Product

Water-for-Injection (WFI) Infusion Liquid Preparation System

Overview

refers to liquids directly administered via intravenous drip. In China, water injections and infusions are generally produced using sterilization processes. The most core technology in the production of water injections and infusions is the liquid preparation process, meaning the key system is the liquid preparation system. The water injection and infusion liquid preparation system refers to the needle liquid preparation tanks, concentrated preparation tanks, dilute preparation tanks, filtration and sterilization systems, etc. used in the pharmaceutical industry. It belongs to the pharmaceutical sanitary-grade liquid preparation system and complies with pharmaceutical GMP standards.

Main Equipment and Characteristics

  1. The water injection and infusion liquid preparation system includes concentrated preparation tanks, dilute preparation tanks, pumps, filters, pipelines, valves, control systems, etc. The system adopts a vertical closed structure. All parts in direct contact with the liquid medicine are made of 316L stainless steel. The capacities of the concentrated preparation tanks and dilute preparation tanks can be customized, and both are equipped with stirring devices, heating and cooling devices, temperature and liquid level display devices, precision filtration devices, etc. The filter elements are respectively configured with 1μm titanium rods, 0.45μm, and 0.22μm polyether sulfone filter elements. According to the process requirements of materials, the concentrated preparation tanks and dilute preparation tanks use integral jacket heating. Steam heating is adopted, which is uniform and can control the heating temperature to reduce the viscosity of materials, facilitating the liquid preparation process. The stirring method is a double-layer stirring paddle: the upper layer is a propeller-type stirrer, and the lower layer is a four-blade open turbine stirrer, which effectively improves the uniformity of the liquid medicine preparation concentration.
  2. To improve the production efficiency of the liquid medicine dispensing system and the precision of liquid medicine dispensing, the system adopts an advanced weighing control system to automatically control the amount of injection water, reducing the labor intensity of manual operations and improving the precision of liquid medicine dispensing.

     

    1. The human-machine interaction mode of the intelligent weight control system can use a touch screen human-machine interface (HMI), which realizes simple and convenient data input and display, as well as real-time information display on the operation status of the system or equipment.
    2. The control mode of the intelligent weight control system adopts PLC programming control, which can realize the automatic control of the injection water volume with a control accuracy of ±0.1%, as well as the display of the liquid medicine temperature during the dispensing process.
    3. Accessories of the dispensing system: CIP & SIP systems, level gauges (material level meters), manholes (hand holes), breathers (fire-proof and explosion-proof), sight glass spotlights, temperature sensors, pressure gauges, valve instruments, etc. CIP and SIP are used for effective cleaning and sterilization to ensure the cleanliness and hygiene of product quality, meet the cleaning and sterilization requirements, and guarantee product quality. Sight glasses and spotlights are used to observe the material status during liquid dispensing for better process control. Temperature sensors are used to realize temperature display and control.
    4. The water injection and infusion liquid dispensing system has online monitoring functions, online alarm, real-time recording, data storage, and download functions. It can simulate data curves, realize automatic control of the liquid medicine dispensing process, simplify manual operation processes, avoid the risk of human error, and has stable system performance. It is supported by relevant documents to ensure the traceability of the system.

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