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Cleanroom Classification – ISO 14644-1 & GMP Standards

Created on 2025.08.21
When planning a cleanroom, defining the correct cleanroom classification is one of the most critical steps. Cleanroom ratings set strict limits on airborne particle concentrations and ensure compliance with ISO 14644-1 and GMP standards, helping maintain product quality, process stability, and regulatory approval.
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What Is Cleanroom Classification?

Cleanroom classification defines the maximum allowable number of airborne particles per cubic meter at specified particle sizes.
Different industries—such as pharmaceuticals, biotechnology, electronics, medical devices, and food processing—require different cleanliness levels based on process sensitivity and regulatory requirements.
The international standard ISO 14644-1 is the most widely used system for cleanroom classification.

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, precision laboratories
ISO 4
10,000
352
—
Pharma 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
Typical Usage
Grade A
Laminar flow zone
Critical aseptic operations
Grade B
Background for Grade A
Aseptic preparation
Grade C
Cleanroom
Less critical processing steps
Grade D
Controlled area
Non-sterile processes
GMP grades are commonly used in pharmaceutical cleanrooms and align closely with ISO 14644-1 classifications.

How to Choose the Right Cleanroom Classification

Step 1 – Define Industry Requirements
Pharmaceutical and biotech facilities must comply with ISO 14644-1 and GMP regulations.
Step 2 – Evaluate Process Sensitivity
Sterile and high-risk operations typically require ISO 5 / GMP Grade A environments.
Step 3 – Consider Regulatory Guidelines
Standards from FDA, EU GMP, and WHO specify required cleanroom classes.
Step 4 – Balance Cost and Performance
Higher ISO classes increase construction and operating costs, so the classification should match actual process needs.

Why Work with GCC Cleanroom?

  • ISO 14644-1 & GMP Expertise
– Professional cleanroom classification planning
  • Turnkey Services
– Design, construction, installation, testing, and validation
  • Multi-Industry Experience
– Pharmaceuticals, biotechnology, electronics, laboratories, food processing

Get Started with Your Cleanroom Classification

Contact GCC Cleanroom to discuss your project and receive a customized ISO 14644-1 cleanroom classification plan that meets both regulatory and operational requirements.
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