Isolator contribute a controlled environment which meet the regulation and products requirements
- An absolute physical barrier between operators and the process
- Integrated with VPHP decontamination system to achieve a 6 log reduction of BI
- Grade A unidirectional airflow protect the critical area, ensure SAL 10-6
- Background cleanroom controlled Grade C (ISO 8)
- Temperature and humidity can be controlled by a dedicated HVAC system
Technical Highlights
- 316L stainless steel chamber in a double-wall (double-door) construction or return air ducts with radial edges and rounded corners for easy cleaning and drainage.
- Safety glass doors are sealed by inflatable gaskets which are electrically monitored.
- A detailed operation process of isolator will be simulated during mock-up study.
- RTP or RTA (Rapid Transfer airlock) can be used for material transfer during the production
- A well designed pressure cascade are controlled inside the isolator in each section.
- WIP and CIP can be designed for those chambers or ducts need to be washed after certain production. Neutralizer or WIP ports are reserved.
- Bag- in- Bag-out filters are used for air return duct when isolators are containment design.
- Air return is designed base on the unidirectional airflow visualized study.
VPHP Decontamination
- The invisible vapor phase hydrogen peroxide is generated by evaporate 30%~35% hydrogen peroxide solution at high temperature, and transfer into the environment
- Fully consider the loading condition, airflow, temperature and humidity inside the environment to be decontaminated.
- Stable controlled parameter to achieve a reproducible cycle of decontamination.
- Special catalyst filters are equipped for fast aeration, the total cycle time can be reduced to 3~4 hours each chamber.