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 Cup, Teclen® 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.
- 1:1 trehalose/mannitol, 10% aqueous solution
- Single-step drying cycle (sheet temperature 40°C)
- Sublimation time 7h
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: firstname.lastname@example.org.
- 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!