The highest level of cleanroom

The Highest Level of Cleanroom

1. Definition and Standards

ISO1 cleanrooms are defined according to ISO 14644-1, and the number of particles of 0.1 microns and above in the air shall not exceed 10 per cubic meter. This level of cleanroom has extremely high requirements and is suitable for applications that are extremely sensitive to particulates and contaminants.

2. Air Change Frequency

In order to maintain ISO1 cleanliness, the air change frequency of the cleanroom must be very high, usually requiring at least 300 air changes per hour. This high frequency helps to quickly exhaust contaminated air and ensure a continuously clean environment.

3. Application Fields

ISO1 cleanrooms are widely used in semiconductor manufacturing, aerospace, and advanced medical device production. These fields have extremely strict requirements for the control of particle contamination, and ISO1 cleanrooms provide the necessary environmental protection.

4. Equipment and Technology

In order to meet ISO1 standards, cleanrooms need to be equipped with high-efficiency filters (such as HEPA or ULPA), as well as advanced air circulation and monitoring systems. These devices ensure that the indoor air is continuously clean and can monitor the concentration of particulate matter in real time.

• ISO 14644-1: Standard for cleanrooms and related controlled environments.

• iso 14644-2: Standard for the monitoring and maintenance of cleanrooms.

• ISO 14644-3: Test methods for cleanrooms.

• ISO 14644-4: Guidelines for the design and construction of cleanrooms.

• iso 14644-5: Guidelines for the operation of cleanrooms.

What are the ISO Grade Levels?

• ISO 1

ISO 1 is the highest grade of cleanrooms, requiring no more than 10 particles of 0.1 micron or larger per cubic meter of air. This grade is suitable for applications that are extremely sensitive to contaminants, such as semiconductor manufacturing.

• ISO 2

ISO 2 cleanrooms must have no more than 100 particles of 0.1 micron per cubic meter of air. This grade is suitable for high-precision scientific research and production environments, and is commonly used in the pharmaceutical and optical industries.

• ISO 3

ISO Grade 3 requires no more than 1,000 particles of 0.1 micron per cubic meter of air. It is suitable for the manufacture of biotechnology and certain medical devices, ensuring a high degree of cleanliness.

• ISO 4

At ISO Grade 4, no more than 10,000 particles of 0.1 micron per cubic meter of air are allowed. This grade is commonly used in the production of pharmaceuticals, electronics, and optoelectronic devices.

• ISO 5

ISO 5 requires no more than 3,520 0.1 micron particles per cubic meter of air, which is suitable for environments with strict particle control requirements, such as biopharmaceutical and medical device production.

Is ISO 8 Grade D?

ISO 8 Definition

ISO 8 Cleanroom standards stipulate that the number of 0.5 micron particles per cubic meter of air must not exceed 29,300. It is generally used in applications with relatively low cleanliness requirements.

Grade Classification

According to iso 14644-1, ISO 8 is a lower cleanroom grade, mainly used in industrial and laboratory environments. Its cleanliness is suitable for the manufacture of some less sensitive products.

Grade D Explanation

In FDA classification, the standard of Grade D cleanroom is similar to ISO 8. Its air quality is suitable for the production of some non-sterile products and is commonly used in certain links of the pharmaceutical industry.

Application Areas

ISO 8 and Grade D cleanrooms are commonly used in the production of pharmaceuticals, food processing, and certain electronic products. These environments are suitable for operations that do not require a high degree of cleanliness.

What is an ISO 9 Clean Room?

1. ISO 9 Definition：ISO 9 cleanrooms are the lowest standard among cleanroom levels, allowing the number of particles of 0.5 microns and above to reach 29,300,000 per cubic meter of air. Suitable for environments with low cleanliness requirements.

2. Application Scenarios: ISO 9 cleanrooms are generally used in industries that do not have strict environmental requirements during manufacturing and assembly, such as general manufacturing and certain food processing fields, and are suitable for products with low requirements for particulate control.

What is the FDA Classification of Clean Rooms?

• FDA Classification Overview

FDA divides cleanrooms into multiple levels, mainly used in the pharmaceutical and biotechnology industries. Different levels correspond to different cleanliness requirements to ensure the safety and effectiveness of the product.

• Grade A

Grade A is the highest FDA cleanroom standard and is suitable for direct contact areas with sterile products. It requires extremely high particle control and is suitable for important pharmaceutical processes.

• Grade B

Grade B cleanrooms are used to support Grade A areas and require higher cleanliness. They are usually used for the preparation and handling of drugs to ensure that the particles in the environment are within an acceptable range.

• Grade C and D

Grade C and D cleanrooms have relatively lower standards and are suitable for operations that do not require a sterile environment. They are usually used in production and packaging processes that do not require high cleanliness.

What is a GMP Clean room?

GMP Definition

GMP (Good Manufacturing Practice) cleanrooms are clean environments that meet international standards and are designed to ensure product consistency and quality. It is suitable for industries such as pharmaceuticals, food, and medical devices.

Design Standards

GMP Cleanrooms have extremely strict design requirements, including air filtration, temperature and humidity control, and the selection of surface materials to reduce contamination risks and ensure the reliability of the production process.

Operational Requirements

In a GMP clean room, operators must follow strict hygiene and operating procedures, including wearing appropriate protective clothing and undergoing regular training to maintain high standards of operating practices.