GORE LYOGUARD Freeze-Drying Trays are fully enclosed, single-use, disposable containers that use expanded polytetrafluoroethylene (ePTFE) membrane technology to contain and protect liquid or lyophilized active pharmaceutical ingredient (API) during the entire freezedrying process.
PROTECT YOUR OPERATORS AND ELIMINATE TRAY CLEANING
Keeping liquid or lyophilized API in stainless steel trays is a challenging and time-consuming problem during processing. GORE LYOGUARD Freeze-Drying Trays were designed in consultation with industry experts to contain product during the freeze-drying process. For nearly 20 years, GORE LYOGUARD Trays have been trusted to help manufacturers minimize the risk of exposure to drug product and spend less time worrying about product ejection and cleaning.
These disposable trays are ideal for bulk freeze-drying a variety of drug substances, especially:
- APIs or highly potent APIs
Unique to this tray is its GORE Membrane — an integrated top barrier that delivers:
- a highly effective protection barrier to keep product contained in the tray
- a high vapor transmission rate, so water and solvent vapors are readily released
Addressing an Unmet Need, One Tray at a Time
|Integrated membrane top allows for high vapor transmission while also providing containment||
|Single-use, disposable (SUD) trays save time||
|Easily integrated with your processes||
|Gore quality is assured||
How it Works
THE PERFORMANCE ADVANTAGES OF GORE
GORE LYOGUARD Freezing Trays are a direct replacement for open or covered stainless trays traditionally used for bulk lyophilization of API. 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.
The tray top
The tray top is an integrated GORE Membrane with a spout to make tray-filling easy and convenient. It forms a barrier to reduce product fly-out or ejection during lyophilization and to minimize risk of inadvertent spills and associated cleanups. 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.
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 closely conforms to dryer shelves, for efficient and uniform heat transfer.
GORE LYOGUARD Freeze-Drying Trays provide the optimal balance of barrier protection and breathable vapor transmission. This keeps product in the tray while allowing for efficient lyophilization.
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
Replace Stainless Steel Trays
An Innovation for Lyophilization
Open stainless-steel trays are the norm for lyophilization, but that doesn’t mean they’re ideal. Introduce yourself to the only single-use, self-contained tray on the market. GORE LYOGUARD Freeze-Drying Trays offer a number of benefits for the synthesis of peptides and oligonucleotides.
Contain Product — and Costs
In traditional freeze-drying processes using open trays, drug product can escape the tray into the lyophilization chamber. GORE LYOGUARD Freeze-Drying Trays help prevent product ejection for less mess and less product loss.
Easier Filling, Less Spilling
Filling open trays can leads to product spills, which creates messes, wastes product and exposes workers to potentially hazardous APIs. GORE LYOGUARD Freeze-Drying Trays feature an innovative top membrane and spout that makes tray filling easier and safer.
Get a Handle on Handling
Stainless-steel trays are challenging to handle because drug product can spill, exposing operators to active pharmaceutical ingredients. GORE LYOGUARD Freeze-Drying Trays enclose liquids completely, preventing spills and making tray handling more efficient.
Never Clean Another Tray
Single-use lyophilization trays don’t need to be cleaned, which saves pharmaceutical companies and drug manufacturers time and money. GORE LYOGUARD Freeze-Drying Trays are the only single-use, self-contained tray on the market.
It is important for us to understand how GORE LYOGUARD Freeze-Drying trays will be used so that we can ensure compliance with appropriate 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.
Visit Gore at AsiaTIDES 2020 in Kyoto Japan February 24-26, Stand 18 at the Westin Miyako Kyoto
Visit Booth 70 at BPI Europe in Vienna and Booth 3737 at Interphex in New York City to learn how Gore's innovative technologies help biopharmaceutical manufacturers achieve efficiency and operate reliably.
Cherish Robinson, Product Specialist with Gore's PharmBIO business, discusses the advantages and disadvantages of freeze-drying bulk drug ingredients.