What is ISO Class 8 Cleanroom Standards?

What is ISO 8 Cleanroom Standards?

1. Particulate Limits

The standard for ISO8 specifies that the maximum allowable particle count in A CleanRoom is 3,520 particles per cubic meter for particles 0.5 micrometers and larger. This means that while the environment is relatively clean, it is not as stringent as lower ISO classes like ISO 7 or ISO 6.

2. Air Quality and Filtration

ISO 8 cleanrooms typically utilize HEPA (High-Efficiency Particulate Air) filters to maintain air quality. These filters can capture 99.97% of particles that are 0.3 micrometers in size. The air exchange rate in such cleanrooms is critical, with at least 15 air changes per hour recommended to ensure that contaminants are diluted effectively.

3. Temperature and Humidity Control

Maintaining a consistent temperature and humidity level is vital in ISO 8 cleanrooms to ensure the stability of sensitive materials. Typical ranges are between 20-22°C for temperature and 30-60% for relative humidity, depending on the specific requirements of the processes being conducted.

4. Personnel and Equipment Protocol

Strict protocols for personnel entering the cleanroom are essential. This includes wearing appropriate cleanroom attire, adhering to proper gowning procedures, and ensuring equipment is sanitized and maintained to prevent contamination.

5. monitoring and Maintenance

Continuous monitoring of air quality and cleanliness levels is necessary to ensure compliance with ISO8 standards. Regular maintenance and cleaning schedules should be established to uphold the integrity of the cleanroom environment.

What Does ISO 8 Mean?

ISO 8, part of ISO 14644-1 standards, allows up to 3,520 airborne particles per cubic meter (≥0.5 micrometers). While less stringent than ISO 7 and 6, it’s essential for industries like pharmaceuticals to ensure product integrity and safety.

ISO Cleanroom 7 vs. 8: What's the Difference?

The comparison between ISO7 and ISO 8 cleanrooms primarily revolves around the permissible levels of airborne particulates, which directly affects the cleanliness and control measures required in these environments.

• Particulate Levels: ISO7 allows a maximum of 352 particles per cubic meter for 0.5 micrometers or larger, whereas ISO8 permits 3,520 particles, making ISO 7 significantly cleaner.

• Air Change Rates: ISO7 typically requires a higher air change rate compared to ISO 8, meaning that the air in a ISO 7 Cleanroom must be exchanged more frequently to maintain its cleanliness.

• Applications: Due to these differences, ISO 7 Cleanrooms are generally used for more sensitive operations, such as sterile pharmaceutical production, while ISO 8 environments can be suitable for less critical tasks.

How Do I Find ISO Rating?

1. Consult Documentation: The first step is to check the facility's cleanroom documentation. ISO ratings are typically documented in the cleanroom's design specifications, operational procedures, and periodic certification reports. These documents provide detailed information on the cleanroom's compliance with specific ISO classifications.

2. Hire a Professional Certification Body: If documentation is unavailable or unclear, consider hiring a professional Cleanroom Certification body. These organizations specialize in evaluating cleanroom environments and can conduct thorough testing to determine the ISO rating. The certification process usually includes air sampling, particle counting, and an assessment of the facility's cleanliness protocols.

3. Regular Monitoring and Maintenance: Regular monitoring of the cleanroom environment is crucial for maintaining compliance with ISO standards. This involves consistent air sampling and particle monitoring using calibrated equipment. Cleanrooms should have a defined schedule for testing to ensure they remain within the parameters of their designated ISO class. 

How to Use ISO-8 Cleanroom?

Gowning Procedures:

Before entering the cleanroom, personnel must follow strict gowning procedures. This involves wearing cleanroom-specific attire, such as coveralls, hoods, gloves, and shoe covers, to minimize the introduction of contaminants. Ensure all garments are made from materials that do not shed particles.

Access Control:

Limit access to the cleanroom to essential personnel only. Implement a sign-in system to track who enters and exits the space. This helps in maintaining accountability and minimizes contamination risks.

Cleaning Protocols:

Establish regular cleaning and sanitization protocols for the cleanroom. Use appropriate cleaning agents that are compatible with the cleanroom’s requirements. High-touch surfaces should be cleaned frequently, and the entire cleanroom should undergo routine deep cleaning based on a defined schedule.

Equipment Maintenance:

Ensure that all equipment used within the cleanroom is properly maintained and cleaned. Regularly check and replace HEPA filters, and ensure that all instruments are sanitized before use. This is essential to prevent contamination of the environment.

Monitoring and Documentation:

Implement a monitoring system for air quality and particulate levels. Keep logs of monitoring results, maintenance activities, and cleaning schedules to ensure compliance with ISO8 standards. This documentation can also be useful during audits or inspections.

Training and Awareness:

Provide regular training for all personnel on cleanroom protocols and contamination prevention techniques. This includes educating staff on the importance of maintaining cleanliness and the procedures to follow when entering or working in the cleanroom.

What is the Air Change Rate for ISO 8?

Importance of Air Change Rate: A higher air change rate helps reduce the concentration of particulates in the air, thus lowering the risk of contamination in sensitive processes. The air change rate also plays a role in maintaining temperature and humidity levels, which are crucial for specific applications.

Design Considerations: When designing an ISO 8 cleanroom, careful consideration must be given to the HVAC (Heating, Ventilation, and Air Conditioning) system to ensure it can achieve the required air change rate. This involves selecting appropriate fans, ductwork, and filters that can handle the volume of air needed.

Monitoring Compliance: Regular monitoring of the air change rate is essential to ensure ongoing compliance with ISO8 standards. Facilities should implement systems to measure air velocity and flow rates to confirm that the cleanroom maintains the necessary air exchange levels.

How to Upgrade ISO-8?

1. Assess Current Conditions

Begin by conducting a thorough assessment of the existing cleanroom environment. This includes evaluating particle counts, airflow patterns, temperature, and humidity levels. Understanding the current performance will help identify specific areas that need improvement.

2. Design Modifications

Based on the assessment results, design modifications may be necessary. This could involve upgrading the HVAC system to increase air change rates, adding more HEPA or ULPA filters, and redesigning the layout to minimize contamination risks. Engage with Cleanroom design experts to ensure that changes meet the requirements of the desired ISO classification.

3. Implement Enhanced Protocols

Revise operational protocols to align with the stricter requirements of a higher ISO class.