The aseptic processing isolator is used for aseptic processing and sterile compounding routines where an internal aseptic/sterile environment with EU GMP Grade A air over the workspace is needed. The system is ideal for manufacturers of liquid medicinal products and independent sterility test companies.
The aseptic processing isolator is monitored, controlled and alarmed to provide and maintain strict internal environmental conditions within the isolator workspace. This ensures the integrity of the system to achieve the required cleanliness levels. Designed and manufactured following cGMP and GAMP 5 guidelines, the isolator also follows other industrial equipment directives.
Key Features
Siemens S7 PLC control system with HMI touchscreen display
Automatic inflating silicone seals on main chamber and hatch doors
Integrated Vaporised Hydrogen Peroxide (VHP) decontamination system capable of providing a 6-log reduction of microbiological spores
Rapid decontamination cycle times
Integrated viable & non-viable air sampling controlled via the HMI touchscreen display
CFR 21 Part 11 compliant
Flexible design and chamber layouts