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Cell Culture Isolator System
Réf : CC-IS | Fabricant : Tema Sinergie
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 those on traditional
biosafety cabinets, clean booths or standard cleanrooms, by eliminating any risk for
human contamination of cell cultures.
GUARANTEED ASEPSIS
MODULAR BASED CONFIGURATION
AUTOMATIC LEAK TEST
EASE OF MAINTENANCE
ERGONOMIC DESIGN
GLOVE INTEGRITY TESTING
DATA MANAGEMENT
ENERGY SAVING
Key features
- Fully PLC controlled isolator system
- Modular configuration concept of the system
- Integrated VPHP generator (HYPER) and distribution circuit
- VPHP resistant anemometer
- VPHP resistant relative humidity and temperature (rH%+T) sensor
- Control Cabinet made of AISI 316L stainless steel
- View/Access panel latches with integrated safety switches
- LED lighting system
- Integrated process equipment, such as incubator, centrifuge, refrigerator and microscope
- Safe change (Bag-In/Bag-Out) filtering units for the process environment
- Integrated systems (RTP) to transfer solid and liquid products without breaking the aseptic containment
- Integrated Flexicon® PD12 Series Peristaltic Pump for flexible and reliable filling processes (IQ/OQ ) protocols and execution upon request
- Performance Qualification (PQ ) protocols and execution upon request
Specifications
The CC-IS assures the highest air quality of the isolated environment thanks to:
- an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional down flow, return, 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 (Rapid Gas Chamber complete cycle last in 30 minutes, full aeration included)
- inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors.