New Bag Format for CellGenix(R) Media Products 2018-03-15T11:41:39+00:00

CellGenix® Media Bags with new ports

We further improved the quality and safety of our CellGenix® Media Bags

 New MPC coupling allows for safe and reliable closure after the filling process

  • this new MPC coupling is exclusively used for filling the media into the bag during the manufacturing process
  • no tubing or port has to be re-used after it has already been used for filling the bag

Male & Female Luer Lock ports

    • standardized ports with internal screw thread
    • used for making leak-free small-scale fluid connections

The septum port is replaced by a Clave® Connector

        • needleless connector
       
    • Please note that the formulations of our CellGenix® Media remain unchanged!
 

This change concerns exclusively the primary packaging. The new bag is produced by the same manufacturer (Sartorius Stedim) using the same basic bag, tubings, Luer Lock ports and pinch clamps. The secondary packaging* remains unchanged, too. Therefore we did not identify any need for re-validation of the media products when used in cell and gene therapy applications.

All media bag products produced after 01/11/2017 have this new bag design. You however may still receive media bags in the “old” design until our current stock is depleted.

For further detailled information please read the Change Notification Letter of our Senior Regulatory Affairs & Quality Manager including:

– the technical drawing
– a sample certificate of release from Sartorius Stedium

*) Secondary packaging: we seal our media bags in a second low-density polyethylene (LDPE) bag to ensure the best protection of the complete bag during transportation and application.

If you have any questions, please contact us at customerservice@cellgenix.com

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