Pharmaceutical Processing

Handling Tips


Filling

  1. Place the GORE® LYOGUARD® Freeze-Drying Tray on a flat surface.
  2. Unscrew cap from fill port.
  3. Fill appropriate volume of product into container using aseptic procedure.

     1.2L=½" (12.7 mm) fill height
     1.8L=¾" (19.0 mm) fill height
  4. Replace cap on fill port and tighten "finger tight."

Note: Stacking trays filled with liquid is not recommended because vapors transmitted through the membrane of the lower tray may condense onto external surfaces of trays stacked on top

Loading Into dryer

GORE® LYOGUARD® Freeze-Drying Trays are loaded into lyophilizer shelves in the same fashion as an open tray.

  • It is recommended that GORE® LYOGUARD® Trays be carried in a horizontal orientation when filled with fluid
  • Incidental contact occurring between solution and membrane is not a cause for alarm as the ePTFE membrane barrier is highly resistant to liquid penetration. Most solutions will simply roll off of the membrane if contact is made

Removing from dryer

  • GORE® LYOGUARD® Freeze-Drying Trays are removed from a lyophilizer in the same fashion as an open tray.
  • GORE® LYOGUARD® Freeze-Drying Trays containing dried product may be stacked on top of each other at alternating angles.

Product sampling

  1. Place tray on flat surface.
  2. Remove fill port cap.
  3. Insert sampling probe through fill port and collect samples from appropriate areas, exercising caution not to damage tray bottom or membrane barrier with the sampling probe.
  4. Replace fill port cap and tighten to "finger tight."

Product storage

If dried product will be stored or shipped inside GORE™ LYOGUARD® Freeze-Drying Trays, each tray should be sealed inside a foil barrier pouch to prevent degradation of the dried product by ambient moisture.

Product recovery

Dried powder removal:

  1. Invert tray.
  2. Using a sharp instrument, score the flexible film bottom along a corner, taking care not to cut into the rigid frame. Hold the tray by opposite, non-scored corners and flex tray to empty product contents through the scored corner.
  3. Product removal technique will vary, depending on dried-cake characteristics.
  4. Another method for removal of the dried powder entails crushing the cake into smaller pieces inside the GORE® LYOGUARD® Tray, removing the cap and vacuuming the cake into a powder filler or other containment device.

Note: Film may be peeled away from some solid product cakes. Other cakes may be scooped from the tray top and, if needed, gently scraped from the film or internal tray surfaces. The most appropriate method will depend on the individual product.

Reconstituted liquid removal:

  1. Place tray on flat surface.
  2. Remove fill-port cap.
  3. Add appropriate amount of dilutent to tray.
  4. Replace cap.
  5. If needed, tray may be gently rocked to facilitate reconstitution.
  6. Place tray on flat surface.
  7. Remove fill-port cap.
  8. Insert product transfer tubing into fill port and transfer product. Tray may be gently tilted to facilitate complete liquid recovery.