CONSTANT-TEMPERATURE TRANSPORTATION METHOD

Abstract

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.

Description

TECHNICAL FIELD

The technical field relates to a constant-temperature transportation method in which a biological material containing a regenerated tissue or the like, which is manufactured at a cell processing center or the like, is transported while being held in a specific culture environment such as a predetermined temperature, humidity, and pressure.

BACKGROUND

Regenerative medicine restores the lost function of an organ using biological material such as regenerated tissue manufactured by culturing a small amount of cells. In the recent years, regenerative medicine has progressed and attracted a great deal of attention. Regenerative medicine is innovative technology which is anticipated to be considerably effective in treating incurable diseases in the related art. Biological material such as regenerated tissue used in regenerative medicine is manufactured based on good manufacturing practices (GMP) which are a standard of manufacturing control and quality control for medicine. Manufacturing is performed in a cell processing center (CPC) according to a standard operating procedure (SOP) satisfying the GMP. In Japan, the law regarding the GMP legislated by the Ministry of Health, Labor, and Welfare is already in enforcement (Ministry of Health, Labor, and Welfare Ordinance No. 179, Medicine Development No. 480). Related laws have been legislated mainly by European and U.S. organizations (for example, the Food and Drug Administration, and the European Commission) outside of Japan.

At an early stage in putting regenerative medicine into practical use, biological materials were assumed to be manufactured in a small number of CPCs (that is, production bases), and shipped to medical institutions at many locations, that is, transported and used in treatment. Even if a medical institution, in which treatment is performed, is located in the same site in which a cell processing center in which manufacturing is performed is located, the medical institution has cleanliness lower than that of the culture environment, and a daily living space is present between the medical institution and the cell processing center. Accordingly, biological materials are inevitably required to be transported various distances. In the coming years, it is assumed that foreign countries' need for regenerative medicine will be increased, and the possibility of transportation between foreign countries and Japan in a state where the quality is maintained securely and safely is increased.

Currently, biological material such as regenerated tissue is routinely transported in the field of research and development. In contrast, a transportation method based on a standard (standard regarding good logistics) such as a typical good distribution practice (GDP) set to ensure the quality in the transportation and storage processes has not yet been established in the pharmaceutical industry. Various transportation methods are present, and a transportation method is appropriately selected from these transportation methods according to the type of a cell, or the use of the cell after being transported. Examples of the transportation method different from each other include: a method in which cells are transported in a state where a transportation temperature is set to be the same as the culture temperature, and is maintained at a constant temperature (for example, at approximately 37° C.) ; a method in which cells are transported in ambient air in a state where temperature control is not performed (for example, at 10° C. to 37° C.) ; a method in which cells are transported in a refrigerated state in a state where cell metabolism is suppressed (for example, at 4° C.) ; and a method in which cells are transported in a frozen state (for example, in liquid nitrogen or the like at −20° C.). Unlike the manufacturing process, the transportation process is affected by temperature, humidity, pressure, impact, vibration, or the like.

First, the temperature of the external environment, to which a biological material is exposed during transportation, is different from the temperature of the culture environment. The temperature is appropriately selected in the culture environment of a cell processing center according to the type or use of a cell. In many cases, the culture temperature is 37° C. Since a constant temperature chamber is used for temperature control, the range of a temperature change is small. In contrast, the external environmental temperature is changed according to locations during transportation. Accordingly, a mechanism for maintaining the internal temperature of a cell transport container at a constant temperature is required to eliminate an impact of the external environmental temperature. It is necessary to ensure thermal insulation properties by installing an insulation material or the like around the cell transport container to reduce an impact of the external environmental temperature. A considerable amount of time for which the internal temperature is maintained to be constant is desired. When a cell transport container is transported far off to foreign countries by airplane in the future, the cell transport container is assumed to be on standby due to the occurrence of unexpected troubles during loading and unloading under severe conditions in an airport's apron site or during customs formalities, or due to inspection or the preparation of an operation after the cell transport container is delivered to a medical institution which is a destination of transportation.

An important requirement item is that a cell transport container maintains the temperature of a transport object over a long period of time. The reason for this is that a transport object is assumed to be transported overseas in the future. It is also assumed that a treatment is prepared in a state where a culture container is accommodated inside a cell transport container after being delivered to a medical institution. It is possible to maintain the temperature over a considerable amount of time by increasing the amount of a chemical substance or a heat storage material used, but this leads to an increase in the total weight of the cell transport container. As a result, a burden on transport workers is increased. An improvement in thermal insulation properties and heat-retaining efficiency is required to avoid the burden.

As illustrated in FIG. 6, in the configuration disclosed in Japanese Patent No. 5476556, a second insulated container 603 is disposed inside a first insulated container 601 with a thermal conductive cushioning material 602 interposed between the first insulated container 601 and the second insulated container 603. An air-tight container 605 is built into the second insulated container 603 via multiple split heat-storage boxes 604 which are disposed without gaps present in any direction to form a structure in which insulation materials and thermal conductive members are alternately stacked on top of each other in a duplicated manner. Therefore, an improvement in thermal insulation properties and heat-retaining efficiency is realized.

In contrast, pressure is another factor which is changed in the external environment during transportation from the temperature when cells are cultured. A normal pressure of approximately 1 atm. is applied to a culture container in a culture environment, and particularly when transportation is made by airplane, a pressure of approximately 0.8 atm. is applied to the cabin. When a typical culture container is depressurized, gas dissolved in a culture medium is eluted, pH is changed, and thus, the culture medium is brought into a condition not suitable for cell growth. The culture medium may also leak out through the gap between a cover and a body of the culture container. In this case, cleanliness is lost, and biological contamination occurs. An air tightening mechanism to eliminate an impact of pressure is required to avoid the loss of cleanliness and biological contamination. Air tightening can be realized by means such as screws or a hinge fixture. When the volume of an air-tightening target is increased, the sizes of necessary components are increased, and the entire weight of a cell transport container is increased. As a result, a burden on transport workers is increased.

In contrast, in the configuration disclosed in Japanese Patent No. 5476556, the size of a cell accommodating container is reduced such that the cell accommodating container can be placed into a pass box, and safety is ensured by installing a temperature sensor and a pressure sensor in addition to ensuring air-tightness of the cover.

When the cell accommodating container is transported from a cell culture facility, it is necessary to remove the cell accommodating container from a room temperature or 37° C. environment, and to place the cell accommodating container into a transport container, the temperature of which is controlled to a desired temperature. At this time, a rapid temperature change is not avoidable in any case, and the internal pressure of a sealed container may be changed according to the temperature change. Similarly, when the sealed container is delivered to a laboratory or a hospital which is a destination of transportation, and then the sealed container at a low temperature is opened, a pressure change according to a rapid temperature increase may occur, thereby causing damage to cells.

A constant-temperature transportation method is required to cope with a state change caused by a change in the environment during operations before and after transportation.

SUMMARY

As described above, in the constant-temperature transportation method of the related art, technology for maintaining a constant temperature is required, or it is necessary to eliminate an impact of a pressure change when transportation is made by airplane or the like. A cell transport container is required to be transported into a clean culture area in a cell processing center. Therefore, a transport container in which technology for ensuring cleanliness is implemented has been validated.

Cells are stored in a sealed container to prevent the occurrence of a change in the atmospheric pressure when the cells are transported by air. During an actual operation in which tissues such as cells are packed in a laboratory or a hospital, and are placed into a sealed container disposed inside a transport container, air tightness is ensured; however, the internal pressure of a cell containing container may be decreased according to a temperature change when the cell tissues are removed from a cell culture environment, and are placed into a low-temperature transport environment, and the cells may be damaged. When the low-temperature sealed container is opened at a laboratory or a hospital which is a destination of transportation, a pressure change according to a rapid temperature increase may occur, and the cells may be damaged. Care must be taken in controlling a pressure change in an actual operation.

In contrast, in the method of the related art, a pressure change according to a rapid temperature change when a transport object is placed into a transport container is not taken into consideration. For example, in a case where a transport object is packed in a 37° C. environment, and is set into a sealed container disposed in a transport container to keep the transport object at 5° C., due to sealability, the pressure of the sealed container apparently becomes 897 hPa according to the gas state equation. Similar to the case where care is taken in controlling a change in the atmospheric pressure when transportation is performed by air, care must be taken into damage caused by such a pressure decrease.

Accordingly, the present disclosure concerns a constant-temperature transportation method in which the occurrence of a pressure change according to a change in an environment temperature is prevented when a tissue such as a cell is packed and placed in a sealed container disposed inside a constant-temperature transport container.

According to an aspect, there is provided a constant-temperature transportation method, in which a transport object, that 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, and 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 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.

According to the aspect, the internal pressure of the sealed container is maintained at the constant atmospheric pressure by changing the state of the pressure adjustment valve from an initial closed state to an open state when placing the sealed container containing the transport object into the soaking container, the temperature of which is controlled to a predetermined temperature.

After the internal temperature of the sealed container reaches a predetermined temperature, the pressure adjustment valve is closed again, and then, transportation is performed. Therefore, the transport object can be transported in a state where the constant temperature and pressure are maintained during the transportation of the transport object. When the sealed container is removed from the soaking container, it is possible to remove the transport object in a state where the internal pressure of the sealed container is maintained at the same atmospheric pressure by changing the state of the pressure adjustment valve from a closed state to an open state. In this configuration, the transport object can be transported to and actually used in treatment facilities such as a laboratory and a hospital while almost no transport object is affected by a pressure change during an operation caused by a rapid temperature change when the transport object is placed into and removed from the constant-temperature transport container.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial sectional view illustrating the configuration of a sealed container according to an embodiment.

FIG. 2 is a partial sectional view illustrating the configuration of a sealed bag containing glass bottles in the embodiment.

FIG. 3 is a partial sectional view illustrating the configuration of a sealed bag containing a Schale dish in an embodiment.

FIG. 4 is a partial sectional view illustrating the configuration of a sealed container with an automatic opening and closing control function according to an embodiment.

FIG. 5 is a partial sectional view illustrating the configuration of a constant-temperature transport container according to an embodiment.

FIG. 6 is a partial sectional view illustrating the configuration of a cell transport container in the related art.

DESCRIPTION OF EMBODIMENTS

Hereinafter, embodiments will be described with reference to the accompanying drawings.

FIG. 1 is a configuration view of sealed container 101 used in a constant-temperature transportation method in an embodiment.

In FIG. 1, transport object 90 is a temperature-control target object, the temperature of which is required to be controlled to a desired temperature. Transport object 90 is disposed in metal sealed container 101 while being sealed in sterilized sealed bag 201. Air ventilation tube 103 passes through cover 101a of sealed container 101, and extends to the outside of the container. Pressure adjustment valve 104 is disposed at a distal tip of air ventilation tube 103. Pressure adjustment valve 104 serves as an example of a pressure adjuster. When transport object 90 contained in sealed bag 201 is set in sealed container 101, and then, container body 101c is covered with metal cover 101a, press contact between container body 101c and cover 101a can be maintained with O-ring 101b interposed therebetween.

In this configuration, a pressure change caused by a temperature change occurring after the setting of transport object 90 can be cancelled out in sealed container 101. That is, an air flow is allowed to flow through pressure adjustment valve 104 to cancel out a differential pressure between the outside air pressure and the internal pressure of sealed container 101, and to prevent the occurrence of a pressure change in sealed container 101 by opening pressure adjustment valve 104 in a normally closed state.

According to the transportation method in the related art, the temperature when transport object 90 is prepared differs from a set temperature when sealed container 101 is transported. Due to this temperature difference, after transport object 90 is set in sealed container 101, the internal temperature of sealed bag 201 is changed, and the internal pressure of sealed bag 201 is also changed according to that change. For example, when a cell tissue, that is, transport object 90, is set in sealed bag 201 in a 37° C. environment, and then, sealed container 101 is cooled down to 5° C., internal pressure A of sealed container 101 is decreased from the atmospheric pressure to 897 hPa according to the following gas state equation (Expression 1).

(273+37)/1000 hPa=(273+5)/A hPa

A=1000 hPa×278/310  (Expression 1)

In this case, the cell is highly likely to be damaged, and thus, it is necessary to prevent the occurrence of an apparent pressure change during such an operation.

Sealed bag 201 used in constant-temperature transport container 80 in the embodiment will be described with reference to FIGS. 2 and 3.

First, FIG. 2 illustrates a case in which transport object 90 is sealed in glass bottle 202. Glass bottle 202 serves as an example of a holder for a transport object, the temperature of which is required to be controlled.

Sealed bag 201 includes multiple glass bottles 202, each containing a transport object (temperature-control target object), the temperature of which is required to be controlled to a desired temperature; and volume adjuster 203. In this case, a gap (space) is provided as volume adjuster 203 between glass bottles 202, and is filled with air occupying 15% or more of the total volume of sealed bag 201. During the transportation of sealed bag 201, the volume of the space is changed by a pressure change outside of the sealed bag. Air ventilation hole 204 is provided in cover 202a of glass bottle 202.

Thereafter, when sealed bag 201, in which multiple glass bottles 202 containing transport objects 90 are set, is actually placed inside sealed container 101 illustrated in FIG. 1, the internal temperature of sealed bag 201 containing transport objects 90 is higher than room temperature, and approaches the internal temperature of sealed container 101 which is set to a low temperature. After the internal temperature of sealed container 101 reaches a predetermined temperature, pressure adjustment valve 104 is closed again. Thereafter, sealed container 101 is transported. The internal pressure of sealed container 101 is gradually decreased. At the same time, external air enters sealed container 101 due to the differential pressure by manually opening pressure adjustment valve 104 in a closed state when placing transport objects 90 inside constant-temperature transport container 80 or removing transport objects 90 from constant-temperature transport container 80. Therefore, the internal pressure of sealed container 101 is maintained to be constant (that is, at a constant atmospheric pressure). The following case is assumed as the reason the gap filled with air occupying 15% or more of the total volume of sealed bag 201 is provided as volume adjuster 203. Since the temperature may exceed 40° C. in a high temperature environment assumed to be encountered in a case where transport object 90 is transported overseas by air in the future, particularly, in Middle Eastern territories, the temperature of transport object 90 is set to an environment temperature of approximately 45° C., and thereafter, transport object 90 is cooled to a supercooled state at 0 degrees Celsius or less, and is transported.

In this case, since the pressure is decreased to 85.8% of the atmospheric pressure according to the following gas state equation (Expression 2), a change of 14.2% in percentage is assumed.

(273−0)/(273+45)=85.8%  (Expression 2)

In a case where transportation is made in a state where a constant temperature is also maintained in such a severe environment, a gap filled with air occupying at least 15% of the total volume is required to be provided as volume adjuster 203. That is, in a case where the gap (space) filled with air occupying at least 15% of the total volume is provided as volume adjuster 203, even if a 15% pressure change occurs during the transportation of transport object 90, it is possible to cancel out the pressure change, and to prevent damage to transport object 90 (for example, a cell) by changing the volume of the space, that is, volume adjuster 203.

It is possible to maintain a sterilized state by preventing the flowing in and out of air through sealing portion 201a (for example, upper end edge in FIG. 2) provided in an opening portion of sealed bag 201, and thus, it is possible to prevent an invasion of bacilli from an external environment.

A case in which transport object 90 is placed in Schale dish 302 together with a culture medium as illustrated in FIG. 3 is assumed to be the same as the case in which glass bottle 202 in FIG. 2 is used. Sealed bag 301 includes Schale dish 302 containing transport object 90, the temperature of which is required to be controlled to a desired temperature; and volume adjuster 303. Schale dish 302 containing the transport object is covered with air-breathable film 304. Since a gap is provided as volume adjuster 303 between Schale dishes 302, and is filled with air occupying 15% of the total volume of sealed bag 301, a change in the internal pressure of sealed container 101 caused by a temperature change can be cancelled out by opening pressure adjustment valve 104 when placing sealed bag 301 into sealed container 101 in a high temperature state.

The internal pressure of sealed container 101 is maintained at a constant atmospheric pressure by changing the state of pressure adjustment valve 104 from a closed state to an open state, and after the internal temperature of sealed container 101 reaches a predetermined temperature, pressure adjustment valve 104 is closed again. Thereafter, sealed container 101 is transported.

The opening and closing of pressure adjustment valve 104 can be controlled not only manually but also automatically. FIG. 4 illustrates an automatic opening and closing control system. The automatic opening and closing control system includes electromagnetic valve 404 instead of pressure adjustment valve 104, and further includes in-container pressure gauge 401; ex-container pressure gauge 402; and controller 403. Although not shown, the controller 403 can be a processor configured according to instructions in an associated memory, or can be a dedicated chip. As illustrated in FIG. 4, internal and external pressures of sealed container 101 are respectively measured by in-container pressure gauge 401 and ex-container pressure gauge 402, and measurement information is transmitted to controller 403 in real time. At this time, controller 403 cancels out a change in the internal pressure of sealed container 101 by calculating the magnitude of pressure required to cancel out the difference between the external air pressure and the internal pressure of sealed container 101, and controlling the opening of electromagnetic valve 404 to obtain the magnitude of pressure required to cancel out the calculated pressure difference.

FIG. 5 illustrates the structure of constant-temperature transport container 80 in the embodiment when sealed container 101 is transported in a state where the temperature is actually adjusted.

Constant-temperature transport container 80 is configured to include soaking container 501; thermal conductive block 502; Peltier module 503; heat sink 504; heat dissipating fan 505; vacuum insulated material 506; power supply-control temperature sensor 507; temperature-display temperature sensor 508; power supply controller 509; battery 510; and insulated container 511.

First, sealed container 101 is placed in soaking container 501 made of metal having good thermal conductivity. A surface of Peltier module 503 is in contact with and is mounted to soaking container 501 with thermal conductive block 502 interposed between the surface of Peltier module 503 and soaking container 501. The transferring of heat to and from Peltier module 503 is promoted via heat sink 504 and heat dissipating fan 505 provided on the opposite surface of Peltier module 503. Vacuum insulated material 506 is disposed in the vicinity of soaking container 501 without gaps between soaking container 501 and vacuum insulated material 506 such that soaking container 501 is insulated.

In this configuration, heat is dissipated to soaking container 501 from Peltier module 503, or soaking container 501 is heated via thermal conductive block 502 by supplying electrical power to Peltier module 503 interposed between thermal conductive block 502 (an example of a cooling-side thermal conductor) and heat sink 504 (an example of heat dissipation-side conductor).

Power supply-control temperature sensor 507 is installed in the vicinity of a portion of a surface in which thermal conductive block 502 is in contact with Peltier module 503 outside of soaking container 501. Power supply-control temperature sensor 507 measures the temperature of the vicinity of the portion of thermal conductive block 502 which is in contact with Peltier module 503. Temperature-display temperature sensor 508 formed of a wireless thermometer, a thermocouple, or the like is installed in a portion of an external side surface of soaking container 501, which indicates a temperature approximate to the temperature of the center inside of soaking container 501. Temperature-display temperature sensor 508 measures the temperature of the portion indicating a temperature approximate to the temperature of the center inside of soaking container 501. The following temperature control is performed such that the temperature measured by temperature-display temperature sensor 508 becomes a set temperature (to be described later). In a temperature control method, when a predetermined difference between detection results from power supply-control temperature sensor 507 and temperature-display temperature sensor 508 occurs, power supply controller 509 controls power supply to Peltier module 503 such that electrical power is supplied to Peltier module 503 from battery 510 which is an example of a power supply. Basically, power supply controller 509 is configured to control power supply to Peltier module 503 based on the detection result from power supply-control temperature sensor 507, and to perform control based on the detection result from temperature-display temperature sensor 508 such that the power supply to Peltier module 503 is corrected. Such temperature control enables the maintaining of the set temperature set in power supply controller 509 during transportation.

Soaking container 501, thermal conductive block 502, vacuum insulated material 506, power supply-control temperature sensor 507, temperature-display temperature sensor 508, power supply controller 509, and battery 510 are accommodated and fixed inside insulated container 511 made of metal.

As an example, the set temperature can be set to any value accurately to 0.1° C. between—20.0° C. and 50.0° C. in power supply controller 509 of constant-temperature transport container 80. Accordingly, when the predetermined difference between detection results from power supply-control temperature sensor 507 and temperature-display temperature sensor 508 occurs, power supply controller 509 controls power supply to Peltier module 503 such that the set temperature can be maintained during transportation regardless of a change in the ambient temperature.

The use of constant-temperature transport container 80 enables highly accurate secure and safe transportation of transport object 90 without preparation of a heat storage material or a cold insulation material being required in a state where the temperature and pressure of transport object 90 placed inside sealed container 101 in FIG. 1 are maintained to be the same as before transportation.

The internal pressure of sealed container 101 is maintained at a constant atmospheric pressure by changing the state of pressure adjustment valve 104 or electromagnetic valve 404 from a closed state to an open state when placing sealed container 101 containing transport object 90 into soaking container 501, the temperature of which is controlled to a predetermined temperature. After the internal temperature of sealed container 101 reaches the predetermined temperature, pressure adjustment valve 104 or electromagnetic valve 404 is closed again, and then, transportation is performed. Therefore, transport object 90 can be transported in a state where the constant temperature and pressure are maintained during the transportation of transport object 90.

When sealed container 101 is removed from soaking container 501, it is possible to remove transport object 90 in a state where the internal pressure of sealed container 101 is maintained at the same atmospheric pressure by changing the state of pressure adjustment valve 104 or electromagnetic valve 404 from a closed state to an open state. In this configuration, transport object 90 can be transported to and actually used in treatment facilities such as a laboratory and a hospital while almost no transport object 90 is affected by a pressure change during an operation caused by a rapid temperature change when transport object 90 is placed into and removed from constant-temperature transport container 80.

The aforementioned various embodiments, an arbitrary embodiment of modification examples, or the modification examples are appropriately combined together such that effects of each of the aforementioned embodiments, the arbitrary embodiment, and the modification examples can be obtained. Embodiments can be combined together, examples can be combined together, or embodiments and examples can be combined together. The features of embodiments can be combined together, or the features of examples can be combined together.

A constant-temperature transport container according to the various embodiments described above enables highly accurate secure and safe transportation of a transport object without requiring preparation of a heat storage material or a cold insulation material in a state where the temperature and pressure of the transport object are maintained to be the same as before transportation. The constant-temperature transport container can be applied to the transportation of cells or the like. In the future, as need for cell sheet transplantation using Japan's regenerative medicine technology in Japan and foreign countries increases, the transportation of cell tissue from a donor in a constant temperature environment will be frequently required. For example, it is possible to easily, securely, and safely transport an expensive transport object (for example, a cell) to a rich country in the Middle East by using the constant-temperature transport container of the various embodiments. Many transportation chances are expected to occur. This may be taken as one of Japan's growth strategies, and may lead to a large scale of business.

Claims

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 , andwherein, 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, andwherein 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, andwherein 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, andwherein 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, andwherein 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; anda 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; andcontrol 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 of total volume of the sealed bag after the transport object is set is provided as the volume adjuster of the sealed bag, and during transportation of the container, a volume of the space is changed according to a change in the external pressure of the sealed bag.

11. The constant-temperature transport container of claim 9, 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; anda 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,wherein the controller is further 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, andwherein during the transportation of the 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.