how to build a class 100clean room？

How to Build a Class 100 Cleanroom

Building a Class 100 Cleanroom requires meticulous planning and adherence to strict standards to ensure a controlled environment suitable for sensitive operations. A Class 100 cleanroom, defined by the ISO 14644-1 standard, permits a maximum particle count of 100 particles per cubic foot (or 3,520 particles per cubic meter) for particles equal to or greater than 0.5 microns. To achieve this, specific design elements and operational protocols must be implemented.

Design Considerations

The design of a Class 100 cleanroom is crucial for maintaining cleanliness. The room should be constructed using non-porous materials, such as stainless steel or epoxy-coated surfaces, which facilitate easy cleaning and minimize particle generation. The floor area typically ranges from 100 to 1000 square feet, depending on the intended use. 

Air Filtration System

An efficient air filtration system is paramount in a Class 100 cleanroom. HEPA (High-Efficiency Particulate Air) filters must be installed to capture 99.97% of particles that are 0.3 microns and larger. The air handling units (AHUs) should be designed to achieve a minimum of 600 air changes per hour (ACH), ensuring that the air is continuously refreshed and contaminants are expelled. Each air intake and exhaust should be strategically placed to optimize airflow and minimize dead zones.

Temperature and Humidity Control

Maintaining specific temperature and humidity levels is essential in a Class 100 cleanroom. The temperature should be controlled between 68°F to 72°F (20°C to 22°C), while relative humidity should be kept between 30% to 60%. This stability not only protects sensitive materials but also enhances the comfort of personnel working within the cleanroom. Monitoring systems should be in place to provide real-time data on these critical parameters.

Personnel Protocols

Personnel protocols are vital for maintaining cleanliness in the cleanroom environment. All individuals entering the cleanroom must undergo rigorous gowning procedures, including the use of coveralls, gloves, masks, and hairnets. Training programs should emphasize the importance of minimizing movement and avoiding the introduction of contaminants. 

Building a Class 100 cleanroom is a complex process that requires a thorough understanding of cleanroom technology, design standards, and operational procedures. Adhering to ISO 14644-1 and other relevant guidelines will ensure that the facility meets the necessary cleanliness levels for its intended applications.

Relevant Standards and Regulations

1. iso 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness.

2. Federal Standard 209E: Airborne particulate cleanliness classes in cleanrooms and clean zones.

3. IEST-STD-001: Institute of Environmental Sciences and Technology standard for Cleanroom design and operations.

What are the specs for Class 100 cleanroom?

A Class 100 cleanroom must maintain a particle count of no more than 100 particles per cubic foot and ensure 600 air changes per hour. Stringent controls on temperature (68-72°F) and humidity (30-60%) are essential for preventing contamination in sensitive industries.

What are the requirements for a Class 100 clean room?

1. Air Cleanliness Level: The cleanroom must comply with ISO 14644-1 standards, allowing no more than 100 particles per cubic foot of 0.5 microns or larger.

2. Air Filtration: HEPA filters must be used to achieve a minimum efficiency of 99.97% for particles of 0.3 microns. Regular testing and maintenance of the filtration system are required.

3. Air Changes: A minimum of 600 air changes per hour (ACH) is necessary to ensure that contaminants are effectively removed and replaced with clean air.

4. Temperature Control: The cleanroom should maintain a temperature range of 68°F to 72°F (20°C to 22°C) to protect sensitive materials and ensure comfort for personnel.

5. Humidity Control: Relative humidity must be maintained between 30% and 60% to prevent static electricity and ensure optimal conditions for any processes involving moisture-sensitive materials.

6. Room Materials: The walls, floors, and ceilings of the cleanroom must be constructed from non-porous, easy-to-clean materials such as stainless steel or specialized coatings that minimize particle generation.

7. Personnel Protocols: All personnel must undergo strict gowning procedures, including wearing cleanroom suits, gloves, masks, and hair covers to minimize contamination risks. Training on cleanroom protocols and contamination control is mandatory.

8. Monitoring Systems: Continuous monitoring systems for air quality, temperature, humidity, and particle counts should be implemented to ensure compliance with cleanroom standards. Alarms should be in place to alert personnel of any deviations.

9. Access Control: Access to the cleanroom must be restricted to authorized personnel only. Entry protocols should include airlocks and anterooms to reduce the risk of contamination from outside.

10. Regular Audits: Periodic audits and validations must be conducted to ensure that the cleanroom meets all operational and environmental requirements, including routine checks of air quality, equipment calibration, and adherence to SOPs.

How much air change for Class 100 cleanroom?

The air change rate in a Class 100 cleanroom is a critical factor in maintaining its stringent cleanliness standards. Typically, a minimum of 600 air changes per hour (ACH) is necessary to ensure that the concentration of airborne particles is kept within acceptable limits. This means that the entire volume of air in the cleanroom is replaced at least 10 times every minute, facilitating the rapid removal of contaminants.

The high air change rate helps to dilute and remove any particles that may be introduced into the cleanroom environment. This can be achieved through the use of high-capacity air handling systems equipped with HEPA filters, which trap 99.97% of particles that are 0.3 microns or larger. 

Moreover, achieving the required air change rate is influenced by the cleanroom's design, including its size, layout, and the number of personnel present. Each of these factors can affect airflow dynamics and the overall efficiency of the air handling system. Therefore, it is vital to conduct airflow modeling and testing during the design phase to optimize the system for the specific requirements of a Class 100 cleanroom.

What is the particle count in a Class 100 clean room?

Definition and Standards

In a Class 100 cleanroom, the particle count must not exceed 100 particles per cubic foot for particles that are 0.5 microns or larger. This specification is in accordance with the ISO 14644-1 standard, which sets the criteria for CleanRoom Classification based on airborne particulate cleanliness.

Measurement Protocols

Particle counts are typically measured using a particle counter, which can detect particles of various sizes. Regular monitoring is essential, as it helps in maintaining compliance with the cleanroom's cleanliness standards. The measurements should be taken at defined intervals and under specific conditions to ensure accuracy.

Impact on Operations

Maintaining the appropriate particle count is crucial for industries such as pharmaceuticals, semiconductor manufacturing, and biotechnology, where even a small number of particles can lead to contamination and product defects. Therefore, continuous monitoring, along with effective cleaning protocols and air filtration systems, is necessary to uphold the integrity of the cleanroom environment.

Comparison with Other Classes

For context, higher cleanliness classes, such as Class 10, allow for even fewer particles (10 particles per cubic foot), while lower classes, such as Class 1000, permit up to 1,000 particles. 

What is the difference between Class 10 and Class 100 cleanroom?

Class 10 and Class 100 Cleanrooms are both essential in controlled environments, but they differ significantly in cleanliness levels and operational suitability. Here’s a breakdown of their differences: