GORE® LYOGUARD® Freeze-Drying Trays

Single-use, enclosed freeze-drying trays that keep product in the tray during the lyophilization process. 

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Data sheet for GORE LYOGUARD Freeze-Drying Trays

Lyophilization

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.

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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, 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:

  • polypeptides
  • oligonucleotides
  • 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
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.

Addressing an Unmet Need, One Tray at a Time
PROTECT
Integrated membrane top allows for high vapor transmission while also providing containment
  • covered tray keeps API cake contained, traps dust and reduces chance of fly-out
  • risk of operator exposure to highly potent APIs is limited
OPTIMIZE
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
REPLACE
Easily integrated with your processes
  • a direct replacement for open or covered trays or containers
  • convenient fill-cap for efficient filling operations
  • compatible with most bulk tray freeze-drying processes, solvents and equipment
  • can be sterilized using autoclaving
TRUST
Gore quality is assured
  • produced under relevant current Good Manufacturing Practices (cGMPs)
  • assembly operations are conducted in an ISO 7
  • final inspection and packaging are conducted in a controlled environment
  • 100% visual inspection for defects in workmanship and visible contamination

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.

Closeup of top of a GORE LYOGUARD Tray
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.

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.

 

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.

Trays vs. Alternatives
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.

 

Questions?

Image of application questionnaire

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.

Resources

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