Lyoprotect® Membrane for sterile Freeze-Drying

Functionality of the Lyoprotect® Membrane

During sublimation, the vapor can escape smoothly via the hydrophobic membrane. Sterile freeze-drying process parameters determined with an open container can be transferred and lead to the same drying results. The same filling level has to be applied.

 

Products for sterile freeze-drying in pharma industry

Teclen GmbH develops products for sterile freeze-drying in dialogue with customers. Our product range includes:
Lyoprotect® Threaded CupTeclen® Lyoprotect Tray and Teclen® Lyoprotect Bag. All products are designed for sterile freeze-drying for the pharmaceutical production of API. The cup and the tray are reusable containers, and their membrane covers are single-use products that can easily be replaced.

The Lyoprotect® membrane reliably protects API and constitutes no barrier for sublimation.

To that end, both drying speed and drying result (lyo cake) achieved with a Lyoprotect® product and an open container were compared in a challenging comparative test. The process as well as the result are nearly identical.

Testing conditions:

  • 1:1 trehalose/mannitol, 10% aqueous solution
  • Single-step drying cycle (sheet temperature 40°C)
  • Sublimation time 7h

Lyoprotect residual moisture after sterile freeze-drying               Open container residual moisture

The tests were conducted at ProJect Pharmaceutics GmbH in Martinsried, Germany. Details and further results are available upon request.

 

Characteristics of Lyoprotect® Single Use Membrane

  • Material: ePTFE – expanded Polytetrafluorethylen
    • natural hydrophobic
    • Inert – low extractables
  • Membrane type: bacterial retentive, gas- and vapor permeable
    • Freeze drying tests showed the suitability for the application
    • Bacterial retentive, passed BFE test (bacterial filtration efficiency test) according standard ASTM F2101-14 and EN 14683:2014 B
    • Bacterial retentive in the application itself – Examination Report from SMP GmbH: “Microbial Barrier testing of Teclen® Lyoprotect® Cup with Lid equipped with single use Membrane”. Text can be provided upon request, please send us an email to: sales@teclen.com.
  • Non-woven polypropylene backing
  • Ready to use with Lyoprotect® threaded cup or tray
  • Top layer of the Lyoprotect® bag product

 

Contact us for questions or your unbinding quote!