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Clean room requirements for medical devices

日期:2024-04-22 15:16
浏览次数:363
摘要:Industrial clean room: According to federal standards, a clean room means that "the number of dust particles in the air in the room, as well as its temperature, humidity and pressure, can be controlled when necessary." The main purpose of a clean room is to control dust. The density of dust in a given room depends on the process requirements of the products handled in that room. Therefore, the following problems should be considered in the construction of medical device purification engineering:
Industrial clean room: According to federal standards, a clean room means that "the number of dust particles in the air in the room, as well as its temperature, humidity and pressure, can be controlled when necessary." The main purpose of a clean room is to control dust. The density of dust in a given room depends on the process requirements of the products handled in that room. Therefore, the following problems should be considered in the construction of medical device purification engineering:

1. Purification materials needed for the clean room project of the medical device packaging workshop;

2. Comprehensive services such as design, installation, debugging and maintenance of the clean room of the medical device workshop and the clean room of the medical device packaging workshop;

3. Air conditioning purification part of clean room engineering of medical device packaging workshop

At the same time, the following aspects should be paid attention to in the design of clean room (area) :

1. Layout according to the production process. The process as short as possible, reduce cross reciprocating, the flow of people, logistics towards a reasonable. Must be equipped with personnel decontamination chamber (put the coat room, bathroom, wear clean work clothes room and buffer rooms), material clean rooms (rooms outside, buffer room and double transfer window), in addition to equip them with product process requirements of outdoor, should also be equipped with clean room, laundry room, store room, cleaning equipment, etc., between each room are independent of each other, clean workshop area should be under the premise that adapt to the basic requirements, corresponding to the scale of production.

2. According to the air cleanliness level, it can be written as the direction of human flow from low to high; The workshop is from the inside out, from high to low.

3. There will be no cross contamination within the same clean room (area) or between adjacent clean rooms (area)

1) The production process and raw materials will not affect each other on product quality;

2) There are air lock Chambers or anti-pollution measures between clean rooms (areas) of different grades, and the material is transferred through double-layer transfer window.

4. The air purification shall meet the requirements of Chapter 9 of Gb50457-2008 Clean Workshop Design Specification for Pharmaceutical Industry.

The amount of fresh air in the clean room should be as follows:

1) The amount of fresh air needed to compensate for indoor exhaust and maintain positive indoor pressure;

2) The fresh air without people in the room should not be less than 40 m3 /h.

5. The per capita area of the clean room shall be no less than 4 square meters (except corridors, equipment, etc.), and there shall be a safe operation area.

6. If they are in vitro diagnostic reagents, they should meet the requirements of the Implementation Rules for the Production of in vitro diagnostic reagents (Trial implementation). The treatment of negative or positive serum, plasmid or blood products shall be carried out in at least ten thousand levels of environment, with the adjacent areas or maintain a relative negative pressure, and meet the protection requirements.

7. Direction of return air, supply air and water supply pipe shall be indicated.