News

New Patent for GMP Validated transfer system “BioBoxß”


The use of BioBox for the transfer of biological samples from the grade A area of a production isolator provides an ideal system for: 

  • the transfer, from the isolator to an external standard CO2 incubator, of biological samples without breaking the continuity of the isolation.
  • reducing significantly the costs, when compared with CO2 systems integrated into the Isolator or with systems that use CO2 incubators with docking system
  • an optimal performance of the expansion phase of biological samples in standard incubators external to the isolator, thanks to the gas permeability of the H14 filters which the BioBoxß container is equipped with.
  • use as a validated component in strict adherence to the Eudralex GMP Guidelines as a sterile bio-confined transfer system, based on the RTP concept already widely used in pharma regulated environments. 
  • a simple sterilization with automated VHP systems. 

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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