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ISO 7 Cleanroom: Particle Count, ACH, Airflow, Construction Cost & More

  • 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

  • 2024-10-19  |  Visits:

Creating an ISO 7 Cleanroom is about maintaining precise control over the environment to ensure high-quality production or research conditions. These cleanrooms are crucial for industries like pharmaceuticals and Electronics, where even minor contamination can lead to significant issues. Let’s delve into what makes an ISO 7 cleanroom effective and explore the key factors involved in its construction and operation.

Particle Count Limits

ISO 7 Cleanrooms are designed to handle up to 352,000 particles per cubic meter for particles that are 0.5 microns or larger. This level of control minimizes contamination risks, which is vital in sectors that demand pristine conditions. By adhering to these standards, set by the ISO 14644, environments remain suitable for sensitive operations.

Deiiang™, renowned for its precision engineering, incorporates advanced filtration systems to keep particle counts within allowable limits, ensuring compliance and operational efficiency.

ISO 14644 Particle Count Standards Comparison

ISO ClassParticles ≤0.1μmParticles ≤0.5μmParticles ≤5μm
ISO 510010
ISO 61,000100
ISO 7352,0003,52029
ISO 83,520,00035,200290

Air Changes per Hour (ACH)

Air changes per hour (ACH) in an ISO 7 cleanroom typically range from 60 to 90. This frequency of air exchange is crucial for removing particulates and maintaining temperature and humidity levels. ACH helps ensure that any contaminants introduced into the environment are swiftly removed or diluted, providing a stable atmosphere for sensitive work.

Deiiang Jason.peng designs HVAC systems that optimize airflow precisely to meet these requirements, crucially maintaining the cleanroom’s integrity and functionality.

Air Changes per Hour (ACH).jpg 

HVAC system for cleanroom air circulation

ACH Requirements by Cleanroom Class


  • ISO 5 (Class 100): 100-150 ACH

  • ISO 6 (Class 1,000): 60-100 ACH

  • ISO 7 (Class 10,000): 60-90 ACH

  • ISO 8 (Class 100,000): 15-60 ACH              

HEPA Filtration

HEPA (High-Efficiency Particulate Air) filters are essential in ISO 7 cleanrooms for removing particulates from the air. These filters capture 99.97% of airborne particles that are 0.3 microns or larger. The use of HEPA filtration confronts contamination, which is a primary concern in ensuring the cleanroom remains within its particle count limits.

Deiiang™ employs top-of-the-line HEPA filtration technology, engineered to provide consistent and reliable performance, thus securing the cleanroom’s environment.

HEPA vs. ULPA Filters

HEPA Filters


  • 99.97% efficiency at 0.3μm

  • Common in ISO 7-8 cleanrooms

  • Lower pressure drop
  • Cost-effective for most applications

ULPA Filters

  • 99.999% efficiency at 0.12μm

  • Used in ISO 5-6 cleanrooms

  • Higher pressure drop

  • More expensive, higher maintenance

airflow design

The airflow design in an ISO 7 cleanroom is carefully planned to maintain consistent environmental conditions. The layout typically uses a combination of laminar and turbulent flow to ensure that clean air is directed precisely over critical areas while maintaining overall air cleanliness. Proper airflow design is paramount for preventing particle build-up and ensuring the efficient operation of the cleanroom.

Experts like Deiiang Jason.peng utilize innovative design methodologies to enhance air distribution, supporting operational and regulatory standards.

Types of Airflow in Cleanrooms

Laminar Flow

Laminar Flow.jpg 

Uniform, parallel airflow that moves in straight lines, ideal for critical areas requiring maximum cleanliness.

Turbulent Flow

Turbulent Flow.jpg

Non-uniform airflow with mixed directions, commonly used in less critical areas of ISO 7 cleanrooms.

Gowning Requirements

Gowning protocols in an ISO 7 cleanroom are fundamental to minimizing contamination. Personnel are required to wear gowns, gloves, masks, and often headgear to protect the clean environment from human particles. Such protocols are necessary to meet GMP guidelines and ISO standards, making sure that every individual entering the space contributes to its cleanliness rather than detracting from it.

Deiiang™ provides comprehensive gowning solutions that align with these protocols, ensuring that the workforce maintains high standards of hygiene.

Proper gowning attire for cleanroom personnel.jpg 

Proper gowning attire for ISO 7 cleanroom personnel

Cleanroom Gowning Checklist

  1. Hand and arm sanitization before gowning
  2. Wearing a hairnet or head covering
  3. Putting on A CleanRoom gown or jumpsuit
  4. Wearing a face mask or respirator
  5. Putting on cleanroom gloves (often double-gloved)
  6. Wearing cleanroom shoes or boot covers
  7. Final sanitization of gloves before entering

Applications

ISO 7 cleanrooms serve a variety of applications across different industries. They are used in pharmaceutical manufacturing, biotechnology processes, and electronics production, where particle control is paramount to product integrity. Such cleanrooms are also pivotal in research environments, where controlled conditions are necessary for experimentation and analysis.

Pharmaceutical Manufacturing.jpg

Pharmaceutical Manufacturing

Production of tablets, injectables, and medical devices requiring controlled contamination levels.

Electronics Production cleanroom.jpg

Electronics Production

Manufacturing of Semiconductors, microchips, and sensitive electronic components.

Biotechnology Research Cleanroom.jpg

Biotechnology Research

Cell culture, genetic research, and pharmaceutical development in controlled environments.

Construction Cost

The construction cost of an ISO 7 cleanroom can vary significantly based on size, location, and specific requirements, such as advanced HVAC systems and regulatory compliance measures. On average, costs can range from $1,500 to $3,000 per square meter. Key factors affecting cost include the choice of materials, installation of sophisticated air handling systems, and integration of smart monitoring technologies.

Deiiang™ works alongside clients to tailor solutions that fit budget constraints while ensuring that all design and regulatory standards are adhered to, balancing cost with functionality.

Cleanroom Construction Cost Breakdown

Cost ComponentPercentage of Total Cost
HVAC System30-40%
Filtration Systems15-25%
Walls, floors, Ceilings15-20%
Electrical & Lighting10-15%
Testing & Validation5-10%

Conclusion

Developing an ISO 7 cleanroom involves a detailed understanding of particulate management, airflow design, and rigorous adherence to regulations. These elements collectively ensure that the environment remains controlled and compliant, supporting the integrity of operations within. With expertise from industry leaders like Deiiang™ and guidance from professionals such as Deiiang Jason.peng, cleanrooms are developed to uphold standards that are critical for success across various high-stakes industries.

By focusing on key components—from particle count limits to advanced HEPA filtration—these cleanrooms continue to be indispensable assets in the technological and pharmaceutical landscapes.

Complete ISO 7 cleanroom environment for critical operations

© 2025 Deiiang™ - Expert in ISO Cleanroom Solutions

Cleanroom Insiders Expert Team

Deiiang's expert team specializes in designing and constructing state-of-the-art cleanrooms tailored to meet diverse industry needs. With a focus on innovation and compliance, we deliver pristine environments that ensure operational excellence and product integrity.

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