Clean Room Classifications_第3页

The ISO cleanroom classification standard is specified by ISO 14644-1, which aims to classify cleanrooms of different levels according to the concentration of particulate matter in the air.

According to the air cleanliness standard in the cleanroom, cleanrooms are divided into multiple levels, from ISO Class 1 to ISO Class 9. The lower the level number, the lower the concentration of particulate matter allowed in the air and the higher the cleanliness requirement.

ISO 14644 is a series of international standards developed by the International Organization for Standardization (ISO) that outlines the requirements for cleanrooms and controlled environments. The purpose of these standards is to ensure that the cleanliness of air in these environments is controlled to minimize contamination, thus protecting product quality and safety in various industries.

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ISO 14644-1 Clean Room Standards

Airborne Particulate Cleanliness Classes
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

AirborneParticulate Cleanliness Class Comparison
ISO14644-1	FEDERALSTANDARD209E
ISO Class	English	Metric
ISO 1
ISO 2
ISO 3	1	M1.5
ISO 4	10	M2.5
ISO 5	100	M3.5
IS0 6	1,000	M4.5
ISO 7	10,000	M5.5
ISO 8	100,000	M6.5
ISO 9

Energy Efficient Low Operating Cost Cleanroom Airflow Design
FS Cleanroom Class	ISO Equivalent Class	Air Change Rate
1	ISO3	370-530
10	ISO 4	300-530
100	ISO 5	230-480
1,000	IS0 6	150-230
10,000	IS0 7	70-90
100,000	ISO 8	5-48

Federal and lSO Airflow Velocity Standards
Class ISO 146144-1 (FSD 209E)	Average Airflow Velocity m/s(ft/min)	Air Changes Per Hour	Ceiling Coverage
ISO8(Class 100,000)	0.005-0.041(1-8)	5-48	5-15%
ISO 7(Class 10,000)	0.051-0.076(10-15)	70-90	15-20%
ISO 6(Class 1,000)	0.127-0.203(25-30)	150-230	25-30%
ISO 5(Class 100)	0.203-0.306(30-80)	230-480	35-70%
ISO 4(Class 10)	0.254-0.457(50-90)	300-530	50-90%
ISO 3(Class 1)	0.305-0.457(70-90)	370-530	70-100%
ISO 2	0.305-0.508(70-100)	370-700	80-100%

CleanRoom ISO Classifications

1. ISO Class 1 Clean rooms

ISO Class 1 is the most stringent cleanroom requirement. According to ISO 14644-1, ISO Class 1 cleanrooms allow a maximum of 10 particles per cubic meter of air (particle size 0.1 micron). This level of cleanroom is often used in industries with extremely high air cleanliness requirements, such as semiconductor manufacturing and nanotechnology.

2. ISO Class 2 Clean rooms

ISO Class 2 cleanrooms allow a maximum of 100 particles per cubic meter of air (particle size 0.1 micron). This level of cleanroom is suitable for applications with high cleanliness requirements, such as high-precision electronic equipment production and aerospace technology.

3. ISO Class 3 Clean rooms

ISO Class 3 cleanrooms have a maximum particle concentration of 1,000 particles per cubic meter (particle size 0.1 micron). This cleanroom is widely used in fields such as biotechnology and the pharmaceutical industry to ensure that product quality is not affected by air pollution during the production process.

4. ISO Class 4 Clean rooms

ISO Class 4 cleanrooms allow up to 10,000 particles per cubic meter of air (particle size 0.1 micron). This cleanliness requirement is suitable for industries with high cleanliness requirements, such as precision optics and medical equipment production.

5. ISO Class 5 Clean rooms

ISO Class 5 cleanroom standards allow up to 100,000 particles per cubic meter of air (particle size 0.1 micron). It is suitable for fields such as pharmaceutical production and electronic component assembly, especially those production environments that require strict control of particle contamination.

6. ISO Class 6 Clean rooms

ISO Class 6 cleanrooms allow up to 1,000,000 particles per cubic meter of air (particle size 0.1 micron). This level of cleanroom is suitable for industries such as food processing and certain laboratories.

7. ISO Class 7 Clean rooms

ISO Class 7 cleanrooms have a maximum particle concentration of 10,000,000 particles per cubic meter (particle size 0.1 micron). Commonly used in the automotive industry, cosmetics production and other occasions, it meets higher cleanliness requirements, but is not as strict as ISO Class 5 and ISO Class 6.

8. ISO Class 8 Clean rooms

ISO Class 8 cleanrooms allow up to 100,000,000 particles per cubic meter of air (particle size is 0.1 micron). This level of cleanroom is usually used in ordinary industrial environments, where the cleanliness requirements are lower, but pollutants in the air still need to be controlled.

9. ISO Class 9 Clean rooms

ISO Class 9 is the lowest level of cleanroom, allowing up to 1,000,000,000 particles per cubic meter of air (particle size is 0.1 micron). This level of cleanroom is suitable for occasions where air cleanliness requirements are not high, equivalent to regular indoor air.

OverView Of ISO 14644

1. Purpose and Scope:

The ISO 14644 standards provide a framework for designing, operating, and maintaining cleanrooms and controlled environments. They are essential for industries where the control of airborne particulate contamination is critical, such as pharmaceuticals, biotechnology, aerospace, and semiconductor manufacturing.

2. Structure of ISO 14644:

The ISO 14644 series includes several parts, each addressing different aspects of cleanroom management:

ISO 14644-1:
Classification of air cleanliness by particle concentration. This part defines the classification system for cleanrooms based on the maximum allowable particle counts in specified volumes of air. Cleanrooms are categorized into classes (e.g., ISO Class 1 to ISO Class 9), with Class 1 being the cleanest.
ISO 14644-2:
ISO-14644-2-2000.pdf
Monitoring and control of cleanrooms and controlled environments. This part outlines the requirements for ongoing monitoring, including the frequency and methods of testing for airborne particles.
ISO 14644-3:
ISO-14644-3-2005.pdf
Test methods. This provides guidelines on how to perform the tests necessary for determining the cleanliness of the air in cleanrooms.
ISO 14644-4:
ISO-14644-4-2022.pdf
Design, construction, and start-up. This section covers best practices for the design and construction of cleanrooms to ensure they meet the necessary cleanliness standards.
ISO 14644-5:
ISO-14644-5-2004.pdf
Cleaning and disinfection of cleanrooms. This part addresses cleaning protocols, including the selection of cleaning agents and methods.
ISO 14644-6:
Contamination control. This part offers guidance on strategies to control and minimize contamination in cleanroom environments.
ISO 14644-7:
Application of the standards. This section discusses the application of the ISO 14644 standards across various industries.

3. Cleanroom Classification:

The classification system established in ISO 14644-1 is based on the concentration of airborne particles. The classes range from ISO Class 1 (the cleanest, with fewer than 10 particles of size 0.1 micrometers per cubic meter) to ISO Class 9 (less clean, with more than 35,200,000 particles of size 0.5 micrometers per cubic meter). This classification helps organizations determine the appropriate cleanroom design and operational practices based on their specific needs.

4. Monitoring and Testing:

Ongoing monitoring of cleanroom environments is critical to ensure compliance with the designated class. ISO 14644-2 and ISO 14644-3 provide methodologies for conducting regular tests, including particle count measurements, air flow assessments, and pressure differentials, to maintain the required cleanliness levels.

5. Application in Various Industries:

ISO 14644 is widely adopted in industries where contamination control is vital, including:

Pharmaceuticals: Ensuring the safety and efficacy of drug products.
Biotechnology: Protecting sensitive biological products and processes.
Semiconductors: Maintaining stringent cleanliness levels for manufacturing microelectronics.
Aerospace: Ensuring the integrity and performance of aerospace components.

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FAQ

What is clean room classification?

It follows standards set by organizations such as the ISO (International Organization for Standardization). The classifications, such as ISO 1 to ISO 9, denote the maximum allowable particle count per cubic meter of air for specific particle sizes (e.g., 0.5 micrometers). Higher classifications (e.g., ISO 1) indicate cleaner environments with fewer particles.

clean room classification?

What are the cleanroom classifications?

ISO 14644-2:ISO 1、ISO 2、ISO 3、ISO 4、ISO 5、ISO 6、ISO 7、ISO 8、ISO 9
FS 209E: Class 1,Class 10,Class 100,Class 1000,Class 1000,Class 10000,

What is the FDA classification of clean rooms?

Class A clean area: The level of airborne suspended particles is ISO 5, with ≥5.0μm suspended particles as the limit.
Class B clean area: The class of airborne suspended particles is ISO 6, which includes both ≥0.5μm and ≥5.0μm suspended particles.
Class C clean area: Airborne particles are classified as ISO 7 for static and dynamic conditions respectively.
Class D clean area: The airborne particulate level is ISO 8 for static conditions.

FDA clean rooms

What is a Class 7 or 8 clean room?

ISO Class 7 clean room: Permissible dust particle count (0.5μm): not more than 352,000 particles per cubic meter.
ISO Class 8 clean room: Permissible dust particle count (0.5μm): not more than 3,520,000 particles per cubic meter.

What is class 1000 clean room?

A Class 1000 clean room, as defined by the Federal Standard 209E (FS209E), In a Class 1000 clean room, the environment is controlled to maintain an acceptable level of airborne particles, For particles of size 0.5 micrometers (μm)1,000 particles per cubic foot(approximately 35,300 particles per cubic meter).

What is a class 10 clean room?

A Class 10 clean room, as defined by the Federal Standard 209E (FS209E), For particles of size 0.5 micrometers (μm).10 particles per cubic foot (approximately 353 particles per cubic meter).

class 1000 clean room

What are the lSO 6 standards?

Key Specifications for ISO 6 Clean Rooms:

For particles of 0.5 micrometers (μm) in size: 1,000,000 particles per cubic meter (approximately 35,300 particles per cubic foot).

For particles of 5.0 micrometers (μm) in size: 29,300 particles per cubic meter (approximately 1,000 particles per cubic foot).

ISO 6 defines a clean room environment with specific limits on airborne particulate contamination, providing guidance for industries that require controlled environments but do not need the stricter cleanliness levels of ISO 5 or higher classifications.

ISO 6 Clean Rooms

What is lSO 14644 clean room classification?

ISO 14644 is an international standard that provides guidelines for cleanrooms and controlled environments. It includes a series of standards that define the classification of air cleanliness according to the concentration of airborne particulate contamination.
The classifications range from ISO Class 1 (the cleanest) to ISO Class 9 (the least clean).

What is GMP Class A and B cleanroom environments?

Class A: 3520 suspended particles greater than or equal to 0.5 microns and 20 suspended particles greater than or equal to 5.0 microns per cubic meter in a static environment. The requirements for dynamic environments are the same as for static.
Class B (Class B): per cubic meter, static environment, close to Class A, suspended particles greater than or equal to 0.5 microns are allowed 3520, and suspended particles greater than or equal to 5.0 microns are allowed 29. In a dynamic environment, 352,000 suspended particles greater than or equal to 0.5 microns and 2900 suspended particles greater than or equal to 5.0 microns are allowed.

GMP Class B cleanroom environments

What is lSO 14644 clean room classification?

ISO (International Organization for Standardization) and GMP (Good Manufacturing Practice) are both important frameworks that establish standards for cleanrooms, but they serve different purposes and focus on different aspects of cleanroom management and operation.