ISO Class 7 Clean Room

An ISO Class 7 cleanroom is a controlled environment defined by the ISO 14644-1 standard, which limits the concentration of airborne particles to ensure a clean and controlled atmosphere.

1.Particulate Limit:

The cleanroom must have no more than 352,000 particles per cubic meter (or 10,000 particles per cubic foot) for particles 0.5 microns or larger.

2.Air Changes per Hour (ACH):

ISO Class 7 cleanrooms typically require 30 to 60 air changes per hour (ACH). This helps to maintain the cleanliness of the room by continuously filtering and replacing the air to control particle contamination.

Your Reliable Manufacturer of ISO Class 7 Clean Room

Clean room grade table

Airborne Particulate Cleanliness Classes (by cubic meter)
CLASS	Number of Particles per Cubic Meter by Micrometer Size
	0.1 micron	0.2micron	0.3micron	0.5micron	1 micron	5 microns
IS01	10	2
ISO2	100	24	10	4
IS03	1,000	237	102	35	8
IS04	10,000	2,370	1,020	352	83
IS05	100,000	23,700	10,200	3,520	832	29
IS06	1,000,000	237,000	102,000	35,200	8,320	293
IS07				352,000	83,200	2,930
IS08				3,520,000	832,000	29,300
IS09				35,200,000	8,320,000	293,000

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

ISO Class 7 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

ISO Class 7 Clean Room wall

class 7 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

iso class 5 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

iso class 5 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.

ISO Class 7 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

ISO Class 7 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 Chemicalresistance: Able to withstand a wide range of chemicals and cleaning agents Easy to clean: Smooth surface makes cleaning and maintenance relatively easy.

Video
Workshop
Data sheet
Certificate

ISO 7 Cleanroom Applications:

Pharmaceutical manufacturing: Particularly for sterile products (e.g., injectable drugs).

Biotechnology and biomedical: For research or the production of biologics.

Semiconductor manufacturing: For assembling microelectronics or semiconductors, where even minute particles can lead to defects.

Aerospace and optics: For manufacturing sensitive components.

ISO 7 Cleanroom Air Changes Per Hour

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)

Enterprise qualification certificate

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Help to Find Your Cleanroom Related Products

ISO Class 7 Clean Room Video Introduction

FAQ

What is ISO class 7 cleanroom?

An ISO Class 7 cleanroom provides a highly controlled environment where particle contamination is tightly regulated. This type of cleanroom is essential in fields where even small amounts of airborne particles can affect product quality, such as in pharmaceutical production or electronics manufacturing. The cleanroom is maintained with high airflow, air filtration, and stringent environmental conditions to ensure products are made in a low-contamination atmosphere.

What is the pressure in ISO Class 7 cleanroom?

In an ISO Class 7 cleanroom, the pressure is typically maintained at positive pressure relative to the surrounding environment. This is done to prevent contamination from entering the cleanroom and to ensure that air flows out of the room when doors or entry points are opened, which helps to keep airborne particles outside.

What are the ISO guidelines for clean rooms?

The ISO guidelines for cleanrooms are primarily outlined in the ISO 14644 series, which establishes the standards for the design, operation, and maintenance of cleanrooms and controlled environments. These guidelines ensure that the cleanroom meets specific cleanliness requirements and provides a suitable environment for various sensitive industries like pharmaceuticals, electronics, biotechnology, and aerospace.

What are the temperature requirements for ISO 7 cleanroom?

For an ISO Class 7 cleanroom, the typical temperature range is between 18°C to 22°C (64°F to 72°F), with precise control to prevent issues such as static buildup, condensation, and personnel discomfort. Proper temperature and humidity control are essential for maintaining the cleanliness and ensuring the quality of products in the cleanroom.

What are the requirements for ISO Class 7 clean room?

An ISO Class 7 cleanroom is designed to maintain moderate levels of cleanliness, with a focus on controlling airborne particles, temperature, humidity, and pressure. It is typically used in industries that require stringent contamination control but do not need the ultra-clean conditions of lower-class cleanrooms (e.g., ISO Class 5 or Class 6). Proper filtration, airflow, environmental control, and personnel protocols are critical for maintaining the integrity of the cleanroom environment.

What is ISO 7 cleanroom equivalent?

The ISO 7 cleanroom is most commonly equivalent to Class 10,000 under the US Federal Standard 209E and Class D under GMP (Good Manufacturing Practice) guidelines. It is aISO similar to JIS B 9920 Class 7 in Japan. These equivalences are based on particle concentration limits, air cleanliness, and overall cleanliness standards used in various global systems. However, it's important to note that different standards may define additional operational criteria, so it's always important to consult the specific regulatory or industry guidelines for the cleanroom you're working with.

What are the ISO 7 and 8 gowning requirements?

Gowning in both ISO Class 7 and ISO Class 8 cleanrooms is essential for controlling contamination from personnel. While the requirements for ISO Class 7 are generally more stringent due to the need for a higher level of cleanliness, the fundamental gowning protocols—full-body coverage, gloves, face mask, and shoe covers—are required in both environments. The materials used for gowning may differ slightly, but the goal of preventing contamination from personnel remains the same.

How many air changes per hour in a clean room?

A cleanroom typically requires **30 to 60 air changes per hour (ACH)**, depending on the class and specific requirements.

What is the minimum air changes per hour for ISO 7?

The minimum air changes per hour (ACH) for an ISO 7 cleanroom typically ranges from 20 to 30 ACH. This ensures proper ventilation and particle dilution, helping to maintain the cleanliness level required for ISO Class 7, which allows up to 352,000 particles per cubic meter (≥ 0.5 microns). Higher air change rates may be used to improve air quality further, but the 20-30 ACH range is considered the minimum to maintain the desired particulate control and airflow efficiency.