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Requirements for medical equipment clean room

日期:2021-09-29 00:34
浏览次数:175
摘要:Industrial clean room: According to the US Federal Standards, a clean room means: "The number of dust particles in the air in the room and its temperature, humidity, and pressure can be controlled if necessary." The main purpose of a clean room is to control dust. The dust density of a given room depends on the process requirements of the products handled in that room. Therefore, the following issues need to be considered in the construction of medical equipment purification projects: 1. Purif
Industrial clean room: According to the US Federal Standards, a clean room means: "The number of dust particles in the air in the room and its temperature, humidity, and pressure can be controlled if necessary." The main purpose of a clean room is to control dust. The dust density of a given room depends on the process requirements of the products handled in that room. Therefore, the following issues need to be considered in the construction of medical equipment purification projects:
1. Purification materials required for clean room engineering of medical device packaging workshop;
2. Comprehensive services such as design, installation, commissioning, and maintenance of the clean room of the medical device workshop and the clean room of the medical device packaging workshop;
3. Clean room engineering air conditioning purification part 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 should be as short as possible, to reduce cross-over, and the flow of people and logistics is reasonable. Personnel clean room (storage room, washroom, clean overalls room and buffer room), material clean room (outsourcing room, buffer room and double-layer transfer window) must be equipped. In addition to the outdoor room required by the product process, it should Equipped with sanitary ware room, laundry room, temporary storage room, station appliance cleaning room, etc., each room is independent of each other. The area of the clean workshop should be adapted to the scale of production under the premise of adapting to the basic requirements.
2. According to the level of air cleanliness, it can be written as the direction of flow of people, from low to high; the workshop is from inside to outside, from high to low.
3, there is no cross contamination in the same clean room (area) or between adjacent clean rooms (area)
1) The production process and raw materials will not affect the quality of the product;
2) There are air lock rooms or anti-pollution measures between clean rooms (zones) of different levels, and materials are conveyed through double-layer transfer windows.
4. Air purification should meet the requirements of Chapter 9 of GB50457-2008 "Code for Design of Clean Workshops in the Pharmaceutical Industry".
The amount of fresh air in the clean room should be the larger of the following values:
1) Compensate the amount of indoor exhaust air and the amount of fresh air required to maintain positive indoor pressure;
2) No one in the room, fresh air should not be less than 40 cubic meters/h.
5. The per capita area of the clean room should be no less than 4 square meters (except for corridors, equipment and other items), and there should be a safe operation area.
6. In the case of in vitro diagnostic reagents, it should meet the requirements of the "Detailed Rules for the Production of In Vitro Diagnostic Reagents (Trial)". Among them, the processing operation of negative and positive serum, plasmid or blood products should be carried out in at least a 10,000-level environment, and the adjacent area or maintain a relatively negative pressure, and meet the protection requirements.
7. The direction of return air, supply air and water pipes should be marked.