1. Procedure for Airborne Particle Count Test

Purpose

To measure the airborne particulate level in the cleanroom and to determine the room cleanliness grade with reference to ISO 14644-1, EU GMP classifications at the time of the test (As-Built, At-Rest, or Operational).

Instrument

Discrete Particle Counter

Procedure

1. Verify that all aspects of the cleanroom system which contribute to its operational integrity (air handling, filtration systems, walls, ceilings, floors, etc.) are complete and functioning. The following primary tests shall be completed prior to performing the cleanliness classification tests:
   1. Airflow test
   2. Filter leak test
   3. Room pressurization test
2. The Cleanroom has been purged for at least 12 hours before testing commences.
3. The rooms are divided into test grids as per minimum sampling locations requirement by ISO 14644-1:2015.
4. The counter’s sample rate is set to 1 m³/min and the sampling time set to 1 minute or as required.
5. A minimum of 1 sample is taken at each grid, at a height of 1 meter above the floor.
6. When an obstruction is encountered, the sample is to be taken at 300 mm above the obstruction.

References  :  ISO 14644-1:2015(E) Cleanrooms and associated controlled environments-Part 1: Classification of Air Cleanliness by Particle Concentration.

Acceptance Criteria

1. The cleanroom or controlled environment shall have met the acceptance criteria for an airborne particulate cleanliness class (see Table 1 ISO Class, GMP Classification) when the averages of the particle concentrations measured at each of the locations fall at or below the class limit.

ISO 14644-1:2015 – Classification

EU GMP Classification

ISO 14644-1:2015 – Sampling locations