GORE® LYOGUARD® Lyophilization Trays
Single-use, enclosed freeze-drying trays that keep product in the tray during the lyophilization process.
Protect Your Operators and Eliminate Tray Cleaning
For over 20 years, manufacturers have trusted GORE Lyoguard Trays to help minimize the risk of exposure to liquid or lyophilized active pharmaceutical ingredient (API) and Highly-Potent APIs, and enable operators to spend less time worrying about product ejection and cleaning.
These fully enclosed disposable trays are ideal bulk lyophilization containers, because the GORE Membrane — an integrated 100% ePTFE tray cover — can enable improved process efficiencies and yields, and reduced risk of operator exposure.
Addressing unmet needs in bulk tray lyophilization
Explore the advantages of LYOGUARD single-use disposable freeze-drying trays over traditional stainless steel trays for lyophilization. These innovative trays feature a GORE Membrane - a 100% ePTFE integrated tray cover, which offers:
- Enhanced contamination protection: A built-in barrier that prevents contaminants from entering.
- Secure containment: A permanently attached cover that safely contains the product, unlike removable covers on steel trays.
- Efficient lyophilization: A high vapor transmission rate for effective removal of water and solvent vapors.
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.
The GORE Difference
Tray Top
The tray top features an integrated GORE Membrane and a threaded fill-port for easy filling. The microporous membrane optimizes vapor transmission for efficient drying while preventing product fly-out, minimizing spills, and reducing cleanup risks.
ePTFE Membrane
This 100% ePTFE membrane is designed with a surface that is chemically inert, biocompatible, non-particulating, and thermally stable, ensuring it meets the stringent requirements for sensitive pharmaceutical applications.
Tray Base
The flexible, thin-film tray base ensures efficient, uniform heat transfer by conforming to lyophilizer shelves when tray is filled.
LYOGUARD Applications
GORE LYOGUARD Freeze-Drying Trays streamline processing by eliminating tray cleaning operations while working with various fluid and lyophilized drug products. The integrated GORE Membrane ensures exceptional mass transfer, while the thin, flexible tray bottom enables efficient thermal transfer.
These trays simplify filling and freeze-drying by reducing contamination risks, operator exposure, and product loss from fly-out or ejection. They also minimize the chance of spills, enhancing safety by reducing risk of operator exposure and reduce product loss in any lyophilized drug development process.
GORE LYOGUARD Trays vs Competitors
| GORE LYOGUARD Trays | Tray Covers or Improvised Wraps | |
|---|---|---|
| Handling | Integrated top, no need for separate covers | Require extra handling to install/remove |
| Cleaning | Covered trays are single-use; no cleaning | Require extra labor to clean after use |
| Spills/Fly-Outs | Effectively block contents from escaping | Vulnerable to leaks, spills, fly-outs |
| Contamination | Effectively reduces risk of product contamination | Vulnerable to external contaminants |
| GORE LYOGUARD Trays | Open Stainless-Steel Trays | |
|---|---|---|
| Filling Requirements | The integrated top membrane minimizes splash risk, eliminating the need for special precautions, and allows faster filling for improved productivity | Low speed filling in Class-A environment, close to dryer loading area, required to minimize splashing |
| Tray Handling | The integrated top membrane protects the product, reducing splash and fly-out risks, ensuring flexibility during filling, loading, unloading, and transport. Trays are stackable for transport and post-lyophilization storage | Requires multiple slow and careful manipulations to fill, load, download, and transport open trays without incident. Trays cannot be stacked |
| Impact on Thermal Transfer | Flexible, thin film base provides uniform tray-to-shelf contact, minimizing air gaps and improving thermal transfer | Stainless-steel trays may warp creating inconsistent tray-to-shelf contact, resulting in poor thermal transfer |
| Contamination | Efficient barrier protection effectively reduces risk of contamination | Open stainless-steel trays have no barrier protection to reduce the risk of contamination |
| Fly-Out | Reduced fly-out risk ensures high productivity and yields, with fewer unplanned clean-ups to disrupt workflow | Prone to fly-out, leading to reduced production yields and increased cleanup needs |
| Product Recovery | Fast, simple recovery process: use integrated fill-port or cut bottom film to recover product | Spatula use requires a slow, careful process |
| Remedial Cleanings | By protecting against spills and fly-outs, the need for additional remedial cleanings or validations is effectively reduced | After spills or fly-out, cleaning of freeze dryer requires additional validation, consuming worker time and resources |
Learn More About GORE LYOGUARD Below
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.
FOR INDUSTRIAL USE ONLY
Not for use in food, drug, cosmetic or medical device manufacturing, processing, or packaging operations.
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