SOP for Particulate Dispersion Test Procedure

Prepared by： X X
Department Name Date

Approve by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose
The purpose is to verify the parallelism of airflow throughout the work zone and the
capability of the cleanroom to limit the dispersion.
2. Scope
 This procedure is applicable to – HEPA filter Utilities in Humanwell Pharmaceutical
Ethiopia PLC

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

The Utility division & the quality assurance manager are responsible for SOP compliance.

5. Material and Equipment

 Visual smoke generator
 Particle counter
 Anemometer
6. Procedure
6.1. Complete the air velocity uniformity tests.
6.2. Divide the work zone into 2 3 2 ft equal areas.
6.3. Set up the smoke generator, with outlet tube pointing in the direction of airflow
and located at the center of a grid area at the work zone entrance plane.
6.4. If smoke is introduced with air pressure, adjust it to provide a smoke outlet
velocity equal to the room air velocity at that point.
6.5. Operate the particle counter with the sample tube at the normal work level and at
a point remote from the smoke source. Verify that the counter indicates particle
concentrations less than 100 particles of 0.5 µm or greater.
6.6. Move the sample tube in toward the smoke source from all directions at this level
to the point where particle counts show a sudden and rapid rise to high levels (106 per
cubic foot). This defines the envelope of dispersion away from the smoke source and
demonstrates the airflow parallelism control of the room.
6.7. Repeat for all grid areas. Prepare a diagram showing grid areas and corresponding
dispersion envelopes.
6.8. Acceptance Criteria
The dispersion should not extend beyond 2 ft radically from the point of smoke source;
i.e., at 2 ft from the generation point, the particle count should be less than 100/ft3 of the
0.5-µm size and larger.
 7. Abbreviations
 SOP - Standard Operating Procedure
 HEPA-High Efficiency Particulate Air

8. Related Documents /Applicable document/

Related Documents./ Title

SOP/UL/009/F01
Particulate Dispersion Test Procedure Recording Form

9. Revision History

Version
Revision Description
No.

1 New