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    • Overview
    To provide pharmaceutical enterprises with storage and distribution SKID of water for injection system. The equipment uses 3D modular design with characteristic of compact, attractive and nice shape. The main materials of equipment, such as pumps, heat exchangers, valves and piping, were picked from international 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. In order to check whether water for injection system can stably produce water conforming to quality requirement under different possible circumstances in the future, we need to validate the system. The activity and testing includes: RA/ DQ/ IQ/ OQ. The system is fully satisfied with the relative requirements of FDA cGMP, EU GMP, WHO GMP and CFDA GMP.
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