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

Great success for BioAir's webinar
Great success for BioAir's webinar "Advanced Cell and Gene Therapies Using a Closed System", organized with the prestigious...
Confirmation of the ISO 9001 certification
BioAir brilliantly confirmed the ISO 9001 certification, demonstrating the excellence of its Quality Manage Systems and the high-level...
Webinar “Advanced Cell and Gene Therapies...
Thursday, June 30, 2022, BioAir and the publisher Mary Ann Liebert will hold an interesting webinar titled " Advanced Cell and Gene...
New location for the BioAir’s Advanced...
The molecular biotechnology centre of Turin (Italy), location of BioAir’s Advanced Therapy Laboratory, has been ampliated with a new...

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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