Purification Engineering Standards And Cleanliness Analysis

Purification clean room refers to a special space in which the dust particles, temperature, humidity, pressure, airflow direction, lighting, and noise in the air are controlled within the required range, and it is guaranteed not to be affected by changes in the external environment. Clean rooms are usually used for scientific research experiments, product development, and product production.

There are many common standards in the clean room industry. Today, we will introduce the three most common ones.

1. GMP Standard. The GMP standard divides clean rooms into four levels A、B、C、D. The basis for the division is mainly the number of microorganisms, bacteria, and dust particles in the air per unit volume. The smaller the value, the higher the purification level.

Static means that the clean room and its internal equipment are in normal operation, and there is no flow of personnel within 20 minutes. Dynamic means that the clean room and its internal equipment are in normal operation and there is personnel flow. Class A cleanroom is the highest level of cleanliness and is usually used in environments that require sterile production, filling, or experiments. Class B cleanliness level is the environmental area level where Class A cleanliness is located. It refers to the background area where Class A areas for high-risk operations such as sterile preparation and filling are located. It can be used in the aseptic production pharmaceutical industry. Class C cleanliness level refers to operating areas with low purification level requirements and can be used in the food industry. Class D cleanliness level refers to operating areas with low purification level requirements.

• ISO Standard.ISO standards are applied in many industries, with nine levels from class 1 to class 9. Among them, class 5 is equivalent to class B, class 7 is equivalent to class C, and class 8 is equivalent to class D.

• US FS-209E standard. The classification of clean rooms was first proposed by the United States, and this classification standard is FS-209E. The 100-level, 10,000-level and 100,000-level cleanrooms that are currently in use are all derived from this standard. Although the United States stopped using this standard many years ago, many customers still insist on using this standard.

Suzhou Pharma Machinery Co.,Ltd.

2025/06/03

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