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Cleanroom Air System Design: How to Meet ISO 14644 and GMP Cleanroom Classes

Created on 11.14

Introduction

Cleanrooms rely heavily on air systems to maintain controlled cleanliness levels. Whether for pharmaceutical, semiconductor, or biotechnology facilities, the air system is the core of ensuring airborne particle control and compliance with ISO 14644 and GMP standards. A well-designed air system stabilizes temperature, humidity, pressure, and airflow, ensuring long-term reliability and cleanroom certification.
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1. Understanding ISO 14644 & GMP Requirements

ISO 14644-1 particle concentration limits

ISO defines cleanroom classes such as ISO Class 5, 6, 7, and 8, each with specific particle count requirements.

GMP environmental control

GMP focuses on both air cleanliness and process control, requiring:
Pressure cascades
Controlled microbial contamination
Defined airflow patterns
Regular monitoring and validation
Together, these standards guide cleanroom air design.

2. Key Elements of a Cleanroom Air System

• Air Handling Unit (AHU)

Provides filtration, cooling, heating, and humidification.

• HEPA/ULPA filtration

Ensures particle removal efficiency up to 99.99%.

• Supply and return air diffusers

Regulate airflow and maintain uniform air distribution.

• Pressure control

Positive pressure prevents outside contamination; negative pressure is used for hazardous processes.

• Temperature & humidity stability

Essential for sensitive materials and instruments.

3. Designing Airflow Patterns

Different processes require different airflow patterns.

• Unidirectional (laminar) airflow

Used in ISO 5 zones such as filling areas or critical benches.

• Non-unidirectional (turbulent) airflow

Used in ISO 7–8 general cleanrooms.

• Hybrid airflow

Ensures both efficiency and energy savings.
Proper airflow reduces particle accumulation and maintains validation stability.

4. Meeting ISO & GMP Through Proper Design

Step-by-step design process

Identify process requirements
Determine ISO class or GMP grade
Calculate air changes per hour
Design pressure differentials
Choose HEPA filter efficiencies
Consider energy optimization (VAV, heat recovery)
Ensure maintainability and future upgrades

Conclusion

Meeting ISO 14644 and GMP standards requires precise engineering. Through optimized airflow distribution, correct pressure cascade, and high-efficiency filtration, cleanrooms can maintain stable environmental conditions and achieve long-term compliance. A well-designed air system not only ensures product quality but also enhances operational reliability and energy efficiency.
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