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 that 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 becomes infectious or overexpressed.

Cell culture isolator by Tema Sinergie

Cell Culture Isolator System (CC-IS)

Centrifuge: 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.

Incubator: 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 into the back wall of the isolator; an inflatable seal made of FDA-approved White Silicon Bio-Guardian® guarantees the tightness with the Process Chamber.

Refrigerator: An integrated refrigerator, monitored and controlled through the isolator HMI, keeps media and other reagents cool (0 – 20° C).
The refrigerator is integrated into the back wall of the isolator, an inflatable seal made of FDA-approved White Silicon Bio-Guardian® guarantees the tightness with the Process Chamber.

Microscope: 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.

  • 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

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 for every need and process. A selected group of available options may be added at a future date.

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 (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.

Automatic Leak Test: The Cell Culture Isolator CC-IS is equipped with a routine automatic leak testing system that performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2(E).

Ease of Maintenance: A remote control module made of AISI 316L stainless steel allows direct access for all maintenance operations.
A Virtual Private Network (VPN) connection allows secure and private communication via Internet network and provides remote access for assistance, updates, and maintenance anytime, everywhere.

Ergonomic Design: Maximizing the operators’ effectiveness is essential to minimize any risk of accidents, remove unscheduled downtime and boost production quality. Operators have assured the most comfortable working conditions by the outstanding ergonomics of the Cell Culture Isolator CC-IS.

Glove Integrity Testing: 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.

Data Management: 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.

Energy Saving: Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.

  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request