Cleanroom Classification Standards | ISO 14644 & GMP Grades

Why Cleanroom Classification Matters

Cleanroom classification standards define the allowable concentration of airborne particles and microorganisms in controlled environments. These standards are fundamental to industries such as pharmaceuticals, biotechnology, medical devices, electronics, and healthcare.

Proper cleanroom classification ensures product quality, regulatory compliance, and repeatable manufacturing conditions. Incorrect classification or misunderstanding of standards can lead to compliance risks, failed audits, and unnecessary construction costs.

1. Overview of Cleanroom Classification Standards

Two major systems are used globally:

• ISO 14644-1 – International standard for airborne particle cleanliness

• GMP Cleanroom Grades – Regulatory classification used in pharmaceutical manufacturing

While ISO standards are widely applied across industries, GMP grades are mandatory for pharmaceutical applications.

GMP Requirements for Pharmaceutical Cleanrooms

2. ISO 14644-1 Cleanroom Classification

ISO 14644-1 classifies cleanrooms based on the maximum allowable concentration of airborne particles per cubic meter.

ISO Cleanroom Classes

ISO classification applies to non-viable particle control and must be verified through regular testing.

3. EU GMP Cleanroom Grades

GMP grades are specifically defined for pharmaceutical cleanrooms and focus on both viable and non-viable contamination control.

GMP Cleanroom Grades

GMP grades include stricter operational controls and environmental monitoring requirements than ISO classifications.

4. ISO vs GMP: Key Differences

ISO standards define cleanliness levels, while GMP standards govern how cleanrooms are designed, operated, and validated.

5. Cleanroom Classification and HVAC Design

Cleanroom classification directly influences HVAC system design.

HVAC Design Impacts

• Air change rates increase with higher cleanliness levels

• Higher-grade areas require tighter pressure control

• HEPA filtration efficiency depends on target classification

 GMP Cleanroom HVAC Design

Proper HVAC design ensures that required cleanroom classifications are maintained consistently during operation.

6. Cleanroom Classification Testing and Validation

Classification must be verified through qualification testing.

Common Tests

• Airborne particle counting

• Airflow visualization

• Pressure differential testing

• HEPA filter integrity testing

Testing frequency depends on cleanroom grade, regulatory requirements, and risk assessment.

 Cleanroom Validation and Qualification

7. Common Cleanroom Classification Mistakes

Selecting the correct cleanroom class based on process needs is essential for cost-effective compliance.

8. DERSION’s Approach to Cleanroom Classification

DERSION supports clients in selecting and implementing appropriate cleanroom classification standards.

• Industry-specific classification assessment

• GMP and ISO-compliant cleanroom design

• Modular cleanroom solutions

• Integrated HVAC and validation support

• CE, ISO, UL certified manufacturing

DERSION ensures cleanroom classifications align with both regulatory and operational requirements.

Conclusion

Understanding cleanroom classification standards is essential for compliant cleanroom design and operation. ISO 14644 and GMP grades provide structured frameworks to control contamination and ensure product quality.

DERSION delivers cleanroom solutions designed to meet global classification standards and regulatory expectations.