I need a clean room

A Clean Room is a specific environment designed to control pollutants in the air, such as particles, bacteria, chemical gases, etc. It is widely used in industries such as Semiconductor manufacturing, pharmaceuticals, and biotechnology. In order to ensure that the clean room can meet specific production needs, we first need to clarify the purpose of the clean room, which is the basis for designing and building a clean room.

Determine the purpose of the clean room

1. Industry demand

The purpose of the modular clean room is often determined by industry needs. Different industries have different requirements for the cleanliness, area, and function of the clean room. For example, in the semiconductor manufacturing industry, the contaminant control standards for clean rooms are very strict, usually requiring ISO 5 level, which means that the number of particles allowed per cubic meter of air does not exceed 3,520 (≥0.5μm). In the pharmaceutical industry, according to the GMP Standard, the cleanliness level requirements of the clean room are also increased accordingly, usually requiring ISO 7 or ISO 8 level, especially in the aseptic production process.

2. Cleanliness level requirements

The cleanliness level of a clean room is an important criterion for measuring its performance. The ISO 14644 series of standards is usually used to classify the level of cleanrooms. For example, ISO1 cleanrooms must not exceed 10 particles (≥0.1μm) per cubic meter of air, while ISO9 allows 35,200,000 particles per cubic meter. Depending on the manufacturing requirements of different products, the required cleanliness level needs to be evaluated to ensure the quality and safety of the final product.

3. Area requirements

The area requirements of A CleanRoom are closely related to its purpose of use and the number of people. Generally speaking, the design of a cleanroom needs to follow certain space standards to ensure the efficient operation of personnel and equipment. According to industry standards, the minimum area of a cleanroom can be calculated by the following formula:

For example, if each operator requires 4 square meters of space, there are 10 operators, and the equipment occupies an area of 20 square meters, then at least 40 square meters of cleanroom area is required.

Cleanroom design according to demand

1. Cleanroom building structure design

The building structure design of the cleanroom needs to take into account factors such as air flow, temperature and humidity control. The material selection of walls, floors and ceilings is crucial, and smooth and easy-to-clean materials such as stainless steel or polyvinyl chloride (PVC) are usually used to reduce the adhesion of dust and particles. At the same time, the design of the cleanroom should also follow structural strength and fire protection standards, such as GB50016-2014 "Building Design Fire Protection Code" to ensure that the spread of fire can be effectively prevented in the event of an accident.

2. Cleanroom HVAC purification system design

The HVAC purification system is the core part of the cleanroom design. The system needs to be able to effectively filter particles and microorganisms in the air, usually using a high-efficiency Air Filter (HEPA) or an ultra-high-efficiency air filter (ULPA). According to the ISO 29463 standard, the efficiency of the HEPA filter should be ≥99.97% (≥0.3μm), while the efficiency of the ULPA filter can reach 99.999% (≥0.12μm). The air replacement rate should be considered during design, which is usually required to be changed 3 to 20 times per hour to maintain indoor air quality.

3. Clean room electrical circuit design

The electrical circuit design of the clean room needs to ensure the normal operation and safety of the equipment. All electrical equipment should comply with the IEC 60601 standard to ensure the safety and reliability of the equipment in the Clean room environment. In addition, the power supply system should be designed for redundant power supply to prevent production stagnation due to power outages. The lighting system needs to use dust-free lamps to avoid dust and particles.

4. Clean room fire protection design

Fire protection design is an important part of clean room design. It should be designed in accordance with local fire protection regulations and the "Building Design Fire Protection Code" to ensure that there are enough fire extinguishers and fire alarm systems in the clean room, and emergency lighting and evacuation instructions are set. The material selection of the clean room should also consider fire resistance and avoid the use of flammable materials to reduce the risk of fire.

Clean room construction

The construction process of the clean room needs to strictly follow the design plan and industry standards. During the construction process, workers should wear appropriate protective equipment to avoid bringing external pollutants into the clean room

1. Selection of construction materials

In the construction of clean rooms, it is crucial to choose the right materials. All construction materials should meet the relevant clean room standards and usually need to have antibacterial, dust-proof and easy-to-clean properties. Commonly used materials include stainless steel, polyvinyl chloride (PVC) and special coatings. The selection of these materials not only affects the air quality of the clean room, but also affects the subsequent maintenance and cleaning work. For example, the use of workbenches and equipment surfaces made of stainless steel can effectively reduce the accumulation of particles and is also easy to clean and disinfect.

2. Control of the construction process

During the construction of the clean room, the cleanliness of the construction environment must be strictly controlled. Before construction, all materials and tools must be cleaned and disinfected to minimize contamination. In addition, before entering the clean room, construction personnel must undergo a strict dressing procedure, including wearing special clean clothes, gloves and masks. During construction, a phased construction approach should be adopted to ensure that necessary cleaning and testing are carried out after each stage is completed to meet the design requirements.

3. Testing and verification after construction

After construction is completed, the modular clean room needs to undergo a series of tests and verifications to ensure that it meets the design standards and clean requirements. According to the ISO 14644 standard, an air particle count test is carried out to ensure that the clean room reaches the predetermined cleanliness level. At the same time, temperature and humidity tests, airflow tests, and pressure tests are also required to ensure that the system operates normally. The test results should be recorded and archived for subsequent quality control and traceability.

Use and maintenance of clean rooms

1. Use specifications and training

The use of clean rooms needs to follow strict operating specifications to maintain their cleanliness and safety. All personnel entering the clean room must receive training to understand the operating procedures and precautions of the clean room. The training content includes how to wear clean clothes, how to operate equipment correctly, how to clean and disinfect, etc. In addition, a detailed operation manual is formulated and regular refresher training is conducted to ensure that all personnel always pay great attention to the clean room environment.

2. Regular maintenance and inspection

In order to maintain the performance of the clean room, regular maintenance and inspection are indispensable. The filters in the clean room need to be replaced according to the recommended cycle in the manual, usually every 6 months to 1 year, depending on the use environment and the degree of pollution. In addition, the airflow, temperature, humidity and cleanliness of the clean room are monitored regularly to ensure that they are always within the design standards. Maintenance records should be recorded in detail for subsequent analysis and improvement.

3. Emergency plan and handling

In the management of the clean room, a detailed emergency plan should be formulated to deal with emergencies, such as equipment failure, pollution accidents, etc. The emergency plan should include incident reporting procedures, emergency handling measures and personnel evacuation plans. Conduct emergency drills regularly to ensure that all personnel are familiar with emergency procedures and improve their ability to deal with emergencies. In addition, set up a special emergency team to monitor and handle emergencies in the clean room to ensure the continuity and safety of the production process.

Building an efficient clean room requires a deep understanding of its use, design, construction and subsequent maintenance management. Only by accurately calculating the area requirements, strictly following the relevant standards, selecting the right materials, and implementing effective management measures can we ensure that the clean room meets the industry requirements while guaranteeing the quality and safety of the products. With the development of science and technology, the design and management of clean rooms are also constantly improving, and in the future they will develop in a more intelligent and automated direction to better serve the needs of various industries.