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

Israeli Advanced Technology Medicinal Therapies...
BioAir has recently taken part in the fascinating Advanced Technology Medicinal Therapies Symposium, organized in Abu Gosh (Israel) by...
New scientific publication by our R&D team
The innovative results of a collaboration between BioAir’s R&D team and the group of Experimental Ophthalmology, part of the...
BioAir at ArabLab in Dubai
From October 24th to 26th BioAir will participate in ArabLab, in Dubai (UAE). ArabLab is one of the most important laboratory and...
CleanTech 2022, October 18th – 19th
BioAir will be part of the CleanTech 2022, in Milan (Italy) October 18th – 19th, organized by ASCCA, one of the most important...

Closed Systems vs Open Systems: Operational cost savings*





Total Saving

Energy

Validations

Decontamination

Gowning

* Values are given for an identical production output


Any Questions? Feel Free to Contact Us