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.