PURPOSE:
To verify that the airborne particulates count in HVAC System in cleanroom area measured at rest, complies with the respective cleanliness level of particulate concentration.
PROCEDURE:- This test should be performed by trained personnel. Testing is to be carried out in accordance with ISO 14644-1:2015, ISO 14644-3:2005 standard. Measuring points quantity and position will be executed as per attached sampling layout.
- Using a calibrated particle counter to sample at a rate of 50 L/min. The sample time of 1 minute with cleanliness grade D (0.05 m3).The sample time of 20 minute with cleanliness grade C, B, A (1 m3).
- A single sample is to be taken at each location at a height of 1 meter above the floor level.
- The data will be autosave in instrument and print out directly at testing field. The data will be attach in testing report.
- Note: When testing, limit noise, movement or any activation can generate particle.
- Complete the Test Data Summary in the report form below.
ACCEPTANCE CRITERIA:
ISO 14644-1:2015 standard & EU GMP Annex 1 Standard