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How many air changes per hour for ISO Class 8?

  • Author:Jason Peng

  • Cleanroom Engineering Technology Manager of Deiiang Company.

    Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

    Executive Director of Guangdong Cleanroom Industry Association of China.

    Engaged in R&D of related products for 15 years, with rich relevant technical experience

  • 2024-12-05  |  Visits:


How Many Air Changes Per Hour for ISO8?

What Is a Cleanroom?

Importance of Air Changes

Air changes per hour refers to the volume of air that is replaced in a cleanroom in one hour. This metric is vital for controlling airborne contaminants, maintaining temperature and humidity levels, and ensuring a comfortable working environment for personnel. In ISO 8 Cleanrooms, maintaining an adequate rate of air changes helps to dilute and remove particulate matter, thus minimizing the risk of contamination during manufacturing processes.

Factors Influencing Air Change Requirements

The specific air change requirements for ISO8 can vary based on several factors, including the type of operations being conducted, the number of personnel in the cleanroom, and the equipment used. For example, processes that generate more airborne particles, such as certain pharmaceutical manufacturing tasks, may require higher ACH to ensure that the air remains clean. 

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Best Practices for Maintaining Air Changes

To achieve the recommended air changes in an ISO ISO 8 cleanroom, effective ventilation systems must be installed and properly maintained. HEPA (High-Efficiency Particulate Air) filters are commonly used to ensure that the recirculated air is free of contaminants. 

Furthermore, the airflow design should promote laminar flow, ensuring that air moves in a uniform direction and minimizes areas of turbulence where contaminants could accumulate. Training personnel on cleanroom protocols, such as minimizing door openings and maintaining proper gowning procedures, can also contribute to maintaining air quality and achieving the desired number of air changes per hour.


How Many Air Changes Per Hour in a Cleanroom?

How Do You Calculate Air Changes Per Hour (ACH)? | MECART

Air changes per hour (ACH) are crucial for cleanroom air quality. ISO 8 cleanrooms typically require 10 to 25 ACH to dilute airborne contaminants. Higher rates are necessary for sensitive manufacturing processes, emphasizing the need for regular ventilation system monitoring and maintenance.




What is the ISO Standard for Air Changes Per Hour?

The ISO standard for air changes per hour varies based on the CleanRoom Classification. Different classes have established guidelines to ensure adequate air quality and control of contamination. ISO 14644-1 specifies the cleanliness levels for various cleanroom classes, and the air change rates are typically aligned with these classifications. The standard recommends that cleanrooms operate within specific ACH limits to maintain air cleanliness.

Cleanroom ClassRecommended ACHNotes
ISO1100 - 200+Highest air exchange required due to sensitivity.
ISO525 - 50Critical for semiconductor and pharmaceutical applications.
ISO810 - 25Sufficient for moderate contamination control.
ISO95 - 15General purpose with lower sensitivity requirements.


What is the Acceptable Air Change Per Hour?

The acceptable air change per hour (ACH) in cleanroom environments is defined by the specific class of the cleanroom and the processes taking place within it. For ISO 8 cleanrooms, the typical range of 10 to 25 air changes per hour is crucial for maintaining product integrity and minimizing contamination risks. This range provides a balance between energy efficiency and sufficient air quality.

Air Changes Per Hour” and other things you should know about air quality  and ventilation | Aeramax Professional

In practice, achieving the desired ACH involves careful planning of the cleanroom’s HVAC system. This includes selecting appropriate filter types, ensuring proper airflow patterns, and conducting regular maintenance checks. Cleanroom operators must also consider factors such as personnel flow and equipment layout to optimize air changes effectively.

Moreover, the acceptable ACH may need to be adjusted based on real-time monitoring of airborne particles. 


How Many Air Changes Per Hour for Class 10000 Clean Room?

1. Importance of Air Changes in Class 10000 Clean Rooms

Maintaining the appropriate number of air changes is critical in Class 10000 Cleanrooms to ensure that airborne contaminants are effectively diluted and removed from the environment. The higher air change rates help control the concentration of particulate matter, which is essential for industries such as pharmaceuticals, biotechnology, and semiconductor manufacturing. 

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2. Factors Influencing Air Change Rates

The specific air change rate needed in a Class 10000 cleanroom can vary based on several factors, including the level of activity within the cleanroom, the number of personnel present, and the types of processes being carried out. 

3. Best Practices to Achieve Required Air Changes

To ensure that a Class 10000 Cleanroom meets the necessary air change requirements, it is essential to have a well-designed HVAC system in place. This should include HEPA or ULPA filters to capture airborne particles effectively. Regular maintenance and monitoring of the HVAC system are crucial to maintain optimal airflow and filter performance. 




Cleanroom Industry Standards

Cleanroom industry standards are established to ensure consistency in cleanliness levels and operational protocols across various sectors, including pharmaceuticals, biotechnology, and electronics. 

The ISO 14644 series outlines the classification of air cleanliness, with iso 14644-1 specifically detailing the maximum allowable particle counts for different cleanroom classes. Compliance with these standards is critical for companies operating in regulated industries, as it ensures that products meet safety and quality requirements.

StandardDescription
ISO 14644-1Classification of air cleanliness in cleanrooms
iso 14644-2Monitoring and control of cleanroom environments
ISO 14644-3Test methods for cleanrooms
ISO 14644-4Design, construction, and start-up of cleanrooms




Cleanroom Air Flow Rates

Overview of Air Flow Rates in Cleanrooms: Airflow rates in cleanrooms are crucial for maintaining the required air quality and cleanliness levels. The airflow design must ensure that the air is distributed evenly throughout the cleanroom, minimizing dead zones where contaminants can accumulate. Effective airflow management is essential to achieving the desired number of air changes per hour and ensuring compliance with cleanliness standards.

Types of Airflow Systems: There are several types of airflow systems commonly used in cleanrooms, including laminar flow and turbulent flow systems. Laminar flow systems provide a unidirectional airflow pattern, which is ideal for maintaining a sterile environment, particularly in high-class cleanrooms. 

Cleanroom Terminology: What Are Air Change Rates? - Angstrom Technology

Importance of Regular Monitoring and Maintenance: Regular monitoring of airflow rates is essential to ensure that cleanrooms operate within the specified parameters. This includes routine checks of air velocities, pressure differentials, and particulate counts. 

In conclusion, maintaining the correct number of air changes per hour is vital for the proper functioning of cleanrooms, particularly for ISO8 and Class 10000 environments. Understanding the factors influencing air change requirements and adhering to industry standards ensures that cleanrooms remain effective in controlling contamination and maintaining product integrity.

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