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What You Need to Know About Cleanroom Classifications

 Cleanroom classifications are a crucial aspect of maintaining controlled environments in various industries, such as pharmaceuticals, electronics manufacturing, aerospace, and healthcare. These classifications provide a standardized way to measure and maintain the cleanliness and contamination levels within a cleanroom facility. Here's what you need to know about cleanroom classifications:

1.Purpose of Cleanrooms:

Cleanrooms are designed to control airborne particles, temperature, humidity, and other environmental factors to ensure the quality and integrity of products being manufactured or processed within them. These environments are essential for industries where even microscopic contaminants can have serious consequences.

2.ISO Cleanroom Standards:

The International Organization for Standardization (ISO) has established a set of standards known as ISO 14644, which provides guidelines for cleanroom classifications. These standards are widely recognized and used globally.



3.Cleanroom Classification by Particle Count:

Cleanrooms are classified based on the maximum allowable number of airborne particles per cubic meter (cubic foot) of air, typically for particles ≥0.5 micrometers in size. The ISO standards classify cleanrooms from ISO 1 (highest cleanliness) to ISO 9 (lowest cleanliness). The lower the ISO class number, the cleaner the environment. For example, an ISO 1 cleanroom allows fewer particles than an ISO 5 cleanroom.

4.Federal Standard 209E (Obsolete):

In the past, cleanrooms were classified using the Federal Standard 209E, which used a different particle count system. However, this standard has been replaced by the ISO 14644 standards.

5.Cleanroom Classes and Particle Counts:

Here are the ISO cleanroom classes and their corresponding particle count limits (particles per cubic meter):

ISO 1: ≤ 10 particles

ISO 2: ≤ 100 particles

ISO 3: ≤ 1,000 particles

ISO 4: ≤ 10,000 particles

ISO 5: ≤ 100,000 particles

ISO 6: ≤ 1,000,000 particles

ISO 7: ≤ 10,000,000 particles

ISO 8: ≤ 35,000,000 particles

ISO 9: > 35,000,000 particles

Other Factors:

Cleanrooms may have additional classification criteria, such as temperature, humidity, and airflow velocity, depending on the specific requirements of the industry or application.

6.Maintenance and Monitoring:

Cleanrooms require stringent maintenance and monitoring to ensure they consistently meet their classification standards. This includes regular testing, cleaning, and maintenance of HVAC systems, as well as proper gowning procedures for personnel.

7.Application-Specific Requirements:

Different industries and applications may have unique cleanroom requirements. For example, the pharmaceutical industry may require stricter cleanliness standards compared to a semiconductor manufacturing cleanroom.

8.Design and Construction:

The design and construction of cleanrooms are critical to achieving and maintaining their classifications. Factors such as room layout, airflow, filtration systems, and materials used in construction all play a role in maintaining cleanliness.

9.Compliance and Documentation:

Cleanroom operators must maintain detailed records of environmental conditions and performance to demonstrate compliance with cleanroom classifications to regulatory authorities and customers.

In summary, cleanroom in Jordan  classifications are essential for industries where the control of contamination and environmental factors is critical. Adhering to ISO standards and maintaining the cleanliness of these controlled environments is crucial for product quality, safety, and regulatory compliance.

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Location: Jordan

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