When designing the airflow system for an ISO 6 modular cleanroom, several factors must be considered:

Air Changes Per Hour (ACH):

• ISO Class 6 cleanrooms typically require 70-160 air changes per hour to maintain cleanliness.

• The exact number depends on the cleanroom’s size, usage, and contamination sources.

Importance of testing

Clean room testing is extremely important to ensure product quality and the stability of the production environment. It can help to confirm whether the clean room meets the intended cleanliness requirements, and whether the various environmental indicators comply with the specified standards.

Testing Standards

ISO 6 Modular Cleanroom Testing Standards are guided by ISO 14644-1 and related protocols to ensure compliance and performance. Key standards include:

• Particle Count Testing: Verifies airborne particle levels (≤35,200 particles ≥0.5 µm/m³).

• Airflow Velocity Testing: Ensures proper airflow speed and uniformity.

• Filter Integrity Testing: Detects HEPA/ULPA filter leaks using DOP/PAO aerosols.

• Pressure Differential Testing: Maintains positive pressure to prevent contamination.

• Air Changes Per Hour (ACH): Confirms sufficient air replacement (70-160 ACH).

• Recovery Testing: Measures contamination recovery time.

• Environmental Monitoring: Tracks temperature, humidity, lighting, and noise levels.

These standards ensure the cleanroom meets ISO Class 6 requirements for controlled environments.

What are the selection criteria for air filters in modular cleanrooms?

Selection criteria for air filters include filtration efficiency, airflow capacity, and compatibility with existing systems. Regular maintenance needs and cost should also be considered for optimal performance.

What are the maintenance requirements for modular cleanrooms?

Maintenance requirements for modular cleanrooms involve routine cleaning, air filter replacements, and environmental monitoring. Staff should be trained to follow standardized procedures and maintain documentation for compliance.

How to conduct a risk assessment for a modular cleanroom?

Conducting a risk assessment involves identifying hazards and evaluating their potential impact.
Control measures should be implemented to mitigate risks, with regular reviews to adapt to new challenges. This ensures a safe and compliant cleanroom environment.

What is the cleaning procedure for modular cleanrooms?

The cleaning procedure for modular cleanrooms consists of several steps:

1. Remove all items from the cleanroom.
2. Wipe down surfaces with approved disinfectants.
3. Clean floors using specialized cleaning agents.
4. Change air filters regularly.
5. Document all cleaning activities for compliance.
   Following these steps maintains cleanliness and reduces contamination risks.

What types of airflow patterns are used in modular cleanrooms?

Modular cleanrooms typically use unidirectional and non-unidirectional airflow patterns.
Unidirectional airflow provides consistent air movement to minimize contamination, while non-unidirectional patterns can be used in specific scenarios.
Mixing airflow patterns may also be applied in certain areas to balance conditions.

What fire safety measures are necessary for modular cleanrooms?

Fire safety measures in modular cleanrooms include:

1. Installation of smoke detectors and alarms.
2. Use of non-combustible construction materials.
3. Regular fire drills and staff training.
4. Availability of fire extinguishers and clear exit routes.
   These measures ensure safety and compliance with regulations.

What are the usage limitations of modular cleanrooms?

Modular cleanrooms have several limitations:

1. They are restricted to specific cleanliness classifications (ISO standards).
2. Limitations on the types of materials and equipment used.
3. Fixed environmental parameters that must be maintained.
   These factors can affect operational flexibility and application areas.

How to ensure compliance with ISO 6 standards?

Ensuring compliance with ISO 6 standards involves implementing strict protocols for cleanliness and environmental control.
Regular monitoring of particulate levels and air quality is essential, along with staff training on compliance procedures.
Documentation of all processes and audits supports ongoing adherence to ISO requirements.

What steps are involved in cleanroom qualification?

Cleanroom qualification involves several key steps:

1. Installation qualification (IQ) to verify equipment setup.
2. Operational qualification (OQ) to ensure systems function correctly.
3. Performance qualification (PQ) to validate cleanroom operations meet specified standards.
   Each step requires thorough documentation and testing to ensure compliance.

How to train staff on cleanroom best practices?

Training staff on cleanroom best practices should include:

1. Orientation on cleanroom protocols and procedures.
2. Hands-on training in gowning and de-gowning techniques.
3. Regular refresher courses on contamination control.
4. Emphasis on the importance of documentation and compliance.
   This comprehensive approach enhances staff awareness and effectiveness.

What are the ISO 6 cleanroom standards?

ISO 6 cleanroom standards specify allowable particle counts for clean air environments.
The maximum allowable particle size is 0.5 µm, with a limit of 3,520 particles per cubic meter.
These standards ensure that the environment is suitable for sensitive processes and products.

What technologies are used for cleanroom monitoring?

Cleanroom monitoring technologies include:

1. Particle counters for air quality assessment.
2. Temperature and humidity sensors for environmental control.
3. Differential pressure monitors to verify airflow integrity.
4. Data logging systems for documentation and compliance tracking.
   These technologies help maintain cleanroom conditions effectively.

What is the procurement process for modular cleanrooms?

The procurement process for modular cleanrooms generally involves:

1. Needs assessment to determine specifications.
2. Vendor selection based on quality, cost, and compliance.
3. Contract negotiation and order placement.
4. Installation and verification of the cleanroom setup.
5. Final inspections and acceptance testing before operation.
   This structured approach ensures successful procurement and installation.

What wall and floor materials are recommended for ISO 6 cleanrooms?

Recommended wall and floor materials for ISO 6 cleanrooms include:

1. Smooth, non-porous surfaces for easy cleaning.
2. Epoxy or polyurethane flooring for durability.
3. Stainless steel or fiberglass walls for resistance to contamination.
   These materials help maintain cleanliness and structural integrity.