Cleanroom Certification: Key Considerations for Effective Planning
Created on 07.09
Cleanroom Certification: Key Considerations for Effective Planning
When designing and planning a cleanroom, certification is a critical step to ensure compliance with industry standards, operational efficiency, and contamination control. Proper certification validates that the cleanroom meets the required cleanliness levels (ISO 14644-1), airflow patterns, pressure differentials, and other critical parameters. Below, we outline the key factors to consider when planning for cleanroom certification, including detailed cleanroom classification parameters.
1. Cleanroom Classification & Standards (ISO 14644-1)
Cleanrooms are classified based on the maximum allowable particle count per cubic meter (m³) at specified particle sizes. The ISO 14644-1 standard defines nine classes, with ISO Class 1 being the cleanest and ISO Class 9 the least controlled.
ISO 14644-1 Cleanroom Classification Table
ISO Class | ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5 µm | ≥1 µm | ≥5 µm |
ISO 1 | 10 | 2 | - | - | - | - |
ISO 2 | 100 | 24 | 10 | 4 | - | - |
ISO 3 | 1,000 | 237 | 102 | 35 | 8 | - |
ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | - |
ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
ISO 7 | - | - | - | 352,000 | 83,200 | 2,930 |
ISO 8 | - | - | - | 3,520,000 | 832,000 | 29,300 |
ISO 9 | - | - | - | 35,200,000 | 8,320,000 | 293,000 |
Note: Values represent maximum permitted particles per cubic meter (m³).
Industry-Specific Standards
- Pharmaceuticals (GMP EU/WHO/USP): Typically requires ISO 5-8 (Grade A-D).
- Semiconductor Manufacturing: Often ISO 1-5 due to extreme sensitivity to particles.
- Healthcare & Compounding (USP <797>): Mandates ISO 5 (critical zones) and ISO 7-8 (background).
- Medical Device Manufacturing: Usually ISO 5-8 depending on product requirements.
2. Airflow & Pressure Testing for Certification
To maintain the required ISO class, cleanrooms must undergo:
- Airflow velocity tests 0.45 m/s ±20%
- Air changes per hour (ACH)
- ISO 5 (Class 100): ~250-600 ACH (HEPA-filtered unidirectional flow).
- ISO 6 (Class 1,000): ~90-180 ACH.
- ISO 7 (Class 10,000): ~30-60 ACH.
- ISO 8 (Class 100,000): ~10-25 ACH.
- Pressure differential checks +10 to +15 Pa
3. Particle Count Testing & Viable Monitoring
Particle counting must be performed at critical locations (workstations, filling lines, etc.) under three conditions:
- As-built (at rest) – No personnel or equipment running.
- At operational – Normal working conditions.
- Recovery test – Measures how quickly the cleanroom returns to ISO class after contamination.
Microbial (Viable) Monitoring Requirements (for GMP/Healthcare)
- Settle plates (exposure for 4 hours).
- Active air sampling (CFU/m³ limits vary by ISO class).
- Surface monitoring (swab tests on critical surfaces).
4. HEPA/ULPA Filter Integrity Testing
- DOP/PAO aerosol challenge test ≥99.97% efficiency (HEPA) or ≥99.999% (ULPA)
- Scan testing 10-20% of rated airflow
5. Environmental Controls (Temperature, Humidity, ESD)
- Temperature: 20-24°C
- Humidity: 30-60% RH
- ESD Control (for electronics): <100 volts surface resistance
6. Compliance & Re-Certification
- Initial certification must be performed before operational use.
- Routine monitoring (continuous or periodic, depending on risk).
- Re-certification 6-12 months (or after major modifications).
Conclusion
Proper cleanroom certification ensures compliance with ISO 14644-1, GMP, USP, and other industry standards. By carefully planning for airflow, particle counts, filter integrity, and environmental controls, you can maintain the required cleanliness levels and operational reliability.
For expert certification support, consult accredited cleanroom testing professionals to meet your specific regulatory requirements.
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