insta notes

air flow velocity and uniformity test and air flow parallelism test

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Airflow Velocity and Uniformity Test

  1. Test objective: To determine that the UAD meet the criteria for airflow velocity and uniformity set in the design specifications.
  2. Acceptance criteria: The airflow velocity in a uni­directional airflow device should not exceed the limits set in the design criteria. Typically the highest and lowest reading should not be more than 15% to 20% from the unit average velocity.
  3. Test procedure
    1. In general the environment is divided by a grid, depending on the configuration of the room and classification of the environment. A 60 X 60-cm (2X 2-ft) grid is typically used. Velocities are measured by using a thermal anemometer, vane-type anemometer, or its equivalent.
    2. Readings are taken at the center of each square. If a single-point-sampling anemometer is used or a one-reading, multiport matrix-type sampler is used, the probe should be located at a distance equivalent to 15 cm or 6 in., from the filter face or before the air encounters an obstacle.
    3. Readings at work height are taken for infor­mational purposes only. Turbulence induced by non aerodynamically designed objects upstream may impede the proper and accurate measure­ment.
  4. Reporting requirements
    1. Report results in the approved forms.
    2. Specify the basis for the acceptance or rejection as a function of the acceptance criteria.

Airflow Parallelism Test

  1. Test objective: Verify the parallelism of the airflow throughout the work zone.
  2. Acceptance criteria: Air should flow in a parallel stream to prevent the flow of outside air into the critical environment.
    1. Test procedure
      1. Generate visible smoke (theatrical smoke or similar) upstream from the work zone.
      2. Establish a reference point by using a plumb bob or similar device.
      3. Generate smoke over the manufacturing environ­ment.
      4. Videotape the direction of the flow in both cases.
        1. Determine the direction of the airflow. Depending on the source of smoke, protection gear may be needed to protect personnel.
        2. Reporting requirements
        3. Report results in the approved forms.
        4. Inventory and label the videotapes.
          1. Specify and report the basis for the acceptance or rejection as a function of the acceptance criteria.

reference by: validation of pharmaceutical process by james and frederick

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