Simple handling, safe sublimation, easy storage
Transferring your lyophilizate is a safety challenge?
Transferring a lyophilizate under aseptic conditions involves several challenges to maintain sterility throughout the process. The design of the transfer system minimizes the potential for contamination.
With the Lyoprotect® Bag for Direct Fill with Storage, you can directly pour the dried API from the lyophilization compartment into the storage compartment. It works as a closed system. This concept is protected by a patent.
Features of the Lyoprotect® Bags for Direct Fill
Versatility in storage
The Bag FA can come with an integrated storage compartment, so you can pour the freeze-dried product into the compartment and seal it for storage. Pack the bag in a separate barrier pouch for storage or shipment.
Safe sublimation
The Lyoprotect® Membrane on the upper side of the bag acts as a sterile barrier and ensures zero fly-out. Vapor effortlessly passes through the hydrophobic membrane, which supports fast drying.
Customized sizes
The bags are manufactured in individual dimensions for optimized footprint utilization of the freeze dryer shelves. They can come with a filler assembly to facilitate your processes.
High quality
Our bags are manufactured in Germany, with 100% visual inspection of the individual components and final bags. Extraction study plus toxicological assessment and Validation Guide available.
Sterilization
All components are suited for sterilization in an autoclave at 121°C (250°F) for 20 minutes. Sterilization validation available on request. APIs can be aseptically produced in compliance with GMP.
Simple handling
The Bag FA (Filler Assembly) is easily filled via the filler assembly by means of a funnel or tube. The small Bag DF (Direct Fill) without filler assembly is ideal for formulation and process development.
Lyoprotect® Bags for Direct Fill
With or without storage compartment. Suitable for sterile GMP requirements.
BAG WITH STORAGE
Handling is easy: Place the bag into the open tray. Wind up the storage compartment. Slide the ends of the clip band into the corner slots of the tray and secure the assembly by folding them to the middle.
FILLING THE BAG
READY TO MOVE
Functional Claims
Bacteria-proof bag with vapor-permeable membrane
High sublimation rate
No fly-out
No cross-contamination
Leakage-tight filler assembly with cap
Safe compliance with occupational exposure limits (OEL 100 ng/m³) with flexible isolators
Quality Claims
100% visual inspection of bags and components
Lot release tests (seam strength/tightness)
BSE/TSE safe and complies with (EU) No 10/2011 regarding food safety
Bag fulfills requirements of SVP (sub visible particles) acc. to standard for LVP (large volume parenterals).
Full traceability and receiving inspection of plastics with FTIR spectrometer
Quality documentation with CoI, CoC, CoA
Made in Germany
Dimensions
| Product name | Material | Dimensions | Volumes |
|---|---|---|---|
| LPSU-BagFA-xx-xx | ePTFE membrane, PP bottom film, PP filler assembly | max. 460 x 920 mm | ca. 500–4,200 ml |
| LPSU-BagFA-xx-xx-Sxx | ePTFE membrane, PP bottom film and storage compartment, PP filler assembly | max. 460 x 920 mm | ca. 500–4,200 ml |
| LPSU-BagDF-13-25 | LPSU-BagDF-13-25 | 135 x 250 mm | ca. 350 ml |
Useful resources
Related Products
The open Aluminum Tray is the perfect partner for your Bag FA. Secure the rolled-up storage compartment in the corner slots. The small Bag DF can be closed with a corresponding Closing Stick.
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