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Design of Class 1000 Cleanroom
1. Structural Design
The structural design of the cleanroom requires good sealing and load-bearing capacity to ensure the stability of the internal environment of the cleanroom.
Wall materials: It is recommended to use seamless and smooth materials such as stainless steel or high-density polyethylene, which are easy to clean and corrosion-resistant.
floor design: Wear-resistant and antibacterial materials such as epoxy resin are used, and the floor should have a certain slope for drainage.
Isolation: The cleanroom should be isolated from the external environment, and airtight doors and sealed windows should be used.
2. Architectural design
The architectural design needs to consider the spatial layout and flow of people in the cleanroom to ensure efficient production and operation.
Spatial layout: The layout of "front room-clean room-back room" should be adopted to form multiple isolations.
Flow of people: Design one-way flow to reduce the risk of cross-contamination.
Natural lighting: Make full use of natural light to reduce energy consumption.
3. HVAC system design
The HVAC system is the core of clean room environmental control, responsible for air circulation, temperature and humidity control and filtration.
Air exchange rate: Class 1000 Clean rooms require 4-10 air exchanges per hour.
HVAC system: Use high-efficiency HEPA (high-efficiency particulate air) filters with a filtration efficiency of 99.97%.
Temperature and humidity control: The temperature should be controlled at 20-22°C, and the humidity should be maintained between 30%-60%.
4. Fire protection system design
Fire protection system design is an important part of ensuring the safety of clean rooms and must comply with relevant regulations and standards.
Alarm system: Set up smoke detectors and fire alarms to ensure timely alarms when a fire occurs.
Fire extinguishing system: Use a gas fire extinguishing system (such as FM-200 or dry powder fire extinguisher) to reduce the impact on clean room items.
Emergency passage: Design emergency exits that comply with regulations to ensure rapid evacuation of personnel.
5. Electrical system design
The electrical system design should ensure the stable operation and safety of the clean room.
Power supply design: Use dual-circuit power supply to ensure backup power support when the main power fails.
Lighting system: Use LED dustproof lamps, the illumination should reach 300-500Lux to avoid heat generation.
Equipment grounding: All equipment in the clean room should be grounded to prevent static electricity accumulation.
6. Weak current system design
The weak current system includes monitoring, alarm and communication equipment, and it is necessary to ensure the security and stability of data transmission.
Monitoring system: Configure high-definition cameras to cover all areas of the clean room and have recording function.
Alarm system: Set up environmental monitoring equipment to monitor temperature and humidity changes in real time.
Communication system: Use wireless network or dedicated communication line to ensure rapid information transmission.
7. Intelligent system design
Intelligent system can improve the efficiency and accuracy of clean room management.
Central control system: Realize centralized management of HVAC, lighting and alarm systems.
Environmental monitoring: The environmental monitoring system monitors various indicators of the clean room in real time through sensors to ensure that the operating status meets the requirements.
Automatic adjustment: The system can automatically adjust temperature, humidity, air flow speed, etc. according to real-time data to maintain optimal cleanliness.
Data recording and analysis: All monitoring data should be stored and analyzed regularly to facilitate tracking and optimization of operation processes.
Remote monitoring: Support remote access and monitoring, managers can check the status of the clean room at any time and respond to emergencies in time.
List of relevant standards and specifications
ISO 14644-1- Air cleanliness level standard.
GMP (Good Manufacturing Practice)- Production standards for the pharmaceutical and biotechnology industries.
ASHRAE 170- Ventilation and air conditioning standards.
NFPA 70- National Electrical Code.
NFPA 72- Fire alarm system standards.
ISO 9001- Quality management system standards.
What is Cleanroom design Qualification?
Definition of Cleanroom Design Qualification
Cleanroom design qualification is a systematic process that ensures a cleanroom meets specific regulatory and performance standards. It focuses on evaluating the design, construction, and operational capabilities of cleanroom facilities.
Importance of Compliance
Compliance with industry standards, such as ISO classifications, is crucial for cleanroom design qualification. It ensures that the environment is suitable for sensitive processes, particularly in pharmaceuticals and semiconductor manufacturing.
Validation Process
The validation process involves rigorous testing and documentation, confirming that the cleanroom operates as intended. This may include performance qualification (PQ) and operational qualification (OQ) to validate the cleanroom's functionality.
When a Cleanroom is Classified as Class 1000
1. Definition of Class 1000 Cleanroom: A Class 1000 cleanroom is defined by a maximum allowable particle count of 1,000 particles per cubic foot for particles ≥ 0.5 micrometers. This classification indicates a controlled environment with specific cleanliness standards.
2. Implications for Facility Operations: Class 1000 Cleanrooms are suitable for processes that require moderate levels of cleanliness. Industries such as electronics and pharmaceuticals often utilize this classification for production and assembly processes.
3. Air Quality Control: To maintain Class 1000 standards, facilities must implement effective air filtration systems, such as HEPA filters, and ensure proper airflow management. Regular monitoring of particle counts is essential to uphold cleanliness.
What are the Specifications for Class 1000 Cleanroom?
Air Changes Per Hour
A key specification is the required air changes per hour (ACH). Class 1000 Cleanrooms typically require a minimum of 12 to 30 ACH to maintain adequate air quality and dilution of contaminants.
Temperature and Humidity Control
Temperature and humidity must be controlled within specific ranges to ensure optimal product quality and personnel comfort. Generally, a temperature range of 20-25°C and relative humidity of 30-60% is maintained in Class 1000 cleanrooms.
Material and Construction Standards
Materials used in Class 1000 cleanrooms should be non-porous and easy to clean. Walls, floors, and ceilings must be constructed from materials that minimize particle generation and facilitate regular maintenance.
Monitoring and Maintenance
Regular monitoring of air quality and particle levels is crucial for Class 1000 cleanrooms. Maintenance schedules should be established for HEPA filters and HVAC systems to ensure compliance with cleanliness standards.
What is Cleanroom Model?
Definition of Cleanroom Model
A cleanroom model refers to the structured approach used to design, implement, and manage cleanroom facilities. It encompasses various methodologies to ensure compliance with cleanliness and operational standards.
Types of Cleanroom Models
Different cleanroom models exist depending on industry needs, such as modular cleanrooms or traditional fixed facilities. Each model serves specific applications, impacting flexibility, scalability, and cost.
Design Considerations in the Model
Key design considerations in a cleanroom model include airflow patterns, contamination control, and personnel flow. These elements are critical in preventing contamination and maintaining the required cleanliness levels.
What are the Requirements for a Semiconductor Clean Room?
Temperature and Humidity Control
Maintaining stable temperature and humidity levels is crucial in Semiconductor cleanrooms. Temperature should generally remain between 20-25°C, while humidity is typically controlled between 30-50% to protect sensitive materials.
Airflow and Filtration
Effective airflow management is essential for semiconductor cleanrooms. High-efficiency particulate air (HEPA) filters are commonly used to remove airborne contaminants, while laminar airflow systems help maintain uniformity.
Personnel Gowning Procedures
Strict gowning procedures are mandatory in semiconductor cleanrooms to minimize contamination. Personnel must wear specialized garments, including coveralls, gloves, masks, and shoe covers, to prevent the introduction of particles.
Equipment and Material Control
Regular maintenance and cleaning procedures are essential to uphold cleanliness standards. Scheduled inspections, filter replacements, and cleaning of surfaces help ensure ongoing compliance with the stringent requirements of semiconductor cleanrooms.
