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The concept of cleanliness cleanliness

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The clean room level standard and the international standard \"ISO14644 clean room and related control environment\" are based on the level of clean room (district) and related control environment in accordance with the concentration of suspended particles. The diameter limit is in the range of 0.1um to 5.0um. According to the particle diameter, it can be divided into conventional particles (0.1um ~ 5.0um), ultra -particle (<0.1um) and macro particles (> 5.0um).

The standards for the cleanliness of clean room cleanliness are as described as described below:

1. Domestic standard GMP (the quality management specifications of pharmaceutical production {2010 revised}), and the cleanliness level of the pharmaceutical plant is divided into four levels: A, B, C, and D.

Class A: High -risk operation areas, such as the irrigation area, placing tubing buckets, etc., a unidirectional flow operation table (cover) should be used to maintain the environment of the area.

Grade B: refers to the background area where high -risk operations such as sterile preparation and filling are used.

Class C and D: Refers to the clean area of ​​lower operation steps in the production process of sterile drugs.

Clean room cleanliness level

Clean room cleanliness level

2. The air cleanliness level in \"Clean Factory Design Specifications GB50073-2013\":

Air cleanliness

3. \"Technical Specifications for Hospital Clean Surgery Department\" GB50333-2013

Compared with the old version of the new version, there are the following modifications in the terms of cleanliness:

Cleanliness comparison

Clean and reference surgery for clean operating rooms:

Clean operating room

The two editions of the two editions of my country (the technical specifications of the hospital clean surgery department) are used as technical measures for air cleaning technology as the air environment of the operating room.

Air cleaning technology is to establish a clean air environment through blocking, airflow tissue and pressure gradient, and naturally combine with the air conditioner, that is, clean air conditioners (or purifying air conditioners).

Purifying air conditioner

Significance of clean air conditioning/purification air conditioning system

1) Blind filtration

The purification air -conditioning system must ensure that the cleanliness of the cleaning room must be set up three levels of filtration. The purification air -conditioning system with high cleaning levels is generally designed to be filtered in the central air -conditioning unit in the middle of the middle. The cleaning wind is sent to the clean room, and the correct choice of high -school filter in junior high school is an important factor in the standard of cleanliness:

① Early efficiency filter

It is mainly filtering dust particles greater than 10 microns, for fresh air filtration and protection of air-conditioning units. The filter materials are WY-CP-200 polyfront non-woven fabrics. Composition. When the filter material accumulates to a certain degree, the pressure alarm device of the initial filter section reminds the operator to replace the filter immediately. The filter material used by the first -effect filter can be washed and reused.

② mid -efficiency filter

It is mainly filtered out of the dust particles of 1-10 microns. It is generally placed in front of high-efficiency filters. After the fan, it is used to protect high-efficiency filters. Generally, it is a bag-type mid-efficiency filter, and the filter material is WZ-CP-2 polyester non-woven fabric.

③ Asian high -efficiency filter

The dust particles with less than 5 microns can be filtered, and the filter material is generally glass fiber products.

④ High -efficiency filter (HEPA)

It is mainly used to remove dust particles less than 1 micron. It is generally installed at the end of the purifying air conditioning ventilation system, that is, high-efficiency air outlets. The GB-01 high-efficiency filter can be used. The filter material is ultra-fine glass fiber paper. The above, high -efficiency filters are characterized by high efficiency and high resistance. High-efficiency filters can generally be used for 2-3 years.

2) Air flow tissue

The airflow tissue of the clean room is also one of the guarantee measures for purifying the environment. There are two types of airflow tissues: non -stratified or layer flow. Diluted the dust generated in the workshop with a highly purified air, called a non -streaming method (disorderly flow method). The height purification air flow is used as a carrier, and the dust is discharged as a layer flow method. The latter has vertical layer flow and horizontal streaming. Blind the cleaning air from the roof direction and discharge vertical layers through the ground surface, scrape the clean air from the side wall, and discharge the horizontal layer stream formula from the side wall of the side.

3) Pressure gradient

In order to prevent external pollutants from penetrating into a clean room from the doors and windows or other gaps in the enclosure structure, and to prevent the air from flowing from a low -clean area to a high -clean area after the door is turned on The pressure value is another important measure in air purification.

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