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问题解答
如何建设医疗器械无尘车间?

作者:深圳市林云净化技术有限公司 发表时间:2019-04-28浏览量:128






如何建设医疗器械无尘车间?  

How to build a spotless workshop for medical devices?


        什么是无菌医疗器械呢?


 
        无菌医疗器械就是所有标明了无菌的医疗器械。
 
        为了确保无菌环境,我们在建设医疗器械无尘车间、药品生产无尘车间、医学生物学实验室、医药净化车间、手术室等无尘车间的时候,要进行严格控制,以确保无菌医疗器械的生产过程的环境处于无菌状态。
 
        主要注意事项有以下几个方面:
        一、无尘车间在选址时要远离污染源和交通干道货场等。厂区宜灰尘较少,绿化措施极佳,周围的环境不会对无菌医疗器械的生产造成影响。
        
        二、除去走廊设备等物品外,洁净室的人均面积应该大于4平方米。
 
        三、在建设无尘车间之前,必须先设置好人流、物流的合理走向,员工在进入洁净区域之前,必须要经过净化室,货物在进入洁净区域之前,必须要经过物料净化室。除此之外,还要相对应地建设好洁具室、洗衣间、暂存室、工位器具清洗间等,并保证每间用室相互独立,不会对洁净区域造成污染。
 
        四、按照人流方向空气洁净度,等级为从低到高,按照车间从内向外的方向,空气洁净度级别从高到低。
 
        五、无尘车间的温度湿度要求要与生产工艺相适应。
 
        六、为了确保无菌环境,应该在无尘车间内配备独立净化空调系统的无菌检测室,主要包括人员净化室,物料净化室,无菌检查间,阳性对照间。
 
        七、植入和介入到血管内及需要在万级下的局部百级洁净区域内进行后续加工的无菌医疗器械或单包装出厂的配件,其零部件的加工,末道清洗、组装、初包装及其封口等生产区域应不低于万级洁净度级别。
 
        八、请专业的第三方检测机构为建设好的无尘车间,开具环境检测报告。
 
装修无尘车间,就上林云净化技术有限公司!
 
 
        What is aseptic medical device?


        Sterile medical devices are all medical devices that are labeled aseptic.

        In order to ensure a sterile environment, we must strictly control the construction of dust-free workshops for medical equipment, drug production, medical biology laboratories, medical purification workshops, operating rooms and other dust-free workshops. To ensure that the environment during the production of sterile medical devices is in a sterile state.

        The main points of note are the following:

        First, the dust-free workshop should be far away from the pollution sources and traffic roads during the site selection. The factory area should be less dust, green measures are excellent, and the surrounding environment will not affect the production of sterile medical equipment.

        Second, excluding corridor equipment and other items, the per capita area of the cleaning room should be greater than 4 square meters.

        Third, before building a dust-free workshop, it is necessary to set up a reasonable flow of people and logistics. Employees must go through the purification room before entering the clean area. Before the goods enter the clean area, they must go through the material purification room. In addition, the cleaning room, laundry room, temporary storage room, workplace equipment cleaning room, etc. must be built accordingly, and ensure that each room is independent of each other and will not cause pollution to the clean area.

        Fourth, according to the direction of the flow of people air cleanliness, the level is from low to high, according to the direction of the workshop from the inside out, the air cleanliness level from high to low.
The temperature and humidity requirements of the dust-free workshop should be adapted to the production process.

        In order to ensure aseptic environment, aseptic testing room should be equipped with independent purification air conditioning system in the dust-free workshop, including personnel purification room, material purification room, aseptic examination room, and positive control room.

        The processing of sterile medical instruments or single-package factory accessories, parts and components implanted in or involved in blood vessels and requiring subsequent processing in a local 100-level clean area under ten thousand grades, Production areas such as final cleaning, assembly, initial packaging and sealing shall not be lower than ten thousand levels of cleanliness.

        Please professional third party testing institutions for the construction of a good spotless workshop, issued environmental inspection reports.


Decoration clean workshop,
on the lingyun purification technology Co., Ltd.!
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