Frozen Plasma and Cryoprecipitated AHF Component Storage

All frozen components must be stored in a controlled, monitored freezer. See the table below for shelf-life of common components in a closed system. When the system is "opened", components stored at 1-6C must be used within 24 hours. Additional information on storage may be found in the following sections of the Circular of Information for the Use of Human Blood and Blood Components:

• Frozen plasma, LR: Amendment 1
• FFP, LR and FFP, Apheresis: E.7
• Cryosupernatant Plasma,LR and Cryoprecipitated AHF, LR: F.7

Shelf Life

Component Shelf Life When Frozen Shelf Life When Thawed
Frozen Plasma, LR 12 months at -18C or colder 4 hours stored at 1-6C
FFP, LR, FFP Apheresis,
Cryosupernatant Plasma, LR
12 months at -18C or colder 24 hours stored at 1-6C
Cryoprecipitated AHF, LR 12 months at -18C or colder Up to 4 hours stored at 20-24C

Specifications for Blood Component Storage Devices

Blood component storage freezers are specially manufactured for this purpose. The following are requirements for frozen blood component storage. Storage must:

  • have or be connected to a validated continuous recording device. If there is not continuous recording device, the temperature should be documented manually using a calibrated thermometer every four hours.
  • have an alarm system with an audible signal.

Examples of manufacturers of blood storage equipment (with specifications)

Laboratory Operating Requirements

The laboratory must have written procedures that contain directions for actions to take in the event of a power failure or malfunction.

Contingency Plan in Case of Malfunction

All laboratories should have written procedures that identify the steps to follow when critical equipment malfunctions. A Standard Operating Procedure (SOP) that addresses this type of situation should be written. The SOP should include steps for interim storage of blood components. These may include but are not limited to:

  • Not opening the freezer when malfunction is found.
  • Contact names for notification and for repair.
  • Careful monitoring and documentation of temperature. When the temperature is close to the upper temperature limit, steps to remove the blood products for shipment to an alternate storage freezer.
  • Use of blood component transport containers for shipment to nearby freezer or facility for storage.
  • Monitoring of temperatures when an alternate freezer is located/used. If there is no continuous monitoring device on this freezer, the temperature must be read and documented every four hours.

Further Reading

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