Tips for Passing ISO, cGMP, FDA and Other Certifications
Know your ISO requirement
Either way, make sure you know the applicable performance requirements before you select a room design or cleanliness level.
FFU Ceiling Coverage and Air Change Rate
| Class ISO 146144-1 (Federal Standard 209E) | Average Airflow Velocity m/s (ft/min) | Air changes/hour | Ceiling Coverage |
|---|---|---|---|
| ISO 8 (Class 100,000) | 0.005 – 0.041 (1 – 8) | 5 to 48 | 5 – 15% |
| ISO 7 (Class 10,000) | 0.051 – 0.076 (10 -15) | 60-90 | 15 – 20% |
| ISO 6 (Class 1,000) | 0.127 – 0.203 (25 – 40) | 150 - 240 | 25 – 40% |
| ISO 5 (Class 100) | 0.203 – 0.406 (40 – 80) | 240 - 480 | 35 – 70% |
| ISO 4 (Class 10) | 0.254 – 0.457 (50 – 90) | 300 - 540 | 50 – 90% |
| ISO 3 (Class 1) | 0.305 – 0.457 (60 – 90) | 360 - 540 | 60 – 100% |
| ISO 1 – 2 | 0.305 – 0.508 (60 – 100) | 360 - 600 | 80 – 100% |
| Note: Actual average velocity and air changes required may vary depending on the application and floor plan. Source: Institute of Environmental Science | |||
Terra recommends the high value within each range, which in most cases accommodates typical contamination loads presented by personnel and equipment. Modular Power Distribution Modules make it easy to add as requirements change – plug-and-play connections eliminate the need for hard-wiring by an electrician.
Cleanroom Design and Materials
Environmental Control and Documentation
Modular cleanrooms are available with stand-alone air conditioning modules or can be integrated with existing A/C systems. Humidification and De-humidification systems meet specific RH requirements.
