The lay-out of the entire system for sterile preparations is made by 3D modular design, aiming to be compact, using high quality materials for tanks, pumps, heat exchangers, filters, valves, pipes, sensors, etc. These are all selected from well-respected international brands to ensure the overall quality of the system.
The hardware selection of the automation control system is based on the widely used global standard modules. The program design is optimized based on GAMP5, which improves the stability of the program and is supported by relevant documents to ensure system traceability. The system can achieve fully automatic control of production, cleaning, and sterilization. To ensure that the sterile preparation system performance consistently with stable production meeting customer’s quality requirements in various future scenarios, Winatech will provide system qualifications. The main activities and tests include Risk Assessment (RA), Design Qualification (DQ), Installation Qualification (IQ), and Operation Qualification (OQ) etc..
We provide our customers with total solutions for sterile systems:
I: Process Design
Design strictly in accordance with ASME BPE and ISPE guidelines
II: Modular design
Full 3D modular design, accelerating project progress and reducing footprint
III: Data integrity
Automatic recording of production and cleaning process parameters in accordance with FDA 21 CFR part11 requirements
