How Does class 7 clean room Work?

Clean rooms are classified according to the cleanliness level of the air inside the controlled environment. The clean room class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air. The primary authority in the US and Canada is the ISO classification system ISO -1.

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This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the &#;cleanest&#; class and ISO 9 is the &#;dirtiest&#; class. Even if it&#;s classified as the &#;dirtiest&#; class, the ISO 9 clean room environment is cleaner than a regular room.

The most common ISO clean room classes are ISO 7 and ISO 8. The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Class 10,000 and Class 100 000.

The old Federal Standard 209E ( FS 209E ) includes these clean room classes : Class 100,000; Class 10,000; Class 1,000; Class 100; Class 10; Class 1. This standard was replaced in by ISO--1. It was withdrawn in , but it is still widely used.

Clean rooms must also follow industry-specific and international standards. For example, EU GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies.

You might also like this article &#;>How Classification Impacts your Cleanroom Design

Want to learn more about Clean Rooms? &#;>What is a Clean room?

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What Is an ISO Class 7 Cleanroom?

An ISO Class 7 cleanroom is a controlled environment that adheres to specific cleanliness standards defined by the International Organization for Standardization (ISO). Cleanrooms are essential in industries where the presence of contaminants, such as dust, microbes, or particles, can compromise the quality and integrity of products, processes, or research. The ISO standards classify cleanrooms on a scale ranging from ISO Class 1 (most stringent) to ISO Class 9 (least stringent), based on the allowable particle count within the cleanroom environment.

For an ISO Class 7 cleanroom:

• Particle Count: The ISO Class 7 standard specifies the maximum allowable particle count per cubic meter of air for particles equal to or larger than 0.5 micrometers. In the case of an ISO Class 7 cleanroom, the permissible particle count is limited to 352,000 particles per cubic meter.
• Air Quality: ISO Class 7 cleanrooms require high-efficiency air filtration systems, often utilizing HEPA (High-Efficiency Particulate Air) or ULPA (Ultra-Low Penetration Air) filters. These filters effectively remove particles from the air, contributing to the cleanroom's controlled environment.
• Temperature and Humidity Control: Maintaining stable temperature and humidity levels is crucial in an ISO Class 7 cleanroom. Control over these factors helps prevent the generation of particles and ensures a consistent environment for sensitive processes.
• Personnel Garb and Procedures: Strict gowning procedures are implemented for personnel entering ISO Class 7 cleanrooms. This typically involves wearing specialized cleanroom suits, gloves, masks, and other protective gear to minimize the introduction of contaminants from outside sources.
• Cleanroom Design: The design and construction of ISO Class 7 cleanrooms involve careful consideration of materials and surfaces to minimize particle generation. Smooth, non-porous materials are used to create an environment that is easier to clean and less prone to contamination.
• Airflow Control: Positive air pressure is often maintained within the cleanroom to prevent the entry of external contaminants. The controlled airflow helps create a barrier, ensuring that particles are pushed out of the cleanroom rather than being drawn in.

ISO Class 7 cleanrooms find widespread application in industries such as pharmaceuticals, biotechnology, electronics, healthcare, aerospace, and other sectors where precision and cleanliness are critical for product quality and safety. The controlled environment provided by these cleanrooms is essential for processes where the slightest contamination can have significant consequences.

How Technical Safety Services Can Help You With Cleanroom Testing

Technical Safety Services is your one-stop shop for cleanroom certification services.

Our experts are experienced in conducting certification tasks, including: 

• Accurately assessing your facility&#;s airflow volume
• Testing the integrity of your HEPA filter system 
• Measuring non-viable airborne particulate levels
• Calculating room air exchange rate 
• Measuring room differential pressure 
• Measuring temperature and relative humidity 
• Conducting viable environmental monitoring 

To learn more about Technical Safety Services&#; approach to&#;cleanroom air monitoring&#;services, or to get started on a new project, please&#;contact us&#;today. 

If you want to learn more, please visit our website class 6 cleanroom.