The vapor hydrogen peroxide (VHP) is taken as the biological decontaminating agent for aseptic transfer cabin to effectively kill fungus, bacterial propagules and spore, virus, mycoplasma and other microbes. VHP sterilization is a decontaminating process at low temperature and normal pressure, featured by good material compatibility, broad spectrum, high efficiency and environmental protection;
It adopts the SIEMENS PLC to automatically control all running phases with the HMI to set up and acquire the parameters. The system operation is precise, stable and reliable;
The material feeding and discharging system is of double-door structure, featured by the pneumatic sealing, pneumatic locking and double-door interlocking functions under the work status;
The materials are always under a Class 100 (Class A) environment throughout the cycle to prevent materials from being polluted. The clean environment in the cabin also prevents the sterile Class A/B from being polluted after the cabin door is opened;
The aseptic transfer cabin is internally provided with the cart material bracket and the rail guide system to facilitate material feeding and discharging. The system carries out real-time monitoring on temperature, humidity and pressure in the cabin, and is equipped with user friendly HMI. The VHP concentration selection and the inspection ports for dust particles and floating bacteria are the optional configurations which will enable more convenient machine operation;
The built-in VHP generation system and circulation loop technology optimize the sterilizing time. The sterilization process can be illustrated by diagram to display the key real-time parameters. The data can be saved for each circulation cycle and the data record can be checked and he data, parameters and diagrams can also be exported during the real-time query;
The independent ventilation and residue removing unit is installed, which includes the fan, valve and exhaust pipe that can quickly displace VHP gas inside the cabin and prevent it from entering the HVAC system. The VHP gas residue is in line with occupational health requirement. The residual VHP concentration ≤ 1ppm;
The product design and production specification are conformed with the cGMP requirements, which can be easily validated with good reproducibility;
The biological sterilization circulation service and MQ/PQ support will be provided.