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what does class 100 000clean room mean?

  • 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

  • 2024-12-10  |  Visits:

A Class 100,000 Cleanroom is a controlled environment that allows a maximum of 100,000 particles of size 0.5 micrometers or larger per cubic meter of air. This classification is essential in industries like pharmaceuticals, biotechnology, and Electronics, where even minor contamination can compromise product quality. Companies such as Deiiang specialize in designing and constructing cleanrooms that adhere to these standards, ensuring optimal conditions for sensitive manufacturing processes.

A Class 100,000 cleanroom

What is A CleanRoom?

A cleanroom is a controlled environment designed to minimize contamination by airborne particles, microbes, and other pollutants. These rooms are vital in various industries, including pharmaceuticals, biotechnology, and Semiconductor manufacturing, where product quality must be safeguarded against contamination. Cleanrooms utilize high-efficiency particulate air (HEPA) filters, controlled airflow, and strict protocols to maintain cleanliness. For instance, Deiiang focuses on creating cleanroom solutions tailored to meet the specific requirements of industries, ensuring compliance with international standards like ISO 14644-1, which sets guidelines for CleanRoom Classification.

Cleanroom Classification Standards

Cleanrooms are categorized based on the maximum allowable concentration of airborne particles. This classification helps industries determine the level of cleanliness required for their operations.

Classification details:

  • Class 1: Up to 10 particles ≥0.5 µm/m³

  • Class 10: Up to 100 particles ≥0.5 µm/m³

  • Class 100: Up to 1,000 particles ≥0.5 µm/m³

  • Class 1,000: Up to 10,000 particles ≥0.5 µm/m³

  • Class 10,000: Up to 100,000 particles ≥0.5 µm/m³

  • Class 100,000: Up to 100,000 particles ≥0.5 µm/m³

These classifications are crucial for companies like Deiiang to design cleanrooms that meet the specific needs of their clients while ensuring compliance with regulations.

The classification of cleanrooms is vital for maintaining product integrity. By adhering to these standards, industries minimize contamination risks, enhancing operational efficiency and safety.

Class 100,000 Cleanroom Specific Standards Data

In a Class 100,000 cleanroom, the maximum allowable concentration is 100,000 particles of size 0.5 micrometers or larger per cubic meter. This level of cleanliness is crucial for applications where contamination can significantly impact quality.

Key data for Class 100,000 cleanrooms

  • Maximum particles: 100,000 particles ≥0.5 µm/m³

  • air changes per hour: typically 10-20

  • Temperature and humidity control to prevent condensation

  • Compliance with iso 14644-1: ISO 14644-1

Deiiang ensures that their Cleanroom designs align with these standards, providing an optimal environment for various industries.

Applications of Class 100,000 Cleanrooms

Class 100,000 cleanrooms are essential in industries like pharmaceuticals, biotechnology, and electronics manufacturing. These environments help prevent contamination, which is vital for maintaining product quality and safety.

Key applications include

  • Pharmaceuticals: Ensures safe drug production and packaging.

  • Electronics: Critical for semiconductor manufacturing, where particles can damage components.

  • Biotechnology: Provides a controlled environment for research and development.

  • Food Processing: Maintains product safety by minimizing contamination.

By utilizing Class 100,000 cleanrooms, companies like Deiiang can ensure high standards of cleanliness and compliance with international regulations.

Additional applications include

  • Medical Device Manufacturing: Ensures sterile conditions for device production.

  • Aerospace: Critical for manufacturing components where precision is essential.

  • Nanotechnology: Required for processes involving nanoscale materials.

In summary, Class 100,000 cleanrooms play a crucial role in various industries by ensuring product safety and quality. Deiiang's expertise in cleanroom design helps clients meet stringent standards, promoting compliance and operational efficiency.

For reference international standard: 

ISO 14644-1 ISO 14644-1.

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