Perfect for freeze-drying of bulk. High-quality, robust and sustainable solution.
The Lyoprotect® Stainless Steel Tray for Lyophilization, multiple use, is designed for freeze-drying of pharmaceutical APIs (Active Pharmaceutical Ingredients). Thanks to the polished surface, cleaning is easy. The serial number engraved on the tray facilitates the documentation e.g. of the filled-in substances. All components, including the Lyoprotect® Membrane, can be sterilized in an autoclave. APIs can be produced aseptically in compliance with GMP.
Membrane
The membrane is designed for single use and is replaced before every new drying cycle. During sublimation, the vapor can escape smoothly via the hydrophobic membrane which protects the API against contamination and also protects the working environment and staff against fly-out. Check out our Lyoprotect® Membrane with integrated Filler Assembly for easy filling of the assembled tray.
Process development
The dimensions of the Stainless Steel Trays permit individual upscaling. In combination with the Stainless Steel Cups this allows for a continuous process development from a few milliliters in the laboratory up to a filling volume of 6 liters on a GMP production level. Especially in the last expansion stage, it is economically viable to make optimum use of the existing shelves by adjusting the dimensions of tray and membrane accordingly.
Sustainability
The combination of single-use and multiple-use components helps to reduce waste. The high-grade stainless steel tray is very resistant, only the membrane must be discarded.
Product Claims of Teclen® Lyoprotect
- Bacteria-proof container with vapor-permeable membrane
- 100% visual inspection of membrane and components
- Serial number and work’s test certificate 3.1 for stainless steel plates
- Components comply with the regulations for materials and articles intended to come into contact with food according to (EC) No 1935/2004 and (EU) No 10/2011
- The Lyoprotect® Membrane does not contain any material of animal origin
Design Features and Materials of the Lyoprotect® Stainless Steel Tray
Multiple-use Components
- Tray with Fixing Frame: Stainless steel ANSI 316 L (1.4404) with polished surface (Ra < 0.4 µm); work’s test certificate 3.1 for steel plates used; engraved serial number; plate thickness: tray 2 mm, fixing frame 3 mm;
- Sealing: Expanded PTFE flat gasket, 1 mm
Single-use Component
- Teclen® Lyoprotect® Membrane: Expanded PTFE on polypropylene non-woven backing material; membrane facing the pharmaceutical product after assembly, asymmetrical design serving as positioning aid
Dimensions
The Lyoprotect® Stainless Steel Tray is available in different sizes.
| Product name | Material | Dimensions | Volumes |
|---|---|---|---|
| Teclen® Lyoprotect® LPMU-V1622B-WS | Stainless Steel ANSI 316 L (1.4404) | 155 x 224 x 43 mm | 100–500 ml |
| Teclen® Lyoprotect® LPMU-V2740B-WS | Stainless Steel ANSI 316 L (1.4404) | 270 x 400 x 43 mm | 400–1800 ml |
| Teclen® Lyoprotect® LPMU-Vxxxx-WS | Stainless Steel ANSI 316 L (1.4404) | Customizable max. 400 x 700 x 53 mm | up to 6000 ml |
Contact us for questions or your unbinding quote!