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Class 100,000 Cleanroom - ISO8 Cleanroom Guidance

Related Information

1.Introduction of ISO8 ( class 100,000) Cleanroom
  A cleanroom is a room where the concentration of suspended particles in the air is controlled. 100,000-class is the classification name for evaluating the concentration level of suspended particles in the air in a cleanroom. It means that the number of particles with a particle size of ≥ 0.5μm per cubic feet of air in the cleanroom does not exceed 100,000, which meets the requirements of 100,000-class cleanrooms in terms of particles. 100,000-class cleanrooms correspond to Class 8 rooms defined in ISO14644-1 (see the table below).
ISO14644-1 Standards for suspended particles in clean areas:

ISO  Class

Greater than or equal to the maximum concentration limit of the particle size in the table

(pc/m3 air concentration limit is calculated according to the formula in 3.2)

 

0.1μm

0.2μm

0.3μm

0.5μm

1μm

5μm

ISO Class 1

10

2

 

 

 

 

ISO Class 2

100

24

10

4

 

 

ISO Class 3

1,000

237

102

35

8

 

ISO Class 4

10,000

2,370

1,020

352

83

 

ISO Class 5

100,000

23,700

10,200

3,520

832

29

ISO Class 6

1,000,000

237,000

102,000

35,200

8,320

293

ISO Class 7

 

 

 

352,000

83,200

2,930

ISO Class 8

 

 

 

3,520,000

832,000

29,300

ISO Class 9

 

 

 

35,200,000

8,320,000

293,000

Note: Due to the uncertainty involved in the measurement process, three valid data are required to determine the concentration level

  There are no limitations requirements on particles smaller than 0.5μm for ISO 8 cleanroom as such particle size has minimum impact on the production process of ISO 8 cleanroom.

 

2.Requirement of Class 100,000 (ISO8) Cleanroom:
  In addition to the indoor airborne particle concentration meeting the ISO14644-1 cleanliness standard, the environmental factors affecting production such as indoor temperature and humidity, pressure, air flow velocity, noise, illumination and static electricity in the 100,000-class cleanroom must be controlled within a certain design requirement range to ensure that product quality and safe production are not affected. In addition, the construction materials (partition walls, ceilings, floors) of the 100,000-class cleanroom should be smooth, dust-free, easy to clean, corrosion-resistant, mildew-proof, and antibacterial. The entrances and exits of the cleanroom doors and windows need to have good sealing performance, and the HVAC purification and air supply system needs to be equipped with a primary, medium and high-efficiency three-stage air filtration system.

 

3.Layout and Functional Division of Class 100,000(ISO8) Cleanroom: 
  The layout and functional division of cleanrooms directly affect production efficiency and quality. When designing the layout, it is necessary to fully consider the layout of production equipment, the design of the flow of people and goods, and the relationship between each production area and auxiliary rooms. First of all, the functional area division of the main production area (clean area), auxiliary room area (changing room, hand washing and disinfection area, material unpacking area, material room, sanitary ware storage area, etc.), and management area (office area, central control room, etc.) should be handled properly. The flow routes of raw materials, semi-finished products, finished products and waste should be reasonably planned between each area to ensure smooth logistics and no conflict with the flow of personnel. One-way flow or circular flow design is adopted to reduce the risk of cross contamination. Secondly, the main production area (clean area) can be further subdivided into front-end processing area, assembly area, testing area, etc. according to the production process. The areas are connected by airlocks or buffer rooms to reduce cross contamination. The equipment in the production area is arranged in the order of the process flow, considering the operating distance, maintenance space and safe passage between equipment. For large size equipment, sufficient hoisting and maintenance space must be reserved. In addition, it is also necessary to consider reserving the AC room and power equipment rooms required for clean production. In short, reasonable HVAC layout and area division can greatly improve the utilization rate of workshop space, improve production efficiency and quality.

 

4.Requirements for temperature, humidity, and pressure difference of Class 100,000(ISO8) Cleanroom:
  The temperature and humidity of Class 100,000 cleanrooms should first meet the requirements of the production process in the workshop. If there are no special requirements for the production process, the temperature of the Class 100,000 cleanroom can be designed according to 20~22℃ in winter and 24~26℃ in summer, and the relative humidity can be designed according to 30~50% in winter and 50~70% in summer. Regarding the pressure difference requirements, the pressure difference between the Class 100,000 cleanroom and the outdoors should be greater than or equal to 10Pa, and the pressure difference between cleanrooms (areas) of different cleanliness levels should also be greater than or equal to 10Pa.

 

5.Application of Class 100,000(ISO8) Cleanroom:
  Class 100,000 cleanrooms are widely used in electronics, pharmaceuticals, biomedicine, food and cosmetics, laboratories and other industries, such as assembly and SMT workshops in the electronics industry, printing and 3D printing processes, final cleaning, assembly or packaging of sterile pharmaceutical packaging materials and containers, medical equipment production, mask production and packaging, food processing workshops, cosmetics production and packaging workshops, textile production workshops, and auxiliary rooms of higher-level cleanrooms in the electronics or pharmaceutical medical industries (changing areas, clean corridors, material storage areas, etc.).

Class 100,000 modular cleanroom

 

6.Daily management and maintenance of Class 100,000(ISO8) Cleanroom:
  The daily management of Class 100,000 cleanrooms mainly involves personnel management and equipment management. A sound personnel and equipment management system should be established.
People are the core of maintenance management. First of all, people should be educated and trained.
(1) The number of people entering the clean production area should be strictly controlled. Unrelated personnel are not allowed to enter the clean production area.
(2) All people entering the clean production area should be trained regularly. The training content includes basic knowledge of cleanliness, hygiene and microorganisms.
(3) When the risk of microbial contamination increases due to the health of the people, appropriate measures should be taken.
(4) People entering the clean production area should change clothes, wash hands and disinfect according to the operating procedures. The quality, style and wearing method of work clothes should be consistent with the requirements of production operations and the cleanliness level of the operation area.
In addition, the quality of cleanroom production equipment management can also directly affect the cleanliness. Production equipment should be regularly cleaned, disinfected and sterilized according to the management system.

The maintenance of Class 100,000 cleanrooms mainly includes several parts: 
1.Regular inspection and replacement of filters: The filter cleaning and replacement cycle varies depending on the use environment. It is generally recommended to clean the primary filter once a month, replace the medium filter every three months, and replace the high-efficiency filter once a year (it can also be replaced by testing the filter resistance when the high-efficiency filter resistance reaches twice the initial resistance); 
2.Maintenance of HVAC equipment: Regularly check and maintain the performance of the fan, heat exchanger (cooler or heater), humidifier, and motor of the HVAC equipment to ensure that they operate normally. The equipment should be inspected at least twice a year; 
3. Calibration of monitoring equipment: Monitoring equipment such as temperature and humidity sensors and pressure sensors should be calibrated regularly, and the calibration results should be recorded. In addition, daily cleaning and maintenance (partition wall/ceiling/floor sanitation cleaning, regular disinfection and sterilization, etc.) and supervision and inspection of the cleanroom should be realized in time.

 

7.Design of airflow organization, air change rate, air supply volume, etc. of Class 100,000(ISO8) Cleanroom:
  The airflow organization of cleanrooms can be divided into unidirectional flow (laminar flow), non-unidirectional flow (turbulent flow), mixed flow, vector flow (diagonal flow), etc. Class 100,000 cleanrooms usually adopt non-unidirectional flow (turbulent flow) airflow organization, with air supply at the top of the room and return air at the lower side. Under the premise of ensuring sufficient circulating air volume, the cleanliness requirements can be met while taking into account affordability and energy conservation. If a product process or a specific area has higher requirements for cleanliness, laminar air supply can be used locally, that is, mixed airflow organization (turbulent flow in the workshop environment, laminar flow in local workstations). In this way, the requirements for cleanliness of product quality and process can be met, and the laminar flow of the entire workshop can be avoided to reduce costs.
The number of air changes is of great significance to maintaining the cleanliness and air quality of the cleanroom. The requirements for the number of air changes in the cleanroom specified in the ISO14644-1 standard are as follows:

 

ISO Class

Airflow Type

Average air velocity

m/s

Air changes/H

m3/m2xh

 

Application

2

U

0.3-0.5

NA

Photolithography, semiconductor processing area

3

U

0.3-0.5

NA

Working area, semiconductor processing area

4

5

U

U

0.3-0.5

0.2-0.5

NA

NA

Working area, multi-layer mask processing, compact disk manufacturing, semiconductor service area, utility area

6

M

0.1-0.3

 

Public utility area, multi-layer processing area, semiconductor service area

 

N or M

NA

70-160

semiconductor service

Area

7

N or M

NA

30-70

Service area, surface treatment

8

N or M

NA

10-20

Service area

Note: NA= Not applicable

  As can be seen from the table above, the air change rate of a Class 100,000 (ISO 8) cleanroom should not be less than 10-20 times/hour. Within this ventilation frequency range, when the air quality or particulate matter in the cleanroom has a low impact on product quality and safety, the lower limit can be taken to meet the cleanliness while taking into account cost and energy saving; when particulate matter, dust, bacteria, etc. in the cleanroom air have a greater impact on product quality and safety or personnel health, work efficiency, or requirements for product stability are higher, the upper limit of the specification requirement range should be taken or the air change rate should be appropriately increased to give priority to meeting the requirements of process production and safety.
 

  The air supply volume of a Class 100,000 cleanroom should be reasonably designed based on the room volume and air change rate requirements (not less than 10-20 times/hour) and combined with the characteristics of the production process to meet production needs.

 

8.Testing and certification of Class 100,000(ISO8) Cleanroom:
  The testing of cleanrooms includes multiple items to ensure the cleanliness and safety of the indoor environment and meet production needs. The test items mainly include: suspended particle detection (to ensure the cleanliness of indoor air), temperature and humidity detection, wind speed and wind speed uniformity detection, filter leakage detection, illumination detection, noise detection, pressure difference detection, colony detection (floating bacteria, settling bacteria detection, to evaluate the microbial control level of the cleanroom), and water quality detection.

  The main certifications for cleanrooms include NEBB certification, ISO17025 management system certification, and GMP certification.
  NEBB's testing items include but not limited to wind speed and wind speed uniformity testing, filter leakage testing, cleanliness testing, temperature and humidity testing, illumination testing, noise testing, and pressure difference testing.
ISO17025 management system certification is a quality management system standard for testing and calibration laboratories to ensure that the laboratory's operations meet international standards and provide reliable and effective testing services.
  GMP certification includes a complete set of system documents for pharmaceutical production, DQ, IQ, OQ, and PQ verification to ensure the quality of pharmaceutical production.

  In order to pass these certifications, it is necessary to conduct tests according to the standards of these certification agencies (which requires that the design and construction meet the corresponding specifications), participate in training courses provided by the certification agencies, improve the quality of practitioners, and meet other certification conditions of the certification bodies.


9.How to achieve energy saving and efficient operation of Class 100,000(ISO8) Cleanroom:
  The main components of energy consumption in Class 100,000 cleanrooms are: HVAC system, lighting system, equipment and process parts. To achieve efficient and energy-saving operation of Class 100,000 cleanrooms, it is necessary to take efficient energy-saving measures as much as possible in various factors and components that affect energy consumption.

  The HVAC system is one of the main sources of energy consumption in cleanrooms. Maintaining the high air cleanliness of cleanrooms requires a lot of air filtration, circulation and temperature and humidity control, which consume a lot of energy.

To achieve energy-saving operation of HVAC system, measures can be taken from several aspects: 
1. Select energy-saving (high energy efficiency ratio) or energy recovery and cold storage HVAC equipment;
2. Fans used in HVAC or cleanrooms adopt energy-saving DC fan to improve air supply efficiency; 
3. Air supply, exhaust fan, water pump and other motors adopt frequency conversion technology, reasonably adjusting the air supply and cooling capacity of HVAC system according to workshop needs, and avoid unnecessary energy waste; 
4. Set appropriate temperature and humidity in the workshop to save electricity and energy as much as possible under the premise of meeting process production; 
5. The HVAC room and workshop FFU are made into group control system, and the operating load of each AC equipment, FFU and fan is intelligently adjusted according to the cleanliness and temperature and humidity requirements of each area and terminal of the workshop to achieve energy-saving and efficient operation; 
6. AC equipment should be regularly maintained, filters and other consumables should be cleaned and replaced in time, and operation management should be strengthened to ensure overall optimization and energy saving of the system and ensure that the system operates in the best state; through the above measures, the AC system is always guaranteed to operate efficiently and energy-saving.

  Energy saving of lighting system is mainly reflected in the use of energy-saving lamps such as LED, installation of automatic induction switches, and adjustment of the number and position of lighting equipment, which can improve lighting efficiency and reduce unnecessary energy waste.

  In terms of equipment and process, replacing high-efficiency equipment, regularly maintaining equipment, and optimizing equipment utilization can reduce equipment energy consumption. Increasing the degree of automation of equipment and reducing idling time can also improve operating efficiency.

  In addition, a 100,000-level cleanroom should establish an energy management system to monitor and analyze energy consumption, find energy-saving potential and optimization space, and achieve the goal of reducing energy consumption.

 


10.Modular Class 100,000 Cleanroom vs. Traditional Class 100,000 Cleanroom
There are significant differences between modular class 100,000 cleanrooms and traditional class 100,000 cleanrooms in many aspects. These differences are mainly reflected in design, flexibility, construction period, cost, and application scenarios.

表格

  To sum up, there are significant differences between modular cleanrooms and traditional cleanrooms in terms of design, flexibility, construction period, cost and application. When enterprises choose the type of cleanrooms, they should make comprehensive considerations based on their actual needs, budget, and scenario characteristics.

 


11.Construction Process and Project Management of Modular Class 100,000(ISO8) Cleanrooms
  The construction process of modular class 100,000 cleanrooms mainly includes the following steps:
Preliminary preparation and design calculation: Confirm the plane layout according to the customer's production process requirements; perform overall design calculations and equipment selection and design drawings according to parameters such as cleanliness, temperature and humidity, and pressure.
Factory production: According to the design drawings, various prefabricated components are produced and processed.

  Testing and transportation: After production is completed, the modular cleanroom is assembled and various parameters are tested in the factory. After the test is qualified, it is dismantled, packaged, and transported to the installation site.

  On-site assembly: The modular cleanroom is assembled on site.

  Commissioning and acceptance: After assembly, the modular cleanroom is debugged and tested to ensure that the ventilation system, filters, AC and other equipment are operating normally and meet the requirements, and then tested, accepted, and delivered for use.
The on-site installation time of modular class 100,000 cleanrooms varies slightly according to the size of the cleanroom area. Usually, it only takes 3 to 5 days to assemble a small modular cleanroom on site, and it takes about 7 to 10 days to assemble a larger modular cleanroom.
The main components of the modular class 100,000 cleanroom are prefabricated in the factory and assembled on site. There is no cutting or welding or other construction processes on site, which causes little pollution to the site. During on-site installation, the main safety tasks include product positioning, on-site finished product protection, power connection and debugging, etc.

 

12.Intelligent Solutions for Modular Class 100,000(ISO8) Cleanrooms
  The modular class 100,000 cleanrooms are equipped with intelligent central control panels according to functional requirements, which can centrally control the lighting system and FFU air supply system in the cleanroom, realize one-button on/off, centralized and zoned speed control, FFU fault alarm, high-efficiency filter blockage alarm and other functions. And the cleanliness online monitoring system can be configured as needed to monitor the cleanliness of designated workstations in real time.

  At the same time, the Internet of Things (IoT) technology is widely used in modular cleanrooms. The intelligent central control panel can communicate with the host computer of the production system to realize the monitoring and control of the modular cleanroom environment: the Internet of Things technology can monitor the temperature, humidity, air pressure, air cleanliness and other environmental parameters in the cleanroom in real time through sensors, and automatically adjust the AC system, air purification system and other equipment through data analysis and processing to ensure that the environment in the modular cleanroom is kept in the best state; through the Internet of Things technology, various equipment in the clean room can be remotely monitored and managed, and the modular cleanroom can be equipped with electric doors and logistics AGV carts (the AGV robot controls the opening and closing of the modular cleanroom electric doors) to realize intelligent automatic logistics solutions; the Internet of Things technology can also perform intelligent management and energy management on modular cleanrooms. The combination of big data and artificial intelligence technology can monitor and analyze the operating data of the cleanroom in real time, predict and discover potential problems in advance, and realize preventive maintenance and optimization management. Energy management can automatically adjust parameters such as air volume and wind speed according to actual needs to achieve the best energy efficiency ratio and reduce operating costs and environmental impact.
 

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