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GMP车间净化公司净化设计如何安排呢?

来源:http://www.henganjh.cn │ 发表时间:2019-06-05 

  GMP车间净化公司净化设计如何安排呢?
  How to arrange the purification design of GMP workshop purification company?
  山东GMP车间净化工程是一系列应用于制药、食品等行业的强制性生产指南,是一套科学、系统的质量管理体系。新版GMP对车间技术提出了更高的要求,对GMP车间净化的布局应进行相应的调整。为了满足生产过程中的质量要求,提高制药效率,如何在GMP车间安排净化设计?
  Shandong GMP workshop purification project is a series of mandatory production guidelines applied in pharmaceutical, food and other industries. It is a scientific and systematic quality management system. The new version of GMP puts forward higher requirements for workshop technology, and the layout of GMP workshop purification should be adjusted accordingly. In order to meet the quality requirements in the production process and improve pharmaceutical efficiency, how to arrange purification design in GMP workshop?
  首先,整个车间要按照工艺流程和生产要求进行划分,区域划分要合理、紧凑,避免人员和物流的混搭。无论是新厂还是老厂改造,GMP车间净化平面布置应满足以下要求。
  Firstly, the whole workshop should be divided according to the process and production requirements, and the regional division should be reasonable and compact, so as to avoid the mixing of personnel and logistics. Whether the new plant or the old plant is renovated, the purification layout of GMP workshop should meet the following requirements.
  1. 按照工艺流程安排,减少生产过程的往返和返程。
  1. Reduce the round trip and round trip of the production process according to the process flow arrangement.
  2. GMP净化车间净化公司人员、物料的进出必须单独设置。原料、辅料和成品的进出口应分开,防止原料、中间体和半成品交叉污染。布局,避免无关人员或物流通过生产区域。
  2. The entry and exit of personnel and materials in GMP purification plant must be set up separately. The import and export of raw materials, accessories and finished products should be separated to prevent cross-contamination of raw materials, intermediates and semi-finished products. Layout, avoid irrelevant personnel or logistics through the production area.
  3.山东省GMP车间净化生产区域(含留检、包装)与原料、成品存放区域的距离应尽可能缩短,避免来回运输造成药品污染;对于易造成污染的物料和废弃物,可在必要时设置专用出入口。
  3. The distance between the purified production area (including inspection and packaging) of GMP workshop in Shandong Province and the storage area of raw materials and finished products should be shortened as far as possible, so as to avoid drug pollution caused by round trip transportation; special entrances and exits can be set up when necessary for materials and wastes liable to pollution.
  4. 进入GMP净化车间的人员和物料,应有自己的净化室和净化设施。净化室的设置要求与生产区域的洁净水平一致。电梯内的人员和物料应分开放置,尽量不要放置在干净的地方。
                       GMP车间净化公司
  4. Personnel and materials entering the GMP purification workshop should have their own purification rooms and facilities. The cleaning room should be set up in accordance with the cleanliness level of the production area. Elevator personnel and materials should be placed separately, try not to be placed in a clean place.
  5. 应将空气洁净的房间或区域布置在尽可能少的人能到达或接近空调室的地方。不同洁净水平的房间或区域应根据空气洁净的高度由内而外布置;洁净程度相同的房间或区域的布置则宜相对集中。防止不同洁净度房间间交叉污染的措施,如气锁室、风淋室、缓冲器或转移窗等。
  5. Clean air rooms or areas should be arranged where as few people as possible can reach or approach the air conditioning room. Rooms or areas with different cleanliness levels should be arranged from inside to outside according to the height of air cleanliness; rooms or areas with the same cleanliness level should be relatively centralized. Measures to prevent cross-contamination between rooms with different cleanliness, such as air lock room, air shower room, buffer or transfer window, etc.
  6. 清洁面积应尽量减少。只有必要的工艺设备和设施应放置在GMP净化车间,室内工作人员的数量应保持在比较低。同时,应根据生产规模调整原材料、半成品和成品的存放面积。
  6. Clean area should be minimized. Only the necessary process equipment and facilities should be placed in the GMP purification workshop, and the number of indoor workers should be kept to a minimum. At the same time, the storage area of raw materials, semi-finished products and finished products should be adjusted according to the production scale.
  7. 根据需要合理安排辅助车间。例如,称量室应靠近原料仓库,其清洁度应与配料室相同。本区域可设置10万级以上净化车间设备洁净室和容器洁净室。净化车间100级以上洁净室和10000级洁净室应设在洁净区外,洁净程度可低于生产区域。清洗工具、储藏室、维修室不应设在清洁生产区内;清洁工作服的清洗烘干间一般可以比生产区低一级,无菌服装的清洗灭菌间应与生产区相同。
  7. Arrange the auxiliary workshop reasonably according to the need. For example, the weighing room should be close to the raw material warehouse and its cleanliness should be the same as that of the batching room. The area can set up more than 100,000 class purification workshop equipment clean room and container clean room. Clean rooms of Class 100 or above and Class 10000 in the purification workshop should be located outside the clean area, and the cleanliness level can be lower than that in the production area. Cleaning tools, storage rooms and maintenance rooms should not be located in cleaner production areas; cleaning and drying rooms of clean work clothes can generally be lower than those of production areas, and cleaning and sterilization rooms of aseptic clothing should be the same as those of production areas.
  山东GMP车间净化公司、良好的计划提前装修设计之前,承包商接触净化车间,再好的规划方案,该方案是非常重要的,良好的程序可以决定你的装修质量,所以比较好让承包商净化车间现场检查,比较后确定的计划和计划开始装修,做错了就会受损。
  Shandong GMP Workshop Purification Company, a good plan before decoration design, contractors contact the purification workshop, then a good plan, the program is very important, good procedures can determine the quality of your decoration, so it is best to let contractors clean workshop site inspection, the final plan and plan to start decoration, do wrong will be damaged.

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