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Biological Product Preparation System

  • Biological Product Preparation System

    • Overview
    To provide pharmaceutical enterprises with preparation system of biological product such as vaccine, monoclonal antibody,insulin,etc. including media preparation, fermentation, harvest, buffer preparation, purification, formulation subpackage etc..The system uses 3D modular design with characteristic of compact, attractive and nice shape. The main materials of system, such as tanks, pumps, heat exchangers, filters, valves, piping and instruments, were picked from international and domestic excellent brands in order to ensure the overall quality of system. The selection of control system for equipment bases on the standard modular which is widely used in the world, of which PLC selects Siemens 300 series touch screen and HMI selects Siemens MP277 series touch screen. The design, reviewing and composition of program conform to the V-model of GAMP5. Software model applies to all S7 PLC system. Program design has referenced GAMP5 for design optimization. The stability of program was improved. And the traceability of system is ensured with the support of relevant documents. System can realize full automatic control of production, cleaning and sterilization. In order to check whether the preparation system can stably produce products conforming to quality requirement under different possible circumstances in the future, we need to validate the system. The main activity and testing include: RA/ DQ/ IQ/ OQ.
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