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

Tecniplast group's strategic collaboration with...
We are thrilled to share some exciting news with our valued customers and partners. The Tecniplast Group is embarking on a...
Dr Ander Izeta comments the success and the...
Couple of questions to Dr Ander Izeta, one of the 2 speakers of the webinar can give us little taste of this great Webinar. Dear...
Don't miss the opportunity to meet our ATMP...
Don't miss the opportunity to meet our ATMP expert at the 31st ESGCT ANNUAL CONGRESS. La Nuvola Rome - 22-25 Oct 2024....
Terapie Avanzate: sviluppo, qualità e...
Don't miss the opportunity to join us and our reference and expert isolator Dr. Ander Izeta  at the symposium " Terapie Avanzate:...

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