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ValueCell SOLO
Stand alone Cell & Gene Therapy isolator

Comecer offers a simplified isolator configuration for Cell & Gene Therapy, from R&D to small clinical applications.

ValueCell SOLO has been thought for development and production activities who require aseptic conditions for sterile handling of Cell&Gene products. It is designed to allow the manipulation of cell cultures in a pharmaceutical context complying with GMP guidelines, facilitating the road to future marketing authorization.

Inside the isolator there are typical laboratory instruments for the analysis and processing of cell cultures. The isolator works in positive pressure with respect to the laboratory to maintain the sterility of the internal environment and thus preserve the product.

ValueCell SOLO - Stand alone Cell & Gene Therapy isolator

Highlights

  • Integrated incubator
  • Large capacity centrifuge
  • SART port for waste & product exit
  • Laminar airflow
  • Fully PLC controlled
  • Software GAMP 5 compliant (21CFR Part 11 available upon request)
  • Friendly operator interface (HMI)
  • Integrated decontamination system (Vapor Phase Hydrogen Peroxide)
  • Illuminate™ MI: IIoT manufacturing intelligence platform and factory-floor management

The isolator consists two chambers:

Pre-chamber: a large pass box for entering consumables and starting materials with full compliance in terms of contamination

Main chamber: used for the manipulation of cell cultures. The isolator is equipped with a VPHP generator for the decontamination of the work areas.

Most of the operations take place in the main chamber, which is equipped with centrifuge and large sliding platforms for creating a flat working surface. Several accessory areas, which have a significant part in the process, complete the system.

On the counter side several accessories for material exchange: in particular a continuous liner for product or waste delivery distributed overtime and SART port for supplementing liquid media to the process chamber.

Design is compact and useful for many applications from R&D to small production for clinical purposes.

Despite compact design both the back wall and the workbench can be integrated with different accessories able to satisfy the needs of a full range of different processes.

ValueCell SOLO - Stand alone Cell & Gene Therapy isolator + illuminate

Release the full potential of ValueCell SOLO with Illuminate™ Manufacturing Intelligence

Use real-time machine performance data to pinpoint where to focus efforts to reduce downtime, maximize line throughput, improve product quality, and make sustainable production improvements. Learn more »

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