Performance and features：

1. Comprehensive product portfolio: isolation systems for water injection, powder injection, prefilled syringe and sterile powder production lines;
2. Stable and reliable environment: reliable and stable class A environment, which meets cGMP, FDA, ISO, ISPE, and pharmacopoeia requirements;
3. New VHPS technology: the latest H₂O₂ sterilization system, which can achieve rapid sterilization, control the concentration and saturation of H₂O₂, with good sterilization reproducibility;
4. Intelligent control system: Siemens PLC+IPC control system; intelligent alarms of pressure, H₂O₂ solution concentration, temperature and humidity, air speed and other monitoring parameters; the system has multi-level access control; comply with FDA 21 CFR part 11 requirements;
5. Independent temperature and humidity control mode: with the integrated independent air conditioning system, it can realize that the internal temperature and humidity in the chamber is not affected by the external environment;
6. MOCK-UP: complete wood model verification service, ergonomic operation qualification and 3D model display service in the middle of the project.
7. Sterilization process development support: qualification and validation services for sterilization cycle development of the whole process can be provided;
8. Customization: support customized isolation system design, and provide systematic closed isolation solutions and CE certification services;
9. Integrated monitoring system: integrated monitoring systems of temperature and humidity, differential pressure, air speed, H₂O₂ concentration, optical grating, particles and airborne viable bacteria, etc.;
10. Multiple sterile transfer solutions: multiple and combined sterile transfer solutions are available to meet customers’ diversified production needs;
11. Complete life cycle support: covering consulting, project design, installation scheme design and verification design, etc.;
12. Wireless glove leakage detector: multi-head wired glove leakage detector or wireless glove leakage detector is optional;
13. CDCV service: sterilization cycle development, validation studies and services;