Simple solution for aseptic bulk freeze-drying of pharmaceutical APIs
Are you looking for a simple solution for aseptic freeze-drying in bulk? At the same time, you wish to avoid an elaborate cleaning process?
With the Lyoprotect® Single-use Tray with Filler Assembly you avoid cross-contamination in your freeze-drier. It offers simple handling and optimum protection of your product and working environment.
Safe Sublimation
During sublimation, the vapor escapes via the hydrophobic ePTFE membrane, which is firmly welded to the single-use tray and ensures a safe cover. The membrane acts as sterile barrier and protects the API against contamination and the working environment and staff against fly-out.
Easy Filling
Thanks to the filler assembly, the Lyoprotect® Single-use Tray can simply be filled via a funnel or tube. An important asset, if time is an issue for the formulation stability.
Safe Closure
The cap of the filler assembly is hand-screwed without any tools. Afterwards, the single-use tray can safely be moved to the freeze-drier. Preliminary freezing in a deep freezer is also possible.
For you, this means: easy filling under the laminar flow for aseptic production, fast closing of the screw-on cap and safe transport between laminar flow and freeze-drier.
Sterilisation
The Lyoprotect® Single-use Tray can be sterilized in an autoclave by up to 121°C (250°F) for 20 minutes. The tray must be placed on the edge and the cap must be open for sterilization.
Components of the Single-use Tray
Lyoprotect® Membrane:
- Expanded PTFE on non-woven polypropylene backing
- Firmly welded to PP tray
PP Tray:
- Polypropylene tray, medical grade
Filler assembly:
- Firmly welded to membrane
- PP (polypropylene), pharma grade
- Opening of filler assembly: Ø 21.5 mm; suitable for tubes with approx. Do ¾ inch or 20 mm
- Non-slip retaining tab
Dimensions
The Lyoprotect® Single-use Tray is offered in the following sizes. Individual dimensions available on request.
| Order number | External dimensions W x L x H | Filling volume | Filling level |
|---|---|---|---|
| LPSU-T1522-FA0909* | 150 x 225 x 50 mm | 230–570 ml | 10–25 mm |
| LPSU-T1623-FA0009* | 160 x 235 x 50 mm | 230–570 ml | 10–25 mm |
| LPSU-T2230-FA0909* | 225 x 300 x 50 mm | 500–1,300 ml | 10–25 mm |
| LPSU-T2331-FA0009* | 235 x 310 x 50 mm** | 500–1,300 ml | 10–25 mm |
| LPSU-T3045-FA0909* | 300 x 450 x 50 mm | 1,100–2,800 ml | 10–25 mm |
| LPSU-T3146-FA0009* | 310 x 460 x 50 mm** | 1,100–2,800 ml | 10–25 mm |
| * The last 4 digits reflect the position of the filler assembly and the orientation of the retaining tab. Individual solutions possible upon request. ** In stock |
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Functional claims
- Bacteria-proof container with vapor-permeable membrane
- High sublimation rate
- No fly-out
- No cross-contamination
- Preliminary freezing possible
- Safe compliance with occupational exposure limits (OEL 100 ng/m³) with flexible isolators
Quality claims
- 100% visual inspection of membrane and components
- Receiving inspection with FTIR spectrometer and full traceability
- BSE/TSE safe
- Complies with (EU) No 10/2011 regarding food safety
- On request: endotoxin test, extractables profile, toxicological evaluation
- Made in Germany
Further details can be found in the Lyoprotect® Single-use Tray with Filler Assembly data sheet.
If you wish to learn more about our product range, please see the Lyoprotect® Product Catalog.
Contact us for questions or your unbinding quote!