What is the difference between Class 8 and Class 7 clean rooms?

Cleanrooms are essential in various industries, particularly in Semiconductor manufacturing, pharmaceuticals, and biotechnology, where controlling contamination is critical. Cleanrooms are classified based on the number and size of particles permitted per volume of air. This article will explore the differences between Class 8 and Class 7 Cleanrooms, highlighting their specifications, applications, and compliance with international standards.

CleanRoom Classifications Overview

What is a Cleanroom?

A cleanroom is a controlled environment with a specified level of cleanliness, designed to minimize the introduction, generation, and retention of airborne particles.

Key Characteristics of Cleanrooms:

• Controlled temperature and humidity

• Filtration systems to remove particulate matter

• Strict protocols for personnel and materials entering the space

Cleanroom Classification Standards

Cleanrooms are classified according to the ISO 14644-1 standard, which defines the maximum allowable particle counts in a specified volume of air.

iso 14644-1 Classifications:

• Class 1: Maximum of 12 particles per cubic meter (≥0.1 micrometers)

• Class 7: Maximum of 352,000 particles per cubic meter (≥0.5 micrometers)

• Class 8: Maximum of 3,520,000 particles per cubic meter (≥0.5 micrometers)

Class 8 Cleanroom Specifications

Particle Count Requirements

Class 8 Cleanrooms allow for a higher level of particulate contamination compared to Class 7 Cleanrooms.

Particle Count Specifications:

• Maximum of 3,520,000 particles per cubic meter (≥0.5 micrometers)

• Maximum of 29,300 particles per cubic meter (≥5 micrometers)

Air Quality and Filtration

Class 8 cleanrooms utilize air filtration systems but do not require the same level of stringency as Class 7.

Filtration Characteristics:

• Generally equipped with HEPA filters

• Less frequent filter changes compared to Class 7 environments

Typical Applications

Class 8 cleanrooms are suitable for processes where contamination is less critical but still needs control.

Common Uses:

• Assembly of non-critical electronic components

• Production of certain pharmaceuticals

• Testing and packaging environments

Class 7 Cleanroom Specifications

Particle Count Requirements

Class 7 cleanrooms have stricter particle count limits, which makes them suitable for more sensitive operations.

Particle Count Specifications:

• Maximum of 352,000 particles per cubic meter (≥0.5 micrometers)

• Maximum of 2,930 particles per cubic meter (≥5 micrometers)

Air Quality and Filtration

Class 7 cleanrooms require more advanced air filtration and circulation systems to maintain cleaner air.

Filtration Characteristics:

• Often equipped with HEPA or ULPA filters

• More frequent maintenance and filter replacements

Typical Applications

Class 7 cleanrooms are utilized in more sensitive manufacturing processes where contamination could significantly impact product quality.

Common Uses:

• Semiconductor manufacturing

• Pharmaceutical production of sterile products

• Biotechnology research and development

Key Differences Between Class 7 and Class 8 Cleanrooms

Compliance with International Standards

Importance of Compliance

Both Class 7 and Class 8 cleanrooms must adhere to international standards to ensure operational effectiveness and product safety. Compliance is essential for regulatory approvals and maintaining quality assurance.

Relevant Standards:

• ISO 14644-1: Cleanrooms and associated controlled environments

• ISO 13485: Quality management systems for medical devices

• GMP (Good Manufacturing Practice): Ensures products are produced consistently and controlled to quality standards

Role of Deign in Compliance

Deign offers comprehensive solutions for Cleanroom design and management, ensuring compliance with international standards. Their expertise in cleanroom technology helps businesses achieve and maintain the required cleanliness levels.

Conclusion

Understanding the differences between Class 7 and Class 8 cleanrooms is crucial for industries that require stringent contamination control. Class 7 cleanrooms offer more stringent standards for particle counts and air quality, making them suitable for sensitive applications. In contrast, Class 8 cleanrooms provide a less stringent environment for non-critical processes.