Challenges with open trays
Do you encounter problems with lyophilization in open trays?
Freeze-drying in an open container entails a few risks. Dry powder can escape, leading to product loss and safety concerns. There is a risk of product contamination, and your freeze dryer may require cleaning validations between different batches.
Features of the Lyoprotect® Single Use Trays
Simple handling
The filler assembly makes filling and closing the single-use tray really easy. An elaborate cleaning process is not necessary, as the tray is a single-use product.
Safe sublimation
The Lyoprotect® Membrane acts as a sterile barrier and ensures zero fly-out. Vapor effortlessly passes through the hydrophobic membrane, which supports fast drying.
Separate freezing
Preliminary freezing in a conventional deep freezer is possible. The solid tray bottom facilitates safe transport and handling.
High quality
Our Single-use Trays are manufactured in Germany, with 100% visual inspection of the individual components and final trays. Extraction study and Validation Guide available.
Sterilization
All components are suited for sterilization in an autoclave at 121°C (250°F) for 20 minutes. APIs can be aseptically produced in compliance with GMP.
Process development
Lyoprotect® Single-use Trays are available in three sizes for filling volumes from 230 ml up to 2,800 ml (filling level 10-25 mm). Individual dimensions available on request.
Lyoprotect® Single-use Trays
For freeze-drying pharmaceutical APIs. Simple handling and optimum protection of product and working environment.
COMPLETE VIEW
Setup of a Lyoprotect® Single-use Tray. Click below for more information about the individual components.
FILLER
MEMBRANE
TRAY
Functional Claims
Bacteria-proof container with vapor-permeable membrane
High sublimation rate
No fly-out
No cross-contamination
Preliminary freezing
Safe compliance with occupational exposure limits (OEL 100 ng/m³) with flexible isolators
Quality Claims
100% visual inspection of all components
Full traceability and receiving inspection of plastics with FTIR spectrometer
Tray is BSE/TSE safe and complies with (EU) No 10/2011 regarding food safety
Membrane fulfills requirements of SVP (sub visible particles) acc. to standard for LVP (large volume parenterals).
Endotoxin test, extractables profile, toxicological evaluation
Validation Guide available
Made in Germany
Dimensions
| Product name | Material | Dimensions | Volumes |
|---|---|---|---|
| LPSU-T1522-FA0909 | ePTFE membrane, PP tray, PP filler assembly | 150 x 225 x 50 mm* | 230-570 ml** |
| LPSU-T2230-FA0909 | ePTFE membrane, PP tray, PP filler assembly | 225 x 300 x 50 mm* | 500–1,300 ml** |
| LPSU-T3045-FA0909 | ePTFE membrane, PP tray, PP filler assembly | 300 x 450 x 50 mm* | 1,100–2,800 ml** |
* incl. cap, edge height of tray 30 mm
** filling level 10–25 mm
Useful resources
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