How to build class 10000 clean room?

How to Build a Class 10000 Clean room

Building a Class 10000 Clean room requires meticulous planning and adherence to strict standards to ensure a controlled environment that minimizes contamination. According to ISO 14644-1, a Class 10000 clean room must maintain a maximum allowable particle count of 10,000 particles per cubic meter for particles of 0.5 micrometers and larger. This level of cleanliness is essential for industries such as pharmaceuticals, biotechnology, and electronics.

1. Design and Layout

The design of a Class 10000 clean room should facilitate smooth workflow while minimizing contamination risks. The layout often includes anterooms for personnel gowning and airlocks to prevent unfiltered air from entering the clean area. The clean room should ideally be rectangular or square to optimize air circulation. The dimensions depend on the specific requirements but typically range from 100 to 1,000 square feet.

2. Airflow and Filtration

Maintaining proper airflow is critical in a Class 10000 clean room. The use of High-Efficiency Particulate Air (HEPA) filters is standard, capable of trapping 99.97% of particles down to 0.3 micrometers. The clean room should have a minimum air change rate of 10 to 15 air changes per hour to ensure that airborne particles are constantly filtered out. This ensures that the total particle count remains within the allowable limits set by ISO standards.

3. Materials and Construction

The materials used in constructing a Class 10000 clean room must be non-porous, easy to clean, and resistant to microbial growth. Walls, ceilings, and floors are typically constructed from materials such as stainless steel, vinyl, or epoxy-coated surfaces. All seams should be sealed to prevent contamination. The clean room should also be equipped with smooth surfaces and minimal joints to facilitate cleaning.

4. Monitoring and Maintenance

Ongoing monitoring of air quality is essential in a Class 10000 clean room. Particle counters should be used regularly to measure the levels of particulate contamination. Additionally, routine maintenance of HVAC systems, filters, and other equipment is vital to ensure compliance with cleanliness standards. Records of monitoring results should be maintained for regulatory compliance and quality assurance.

Standards and Regulations

For building and maintaining a Class 10000 clean room, various standards and regulations should be followed, including:

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

• iso 14644-2: Cleanrooms and controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by airborne particulate contamination.

• ISO 14644-3: Cleanrooms and controlled environments – Part 3: Test methods.

• FDA Guidelines: For pharmaceutical clean rooms.

How Do You Classify Cleanrooms?

Cleanrooms are classified according to the maximum allowable levels of airborne particulate contamination, as outlined by international standards such as ISO 14644-1. The classification system ranges from ISO1, which allows for the least amount of particles, to ISO 9, which permits a significantly higher particle count. 

What Are the Class 10000 Clean Room Requirements?

Building a Class 10000 clean room involves specific requirements aimed at controlling contamination and maintaining air quality. Below are the key requirements:

Air Cleanliness

The primary requirement for a Class 10000 clean room is to maintain a maximum allowable particle count of 10,000 particles per cubic meter for particles greater than or equal to 0.5 micrometers, as per ISO 14644-1. This necessitates effective air filtration and circulation.

Air Flow and Change Rates

A minimum of 10 to 15 air changes per hour is required to ensure that any airborne contaminants are effectively removed. This helps maintain the desired cleanliness level and prevents particle accumulation.

HVAC System

An effective HVAC (Heating, Ventilation, and Air Conditioning) system is essential for maintaining the specific temperature, humidity, and cleanliness levels required in a Class 10000 clean room. The system should include HEPA filters to capture airborne particles, and it must be capable of maintaining consistent airflow patterns to avoid stagnant air areas where contaminants can accumulate. The design should also facilitate rapid and thorough cleaning procedures.

Construction Materials

The materials used in the clean room's construction should be non-porous, smooth, and easy to clean. Common materials include stainless steel, epoxy-coated surfaces, and vinyl. All surfaces should be sealed to minimize dust and particle accumulation, and joints should be minimized to facilitate cleaning.

Monitoring Equipment

Regular monitoring of the clean room environment is crucial for compliance with the cleanliness standards. This includes using particle counters to measure airborne particulate levels and environmental sensors for temperature and humidity control. Continuous monitoring systems may also be installed for real-time data collection and analysis.

Personnel Training and Gowning Procedures

Personnel must undergo training on contamination control and clean room protocols. Strict gowning procedures should be enforced to minimize the introduction of contaminants. This typically includes wearing cleanroom suits, gloves, masks, hair covers, and shoe covers.

Maintenance and Cleaning

Routine maintenance of the clean room, including regular cleaning protocols, filter changes, and equipment servicing, is critical to ensuring that the cleanliness requirements are continuously met. Cleaning schedules should be documented, and all cleaning agents used should be compatible with the clean room environment.

Compliance with Regulations

Compliance with relevant regulations and standards, such as ISO 14644 and Good Manufacturing Practices (GMP), is essential. Regular audits and inspections should be conducted to ensure ongoing compliance and to identify any areas for improvement.

How Much Does a Class 10,000 Clean Room Cost?

The cost of building a Class 10,000 clean room can vary significantly based on multiple factors, including size, location, design complexity, and specific requirements. On average, the construction cost for a clean room can range from $200 to $600 per square foot. For example, a small clean room of 500 square feet could cost anywhere from $100,000 to $300,000. This cost typically includes materials, labor, and the installation of specialized equipment.

In addition to initial construction costs, ongoing operational costs must also be considered. These costs include HVAC system maintenance, filter replacements, utilities, and personnel training. Over time, these operational expenses can add up, potentially amounting to several thousand dollars annually. For instance, maintaining the air filtration systems and monitoring equipment can cost around $5,000 to $10,000 per year, depending on usage and environmental conditions.

Finally, it is important to factor in costs related to compliance with industry standards and regulations. These may include expenses for regular audits, certifications, and monitoring equipment. Depending on the frequency and scope of these activities, annual compliance costs could range from $2,000 to $15,000. 

What is the Particle Count Requirement for a Clean Room?

Particle count requirements for clean rooms are determined by international standards such as ISO 14644-1, which outlines the maximum allowable levels of particulate contamination based on the clean room classification. Here are the key points regarding particle count requirements:

1. Classification Overview: Clean rooms are classified based on the maximum permissible particle counts per cubic meter of air. For a Class 10000 clean room, the allowable particle count is up to 10,000 particles of size 0.5 micrometers or larger. This limit is critical for industries where contamination can compromise product quality, such as pharmaceuticals and semiconductor manufacturing.

2. Measurement Methodology: Particle counts are typically measured using laser particle counters, which provide real-time data on the number of particles present in the air. The measurement process involves sampling air from the clean room and analyzing it for particle concentration across various sizes. This data helps assess compliance with cleanliness standards.

3. Importance of Monitoring: Continuous monitoring of particle counts is essential for maintaining clean room integrity. Regular monitoring helps identify any fluctuations in air quality, allowing for timely interventions. If particle counts exceed the allowable limits, immediate actions, such as adjusting airflow or performing additional cleaning, may be necessary to restore compliance.

4. Impact on Operations: Exceeding particle count limits can lead to significant operational impacts, including product contamination, increased rejection rates, and potential regulatory penalties. Therefore, strict adherence to particle count requirements is vital for maintaining product quality and operational efficiency.

5. Reporting and Documentation: Comprehensive documentation of particle count measurements and trends is essential for regulatory compliance and quality assurance. Records should include information on sampling dates, locations, and results. 

How Many People Are Allowed in a Cleanroom?

The number of people allowed in a cleanroom is determined by several factors, including the cleanliness class, the size of the cleanroom, and the specific activities being carried out. Each cleanroom environment is designed to minimize contamination, and personnel are one of the primary sources of potential contaminants, such as particles, skin flakes, and clothing fibers. As a result, the number of individuals allowed in a cleanroom is strictly controlled to maintain optimal conditions. Here are key considerations:

CleanRoom Classification:

The cleanliness level of the cleanroom (ISO1 to ISO9) plays a significant role in determining the number of people permitted inside. Cleanrooms with stricter standards, such as ISO1 or ISO 5, can accommodate fewer people due to their higher sensitivity to contamination. 

Size of the Cleanroom:

The size of the cleanroom also dictates how many people can be inside at any given time. Larger cleanrooms with more space and higher airflow capacity can support a greater number of personnel while maintaining proper air quality and cleanliness. However, crowding should still be avoided, as it can lead to increased particle contamination and make it harder to maintain the required airflow patterns.

Personnel Gowning and Behavior:

The number of people in a cleanroom is also influenced by the necessary gowning protocols and work activities. Strict gowning procedures, including the use of hair covers, face masks, gloves, and full-body suits, help minimize the risk of contamination from personnel. 

Airflow and Environmental Control:

The ventilation system in the cleanroom is designed to maintain the appropriate level of cleanliness. For cleanrooms with high air change rates, such as ISO5, the number of people allowed must be closely regulated to prevent overloading the system, which could result in a reduction of airflow and increased particle levels. Therefore, any increase in personnel requires recalculating the system’s capacity to maintain the required environment.

Operational Needs:

The nature of the work being performed also dictates the number of people allowed in the cleanroom. In some industries, such as semiconductor manufacturing or pharmaceutical production, the presence of personnel is kept to an absolute minimum to avoid contamination. In other cases, such as research labs or certain manufacturing processes, more people may be needed to operate equipment, conduct experiments, or assemble products, but only if contamination risks are properly managed.

In conclusion, the number of people allowed in a cleanroom is carefully controlled based on its cleanliness class, size, the tasks being performed, and the cleanroom’s ability to maintain optimal environmental conditions. Adhering to these guidelines ensures that contamination risks are minimized, thereby protecting both the products and the integrity of the cleanroom.

What is the Difference Between ISO 7 and ISO 8 Cleanroom?

The difference between ISO 7 and ISO 8 Cleanrooms primarily lies in the particle count limits and the overall environmental control requirements. Both ISO 7 and ISO 8 fall under the ISO 14644-1 classification standard, but they have different levels of cleanliness, making them suitable for different types of applications.

An ISO7

cleanroom has stricter cleanliness standards, allowing no more than 352,000 particles per cubic meter (for particles 0.5 micrometers and larger). This makes it suitable for industries such as pharmaceuticals, biotechnology, and medical device manufacturing, where contamination risks need to be tightly controlled. The higher air change rates and more stringent operational procedures required in ISO 7 Cleanrooms help ensure a higher level of contamination control than in ISO 8.

On the other hand, an ISO8

cleanroom has more relaxed standards, allowing up to 3.5 million particles per cubic meter. ISO 8 cleanrooms are typically used in industries where contamination control is important but not as critical as in ISO 7. Common applications include assembly of electronic components and some general manufacturing processes. The air filtration and cleanliness standards in ISO 8 are sufficient for these less sensitive applications, though the cleanroom environment still needs to be monitored and maintained.