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山东无尘车间无菌洁净室工程设计的标准参照!

来源:http://www.henganjh.cn │ 发表时间:2019-11-06 

  医疗器械净化工程建设中需考虑从以下问题:
  The following problems should be considered in the construction of medical device purification project:
  1. 医疗器械包装车间洁净室工程所需要的净化材料。
  1. Purification materials required for clean room engineering of medical equipment packaging workshop.
  2. 医疗器械厂房洁净室及医疗器械包装车间洁净室工程的设计、安装、调试、维护等综合服务。
  2. Design, installation, commissioning, maintenance and other comprehensive services for the clean room project of the medical equipment workshop and the medical equipment packaging workshop.
  3. 医疗器械包装车间洁净室工程空调净化部分。
  3. Air conditioning purification part of clean room project of medical equipment packaging workshop.
  温度和相对湿度
  Temperature and relative humidity
  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 C,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 ~ 28c, and the humidity is 45% ~ 65%. Generally, the enterprise 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.
  风量、换气次数、静压差
  Air volume, air change times, static pressure difference
  在洁净室体积确定的情况下,换气次数由该室的送风量决定,而静压差取决于房间的送风量与回风量、排风量的差值。系统总送风量、新风量、总排风量和对外压差可以通过调整风机频率转速或总阀门开启度来实现,各房间的风量和压力则可通过调整分支管路阀门开度来实现。
  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.
  实际检测过程中发现,在通过调节支管风阀对某间换气次数不合格洁净室进行送风量调节时,往往会使同一洁净区其余的洁净室送风量改变,即打乱了整个洁净区 的风量分配,从而使问题变得更为复杂。另外还常遇到换气次数合格而压差不合格,主要原因在于护围结构气密性较差和回风口栅格不易调节。
  In the actual detection process, it is found that when the air supply volume of a clean room with unqualified air change times is adjusted by adjusting the branch air valve, the air supply volume of the rest clean rooms in the same clean area will change, that is, the air distribution of the whole clean area will be disrupted, which makes the problem more complex. In addition, it is often encountered that the air change times are qualified and the pressure difference is unqualified, which is mainly due to the poor air tightness of the enclosure structure and the difficulty in adjusting the return air inlet grid.
  洁净室的动态监测中,人员流动、新风量不足及房门开启频繁是各洁净室间压差变化的主要原因 , 如果洁净室与大气之间或不同级别洁净室间静态压差处于临界状态,动态下检测很可能由于人员流动,新风量补充不够而造成压差达不到要求。
山东无尘车间
  In the dynamic monitoring of clean rooms, the main reasons for the change of the pressure difference between clean rooms are the flow of people, the insufficient fresh air volume and the frequent opening of doors. If the static pressure difference between clean rooms and the atmosphere or between clean rooms of different levels is in a critical state, it is likely that the pressure difference can not meet the requirements due to the flow of people and the insufficient supply of fresh air during the dynamic detection.
  悬浮粒子、浮游菌、沉降菌
  Suspended particles, floating bacteria and settling bacteria
  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。只有这样,才能全面、系统监测生产洁净室,为确保洁净室性能监测的数据科学 性、准确性,测试部门在进行关键项目悬浮粒子、微生物测试时,应同时进行温度、相对湿度、换气次数、静压差等前提条件的测试。
  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.
  医药洁净室与无菌医疗器械的洁净室设计在温度、相对湿度、风速、换气次数、静压差项目上的检测标准均按照《洁净厂房设计规范》来执行,药厂洁净室的设计出现问题对无菌医疗器械洁净室同样具有参考价值。
  The test standards of the clean room design of pharmaceutical clean room and sterile medical equipment in terms of temperature, relative humidity, wind speed, air change times and static pressure difference are all implemented in accordance with the code for design of clean workshop. The problems in the design of clean room of pharmaceutical factory also have reference value for sterile medical equipment clean room.
  温度
  temperature
  洁净室夏季室温超过设计范围的原因,多是由于开始确定的各洁净室的空调送风量即换气次数时只注重满足洁净度指标,忽视了对各洁净室热平衡的校核计算。因此在生产洁净室的设计及运行过程中,必须对洁净室的空调送风参数进行实时修正,保证各个季节生产洁净室的温度都维持 18~28 C。温度和相对湿度主要影响产品生产工艺及细菌的繁殖条件,还能引发由生产操作人员舒适度对产品质量的影响。
  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, it is necessary to modify the parameters of air conditioning and air supply in the clean room in real time to ensure that the temperature of the production clean room is maintained at 18-28 C in each season. 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.
  送风量、换气次数
  Air supply volume and air change times
  医疗器械净化工程-无菌洁净室工程设计阶段对送风量的确定,首先要满足相应洁净度级别的换气次数要求,同时还要通过热、湿负荷校核来进一步确定风量,在此基础上对过滤器进行选用。过滤器的处理风量应小于或等于额定风量,设置在同一洁净区内的 ( 亚、超 ) 空气过滤器的阻力、效率宜接近。
  In the design stage of medical equipment purification engineering sterile clean room engineering, the determination of air supply volume should first meet the requirements of air change times of corresponding cleanliness level, and at the same time, the air volume should be further determined through heat and humidity load verification, on the basis of which the high-efficiency filter should be selected. The treatment air volume of the filter shall be less than or equal to the rated air volume, and the resistance and efficiency of the high-efficiency (sub high efficiency and super high efficiency) air filter set in the same clean area shall be close.
  通常洁净室的送风量,为保证空气洁净度等级的送风量,应根据热、湿负荷计算确定的送风量。向洁净室内供给的新鲜空气量。而新鲜空气量应取补偿室内排风量和保持室内正压值所需新鲜空气量之和,此外,为了保证供给洁净室内每人每小时的新鲜空气量不小于 40m3。
  Generally, the air supply volume of the clean room should be calculated according to the heat and humidity load to ensure the air supply volume of the air cleanliness level. The amount of fresh air supplied to the clean room. The fresh air volume shall be the sum of the fresh air volume required to compensate the indoor exhaust air volume and maintain the indoor positive pressure value. In addition, in order to ensure that the fresh air volume for each person in the clean room per hour is not less than 40m3.
  对某一个特定的洁净室工程而言,换气次数要根据实际情况确定。特别是洁净要求较低的,有时换气次数取决于室内排热量。一般根据室内工作人员和设备的发尘量 ( 或工作人员的发尘量乘以一个系数 ) 计算出一个换气次数,两者取大者即可,有时为了保险起见,可以乘以一个使用系数,计算得出换气次数。
  For a specific clean room project, the air change frequency should be determined according to the actual situation. In particular, the cleaning requirements are low, sometimes the number of air changes depends on the indoor heat. Generally, a ventilation frequency is calculated according to the dust emission of indoor staff and equipment (or the dust emission of staff multiplied by a factor), whichever is larger. Sometimes, for the sake of safety, the ventilation frequency can be calculated by multiplying by a service factor.
  尘埃粒子悬浮粒子和微生物主要影响产品质量,造成交叉感染等,洁净室的尘、菌来源于室外空气的占 80%~90%,在其余因素即人、围护结构等方面 , 来源于人的又占80%~90%。可见 , 除了室外空气带来的尘、菌外,人员是使洁净室产生尘粒的主要原因。测试数据表明了人员动作幅度、走动的快慢产尘量都不同。
  Dust particles, suspended particles and microorganisms mainly affect product quality and cause cross infection. 80% - 90% of the dust and bacteria in the clean room come from outdoor air, and 80% - 90% of them come from people in other factors, such as people and enclosure structure. It can be seen that in addition to the dust and bacteria brought by the outdoor air, personnel are the main reason for dust particles in the clean room. The test data show that the movement range and the speed of walking are different.
  洁净室操作人员的动作应轻缓、平稳,应尽量避免不必要的动作,特别是快速走动等下肢动作更应避免,这样才能减少洁净室的产尘量。选择洁净服因材质及式样不同,产尘量有很大的区别。应连体式、致密尼龙稠洁净服,这种洁净服比其它几种洁净服的产尘量要少。洁净室设计采用环氧树脂自流平涂地面、金属彩钢壁板比采用其它几种建筑材料产生的尘埃数少。
  The operation of the clean room operator should be gentle and stable, and unnecessary actions should be avoided as much as possible, especially the movements of legs such as fast walking, so as to reduce the dust production in the clean room. Due to different materials and styles, there are great differences in dust production. The first choice should be one-piece, dense nylon thick clean clothes, which produce less dust than other kinds of clean clothes. The design of clean room adopts epoxy resin self leveling coating on the ground and metal color steel siding, which produces less dust than other building materials.
  因此,从人员控制、厂房设计两方面考虑,可以降低洁净室中尘埃粒子的数量。
  Therefore, from two aspects of personnel control and plant design, the number of dust particles in the clean room can be reduced.
  除上述控制污染源、减少污染发生量来防止微粒污染洁净室,空气净化处理的方法如控制室内的压力,可以有效阻止室外污染入侵室内或防止室内污染逸出室外。 并用合理的气流组织有效排除室内发生的污染。这几种途径又均与净化系统的风量 ( 风速 ) 或换气次数有关。洁净室是一个对换气次数、静压差、温度、湿度、照度等都有要求的综合体。
  In addition to controlling pollution sources and reducing the amount of pollution to prevent particulate pollution in the clean room, air purification treatment methods such as controlling the pressure in the room can effectively prevent outdoor pollution from invading the room or preventing indoor pollution from escaping out of the room The reasonable air distribution can effectively eliminate the indoor pollution. These ways are all related to the air volume (wind speed) or air change times of the purification system. Clean room is a complex with requirements for air change times, static pressure difference, temperature, humidity, illumination, etc.
  洁净室的设计、建设和监测、管理同等重要。无菌医疗器械的洁净室建设首先要从设计开始,洁净室监测又涉及到企业自身的管理规程、人员的操作培训。洁净室 投入运行前应进行综合性能的验证,贯穿施工前的设计、工程准备、施工周期的监控、竣工后静态监测、实际生产过程的动态监测等。企业应制定一套科学有效的洁 净室管理制度和规程,管理存在的问题及时记录并分析解决。
  The design, construction, monitoring and management of clean rooms are equally important. The clean room construction of sterile medical devices should start from the design, and the clean room monitoring involves the enterprise's own management procedures and personnel operation training. Before the clean room is put into operation, comprehensive performance verification shall be carried out, including design before construction, project preparation, monitoring of construction period, static monitoring after completion, dynamic monitoring of actual production process, etc. The enterprise should establish a set of scientific and effective clean room management system and procedures, and record and analyze and solve the existing problems in time.
  以上是山东无尘车间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 Shandong dust free workshop company. To learn more, please visit the website: http://www.henganjh.cn

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