International Cleanroom ISO 14644 Standard
The ISO 14644 standard provides the fundamental basis for the planning, operation, and management of cleanroom facilities. As a special controlled area, the core control principles of a cleanroom lie in controlling the supplied filtered air, controlling airflow organization, controlling pressure differentials, and controlling materials and personnel.
1. Cleanliness Classification
ISO 14644 classifies cleanliness levels based on the concentration of airborne particulate matter. Critical areas require real-time monitoring of particle concentration, with automatic alarm triggering when levels exceed limits.
|
Cleanliness level |
Maximum concentration limit (pcs/m³) |
|||||
|
0.1 um |
0.2 um |
0.3 um |
0.5um |
1um |
5 um |
|
|
ISO Class 1 |
10 |
2 |
|
|
|
|
|
ISO Class 2 |
100 |
24 |
10 |
4 |
||
|
ISO Class 3 |
1 000 |
237 |
102 |
35 |
8 |
|
|
ISO Class 4 |
10 000 |
2 370 |
1 020 |
352 |
83 |
|
|
ISO Class 5 |
100 000 |
23 700 |
10 200 |
3 520 |
832 |
29 |
|
ISO Class 6 |
1 000 000 |
237 000 |
102 000 |
35 200 |
8 320 |
293 |
|
ISO Class 7 |
|
352 000 |
83 200 |
2 930 |
||
|
ISO Class 8 |
|
3 520 000 |
832 000 |
29 300 |
||
|
ISO Class 9 |
|
35 200 000 |
8 320 000 |
293 000 |
||
2. Core Requirements for Design and Construction:
Airtightness: All gaps ≤ 0.5mm, treated with specialized sealant.
Material Selection: Wall/ceiling corrugated steel plate thicknes ≥ 50mm, floor epoxy resin thickness ≥ 3mm.
Pressure Differential Control: Pressure difference between clean and non-clean areas ≥ 10Pa, pressure difference between areas with different cleanliness levels ≥ 5Pa.
Airflow Organization: Unidirectional flow cleanroom air velocity 0.36-0.54m/s, non-unidirectional flow air exchange rate ≥ 15 times/hour.
3. Equipment Requirements:
Filtration System: HEPA filter efficiency ≥99.99%@0.3μm, ULPA filter efficiency ≥ 99.9995%@0.12μm.
Temperature and Humidity Control: Temperature 22±1℃, humidity 45±5%RH.
Vibration Control: Vibration velocity in precision equipment areas ≤ 0.5mm/s.
4. Main Testing and Monitoring Methods
Particle Concentration Testing: Measurement is performed at designated sampling points using a dust particle counter, which is the core method for verifying cleanliness levels.
Airflow Testing: Includes wind speed and air volume testing to ensure sufficient airflow replacement capacity.
Differential Pressure Testing: Measures the static pressure difference between the cleanroom and adjacent areas to ensure correct airflow direction.
Filter Leakage Testing: Scans HEPA/ULPA filters and their frames to ensure no leaks.
Airflow Pattern Testing: Visualizes or measures airflow direction and uniformity to assess contaminant removal efficiency.
Temperature and Humidity Testing: Monitors and records ambient temperature and relative humidity to ensure compliance with process requirements.
Self-Cleaning Time Testing: Assesses the time required for the cleanroom to recover from a contaminated state to a specified cleanliness level.
5. Basic Operation and Maintenance Requirements
Personnel Standards: All personnel must undergo rigorous training and adhere to cleanroom clothing (cleanroom suits, gloves, masks, etc.) and behavioral guidelines.
Cleaning Procedures: Establish regular cleaning plans and use specialized tools and reagents to clean surfaces and equipment.
Material Access: All materials entering the cleanroom must undergo cleaning and airlock transfer procedures.
Preventive Maintenance: Perform regular preventative maintenance and replacement of the air conditioning and purification system.
Continuous monitoring: Real-time or frequent monitoring of key parameters (particle count, differential pressure, temperature, and humidity) with alarm limits set.
Documents and records: Preserve all test reports, monitoring data, maintenance records, and deviation handling reports to demonstrate continued compliance.
Suzhou Pharma Machinery Co.,Ltd.
2026/01/12
Icey
