GORE® LYOGUARD® Freeze-Drying Trays

Developed in consultation with the pharmaceutical lyophilization industry, GORE LYOGUARD Freeze-Drying Trays provide a cost-effective method of freeze-drying by containing product throughout the lyophilization process.

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Validation Guide: GORE LYOGUARD Freeze-Drying Trays

Lyophilization

A comprehensive guide for validating these trays for use in your application. This document is available upon request.

English (U.S.)

All Resources For GORE® LYOGUARD® Freeze-Drying Trays

Overview

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:

  • biologics
  • peptides
  • oligonucleotides
  • proteins
  • intermediate drug substance
  • API

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
Illustration shows how GORE™ ePTFE Membrane repels contaminants and allows vapor to escape.

Gore's unique ePTFE membrane enables high efficiency lyophilization yet provides a barrier to product cross-contamination.

Disposable, single-use trays save time
  • optimize throughput, with shorter cycle times
  • eliminate cleaning of trays and/or covers after use
  • covered tray reduces chance fly-out; averts spills and associated cleanups
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 freeze-drying processes and equipment
  • can be sterilized using autoclaving
Gore quality is assured
  • produced under relevant current Good Manufacturing Practices (cGMPs)
  • assembly operations are conducted in an ISO 8 clean room with particle monitoring to ensure operation to at least ISO 7 (Class 10,000)
  • 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 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.

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. 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.

 

SEM image of Lyoguard Tray ePTFE membrane
About 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 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.

 

Product Comparison

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

Questions?

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 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.

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