Criteria for container covers
Crucial requirements for effective lyophilization
To ensure successful sublimation in covered containers, the ideal cover material should exhibit low resistance to vapor flow, possess sterile barrier capabilities, and demonstrate minimal extractables. Moreover, it should be chemically stable, TSE/BSE safe, suitable for primary packaging and autoclavable.
Features of the Lyoprotect® Membrane
High sublimation rate
Thanks to the membrane’s negligible resistance against vapor flow, primary drying can nearly be as aggressive as with open containers. Comparison data on request.
Sterile barrier capability
The examination report, “Microbial barrier testing of Teclen Lyoprotect® Cup with lid equipped with single-use membrane”, shows the superior germ retention capacity (report available on request).
Chemically stable
The membrane is made of PTFE (polytetrafluoroethylene) resins with an additional process step of an expansion. PTFE has a very broad chemical resistance against most acids, bases and solvents.
TSE/BSE safe
We can provide lot-based documents such as a Certificate of Analysis (CoA), attesting that our membrane or related products are safe in the sense of TSE/BSE regulations.
Sterilization
The membrane including the filler assembly are autoclavable at 121°C (250°F) for 20 minutes. EtO and VHP sterilization is also possible. The Lyoprotect® Membrane can also be sterilized a second time after installation.
For primary packaging
Our membrane fulfills pharmaceutical primary packing requirements. This aids in designing a flexible, cost-effective process. After freeze-drying, your bulk API can remain and be shipped in the same container.
Lyoprotect® Membrane
At the core of performance: versatile membranes customized to your needs
LYOPROTECT® MEMBRANE
Expanded PTFE on non-woven PP backing. Bacterial retentive, gas- and vapor-permeable with excellent properties for lyophilization. Sterile barrier for Lyoprotect® Trays, Cups and Bags.
WITH FILLER ASSEMBLY
BESPOKE SIZES
Functional Claims
Bacterial retentive, gas and vapor permeable membrane, excellent quality for lyophilization
Very high sublimation rate
Customized to your needs
No fly-out or cross-contamination
Safe compliance with occupational exposure limits (OEL 100 ng/m³) with flexible isolators
Quality Claims
100% visual inspection of membrane and components on light table
Full traceability and receiving inspection of the membrane with FTIR spectrometer
Membrane fulfills requirements of SVP (sub visible particles) acc. to standard for LVP (large volume parenterals).
Membrane is BSE/TSE safe and complies with (EU) No 10/2011 regarding food safety
Delivery non-sterile, sterile delivery on request with SAL 10^-6
Made in Germany
Dimensions
| Product name | Material | Dimensions | Filler opening |
|---|---|---|---|
| LPMU-Vxxxx-M | ePTFE membrane, part of the Lyoprotect® system | corresponding to Lyoprotect® Cup or Tray | |
| LPMU-Vxxxx-MFA | ePTFE membrane with PP filler assembly, part of the Lyoprotect® system | corresponding to Lyoprotect® Tray | Ø 21.5 mm, suitable for tubes with approx. OD ¾ inch or 20 mm |
| LPCD-xxxx-M | ePTFE membrane, bespoke sizes | max. 600 x 1,000 mm | |
| LPCD-xxxx-MFA | ePTFE membrane, bespoke sizes | max. 600 x 1,000 mm | Ø 21.5 mm, suitable for tubes with approx. OD ¾ inch or 20 mm |
Useful resources
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