The CC-IS is a Cell Culture Isolator cGMP Class A/ISO 5 system specifically designed to provide the users with a cell culture environment which is safer than environments on traditional biosafety cabinets, clean booths or standard cleanrooms, by eliminating any risk from human contamination of cell cultures.
The Cell Culture Isolator CC-IS is intended to perform cell & gene autologous therapy activities, which include activation and transduction process of non-infectious viruses, viral vectors, that might become infectious or overexpressed.
GUARANTEED ASEPSIS
The Cell Culture Isolator CC-IS assures the highest air quality for the isolated environment thanks to:
– an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional downflow, and exhaust filters
– Single pass 100% extraction airflow to avoid potential contamination of the process environment
– HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle (the Rapid Gas Chamber completes its cycle in 30 minutes, full aeration included)
– inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors.
MODULAR BASED CONFIGURATION
The Cell Culture Isolator is based on a versatile modular concept: the base isolator can be easily expanded with additional Process Chambers and Transfer Chambers.
This makes CC-IS perfectly suitable to every need and process.
A selected group of available options may be added at a future date.