This ensures that the cleanroom meets the required cleanliness levels set by standards like ISO 14644-1 or GMP guidelines.

How the Test is Done:

1️⃣ Use a Particle Counter

A device called a TSI Airbone Particle Counters is placed at different locations inside the cleanroom.

2️⃣ Measure Air Cleanliness

The device captures air and counts microscopic particles suspended in it.

- 0.3 µm

- 0.5 µm

- 5.0 µm

3️⃣ Compare with Standards

The readings are checked against the limits defined for that cleanroom class.

- Pass – If particle levels are within limits, the cleanroom is compliant. - Fail – If levels are too high, cleaning or corrective action is needed.

Equipment Used:

- TSI Airbone Particle Counters – Measures and displays particle counts.

- Isokinetic Probe – Ensures accurate air sampling.

- Tubing & Stand – Holds the probe in the correct position during testing.

Why It Matters:

- Ensures product safety and quality

- Supports regulatory compliance (ISO, GMP)

- Helps maintain cleanroom certification

- Identifies airflow or contamination issues

Need Particle Count Testing?

Aimtech Systems LLP provides professional cleanroom validation services, including:

- On-site particle count testing

- Detailed compliance reports

- Corrective recommendations if required