Data Sheet: GORE® LYOGUARD® Freeze-Drying Tray

United States

GORE LYOGUARD Freeze-Drying Trays are fully enclosed, single−use, disposable containers that use a unique ePTFE membrane technology to both prevent cross−contamination and fly-out, and enable the free exchange of moisture vapor during lyophilization.


Product Description

GORE LYOGUARD Freeze-Drying Trays are fully enclosed, single−use, disposable containers that use a unique ePTFE membrane technology to both prevent cross−contamination and fly-out, and enable the free exchange of moisture vapor during lyophilization.

The ePTFE tray surface is chemically inert, non-shedding, and biocompatible and includes a convenient fill cap. The flexible, thin−film polypropylene tray bottom closely conforms to dryer shelves for efficient and uniform heat transfer.

These autoclavable trays are designed to be direct replacements to open trays and are compatible with most freeze-drying processes.

Common Applications

  • Bulk API lyophilization up to 1800 ml
  • Formulation research and development
  • Clinical phases and full scale manufacturing
Illustration shows tray with GORE ePTFE Membrane barrier repelling contaminants while allowing vapor (water and solvents) to escape.

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

Material of Construction

Product Contact Surfaces

  • Polypropylene
  • GORE™ expanded polytetrafluoroethylene (ePTFE) membrane

Other External Materials

  • Polyester

Regulatory Information

The GORE LYOGUARD Freeze-Drying Tray is intended for use as a processing aid in the production of materials that are frequently subject to FDA regulation. The regulatory status of the end product resulting from a manufacturing process, such as a pharmaceutical, does not transform a manufacturing apparatus into a medical device. The GORE LYOGUARD Tray is neither classified nor regulated as a medical device.

Tray Manufacturing and Quality

Assembly operations for the GORE LYOGUARD Trays are conducted in an ISO 8 clean room with particle monitoring to ensure that the room is operating to at least ISO 7 (class 10,000) during operation. Final inspection and packaging are conducted in a controlled environment.

GORE LYOGUARD Freeze-Drying Trays are manufactured in a manner that adheres to relevant current Good Manufacturing Practices (cGMP), as defined in a quality system certified to ISO13485, and ISO15378.

GORE LYOGUARD Freeze-Drying Trays are 100% visually inspected for defects in workmanship and visible contamination.

Performance Data Summary

Biocompatibility USP ‹87› Biological Reactivity Tests In Vitro
USP ‹88› Biological Reactivity Tests In Vivo, Class VI
Bacterial Endotoxin USP ‹85› Bacterial Endotoxin limits
Physicochemical Physicochemical Tests set forth in the Test Method section and Expanded Extracts (Solvents) per USP ‹661›, Physicochemical Testing
Particulates USP ‹788› Particulate Matter in Injections for Large Volume Parenterals
Barrier Testing The adequacy of this tray to maintain a sterile barrier was demonstrated through the Aerosol Challenge and Talc Challenge tests.

The details of test procedures and results are available in the GORE LYOGUARD Freeze-Drying Trays Validation Guide.

Operating Conditions

Chemical Compatibility

All product contact surfaces are composed of polytetrafluoroethylene or polypropylene. Both polymers are chemically inert and have a high degree of compatibility with a variety of fluids.

As with other processing aids, the user, who is most knowledgeable about the formulation of the product, is responsible for ensuring the compatibility of their formulation with GORE LYOGUARD Trays.

Sterilization

The GORE LYOGUARD Tray may be steam sterilized once (if necessary), using a moist heat, pre-vacuum autoclave cycle. Refer to GORE LYOGUARD Freeze-Drying Trays Validation Guide for more information.

Recommended Tray Fill Volume Recommended Temperature
Maximum volume: 1800 ml Maximum temperature: 125°C (257°F)
Minimum volume: 200 ml Minimum temperature: -60°C (-76°F)

Dimension and Design

GORE® LYOGUARD® Freeze-Drying Tray Dimensions and Design

Storage

Storage Recommendation

Store in original packaging at temperatures between 10-40°C (50-104°F) with humidity less than 65%.

Shelf Life

When properly stored, it is recommended to use GORE LYOGUARD Freeze-Drying Trays within two years of the date of manufacture.

Ordering Information

Part Part Number Minimum Order Quantity Accessories Sold Separately
Tray LGT2000 15 Trays (1 box)  
Foil Pouch FP30031 50 Pouches Foil pouches are recommended for product stored in trays after lyophilization
Crossbar P229 10 Bars Crossbars are recommended for use during autoclaving