ISO Class 6 Cleanroom Design and Build

ISO 6 Cleanroom Design and Build

The design and construction of an ISO6 cleanroom is a critical process that ensures controlled environments for industries requiring stringent cleanliness standards, such as pharmaceuticals, biotechnology, and Electronics manufacturing. ISO6 cleanrooms are characterized by specific cleanliness levels, airflow design, and materials that minimize contamination risks. This article outlines the fundamental aspects of ISO6 Cleanroom design and build, detailing requirements, standards, key design considerations, and qualification.

Requirements for ISO 6 Cleanroom

ISO 14644-1 outlines the standards and requirements for cleanrooms, specifically detailing the maximum allowable particles in the air. For an ISO6 cleanroom, the primary requirement is the control of particulate contamination. This class allows a maximum of 3,520 particles per cubic meter for particles that are 0.5 micrometers or larger, and a maximum of 29 particles per cubic meter for particles that are 5 micrometers or larger. Other requirements include:

• Air Change Rate: At least 20 air changes per hour.

• Temperature Control: Typically maintained between 18°C and 24°C (64°F and 75°F).

• Relative Humidity: Kept between 30% and 60%.

• Material Selection: Use of non-porous, easy-to-clean materials.

• Personnel Training: Staff must be trained in cleanroom protocols and contamination control.

What is the Standard for Cleanroom Design?

Cleanroom design standards are essential for ensuring that facilities meet specific cleanliness and operational requirements. The main standards include:

1. ISO 14644 Series

This series outlines the classification of air cleanliness and the specifications for Cleanroom Testing and monitoring.

2. Federal Standard 209E

Although retired, it is still referenced for historical context; it classified cleanrooms based on particle counts.

3. Good Manufacturing Practice (GMP)

In pharmaceutical and biotechnology sectors, GMP guidelines dictate design and operational standards.

4. International Organization for Standardization (ISO)

Various ISO standards guide cleanroom materials and construction practices to ensure compliance.

How to Design a Cleanroom?

1. Define the Purpose: The first step in cleanroom design is to clearly define the intended use. Whether it’s for Semiconductor manufacturing, pharmaceutical production, or medical device assembly, the specific processes will dictate the cleanroom requirements.

2. Establish CleanRoom Classification: Based on the intended use, determine the classification required, such as ISO6. This will inform all design decisions, from airflow design to materials and finishes.

3. Plan the Layout: The layout must facilitate efficient workflow while minimizing contamination risks. This includes considering the placement of equipment, personnel flow, gowning areas, and material entry points. A logical flow minimizes cross-contamination and maximizes operational efficiency.

What are the Key Cleanroom Design Considerations?

Air Filtration

High-efficiency particulate air (HEPA) filters should be used to maintain air quality.

Positive Pressurization

Ensure that the cleanroom is positively pressurized to prevent outside contaminants from entering.

Material Selection

Use smooth, non-porous surfaces that are easy to clean.

Lighting

Adequate lighting without creating shadows or glare is essential.

Environmental Control

Systems for controlling temperature, humidity, and airflow must be integrated into the design.

Monitoring Systems

Include continuous monitoring systems for airborne particles, temperature, and humidity.

Accessibility

Design should allow for easy access to equipment and maintenance without compromising cleanliness.

What is Cleanroom Design Qualification?

1. Design Qualification (DQ)

Establishing that the design meets the intended use and regulatory requirements.

2. Installation Qualification (IQ)

Ensuring that all systems are installed according to specifications and that all components function as intended.

3. Operational Qualification (OQ)

Testing the cleanroom under operational conditions to confirm that it meets performance criteria.

What is the Particle Count for ISO6 Cleanroom?

To ensure the functionality and compliance of an ISO ISO 6 cleanroom, several critical requirements must be met, focusing primarily on contamination control and environmental conditions.

1. Airborne Particulate Levels

Maximum allowable limits:

• 0.5 µm: 3,520 particles/m³

• 1.0 µm: 832 particles/m³

• 5.0 µm: 29 particles/m³

2. Air Change Rates

A minimum of 20 air changes per hour is required to maintain air quality and prevent contamination.

3. Temperature and Humidity Control

Temperature typically maintained between 18°C and 24°C (64°F to 75°F).

Relative humidity should be controlled between 30% and 60% to prevent static and condensation.

4. Material Specifications

Surfaces should be smooth, non-porous, and easy to clean.

Use of materials that do not shed particles.

5. Personnel Training

Staff must be properly trained in cleanroom protocols and contamination control procedures.

6. Monitoring Equipment

Continuous monitoring of air quality, temperature, and humidity levels should be implemented to ensure compliance with standards.

7. Design Features

Include features such as positive pressurization, proper airflow patterns, and adequate filtration systems (HEPA or ULPA filters).

With these requirements in place, an ISO6 cleanroom can effectively support the critical processes found in high-tech industries.