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Sterile formulation Preparation system
EQUIPMENT DESCRIPTION

Juchuang provide sterile preparation for in variety of pharmaceutical formulation, involving transfusion, injection, freeze-dried powder, eye drops and oral liquid etc. Products are divided into water soluble and oil soluble. Using 3D modular design, compact, beautiful and generous. The pump, heat exchanger, valves, pipeline materials required by equipment are used for outstanding international brands, to ensure the quality of the system. The selection of control system hardware is based on the standard module widely used in world. For PLC we use SIEMENS 300 series, MP277 series of touch screen for HMI. The program design, check and constitute are in conjunction with V- GAMP5 model, the software model is applicable to all the PLC S7 system. The design of program refers to the GAMP5 to optimize the design, improving the stability of the program, and there are relevant documents to support, to ensure the traceability of the system. The system can realize automatic production, clean and sterilization. In order to check whether the purified water system can produced stably in accordance with the quality requirements in a variety of situations that may occur in the future, Juchuang verify and test the system involving: risk assessment (RA) /design qualification (DQ)/installation qualification (IQ) operational qualification (OQ).

DESCRIPTION OF FEATURES

• It adopts modular design concept. The system consists of several modules, which can test the system by adopting on-line 3D simulation of user’s utility conditions, so that problems can be detected early.

• The module is easy to transport. The tested modules are shipped to the customer site, and as long as various utilities such as water, electricity, compressed air, steam, etc., are connected, it can be put into use very quickly. It saves at least two months compared with traditional on-site assembly.

• This system consists of four modules. Each module and relevant pipes can be cleaned and sterilized separately. CIP only takes 25 minutes and SIP 1.5 hours, saving more than 5 hours for the system compared with traditional CIP and SIP.

• As each module section can be independent from CIP and SIP for process flow, continuous production can be achieved to enhance the utilization rate of production line and enhance production capacity by more than 50%.

•It adopts the docking system and tube connection with moveable tank, so that the production is more flexible.

• It adopts the transfer plate to avoid cross-contamination.