ADVANCED THERAPY ISOLATOR

ISOCellPRO® 4.0: A clean room in 1m3

ISOCellPRO® 4.0 - a clean room in 1m3 - is the ideal Bioair solution for GMP production in closed systems (AinD) of ATMPs (Gene therapy medical products, Somatic Cell based Therapy medicinal products or Tissue engineering and Regenerative Medicine products).


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.

LATEST NEWS

BioAir at the 50th anniversary of Mondo Cinese...
An event to retrace half a century of history of the most authoritative Italian journal: Mondo Cinese, the most authoritative Italian...
The ATMP revolution in Milan at the EUHA...
An interesting symposium organized in Milan, with the following title “ European academia at the forefront of Advanced Therapies...
Published the latest Italian ATMP Forum Report
The 7th ATMP Report, a very interesting PharmaLex initiative,  illustrates the state of the art of ATMPs in the main European countries,...
Prof. Locatelli gave a fantastic presentation...
Prof. Locatelli, one of the most important Researchers in ATMP arena, is the Head of the Department of Paediatric Haematology and...

Closed Systems vs Open Systems: Operational cost savings*





Total Saving

Energy

Validations

Decontamination

Gowning

* Values are given for an identical production output


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