What is ISO 6 cleanroom?

What is ISO 6 Cleanroom?

An ISO 6 cleanroom is a controlled environment designed to minimize the presence of airborne particles and contaminants, ensuring a high level of cleanliness. Cleanrooms are classified according to the ISO 14644-1 standard, which specifies the maximum allowable particle counts per cubic meter of air at specified particle sizes. For ISO6, the cleanroom must maintain stringent cleanliness levels, making it suitable for industries such as pharmaceuticals, biotechnology, and Electronics manufacturing.

Particle Count Specifications

In an ISO 6 cleanroom, the permissible particle count is limited to a maximum of 1,000 particles per cubic meter for particles of size 0.5 micrometers or larger. This standard ensures that the environment remains free from dust, microbes, and other contaminants that could compromise product quality or research integrity. The specified particle limits help in achieving a controlled atmosphere where sensitive processes can occur without interference from environmental factors.

Applications of ISO 6 Cleanrooms

ISO 6 cleanrooms are commonly used in sectors where product sterility and precision are critical. For example, in the pharmaceutical industry, they are vital for the production of sterile drugs and medical devices. In electronics manufacturing, ISO 6 environments help prevent contamination of sensitive components such as microchips. The ability to control not just particulate contamination but also factors like temperature and humidity is essential for maintaining product integrity.

Design and Operational Features

The design of an ISO 6 cleanroom includes high-efficiency particulate air (HEPA) filters that capture particles as small as 0.3 micrometers. Airflow is typically maintained at a high rate to ensure that particles are continuously removed, and the room is kept at a constant temperature and humidity level. 

Maintenance and monitoring

Compliance with ISO 6 standards requires regular monitoring and maintenance. Particle counts must be routinely measured using laser particle counters to ensure that they remain within acceptable limits. Furthermore, personnel must adhere to strict gowning procedures to minimize the introduction of contaminants from clothing and skin. 

What is an ISORating?

An ISO class rating refers to the classification of cleanrooms based on the maximum allowable levels of airborne particulate contamination. These ratings are defined by the iso 14644-1 standard, which categorizes cleanrooms from ISO1 (the cleanest) to ISO9 (the least clean). Each class specifies the maximum number of particles allowed in a cubic meter of air at various sizes, making it easier for industries to choose the appropriate cleanroom environment based on their specific contamination control requirements.

What ISO Level is Cleanliness?

Cleanliness in A CleanRoom context is determined by the ISO classification system, which includes several levels:

1. ISO1

• The highest level of cleanliness, with no more than 1 particle (≥0.3 µm) per cubic meter.

• Used in sensitive operations like Semiconductor manufacturing and advanced pharmaceuticals.

2. ISO2

• Allows up to 10 particles (≥0.3 µm) per cubic meter.

• Common in high-tech research environments and specialized laboratories.

3. ISO3

• Permits a maximum of 100 particles (≥0.5 µm) per cubic meter.

• Suitable for certain electronic component production.

4. ISO4

• Limits to 10,000 particles (≥0.5 µm) per cubic meter.

• Often used in pharmaceuticals and biotechnology.

5. ISO5

• Allows up to 3,520 particles (≥0.5 µm) per cubic meter.

• Ideal for sterile product manufacturing.

6. ISO6

• Permits 1,000 particles (≥0.5 µm) per cubic meter.

• Common in medical device manufacturing and certain clean applications.

7. ISO7

• Limits to 352,000 particles (≥0.5 µm) per cubic meter.

• Used in less sensitive applications.

8. ISO8

• Allows 3,520,000 particles (≥0.5 µm) per cubic meter.

• Suitable for general manufacturing processes.

9. ISO9

• The least clean, allowing more than 3,520,000 particles (≥0.5 µm) per cubic meter.

• Used in less critical environments.

What is the Humidity in ISO 6 Cleanroom?

Humidity Control

Humidity control is vital for ISO 6 cleanrooms, typically maintained between 30% and 60%. This range prevents static electricity buildup and minimizes microbial growth, protecting sensitive processes and ensuring sterile environments.

HVAC Systems

Specialized HVAC systems manage temperature and humidity in cleanrooms through dehumidification and humidification. Continuous monitoring is essential for ISO compliance, safeguarding product integrity and process reliability.

Environmental monitoring

Monitoring additional parameters like temperature and particle counts is crucial. A comprehensive approach ensures cleanliness standards are met, requiring regular calibration of equipment for accurate readings and compliance with ISO 6 requirements.

How Do You Reduce Particle Count in a Cleanroom?

To maintain a low particle count in a cleanroom, several strategies can be employed:

Adequate Air Filtration:

- Utilize HEPA or ULPA filters that can capture particles as small as 0.3 micrometers.

- Regularly replace filters based on manufacturer recommendations and operational use to ensure maximum efficiency.

Controlled Airflow:

- Establish a unidirectional airflow pattern to minimize turbulence and reduce particle distribution.

- Increase air changes per hour (ACH) to enhance particle removal from the environment.

Gowning Procedures:

- Implement strict gowning protocols for personnel entering the cleanroom, including the use of cleanroom suits, gloves, masks, and shoe covers.

- Ensure proper training on gowning techniques to minimize the introduction of contaminants.

Regular Cleaning and Maintenance:

- Schedule routine cleaning of surfaces, equipment, and tools using appropriate cleanroom-approved materials.

- Use cleaning protocols that prevent the generation of additional particles during the cleaning process.

Minimize Foot Traffic:

- Limit the number of personnel entering and exiting the cleanroom to reduce potential contamination.

- Design workflows to minimize the need for personnel movement within the cleanroom.

Equipment and Material Control:

- Ensure that all materials and equipment brought into the cleanroom are properly cleaned and decontaminated.

- Use equipment that generates minimal particles and is easy to clean.

Monitoring and Testing:

- Regularly monitor particle counts using laser particle counters to detect any increases in contamination levels.

- Perform routine audits of cleanroom protocols and practices to identify areas for improvement.

What is the Particle Count for ISO 6 Cleanroom?

The particle count for an ISO6 cleanroom is strictly regulated to ensure a high level of cleanliness. According to the ISO 14644-1 standard, an ISO 6 cleanroom can have a maximum of 1,000 particles per cubic meter for particles that are 0.5 micrometers or larger. This specific measurement is critical for industries that require stringent contamination controls, such as pharmaceuticals, biotechnology, and electronics manufacturing.

To break this down further, the particle count limits for ISO6 are as follows:

• 0.1 µm: Up to 3,520,000 particles per cubic meter.

• 0.2 µm: Up to 832,000 particles per cubic meter.

• 0.3 µm: Up to 29,300 particles per cubic meter.

• 0.5 µm: Up to 1,000 particles per cubic meter.

• 1.0 µm: Up to 35 particles per cubic meter.

• 5.0 µm: Up to 3 particles per cubic meter.

These limits are crucial for maintaining the integrity of products and processes that are sensitive to contamination. As a result, cleanroom operators must implement rigorous monitoring and control measures to ensure compliance with these standards.

What is the ACPH for ISO 6?

ACPH, or Air Changes Per Hour, is a critical metric for maintaining air quality in controlled environments like cleanrooms. For an ISO6 cleanroom, which is designed to limit the number of airborne particles, the maximum allowable particle count is 1,000 particles per cubic meter for those measuring 0.5 micrometers and larger. To achieve and maintain this level of cleanliness, the ACPH typically recommended for ISO 6 cleanrooms ranges from 20 to 60 air changes per hour. This means that the entire volume of air in the cleanroom should be replaced 20 to 60 times each hour.