According to the "Cleansing Workshop Design Code" implemented in 2013, it is clearly pointed out that "the layout of the process plan should be reasonable and compact." The cleanroom or clean area shall be furnished only with the necessary process equipment, as well as processes and workshops with air cleanliness requirements. " Gmp standard is very important for pharmaceutical factory, and preventing clean room cross-contamination is one of the key points of gmp. Cross contamination refers to the movement of personnel, material transportation, means transportation, air flow, equipment cleaning and disinfecting, and other activities, such as mixing different components to cause pollution; Or pressure drop waste, etc., causing air to flow into low cleanliness areasHigh degree area, this is fatal to clean room, must avoid cross pollution during operation of clean room, lest cause huge loss.
你知道 怎样 防止 清洁 室交织 污染 吗?
Do you know how to prevent cross-contamination of clean rooms?
关于 室内的结构 ，要凭证 合理的工艺流程来举行 结构 ，阻止 往复 往复 。合理结构 既有益 于工艺职掌 ，也有益 于空间的整合。清洁 室其实不 是越大越好的，送风量是凭证 面积和空间巨细来决议 的，也决议 了能耗。清洁 室的面积不行 过大或许 过小，不要有预留闲置的面积和空间，也不行 太小浸染 职掌 、维修。
合理的结构 是经过 思量 装备 巨细、工艺职掌 的需求，消费 区和贮存 区应有与消费 规模相顺应 的空间面积，用以安排 装备 、物料，便于职掌 和维修。一样往常 清洁 室高度控制在2.60米，对集体 较高的装备 可在局部 加高，而不宜周全 提高 清洁 区的高度。车间外部 应设有物料的中央 站，其面积足以寄存 物料、中央 产品 、待验品和制品，且便于明白 分区，以最大限制 地镌汰 过失 和交织 污染 。
Step one, reasonable layout
For indoor layout, according to the reasonable process to layout, avoid round trip. Reasonable layout is not only conducive to the operation of the process, but also conducive to the integration of space. Clean room is not the bigger the better, the air supply is determined by the size of the area and space, but also determine the energy consumption. Clean room area must not be too large or too small, do not have reserved space and spare space, nor too small impact on operation, maintenance.
The reasonable layout is to take into account the size of the equipment, the requirement of the process operation, the space area of the production area and the storage area, which should be suitable for the production scale, so as to arrange the equipment and materials, and facilitate the operation and maintenance. The general cleanroom height is controlled at 2.60 meters, and the height of the clean area can be raised locally for some higher equipment, but it is not suitable to increase the height of the clean area in an all-round way. There should be an intermediate station for materials in the workshop, which is large enough to store materials, intermediate products, products to be inspected and finished products, and to facilitate clear zoning in order to minimize errors and cross-contamination.
第二步、提高 装备 水平
装备 的材质、加工精度、密闭水平 以及管理 制度都与交织 污染 相关 。以是 除了合理结构 外，提高 装备 的自动化水平 和组成联动的消费 线，以镌汰 职掌 职员 ，降低职员 的运动频率，是防止 交织 污染 的需要 措施。
The second step is to raise the level of equipment
Equipment material, processing accuracy, airtight degree and management system are related to cross-contamination. Therefore, in addition to reasonable layout, it is necessary to improve the automation level of the equipment and form a linkage production line in order to reduce the number of operators and reduce the frequency of activities of the personnel, which is the necessary measure to prevent cross-contamination.