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GMP车间净化公司过滤器检漏剖析

来源:http://www.henganjh.cn │ 发表时间:2019-11-13 

  过滤器是可以过滤细菌的,所以风管中假如有细菌普通也不会招致干净区有细菌,但是过滤器需求进行定期检测,测试风速等参数来检查能否完好,另外,如今干净区空间杀菌普通运用臭氧,其也能够进行恰当的杀菌,但是臭氧杀菌,是不可以杀死芽孢的,而且臭氧杀菌需求一定湿度,才干起到比拟好的效果.
  The filter can filter bacteria, so if there are bacteria in the air duct, it will not cause bacteria in the clean area. However, the filter needs to be tested regularly to test the wind speed and other parameters to check whether they are in good condition. In addition, nowadays, ozone is commonly used for sterilization in the clean area, which can also carry out proper sterilization. However, ozone sterilization cannot kill spores, and ozone sterilization needs one Fixed humidity, can play a better effect
  在净化系统中, 过滤器 是高干净度空气净化的关键设备。对 过滤器 检漏的测定,是为了肯定 过滤器自身及系统装置能否有明显渗漏,发现过滤器及其装置的缺陷,以便采取弥补措施。过滤器装置或改换,以及运用一个周期后,必需对过滤器和装置衔接处进行检漏。
GMP车间净化公司
  In the purification system, the filter is the key equipment of high purity air purification. The measurement of filter leakage detection is to confirm whether the filter itself and the system device have obvious leakage, find out the defects of the filter and its device, so as to take remedial measures. After the filter device is changed or used for one cycle, it is necessary to check the connection between the filter and the device for leakage.
  上普遍应用DOP法检漏。DOP 检漏办法采用的仪器有:气溶胶光度计、DOP发作器。DOP法检漏的尘源就是DOP 溶剂喷雾后,粒子呈球外形。由于DOP的测漏原理是在被测过滤器上风侧产生DOP气溶胶作为尘源,在下风侧用光度计采样,含尘气体经过光度计产生的散射光由光电效应线性放大转换为电量,并由微安表快速显现,光度计便可测得气溶胶的相对浓度。检查一个过滤器在5分钟内就可完成。DOP法检漏的仪器价钱昂贵,据统计,DOP 法检漏议在外资、合资企业应用较多。空调 净化设备 的生产厂家也普遍开端采用此办法检漏,其特性是快速烦琐,精确牢靠,便于携带。但是,据材料标明:作为尘源的DOP 溶剂,己被指出具有致变物特性,由于需求定期检漏,发尘源DOP 溶剂残留在空气净化系统中的浓度相应增加,会产生新的化学污染物,对空气净化产生新的影响,对药品生产带来难以剖析的污染。
  DOP method is widely used in the world. The instruments used for DOP leak detection include aerosol photometer and DOP detector. The dust source of DOP leak detection is DOP solvent spray, and the particles are spherical. Because the principle of DOP leak detection is to produce DOP aerosol on the windward side of the filter to be tested as the dust source, and use photometer to sample on the downwind side. The scattered light generated by the dust gas through the photometer is linearly amplified by photoelectric effect to electric quantity, and quickly appears by the microammeter, so the relative concentration of aerosol can be measured by the photometer. Check a filter in 5 minutes. According to statistics, DOP method is widely used in foreign and joint ventures. Air conditioning purification equipment manufacturers generally began to use this method of leak detection, which is characterized by fast and cumbersome, accurate and reliable, easy to carry. However, according to international materials, DOP solvent, as a dust source, has been pointed out to have mutagenic properties. Due to the need for regular leak detection, the concentration of DOP solvent residue in the air purification system will increase correspondingly, which will generate new chemical pollutants, have new impact on air purification, and bring difficult to analyze pollution to drug production.
  为此,美国己寻觅新的替代物,以取代DOP 溶剂,即DOP检漏仪。如5C悬浮粒子发作器,能应用于干净房、层流台、生物平安柜、手套箱、 HEPA吸尘机、HVAC系统、HEPA过滤器、ULPA过滤器、负压过滤安装、手术室、核子过滤系统、聚集维护过滤器、研讨与开展等。国内局部企业苦于缺乏资金,难以装备DOP检漏仪,对展开过滤器一筹莫展,以为难以展开净化系统的考证。为此,有关空调干净技术专家、药品生产厂房设计专家就如何为普通企业处理净化系统检漏问题进行专题讨论,以为采用传统的尘埃粒子计数器办法检漏,同样能到达检测过滤器走漏的目的,详细办法如下:
  Therefore, the United States has been looking for new substitutes to replace DOP solvent, namely DOP leak detector. For example, 5C suspended particle generator can be used in clean room, laminar flow table, biological safety cabinet, glove box, HEPA vacuum cleaner, HVAC system, HEPA filter, ULPA filter, negative pressure filter installation, operating room, nuclear filter system, aggregate maintenance filter, research and development, etc. Due to lack of funds, some domestic enterprises are hard to equip with DOP leak detector, and have no idea how to develop the filter. They think it is difficult to carry out the research of purification system. For this reason, experts on air-conditioning cleaning technology and design of pharmaceutical production plant have a special discussion on how to deal with leakage detection of purification system for ordinary enterprises, in order to achieve the same purpose of detecting filter leakage by using the traditional dust particle counter method. The detailed methods are as follows:
  尘埃粒子计数器检漏简单可行。在过滤器上风侧,以大气层作为尘源,在下风侧用尘埃粒子计数器采样头扫描。详细检测办法如下:1、检测仪器:尘埃粒子计数器:2、测试办法:尘埃粒子计数扫描巡检法.3、测试范围:过滤器的滤材,过滤器框架的密封和过滤器组支撑框架之问的衔接、支撑框架和固定壁间衔接4、检测原理:依据浮游粒子在一定强度的光照下所散射出与其粒径成一定比例关系的光通量原理,粒子散射光经光电转换变成电信号,经放大和计算机处置后被显现粒子当量直径和相应粒子数量.5、检测程序:(1)用尘埃粒子计数器采样头扫描过滤器的嵌风侧,采样头离过滤器间隔约2cm,沿过滤器内边框等巡检,扫描速度低于5cm/s.(2)当检测周期为10min 时,0.5u m 粒子数>20,报警叫响,标明走漏量起标.需求修补或更凌。(3)用环氧树脂胶堵漏或紧固螺栓后,再进行扫描巡检.6、检测周期(1)正常运用。每季度至少检测一次.(2)新装过滤器应进行检测.采用尘埃粒子计数器扫描办法固然检测时间较长,普通一个过滤器检漏需用一小时右右,但测试设备价钱低,是企业常用的测试仪器,不存在负效应隐患,较合适于普通药品生产企业考证时选用。
  The detection of dust particle counter is simple and feasible. On the windward side of the filter, the atmosphere is used as the dust source, and on the downwind side, the dust particle counter sampling head is used for scanning. Detailed testing methods are as follows: 1. Testing instrument: dust particle counter; 2. Testing method: scanning inspection method of dust particle count; 3. Testing range: filter material of filter, sealing of filter frame and connection between filter group support frame, connection between support frame and fixed wall; 4. Testing principle: according to the scattering of floating particles under certain intensity of light, it can be connected with the floating particles The principle of light flux that the particle size is in a certain proportion. The scattered light of particles is converted into electrical signal by photoelectric conversion. After being magnified and processed by computer, the equivalent diameter of particles and the number of corresponding particles are displayed. 5. Detection procedure: (1) scan the air side of filter with the sampling head of dust particle counter. The interval between the sampling head and filter is about 2cm. Patrol along the inner frame of filter. Scanning speed Below 5cm / S. (2) when the detection period is 10min, the particle number of 0.5u m is more than 20, the alarm will sound, indicating the leakage amount to start the standard, and the need for repair or better. (3) after plugging or tightening the bolts with epoxy resin glue, carry out scanning inspection. 6. Inspection cycle (1) normal operation. At least once a quarter. (2) the new filter should be tested. Although it takes a long time to test by using the dust particle counter scanning method, it takes an hour to check the leakage of a common filter, but the price of the testing equipment is low. It is a common testing instrument used by enterprises, and there is no potential negative effect, which is more suitable for the selection of ordinary drug manufacturers.
  以上是GMP车间净化公司为大家介绍的相关内容,想要了解更多内容,欢迎访问网站:http://www.henganjh.cn
  The above is the relevant content introduced by GMP workshop purification company. For more information, please visit the website: http://www.henganjh.cn

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