What are the requirements for ISO Class 7 clean room?

What are the Requirements for ISO7 Clean Room?

1. Air Quality Standards

Particulate Count: The air cleanliness level must not exceed 352,000 particles per cubic meter for particles ≥0.5 microns.

Air Changes Per Hour (ACPH): A minimum of 30 air changes per hour is recommended to ensure adequate ventilation and filtration.

2. Temperature and Humidity Control

Temperature Range: The temperature should be maintained between 20°C to 24°C (68°F to 75°F) for optimal comfort and operation.

Humidity Levels: Relative humidity should be controlled between 30% to 60% to prevent static electricity and moisture-related issues.

3. Filtration Systems

HEPA Filters: High-Efficiency Particulate Air (HEPA) filters must be employed to capture 99.97% of particles that are 0.3 microns in size.

Filter Maintenance: Regular monitoring and replacement of filters are essential to maintain air quality.

4. Clean Room Construction

Materials: Walls, ceilings, and floors should be made of non-porous, smooth, and easy-to-clean materials.

Design: Clean rooms should have a minimal number of seams and joints to reduce areas where contaminants can accumulate.

5. Personnel Requirements

Gowning Procedures: Personnel must adhere to strict gowning protocols, including wearing gowns, gloves, masks, and hair covers to prevent contamination.

Training: Staff should receive thorough training on clean room protocols and contamination control.

6. Monitoring and Validation

Environmental monitoring: Continuous monitoring of particulate levels and environmental conditions is essential for compliance.

Validation Protocols: Regular validation of Clean room performance must be conducted to ensure it meets ISO standards.

7. Material and Equipment Control

Controlled Access: Only authorized personnel should have access to the clean room, and all materials must be properly sanitized before entry.

Equipment Maintenance: Regular maintenance and calibration of equipment are vital to ensure they function correctly and do not introduce contaminants.

What is ISO7 Environment?

The ISO7 environment refers to a controlled clean room that adheres to specific standards outlined by the International Organization for Standardization (ISO). In this environment, the maximum allowable particle count is 352,000 particles per cubic meter for particles equal to or greater than 0.5 microns. The room is designed to minimize contamination and maintain controlled conditions, including temperature and humidity, essential for industries such as pharmaceuticals and Electronics. 

What is ISO 7 Controlled Environment?

1. Definition and Importance：An ISO 7 controlled environment is designed to limit the amount of airborne particles and maintain specific conditions critical for sensitive processes. This environment is crucial for industries such as pharmaceuticals, biotech, and Semiconductor manufacturing, where even minor contamination can lead to significant product issues.

2. Standards and Specifications：ISO 7 requires a maximum permissible particulate level of 352,000 particles/m³ for particles ≥0.5 microns. To achieve this, cleanrooms must implement strict air filtration systems, primarily utilizing HEPA filters. Additionally, a minimum of 30 air changes per hour is necessary to maintain air quality.

3. Controlled Conditions：Temperature and humidity control is essential in an ISO 7 Cleanroom. Typically, temperatures should be maintained between 20°C and 24°C, while humidity levels should range from 30% to 60%. These conditions help prevent static electricity build-up and moisture-related contamination.

4. Personnel and Equipment Protocols：Personnel must adhere to strict gowning procedures to minimize contamination risks. This includes wearing cleanroom garments, gloves, and masks. Equipment used in ISO 7 environments must be regularly cleaned and maintained to prevent contamination and ensure compliance with ISO standards.

5. Continuous Monitoring：Regular monitoring of environmental conditions, including particulate levels, temperature, and humidity, is essential. This includes routine checks and validation processes to ensure ongoing compliance with ISO 7 standards.

What are the Requirements for ISO 7 Cleanroom Cleaning?

• Systematic Cleaning Procedures

ISO 7 Cleanrooms require systematic, documented cleaning procedures on a defined schedule. Daily tasks involve disinfecting surfaces, vacuuming with HEPA-filtered vacuums, and mopping with sterile solutions, while weekly and monthly tasks include thorough cleaning and HEPA filter inspections.

• Compatible Cleaning Agents

Cleaning agents must meet cleanroom standards, being non-volatile, non-toxic, and particulate-free. Common solutions include isopropyl alcohol, sterile water, and specific disinfectants, carefully chosen to avoid damaging surface materials while ensuring air quality is maintained.

• Trained Personnel

Cleaning personnel must be trained in cleanroom protocols to control contamination effectively. They should wear appropriate attire, follow strict gowning procedures, and document cleaning activities through checklists and logs for accountability and traceability in maintaining cleanroom standards.

What is the Minimum ACPH for ISO7 Buffer Room?

Definition of ACPH

Air Changes Per Hour (ACPH) is a critical parameter in Cleanroom design and operation. It measures how many times the total volume of air in a room is replaced with fresh air within an hour. For ISO7 buffer rooms, a minimum of 30 ACPH is recommended to ensure adequate ventilation and minimize airborne contaminants.

Importance of ACPH in ISO7

Maintaining a minimum of 30 ACPH in an ISO7 buffer room is essential for several reasons. 

Firstly, it helps dilute and remove particulate matter generated from activities in the room, such as personnel movement or equipment operation. 

Secondly, this level of air exchange ensures that the air quality meets the stringent standards set for ISO7 environments, thereby reducing the risk of contamination during critical processes like aseptic manufacturing.

Implementation of ACPH Standards

To achieve the required ACPH, cleanroom facilities must be equipped with efficient HVAC (Heating, Ventilation, and Air Conditioning) systems. These systems should be designed to facilitate the rapid exchange of air while maintaining controlled temperature and humidity levels. Regular maintenance and monitoring of the HVAC system are crucial to ensure it operates effectively and meets the ISO7 standards.

What is the Appropriate Pressure for the ISO7 Non-Hazardous Clean Room?

1. Pressure Differential Requirements

For an ISO7 non-hazardous clean room, maintaining a positive pressure relative to adjacent areas is crucial. Typically, the clean room should operate with a pressure differential of 0.02 to 0.05 inches of water column (in. wc) above the surrounding areas. This positive pressure helps prevent the ingress of contaminants from less controlled environments.

2. Importance of Pressure Control

Maintaining appropriate pressure is essential for several reasons. It ensures that airborne particles do not enter the clean room from adjacent spaces, which could compromise the cleanliness levels required in ISO7 environments. Positive pressure also helps in controlling airflow patterns, directing air from clean areas to less clean areas, thereby enhancing contamination control.

3. Monitoring and Maintenance

Regular monitoring of the pressure differential is vital to ensure that the clean room remains within the specified limits. This can be achieved using pressure gauges or differential pressure monitors. Additionally, the HVAC system must be designed to maintain this positive pressure under varying operational conditions, including when doors are opened or closed. 

These articles provide a comprehensive overview of the requirements and protocols associated with ISO7 clean rooms, addressing critical aspects such as cleaning procedures, air quality standards, and environmental controls.