What Is a Cleanroom?
A cleanroom is a sterile environment in which the quantity of airborne particles and other environmental parameters are controlled according to specific standards. These rooms are designed to protect product quality and worker health.
On What Basis Are Cleanrooms Classified?
Cleanroom classifications are determined according to international standards. The two most widely used standards are:
- ISO 14644-1: The most widely used international standard.
- FED STD 209E: The old American standard, still referenced in some places.
Cleanroom Classifications According to ISO 14644-1
According to the ISO standard, cleanrooms are classified between ISO 1 (cleanest) and ISO 9 (least clean) based on the number of airborne particles between 0.1 and 5 microns.
| Class | ≥0.1 µm Particles/m³ | ≥0.5 µm Particles/m³ | Application Area |
|---|---|---|---|
| ISO 1 | 10 | 0 | Nanotechnology |
| ISO 5 | 100,000 | 3,520 | Pharmaceutical production |
| ISO 7 | 352,000,000 | 352,000 | Electronics |
| ISO 8 | 3,520,000,000 | 3,520,000 | Packaging, etc. |
✅ Note: An ISO 5 class cleanroom is generally supported by laminar air flow systems.
How Is a Cleanroom Class Selected?
The following criteria are taken into account when selecting a cleanroom class:
- The sensitivity of the product to be manufactured
- Legal regulations
- Industry standards
- Worker safety and product sterility
Which Industry Uses Which Class?
🔬 Pharmaceutical Industry
The ISO 5 – ISO 7 range is generally used for pharmaceutical production and filling processes.
🧬 Biotechnology and Laboratories
ISO 4 – ISO 6 classes are preferred in fields such as cell culture and genetic analysis.
💻 Electronics and Microchip Manufacturing
ISO 1 – ISO 5 cleanrooms are required for processes such as semiconductor manufacturing.
The Importance of Cleanroom Classifications
Correctly determining and applying cleanroom classifications;
- Increases product safety.
- Minimizes the risk of contamination.
- Ensures legal compliance.
- Reduces costs in the long term.
Conclusion: Maximum Efficiency with the Right Cleanroom Class
Cleanroom classifications are a critical factor that directly affects the quality and safety of production environments. Regardless of the industry, selecting the appropriate class is of great importance for both production success and legal compliance.