HOW TO VALIDATE LAF IN INDUSTRY

(LAMINAR AIR FLOW)?

To maintain Class 100 environmental conditions, Laminar is very important. Laminar air
flow sucks air in the room through pre-filters with the help of blowers and passes the air
through HEPA filters to maintain class 100 environmental condition.

LAMINAR AIR FLOW TEST PROCEDURE TEST PROCEDURE

There are 6 test procedure to validate LAMINAR AIR FLOW.

1. Air Velocity Measurement

2. Integrity Test of HEPA Filters.
3. Non -Viable Air Borne Particle Count Test
4. Recovery test
5. Microbiology Particle counts Monitoring
6. Centrifugal Air Sampling Method

1. Air Velocity Measurement

Objective

To demonstrate that the air system is balanced and capable of delivering air velocities
as per requirement.

Equipment Used: Anemometer

Method Applied:

 Ensure that the blowers are switched “ON” prior to the start of the observations.
 Measure the air velocity 1.5” to 2” below the grill.
 Each filters 5 locations reading to be taken (Four Corners and center) with the
Anemometer and record.
 Calculate the average velocity of the air coming from Supply filter grill.
 The damper can be adjusted depend upon the design requirement.
 Air flow = Average Velocity x Face Area of the Air Inlet Grill / Filter

= Ft / Min. X Ft 2

= Ft 3 / Min. or CFM
Acceptance Criteria

The air velocity of air shall be 90 FPM and the accepted airflow uniformity is the ±20
FPM. In such case if we consider the average velocity 90 FPM 70-110 FPM is the
acceptable range. Efficiency of filter should not be less than 99.97 %.

2. Integrity Test of HEPA Filters

Objective

To check the installation integrity of the HEPA Filter of the Hanging LAF..

Equipment Used

Cold PAO smoke generator Aerosol photometer, duly calibrated with national /
international traceability

Method Applied

Filter testing shall be performed only after operational air velocities have been verified
and adjusted wherever necessary.

Position the smoke generator and introduce PAO smoke into the air stream, ahead of
the HEPA filters, at the concentration of 80-100 mg per liter of air at the filter’s designed
airflow rating and set the instrument at 100% concentration. Scan the downstream side
of the filter with an appropriate photometer probe at a sampling rate of at least 1 ft 3 /
min. The probe should scan the entire filter face and frame at a position about 1 to 2
inches from the face of the filter. Scanning shall be done at the rate of maximum 2 feet
per minute.

Acceptance Criteria

During scanning percentage of the PAO penetration shown by photometer should be

less than 0.01% through the filter media and should be ‘zero’ through mounting joints.

3.Non -Viable Air Borne Particle Count Test

Objective

To establish that in critical work locations within critical and non-critical area meets the
requirement for cleanliness class as per Schedule M.
 Equipment Used

Air borne Particle counter, duly calibrated with national / international traceability.

Method Applied

Air conditioning system shall be in continuous operation for at least 24 hours prior to
performing these tests. Particle count for all pre decided location (layout attached) for
critical and non-critical area, at the working height, shall be taken. Number of sampling
location will be decided as per the SCHEDULE M.

Acceptance Criteria

The clean room or clean zone shall meet the acceptance criteria for an air borne
Particle cleanliness if

 The average of the Particle count measured at each location falls at or below the class
limit.
 The mean of these averages falls at or below class limit (as referred in standard
SCHEDULE M).

Maximum number of permitted particles per cubic meter equal

to or above
Grade

At rest (b) In Operation (a)

0.5µm 5.0µm 0.5µm 5.0µm

A 3500 0 3500 0

B(a) 3500 0 3,50,000 2,000

C(a) 3,50,000 2,000 35,00,000 20,000

Not defined Not defined

D(a) 35,00,000 20,000
(c) (c)

4. Recovery test
Objective

To determine whether the LAF is capable of returning to its specified class within a
finite time.

Equipment Used

A discrete particle counter having a particle size discrimination capability of 0.5 µm or

smaller.

Procedure

Measure the particle counts under LAF outlet to establish the existing particle
concentration level Switch off the LAF until a particle count at the outlet is substantially
above the LAF’s at rest level. Turn on the LAF and record the particle count for a 6
second period each minute, until the cleanliness level at the outlet is restored to the
original condition.

5. Microbiology Particle counts Monitoring:

Settling Plate Method

Objective:

To determine the air borne microbial contamination level in air for the Hanging LAF .

Procedure

Five SCDA / SDA 90mm Petri plates shall be exposed on the working plane in the
area. Plate exposure shall be done under dynamic condition. Plate shall be exposed
for 4 hours. Exposed plate shall be incubated for 20 to 25°C for 72 Hrs followed by 30
to 35°C for further 48 Hrs. Plates shall be observed for any microbial growth after 5
days.

In dynamic condition, mock machine operation with normal man movement shall be
there. The sampling shall be done in three continuous working days.

Acceptance Criteria

Grade Limits (in CFU / plate)

 Action

A < 01

* Fungus should be absent

6. Centrifugal Air Sampling Method

Procedure

1. Operate the instrument at the scheduled locations using the pre incubated Soyabean
Casein Digest Agar Petri plates.
2. Collect the Petri plates in box/carrier and transfer it to incubator room of microbiology
lab for incubation.
3. Incubate the plates at 20° to 25°C for 72 hours for fungal growth followed by 48 hours of
incubation at 30° to 35°C for bacterial growth. When incubation observe carefully and
record the no. of CFU in the observations sheet & correct as per feller table to ensure
true value.

Acceptance Criteria:

Limits of Air Sampling (in dynamic condition):

Grade Air sample CFU/m3

A <1

* Fungus should be absent