138

Liquid distribution system

2019/2/25

配液系统

  Detailed introduction
  I. Overview of the Distribution System
  Distribution system is a liquid preparation system in general. The liquid distribution system is mainly used for material preparation in the fields of bioengineering, infusion, oral liquid, fine chemistry, etc. It can effectively eliminate the risk of cross-contamination and bacterial contamination in the preparation process, and improve the production efficiency and reliability of products. According to the requirements of the new national GMP, laws and regulations, and combined with the actual production needs, every detail is carefully designed to meet the optimum design. Requirements for all kinds of liquid dispensing. The liquid distribution system is a system, which is composed of concentrated tank, dilute tank, filter, pipeline valve and so on. Distribution tank is generally a fully sealed, vertical structure of sanitary and clean containers, with heating, cooling, heat preservation, stirring and other functions. The tank with heating or cooling function is provided with a jacket, which can be heated or cooled by heating or cooling medium respectively, so that the medicinal liquid can be fully dissolved and dispensed by the operation of the agitator. The main configurations of liquid distribution tank system are transmission device, mechanical seal device, temperature control device, spotlight, sight mirror, mixing device, manhole feeding and opening device, steam inlet, condensate outlet, material outlet, sewage outlet, sampling port, 360 degree universal cleaning ball, and some are orifice plate filter device, weighing and measuring device, liquid level measuring device, circulation device, etc.
  CHARACTERISTICS OF LIQUID DISTRIBUTION SYSTEM
  1. Adopt aseptic design and no dead angle movable area to minimize residue; polish the inner surface of the equipment with polishing accuracy of 0.22-0.45 um. External surface mirror polishing or 2B wire drawing board surface.
  2. Automatic liquid distribution system, using touch screen and PLC control, one-button operation, process flow chart is straightforward, the whole process of automatic liquid distribution and material transmission; concise, convenient and humane;
  3. Equipped with automatic CIP online cleaning system and SIP online sterilization system, the system can automatically online SIP and CIP, reduce production costs and labor intensity, and ensure sterile and clean production in the process of liquid distribution.
  4. The integrity of the filter can be automatically detected online.
  5. It can automatically detect weight online and real-time, fix volume and dispense liquid automatically.
  6. Automatic real-time detection, recording and printing of relevant data, which can be imported and exported.
  III. Regulations and National Standards for Liquid Distribution Systems
  1. GMP Requirements: To comply with the relevant provisions of SFDA "Drug Production Quality Management Standards (2010 Revision)"
  2. Industry Standards
  JB/T 20093-2007 Pharmaceutical Machinery Industry Standard
  TJ36-79 Design Hygiene Standard for Industrial Enterprises
  3. National Standards
  General Code for Construction and Acceptance of Mechanical Equipment Installation Engineering GB 50231-2009
  "GB 12348-2008 Industrial Enterprise Factory Boundary Noise Standard"
  Environmental Protection Law of the People's Republic of China
  GB-52261-2002 Mechanical Safety Mechanical and Electrical Equipment Part I: General Technical Conditions
  GB-9706.1-1995 General Safety Requirements for Medical Electrical Equipment Part I
  GB/T5226.1-96 General Requirements for Electrical Safety Requirements of Mechanical Products
  GB/T19910-93 Environmental Requirements and Test Methods for Medical Electrical Equipment
  GB150.1-150.4-2011 Steel Pressure Vessels
  NB/T47003.1-2009 Steel Welded Atmospheric Pressure Vessel
  GAMP Pharmaceutical Production Automation Management Specification
  Code for Design of Clean Workshop in Pharmaceutical Industry (GB50457-2008)

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Buffer Distribution Tank