall meet the acceptance criteria for
recovery time should not be more than 15 minutes.

7.5 AIR FLOW AND VISUALIZATION TEST

Objective:

To demonstrate that the air system is balanced so that airflows throughout the system is
uniform under the supply air grill.

Equipment Used:
Glass stick with cotton or sponge and Dry ice

Method of Testing:
 Take a glass stick with cotton or sponge tied to it. Dip it in Dry Ice and check for airflow
direction in the rooms, under terminal HEPA filters (supply grills), risers, with the doors of
the room both in open and closed condition.
 The Air Flow direction shall be monitored during rest and operation conditions. In rest
condition, no process related activity shall be carried out.

 Record the direction of Dry Ice smoke flow in the video/ if possible take print out of the
same.

Acceptance Criteria:
 Air should flow from the higher-pressure zone to lower pressure zone
 Air should flow towards return air grill or filter

7.6 CONTAINMENT LEAK TEST

Objective
To check the leak rate between two clean rooms
Equipment used
Photometer

Photometer method:

 Produce an aerosol outside the cleanroom or device in accordance with step No 7.3 in
concentration high enough to cause the photometer to exceed full scale on the 0.1% setting.
 A reading on the photometer 0.1% setting in excess of 0.01% indicates a leak.
 To check for leakage through construction joints, cracks or service conduit, scan inside the
enclosure at a distance of NMT 5 cm from the joint, at a scan rate of approximately 5 cm / s.
 To check for intrusion at open doorways, measure the concentration inside the enclosure at a
distance of 0.3m to 1m from the open door.
Acceptance criteria
 Leak rate NMT 0.01%.

7.8 Temperature and Relative Humidity

 HVAC system shall be in operation for at least 8 hours prior to performing these tests. All
lights in the critical area and controlled clean area to be ON during the testing as well as
during the 24 hours prior to test.
 Take Temperature and RH measurements for every 1 hour for a period of 8 hours in each
area.
7.9 Differential Air Pressure Test

 The objective of this test is to verify and document the ability of HVAC system to consistently
maintain the specified pressure differentials relative to the adjacent areas under static and
dynamic conditions.
 Before starting this test, ensure that the (HVAC) system should be in continuous operation
for a minimum of 24 hours, and all area doors are closed.
 Measure and record the pressure differential between the clean room and ante room (if
present) and between the ante room and the external environment.
 If no ante room is present, measure and record the pressure differential between the clean
room and the external environment.
 Differential pressure (s) for the room will be monitored and recorded for every 1 hour for a
period of 8 hours in each area.

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