ISOCellPRO® 4.0 is designed to work within the typical restrictive boundaries of various regulatory bodies (FDA, EUP, USP) and related industry guidelines (GMP, PDA, Eudralex vol 4 Part IV, Annex 1, etc).
Now in its 4th generation, ISOCellPRO® 4.0 is controlled by a panel PC interface acting as a local SCADA module interfacing with the isolator control system, allowing control, monitoring and data recording in compliance with GAMP 5 and FDA CFR21 part 11 requirements. It has standard features that include an “embedded” CO2 incubator, an external or integral VHP system, a waste management based on RTP.
ISOCellPRO® 4.0 can be equipped with automated handling of products and samples within the Grade A area or be used as a sample preparation for external Bioreactors, etc.
ISOCellPRO® 4.0 is equipped with PLC controlled inflatable gaskets that guarantees leak rate class 3 (ISO 14644-7:2004 and ISO 10.