Non viable particle count parameter and Test procedure -HVAC Validation in Pharma

          -Particle count test is performed to measure the available particle count in designated area.
-An optical particle counter shall be used for drawing air sample, which passes through a light scattering device.
-The generated signal is electronically processed to display particle counts of different size ranges.
-Particle size range 0.3µ, 0.5µ, 1.0µ, 3.0µ, 5.0µ, 10.0µ. Reading shall be taken for 0.5 µ and 5.0 µ particle sizes.

-Following are the Acceptance criteria for air borne particle count as per ISO guideline.

ISO Classification
Number (N)
Maximum Concentration Limits (particles/m3 of air) for Non- Viable particles
0.5 µm
5 µm
ISO Class 5
3,520
29
ISO Class 6
35,200
293
ISO Class 7
3,52,000
2,930
ISO Class 8
35,20,000
29,300





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