Overview

PROTECT YOUR OPERATORS AND ELIMINATE TRAY CLEANING
Image of a technician with a GORE LYOGUARD Freeze-Drying Tray

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, manufacturers have trusted GORE LYOGUARD Trays to help minimize the risk of exposure to APIs and Highly-Potent APIs, and to enable operators to spend less time worrying about product ejection and cleaning. 

These 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

    Unique to this lyophilization tray is its GORE Membrane — an integrated 100% ePTFE tray cover that provides:

    • a built-in protective barrier that keeps contaminants out

    • a permanently-attached cover to safely contain product, unlike steel trays

    • a high vapor transmission rate, so water and solvent vapors are readily released
    Illustration shows how GORE ePTFE Membrane repels contaminants and allows vapor to escape.

    Gore's unique microporous ePTFE membrane enables high-efficiency lyophilization yet provides a barrier to keep product in the tray.

    LYOPHILIZATION TRAY APPLICATIONS

    GORE LYOGUARD Freeze-Drying Trays can simplify processing by eliminating many cleaning operations, and can enable greater safety in handling a wide variety of fluid and lyophilized drug products, including: 

    • polypeptides
    • oligonucleotides
    • vaccine adjuvants including lipid nanoparticles
    • microbiome therapeutics

    The integrated GORE Membrane enables exceptional mass transfer while the thin, conforming tray bottom facilitates efficient thermal transfer

    Filling and freeze-drying within GORE LYOGUARD Trays is easy and efficient, as the tray design can reduce the chance of contamination and the risk of operator exposure — or loss of valuable product — due to fly-out or ejection.

    For virtually any lyophilized drug formulation or lyophilized drug development process, GORE LYOGUARD Freeze-Drying Trays totally eliminate tray cleaning, and can reduce the chance of accidental spills and related cleanings of the lyophilization chamber. 

    Lyophilization tray for bacterial applications

    An area of intense clinical focus is preservation of bacteria by lyophilization, whether for traditional therapeutics or emerging microbiome applications relating to gut microbiota, gut flora or live biotherapeutic product. GORE LYOGUARD Freeze-Drying Trays are designed to support a wide range of formulations for freeze-drying of bacteria and lyophilization of nanoparticles because they can enable greater operator safety and process efficiency, and reduce risk of product contamination — all of which are essential in lyophilization of bacterial culture. 

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    CONTAINMENT
    Integrated membrane top allows for high vapor transmission while also providing containment
    • barrier membrane keeps API cake contained, traps dust and reduces chance of fly-out
    • risk of operator exposure to highly potent APIs is limited
    THROUGHPUT
    Single-use, disposable (SUD) trays save time
    • optimize throughput, with shorter cycle times
    • eliminate cleaning of trays and/or covers after use
    • avert spills and associated cleanups
    COMPATIBILITY
    Easily integrated with your processes
    • a direct replacement for open or covered trays or containers
    • convenient fill-port for efficient filling operations
    • compatible with most bulk tray freeze-drying processes, solvents and equipment
    • can be sterilized using autoclaving
    CONFIDENCE
    Gore quality is assured
    • produced under relevant current Good Manufacturing Practices (cGMPs)
    • assembly, final inspection and packaging are conducted in a cleanroom monitored to ISO Class 7
    • 100% visual inspection for defects in workmanship and visible contamination

    How it Works

    THE PERFORMANCE ADVANTAGES OF GORE

    GORE LYOGUARD Freeze-Drying 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.

    Closeup of top of a GORE LYOGUARD Tray
    The tray top

    The tray top includes an integrated GORE Membrane and a fill-port with threaded cap to make tray-filling easy and convenient. The GORE Membrane 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, while at the same time it creates a barrier to reduce product fly-out or ejection during lyophilization. This minimizes the risk of inadvertent spills and associated cleanups.

    SEM image of Lyoguard Tray ePTFE membrane
    The GORE Membrane

    The surface of this 100% ePTFE membrane is engineered to be:

    • chemically inert
    • biocompatible
    • non-particulating
    • thermally stable

     

     

    Closeup of base of a GORE LYOGUARD Tray
    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.

     

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    Product Comparison

    Performance Advantages

    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.

    GORE LYOGUARD FREEZE-DRYING TRAYS vs. Alternatives
      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 Integrated top membrane reduces splash risk; no special precautions needed

    Enable filling at higher speeds for greater productivity
    Low speed filling in Class-A environment, close to dryer loading area, required to minimize splashing
    Tray Handling Integrated top membrane contains and protects product, effectively reducing risk of splash/fly-out incidents for more flexibilty during filling, loading, unloading, or transport

    Trays can be stacked for transport and during post-lyophilization storage
    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 Flexible, thin film base provides uniform tray-to-shelf contact, minimizing air gaps and improving thermal transfer Metal trays may warp creating inconsistent tray-to-shelf contact, resulting in poor thermal transfer
    Contamination Efficient barrier protection effectively reduces risk of contamination Highly vulnerable to contamination of product
    Fly-Out Reduced risk of fly-out means:
    • productivity and production yields remain high
    • fewer unanticipated clean-ups to slow productivity
    Highly vulnerable to fly-out, which can:
    • significantly reduce production yields
    • require extra cleanup after fly-out
    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
    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.

     

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    Resources

    Recent News

    Event

    W. L. Gore & Associates Exhibiting at TIDES Europe

    November 16, 2022 - November 18, 2022

    Gore is exhibiting at this year’s TIDES Europe Conference, and you’re invited to visit our stand, where we’ll be showcasing the benefits of GORE® LYOGUARD® Freeze-Drying Trays. Chat with Gore representatives and see how our freeze-drying trays protect both pharmaceutical products and operator safety.

    Event

    Gore at AsiaTIDES 2020

    February 24, 2020 - February 26, 2020

    Visit Gore at AsiaTIDES 2020 in Kyoto Japan February 24-26, Stand 18 at the Westin Miyako Kyoto

    Press Release

    Gore Attending Two Upcoming Biopharmaceutical Conferences in April

    Posted March 22, 2019

    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.

    News

    Article: Lyophilization: The Basics

    Posted October 23, 2017

    Cherish Robinson, Product Specialist with Gore's PharmBIO business, discusses the advantages and disadvantages of freeze-drying bulk drug ingredients.

    View all News & Events

    NOT INTENDED FOR USE in medical device or food contact applications or with radiation sterilization.