Monitoring of the freezing state of a biopharmaceutical fluid found in a container
US-2016047764-A1 · Feb 18, 2016 · US
US2016341455A1 · US · A1
| Field | Value |
|---|---|
| Publication number | US-2016341455-A1 |
| Application number | US-201615066594-A |
| Country | US |
| Kind code | A1 |
| Filing date | Mar 10, 2016 |
| Priority date | May 20, 2015 |
| Publication date | Nov 24, 2016 |
| Grant date | — |
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A transport object is sealed in a sterilized sealed bag including a volume adjuster, the volume of which is changed according to a temperature change. The sealed bag is placed into a metal sealed container. The sealed container is placed into a temperature-controlled metal soaking container. In a state where the soaking container is fixed to the inside of an insulated container with an insulation material disposed around the soaking container, the internal pressure of the sealed container is maintained at a constant atmospheric pressure by changing the state of a pressure adjustment valve from a closed state to an open state, the pressure adjustment valve being provided in an air ventilation tube which is disposed to extend to the outside of the soaking container and the insulated container from the sealed container. Subsequently, after the internal temperature of the sealed container reaches a predetermined temperature, the pressure adjustment valve is closed again, and then, the insulated container is transported.
Opening claim text (preview).
What is claimed is: 1 . A constant-temperature transportation method, wherein a transport object, which is a temperature-control target object, is sealed in a sterilized sealed bag including a volume adjuster, the volume of which is changed according to a temperature change, the sealed bag is placed into a metal sealed container, the sealed container is placed into a temperature-controlled metal soaking container, and in a state where the soaking container is fixed to the inside of an insulated container with an insulation material disposed around the soaking container, the internal pressure of the sealed container is maintained at a constant atmospheric pressure by changing the state of a pressure adjustment valve from a closed state to an open state, the pressure adjustment valve being provided in an air ventilation tube extending to the sealed container via the soaking container and the insulated container , and wherein, subsequently, after the internal temperature of the sealed container reaches a predetermined temperature, the pressure adjustment valve is closed again, and then, the insulated container is transported. 2 . The constant-temperature transportation method of claim 1 , wherein the internal pressure of the sealed container is maintained at a constant atmospheric pressure by changing the state of the pressure adjustment valve from a closed state to an open state when the sealed container is removed from the soaking container. 3 . The constant-temperature transportation method of claim 1 , wherein a space occupying at least 15% or more of the total volume of the sealed bag after the transport object is set is provided as the volume adjuster of the sealed bag, and during the transportation of the insulated container, the volume of the space is changed according to a change in the external pressure of the sealed bag. 4 . The constant-temperature transportation method of claim 1 , wherein during the transportation of the insulated container, the internal temperature of the sealed container is measured by a wireless thermometer or a thermocouple installed inside the sealed container, and wherein temperature control is performed based on the measured internal temperature of the sealed container such that the temperature of the transport object before and during transportation remains substantially constant. 5 . The constant-temperature transportation method of claim 1 , wherein the soaking container includes a cooling-side thermal conductor; a heat dissipation-side conductor; a Peltier module interposed between the cooling-side thermal conductor and the heat dissipation-side conductor; a power supply configured to supply electrical power to the Peltier module; a power supply-control temperature sensor installed in the vicinity of a portion of a surface in contact with the cooling-side thermal conductor outside of the soaking container, or installed in the cooling-side thermal conductor; a temperature-display temperature sensor installed in a portion of an external side surface of the soaking container, which indicates a temperature approximate to the temperature of the center inside of the soaking container; and a power supply controller configured to control power supply to the Peltier module based on detection results from the power supply-control temperature sensor and the temperature-display temperature sensor, and wherein during the transportation of the insulated container, the power supply to the Peltier module is controlled based on the detection result from the power supply-control temperature sensor and the detection result from the temperature-display temperature sensor such that the temperature of the transport object is maintained at the temperature before transportation. 6 . The constant-temperature transportation method of claim 2 , wherein a space occupying at least 15% or more of the total volume of the sealed bag after the transport object is set is provided as the volume adjuster of the sealed bag, and during the transportation of the insulated container, the volume of the space is changed according to a change in the external pressure of the sealed bag. 7 . The constant-temperature transportation method of claim 2 , wherein during the transportation of the insulated container, the internal temperature of the sealed container is measured by a wireless thermometer or a thermocouple installed inside the sealed container, and wherein temperature control is performed based on the measured internal temperature of the sealed container such that the temperature of the transport object before and during transportation remains substantially constant. 8 . The constant-temperature transportation method of claim 2 , wherein the soaking container includes a cooling-side thermal conductor; a heat dissipation-side conductor; a Peltier module interposed between the cooling-side thermal conductor and the heat dissipation-side conductor; a power supply configured to supply electrical power to the Peltier module; a power supply-control temperature sensor installed in the vicinity of a portion of a surface in contact with the cooling-side thermal conductor outside of the soaking container, or installed in the cooling-side thermal conductor; a temperature-display temperature sensor installed in a portion of an external side surface of the soaking container, which indicates a temperature approximate to the temperature of the center inside of the soaking container; and a power supply controller configured to control power supply to the Peltier module based on detection results from the power supply-control temperature sensor and the temperature-display temperature sensor, and wherein during the transportation of the insulated container, the power supply to the Peltier module is controlled based on the detection result from the power supply-control temperature sensor and the detection result from the temperature-display temperature sensor such that the temperature of the transport object is maintained at the temperature before transportation. 9 . A constant-temperature transport container comprising: a sterilized sealed bag including a volume adjuster, the volume of which is changed according to a temperature change, the sealed bag configured to receive a transport object; a metal sealed container configured to receive the sealed bag; a temperature-controlled metal soaking container configured to receive the sealed container; an insulated container configured so that the soaking container can be fixed to an interior portion of the insulating container with an insulation material disposed around the soaking container; an air ventilation tube extending though the soaking container and the insulated container to communicate with the sealed container; an electromagnetic valve provided in the air ventilation tube; an in-container pressure gauge for measuring an internal pressure of the sealed container; an ex-container pressure gauge for measuring an external pressure of the sealed container; and a controller coupled to the electromagnetic valve, the in-container pressure gauge and the ex-container pressure gauge, the controller configured to: calculate a magnitude of pressure required to cancel out a difference between the measured external pressure and the measured internal pressure of the sealed container; and control opening and closing of the electromagnetic valve to obtain the magnitude of pressure required to cancel out the pressure difference and thereby maintain the internal pressure of the sealed container at a substantially constant atmospheric pressure. 10 . The constant-temperature transport container of claim 9 , wherein a space occupying at least 15% or more o
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