Lyophilization Tray for Safe Freeze-Drying of Highly Potent Substances
The Lyoprotect® Lyophilization Trays for multiple use are designed for pharmaceutical APIs (Active Pharmaceutical Ingredient). The trays are available in several sizes and two materials. Thanks to the anodized or even polished surfaces they are non-sensitive to shock and scratching and allow multiple use after cleaning and all components of the trays, including the Lyoprotect® Membrane, can be sterilized in an autoclave. APIs can be produced aseptically in compliance with GMP.
With Teclen® Lyoprotect® trays for freeze-drying, API can be produced aseptically.
- Zero flyout (no product loss).
- Significant reduction of dust exposure compared to open containers.
- Your freeze-drier does not need cleaning or cleaning validation.
- OEL – Occupational Exposure Limit can be controlled cost-efficiently
- Combination of a multiple-use cup with a single-use membrane significantly reduces plastic waste.
- Scale-up and scale-down with threaded cups and larger trays is easily possible.
In combination with the membrane, the lyophilization trays protect the pharmaceutical product, e. g. an API, as well as the working environment and staff against contamination.
During sublimation, the vapor can escape smoothly via the hydrophobic membrane. 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.
The membrane is designed for single use and can be easily replaced before every new drying cycle. On request, a filling spout can be in-tegrated in the fixing frame, which will facilitate the aseptic procedure. 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.
Sealing the Lyophilization Tray
The silicone gasket (expanded PTFE) ensures reliable sealing throughout the entire process. The required sealing stress is achieved by a threaded assembly.
Teclen® Lyoprotect® Tray in Aluminum
The size of the tray is 216 mm x 152 mm (external dimension) and has got a filling volume of 100 – 500 ml.
|Filling height [mm]||Volume [ml]|
Teclen® Lyoprotect® Stainless Steel Tray for Lyophilization
The design of this tray is identical to the aluminum standard tray. 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 Teclen® Lyoprotect® Stainless Steel Tray for Lyophilization of 6 liters on a GMP production level.
Especially developped for freeze-drying of API, the Laser-welded 45° corners facilitate residue-free cleaning.
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 con-tain any material of animal origin
Contact us for questions or your unbinding quote!