Challenges with open vials
Do you wish to achieve aseptic freeze-drying simply and safely?
During regular freeze drying in vials, fly-out and contamination by airborne particles and germs pose a risk. Isolators and automation may not be an option for small batches because of the high investment costs and structural requirements for CIP/SIP.
Loading of vials
Transport vials in a Lyoprotect® Bag to the freeze dryer
Arrange the filled vials in a frame or tray of your choice. We can customize the bag size to your need. Place the tray or frame containing the vials with an auxiliary sheet into the bag. Remove the auxiliary sheet. When using a frame, please also use a transport sheet under the bag assembly.
Features of the Lyoprotect® Bags for Vials
EU-GMP Annex 1
Suitable for lyophilization of sterile parenterals according to EU GMP Annex 1. For a budget-friendly solution across all systems, even for freeze dryers without CIP/SIP.
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 are customized to accommodate your required number of vials and the corresponding support trays or nests.
High quality
Our bags are manufactured in Germany, with 100% visual inspection of the individual components and final bags. Validation Guide available on request.
Sterilization
All components are suited for sterilization in an autoclave at 121°C (250°F) for 20 minutes. Sterilization validation available on request.
Closure of choice
The bags are safely closed with a heat-sealing strip at the open end. The PP heat-sealing strip is joined using a conventional heat sealer. As an alternative you can use our multiple-use closing stick.
Lyoprotect® Bags for Vials
Different closure options, safe sublimation, easy lyophilization.
BAG WITH HEAT SEAL
Bag for Vials featuring a heat-sealing strip made of PP film. ePTFE membrane facing up, transparent PP bottom film facing down.
LOADING THE BAG
SAFE SUBLIMATION
ALTERNATIVE CLOSURE
CLOSING THE STOPPERS
Functional Claims
Bacteria-proof container with vapor-permeable membrane
Very high sublimation rate
No fly-out, no contamination
Membrane acts as sterile barrier
Suitable for EU GMP Annex 1
No cleaning validation of the freeze dryer
Possible reduction of investment expenses by up to 60%
Quality Claims
100% visual inspection, free of particles
Full traceability and receiving inspection of plastics with FTIR spectrometer
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).
Endotoxin and dry fiber test results available in the Validation Guide on request
Made in Germany
Dimensions
| Product name | Material | Dimensions |
|---|---|---|
| LPSU-Bag-xx-xx-A1 | ePTFE membrane, PP bottom film | customizable sizes; length of closing stick = clearance width of bag + 70 mm |
| LPSU-Bag-xx-xx-HS6 | ePTFE membrane, PP bottom film and heat-sealing strip | customizable sizes; heat-sealing strip 60 mm |
Useful resources
Related Products
With Lyoprotect® Bags for Vials, you can opt for an integrated heat-sealing strip or a reusable Closing Stick to safely close the bags.
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We're here to assist you in finding the optimal solution for your specific needs.