Flexycult™ is a modular incubation system and managemement system of the cell culture used with an isolator composed of a series of modules integrated in a Docking Station (DS). The utilities (electricity, humidified hot air, CO2, decontamination system, etc.) are shared in the DS.
Sterilisation takes place with vapour phase H2O2 at procedure start; a HEPA 14 filtering system on the flow ensures grade A is maintained inside. A sterilised RTP door between incubator and isolator guarantees the opening inside a grade A. The system can be placed in a grade D environment, with evident saving in terms of classification of environments. The expansion is no longer a problem. Management is centralised: prepared and preheated air, water vapour and CO2 are introduced in the incubator ensuring uniform distribution and conditions of temperature, relative humidity and CO2 concentrations. All transitions and significant parameters are monitored and remotely controlled on a digital station.
We can summarise the Flexycult™ product features in the following table:
|Modularity||Expandability and Flexibility||Space and capital management|
|VPHP Sterilisation||Gold Standard and single cleaning procedure||Maximum efficiency and time and cost saving|
|Humidified Air Mixture||No internal water tank||Cleaning, accuracy and protection against contamination|
|Always Grade A||No operator-product contact||Decreased risk|
|Sealed environment||Can be positioned in grade D||Classified area reduction|
|Mono-lot modules||No cross contamination||Decreased risk|
|Digital Connection||Maximum monitoring level||Continuous control and reaction|
We have presented a system that favours the scalability of the ATMP production procedures. The main limitations of the current approach are overcome by the modular approach that allows services sharing, placement in grade D environment, constant environmental conditions and an integrated approach (incubator + isolator) that favours a reduction of operating costs.