What is ISO 7 clean room classification?

What is ISO 7 Clean Room Classification?

ISO 7 Clean rooms are classified as controlled environments with strict limits on particulate contamination. According to the ISO 14644-1 standard, an ISO7 clean room must maintain a maximum allowable particle count of 352,000 particles per cubic meter for particles 0.5 micrometers or larger. This classification is essential in industries that require stringent cleanliness standards, such as pharmaceuticals, biotechnology, and Semiconductor manufacturing. The primary goal of an ISO 7 Clean room is to protect sensitive processes and products from airborne contaminants, ensuring high-quality outcomes.

Key Characteristics of ISO 7 Clean Rooms

1. Particle Count Limits

The clean room's air quality is quantified based on the allowable particle concentration. For ISO 7, the requirement is a maximum of 352,000 particles/m³ for particles ≥0.5 µm. This ensures that the risk of contamination during critical processes is minimized.

2. Air Changes per Hour (ACPH)

ISO 7 clean rooms are designed to achieve a minimum of 30 air changes per hour. This high rate of air exchange helps dilute and remove airborne contaminants effectively, ensuring a consistently clean environment.

3. Temperature and Humidity Control

Maintaining specific temperature and humidity levels is crucial in an ISO 7 clean room. Temperature typically ranges from 20°C to 24°C (68°F to 75°F), while relative humidity is usually kept between 30% to 60%. These conditions help ensure the stability of products and processes.

4. Pressure Differentials

Clean rooms are maintained at a positive pressure relative to surrounding areas to prevent external contaminants from entering. This is critical for upholding the cleanliness standards required for ISO 7 classification.

What is the ISO Requirement for Clean Rooms?

ISO requirements for clean rooms, outlined in the ISO 14644 series, specify the classification of clean rooms based on the maximum allowable levels of airborne particulate contamination. These classifications range from ISO1, which has the strictest limits, to ISO9. Each class defines the maximum permissible particle concentrations per cubic meter of air, along with guidelines for cleanliness maintenance, monitoring, and operational procedures. 

What are the Temperature Requirements for ISO 7 Cleanroom?

1. General Temperature Range: Maintaining a stable temperature is crucial in an ISO ISO 7 clean room. The ideal temperature range is typically between 20°C and 24°C (68°F to 75°F). This range is designed to ensure both the comfort of personnel and the stability of sensitive materials and processes.

2. Impact on Product and Process Stability: Temperature fluctuations can adversely affect the quality and integrity of products. For example, in pharmaceutical applications, variations can impact chemical stability, while in semiconductor manufacturing, it can affect fabrication processes. Therefore, precise temperature control is vital to prevent thermal stress and ensure consistent results.

3. Monitoring and Control Systems: Advanced monitoring systems are implemented to continuously track the temperature within the clean room. These systems often include alarms for deviations outside the set rangeand automated control mechanisms to adjust heating or cooling systems accordingly. 

What is the Pressure in ISO 7 Cleanroom?

Positive Pressure Requirement

ISO7 clean rooms are designed to maintain a positive pressure relative to adjacent areas. This pressure differential is critical for preventing the infiltration of airborne contaminants from less controlled environments, thereby safeguarding the integrity of the clean room. Typically, the positive pressure is maintained at about 0.1 inches of water column (25 Pa) above outside areas.

Importance of Pressure Control

Maintaining positive pressure not only helps in keeping contaminants out but also plays a pivotal role in ensuring that any potential leaks from the clean room do not compromise the surrounding environment. This is particularly important in sensitive operations where even minimal contamination can lead to product failure or safety issues. 

Operational Considerations

The pressure within the clean room can be influenced by various factors, including the number of personnel entering and exiting, the operation of equipment, and the design of HVAC systems. To mitigate fluctuations, airlocks or anterooms are often used as a transitional space between the clean room and external environments. This design helps maintain stable pressure and minimizes the risk of contamination during personnel or material transfers.

ISO 7 Class 10000 Cleanrooms Design Requirements

Room Design and Layout:

An ISO 7 Class 10000 Clean room should be designed with a layout that promotes efficient workflow while minimizing contamination risks. This includes strategically placing equipment and workstations to ensure smooth movement and prevent cross-contamination. The design should also allow for easy cleaning and maintenance.

Materials and Surfaces:

The materials used in constructing the clean room, including walls, ceilings, and floors, should be non-porous, smooth, and easily cleanable. Common materials include stainless steel, epoxy-coated surfaces, and specialized cleanroom fabrics. These materials help reduce particle accumulation and facilitate effective cleaning protocols.

HVAC System Specifications:

The HVAC system in an ISO 7 clean room is crucial for maintaining air quality and temperature control. It should include high-efficiency particulate air (HEPA) filters to meet the required cleanliness standards. The system must also provide a minimum of 30 air changes per hour to dilute and remove contaminants effectively. 

What is the Minimum ACPH for ISO7 Buffer Room?

1. Air Change Requirements

For an ISO7 buffer room, a minimum of 30 air changes per hour (ACPH) is required. This high frequency of air exchange is vital to ensure that any airborne contaminants are rapidly diluted and removed, thus maintaining the cleanliness standards needed for sensitive operations.

2. Importance of Buffer Rooms

Buffer rooms serve as transitional areas between less controlled environments and critical clean areas. They are designed to reduce the risk of contamination during the transfer of materials and personnel. The high ACPH helps in maintaining a controlled environment that adheres to ISO ISO 7 standards, providing a clean space for operations like sterile compounding or equipment preparation.

3. Monitoring and Compliance

Continuous monitoring of airflow and particle counts is essential in buffer rooms to ensure compliance with ISO regulations. Regular maintenance and validation of HVAC systems are necessary to sustain the required air changes and overall cleanliness. Proper training for personnel on gowning and handling procedures further supports the integrity of the buffer room environment.

What are the ISO 7 and 8 Gowning Requirements?

Gowning requirements in ISO7 and 8 cleanrooms are vital to reduce contamination risks. Personnel must wear gowns, gloves, masks, hair covers, and shoe covers, with stricter protocols in ISO 7, to maintain cleanliness and ensure compliance.