Exceptional product protection and containment during lyophilization
The GORE LYOGUARD Freeze-Drying Tray was specifically engineered for use in applications ranging from bulk processing to formulation research and development, and from clinical phases to full-scale pharmaceutical and biopharmaceutical manufacturing, up to 1800 mls. Gore trays are ideal for freeze-drying:
- intermediate drug substance
Unique to this tray is its GORE™ Membrane — an integrated top barrier that delivers:
- a high vapor transmission rate, so water and solvent vapors are readily released
- highly-effective barrier protection, to minimize the risk of cross-contamination, limit exposure to API and reduce the chance of fly-out
|Disposable, single-use trays save time||
|Easily integrated with your processes||
|Gore quality is assured||
How it Works
The Performance Technology of the GORE LYOGUARD Freeze-Drying Tray
These disposable (single-use) trays incorporate innovative GORE Membrane technology and a unique design to make lyophilization processes easier, and more efficient, than other traditional containers.
The tray top
The tray top is an integrated GORE Membrane with a spout to make tray-filling easy and convenient. The GORE Membrane itself has a specialized microporous structure that is ideal for use in freeze-drying applications. It is engineered to optimize vapor transmission so water and solvents can escape readily. At the same time, this membrane provides excellent barrier protection so it simultaneously repels contaminants and minimizes the risk of fly-out.
About the GORE Membrane
The surface of this 100% ePTFE membrane is engineered to be:
- chemically inert
- thermally stable
The Tray Base
The tray base of flexible, thin-film polypropylene closely conforms to dryer shelves, for efficient and uniform heat transfer.
GORE LYOGUARD Freeze-Drying Trays provide the optimal balance of breathable vapor transmission and barrier protection. This ensures that your product remains properly contained and protected.
Performance Advantages with Gore
The GORE LYOGUARD Freeze-Drying Tray is a unique replacement for open stainless-steel trays and other containers traditionally used for the lyophilization process. Neither open trays nor trays with improvised wraps or covers can match the unique combination of performance benefits that GORE LYOGUARD Freeze-Drying Trays provide.
Trays vs. Alternatives
GORE LYOGUARD Trays
Integrated top — no need for separate covers
Covered trays are single-use; no cleaning
Effectively block contents from escaping
Effectively reduces risk of product cross-contamination
Tray Covers or Improvised Wraps
Require extra handling to install/remove
Require extra labor to clean after use
Vulnerable to leaks, spills, fly-outs
Vulnerable to external contaminants
GORE LYOGUARD Trays
Integrated top membrane to reduce splash risk; no special precautions needed
Enable filling at higher speeds for greater productivity
Integrated top membrane contains and protects product, effectively reduces risk of splash/fly-out incidents for more flexibilty during filling, loading, unloading, or transport
Trays can be stacked for transport and storage after lyophilization
Impact on Thermal Transfer
Flexible, thin film base allows for uniform tray-to-shelf contact, minimizing air gaps and improving thermal transfer
Efficient barrier protection effectively reduces risk of cross-contamination
Reduced risk of fly-out means:
- productivity and production yields remain high
- fewer unanticipated clean-ups to slow productivity
Fast, simple recovery process: use integrated spout or cut bottom film to recover product
By protecting against spills and fly-outs, the need for additional remedial cleanings or validations is effectively reduced
Open Stainless-Steel Trays
Low speed filling in Class-A environment, close to dryer loading area, required to minimize splashing
Requires multiple slow and careful manipulations to fill, load, download, and transport open trays without incident
Open trays cannot be stacked
Impact on Thermal Transfer
Metal trays may warp creating inconsistent tray-to-shelf contact, resulting in poor thermal transfer
Highly vulnerable to cross-contamination of product
Highly vulnerable to fly-out, which can:
- significantly reduce production yields
- require extra cleanup after fly-out
Spatula use requires a slow, careful process
After spills or fly-out, cleaning of freeze dryer requires additional validation, consuming worker time and resources
It is important for us to understand how GORE LYOGUARD Freeze-Drying trays will be used so that we can ensure compliance with industry standards as well as those of our own qualification process. Please tell us more about your requirements and application by completing our Application Questionnaire.
Thank you for your consideration. We look forward to working with you.
For more general questions about our trays and their application, please contact us by email using the link below.
Cherish Robinson, Product Specialist with Gore's PharmBIO business, discusses the advantages and disadvantages of freeze-drying bulk drug ingredients.