Class 10000 Clean room_第2页

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.

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Class 10000 Cleanroom Air Changes Per Hour

Class 10000 clean room

Class 10000 Cleanroom (ISO Class 7 Cleanroom)

ISO 5 zone | 240–360 air changes per hour
ISO 6 zone | 90–180 air changes per hour
ISO 7 zone | 30–60 air changes per hour
ISO 8 zone | 15–25 air changes per hour (ante-room)

Clean room grade table

ISO Class FED STD 209E Equivalent
ISO Class	Maximum Particles/m						FED STD 209E equivalent
ISO Class	≥0.1μm	≥0.2um	≥0.3um	≥0.5um	≥11m	≥5um	FED STD 209E equivalent
ISO1	10	2
ISO2	100	24	10	4
ISO3	1,000	237	102	35	8		Class1
ISO4	10,000	2,370	1,020	352	83	3	Class10
ISO5	100,000	23,700	10,200	3,520	832	29	Class100
ISO6	1,000,000	237,000	102,000	35,200	8,320	293	Class 1,000
ISO7				352,000	83,200	2,930	Class10,000
ISO8				3,520,000	832,000	29,300	Class 100,000
ISO9				35,200,000	8,320,000	293,000	Room Air

Comparison table of ISO grade standards and ventilation times
ISO Class	ACH(AIRCHANGE PER HOUR)
ISO 3	360-540
ISO 4	300-540
ISO 5	240-480
ISO 6	50-60
ISO 7	30-40
ISO 8	15-25

Comparison Table GMP/USP/ISO/FED209E

project

China GMP/Europe GMP

ISO

FED STD
209E

Suspended
particles
P/m3

level

Static

dynamic

level

Static

level

dynamic

≥0.5um

≥5μm

≥0.5μm

≥5μm

≥0.5um

≥5μm

≥0.5um

≥5μm

3520

M3.5

3530

100

2220

100

3520

352000

2900

3520

1000

352000

2900

3520000

29000

M5.5

353000

10000

352000

2930

10000

3520000

29300

100000

3520000

29000

No regulations

M6.5

3530000

100000

3520000

29300

100000

Class 10000 Clean Room Airflow

Cleanroom-Systems-air-flow-gif-copyright-2021-resized-1.gif

Air supply from air conditioner:
The air treated by the air conditioner is sent to the return air layer
Air filtration:
The air is deeply filtered through HEPA or ULPA filters to ensure that the cleanliness meets the required ISO level.
Air distribution:
Laminar flow (such as unidirectional flow) or mixed flow is usually used to maintain the uniformity and fluidity of indoor air.
Air return:
The clean room air passes through the return air layer, and 15% of the return air returns to the air conditioner for further treatment

FFU fan:
External air is driven by the FFU fan to be sent in
Air filtration:
The air is deeply filtered through HEPA or ULPA filters to ensure that the cleanliness meets the required ISO level.
Air distribution:
Laminar flow (such as unidirectional flow) or mixed flow is usually used to maintain the uniformity and fluidity of indoor air.
Air exhaust:
Clean room air is discharged through a pressure relief valve or a floor elevated layer

Class 10000 Clean Room wall

Class 10000 clean room

Size and appearance:
Ensure that the size and shape of the product meet the design requirements and have no obvious defects.
Physical properties:
Such as compression, tension, impact resistance and other tests to ensure the strength and durability of the material.
Surface treatment:
Confirm that the surface is smooth, the coating is uniform, and there are no bubbles, peeling, etc.
Test report:
Fire and corrosion resistance test

Class 10000 clean romm door.jpg

Steel standard:
Select high-quality steel that meets national and international standards to ensure its corrosion resistance and strength.
Surface treatment:
The surface of the door body should be treated with anti-rust treatment (such as spraying, anodizing, etc.) to ensure durability and easy cleaning.
Insulation material:
The door core material should have good heat insulation and sound insulation properties, and insulating materials such as polyurethane or rock wool are usually used.
Production process:
Production is carried out strictly in accordance with standardized processes, including cutting, forming, welding and painting

Class 10000 clean romm windows.jpeg

Steel standard:
Select high-quality steel that meets national and international standards to ensure its corrosion resistance and strength.
Surface treatment:
The surface of the door body should be treated with anti-rust treatment (such as spraying, anodizing, etc.) to ensure durability and easy cleaning.
Insulation material:
The door core material should have good heat insulation and sound insulation properties, usually using insulating materials such as polyurethane or rock wool.
Production process:
Strictly follow the standardized process for production, including cutting, forming, welding and painting, to ensure stable quality in each link.

Class 10000 Clean Room Celling


Specifications: Thickness: 980, 1180 Panel material: 50mm, 75mm, 100mm Core material: color-coated steel plate, stainless steel plate, rock wool, gypsum, glass magnesium, aluminum honeycomb, etc. Accessories: Keel: 0.8 galvanized plate Application scope: food, medicine Others: Coating: PE (polyester), PVDF (fluorocarbon), HDP (high weather-resistant polyester)		0.8 thick galvanized steel keels are used on all four sides to increase the strength and sealing of the board The patented heavy-duty hanging beam system of MasterCard is adopted, which is convenient for installation and improves construction efficiency. No need to remove the entire top plate, reducing replacement costs and high cost performance. This product is also suitable for partial top plate replacement

Class 10000 Clean Room Floor


Flexibility: PVC flooring adhesive has good flexibility and impact resistance Anti-slip: There is an anti-slip surface treatment to ensure the safety of personnel while working. Easy to install: Usually provided in roll or tile form, installation is simple and quick. Diversity: A variety of colors and textures are available for easy visual zoning and aesthetics.

Seamless: Avoids accumulation of dust and bacteria at seams Chemical resistance: Able to withstand a wide range of chemicals and cleaning agents Easy to clean: Smooth surface makes cleaning and maintenance relatively easy.

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Enterprise qualification certificate

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Class 10000 Clean room Video Introduction

FAQ

Q:What does class 10,000 clean room mean?
A:A Class 10,000 cleanroom, also known as an ISO Class 7 cleanroom, is an environment where the concentration of airborne particles is controlled to specific limits. It allows no more than 10,000 particles of 0.5 microns or larger per cubic foot of air.
Q:What are the requirements for a 10k clean room?
A:Requirements include HEPA filtration to remove 99.97% of particles ≥0.3 microns, maintaining around 60-90 air changes per hour, smooth and non-shedding surfaces, airlocks and gowning areas for personnel, and rigorous cleaning and gowning protocols.
Q:What is a 100000 class clean area?
A:A Class 100,000 clean area, or ISO Class 8, 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. It is used in less critical production areas.
Q:What is a Class 1000 cleanroom?
A:A Class 1000 cleanroom (ISO Class 6) maintains a maximum of 1,000 particles of 0.5 microns or larger per cubic foot of air. It requires advanced filtration, laminar airflow, and strict operational protocols to ensure cleanliness.
Q:What is a class 10000 clean room?
A:A Class 10,000 cleanroom (ISO Class 7) is a controlled environment that limits airborne particles to 10,000 particles of 0.5 microns or larger per cubic foot of air. It is used in industries where controlled contamination levels are critical.
Q:What is a class 10000 clean room?
A:A Class 10,000 cleanroom (ISO Class 7) is designed to maintain low levels of airborne particles, specifically allowing no more than 10,000 particles of 0.5 microns or larger per cubic foot of air, to protect sensitive processes and products.
Q:How to build class 10000 clean room?
A:To build a Class 10,000 cleanroom, incorporate HEPA filtration systems, ensure proper airflow design, use non-shedding materials, install airlocks and gowning areas, and implement strict construction and operational protocols to control contamination.
Q:How to clean a class 10000 clean room?
A:Cleaning a Class 10,000 cleanroom involves using specialized, lint-free cleaning tools and solutions, following a top-to-bottom cleaning process, regularly disinfecting surfaces, and adhering to strict cleaning schedules to maintain particle levels within required limits.
Q:What is the difference between a 10k and a 1k clean room?
A:The primary difference is the allowable particle concentration. A Class 10,000 cleanroom allows up to 10,000 particles of 0.5 microns per cubic foot, while a Class 1,000 cleanroom allows only 1,000 particles, necessitating stricter controls and more frequent air changes.
Q:What is 100000 level clean room?
A:A Class 100,000 cleanroom (ISO Class 8) allows up to 100,000 particles of 0.5 microns or larger per cubic foot of air. It is suitable for less stringent manufacturing processes where some level of contamination is acceptable.
Q:What are the key points of 10000 class clean room design?
Key points include efficient HEPA filtration, maintaining 60-90 air changes per hour, using smooth, non-shedding materials, proper sealing and airlock systems, ergonomic design for ease of cleaning, and strict contamination control protocols.
Q:What are the installation standards of 10000 class clean room?
A:Installation standards involve ensuring proper HEPA filter integrity and placement, achieving specified airflow patterns, sealing all joints and entrances properly, installing appropriate lighting and environmental controls, and verifying the room meets ISO Class 7 particle limits.
Q:How to do 10000 class clean room certification?
A:Certification involves particle count testing with a calibrated particle counter, verifying airflow rates and patterns, ensuring filter integrity, conducting surface cleanliness tests, and maintaining detailed documentation to demonstrate compliance with ISO Class 7 standards.
Q:What are the equipment of 10000 class clean room?
A:Essential equipment includes HEPA filtration systems, air handling units, laminar flow benches, cleanroom-compatible furniture and fixtures, particle counters, and specialized cleaning tools and materials. Monitoring and alarm systems for environmental conditions are also crucial.
Q:How much does 10000 class clean room cost?
A:The cost of a Class 10,000 cleanroom can vary widely based on size, complexity, and specific requirements, typically ranging from $100 to $200 per square foot. Total costs can range from tens of thousands to several million dollars, depending on the project scope.