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GMP车间净化公司对建设需要控制哪些因素?

来源:http://www.henganjh.cn │ 发表时间:2020-06-19 

  GMP车间净化公司首先,按照以下要求,并与技术经济计划相比较,确定GMP净化车间的选址和总布置布置:一是自然环境好、有毒气体浓度不高、大气粉尘含量少的区域;二是不靠近机场、码头、铁路、交通干线,远离噪声、振动干扰大、空气污染严重、粉尘和有害气体超标的仓储仓库、工厂、堆场。第三,厂区内交通缓慢,环境清净,适合搬迁。严格控制人员净化相关要素和材料净化控制:GMP净化车间施工前,要检查每一位施工人员的身体状况,防止感染传染病的施工人员进入施工现场。GMP净化车间应设有物料、人员、房间的净化设施,并根据需要设置客厅等房间。厕所不应设置在清洁区域。厕所必须设置在施工现场外,并且地址要合适。为保证施工现场清洁有序,控制生产风险,施工现场每天应由保洁员进行清洁,保洁员人数为4人。由于木质材料简单受潮、发霉变质,因而在施工过程中,木材防止进入生产区,预留、预埋的填充物也不能使用木材。在生产区域,地面管道和电气管道均进行气密性试验,以避免洁净室泄漏和污染。设备露出墙面时如开关、灯具、风口、插座等部件,必须用胶水对其所有缝隙进行密封。
  GMP workshop purification company first, according to the following requirements, and compared with the technical and economic plan, determine the location and general layout of GMP purification workshop: first, the area with good natural environment, low concentration of toxic gas and low content of atmospheric dust; Second, it is not close to the airport, wharf, railway and traffic trunk lines, and far away from the warehouses, factories and yards where noise, vibration and interference are large, air pollution is serious, and dust and harmful gases exceed the standard. Third, the traffic in the plant area is slow, the environment is clean and suitable for relocation. Strictly control the personnel purification related elements and material purification control: before the construction of GMP purification workshop, check the physical condition of each construction personnel to prevent the construction personnel infected with infectious diseases from entering the construction site. GMP purification workshop shall be equipped with purification facilities for materials, personnel and rooms, and living rooms and other rooms shall be set as required. Toilets should not be located in clean areas. Toilets must be set outside the construction site and the location shall be suitable. In order to keep the construction site clean and orderly and control the production risk, the construction site shall be cleaned by professional cleaners every day, with 4 cleaners. Due to the simple damp and moldy deterioration of wood materials, during the construction process, the wood shall not be allowed to enter the production area, and the reserved and embedded fillers shall not be used. In the production area, the air tightness test shall be carried out for the ground pipeline and electrical pipeline to avoid the leakage and pollution of the clean room. When the equipment is exposed to the wall, such as switches, lamps, tuyeres, sockets and other components, all gaps must be sealed with glue.
  噪声控制:GMP净化车间非单向流洁净室噪声级(空态)不应超过60db (A),单向流洁净室噪声级(空态)不应超过65db (A);净化空调系统噪声超标时,应采取隔声、消声、隔振等控制措施。洁净室的排风系统除事故排风外,均应执行减排计划。洁净空调系统,根据室内允许噪声水平的要求,风管风速应按以下规则进行选择。总风道6-10m/s;无进、回风口的支管为4-6m/s;进回风支管为2-5m/s。
 层流手术室净化
  Noise control: the noise level (empty state) of non unidirectional flow clean room in GMP purification workshop shall not exceed 60dB (a), and the noise level (empty state) of unidirectional flow clean room shall not exceed 65dB (a); when the noise of purification air conditioning system exceeds the standard, control measures such as sound insulation, noise elimination and vibration isolation shall be taken. The emission reduction plan shall be implemented for the exhaust system of clean room except for the emergency exhaust. Clean air conditioning system, according to the requirements of indoor allowable noise level, the wind speed of air duct shall be selected according to the following rules. The total air duct is 6-10m / S; the branch pipe without air inlet and return is 4-6m / S; the branch pipe of air inlet and return is 2-5M / s.
  GMP车间净化公司的气密性要求的控制:对于属于不同清洁水平的房间,房间拥有优质和相邻房间品位较低,有必要把短时间内压差引起的起动设备和维护积极的静态压差,因此有必要仔细操作按照严重的技巧方法。GMP净化车间地漏采用双不锈钢盖,并经常清洗。施工时不仅要认真寻找准确的标高、排水边坡,防止管道堵塞,而且要保证甚至地面排水本身的表面精度合格,地面排水与地面结合处要明亮、封闭,使与密封和清洁要求一致。GMP净化车间地面要求耐磨、平整、清洗和除灰方便,不易产生静电侵袭,确保表层与底层牢固结合,不仅舒适,而且不产生空裂纹。在施工过程中,应加强骨架的完整性,妥善解决设备启动时因压力变化和静压差引起的密封、开裂、变形等问题,达到预期的气密性;风口、灯具、功能接头、消防箱、配电柜、观察窗等周围的所有孔洞均应按要求采取防裂密封措施,就地更换不同材料,以保证洁净室整体气密性;门窗密封性应突出;GMP净化车间天花板、墙面、施工间隙及地板结构应密封牢固;一般应将聚苯乙烯泡沫板插入车间洁净区与非洁净区之间的伸缩缝内;室内选用彩压钢板,锁紧螺丝膨胀。室外选用不锈钢盖板,并在其边缘全部用密封剂密封。
  Control of air tightness requirements of GMP workshop purification company: for rooms with different cleaning levels, rooms with high quality and low grade of adjacent rooms, it is necessary to start equipment and maintain positive static pressure difference caused by pressure difference in a short period of time, so it is necessary to operate carefully according to serious techniques. The floor drain of GMP purification workshop adopts double stainless steel cover and is cleaned frequently. During the construction, not only the accurate elevation and drainage slope shall be carefully searched to prevent the pipeline from blocking, but also the surface accuracy of the ground drainage itself shall be ensured to be qualified. The joint of the ground drainage and the ground shall be bright and closed to make it consistent with the requirements of sealing and cleaning. GMP purification workshop floor is required to be wear-resistant, flat, easy to clean and remove ash, not easy to generate electrostatic attack, to ensure that the surface layer and the bottom layer are firmly combined, not only comfortable, but also free of empty cracks. In the construction process, the integrity of the framework should be strengthened, and the problems of sealing, cracking and deformation caused by the pressure change and static pressure difference during the start-up of the equipment should be properly solved to achieve the expected air tightness; Anti crack sealing measures shall be taken for all holes around the air vent, lamps, functional joints, fire boxes, power distribution cabinets, observation windows, etc., and different materials shall be replaced on site to ensure the overall air tightness of the clean room; the sealing of doors and windows shall be outstanding; the ceiling, wall, construction gap and floor structure of GMP purification workshop shall be sealed firmly; Generally, the polystyrene foam board should be inserted into the expansion joint between the clean area and the non clean area of the workshop. Stainless steel cover plate shall be selected for outdoor use, and its edges shall be sealed with sealant.
  以上是关于GMP净化车间公司对建设的详细做法,想要了解更多内容欢迎点击http://www.henganjh.cn网站。
  The above is about the detailed construction practice of GMP purification workshop. For more information, please click http://www.henganjh.cn Website.

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