Selecting packaging and coolant systems for shipment of biological products
Disclosed is a process of selecting of a container and temperature-control system, such that biological products (including blood) requiring maintenance within a specified range of temperatures are so maintained during shipment. The process requires a prediction of the maximum period of shipment, and the predicted ambient temperature ranges and time of exposure thereto for the system during the period of shipment. With that information, a system of container(s) with temperature-control agents including dry ice, ice, frozen gel packs or a phase change material, is selected.
1. A process of ensuring blood for transfusion requiring temperature-control is maintained within a range of 22° C.±2° C. during shipment, comprising:
determining the maximum predicted period of shipment for the blood and the predicted ambient temperature ranges during shipment;
establishing a database for a plurality of temperature-control systems, each system including containers and a phase change material within the containers wherein the database can be used to determine the length of time each member system can maintain blood housed in the containers with the phase change material within said range when the temperature-control system is exposed to specified ranges of ambient temperatures for specified time periods, and wherein the specified ranges and time periods can represent, respectively, the predicted ambient temperature ranges and times of exposure thereto for the member system during said maximum total predicted period of shipment;
selecting a system of containers and a phase change material so that the blood is expected to be maintained within said range during the maximum predicted period of shipment at the predicted ambient temperature ranges;
monitoring the system temperature to determine directly if it stays within a specified range or monitoring the ambient temperature and determining, by derivation, if the system temperature stays within the specified range such that the blood is maintained within said range;
alerting an operator if the system temperature is outside the specified range, whereby pursuant to the alert, the operator takes or directs actions to bring the system temperature within the specified range; and
testing the blood using a blood-typing assay wherein, in the course of the assay, there is one or more of: nucleic acid hybridization, nucleic acid chain elongation, antibody-protein binding, or protein-protein binding wherein the relative humidity, pressure, and CO 2 is also monitored during shipment.
2. The process of claim 1 wherein the database is established on a computer and the selection of a member system is performed as an algorithm executed by the computer.
3. The process of claim 1 wherein the systems further include dry ice, ice, or frozen gel packs.
4. The process of claim 1 wherein the database is established by deriving, from the characteristics of the containers and the phase change material, the length of time each member system can maintain products housed in the containers with the phase change material within a specified range of temperatures when the member system is exposed to specified ranges of ambient temperatures for specified time periods.
5. The process of claim 1 wherein the system selected is one which minimizes the use of the phase change material.
6. The process of claim 1 wherein the selection can be performed from a remote location through a web-based system allowing computer access.
7. The process of claim 1 wherein the system(s) selected and their price(s) are displayed in operator-readable form.
8. The process of claim 7 wherein the database also includes the shippers charges for different shipment options to a particular destination, and the alogrithm also determines the lowest-cost combination of system and shippers' charges to said destination.
9. The process of claim 1 wherein the predicted ambient temperature range is from the lowest ambient temperature likely to be experienced to the highest, and the predicted time period a member system is to be exposed to said predicted ambient temperature range is the entire length of the shipment period.
10. The process of claim 1 wherein the blood is in blood bags.
11. The process of claim 1 wherein the predicted ambient temperature range for the system during shipment is based on historic ambient temperature data for the predicted shipping route.
12. The process of claim 11 wherein ambient temperature data is monitored during shipment and alerts indicate excursions from the predicted ambient temperature range.
13. The process of claim 1 wherein the container is made of expanded polystyrene or polyethylene.
14. The process of claim 1 further including obtaining a warranty for delivery within the shipment period from a shipper.
15. The process of claim 1 wherein the system is in a temperature-controlled environment during shipment.
16. The process of claim 1 further including recording the temperatures monitored.
17. The process of claim 1 wherein the temperatures monitored are used in determining the predicted ambient temperature for blood shipped in the future.