Pharmaceutical Processing

Product Data Sheet for the GORE® LYOGUARD® Freeze-Drying Tray


Preserve, Protect and Contain

GORE® LYOGUARD® Freeze-Drying Trays are completely enclosed, single-use, autoclavable trays constructed of polypropylene and expanded polytetrafluoroethylene (ePTFE). The tray’s surface that contacts the product is compatible over a wide range of chemicals and biocompatible. Its flexible, thin-film bottom closely conforms to dryer shelves for efficient and uniform heat transfer. The GORE® LYOGUARD® Freeze-Drying Tray is intended for use during lyophilization.



Benefits of GORE® LYOGUARD® Trays:

  • Helps prevent product cross-contamination
  • Helps protect freeze-drying equipment from potential product contamination
  • Reduce or eliminate cleaning and cleaning validation
  • Increase yields by reducing product loss due to fly-out
  • Optimize operations throughput by enabling shorter cycles

Typical Applications Include:

  • Formulation research and development
  • Clinical manufacturing
  • Full-scale production

Quality Assurance

All GORE® LYOGUARD® Freeze-Drying Trays have been 100% visually inspected. A representative sample of trays are leak tested with sampling in accordance with ANSI/ASQC Z1.4-1993.


Materials of Construction
Product Contact Expanded PTFE, Polypropylene frame, Polypropylene* film inner layer
Other External Materials Polyester, Polypropylene
Dimensions
Outside Dimensions 400 mm x 270 mm x 50 mm
Temperature Range of Use
Minimum: -60° C (during freeze-drying) 
Maximum: 125° C (during 30 minute autoclave exposure)

Tray Capacity

The tray liquid capacity is 200 ml to 1800 ml of solution. Fill volume and approximate fill heights are shown:

Fill Volume (ml) Fill Heights (mm) (inches)
200 2.1 0.08
400 4.2 0.17
600 6.4 0.25
800 8.5 0.33
1000 10.6 0.42
1200 12.7 0.50
1400 14.8 0.58
1600 17.0 0.67
1800 19.0 0.75

Sterilization

The GORE® LYOGUARD® trays can be moist heat steam sterilized once (maximum temperature 125 °C for 30 minutes).

Storage

Recommended storage conditions (unused tray: 10-40 °C)

 


Ordering Information

GORE® LYOGUARD® Freeze-Drying Tray
Part Number LGT-2000
GORE™ LYOGUARD® Accessories:
Cross Bar Part Number P229
Foil Pouch Part Number FP30031
Part Packaging
Finished parts Bagged in lubricant free polyethylene bags
Bagged parts Packaged 15 in a polypropylene box with a box liner
Boxes Labeled as "non-sterile" with the part number, lot number and quantity inside the box

GORE® LYOGUARD® Freeze-Drying Trays are recommended for bulk freeze-drying applications up to 1800 ml per tray.