Gene therapy isolator ValueCell SOLO

class IIIasepticsterile

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. 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.