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MENUClass 10000 Cleanroom
A Class 10000 cleanroom, also known as an ISO Class 7 cleanroom under the ISO 14644-1 standard, is a controlled environment designed to maintain low levels of airborne particles. Specifically, it allows no more than 10,000 particles per cubic foot of air for particles ≥0.5 microns, which translates to no more than 352,000 particles per cubic meter.
Particle Concentration Limits
Particles ≥ 0.5 microns: 10,000 particles per cubic foot (352,000 particles per cubic meter)
Particles ≥ 5.0 microns: 2,930 particles per cubic meter
Airflow and Filtration
HEPA Filters (High-Efficiency Particulate Air filters): These filters must remove at least 99.97% of airborne particles 0.3 microns in diameter.
Turbulent Flow: Often utilized to mix the air in the room, ensuring contaminants are diluted and removed by the filtration system.
Moderate Air Change Rates: Typically around 60-90 air changes per hour to maintain the required cleanliness.
Class 10000 Cleanroom Air Changes Per Hour
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Class 10000 Clean Room Airflow
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Class 10000 Clean Room wall
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Class 10000 Clean Room Celling
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FAQ
A class 10,000 clean room, or an ISO class 7 clean room, is an environment where the concentration of airborne particles is controlled to specific limits. This class of clean room allows no more than 10,000 particles of 0.5 microns or larger per cubic foot of air.
Some of the requirements for a 10k clean room include HEPA filtration to capture 99.97% of particles that are 0.3 microns or larger, approximately 60-90 air changes per hour, smooth and non-shedding surfaces, air locks and gowning areas for personnel, and strict regulatory procedures for cleaning and grooming.
A class 100,000 clean area, or an ISO class 8 clean area, is an environment where the concentration of airborne particles is limited to 100,000 particles of 0.5 microns or larger per cubic foot of air. This class of clean area is used for less critical production areas.
A class 1000 cleanroom, or an ISO class 6 cleanroom, is an environment that allows no more than 1000 particles of 0.5 microns or larger per cubic foot of air. This class of clean room requires advanced filtration and laminar air flow.
A class 10,000 clean room, or an ISO class 7 clean room, is a controlled environment that allows no more than 10,000 particles of 0.5 microns or larger per cubic foot of air. This class of clean room is used in controlled segments of industries where contamination is critical.
A class 10,000 clean room (ISO class 7) is a clean room designation that allows no more than 10,000 particles of 0.5 microns or larger in a cubic foot of air to be present to protect process and product from contamination.
Some methods for constructing a class 10,000 clean room include the use of HEPA filtration systems, design of airflow, use of non-shedding materials, and the use of construction and operational protocols to control contamination.
To clean a class 10,000 clean room, use special cleaning tools that shed no lint, follow a directive of top to bottom cleaning, and strictly adhere to a cleaning schedule to maintain the required levels of particles.
The main difference between the two is the allowed concentration of particles. A class 10,000 clean room allows 10,000 particles of 0.5 microns per cubic foot, whereas a class 1000 clean room allows only 1000 particles, requiring a more controlled environment and a greater number of air changes.
A class 100,000 clean room (ISO class 8) allows 100,000 particles of 0.5 microns or larger in a cubic foot of air. This class of clean room designation can protect less stringent manufacturing processes from a greater level of contamination.
A major feature of a 10,000 class design is a HEPA filtration system with an efficient design to achieve 60-90 air changes per hour. Smooth, non-shedding materials, proper sealing and airlock systems, an ergonomic design that aids in the ease of cleaning, and strict contamination control are also major features.
Installation requires achieving the integrity of HEPA filters and the correct placement, achieving the correct airflow patterns, sealing all joints and entrances, installing the correct lighting and environmental controls, and verifying that the room is isolated to ISO Class 7.
Certification requires particle count testing using a calibrated particle counter, verification of airflow and pattern filters, and integrity tests, surface cleanliness tests, and meticulous documentation to demonstrate compliance with ISO Class 7.
Essential equipment includes HEPA filtration systems, air handling units, laminar flow benches, cleanroom-compatible furniture and fixtures, particle counters, and specialized cleaning equipment and consumables. Monitoring and alarm systems for environmental conditions are also essential.
The cost for a Class 10,000 cleanroom can range from $100 to $200 per square foot, with larger and more complex projects ranging from tens of thousands to several million dollars.
