Abstract:
A temperature sensitive material is transported in an insulated container. The temperature sensitive material is enclosed in an insulated container comprising a double wall container. The container has a front wall a rear wall, two side walls, and a bottom wall, and insulation material in each of the regions between the double walls of said front wall, said rear wall, said two side walls, and the bottom wall. A double wall container cover has insulation material in the cover&#39;s double walls. A releasable hinge is provided and the container cover is releasably secured to the double wall container. A temperature sensing system is provided for monitoring the temperature within the container. The monitored temperature is stored in a temperature history database.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of provisional patent application 60/774,603, filed Feb. 21, 2006, for T RANSPORTATION  O F  T EMPERATURE  S ENSITIVE  M ATERIALS , the disclosure of which is incorporated hereby by reference as though recited in full. 
     
    
     BACKGROUND 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates generally to the transportation of temperature sensitive materials, and more particularly, to a system of transporting temperature sensitive materials, a method of transporting temperature sensitive materials, devices for transporting temperature sensitive materials, devices for maintaining the temperature sensitive materials within a required range, and to the monitoring of thermal history of the temperature sensitive materials that are transported. 
         [0004]    2. Background of the Invention 
         [0005]    There is a global need to ensure that every blood and organ donation is processed to respond to human needs globally and within the existing transportation conditions and requirements. The loss of valuable donated blood supplies due to careless handling, and/or poor packaging is estimated to be over 40%. This valuable donated blood is lost either to processing failure, transport inadequacies, carelessness, or even unintentional handling of materials as it they are being readied for human use. The current transport systems, however, fail to provide a comprehensive solution to the need to be able to respond to dynamic changes and needs in the transport industry to reduce these losses. 
         [0006]    Temperature control is one of the most critical factors in successful blood and organ transport. There is a need to replace wet ice or dry ice, which is now restricted in air transport, with another more efficient, and safe coolant, at low cost. 
         [0007]    There is also a need to extend the time from 24 hours of safe temperature control to five or more days of safe temperature control. The longer time period would enable the global healthcare industry to meet response time requirements in emergency, military, and extraordinary civilian healthcare needs. 
         [0008]    There is a need to protect valuable cargo, such as blood, from the heat to which the vehicle or transport device in which is its being shipped, while on the tarmac of an airport. 
         [0009]    There is a need to maintain the valuable cargo within its safe temperature range, while being transported in regions where electricity is not readily available. Recent military actions in the Middle East, the tsunami in Asia, the hurricane Katrina, and the international interdependence of healthcare and disease control all bring into focus the need for a “State of Art” transport container for this critical supply. 
         [0010]    Paste board or corrugated box constructions with polystyrene and similar foam containers are cheap but have serious environmental problems. 
         [0011]    The 1950&#39;s beer cooler type of container filled with ice is common used, especially for whole blood units transported to aphaeresis centers that are typically in regional locations. There is a need for a system that reduces the time consuming and messy operation of loading ice and maintaining a stable temperature. Additionally, it is difficult to assure the sterility of ice that is used as the coolant. 
         [0012]    Complex transport units that contain battery operated controls for air flow, complex temperature monitors, and alarms are expensive, cumbersome, and deliver small payloads. 
         [0013]    A semi disposable foil laminated insulated container was marketed that delivered 48 hours of temperature stability. The product line also included a battery operated unit for platelet transport up to 48 hours. The 48 hours of stabile control is insufficient to meet many if not most of the requirements in the global temperature sensitive transportation systems. 
         [0014]    A sophisticated cooler is available with integrated electronics capable of PC readout. While it is a good product that provides about three secure days of storage time, it is very expensive and three days of storage time falls short of the needs of the industry. 
       SUMMARY 
       [0015]    According to a first broad aspect of the present invention, there is provided an insulated container for minimizing heat transfer between temperature sensitive materials and the environment through which the temperature sensitive materials are being transported. 
         [0016]    According to a second broad aspect of the invention, there is provided packages of eutectic composition for use in maintaining temperature sensitive material within a required temperature range, during a period in which the temperature sensitive material is being subjected to a combination of external physical conditions that affect and influence temperature of the temperature sensitive material. 
         [0017]    According to another broad aspect of the invention, there is provided a monitoring system for establishing a thermal history of the temperature sensitive material that is being transported. 
         [0018]    According to a further broad aspect of the invention, there is provided a transmitting system for transmitting to an external receiver, thermal information relating to the temperature sensitive material within a transportation container without exposing the temperature sensitive material to external physical conditions that affect and influence temperature or other physical properties of the temperature sensitive material that is being transported. 
         [0019]    According to a further broad aspect of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or relative information relating to the temperature sensitive material. 
         [0020]    According to a further broad aspect of the invention, there is provided an identification system for identifying specifics about the temperature sensitive material that is being transported, to preclude misidentifying the temperature sensitive material. 
         [0021]    According to a further broad aspect of the invention, there is provided a wireless identification system for remotely identifying the temperature sensitive material that is being transported. 
         [0022]    According to a further broad aspect of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or identifying other relative information relating to the temperature sensitive material without exposing the temperature sensitive material to ambient conditions, and for remotely accessing the identification system data. 
         [0023]    According to a further broad aspect of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or identifying other relative information relating to the temperature sensitive material without exposing the temperature sensitive material to ambient conditions. 
         [0024]    According to still another broad aspect of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or relative information relating to the temperature sensitive material, and for remotely accessing the identification system data. 
         [0025]    According to a further broad aspect of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or identifying other relative information relating to the temperature sensitive material without exposing the temperature sensitive material to external physical conditions that affect and influence temperature of the temperature sensitive material. 
         [0026]    According to a further broad aspect of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or relative information relating to the temperature sensitive material, and for remotely accessing the identification system data. 
         [0027]    According to a further broad aspect of the invention, there is provided a system and structure for raising or lower the temperature within the thermal barrier container within which the temperature sensitive material that is being transported, without exposing the temperature sensitive material to ambient conditions. 
         [0028]    According to a still another broad aspect of the invention, there is provided a reusable system for use in maintaining temperature sensitive material within a required temperature range, during a period in which the temperature sensitive material is being subjected to a combination of external physical conditions that affect and influence temperature of the temperature sensitive material. 
         [0029]    According to another broad aspect of the invention, there is provided packages of disposable and/or replaceable containers of eutectic or other compositions for use in maintaining temperature sensitive material within a required temperature range, during a period in which the temperature sensitive material is being subjected to a combination of external physical conditions that affect and influence temperature of the temperature sensitive material. 
         [0030]    According to another broad aspect of the invention, there is provided biologically safe reusable, disposable, and/or replaceable containers of eutectic or other compositions for use in maintaining temperature sensitive material within a required temperature range, during a period in which the temperature sensitive material is being subjected to a combination of external physical conditions that affect and influence temperature of the temperature sensitive material. 
         [0031]    According to another broad aspect of the invention, there is provided a biologically safe reusable highly insulation efficient thermally insulating container for use in maintaining temperature sensitive material within a required temperature range, during a period in which the temperature sensitive material is being subjected to a combination of external physical conditions that affect and influence temperature of the temperature sensitive material. 
         [0032]    In accordance with an embodiment of the invention an insulated container is provided for minimizing heat transfer between a temperature sensitive material and the environment through which the temperature sensitive materials are being transported. The container is a double wall container, having a temperature sensing system, a front wall, a rear wall, two side walls, and a bottom wall. The region between the double walls of said front wall, said rear wall, said two side walls, and said bottom wall, are filled with a thermal insulation material. A double wall container cover is filled with insulation material and has a releasable hinge member is releasably secured to the double wall container by the releasable hinge. 
         [0033]    In accordance with another embodiment of the invention, the temperature sensing system includes means for monitoring the temperature within said container, includes a temperature data recording member, and a database containing stored monitored temperature data. 
         [0034]    In accordance with another embodiment of the invention, monitored temperature data is stored in a database and said data is transmitted to a receiver by means of a wireless transmitter. 
         [0035]    In accordance with another embodiment of the invention, the container cover is filled with a eutectic mixture having a freezing point below that of water. 
         [0036]    In accordance with another embodiment of the invention the container cover is filled with a eutectic mixture eutectic mixture of CaCl 2  and water. 
         [0037]    In accordance with another embodiment of the invention at least five inserts are positioned within the container, proximate to the interior walls of the container. The inserts are dimensioned to fit within the insulated container and have dimensions, in combination, that are equal to or slightly less than the interior dimensions of the insulated container. The inserts and are filled with a eutectic mixture having a freezing point below that of water. The eutectic mixture can be NaCl or CaCl 2  and water, or a similar liquid and solid mixture, or a mixture of two or more liquids. 
         [0038]    In accordance with another embodiment of the invention at least four of the inserts have substantially equal dimensions, and in combination, substantially match the interior wall dimensions of said container. 
         [0039]    In accordance with another embodiment of the invention the space between the double side walls of each of two opposing sides of the container, and the rear double side walls is substantially uniform and free of recesses. Additionally, the front side of the container has a shallow recess into which a temperature data display member and a wireless transmitter for transmitting monitored temperature data unit is mounted. 
         [0040]    In accordance with a further embodiment of the invention the spaces between the double side walls of each of two opposing sides of said container, and the rear double side walls are substantially uniform and free of recesses. Additionally, the front side of the container has a shallow recess and a temperature data display member and a wireless transmitter for transmitting monitored temperature data unit mounted in the shallow recess. The temperature display member can display data visually, or by transmitting data to be displayed to a remote member that includes a visual display. 
         [0041]    In accordance with another embodiment of the invention the container has a flange region that extends upwardly from each side wall and forms a “U”-shaped channel at the top of the container. The said container cover is positioned within the “U”-shaped channel. Preferably, hand holds are formed in each of the flange regions. The hand holds can comprise finger receiving openings in the flange regions and can have a convex outwardly facing surface. 
         [0042]    In accordance with another embodiment of the invention the releasable hinge means comprises a cylindrical shaft member extended from opposite sides of said cover, and a curved channel in each of said flange regions. The curved channels are open at the upper edge of the flange regions, extend toward the rear edge of the flange regions, and are closed at the rear edge. Each cylindrical shaft member is mounted for rotary movement in the curved channel, and is removable from the curved channels via the open upper edge of said curved channel. The curved channels can be in the form of an “L”, with the short leg of the “L” having an open end and the long leg of the “L” having a closed end. 
         [0043]    In accordance with still another embodiment of the invention the releasable hinge means comprises a cylindrical shaft member projecting inwardly from each of the flange regions, and a curved channel is provided in the side walls of the cover. The curved channels are open at the lower edge of the cover, extend toward the rear edge of the cover, and are closed at the rear edge. Each cylindrical shaft member is mounted for rotary movement in a curved channel, and is removable from the curved channels via the open end of said channel. The curved channels can be in the form of an “L”, with the short leg of the “L” having an open end and the long leg of the “L” having a closed end. 
         [0044]    In accordance with another embodiment of the invention means are provided to snap the cylindrical shaft members in place at the rear, closed ends of the channels. 
         [0045]    In accordance with a further embodiment of the invention a locking member is provided for locking the cover to the container, when the cover member is in place within the “U” shaped channel and the rear edges of the cover is at the rear edge of the flange regions. The locking member precludes the cover from being removed from said container by preventing rotation of the cover about said releasable hinge. 
         [0046]    In accordance with another embodiment of the invention the interior of the container has an interior ridge proximate the upper edge of the interior walls of the container, and the ridge forms a longitudinal channel to receive an interior lid member, and hold the lid member in place. Preferably, the lid member is a double wall member filled with a eutectic mixture. The insulated container cover preferably, forms a rabbet joint with the open end of the walls of the insulated container. 
         [0047]    In accordance with another embodiment of the invention the cover upper side and the container bottom wall have a mating recess and ridge. The recess and ridge have asymmetrical configurations, such that the cover of a first container mates with the bottom of another container in only one configuration, wherein the front wall of the first container and the front wall of the another container, lie in substantially the same plane. 
         [0048]    In accordance with another embodiment of the invention at least four insert members are dimensioned to fit within the insulated container and have length, width, and height dimensions, that in combination, are equal to or slightly less than the interior wall dimensions of said insulated container. The inserts are filled with a eutectic mixture having a freezing point below that of water. The width of each of the at least four inserts is at least one inch, and the width plus the length of at least four inserts are equal to or slightly less than the interior wall dimension of the container 
         [0049]    In accordance with another embodiment of the invention a method of transporting a temperature sensitive material comprises enclosing the temperature sensitive material in a double wall insulated container. The container has a front wall, a rear wall, two side walls, and a bottom wall, insulation material in each of the region between the double walls of said front wall, said rear wall, said two side walls, and said bottom wall, a double wall container cover, and insulation material in the container&#39;s cover&#39;s double walls. Preferably, the container has a releasable hinge for releasably securing the container cover to the double wall container. The container further includes a temperature sensing system. The temperature within the container is preferably monitored from the time the temperature sensitive material is inserted into the container until the temperature sensitive material is to be removed from the container. The monitored temperature data is stored in a database. Preferably, the stored temperature data is wirelessly transmitted a data receiver by an RF transmitter or other wireless transmission means, now known, or which may hereinafter be known. 
         [0050]    In accordance with another embodiment of the invention the temperature sensitive material is maintained at a sub-ambient temperature by the enthalpy fusion of a frozen eutectic mixture within the walls of said container. 
         [0051]    In accordance with another embodiment of the invention a temperature sensitive material is maintained at a stable temperature by means of a high heat capacity mixture within the walls of said container which insulates the temperature sensitive material from temperature fluctuations. 
         [0052]    In accordance with another embodiment of the invention the temperature sensitive material is maintained within a predetermined temperature range within said container by enclosing the temperature sensitive material within a padded, filled, pouch member sealed in the manner of a quilt, the member being filled with a eutectic mixture. 
         [0053]    In accordance with another embodiment of the invention the temperature sensitive material is maintained within in a predetermined temperature range within the container by covering the temperature sensitive material with a padded, filled, blanket member sealed in the manner of a quilt, the member being filled with a eutectic mixture. 
         [0054]    In accordance with another embodiment of the invention a method of transporting a temperature sensitive material comprises enclosing the temperature sensitive material in an insulated container. The container has a releasable hinge for releasably securing a container cover to the container. The container cover is filled with a eutectic mixture and the container further includes a temperature sensing system. The cover is separated from the container, placed within a refrigerated unit and the eutectic mixture in cover is frozen and/or maintained in a frozen state. The cover is replaced on the container and the temperature sensitive material is housed within the container. The container with its cargo of a temperature sensitive material is then transported to a desired destination. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0055]    The invention will be described in conjunction with the accompanying drawings, in which: 
           [0056]      FIG. 1  is a perspective view of a standard container in accordance with an embodiment of the present invention; 
           [0057]      FIG. 2  is a plan view of the top of the container in accordance with an embodiment of the present invention; 
           [0058]      FIG. 2A  is a front view of the locking recesses in accordance with an embodiment of the present invention; 
           [0059]      FIG. 3  is a plan view of the bottom of the container in accordance with an embodiment of the present invention; 
           [0060]      FIG. 4  is a perspective view of the bottom of a standard container in accordance with an embodiment of the present invention; 
           [0061]      FIG. 5  is a plan view of the front of the container in accordance with an embodiment of the present invention; 
           [0062]      FIG. 6  is a perspective view of the back of the container with the lid open in accordance with an embodiment of the present invention; 
           [0063]      FIG. 7  is a perspective view of the side rim of the container and hinge in accordance with an embodiment of the present invention; 
           [0064]      FIG. 8  is a perspective view of the side of the container lid in accordance with an embodiment of the present invention; 
           [0065]      FIG. 9  is a side view of the refrigerant tray in accordance with an embodiment of the present invention; 
           [0066]      FIG. 10  is a perspective view of the refrigerant tray of  FIG. 9  in accordance with an embodiment of the present invention; 
           [0067]      FIG. 11  is a perspective view of the interior of the container in accordance with an embodiment of the present invention; 
           [0068]      FIG. 12  is a cutaway perspective view of the double walls of the container, in accordance with another embodiment of the present invention; 
           [0069]      FIG. 13  is a perspective view of an eutectic refrigerant pad for use in the container, in accordance with another embodiment of the present invention; 
           [0070]      FIG. 14  is a perspective view of a vacuum sealed, eutectic refrigerant pad having indicators showing that the vacuum is not lost, in accordance with another embodiment of the present invention; 
           [0071]    that has been air evacuated;  FIG. 15  is a perspective view of the eutectic refrigerant pad of  FIG. 14 , show after the integrity of the pad has been breeched and the vacuum lost. 
           [0072]      FIG. 15  is a is a perspective view of a rectangular container with the placement of single sized heating or cooling panels, in accordance with another embodiment of the present invention; 
           [0073]      FIG. 16  is a is a perspective view of the standard container with the placement of single sized heating or cooling panels, in accordance with another embodiment of the present invention; 
           [0074]      FIG. 17  is a plan view of a refrigerant blanket having a plurality of pockets filled with a eutectic mixture, in accordance with an embodiment of the present invention; 
           [0075]      FIG. 18  is an end view of the refrigerant blanket of  FIG. 17  having a plurality of rows and columns of pockets filled with a eutectic mixture, in accordance with an embodiment of the present invention; 
           [0076]      FIG. 19  is a plan view of a refrigerant panel having a single column of pockets filled with a eutectic mixture, in accordance with an embodiment of the present invention; 
           [0077]      FIG. 20  is a plan view of blood container in accordance with an embodiment of the present invention; 
           [0078]      FIG. 21  is a plan view of an insulated cover for the blood container of  FIG. 20 , in accordance with an embodiment of the present invention; 
           [0079]      FIG. 22  is a plan view of an insulated cover with the blood container of  FIG. 20  in the cover, in accordance with an embodiment of the present invention; and 
           [0080]      FIG. 23  is a cross-sectional view of a secondary container for housing, for example, a human organ, in accordance with an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0081]    It is advantageous to define several terms before describing the invention. It should be appreciated that the following definitions are used throughout this application. 
       Definitions 
       [0082]    Where the definition of terms departs from the commonly used meaning of the term, applicant intends to utilize the definitions provided below, unless specifically indicated. 
         [0083]    For the purposes of the present invention, the term “eutectic” refers to a composition of a mixture having the lowest possible temperature of solidification of the specified constituents of the mixture. A salt water mixture, for example, eutectic point for a water-salt mixture is −21.12° C. (−6.02° F.), as compared to 0° C. or 32° F. 
         [0084]    “Latent heat” means the quantity of heat absorbed or released by a substance undergoing a change of state, such as ice changing to water, or water to steam, as constant temperature and pressure. 
         [0085]    For the purposes of the present invention, the term “refrigerant” means a substance such as air, ammonia, water, or carbon dioxide by direct absorption of heat. The substance can be a eutectic mixture or other substance that has a required freezing point. Preferably, the refrigerant has a high latent heat and require a substantial amount of heat to go from its solid state to its liquid or gaseous state. 
         [0086]    “Freezing point” means the temperature at which the liquid refrigerant solidifies under a specific pressure, which is normally ambient pressure. 
         [0087]    For the purposes of the present invention, the term “wireless” refers to any suitable electronic device for transmitting data from sensors and data collectors to readout devices, and the like. The system of U.S. Pat. No. 6,490,443 is representative of one such system. Alternatively, it can be a chip that is not self powered, but rather is activated by a signal from a remote data reader. 
       Description 
       [0088]    The container is made by plastic blow molding or any other means for forming a double wall container, as well known in the art, or as may become known in the future. Preferably, the container surface has a matte finish. The surface is moderately textured since excessive texturing of the surface can render the surface difficult to clean, sanitize, and/or sterilize. Insufficient texturing of the surface makes it too difficult to remove labels that are placed on the container for identifying the shipment. Moderate texturing is just sufficient to be sensed by a user&#39;s finger and to be visible to the naked eye. Moderate texturing of the surface can be in the form of a moderate matte finish, dimples, surface crinkles, wrinkles, fine waves, other slightly raised surface. A moderate texturing is characterized by having sufficient irregularity to limit the surface contact between the label adhesive and the plastic surface of the container thereby facilitating or enabling complete removable of labels. Moderate texturing is further characterized by having crevices or surface irregularities that are not of such depth or so pronounced as to harbor bacteria or other infectious organism while providing sufficient surface contact area to prevent inadvertent release of the label from the container. Preferably, the combination of surface texture and adhesive provides some what less than an adhesion level that inhibits or precludes complete removal of the label from the container. 
         [0089]    It should further be noted that the system disclosed herein can maintain the initial temperature for approximately eight hours. This applies to ambient temperature, the temperature required for the initial shipping of blood, to sub-zero temperatures. 
         [0090]    The present invention provides a double wall container, indicated generally as  100 , in  FIG. 1 . The area between the container exterior wall  104  and interior wall (not shown) is filled with an insulating material, preferably, a closed cell insulating foam, such as the blown insulation used in home insulation. The side lid receiving rims  160 A and  160 B extend above the body  108  of the container  100  on opposing sides to receive the lid  130 . The front panel  138  and back panel  139  of the lid  130  rest on the front lip  110  and back lip  111  (not shown) of the body  108 , between the side lid receiving rims  160 A and  160 B. The handles  120 A and  120  are recessed into the side lid receiving rims  160 A and  160 B, respectively, to enable easy carrying and will be described in further detail hereinafter. 
         [0091]    The lid  130  has a recessed receiving area  132  which has an aligning angle  134  to interact with the bottom of additional containers  100  to be stacked to ensure that all containers  100  are aligned properly. The alignment of the containers  100  will be disclosed in detail hereinafter. 
         [0092]    To prevent the lid  130  from opening 180° a pair of stops  136 A and  136 B are placed on the back panel  139  of the lid  130 . The stops  136 A and  136 B connect with the back lip  111  ( FIG. 6 ) to prevent the lid  130  from opening further than a predetermined distance. The stops  136 A and  136 B are raised areas having a height sufficient that it limits the rotation of the lid  130  about its pivot point. That is, the stops  136 A and  136 B must project into the path of the lid  130  such that the lid  130  cannot rotate 180°. If the lid can rotate too far, then further rotational pressure on the may break the pivot or hinge mechanism. The width of the stops  136 A and  136 B is not narrowly critical and the height of the stops is determined by the relative dimensions and positions of the lid and pivot. Preferably, the lid  130  opens beyond 90° before being prevented from further movement by the stops  136 A and  136 B. Generally, rotation of the lid should be greater that 90° but less than 135°. The placement and size of the stops  136 A and  136 B can be altered to permit a greater or lesser angle of opening based upon the application. Additionally, although two stops  136 A and  136 B are illustrated herein, a single centered stop or more than two stops can be provided. 
         [0093]    The lid  130  is shown from the top in  FIG. 2 , clearly showing the handles  120 A and  120 B, as well as the dimensioning of the stops  136 A and  136 B. As see here, the stops  136 A and  136 B extend from the edge of the lid  130  to the recess  132 . The angle of the aligning angle  134  can also be easily seen in this Figure. It should be noted that although an angle is used in this embodiment, any other design, protrusion or other method of ensuring that the containers  100  are placed in the same direction as they are stacked can be used. 
         [0094]    The lid lock recess  140  and lock bar hole  142  can also be seen more clearly in this and  FIG. 2A . The alignment between the lock bar hole  142  and bar receiving hole  113  is critical to enable a lock to pass through without binding. Likewise, the body lock recess  112  should be aligned with the lid lock recess  114  to maintain the smooth surface of the container  100 . In the preferred embodiment the lid lock recess  140  and the body lock recess  112  are smooth, curves recesses with no corners for the accumulation of bacteria. 
         [0095]    The front panel  138  of the lid  130  contains the lid lock recess  140 , lock bar hole  142  and the recessed handle  144 . The recessed handle  144  illustrated herein is centered within the lid  130 , however the recessed handle  144  could be moved to one side or the other if desired. The lid lock recess  140  is dimensioned to receive a portion of a small lock to maintain the container  100  locked during transport. Below the lid lock recess  140  is the lock bar hole  142 . Within the front  108  of the container  110  is the body lock recess  112  and lock bar hole  114  (not shown). The body lock recess  112  and the lock bar hole  114  are aligned directly beneath the lid lock recess  140  and lock bar hole  142  to enable a lock to be easily recessed. Alternatively, a locking system can be build directly into the container  100 , however as all surfaces must be easily cleaned when used in medical application, the lock would need to be covered to prevent bacteria growth. In non-medical applications the lock would not need to be as carefully designed. 
         [0096]    The front  108  of the container  100  also contains the electronic recess  180  and probe wire receiving area  182 . The probe wire receiving area  182  is dimensioned to receive a probe connected to the electronics package. The probe extends into the interior of the container from the back of the electronics package. This prevents any change in the interior temperature due to air seepage. The probe monitors temperature fluctuations or migrations within the container, sending the data to a microprocessor where it is recorded. The data is stored for retrial remotely by satellite, by a reader that reads the data when in the proximity of the data storage device, by infrared transmissions, optical readers, Bluetooth wireless transmission, or similar system now in commercial use or which come into use at a future date. The electronics package consists of components that are well known in the art. 
         [0097]    Alternatively, or additionally, the data can be read by a hard wire connection to a PC. The connector  808  can be a USB port, serial port, firewire port, or other comparable data communication port, now in use or that comes into use at a future date. Additionally, a visual display can be provided for facilitating monitoring the temperature at the product being shipped. A parameter that is essential to monitor is the opening of the container. Violating the sealing of the container must be readily determined as part of the system for maintaining the product temperature and assuring product integrity. If the lid is opened, even momentarily, there will be an immediate temperature rise within the container. Sensing a high temperature spike signals that the lid has been opened and ambient air has been permitted to enter the container. The integrity of the temperature of the product being shipped, as for example, whole blood, blood plasma, or an organ, would likely be unaffected by the temperature spike, and a temperature sensor that monitors the product temperature would not reveal the temperature of the spike unless it is positioned to be sensitive to the air temperature within the container. A separate internal air temperature monitor can be provided or, alternatively, the product temperature sensor can have the dual function required. 
         [0098]    When transporting biological materials, there is a maximum and a minimum temperature that is acceptable during the transportation stage. In many instances, if the temperature falls below that range the ability to use the materials may be compromised. In the disclosed system, the processor reads and stores the temperature from the probe and stores the time and temperature. If the temperature rises above the temperature set, an alarm is activated. Preferably this alarm is visual only; however in some applications the alarm can be visual and/or audible. Whether the data is read from the processor only if the alarm has been activated, or if it is always read is dependent upon the user and the protocol for the materials being transported. Additionally, the handling of the material subsequent to exposure to higher temperatures than programmed is a matter of protocol. The temperatures and the temperatures range are dependent upon the type of biological material and will be known to those skilled in the art. 
         [0099]    The microprocessor within the electronics package preferably has the ability to receive data from an external source, thereby permitting the bar codes of the materials being transported to be scanned and stored within the processor. This information is then retrieved upon delivery and can be compared with hard records, contents, etc. 
         [0100]    The bottom  200  of the container  100 , illustrated in  FIGS. 3 and 4 , has a base  202  with a locking rim  204  that is dimensioned slightly less than the recess  132  of the lid  130 . The locking rim  204  interacts with the recess  132  of an adjacent container  100  to prevent the stacked containers  100  from sliding off of the adjacent bottom container  100 . To ensure that the containers  100  are all facing the same direction, the locking area  204  has an angled offset  212  that corresponds to the aligning angle  134  on the lid  130 . The depth of the locking area  204  must be equal to the depth of the recess  132  to enable stable interaction between the stacked containers  100 . To accommodate the stops  136 A and  136 B, recesses  206 A and  206 B are placed in the base  202 . In addition to enabling the containers  100  to sit flat upon one another, the interaction between the stops  136 A and  136 B and the recesses  206 A and  206 B further prevents sliding of the stacked containers. 
         [0101]    The front of the container  100  is illustrated in  FIG. 5  wherein the dimensioning of the elements can be seen more clearly. The container  100 , must for shipping and storage reasons, have a straight sides and backs without any protrusions. This enables the containers  100 , whatever dimensions and configurations are being used, to be stored and stacked compactly. To maintain this,.smooth appearance, the lid  130  has a slightly small periphery than the periphery of the container  100 . This change in dimension enables the handles  120 A and  120 B to be rounded and still be within the periphery of the container body  108 . The locking rim  204  is also seen in this Figure extending beyond the bottom of the container body  108 . It is critical that, as the weight of the container  100  rests on the locking rim  204 , that the locking rim  204  provides a sufficiently wide base to prevent tipping. The stops  136 A and  136 B are seen extending above the top surface of the top  130 . The alignment of the lid lock recess  140  and body lock recess  112  is also easily seen in this figure. Although the lid lock recess  140  and body lock recess  112  in this embodiment are positioned adjacent to the handle  144 , the location of the lid lock recess  140  and body lock recess  112  can be moved. It is critical that the lid lock recess  140  and body lock recess  112  be recessed within the container body  108  to maintain the smooth exterior surface. 
         [0102]    The interaction between the stops  136 A and  136 B is illustrated in  FIG. 6  wherein the lid  130  is shown in the open position. As can be seen the stops  136 A and  136 B contact the back rim  111 , preventing the lid  130  from opening further. As noted heretofore, the stops  136 A and  136 B can be dimensioned and positioned to enable the lid  130  to open to any degree. 
         [0103]    The lid  130  is design to be capable of being separated from the body  108  of the container  100 . In this manner, lids can be refrigerated and maintained at their desired temperature. While the container  100  is too large for it to be practical to refrigerate, having the lid  130  stored at the required temperature enables a user to assemble a container  100  that is immediately at its required temperature. 
         [0104]    In order to remove the lid  130  while still maintaining the desired profile and sterilization ability, the container  100  and top  130  are designed to interact with one another through a slide and locking system within the side lid receiving rims  160 A and  160 B. In  FIGS. 7 and 8  the slide recess  702  is shown molded into the side lid receiving rim  160 B. The slide recess  702  ends at receiving area  704  that is dimensioned to receive the button  802  of the lid  130 . The receiving area  704  has a rim  706  that is slight raised to maintain the button  802  within the receiving area  704 . This design is one embodiment of how the lid can be removably affixed to the container  100  and other designs will be evident to those skilled in the art. 
         [0105]    The lid  103  also has a protrusion  806  that interacts with the snap lock  724  that consists of an entry area  720  and rim  722 . This serves as a friction locking system for the container  100 , preventing the lid  130  from inadvertently opening prior to locking. 
         [0106]    The refrigerant tray  900  is illustrated in  FIGS. 7 ,  9  and  10 . The refrigerant tray  900  is dimensioned to sit within the lower rim  1002  ( FIG. 11 ) of the container  100 , illustrated in  FIG. 10 . The top surface  902  of the refrigerant tray  900  has a recessed handle  910  and concave strips  906  extending from front to back. The concave strips  906  provide additional surface area to enhance freezing. The shape and size of the concave strips  906  as illustrated is for example only and other configurations can be used. The refrigerant tray  900  is fill with refrigeration material appropriate for the temperature level desired and will be evident to those skilled in the art. The bottom of the refrigerant tray  900  (not shown) can contain recesses and other structural element to maintain its integrity. 
         [0107]    The interior of the container  100  is illustrated in  FIG. 11  showing the front lip  110  and lower rim  1002 . The lower rim  1003  extends into the interior of the container  100  to provide the support for the refrigerant tray  900 . A finger notch  1004  is provided in the lower rim  1002 , extending into the front panel  1006 , to enable the user to life up the refrigerant tray  900 . 
         [0108]    To contribute to the maintenance of the consistent temperature, the container  100 , as illustrated in  FIG. 12 , is manufactured with a double wall, exterior side walls  1202  and interior side walls  1204 . Additionally, the exterior base  1208  is spaced from the inner base (not shown). The space between the exterior side walls  1202 , interior side walls  1204 , exterior base  1208  and inner base is filled with insulation to maintain the initial temperature. It should be noted that the none of the recesses on the container  100  are placed in the double walls. By placing all recesses lock, handles, etc. above the double walls, the interior temperature is not compromised. 
         [0109]    To further insure that the contents of the container  100  are kept at the desired temperature, vacuum sealed refrigerant pads  1400  and  1300 , illustrated in  FIGS. 13 and 14  are used. The refrigerant pads contain an open cell, hygroscopic foam and a eutectic mixture such as NaCl, CaCl 2 , Kl, and related members of the sodium and halogen groups. The refrigerant pads can be capable of providing eight hours of stable temperature under normal circumstances or eight days of stable temperature in the system of the present invention. Preferably, the pads and containers are dimensioned such that all pads are the same size. Pads can be color coded to indicate their eutectic temperature to easily select a correct pad corresponding to the required storage temperature of the system. 
         [0110]    Alternatively, as Illustrated in  FIG. 14 , a eutectic pad  1400  can be used. The open cell hygroscopic foam within the container can be provided with embossed indicia  1402 . When the pad  1400  is evacuated, the outer sleeve  1404  is pulled tightly against the open cell foam and is pulled into the embossed region. When the sleeve is forced to conform to the shape of the open cell foam, the sleeve displays the indicia  1402  that indicates that the integrity of the pad has not been breeched. Conversely, when the outer sleeve  1404  is punctured or otherwise is no longer air tight, the vacuum is lost that the sleeve  1404  relaxes. When the sleeve  1404  is no longer sucked into the embossed indicia  1402 , the indicia  1402  is no longer visible. When this happens, the pad  1400  is replaced. 
         [0111]    In the square container the refrigerant pad  1300  pattern of  FIG. 16  can be used, such that pads  1300  are of equal size. In a rectangular container, as illustrated in  FIG. 15 , the end pads  1300  extend the full length of the interior of the container end wall  1504  and the side pads  1300  extend between the ends pads  1300 . In this manner, all of the refrigerant pads  1300  can be of the same dimensions and accordingly, interchangeable. Having all five pads of the same size negates the possible of using a wrong size, or being out of supply of a particular size. 
         [0112]      FIGS. 17-19  show a refrigerant blanket indicated generally as  1700 , having a plurality of eutectic containing cells  1702  separated by seal lines  1704 . The end view of the blanket  1700 , illustrated in  FIG. 18 , shows more clearly the cells  1702  separated by seal lines  1704 .  FIG. 19  shows a refrigerant unit indicated generally as  1900  and having a column of eutectic cells  1902 . Additionally, the refrigerant element can be a single cell. Refrigerant elements such as illustrated in  FIGS. 17-19  are used to fill the otherwise unoccupied space within the shipping container and provides product protection, cushioning, and additional refrigeration. 
         [0113]      FIG. 20  shows a blood container  2000  that requires storage at a predetermined subzero degree C. temperature. The container  2000  can be provided with a plurality of bar codes, such as  2002  and  2004 , and thus readily scanned to provide required data and inventory control. The remote system can be as disclosed and described in U.S. Pat. No. 6,991,160, the disclosure of which is incorporate herein by reference, as though recited in full. 
         [0114]      FIG. 21  shows an insulated, or preferably, a refrigerant container  2100  dimensioned to receive the blood container  2000 , as illustrated in  FIG. 22 . The cells  602  are preferably filled with a eutectic mixture to provide a subzero refrigerant component that preferable has a high latent heat or heat of transformation, and a required low freezing point. 
         [0115]    In some embodiments, an additional container is used to provide increased refrigeration.  FIG. 23  is a cross-sectional view of a container that is employed within the primary shipping container. The secondary container has its own refrigerant component and is capable of maintaining a human organ at the required subzero temperature, during the period in which the organ is transferred from the shipping container to an operating room an awaits being incorporated into a human being. The container indicated generally as  2300  is a double wall unit having an outer wall  2304  and an inner wall  2302 . The space between the inner and outer walls is filled with a eutectic mixture or other refrigerant  2306 , and can provide up to about eight hours of organ storage time, to accommodate the time that it takes to transfer the organ from its primary location to the shipping container, and from the shipping container to an operating room. The padded shipping container  2320  protects the organ and can be similar in design to the shipping sleeves or covers of  FIGS. 13 and 14 . 
         [0116]      FIG. 24  is a temperature regulated transportation system, indicated generally as  100 . The shipping container system includes refrigerant pads  1300  as previously described, and the container is a double wall structure filled with an open cell hygroscopic insulator, a closed cell insulating foam, or other insulating material. 
         [0117]    The maintenance cost of the shipping system is reduced and the life of a system is prolonged by virtue of the ability to replace damaged, soiled, or otherwise unusable components. Conversely, damaging a component of a structurally integrated system requires total replacement of the unit. The disposable components include the lid and its refrigerant unit, eutectic pads ( 204 ), and the absorbent pads ( 1306 ). In the designs where the electronic components are housed in the lid, defective electronic can be replaced without replacing the entire system. 
         [0118]    Specification Details 
         [0119]    The following size and other considerations are provided for reference rather than by way of limitation. 
         [0120]    The pallet sizes routinely used here in the USA are 40×48 inches. The sizes of the common EU metric pallets are 800×1000 mm. While there are other possible dimensions, the container configuration should both maximize the number of units in the layer and stack to provide a combined dimension of under the 96 inches for cargo and 48 inches for warehouse requirements. 
         [0121]    The HPI temperature sensitive transportation product is sized for the internal element needs, payload, and finally best possible fit to the EU pallet. Leaving pallet space unused would not be as negative as “overshoot”. In some markets pallets are less likely to be using in shipping. Single shipments are the norm. The preferred exterior size of HPI TSTD is 16×16×18.5 inches. The exterior size may be less but preferably is not greater than the preferred dimensions. 
         [0122]    Maintaining an interior square payload area is important for the suggested fitting of the insulation/eutectic pads. The taper of the interior should be minimized to insure best side fitting of the pads in the configuration suggested so that all panels will be equal in size for the sides. The interior payload area is 14×14×14.5 inches. 
         [0123]    The vacuum sealed pads of specialty foam for the sides are preferably sized at 11.5×11.5×1.5 inches. They are fitted to overlap at the corners and not be skived or fitted. The base panel of same construction is 13×13×1.5 inches, which allows for some taper in the payload area. The top liquid filled foam panel measures 13.5×13.5×2 inches. This leaves a payload area of 10.5×10.5×12 inches which provides space for a pack of 16 units of whole blood and plasma. 
         [0124]    The exterior of the shipping container has side handles built into the container. Preferably the side handles are not in the side walls of the container, but rather are above the side walls, such that the side walls are free of recesses that can produce a region of reduced thermal insulation. Add on floppy handles is avoided for cleanliness and stacking purposes. The interface between the lid and base allows for a tape seal, and has a locking device to accommodate a security band or padlock. The temperature data display is preferably visible from a side, most preferably the front side, rather than from the top due to stacking of containers obscuring the top surface. 
         [0125]    An electronic access plug for hardwire connections is preferably proximal to the data display. Logo stick-on labels can be used to give flexibility for private label contracts. 
         [0126]    The color of preference is either dull orange or tan. Colors such as blue, black, or white are preferably not used because of a need to provide a distinctive color and wipe-down convenience. 
         [0127]    The lid is preferably breakaway, or releasably hinged and easily opened once the tape seal is broken. 
         [0128]    The wall thickness should be at any point no less than 1.5 inches and have filler ports for adding internal foam insulation. The filler ports preferably are internal or on the bottom of the container for appearance. 
         [0129]    All documents, patents, journal articles, and other materials cited in the present application are hereby incorporated by reference. 
         [0130]    Although the present invention has been fully described in conjunction with several embodiments thereof with reference to the accompanying drawings, it is to be understood that various changes and modifications may be apparent to those skilled in the art. Such changes and modifications are to be understood as included within the scope of the present invention as defined by the appended claims, unless they depart there from.