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 . 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.
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.