Performance and features
- Environmental protection:provide class A clean environment for the whole process of cell production and operation, and meet the sterile requirements of GMP.
- New VHPS technology: integrated vaporized H2O2biological decontamination system for effective bio-decontamination of operating areas and material channels;
- Modular design: freely combined multiple functional modules and configurations according to customer needs;
- 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;
- Online environmental monitoring:online detection of sterile production environment, which complies with regulatory requirements, with higher sterility assurance;
- Wireless glove leakage detector:integrated or wireless glove leakage detector is optional;
- Energy saving and consumption reduction: installed in the environment whose cleanliness is above class D, reducing the construction and operation cost of high-class cleanrooms;
- Full data record: configured with control system to record key parameter data and ensure traceability
- High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm;
- Decomposition filter:the air exhaust module can be equipped with a decomposition filter can effectively shorten the degradation time after H2O2 sterilization, and effectively reduce the concentration level of residues;
- CDCV service:sterilization cycle development, validation studies and services;