CGT-IS Cell and Gene Therapy Isolator
CGT-IS is a cGMP Class A/ISO 5 Cell Culture Isolator specifically designed to create a safer environment for cell culture than traditional biosafety cabinets, clean booths, or standard cleanrooms, eliminating any risk of human contamination of cell cultures.
The CC-IS cell culture isolator is intended for the development of autologous cell and gene therapies, which involve the activation and transduction of non-infectious viruses and viral vectors that could become infectious or overexpressed.
Designed and Manufactured by Tema Sinergie
Settings and Customization
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• Integrated vaporized hydrogen peroxide (VPHP) generator and distribution circuit
• Anemometer resistant to vaporized hydrogen peroxide
• Visual/access panels with integrated safety sensors
• LED lighting system
• Safety filtration systems (Bag-In / Bag-Out) for the process environment
• Integrated systems (RTP) for transferring solid and liquid products without interrupting aseptic containment
• Relative humidity and temperature sensor (rH%+T) resistant to vaporized hydrogen peroxide
• External monolithic control panel made of AISI 316L stainless steel
Additional Features
Control Panel
Additional Features
Transfer Chamber 1
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Transfer Chamber 2
Additional Features
Integrated Incubator
An integrated incubator, monitored and controlled via the isolator’s HMI, ensures optimal environmental conditions for cell cultures, such as controlled temperature (T), humidity (rH%), and levels of carbon dioxide (CO2) and oxygen (O2).
The incubator is integrated into the rear wall of the isolator; an inflatable Bio-Guardian® white silicone gasket, approved by the FDA, ensures a seal with the process chamber.
Additional Features
Integrated Peristaltic Pump
Additional Features
Built-In Refrigerator
A built-in refrigerator, monitored and controlled via the isolator’s HMI, maintains the temperature of the media and other reagents at a low level (0–20 °C).
The refrigerator is integrated into the rear wall of the isolator; an inflatable Bio-Guardian® White Silicone gasket, approved by the FDA, ensures a seal against the process chamber.
Additional Features
Built-in Centrifuge
A built-in centrifuge allows you to perform centrifugation on a wide variety of cell culture containers and conical tubes for cell passage, and to handle a wide range of plates and racks for cell culture analysis.
The centrifuge is available with a refrigeration system (temperature range from -20 °C to +40 °C).
The centrifuge is integrated into the workspace via a process chamber.
Additional Features
Microscope
A built-in microscope for bright-field imaging of live cells can be used during routine cell culture to monitor cell proliferation, motility, and morphology.
The microscope is integrated into the work area of the process chamber.
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Key Features
The CC-IS Cell Culture Isolator ensures the highest air quality within the isolated environment thanks to:
– an engineered filtration system consisting of High-Efficiency Particulate Air (HEPA) pre-filters, unidirectional filters, and exhaust filters;
– a 100% unidirectional exhaust airflow to prevent potential contamination of the process environment;
– an integrated vaporized hydrogen peroxide (HYPER) bio-decontamination system for very rapid bio-decontamination cycles (a complete 30-minute cycle in the Rapid Gas pre-chamber, including full ventilation);
– inflatable seals made of FDA-approved Bio-Guardian® white silicone, with antibacterial inhibitors.
The CC-IS Cell Culture Isolator is equipped with an automatic leak test system, which can be performed as a routine check and runs an independent cycle on each chamber, in accordance with the pressure variation method described in the standard (5.2) ISO 10648-2:1994(E).
A monolithic, sliding external control module, made of AISI 316L stainless steel and housing the electrical and pneumatic components, provides direct access for all maintenance operations.
A Virtual Private Network (VPN) connection enables secure and private communication over the Internet, allowing for remote access, support, updates, and maintenance anytime, anywhere.
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