General Tissue Handling InformationStorageAMNIOGRAFT® and PROKERA® are stored at -80°C (-112°F) before shipping to retain their natural function and integrity. AMNIOGRAFT® and PROKERA® are shipped in a validated, insulated shipping container. It should arrive refrigerated and cool to the touch in the container. Do not open the pouch until the graft is required for use. If the product is not used immediately, the following guidelines should be followed for the storage of the UNOPENED foil pouch containing AMNIOGRAFT® or PROKERA®. The contents of the inner pouch are only frozen solid at -80° C and it only takes 5-10 minutes to thaw before surgery. The storage media used with AMNIOGRAFT® and PROKERA® is in a liquid state at temperatures higher than -20°C and freezes solid if stored at -80°C.
| Storage Time |
Storage Device |
Storage Temperature |
Until expiration date on the tissue package
(media frozen solid) |
-80°C Freezer |
-85°C to -50°C
(-121°F to -58°F) |
1 year after receipt
or until expiration on outer product package,
whichever comes first
(media in liquid state) |
Standard home freezer
|
-49°C to 0°C
(-56°F to 32°F) |
3 months after receipt
or until expiration on outer product package,
whichever comes first
(media in liquid state) |
Standard home refrigerator
|
1°C to 10 °C
(33.8°F to 50 °F) |
Until expiration date written on outer shipping container |
Unopened insulated container
|
2°C to 20°
(35.6°F to 38°F) | |
PackagingBoth AMNIOGRAFT® and PROKERA® are supplied in a dual pouch system. When ready to use, peel open the outer pouch. Using sterile smooth forceps or gloves, carefully remove the clear inner pouch containing the tissue without touching the edges of the foil pouch. The clear inner pouch is then sterile and may be introduced into the sterile field. Using sterile scissors, cut below the sealed line of the inner pouch and remove AMNIOGRAFT® or PROKERA® using smooth, sterile forceps. |