Aseptic freeze drying with Lyoprotect®
Whether you’re looking for information on liquid compatibility, sterilization methods, or product safety, this guide will help you optimize your freeze-drying processes with Lyoprotect® membranes.
What types of liquids are compatible with Lyoprotect® products?
Lyoprotect® products are designed for use with aqueous solutions. For solvent-aqueous mixtures, ensure that the membrane stays above the liquid level when used in trays, to maintain optimal performance.
What is the pore size of the Lyoprotect® membrane?
The exact pore size is proprietary. However, the membrane is specifically designed to act as a flexible, sterile barrier, with negligible impact on the freeze-drying process.
Does the membrane affect the sublimation rate during freeze-drying?
No, the membrane’s influence on sublimation is minimal. Thanks to its specialized porosity, sublimation rates are comparable to those in open containers, ensuring efficient freeze-drying.
Is the membrane semi-permeable?
Yes, it is permeable to gases and vapor in both directions. However, it prevents reabsorption of moisture after freeze-drying, ensuring the stability of the lyophilized product.
Is the membrane supplied sterile?
The membranes are delivered non-sterile by default. However, sterile options (Ready-to-Use or RTU) and Ready-to-Sterilize (RTS) versions are under development for enhanced flexibility.
Which sterilization methods are compatible with Lyoprotect® membranes?
The membranes can be sterilized by steam autoclaving at 121°C (250°F) for 20 minutes. Ethylene Oxide (EtO) and Vaporized Hydrogen Peroxide (VHP) sterilization methods are also suitable.
Does the membrane or the container affect the freeze-drying cycle?
No, the influence of the membrane and the container on the freeze-drying cycle is negligible. The performance is comparable to lyophilization in open containers.
Are the products checked for endotoxins?
Yes, Lyoprotect® membranes undergo endotoxin testing (LAL testing) during incoming goods inspections. These tests are conducted in a GLP-compliant laboratory to ensure product safety.
Does the membrane effectively blocks germs, bacteria, and viruses?
Teclen has conducted comprehensive qualification and validation tests to demonstrate the membrane’s ability to block germs, bacteria, and viruses. Full details of the tests and results are available in the Validation Guide on our website.
Is data on extractables and leachables available?
Yes, an extractables study, including toxicological assessments, has been completed for Lyoprotect® single-use products that come into direct contact with active pharmaceutical ingredients (APIs).
Are Lyoprotect® products TSE/BSE safe?
Yes, all Lyoprotect® products comply with TSE/BSE safety regulations, ensuring that they meet the required standards for transmissible spongiform encephalopathies.
What quality documentation is provided with Lyoprotect® products?
We provide Certificates of Inspection (CoI), Certificates of Analysis (CoA), and Certificates of Conformity (CoC). Additionally, a detailed Validation Guide is available with information on product specifications and test results.
Which Occupational Exposure Limits (OEL) or Occupational Exposure Bands (OEB) can be met using Lyoprotect® technology?
Your specific OEL must be measured for your individual process, which includes filling, freeze-drying, and harvesting. Under certain conditions, an OEL as low as 100 ng/m³ (0.1 µg/m³) can be achieved using Lyoprotect® technology.
How do I safely unload (harvest) the dried API from single-use trays?
Cut the membrane along three sides and fold it back. Use a spatula or spoon to remove the lyophilized product (lyocake). The particle generation during membrane cutting is low and remains within USP 788 and EP 2.9.19 limits.
Why does the closing stick for bags need to be so long?
The length of the closing stick must exceed the width of the bag. The larger or taller the container, the wider the bag and, accordingly, the longer the closing stick. Always check that the stick will fit into your freeze dryer chamber beforehand.
What can I do if the closing stick does not fit into my freeze-dryer?
You have three options:
- For maximum capacity in sterile or toxic production (with high OEB), use heat-sealable bags.
- For R&D or low OEB, fold the edge of the membrane bag and use a shorter stick.
- Reduce the number of vials or container size, leading to smaller bags and a shorter stick.
What is the difference between aluminum and stainless steel trays?
Aluminum trays offer superior heat transfer but are less durable than stainless steel. Stainless steel (316 L) trays withstand a broader range of cleaning agents and may be easier to integrate into existing quality systems.
If you have any more questions feel free to reach out to us at sales@labex.com or check out Teclen’s website.
