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Definition of Class 100,000 Cleanroom
1. Basic Concept of Cleanroom
A cleanroom is a special space that prevents external pollutants from entering and ensures that the internal production or experimental environment meets specific standards by controlling environmental factors such as air cleanliness, temperature, humidity and pressure. The classification of cleanrooms is based on the international standard ISO 14644 series, especially iso 14644-1.
Air cleanliness: Remove particles from the air through filters.
Environmental control: Temperature, humidity and air pressure must be within the specified range.
Application areas: Widely used in Semiconductor, pharmaceutical, biotechnology and other industries.
2. Definition of Class 100,000 Cleanroom
A Class 100,000 cleanroom refers to an air cleanroom that allows no more than 100,000 particles with a diameter of 0.5 microns or larger per cubic meter of air. This standard applies to industries with relatively loose environmental requirements.
Particle limit: No more than 100,000 0.5 micron particles per cubic meter.
Applicable scenarios: Suitable for equipment assembly, non-sensitive biological experiments, etc.
International standards: Comply with the definition and classification of clean rooms in ISO 14644-1.
3. Environmental control requirements for Class 100,000 clean rooms
In Class 100,000 clean rooms, environmental control is a key factor in ensuring cleanliness. The temperature is usually maintained between 20°C and 24°C, and the humidity is controlled between 30% and 60% to avoid static electricity and condensation.
Temperature range: 20°C to 24°C.
Humidity range: 30% to 60%.
Air pressure requirements: Usually positive pressure to prevent external air from entering.
4. Air circulation and filtration of Class 100,000 clean rooms
Class 100,000 clean rooms are usually equipped with high-efficiency filters (HEPA or ULPA) to ensure that particulate matter in the air is effectively removed. The design of the air circulation system must ensure that clean air is evenly distributed and reduce dead corners and pollution sources.
Filter type: HEPA or ULPA filter.
Airflow velocity: Usually between 0.3 and 0.5 meters per second to ensure effective air exchange.
Airflow pattern: Usually laminar or non-laminar design is adopted, which is selected according to the specific needs of the clean room.
5. Material selection for 100,000-class clean rooms
The materials in the clean room should have good anti-pollution performance and be easy to clean and maintain. Common materials include stainless steel, plastic, glass and special coatings, which can effectively reduce the adhesion of microorganisms and particles.
Surface material: stainless steel, plastic, glass.
Cleanliness: The material should be smooth and easy to disinfect.
Anti-pollution: Reduce the accumulation of particles and microorganisms.
6. Operation and maintenance of 100,000-class clean rooms
In order to continuously maintain the performance of 100,000-class clean rooms, regular monitoring and maintenance are required. Including air quality monitoring, equipment calibration, filter replacement and cleaning procedures.
Monitoring frequency: Air quality needs to be monitored daily.
Maintenance plan: Regularly replace filters and calibrate equipment.
Cleaning cycle: Develop a cleaning plan based on usage to ensure that the environment always meets the standards.
7. Certification and standards for Class 100,000 clean rooms
In order to ensure the functionality and safety of Class 100,000 clean rooms, relevant international standards and certification procedures must be followed. These standards include the ISO 14644 series and other industry-specific standards such as FDA and GMP.
Certification standards: ISO 14644-1, iso 14644-2, GMP.
Compliance requirements: Regular review and third-party certification.
Industry standards: Supplement relevant standards based on industry characteristics.
What is the difference between operating room and clean room?
Environmental Control
Operating rooms maintain strict temperature and humidity levels, along with positive air pressure. Clean rooms, on the other hand, prioritize particulate control, using HEPA filters to ensure specific cleanliness standards based on ISO classifications.
Personnel Attire
In operating rooms, surgical personnel wear scrubs, masks, and gloves to maintain sterility. Clean room personnel typically wear coveralls, hoods, gloves, and shoe covers to prevent contamination of sensitive environments.
How much does a Class 100000 clean room cost?
Initial Setup Costs
The initial setup cost for a Class 100,000 clean room typically ranges from $100,000 to $500,000. This includes construction, HVAC systems, and cleanroom Equipment, which can significantly vary based on size and location.
Operational Costs
Ongoing operational costs for a Class 100,000 clean room can be substantial, averaging $20,000 to $50,000 annually. These costs cover utilities, maintenance, and personnel training to maintain cleanliness and compliance.
Customization Factors
The cost may increase based on customization needs, such as specific filtration systems or specialized materials. Industry requirements, such as pharmaceutical or semiconductor standards, can also influence the overall investment.
What class is a semiconductor clean room?
Class 1 Clean Rooms
Class 1 clean rooms are the highest classification, allowing only one particle of 0.1 microns per cubic meter. These ultra-clean environments are critical for advanced semiconductor fabrication, where even minimal contamination can cause significant defects.
Class 10 Clean Rooms
Class 10 clean rooms permit up to 10 particles of 0.5 microns per cubic meter. This class is commonly used for processes like photolithography, where maintaining a controlled environment is essential to product integrity.
Class 100 Clean rooms allow 100 particles of 0.5 microns per cubic meter. Many semiconductor facilities operate at this level, balancing cleanliness with practical operational requirements while still ensuring high-quality manufacturing standards.
What is Clean Room Classification Class C?
1. Overview of Class C：Class c Clean Rooms are designed to control the environment for processes that require a moderate level of cleanliness. They typically have a maximum allowable particle count of 3,520 particles per cubic meter.
2. Particle Count Standards：In Class C clean rooms, the allowable particle count is based on particles sized 0.5 microns or larger. This classification is suitable for processes that are sensitive to contamination but do not require the highest cleanliness levels.
3. Applications：Class C clean rooms are often used in the pharmaceutical and biotechnology industries, particularly for the manufacture of non-sterile products. They support processes that require clean environments but can tolerate higher levels of contamination than stricter classes.
4. Ventilation and Filtration：These clean rooms employ HEPA filters to maintain air quality and reduce particulate levels. Proper ventilation systems help ensure that the environment remains stable, supporting the necessary manufacturing conditions.
What is the FDA classification of clean rooms?
1. Alignment with ISO Standards
While the FDA does not create its own clean room classes, it often references ISO classifications. For instance, ISO5 is commonly required for sterile drug manufacturing, ensuring the highest cleanliness standards.
2. Clean Room Requirements
FDA regulations mandate that clean rooms must meet stringent environmental controls, including air quality, temperature, and humidity levels. These controls are essential to prevent contamination during the manufacturing process.
3. Validation and Compliance
Manufacturers must validate their clean room environments, demonstrating compliance with FDA standards through rigorous testing and documentation. This validation is crucial for maintaining product quality and safety in regulated industries.
