1

Measurement of Air Flow Velocity      

To measure airflow velocity, uniformity and supply airflow rates in clean rooms.

In-house specification.

Once

2

Measurement of Number of Air Changes per Hour

[Air Exchange Rate]

The measurement of air exchange rate is carried out to ascertain the air volume supplied to the clean room per hour and to ensure sufficient quantity of fresh air enters in each room.

Minimum number of air sweeps in a clean room is based on the room design, to flush the prevailing air so as to minimize the ingress of air borne particle contamination.

Once

3

Filter System Leakage Test

To confirm that the filter system is properly installed and that leaks have not developed during installation/use.

According to the ISO – 14644 series guidelines on air cleanliness.

Once

4

Non – viable particle count monitoring

This is to provide the overall cleanliness and classification of the environment with respect to the concentration of nonviable particles.

Based on stringent air classification limits, the acceptance criteria for nonviable particle concentration have been fixed.

Consecutive

3 Days

5

Viable count (Microbial) monitoring

The purpose of this test is to provide overall cleanliness and classification of the environment with respect to the concentration of viable particles.

Based on stringent EU air classification, the acceptance criteria for viable particle concentration have been fixed.

Consecutive

3 Days

6

Air Flow Pattern

The purpose of this test is to demonstrate the flow of air from high pressure zone to lower pressure zone area or more clean zone to less clean zone in order to avoid thecontamination/cross contamination

According to the ISO – 14644 series guidelines on air cleanliness

Once

7

AHU Recovery study

The purpose of the test is to establish how long it takes for the cleanroom to recover from a challenge concentration to the Target Cleanliness Level. The ISO 14644-3

Recovery time for ISO 8 Class is not more than 15 minutes

Once

8

Relative Humidity

The purpose of this test is to verify moisture (expressed as relative humidity or dew point) levels are within the control limits over the time period.

Relative Humidity Should not more 55 %

Consecutive

3 Days

9

Temperature

The purpose of this test is to verify the air temperature levels are within the control limits over the time

period specified by the customer for the area being tested

Temperature not more 27 °C

Consecutive

3 Days

10

Differential Pressure

The purpose of the air pressure difference test is to verify the capability of the cleanroom air movement system to maintain the specified pressure differential between the clean room and its surroundings

WHO TRS 961, Annex 6,

WHO TRS1044- Annex 2

Consecutive

3 Days

11

Containment Study

This test is performed to determine if there is intrusion of unfiltered air into the clean room or clean

zone(s) from outside the clean room or clean zone enclosure(s) through joints, seams, doorways and

pressurized ceilings

According to the ISO – 14644 series guidelines on air cleanliness. Leakage should not more than 0.01 % of Challenge Concentration

Once

12

Segregation test

The purpose of this test is to assess the separation effectiveness achieved by a specific airflow,

challenging the lesser classified area with particles and determining the particle concentration in the

protected area at the other side of the segregation.

• Grade C, The Particle Concentration is reduced by a factor of 10.

• Grade B, The Particle concentration is reduced by a factor of 100.

Once