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Cleanroom Classification – ISO 14644-1 & GMP Standards
Created on 08.21
When planning a cleanroom, determining its classification is one of the most important steps. Cleanroom classification sets limits for airborne particles and ensures compliance with ISO 14644-1 and GMP standards.
What is Cleanroom Classification?
Cleanroom classification defines the maximum number of particles per cubic meter at defined particle sizes. Different industries, including pharmaceuticals, biotechnology, electronics, and food, require different levels of cleanliness.
ISO 14644-1 Cleanroom Classification Table
ISO Class | ≥0.1 µm particles/m³ | ≥0.5 µm particles/m³ | ≥5 µm particles/m³ | Typical Applications |
ISO 1 | 10 | — | — | Nanotechnology, semiconductor |
ISO 2 | 100 | 10 | — | Microelectronics |
ISO 3 | 1,000 | 35 | — | Optics, high-precision labs |
ISO 4 | 10,000 | 352 | — | Pharmaceutical filling support |
ISO 5 | 100,000 | 3,520 | 20 | Aseptic processing, operating rooms |
ISO 6 | 1,000,000 | 35,200 | 293 | Medical device assembly |
ISO 7 | — | 352,000 | 2,930 | General pharmaceutical production |
ISO 8 | — | 3,520,000 | 29,300 | Packaging, non-sterile manufacturing |
ISO 9 | — | 35,200,000 | 293,000 | Controlled environments |
GMP Cleanroom Grades (A–D)
GMP Grade | Area | Usage |
Grade A | Laminar flow workstation | Critical aseptic operations |
Grade B | Background for Grade A | Preparation for aseptic processing |
Grade C | Cleanroom | Less critical processing steps |
Grade D | Controlled area | Non-sterile processes |
How to Choose the Right Cleanroom Classification
Step 1 – Define Industry Requirements
Different industries have different requirements, for example pharmaceuticals must follow GMP and ISO 14644-1.
Step 2 – Match Process Sensitivity
Processes involving sterile products need higher classification (ISO 5 / GMP Grade A).
Step 3 – Consider Regulatory Standards
FDA, EU GMP, and WHO guidelines dictate classification levels for specific industries.
Step 4 – Balance Cost and Efficiency
Higher cleanroom classes are more expensive to build and maintain, so balance quality and budget.
Why Work with GCC Cleanroom
Expertise in ISO & GMP Planning
We provide turnkey solutions for cleanroom planning, design, construction, and validation.
Industries We Serve
Pharmaceuticals, biotechnology, electronics, laboratories, food processing.
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