A Class C cleanroom is an ISO Class 7 environment

A Class c CleanRoom is an ISO7 Environment

Definition of Class C Cleanroom

A Class C cleanroom, classified as ISO7, is designed to control the levels of airborne particulate contamination. According to ISO 14644-1, the maximum allowable particle count for particles ≥0.5 micrometers is 3,520 particles per cubic meter. This stringent standard ensures that sensitive processes can be conducted with minimal contamination risk.

Air Change Rate Requirements

To achieve ISO7 standards, a Class C cleanroom must maintain a specific air change rate. Typically, it requires 30 to 60 air changes per hour. This high air exchange rate helps dilute airborne contaminants effectively, ensuring a stable and clean environment for critical operations.

Temperature and Humidity Control

Maintaining controlled temperature and humidity is crucial in a Class C cleanroom. The recommended temperature range is 20°C to 25°C (68°F to 77°F), with relative humidity levels between 30% and 60%. These conditions help ensure optimal performance of equipment and materials sensitive to environmental changes.

Surface and Equipment Standards

All surfaces in a Class C cleanroom must be smooth, non-porous, and easy to clean. Materials like stainless steel and epoxy finishes are preferred. Equipment must also meet specific cleanliness standards to prevent contamination, adhering to guidelines outlined in iso 14644-5, which details Cleanroom design and layout.

• iso 14644-1- This standard defines the classification of air cleanliness in cleanrooms and controlled environments, including the specific limits for particulate contamination.

• iso 14644-2- This standard outlines the monitoring and periodic testing of cleanrooms to ensure compliance with cleanliness classifications.

• ISO 14644-5- This standard provides guidelines on the design and construction of cleanrooms and controlled environments, emphasizing the importance of material selection and surface finish.

• iso 14644-8- This standard details the requirements for personnel and gowning procedures in cleanrooms, ensuring that human factors do not compromise the controlled environment.

• ISO 9001- While not specific to cleanrooms, this quality management system standard helps organizations ensure consistent quality in their processes, including cleanroom operations.

The Guidelines for ISO7

1. Air Change Rates

To maintain cleanliness, ISO 7 Cleanrooms require 30 to 60 air changes per hour. This ensures effective dilution and removal of airborne contaminants, providing a stable environment for sensitive processes.

2. Temperature Control

Maintaining a stable temperature between 20°C and 25°C (68°F to 77°F) is essential. This temperature range ensures optimal performance and minimizes the risk of thermal-related product degradation or process variations.

3. Surface Cleanliness

All surfaces in an ISO7 cleanroom must be smooth and non-porous. Materials such as stainless steel and epoxy are preferred as they are easier to clean and less likely to harbor contaminants.

4. Personnel Protocols

Strict gowning procedures are crucial for personnel entering ISO 7 Cleanrooms. This includes wearing cleanroom suits, gloves, and face masks to minimize contamination from human sources.

The Pressure in ISO 7 Cleanroom

1. Pressure Differential: A minimum pressure differential of 10 Pa is recommended to protect cleanroom integrity. This differential helps maintain cleanliness by driving air out of the cleanroom when doors are opened.

2. Monitoring Pressure Levels: Continuous monitoring of pressure levels is essential. Automated pressure sensors help ensure compliance with standards, alerting personnel to any deviations that could compromise cleanroom conditions.

3. Airlock Design: Airlocks are often used in ISO 7 cleanrooms to maintain pressure. These entryways allow personnel to transition without disrupting the cleanroom’s positive pressure, thereby minimizing contamination risks.

The Humidity Requirements for ISO7 Cleanroom

Relative Humidity Control

The relative humidity in an ISO7 cleanroom should be maintained between 30% and 60%. This range is crucial for preventing static electricity and product degradation.

Monitoring Humidity Levels

Regular monitoring of humidity levels is critical. Hygrometers and data loggers are often used to ensure that the humidity remains within the specified range, providing alerts for any deviations.

Control Systems

Humidity control systems, such as dehumidifiers and humidifiers, are essential in ISO 7 cleanrooms. These systems automatically adjust humidity levels, ensuring compliance with operational requirements.

Which Area is an ISO7 or Cleaner Room with Fixed Walls and Doors?

• Design Considerations

Fixed-wall cleanrooms are constructed with specific design features, including sealed joints and smooth surfaces. These features facilitate easy cleaning and maintenance, essential for maintaining cleanliness standards.

• Compliance with Standards

Such cleanrooms must adhere to ISO 14644-1 standards, ensuring they meet the required particle count limits. Compliance is verified through regular monitoring and certification processes.

• Applications

ISO7 or cleaner rooms with fixed walls are commonly used in industries such as pharmaceuticals, biotechnology, and electronics. These environments are critical for processes where contamination can severely impact product quality.

• Access Control Measures

Access to these cleanrooms is usually restricted and controlled through airlocks. This design prevents outside contaminants from entering the cleanroom, preserving the integrity of the controlled environment.