How do you install a modular clean room?

How Do You Install a Modular Clean Room?

Installing a modular clean room requires meticulous planning and execution to ensure compliance with international standards and optimal functionality. This article outlines the key steps involved in the installation process, incorporating quantitative data and relevant standards.

1. Planning and Design

Effective installation begins with thorough planning. Identify the Clean Room Classification required, adhering to ISO 14644 standards, which classify cleanliness levels from ISO1 to ISO9. For instance, an ISO7 clean room permits a maximum of 352,000 particles per cubic meter (≥0.5 µm). A detailed layout should include airflow patterns and equipment placement to ensure efficient operations.

2. Site Preparation

Site preparation is critical for a successful installation. The floor should be leveled and capable of supporting the clean room's weight, typically requiring a load-bearing capacity of at least 500 kg per square meter. Ensure that utilities such as electricity, water, and HVAC systems are accessible and compliant with relevant standards, including ISO 14644-4 for design considerations.

3. Structure Assembly

The assembly of modular clean room components typically involves pre-fabricated wall panels, ceilings, and flooring systems. Each panel should meet ISO 9001 quality standards, ensuring durability and performance. For example, wall panels should have a thickness of at least 50 mm to insulate against temperature variations and maintain cleanliness.

4. Installation of Air Handling Systems

Air handling systems are essential for maintaining cleanliness and controlled environments. Install high-efficiency particulate air (HEPA) filters that meet the ISO 29463 standard for filtration efficiency. HEPA filters should capture at least 99.97% of particles ≥0.3 µm. Ensure that the air change rate meets the required standard, typically 15–30 air changes per hour for ISO7 clean rooms.

5. Utilities and Equipment Setup

Integrate utilities such as lighting, electrical outlets, and water supply according to international standards. Lighting should achieve a minimum illumination of 300 lux to ensure visibility without compromising cleanliness. Equipment placement must facilitate workflow and access for maintenance, minimizing the risk of contamination.

6. Validation and Testing

Upon completion, the clean room must undergo validation and testing to ensure it meets specified cleanliness standards. Conduct particle count tests according to iso 14644-1, measuring airborne particles to confirm compliance with the desired clean room classification. Other tests may include airflow measurements and filter integrity checks.

What is a Modular Clean Room?

Definition

A modular cleanroom is a controlled environment designed to minimize contamination. It consists of prefabricated panels and systems that can be easily assembled and reconfigured to meet specific needs.

Features

Modular clean rooms typically include features such as air filtration systems, temperature control, and humidity regulation. These features help maintain a stable environment essential for sensitive processes and products.

Applications

Common applications of modular clean rooms include pharmaceuticals, biotechnology, Electronics manufacturing, and aerospace. They are crucial in industries where product integrity and process reliability are paramount.

Advantages

The advantages of modular clean rooms include flexibility in design, quicker installation times, and cost-effectiveness. Their modular nature allows for easy expansion or reconfiguration as operational needs change.

How to Setup a Clean Room?

• Initial Planning

Begin by assessing the specific requirements of the clean room, including the desired cleanliness level and operational needs. This planning phase is critical to ensure compliance with industry standards.

• Site Preparation

Prepare the installation site by ensuring a clean, dry, and level surface. Check that the infrastructure can support the weight and utilities required for the clean room.

• Assembly of Components

Assemble the modular components according to the manufacturer’s specifications. Ensure all panels, ceilings, and flooring are installed correctly to maintain the integrity of the clean room.

• Installation of Systems

Install essential systems, including HVAC, lighting, and filtration. Ensure that HEPA filters are correctly positioned to achieve the required air quality and cleanliness levels.

What are the Requirements for a Clean Room?

1. Cleanliness Standards: Clean rooms must adhere to specific cleanliness standards outlined by ISO 14644. These standards categorize environments based on the maximum allowable particle counts in the air.

2. Air Quality: High-quality air filtration systems, such as HEPA or ULPA filters, are necessary to ensure particulate matter is removed from the air. Regular monitoring of air quality is crucial for compliance.

3. Equipment Standards: All equipment used within the clean room must comply with cleanliness and contamination control standards. Equipment should be easy to clean and designed to minimize particle generation.

4. Maintenance and Monitoring: Regular maintenance and monitoring of clean room conditions are essential. This includes routine checks of Air Filters, temperature, humidity, and particle counts to ensure compliance with established standards.

What is the Difference Between a Clean Room and a Sterile Room?

Contamination Control

Clean rooms focus on reducing particulate contamination, whereas sterile rooms focus on eliminating all viable microorganisms. Sterile environments often use additional sterilization methods, such as ethylene oxide or gamma radiation.

Applications

Clean rooms are commonly used in industries such as electronics and manufacturing, while sterile rooms are primarily found in pharmaceutical production, hospitals, and laboratories where aseptic conditions are critical.

Standards and Regulations

Clean rooms are regulated by standards like ISO 14644, while sterile rooms must comply with regulations set forth by bodies like the FDA and USP, which outline sterility assurance levels.

What is the FDA Classification of Clean Rooms?

• Class 100 Clean room

A Class 100 Clean room must maintain no more than 100 particles per cubic foot (approximately 3,520 particles per cubic meter) for particles ≥0.5 µm. This level is essential for critical operations in sterile product manufacturing.

• Class 10,000 Clean Room

A Class 10,000 clean room allows up to 10,000 particles per cubic foot (approximately 353,000 particles per cubic meter). This classification is suitable for manufacturing non-sterile pharmaceuticals and other applications requiring moderate cleanliness.

• Compliance and Inspections

The FDA conducts compliance inspections to ensure that clean rooms meet the required classifications and operational procedures. Regular validation and documentation are necessary to maintain FDA compliance and ensure product safety.