Cleanroom Solutions

An ISO 1 cleanroom is designed to have a very low particle count, making it one of the highest cleanroom classifications. The maximum allowable particle counts for particles of various sizes are as follows :

Particles ≥ 0.1 μm: Not specified
Particles ≥ 0.2 μm: 10 particles per cubic meter
Particles ≥ 0.3 μm: 2 particles per cubic meter
Particles ≥ 0.5 μm: 0.5 particles per cubic meter
Particles ≥ 1.0 μm: 0.1 particles per cubic meter
Particles ≥ 5.0 μm: Not specified

Features and Characteristics of ISO 1 Cleanrooms :

Stringent Controls : ISO 1 cleanrooms have the highest level of particle control, with a focus on eliminating even the tiniest airborne particles.

Ultra-Clean Environment : These cleanrooms are used for applications that require an environment nearly free of particles, such as semiconductor manufacturing, advanced scientific research, and specialized pharmaceutical production.

Advanced Filtration : ISO 1 cleanrooms employ highly efficient filtration systems, including high-efficiency particulate air (HEPA) filters and even more advanced technologies, to capture and remove particles from the air.

Gowning and Entry Protocols : Strict gowning procedures and entry protocols are enforced to prevent the introduction of particles into the cleanroom.

Temperature and Humidity Control : Precise temperature and humidity control are maintained to ensure the stability of processes and prevent the formation of contaminants.

Airflow Management : Advanced airflow management systems are implemented to minimize particle circulation within the cleanroom.

Monitoring and Validation : Continuous monitoring and validation of particle counts and other critical parameters are carried out to ensure compliance with the ISO 1 standard.

Applications of ISO 1 Cleanrooms :

ISO 1 cleanrooms are used in highly sensitive industries where even a single particle could have a significant impact on processes, products, or research outcomes. Some common applications include :
Semiconductor manufacturing, where even minor contaminants can affect the performance of microchips.
Advanced scientific research, such as nanotechnology and quantum physics.
Specific pharmaceutical manufacturing processes that demand extreme cleanliness.

Creating and maintaining an ISO 1 cleanroom requires meticulous attention to detail, advanced technologies, and strict adherence to protocols. The goal is to provide an environment with the lowest possible particle levels to ensure the success and quality of the processes conducted within it.

An ISO 2 cleanroom is designed to have a low particle count, making it suitable for applications that require a high level of cleanliness. The maximum allowable particle counts for particles of various sizes in an ISO 2 cleanroom are as follows :

Particles ≥ 0.1 μm: Not specified
Particles ≥ 0.2 μm: 100 particles per cubic meter
Particles ≥ 0.3 μm: 24 particles per cubic meter
Particles ≥ 0.5 μm: 10 particles per cubic meter
Particles ≥ 1.0 μm: 4 particles per cubic meter
Particles ≥ 5.0 μm: Not specified

Features and Characteristics of ISO 2 Cleanrooms :

Particle Control : ISO 2 cleanrooms offer a controlled environment with a focus on reducing airborne particles to a low level.

Controlled Processes : These cleanrooms are used for applications that require a controlled environment, such as research and development, biotechnology, and specialized manufacturing.

Gowning and Entry Protocols : Strict gowning procedures and entry protocols are enforced to prevent the introduction of particles into the cleanroom.

Temperature and Humidity Control : Precise temperature and humidity control are maintained to ensure stable processes and prevent the formation of contaminants.

Airflow Management : Advanced airflow management systems are employed to minimize particle circulation within the cleanroom.

Filtration : ISO 2 cleanrooms typically utilize high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters to remove particles from the air.

Monitoring and Validation : Continuous monitoring and validation of particle counts and other critical parameters are carried out to ensure compliance with the ISO 2 standard.

Applications of ISO 2 Cleanrooms :

ISO 2 cleanrooms are used in industries and applications that require controlled environments to maintain product quality, research integrity, and process stability. Some common applications include :
Research and development in industries such as electronics, biotechnology, and pharmaceuticals.
Precision manufacturing of medical devices and components.
Advanced optics and laser technologies.
Microelectronics assembly and testing.

Creating and maintaining an ISO 2 cleanroom involves careful attention to cleanliness protocols, advanced technology, and consistent monitoring. While the particle count allowed is higher than in ISO 1 cleanrooms, ISO 2 cleanrooms still provide a controlled environment where processes can be conducted with a minimized risk of particle contamination.

An ISO 3 cleanroom is designed to have controlled particle levels, making it suitable for applications that require a moderate level of cleanliness. The maximum allowable particle counts for particles of various sizes in an ISO 3 cleanroom are as follows :

Particles ≥ 0.1 μm: Not specified
Particles ≥ 0.2 μm: 1000 particles per cubic meter
Particles ≥ 0.3 μm: 300 particles per cubic meter
Particles ≥ 0.5 μm: 100 particles per cubic meter
Particles ≥ 1.0 μm: 35 particles per cubic meter
Particles ≥ 5.0 μm: Not specified

Features and Characteristics of ISO 3 Cleanrooms :

Particle Control : ISO 3 cleanrooms provide a controlled environment with a focus on reducing airborne particles to moderate levels.

Controlled Processes : These cleanrooms are used for applications that require controlled environments, such as pharmaceutical manufacturing, electronics assembly, and research.

Gowning and Entry Protocols : Strict gowning procedures and entry protocols are enforced to minimize the introduction of particles into the cleanroom.

Temperature and Humidity Control : Precise temperature and humidity control are maintained to ensure stable processes and prevent the formation of contaminants.

Airflow Management : Advanced airflow management systems are employed to minimize particle circulation within the cleanroom.

Filtration : ISO 3 cleanrooms typically utilize high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters to remove particles from the air.

Monitoring and Validation : Continuous monitoring and validation of particle counts and other critical parameters are carried out to ensure compliance with the ISO 3 standard.

Applications of ISO 3 Cleanrooms :

ISO 3 cleanrooms are used in various industries and applications that require controlled environments to maintain product quality, research integrity, and process stability. Some common applications include :
Pharmaceuticals and biotechnology manufacturing, where a controlled environment is necessary to prevent contamination.
Microelectronics assembly and testing, including manufacturing of semiconductor components.
Aerospace industry, especially for precision manufacturing and assembly of components.
Optical lens and device manufacturing, where cleanliness is critical for performance

Creating and maintaining an ISO 3 cleanroom involves strict adherence to cleanliness protocols, advanced technology, and continuous monitoring. ISO 3 cleanrooms offer a balanced environment where processes can be conducted with a controlled level of particle contamination, suitable for industries that demand a moderate level of cleanliness.

An ISO 4 cleanroom is designed to have a relatively low level of airborne particles, making it suitable for applications that require a controlled environment. The maximum allowable particle counts for particles of various sizes in an ISO 4 cleanroom are as follows :

Particles ≥ 0.1 μm: Not specified
Particles ≥ 0.2 μm: 10000 particles per cubic meter
Particles ≥ 0.3 μm: 3520 particles per cubic meter
Particles ≥ 0.5 μm: 832 particles per cubic meter
Particles ≥ 1.0 μm: 29 particles per cubic meter
Particles ≥ 5.0 μm: Not specified

Features and Characteristics of ISO 4 Cleanrooms :

Particle Control : ISO 4 cleanrooms provide a controlled environment with a focus on maintaining a relatively low level of airborne particles.

Controlled Processes : These cleanrooms are used for applications that require controlled environments, such as pharmaceutical compounding, electronics assembly, and medical device manufacturing.

Gowning and Entry Protocols : Strict gowning procedures and entry protocols are enforced to minimize the introduction of particles into the cleanroom.

Temperature and Humidity Control : Precise temperature and humidity control are maintained to ensure stable processes and prevent the formation of contaminants.

Airflow Management : Advanced airflow management systems are employed to minimize particle circulation within the cleanroom.

Filtration : ISO 4 cleanrooms typically utilize high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters to remove particles from the air.

Monitoring and Validation : Continuous monitoring and validation of particle counts and other critical parameters are carried out to ensure compliance with the ISO 4 standard.

Applications of ISO 4 Cleanrooms :

ISO 4 cleanrooms are used in industries and applications that require controlled environments to maintain product quality, research integrity, and process stability. Some common applications include :
Pharmaceuticals and biotechnology manufacturing, especially for compounding medications and sterile production.
Electronics assembly, testing, and manufacturing of semiconductors
Medical device manufacturing, where cleanliness is crucial for safety and performance.
Some research and development activities that require controlled environments.

Creating and maintaining an ISO 4 cleanroom involves following cleanliness protocols, utilizing advanced technology, and ensuring continuous monitoring. ISO 4 cleanrooms offer a controlled environment where processes can be conducted with a controlled level of particle contamination, suitable for industries that demand a controlled level of cleanliness without the need for ultra-low particle counts.

An ISO 5 cleanroom is designed to have a controlled level of airborne particles, making it suitable for applications that require a clean environment with strict particle control. The maximum allowable particle counts for particles of various sizes in an ISO 5 cleanroom are as follows :

Particles ≥ 0.1 μm: 3520 particles per cubic meter
Particles ≥ 0.2 μm: 832 particles per cubic meter
Particles ≥ 0.3 μm: 294 particles per cubic meter
Particles ≥ 0.5 μm: 83 particles per cubic meter
Particles ≥ 1.0 μm: 29 particles per cubic meter
Particles ≥ 5.0 μm: Not specified

Features and Characteristics of ISO 5 Cleanrooms :

Particle Control : ISO 5 cleanrooms provide a controlled environment with a focus on maintaining a low level of airborne particles.

Controlled Processes : These cleanrooms are used for applications that require stringent cleanliness, such as pharmaceutical compounding, electronics assembly, and research involving sensitive instruments.

Gowning and Entry Protocols : Strict gowning procedures and entry protocols are enforced to minimize the introduction of particles into the cleanroom.

Temperature and Humidity Control : Strict gowning procedures and entry protocols are enforced to minimize the introduction of particles into the cleanroom.

Airflow Management : Advanced airflow management systems are employed to minimize particle circulation within the cleanroom.

Filtration : ISO 5 cleanrooms utilize high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters to remove particles from the air.

Monitoring and Validation : Continuous monitoring and validation of particle counts and other critical parameters are carried out to ensure compliance with the ISO 5 standard.

Applications of ISO 5 Cleanrooms :

ISO 5 cleanrooms are used in industries and applications that require a controlled and clean environment to prevent particle contamination. Some common applications include :
Pharmaceutical manufacturing of sterile products, including aseptic filling and compounding.
Electronics assembly, testing, and manufacturing of semiconductors.
Biotechnology research and development involving sensitive experiments or instruments.
Some medical device manufacturing processes.

Creating and maintaining an ISO 5 cleanroom involves strict adherence to cleanliness protocols, advanced technology, and continuous monitoring. ISO 5 cleanrooms offer a controlled environment where processes can be conducted with a controlled level of particle contamination, suitable for industries that demand strict particle control and cleanliness standards.

An ISO 6 cleanroom is designed to have a controlled level of airborne particles, making it suitable for applications that require a relatively clean environment. The maximum allowable particle counts for particles of various sizes in an ISO 6 cleanroom are as follows :

Particles ≥ 0.1 μm: 35200 particles per cubic meter
Particles ≥ 0.2 μm: 8320 particles per cubic meter
Particles ≥ 0.3 μm: 2930 particles per cubic meter
Particles ≥ 0.5 μm: 832 particles per cubic meter
Particles ≥ 1.0 μm: 293 particles per cubic meter
Particles ≥ 5.0 μm: Not specified

Features and Characteristics of ISO 6 Cleanrooms :

Particle Control : ISO 6 cleanrooms provide a controlled environment with a focus on maintaining a controlled level of airborne particles.

Controlled Processes : These cleanrooms are used for applications that require a clean environment with moderate particle control, such as light manufacturing, research, and development.

Gowning and Entry Protocols : Gowning procedures and entry protocols are enforced to minimize the introduction of particles into the cleanroom.

Temperature and Humidity Control : Precise temperature and humidity control are maintained to ensure stable processes and prevent the formation of contaminants.

Airflow Management : Airflow management systems are employed to minimize particle circulation within the cleanroom.

Filtration : ISO 6 cleanrooms utilize high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters to remove particles from the air.

Monitoring and Validation : Monitoring and validation of particle counts and other critical parameters are carried out to ensure compliance with the ISO 6 standard.

Applications of ISO 6 Cleanrooms :

ISO 6 cleanrooms are used in industries and applications that require a controlled environment with moderate particle control. Some common applications include :
Light manufacturing processes that require a relatively clean environment.
Research and development involving sensitive experiments or instruments
Certain quality control and testing activities.
Some medical device assembly and packaging.

Creating and maintaining an ISO 6 cleanroom involves adhering to cleanliness protocols, utilizing appropriate technology, and ensuring continuous monitoring. ISO 6 cleanrooms provide a controlled environment where processes can be conducted with a controlled level of particle contamination, suitable for industries that demand a moderate level of cleanliness and particle control.

An ISO 7 cleanroom is designed to have a controlled level of airborne particles, making it suitable for applications that require a controlled environment with moderate particle control. The maximum allowable particle counts for particles of various sizes in an ISO 7 cleanroom are as follows :

Particles ≥ 0.1 μm: 352000 particles per cubic meter
Particles ≥ 0.2 μm: 83200 particles per cubic meter
Particles ≥ 0.3 μm: 29300 particles per cubic meter
Particles ≥ 0.5 μm: 8320 particles per cubic meter
Particles ≥ 1.0 μm: 2930 particles per cubic meter
Particles ≥ 5.0 μm: Not specified

Features and Characteristics of ISO 7 Cleanrooms :

Particle Control : ISO 7 cleanrooms provide a controlled environment with a focus on maintaining a controlled level of airborne particles.

Controlled Processes : These cleanrooms are used for applications that require a controlled environment with moderate particle control, such as pharmaceutical packaging, assembly, and testing.

Gowning and Entry Protocols : Gowning procedures and entry protocols are enforced to minimize the introduction of particles into the cleanroom.

Temperature and Humidity Control : Precise temperature and humidity control are maintained to ensure stable processes and prevent the formation of contaminants.

Airflow Management : Airflow management systems are employed to minimize particle circulation within the cleanroom.

Filtration : ISO 7 cleanrooms utilize high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters to remove particles from the air.

Monitoring and Validation : Monitoring and validation of particle counts and other critical parameters are carried out to ensure compliance with the ISO 7 standard.

Applications of ISO 7 Cleanrooms :

ISO 7 cleanrooms are used in industries and applications that require a controlled environment with moderate particle control. Some common applications include :
Pharmaceutical packaging and labeling.
Assembly, testing, and inspection of components and products.
Quality control and testing activities that require a controlled environment.
Certain research and development activities.

Creating and maintaining an ISO 7 cleanroom involves adhering to cleanliness protocols, utilizing appropriate technology, and ensuring continuous monitoring. ISO 7 cleanrooms provide a controlled environment where processes can be conducted with a controlled level of particle contamination, suitable for industries that demand a controlled level of cleanliness and particle control without the need for ultra-low particle counts.

An ISO 8 cleanroom is designed to have a controlled level of airborne particles, making it suitable for applications that require a controlled environment with moderate particle control. The maximum allowable particle counts for particles of various sizes in an ISO 8 cleanroom are as follows:

Particles ≥ 0.1 μm: 3520000 particles per cubic meter
Particles ≥ 0.2 μm: 832000 particles per cubic meter
Particles ≥ 0.3 μm: 293000 particles per cubic meter
Particles ≥ 0.5 μm: 83200 particles per cubic meter
Particles ≥ 1.0 μm: 29300 particles per cubic meter
Particles ≥ 5.0 μm: Not specified

Features and Characteristics of ISO 8 Cleanrooms :

Particle Control : ISO 8 cleanrooms provide a controlled environment with a focus on maintaining a controlled level of airborne particles.

Controlled Processes : These cleanrooms are used for applications that require a controlled environment with moderate particle control, such as manufacturing, testing, and certain research activities.

Gowning and Entry Protocols : Gowning procedures and entry protocols are typically followed to minimize the introduction of particles into the cleanroom.

Temperature and Humidity Control : Precise temperature and humidity control are maintained to ensure stable processes and prevent the formation of contaminants.

Airflow Management : Airflow management systems are employed to minimize particle circulation within the cleanroom.

Filtration : ISO 8 cleanrooms utilize high-efficiency particulate air (HEPA) or other suitable filters to remove particles from the air.

Monitoring and Validation : Monitoring and validation of particle counts and other critical parameters are carried out to ensure compliance with the ISO 8 standard.

Applications of ISO 8 Cleanrooms :

ISO 8 cleanrooms are used in industries and applications that require a controlled environment with moderate particle control. Some common applications include :
Manufacturing processes that require a controlled environment with moderate cleanliness.
Testing and quality control activities for products and components.
Certain research activities where a controlled environment is necessary.

Creating and maintaining an ISO 8 cleanroom involves adhering to cleanliness protocols, utilizing appropriate technology, and ensuring continuous monitoring. ISO 8 cleanrooms provide a controlled environment where processes can be conducted with a controlled level of particle contamination, suitable for industries that demand a controlled level of cleanliness and particle control.