Monitoring temperature-sensitive cargo with automated generation of regulatory qualification
Disclosed is a process of determining, at a point during shipment, whether the solid phase refrigerant in a shipment is sufficient to preserve the shipment cargo, which is blood or other biological products, for the remaining shipment period, by: monitoring the temperatures encountered to said point and estimating the temperatures likely to be encountered during the remaining shipment period; determining the likelihood that the remaining refrigerant can maintain the shipment cargo within a specified temperature range during the remaining shipment period; and if the risk that the remaining refrigerant cannot maintain the shipment cargo within said range during the remaining shipment period is above a cut-off level, then taking action to preserve the value of the cargo.
1. A process of ensuring low cost shipment of biological products requiring temperature-control, comprising:
determining a maximum predicted period of shipment for biological products and predicted ambient temperature ranges during shipment;
selecting a system of containers and solid phase refrigerants, which change from solid phase during shipment, likely to maintain the biological products within a specified range of temperatures during the shipment period;
shipping the products in the selected system and monitoring the temperatures encountered to a certain point during the shipment period using an on board monitor which monitors and records the temperatures and the length of time the system was exposed to particular temperatures throughout the shipment period, and wherein the monitor displays the record of temperatures and times of exposure in a form which can be scanned;
calculating the amount of the solid phase of the refrigerant remaining at said point during the shipment period based on the temperatures encountered;
calculating a value, at said point during shipment, representing the likelihood that the remaining solid phase refrigerant is sufficient to preserve the biological products, for the remaining shipment period, based on the expected ambient temperature range during said remaining shipment period; and
if the likelihood that the remaining refrigerant can maintain the shipment cargo within said specified temperature range during the remaining shipment period is below a cut-off level, then taking action to preserve the value of the cargo, which is one of: adding refrigerant to the shipment, moving the shipment to a faster transportation mode, moving the shipment to a temperature-controlled environment, or diverting the shipment to a different recipient.
2. The process of claim 1 wherein the temperature-controlled environment is a refrigeration unit or a refrigerated cargo hold in a train, airplane or truck.
3. The process of claim 1 wherein the solid phase refrigerants are dry ice, ice, frozen gel packs or phase change material or 1-dodecanol.
4. The process of claim 1 further including a GPS or other geo-location system to allow location of the shipment en route.
5. The process of claim 1 wherein the relative humidity, pressure and CO 2 is also monitored during shipment.
6. A process of ensuring low cost shipment of biological products requiring temperature-control, comprising:
determining a maximum predicted period of shipment for biological products and predicted ambient temperature ranges during shipment;
selecting a system of containers and solid phase refrigerants, which change from solid phase during shipment, likely to maintain the biological products within a specified range of temperatures during the shipment period;
shipping the products in the selected system and monitoring the temperatures encountered to a certain point during the shipment period using an on board monitor which monitors and records the temperatures and the length of time the system was exposed to particular temperatures throughout the shipment period, and records the temperatures and time of exposure in a file format which can be read by software readers;
calculating the amount of the solid phase of the refrigerant remaining at said point during the shipment period based on the temperatures encountered;
calculating a value, at said point during shipment, representing the likelihood that the remaining solid phase refrigerant is sufficient to preserve the biological products, for the remaining shipment period, based on the expected ambient temperature range during said remaining shipment period; and
if the likelihood that the remaining refrigerant can maintain the shipment cargo within said specified temperature range during the remaining shipment period is below a cut-off level, then taking action to preserve the value of the cargo, which is one of: adding refrigerant to the shipment, moving the shipment to a faster transportation mode, moving the shipment to a temperature-controlled environment, or diverting the shipment to a different recipient.
7. The process of claim 6 wherein the file format is pdf or text.
8. The process of claim 6 wherein the recorded temperatures and time of exposure is stored in the format of a certificate.
9. The process of claim 6 further including downloading the file with the recorded temperatures and time of exposure to another device capable of reading the file format.
10. The process of claim 6 wherein the temperature-controlled environment is a refrigeration unit or a refrigerated cargo hold in a train, airplane or truck.
11. The process of claim 6 wherein the solid phase refrigerants are dry ice, ice, frozen gel packs or phase change material or 1-dodecanol.
12. The process of claim 6 further including a GPS or other geo-location system to allow location of the shipment en route.
13. The process of claim 6 wherein the relative humidity, pressure and CO 2 is also monitored during shipment.
14. A process of ensuring low cost shipment of biological products requiring temperature-control, comprising:
determining a maximum predicted period of shipment for biological products and predicted ambient temperature ranges during shipment;
selecting a system of containers and solid phase refrigerants, which change from solid phase during shipment, likely to maintain the biological products within a specified range of temperatures during the shipment period;
shipping the products in the selected system and monitoring the temperatures encountered to a certain point during the shipment period using an on board monitor which monitors and records the temperatures and the length of time the system was exposed to particular temperatures throughout the shipment period, which is attached to or embedded in the containers;
calculating the amount of the solid phase of the refrigerant remaining at said point during the shipment period based on the temperatures encountered;
calculating a value, at said point during shipment, representing the likelihood that the remaining solid phase refrigerant is sufficient to preserve the biological products, for the remaining shipment period, based on the expected ambient temperature range during said remaining shipment period; and
if the likelihood that the remaining refrigerant can maintain the shipment cargo within said specified temperature range during the remaining shipment period is below a cut-off level, then taking action to preserve the value of the cargo, which is one of: adding refrigerant to the shipment, moving the shipment to a faster transportation mode, moving the shipment to a temperature-controlled environment, or diverting the shipment to a different recipient.
15. The process of claim 14 wherein the on board monitor has temperature sensors attached to it which extend to the area in the system where the biological products are housed.
16. The process of claim 14 wherein the temperature-controlled environment is a refrigeration unit or a refrigerated cargo hold in a train, airplane or truck.
17. The process of claim 14 wherein the solid phase refrigerants are dry ice, ice, frozen gel packs or phase change material or 1-dodecanol.