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GMP materials of small volume injection system design

    In pharmaceutical production, the elimination of active components of cross-contamination, remove foreign matter, particulate matter, reduce or eliminate microorganisms and pyrogens on the injection of pollution, booster cables to ensure product quality and safety is extremely important; the injection of materials for production process , the material system cleaning methods can be divided into three modes: manual, semi-automatic and fully automatic.

    1, manual cleaning mode: manual demolition,battery clip such as filters, filter, hoses, etc., must be washable to ensure that the cleaning effect; an unstable approach, reproducibility and validity can not guarantee the quality of risk level - "high.tow rope "

    2, semi-automatic cleaning mode: using ultrasonic technology filters and other accessories for cleaning; is more stable handling, reproducibility and validity of the basic can guarantee the quality of risk level - "the."

    3, the automatic cleaning mode: man-machine interface, information exchange and functional access to or influence each other to achieve a fixed process methods or procedures to complete the dispensing equipment or system operation; use of CIP / SIP technology, the basic conditions have the following : Name and lotion lotion concentration, temperature, flow rate, time to achieve the purpose of cleaning; a stable approach, ratchet tie dowm reproducibility and validity can be fully guaranteed, quality risk rating - "low."


    With the drug quality and improve risk control, risk control batching system has to perform the necessary extent, the past must be eliminated by manual cleaning mode and semi-automatic cleaning mode, reducing the hazards of the product of human error, so sterile preparation of materials for production systems , the increase in reliable online CIP / SIP functions, will remain in the batch production equipment to reduce or remove the material to the next batch will not affect product quality and safety level, which can effectively remove the propagation of microorganisms need organic matter, the device at a certain level of microbial contamination control and verification to achieve the required reproducibility and validity.

    First, the program operating system control program.

    Man-machine interface (abbreviated HMI) is an important center for human-machine system components: people and equipment is the function of information exchange and mutual influence in the area of contact or information exchange, functional access to or influence each other, and the machines that hard contact and soft contact, the joint surface, including not only the direct contact point of line and plane, but also long-distance transmission of information and control the role of space, and how level password protection and automatic alarm function; through the PLC program control system hardware on the ingredients perform scheduled process mode operation, to achieve a stable operation mode, to improve product quality and safety, reduce the risk of the process ingredients.

    Depending on the product or production process requirements, system operation and cleaning materials are entirely different program, refer to the production process required to develop operating and CIP / SIP process; in the operation and verification process to ensure the reproducibility and validity of the basis, HCI fixed by the input mode of operation:

    1, the production mode of operation:

    2, CIP rough cleaning mode:

    3, CIP cleaning cycle mode:

    4, CIP sperm washing mode:

    5, SIP sterilization mode:

    6, data storage mode:

    7, security alarm mode:

    8, password protection mode:

    The above mode of operation includes the production and operation, cleaning treatment, the sterilization process, real-time monitoring, recording, alarm, password protection, etc., and different control points in the material system with online monitoring devices, real-time monitoring and recording the operation status to ensure the effectiveness and safety of its operation.

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iande Weida Electrical Appliance Tools Co.Ltd. professionally manufacture booster cables , battery clip, tow rope,ratchet tie down.