What is clean room classification?

Cleanroom classification refers to a system of categorizing cleanrooms based on their level of cleanliness and the permissible amount of particulate and microbial contamination within the controlled environment. Cleanrooms are highly controlled environments used in various industries, such as pharmaceuticals, electronics, biotechnology, and healthcare, where a high level of cleanliness is required to ensure product quality, safety, and integrity.

Cleanroom classification standards are typically defined and governed by international organizations, such as the International Organization for Standardization (ISO) and the U.S. Federal Standard 209E (FS 209E). However, it is important to note that the FS 209E standard has been officially replaced by the ISO 14644 series, which provides a globally accepted framework for cleanroom classification.

The cleanroom classification system is primarily based on the measurement of airborne particles within a specified volume of air. The most commonly used metric for classifying cleanrooms is the number of particles per cubic meter of air, categorized by their size range. The ISO 14644–1 standard specifies the particle size thresholds for each cleanroom class. The lower the class number, the cleaner the environment.

Here is a breakdown of the ISO 14644–1 cleanroom classes and the corresponding particle limits:

1.ISO Class 1: This is the cleanest class with the lowest particle limit. It allows a maximum of 10 particles per cubic meter (≥0.1 μm).

2.ISO Class 2: This class allows a maximum of 100 particles per cubic meter (≥0.1 μm).

3.ISO Class 3: This class allows a maximum of 1,000 particles per cubic meter (≥0.1 μm).

4.ISO Class 4: This class allows a maximum of 10,000 particles per cubic meter (≥0.1 μm).

5. ISO Class 5: This class allows a maximum of 100,000 particles per cubic meter (≥0.1 μm).

6. ISO Class 6: This class allows a maximum of 1,000,000 particles per cubic meter (≥0.1 μm).

7.ISO Class 7: This class allows a maximum of 10,000,000 particles per cubic meter (≥0.1 μm).

8.ISO Class 8: This class allows a maximum of 100,000,000 particles per cubic meter (≥0.1 μm).

It’s important to note that the ISO 14644–1 standard also specifies limits for larger particles (≥5 μm), as well as limits for microbial contamination, such as bacteria and fungi.

In addition to airborne particle limits, cleanroom classification may also consider factors like air changes per hour, temperature, humidity, pressure differentials, and filtration efficiency. These factors may vary based on the specific industry requirements and the criticality of the processes being conducted within the cleanroom.

Cleanroom Bahrain classification plays a vital role in ensuring product quality, preventing contamination, and maintaining a controlled environment for sensitive manufacturing and research processes. Compliance with the appropriate cleanroom class ensures that the required cleanliness levels are achieved, monitored, and maintained throughout the operational life of the cleanroom facility.

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