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What is the pressure in ISO Class 7 cleanroom?

  • Author:Jason Peng

  • Cleanroom Engineering Technology Manager of Deiiang Company.

    Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

    Executive Director of Guangdong Cleanroom Industry Association of China.

    Engaged in R&D of related products for 15 years, with rich relevant technical experience

  • 2024-12-06  |  Visits:


What is the Pressure in ISO 7 Cleanroom?

Maintaining proper air pressure in an ISO7 cleanroom is crucial to ensure contamination control and prevent the infiltration of unfiltered air. Cleanrooms are designed with specific pressure differentials between rooms, airlocks, and surrounding areas to create a flow of clean air that minimizes the risk of contamination. In an ISO ISO 7 cleanroom, managing pressure is one of the key factors that helps in maintaining its stringent cleanliness standards.

Cleanrooms: Class 10000 ISO 7, Class 1000 ISO 6, Class 100 ISO 5

1. Pressure Requirements in ISO7 Cleanrooms

In ISO 7 Cleanrooms, the pressure differential is typically maintained at a positive pressure relative to adjacent areas, such as hallways or less critical environments. The cleanroom needs to be pressurized so that air continuously flows out of the room, rather than being drawn in from less controlled areas. This positive pressure ensures that airborne particles do not enter the cleanroom and that contaminants are kept to a minimum.

The general pressure differential in an ISO7 cleanroom is around 0.02 to 0.05 inches of water column (WC). This slight positive pressure is enough to force clean air to flow outward, preventing contaminated air from entering. The pressure is continuously monitored and controlled using HVAC (Heating, Ventilation, and Air Conditioning) systems to ensure that the room’s cleanliness is not compromised.

2. Airflow Patterns and Pressure Control

In an ISO7 cleanroom, the air handling system with HEPA filters maintains positive pressure by introducing filtered air at sufficient rates. Unidirectional airflow moves from clean to less clean areas, helping to prevent contamination.

It is critical that the cleanroom maintains this positive pressure to ensure that the volume of air being pumped into the room is greater than the air being exhausted. If the pressure were negative or equal, there would be a risk of air leakage, which could introduce contaminants.

Essential Airflow for Cleanrooms | ACH

3. Maintaining Consistency and Preventing Variations

Maintaining consistent pressure is essential in a cleanroom. Even slight variations in pressure can result in the introduction of contaminants. Therefore, regular checks are conducted to ensure the pressure is within the specified range. 

Pressure gauges and sensors placed at strategic locations within the cleanroom, such as at doorways, airlocks, and ventilation inlets, allow operators to monitor and adjust the pressure. If any deviation is detected, adjustments to the airflow system or the volume of incoming air can be made accordingly.

4. The Importance of Pressure in ISO ISO 7 Cleanrooms

In conclusion, maintaining a proper pressure differential is an essential part of ensuring that an ISO7 cleanroom remains compliant with its cleanliness standards. Positive pressure, typically between 0.02 and 0.05 inches WC, keeps contaminants from entering the room and allows the cleanroom to function as intended. 

Cleanroom Design in Pharma & Life-science Industry | RSNESS


Clean Room Pressure Differential Standard

The pressure differential standard

in cleanrooms is designed to ensure a continuous flow of clean air into the controlled environment while preventing contaminants from entering. The standard is based on maintaining positive pressure inside the cleanroom relative to adjacent spaces. The pressure differential varies based on the classification of the cleanroom, with higher cleanliness classes requiring stricter control.

For cleanrooms classified under ISO 7, the standard pressure differential typically ranges between 0.02 to 0.05 inches WC. This ensures a consistent and controlled airflow that pushes contaminants out of the room, ensuring minimal particle contamination. The pressure differential must be continuously monitored, particularly in high-traffic areas and at entry points, such as airlocks and doorways.

Cleanroom ClassPressure DifferentialRange
ISO7Positive Pressure0.02-0.05 inches WC
ISO8Positive Pressure0.02-0.05 inches WC
ISO5Positive Pressure0.02-0.05 inches WC


ISO 7 Cleanroom Requirements

1. Particle Count:In an ISO7 cleanroom, the allowable concentration of particles is limited to 352,000 particles (≥0.5 microns) per cubic meter. This is significantly lower than in lower classification rooms, ensuring that sensitive processes and products are protected from contamination.

2. Airflow and Filtration:The airflow in an ISO7 cleanroom is typically unidirectional, with HEPA filters used to remove particles from the air. The air change rate is generally around 60-100 air changes per hour, ensuring that the air within the room is continually refreshed.

What Cleanroom Classification Does Your Industry Need? | Dycem

3. Environmental Control:In addition to particle control, ISO7 cleanrooms must also manage temperature, humidity, and air pressure. These environmental factors are controlled to ensure optimal conditions for sensitive manufacturing processes. monitoring equipment is essential to maintain these parameters within acceptable ranges.


ISO7 Particle Count

Particle Count Standards

An ISO7 cleanroom allows for a maximum of 352,000 particles (≥0.5 microns) per cubic meter of air. This is a relatively high number compared to higher-class cleanrooms but still ensures a controlled environment for processes that don’t require the extreme levels of cleanliness seen in ISO 5 or ISO 6 Cleanrooms.

ISO 7 Cleanroom Requirements | Technical Safety Services

Applications for ISO7

ISO 7 cleanrooms are used in industries such as medical device manufacturing and pharmaceutical production, where the products are sensitive but not as prone to contamination as those in more stringent environments. The particle count in these rooms ensures that the risk of contamination is minimized without the need for the highest level of control.

Particle Control and Monitoring

Maintaining a particle count within the standard for ISO7 is critical to ensuring that no unwanted contaminants compromise the quality of the products or processes within the room. Automated particle counters are used to monitor particle levels continuously, alerting operators if the levels exceed acceptable limits.


Air Pressure Differential in A CleanRoom Should Be Checked

1. Why Pressure Differential Matters

The pressure differential in a cleanroom helps ensure that airborne contaminants are prevented from entering the controlled environment. By maintaining positive pressure inside the cleanroom, air naturally flows out through exhausts or vents, preventing contaminated air from infiltrating the room.

2. Methods of Checking Pressure Differential

Pressure differentials should be regularly checked using differential pressure monitors installed at key locations such as doorways and airlocks. These monitors continuously measure the pressure difference between the cleanroom and adjacent areas, ensuring that the pressure remains within the required range.

Air Pressure Differential in a Cleanroom Should Be Checked

3. Consequences of Improper Pressure

If the pressure is not maintained correctly, contaminants can be drawn into the cleanroom, undermining the integrity of the controlled environment. Negative pressure, or a failure to maintain positive pressure, can result in air leaks, which compromise both the cleanliness and the safety of the space. Therefore, regular checks are essential to ensure compliance with the relevant standards.


ISO 14644 Room Pressure Differential

ISO 14644 Standards:

The ISO 14644 standard provides guidelines for CleanRoom Classification, including the pressure differential requirements. These guidelines specify the necessary pressure levels for various cleanroom classifications, ensuring that the room maintains a constant flow of clean air. For cleanrooms such as ISO 7, the standard pressure differential is typically 0.02 to 0.05 inches WC.

Cleanroom and ISO 14644

Pressure Control in Cleanrooms:

Proper pressure control is critical for maintaining a clean environment. Air is typically introduced through HEPA or ULPA filters, and it is crucial that this air flows into the cleanroom in a controlled manner. The air pressure is continuously monitored and adjusted to meet ISO 14644 standards.

Monitoring and Adjustments:

To comply with ISO 14644 standards, cleanrooms must be equipped with automated pressure sensors that monitor the differential in real time. Any deviations from the set pressure range must be promptly addressed by adjusting the airflow system or ventilation settings. This ensures the ongoing effectiveness of the cleanroom in maintaining particle control and overall environmental quality.


ISO 8 Differential Pressure

USP 800 Cleanroom Design - Negative Pressure Changes and Requirements

ISO 8 Cleanrooms require moderate cleanliness, operating at a positive pressure to prevent contamination. Maintaining a differential pressure of 0.02 to 0.05 inches of water column is vital for airlocks and gowning rooms. Regular monitoring, pressure sensors, and HVAC maintenance ensure compliance with iso 14644-1 standards and protect sensitive processes.

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