A Comprehensive Guide to ISO Cleanroom Classifications

January 2, 2025

A Comprehensive Guide to ISO Cleanroom Classifications

Cleanrooms are an essential part of numerous industries, providing controlled environments free from contaminants. The cleanliness of a cleanroom is determined by its classification, which specifies the allowable number of particles in the air. ISO (International Organization for Standardization) cleanroom classifications offer a universal standard for measuring and comparing cleanliness levels. This guide provides a detailed overview of the ISO classification system and its relevance across various applications.

Understanding ISO Cleanroom Standards

ISO cleanroom classifications are defined by the maximum number of particles allowed per cubic meter of air. The size of the particles is also a critical factor, with smaller particles requiring stricter controls. The most common ISO classes range from ISO Class 1 (the cleanest) to ISO Class 8 (the least strict). Here is a breakdown of these classifications:

ISO Cleanroom Classifications

ISO Class 1

• Particle Count: Maximum of 10 particles (0.1 microns or larger) per cubic meter.
• Applications: Nanotechnology, advanced semiconductor manufacturing, and other applications requiring the cleanest environments.

ISO Class 2

• Particle Count: Maximum of 100 particles (0.1 microns or larger) per cubic meter.
• Applications: Ultra-sensitive electronic component production and high-precision optical manufacturing.

ISO Class 3

• Particle Count: Maximum of 1,000 particles (0.1 microns or larger) per cubic meter.
• Applications: High-precision optics, aerospace components, and certain types of medical research.

ISO Class 4

• Particle Count: Maximum of 10,000 particles (0.1 microns or larger) per cubic meter.
• Applications: Microelectronics, pharmaceutical R&D, and medical device assembly.

ISO Class 5

• Particle Count: Maximum of 100,000 particles (0.1 microns or larger) per cubic meter.
• Applications: Sterile pharmaceutical compounding, biotechnology research, and certain food manufacturing processes.

ISO Class 6

• Particle Count: Maximum of 1,000,000 particles (0.1 microns or larger) per cubic meter.
• Applications: Optical lens assembly, electronics manufacturing, and clean packaging facilities.

ISO Class 7

• Particle Count: Maximum of 10,000,000 particles (0.1 microns or larger) per cubic meter.
• Applications: Automotive component testing, medical device production, and food processing facilities.

ISO Class 8

• Particle Count: Maximum of 100,000,000 particles (0.1 microns or larger) per cubic meter.
• Applications: General manufacturing, warehouse clean areas, and non-critical assembly environments.

Factors Affecting ISO Classification

Several factors influence the cleanliness level of a cleanroom, including:

• Airflow: Cleanrooms rely on laminar or turbulent airflow to remove contaminants.
• Filtration Systems: HEPA or ULPA filters are used to trap particles and maintain cleanliness.
• Personnel: Proper gowning protocols are crucial to minimize contamination from individuals working in the cleanroom.
• Processes: Some operations, like chemical processing or sensitive material handling, may require stricter classifications.

ISO Standards Across Industries

ISO classifications are used in various industries to ensure product quality and safety. Here are a few examples:

• Pharmaceuticals: ISO Class 5 for sterile compounding and production.
• Aerospace: ISO Class 3 for precision components and ISO Class 7 for assembly.
• Electronics: ISO Class 4 for microelectronics manufacturing.
• Food & Beverage: ISO Class 7 or 8 for contamination-free packaging and processing.
• Healthcare: ISO Class 6 for surgical instrument preparation and ISO Class 8 for general hospital cleanrooms.

Selecting the Right ISO Class for Your Cleanroom

Choosing the correct ISO classification depends on your industry, the application, and specific cleanliness requirements. Partnering with an experienced cleanroom design and installation firm ensures that your cleanroom meets the appropriate standards for your operations.

Partner with C1D1booths.com

At C1D1booths.com, we specialize in creating custom cleanroom solutions tailored to your unique needs. Whether you require an ISO Class 5 cleanroom for pharmaceutical production or an ISO Class 8 environment for food packaging, we’re here to help. Contact us today to learn more about our design and installation services.