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 can be easily replaced before every new drying cycle. On request, a filling spout can be integrated 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.
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 highgrade stainless steel tray is very resistant, only the membrane must be discarded.
Product Claims of Teclen® Lyoprotect
Bacteria-proof container with vaporpermeable 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; on request, a filling spout can be integrated in the fixing frame.
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.
Contact Teclen for questions and order information to get your Lyoprotect trays inmediately.
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