Closed transfer system for ATMPs productions or applications requiring a strictly controlled bioconfinement
A new tool – extremely simple but very efficient - has been recently developed at this purpose, which facilitate the use of closed system in a GMP contest.
IsocellBIOBOX is a closed system made in a special moulded plastic material PSU or PPSU (Polysulfone and Polyphenilsulfone are part of family of high performance thermoplastics. These polymers are known for their toughness and stability at high temperature: PSU (160°C) – PPSU (180°C). It is possible to autoclave more than 500 times the plastic parts at 121°C – 134°C. The HEPA filter membrane is a consumable part) resistant to thermal and/or chemicals sterilization cycles (H2O2) equipped with an HEPA filter membrane that allows gas exchange (CO2 and O2) but avoid the possibility of external particulate contamination to enter the airtight container [7]. The HEPA filter membrane is a Microbiological filter (H14 as per UNI EN1822-1:2019).
The use of IsocellBIOBOX allows to remove from the Isolator and incubate inside standard external CO2 incubators, the cells contained in flasks, that have been prepared in the Grade A work area of the isolator, keeping cells from different patients safe from cross contamination and reducing drastically the equipment costs, compared to other solutions that uses specially designed CO2 Incubators.
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IsocellBIOBOX represents an unique, reliable, GMP compliant, low-cost, easy-to-use system that guarantees the bio-confinement of the samples in the same aseptic conditions as in the Grade A area of the Isolator, during the transfers of semi- or finished products when these products are moved outside of the Grade A Isolator across the external Grade C or D environment in order to be placed into external incubators or other equipment.