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GMP车间净化公司对设备的管理要求

来源:http://www.henganjh.cn │ 发表时间:2019-08-06 

  GMP车间净化公司设备的设计、选型、装置、改造和维护必需到达预期目的,尽量减少污染、穿插污染、混杂和错误的风险,便于操作、清洗和维护,必要时停止消毒消毒;对设备的运用、清洗、维护和修理,应当制定操作规程,并保管相应的操作记载;装备量具、量具、仪器、仪表,量程和精度适合;设备运用的光滑剂和冷却剂不得污染物品和容器。尽可能运用可食用级或同等级光滑油应运用。设备的维修不影响产品的质量;消费设备清洁程序应当规则细致而完好的清洁办法、清洁用设备或工具的称号,清洗剂和制备办法,删除前一批辨认办法,维护已清洁设备在运用前免受污染的办法、已清洁设备的更长时间限制,保存运用前检查设备清洁的办法,使操作者能够反复的,清洁各类设备的有效办法。
  The design, selection, installation, modification and maintenance of equipment of GMP workshop purification company must achieve the expected purpose, minimize the risk of pollution, interpenetration pollution, mixing and errors, facilitate operation, cleaning and maintenance, stop disinfection and disinfection when necessary, and formulate operational rules for the use, cleaning, maintenance and repair of equipment. And keep corresponding operation records; equip measuring tools, measuring instruments, instruments, measuring range and accuracy is suitable; smoothing agents and coolants used in equipment should not be contaminated products and containers. Use edible grade or smooth oil of the same grade as possible. Maintenance of equipment does not affect the quality of products; cleaning procedures for consumer equipment should be carefully and well-regulated, including cleaning methods, titles of cleaning equipment or tools, cleaning agents and preparation methods, removal of previous identification methods, maintenance of cleaned equipment from pollution before operation, maximum time limit for cleaned equipment, and preservation and transportation. It is an effective way for operators to repeatedly clean all kinds of equipment by checking the cleanliness of equipment before use.
GMP车间净化公司
  消费、检验中运用的称重仪器、计量工具、仪器、记载控制设备和仪器,应当依照操作规程和校准方案,定期停止校准和校验,并做好记载。保证消费、校准中运用的关键称重仪表、计量工具、仪表、记载控制设备和仪表经过校准,所取得的数据精确牢靠;计量规范应运用停止校准,其计量规范应当契合国度有关规则。消费、包装、贮存过程中运用自动、电子设备的,应当依照操作规程定期停止校准、检查,确保其正常运转功用。仲景全球净化可为干净室、干净车间提供咨询、规划、设计、施工、装置、改造等配套效劳。
  Weighing instruments, measuring instruments, instruments, recording and controlling devices and instruments used in consumption and inspection shall be stopped and recorded periodically in accordance with the operating rules and calibration plans. To ensure that the key weighing instruments, measuring tools, instruments, recording control equipment and instruments used in consumption and calibration are calibrated accurately and reliably, and that the measurement norms should be used to stop calibration, and that their measurement norms should conform to the relevant national rules. If automatic or electronic equipment is used in the process of consumption, packaging and storage, the calibration and inspection shall be stopped periodically in accordance with the operating rules to ensure its normal operation. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation services for clean rooms and workshops.
  GMP车间净化公司设备类型开展疾速,型号繁多。设计选型时间必需与肯定的项目范围和工艺流程相分离,并依据GMP请求对生产线进行综合评价。需求顺应产品的消费和工艺流程,整条消费线的配套并能满足消费范围的需求;设备材质稳定,不与消费的产品发作化学反响,不吸附物料,不释放颗粒,消毒灭菌过程中不变形蜕变;构造简单,易于清洗消毒,便于消费操作和维护;仪器、仪表、衡器的运用范围和精度应当契合消费和检验的请求;由于破碎、筛分、制粒、压片过程中粉尘量大,设备的设计和选型应留意设备的密封性和除尘才能。消费过程中的紧缩空气和惰性气体,应有除油、除水、过滤等净化处置设备,废气应有避免空气倒灌的安装。
  The equipment types of GMP workshop purification company are developing rapidly, and there are many types. The design selection time must be separated from the affirmative project scope and process flow, and the production line should be evaluated comprehensively according to GMP request. Demand conforms to product consumption and process flow, and the whole consumption line matches and meets the demand of consumption scope; equipment material is stable, does not have chemical reaction with consumed products, does not adsorb materials, does not release particles, does not change in the process of disinfection and sterilization; structure is simple, easy to clean and disinfect, and is convenient for consumption operation and maintenance. The application scope and accuracy of instruments, instruments and weighing instruments should meet the requirements of consumption and inspection; due to the large amount of dust in the process of crushing, screening, granulating and pressing, the design and selection of equipment should pay attention to the sealing and dust removal ability of the equipment. In the process of consumption, compressed air and inert gas should be purified and disposed of by degreasing, dewatering and filtering, and waste gas should be installed to avoid air backfilling.
  以上是GMP车间净化公司为大家整理的相关内容,想要了解更多内容,欢迎访问网站:http://www.henganjh.com
  The above is the related content of GMP workshop purification company for you. For more information, please visit the website: www.henganjh.com.

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