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

The 2nd International Workshop on Advanced...
The 2nd International Workshop on Advanced Therapies: focus on on-site manufacturing of gene & cell therapy-based products is at...
Deshealth, the "Futures of Sustainable Healthcare"
At the Valentino Castle, Turin on 05/22/24 | 2.00 pm - 4.30 pm BioAir - ATMP solutions will participate in the event Deshealth, the...
Together with ATMP in Spain in May!
Bioair, a Tecniplast Company, together with BioGipuzkoa HRI & Donostia University Hospital and BioAir ATMP has organized the second...
Webinar on sustainability in the production of...
Sustainability in the field of ATMPs cannot fail to be promoted and supported: BioAir - ATMP solutions  has always developed...

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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