Airborne Particle Count & Cleanliness Classification Tests
Airborne particle count testing is used to determine the cleanliness level of controlled environments such as cleanrooms, laboratories, pharmaceutical facilities, semiconductor manufacturing, and hospitals. These tests are critical for ISO 14644-1 compliance and regulatory validation.

1. Purpose of Airborne Particle Count Testing
Ensures air cleanliness levels in cleanrooms and controlled environments.
Verifies compliance with industry standards (ISO 14644, EU GMP, FDA cGMP).
Detects contamination sources that may impact product quality or patient safety.
Monitors cleanroom performance for ongoing validation and maintenance.

2. Cleanroom Classification Standards
Cleanrooms are classified based on the maximum allowable airborne particle concentration at different particle sizes. The most widely used standards are:
a. ISO 14644-1: Cleanroom Classifications
Defines cleanroom classes based on particles per cubic meter (m³) of air.

ISO Class 1-5 → Used in semiconductor and pharmaceutical industries.
ISO Class 6-8 → Used in biotech, healthcare, and general cleanroom applications.
b. EU GMP Cleanroom Classification (For Pharmaceutical & Sterile Areas)
Grade A & B → Used for sterile manufacturing (e.g., injectable drugs).
Grade C & D → Used for less critical processes (e.g., preparation rooms).

3. Airborne Particle Count Testing Procedure
a. Equipment Required
Laser Particle Counter (LPC): Measures airborne particles by size.
Sampling Tubing (if needed).
Isokinetic Probe: Ensures representative sampling.
b. Test Steps
Set up the particle counter according to manufacturer guidelines.
Define sampling locations based on ISO 14644-1 or GMP guidelines (based on room size and airflow pattern).
Place the isokinetic probe at a height representing breathing zones or process areas.
Set sample volume (e.g., 1 cubic meter of air per sample).
Measure particle counts at each location, following the required sample time.
Compare results with the acceptable limit for the cleanroom class.
Document and report findings for compliance.

4. Pass/Fail Criteria for Cleanroom Classification
Pass: Measured particle levels meet or are below the cleanroom classification limits.
Fail: Measured particle levels exceed limits, indicating contamination sources (e.g., improper airflow, equipment failure, or personnel contamination).

5. Corrective Actions for Non-Compliance
Increase air filtration efficiency (e.g., check HEPA filters for leaks).
Improve airflow patterns (e.g., adjust laminar flow in critical zones).
Reduce personnel contamination (e.g., stricter gowning procedures).
Clean and disinfect surfaces to minimize particle shedding.

6. Applications of Airborne Particle Testing
Pharmaceutical & Biotech: Ensures compliance with GMP and FDA guidelines.
Semiconductor Manufacturing: Prevents micro-contamination that affects production yield.
Hospitals & Healthcare: Monitors air cleanliness in operating rooms and isolation wards.
Aerospace & Defense: Ensures precision assembly environments are contaminant-free.
Would you like a detailed test protocol or assistance in interpreting test results?