Construction of 100,000 purification workshop requirements in the selection of the site, should consider the location of the surrounding natural environment and good health conditions, at least there is no source of air or water pollution, it is also desirable to stay away from the main traffic arteries, freight yards and so on. The environment of the ground, the road should be leveled without dust. It is desirable to reduce the area of exposed soil through greening, etc. or to have measures to control dust. Garbage, idle goods should not be stored in the open air, etc. In short, the environment of the plant should not cause pollution to the production of sterile medical devices. The overall layout should be reasonable, should not have a negative impact on the production of sterile medical devices, especially the clean area.
Two, the layout of the requirements
100,000 clean room requirements layout should be arranged according to the production process. Processes as short as possible, reduce cross reciprocation, human flow, logistics towards a reasonable. Must be equipped with personnel purification room, material purification room, in addition to equipping the product process requirements of the room, should also be equipped with sanitary ware room, laundry room, storeroom, workplace equipment cleaning room, etc., each room is independent of each other, purification workshop area should be in the context of ensuring that the basic requirements, and the size of the production scale is appropriate.
Three, temperature, humidity requirements
100,000 clean room requirements for the use of environmental cleanliness standards, and environmental temperature, humidity range has nothing to do. Specific data to production needs and process conditions prevail. General settings are: temperature: 22 ~ 26 degrees Celsius; relative humidity: 55% ~ 65%.
Four, aseptic testing room requirements
100,000 clean room requirements must be equipped with independent purification and air-conditioning system of the aseptic testing room (separate from the production area), the requirements for the 10,000 conditions of the local class 100. Aseptic testing room should include: personnel purification room (storage of outerwear room, washroom, wearing clean overalls room and buffer room), material purification room (buffer room or double-window transfer), aseptic examination room, positive control room.
100,000 clean room is the main role in controlling the product contact with the cleanliness of the atmosphere, as well as temperature and humidity, so that the product can be produced in an excellent environmental space, manufacturing. Clean room design, construction after a century of development, has been widely used in machinery, instrumentation, electronics, aerospace, optics, pharmaceutical, chemical, food industry and medical, laboratory and so on.