Cell Culture Isolator System
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.
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.
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.
The Cell Culture Isolator CC-IS is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2(E).
A remote control module made of AISI 316L stainless steel allows direct access for all maintenance operations.
A Virtual Private Network (VPN) connection allows a secure and private communication via Internet network and provides remote access for assistance, updates and maintenance anytime, everywhere.
Maximizing the operators’ effectiveness is essential to minimize any risk of accidents, remove unscheduled downtime and boost production quality.
Operators are assured the most comfortable working conditions by the outstanding ergonomics of the Cell Culture Isolator CC-IS.
The Cell Culture Isolator CC-IS can be equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5. Wireless Wi-Fi data transmission based on a TCP/IP protocol. Recognition of the glove to be tested by means of Radio Frequency IDentification (RFID) Technology.
Detection of holes down to 100μm diameter.
The Cell Culture Isolator CC-IS can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital.
DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.
An integrated centrifuge allows to run the spin cycle on a multitude of cell culture containers and conical tubes for cell passage, and process a wide range of plates and racks for cell culture analysis.
The centrifuge is available with refrigeration capability, and a temperature range of -20° C to +40° C.
The centrifuge is integrated into the working place of the Process Chamber.
An integrated incubator, monitored and controlled through the isolator HMI, guarantees optimal environmental conditions for cell cultures, such as controlled Temperature (T), Humidity (rH%), Carbon Dioxide (CO2) and Oxygen (O2).
The incubator is integrated in the back wall of the isolator; an inflatable seal made of FDA-approved White Silicon Bio-Guardian® guarantees the tightness with the Process Chamber.
An integrated refrigerator, monitored and controlled through the isolator HMI, keeps media and other reagents cool (0 – 20° C).
The refrigerator is integrated in the back wall of the isolator, an inflatable seal made of FDA-approved White Silicon Bio-Guardian® guarantees the tightness with the Process Chamber.
An integrated microscope for brightfield live cell imaging can be used in routine cell culture processes to monitor cell proliferation, motility and morphology.
The microscope is integrated into the working place of the Process Chamber.