1、 Temperature and relative humidity of purification workshop
无菌医疗器械在无特殊规定时，通常要求温度在法规标准检测Standard and Testing18-28℃，湿度在 45%-65%，企业一般都可以控制在要求内。如在动态监测中发现达不到要求，可能是室内有产热大的仪器设备。
When there is no special regulation for sterile medical devices, the temperature is generally required to be within the standard and testing 18-28 ℃, and the humidity is 45% - 65%. Generally, enterprises can control within the requirements. If it can not meet the requirements in the dynamic monitoring, it may be that there are instruments and equipment with large heat production in the room.
2、 Air volume, air change times and static pressure difference of purification workshop
When the volume of a clean room is determined, the number of air changes is determined by the air supply volume of the room, while the static pressure difference is determined by the difference between the air supply volume, return air volume and exhaust air volume of the room. The total supply air volume, fresh air volume, total exhaust air volume and external pressure difference of the system can be realized by adjusting the fan frequency speed or the opening degree of the main valve, and the air volume and pressure of each room can be realized by adjusting the opening degree of the branch pipeline valve.
3、 Suspended particles, floating bacteria and settling bacteria in purification workshop
测试条件如不能满足规定的环境参数 ( 温湿度、风速、换气次数、静压差在规定范围之内 ) 要求，关键项目悬浮粒子、浮游菌或沉降菌的测试结果应视为无效。由于温度、相对湿度、风速、换气次数、静压差共同构成了洁净室的微气候，是洁净室维护正常与否的重要指征，可将关键工序关键项目测试修订为关键工序全性能测试。
If the test conditions fail to meet the requirements of specified environmental parameters (temperature and humidity, wind speed, air change times, static pressure difference within the specified range), the test results of suspended particles, floating bacteria or settling bacteria of key items shall be regarded as invalid. As temperature, relative humidity, wind speed, air change times and static pressure difference constitute the microclimate of the clean room, which is an important indicator of whether the clean room is maintained normally or not, the key process key item test can be revised to the key process full performance test.
Only in this way can the production clean room be monitored comprehensively and systematically. In order to ensure the scientificity and accuracy of the performance monitoring data of the clean room, the testing department should test the temperature, relative humidity, air change times, static pressure difference and other preconditions at the same time when testing the suspended particles and microorganisms of key projects.
4、 Temperature of purification workshop
The reason why the room temperature of the clean room exceeds the design range in summer is mostly because the air conditioning air supply volume of each clean room, i.e. the air change frequency, which was determined at the beginning, only focused on meeting the cleanliness index, and ignored the check calculation of the heat balance of each clean room.
Therefore, in the process of design and operation of the production clean room, the parameters of air conditioning and air supply in the clean room must be corrected in real time to ensure that the temperature of the production clean room in each season is maintained at 18-28 ℃. Temperature and relative humidity mainly affect the production process and bacterial reproduction conditions, and also cause the impact of the comfort of production operators on product quality.
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