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GMP车间净化公司的预防、控制和维护管理

来源:http://www.henganjh.cn │ 发表时间:2019-06-19 

  洁净室应保持清洁,不得堆放杂物,防止污染。严格防止消毒设备和培养基受到污染,并停止使用。无尘车间净化工程应定期用适当的消毒剂消毒,确保无菌室的清洁符合要求。无尘车间净化工程是指将一定空间范围内的微小粒子在空中的尘埃,细菌和其他有害空气污染物,室内温度和湿度、清洁度、室内压力、气流速度和空气分布,噪声、振动和照明、静电控制在一定的范围内的需求,并给予特殊设计的封闭空间。无论是因为产品质量的提高而对现有工厂进行改造,还是因为市场的需求而对工厂进行扩建,工业生产企业都会面临项目准备的重要问题,这关系到企业的未来。在管道连接和设备安装过程中应注意密封措施,避免二次污染。由于软管与软接头存在粉尘滞留问题,软接头可用于净化管道与机械设备的连接,但不能用于管道。在管道连接和设备安装过程中应注意密封措施,避免二次污染。由于软管与软接头存在粉尘滞留问题,软接头可用于净化管道与机械设备的连接,但不能用于管道。
  Clean rooms should be kept clean and no sundries should be piled up to prevent pollution. Strictly prevent the contamination of disinfection equipment and culture medium, and stop using them. The cleaning engineering of dust-free workshop should be regularly disinfected with appropriate disinfectants to ensure that the cleaning of sterile room meets the requirements. Dust-free workshop purification project is to control the dust, bacteria and other harmful air pollutants, indoor temperature and humidity, cleanliness, indoor pressure, air velocity and air distribution, noise, vibration and lighting, static electricity in a certain range of requirements, and to give special design of closed space. Whether it is the upgrading of existing factories because of the improvement of product quality or the expansion of factories because of market demand, industrial enterprises will face the important problem of project preparation, which is related to the future of enterprises. In the process of pipeline connection and equipment installation, attention should be paid to sealing measures to avoid secondary pollution. Due to the dust retention problem between hose and soft joint, soft joint can be used to purify the connection between pipeline and mechanical equipment, but can not be used in pipeline. In the process of pipeline connection and equipment installation, attention should be paid to sealing measures to avoid secondary pollution. Due to the dust retention problem between hose and soft joint, soft joint can be used to purify the connection between pipeline and mechanical equipment, but can not be used in pipeline.
  净化空调系统的调试是工程验收阶段的一项重要工作。通过调试可以及时发现施工中的一些缺陷并进行纠正和修复,这也是设计图纸的一个重要验证过程。洁净室及空调回风风管安装前应符合清洁要求。净化空调系统必须连续送风12小时以上。吹完风后,对回风管道和空调机组进行清洗和擦洗。经过验证的空调清洗系统可满足正常工况下的洁净度要求。空调清洗系统产生的粉尘有两种:一种是系统运行客观引起的粉尘,另一种是控制因素不达标。
  The debugging of purified air conditioning system is an important work in the acceptance stage of the project. Through debugging, some defects in construction can be found in time and corrected and repaired, which is also an important verification process of design drawings. Clean rooms and air conditioning return air ducts should meet the cleaning requirements before installation. Purification air conditioning system must be continuously ventilated for more than 12 hours. After blowing, the return air duct and air conditioning unit are cleaned and scrubbed. The validated air conditioning cleaning system can meet the requirements of cleanliness under normal working conditions. There are two kinds of dust produced by air-conditioning cleaning system: one is the dust caused by the objective operation of the system, the other is that the control factors do not meet the standards.
  自洁时间(恢复时间)控制要求:事故释放或带入洁净室内的污染物,或正常运行过程中气流或间歇对流气流的中断,或人员、设备的移动,都会导致洁净程度下降。自清洁时间的恢复原来的清洁取决于速度的空气流量。自清洗时间的控制要求取决于在此时间范围内(在清洁度恶化的情况下)产品质量和成品率的公差。
GMP车间净化公司
  Self-cleaning time (recovery time) control requirements: pollutants released or brought into the clean room by accident, interruption of airflow or intermittent convective airflow during normal operation, or movement of personnel and equipment will lead to a decline in cleanliness. The recovery of self-cleaning time depends on the air flow rate of speed. The control requirement of self-cleaning time depends on the tolerance of product quality and product rate within this time range (in the case of deterioration of cleanliness).
  洁净车间净化工程严格执行无菌操作,防止微生物污染。操作人员在进入房间前应关掉紫外线灯。净化工程应配备无菌手术室和缓冲室,无菌手术室洁净度应达到10000级,室内温度应保持在20-24℃,湿度应保持在45-60℃。超净工作台清洁度应达到100级。室内气流检测是净化车间正常运行的检测手段之一。这是整个测试程序的一部分。
  Sterile operation is strictly carried out in clean workshop purification project to prevent microbial contamination. Operators should turn off the ultraviolet light before entering the room. The purification project should be equipped with aseptic operating room and buffer room. The cleanliness of aseptic operating room should reach 10,000 grade. The indoor temperature should be maintained at 20-24 C and the humidity should be maintained at 45-60 C. The cleanliness of ultra-clean worktable should reach 100 grade. Indoor air flow detection is one of the means to detect the normal operation of the purification workshop. This is part of the whole test program.
  为了稀释或消除室内悬浮污染,从而防止污染在室内积聚,房间内必须有足够的空气流量。所以必须检测流量。在一个湍流的洁净室内,风的流动和混合是湍流的。为了确保污染物是清晰的,无尘车间的所有部件必须有良好的空气混合。在单向流动净化车间,空气的供应直接来自于空气过滤器,以确保关键区域达到洁净水平。GMP控制因子对洁净车间的温度、湿度、气压、光和噪声都有明确的要求。空调系统影响这些指标,从正压、通风次数、悬浮颗粒控制等方面来满足清洁度。
  In order to dilute or eliminate indoor suspension pollution, and thus prevent the accumulation of pollution in the room, the room must have sufficient air flow. So traffic must be detected. In a turbulent clean room, the flow and mixing of wind are turbulent. In order to ensure that the pollutants are clear, all parts of the dust-free workshop must have good air mixing. In the one-way flow purification workshop, the air supply comes directly from the high efficiency air filter to ensure that the key areas reach the clean level. GMP control factors have clear requirements for temperature, humidity, air pressure, light and noise in clean workshop. Air conditioning system affects these indicators, from positive pressure, ventilation times, suspended particles control to meet the cleanliness.
  无尘车间净化工程净化室内空气速度在某些清洁,随洁净室的目的等具体情况,不仅仅是室内灰尘和过滤效率,还受到其他因素的影响,工业洁净室而言,选择无尘车间净化工程清洁和气流速度基于因素主要有:室内空气污染:建筑构件、人员数量及作业活动、工艺设备、材料及工艺本身都是扬尘源,根据具体情况,变化很大。
  The cleaning speed of indoor air in dust-free workshop is not only influenced by indoor dust and filtration efficiency, but also by other factors. For industrial clean room, the cleaning speed of cleaning engineering in dust-free workshop is based on the following factors: indoor air pollution: building components, number of personnel and operation activities, process equipment and materials. Material and process itself are dust sources, according to the specific situation, great changes.
  室内空气流动模式与分布:单向流动要求流线均匀均匀,但会受到工艺设备布置、位置变化和人员活动的影响,形成局部涡流。为了避免死角和温度分层,需要混合而不是单向流动。洁净室是广泛应用于环境污染特别敏感行业,如半导体生产,生物技术,生物技术,精密机械,制药行业,等等,在半导体行业尤其严格要求室内温度和湿度,清洁,所以需求所需的控制在一定的范围内,并不影响过程。
  Indoor air flow pattern and distribution: Unidirectional flow requires uniform streamline, but it will be affected by the layout of process equipment, location changes and personnel activities, forming local eddy current. In order to avoid dead angle and temperature stratification, mixing rather than one-way flow is needed. Clean rooms are widely used in environmentally sensitive industries, such as semiconductor production, biotechnology, biotechnology, precision machinery, pharmaceutical industry, etc. In the semiconductor industry, indoor temperature and humidity are strictly required to be clean. Therefore, the control of demand within a certain range does not affect the process.
  洁净室作为一种生产设备,可以在工厂中占据许多位置。洁净室系统按照规范生产洁净空气,并在洁净室生产区域使用结束时,持续稳定地提供足够的洁净空气。以上就是GMP车间净化公司为大家整理的车间净化的预防、控制和维护管理,希望能帮助到大家,我们的网站是http://www.henganjh.cn
  As a kind of production equipment, clean rooms can occupy many positions in factories. The clean room system produces clean air in accordance with the specifications and provides sufficient clean air continuously and steadily at the end of use in the clean room production area. Above is the prevention, control and maintenance management of workshop purification organized by GMP Workshop Purification Company. We hope to help you. Our website is http://www.henganjh.cn.

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