AU2006248044A1 - Container for transporting temperature controlled items - Google Patents

Description

WO 2006/124149 PCT/US2006/013247 CONTAINER FOR TRANSPORTING TEMPERATURE CONTROLLED ITEMS CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a Continuation-In-Part to U.S. Patent Application No. 11/333,194 filed January 17, 2006, which was a Continuation-In-Part to U.S. Patent Application No. 11/281,548 filed November 17, 2005 which claims priority to U.S. Provisional Patent Application No. 60/681,769 filed May 17, 2005. The present application also claims priority to U.S. Provisional Patent Application No. 60/681,774 filed May 17, 2005, U.S. Provisional Patent Application No. 60/681,770 filed May 17, 2005 and U.S. Provisional Patent Application No. 60/682,318 filed May 18, 2005. The entire disclosures of these earlier applications are incorporated herein by reference. FIELD OF THE INVENTION The invention relates generally to a container for transporting temperature controlled items such as one or more of biological material, biologics, pharmaceuticals, chemicals and food products at a required temperature range. BACKGROUND OF THE INVENTION Transporting biological material such as blood and blood products in a timely manner has always been a problem. Generally, the health care industry has relied on the use of insulated containers such as coolers developed and manufactured for the recreational industry for keeping food and beverages cold. The coolers that have been used to cool biological and related materials have significant limitations. For example, they do not address the need for documented temperature monitoring for blood products for transfusions that the Food and Drug Administration (FDA) requires as of 2004. Thus, the healthcare industry is in need of a better solution for the transportation of biological material, biologics and pharmaceuticals which require documented temperature tracking for FDA compliance as well as better custom design configurations that can focus specifically on physical requirements of these critical payloads. The term "biological material" as used herein is intended to include but not to be limited to blood and blood products including any type of human or animal blood, cells including stem {WP283777;3} 1 WO 2006/124149 PCT/US2006/013247 cells, bone marrow, donor organs, tissue products and samples, plasma concentrates, reagents (including standards and controls) used to assay biological functions, specimens and the like, and any other biological products (including pharmaceuticals) that must be kept within predetermined temperature ranges during transport and is not intended to be interpreted in a narrow or limiting manner. Spoilage and the risk of infection from temperature compromised blood, blood products, tissues, cells or donor organs are of paramount concern. The FDA requires that blood and blood products taken out of storage and transported must be maintained at transport temperature range of 1'C to 1 0 0 C which compromises the time of acceptable use. Packed red blood cells and blood products stored for a maximum use of 42 days must be kept between 1 0 C and 6'C under constant temperature monitoring at all times. Thus, keeping packed red blood cells during transport at a monitored temperature range of 1 C to 6'C meets these FDA standards for distribution and negates variable transport conditions; fresh plasma thawed (for use) requires storage temperature range of 1 C to 6'C; platelet concentrates must be maintained at 20*C to 24'C; fresh frozen plasma must be stored at or below -25' C; and tissue and organs must be kept at 2'C to 6'C. Biologics such as vaccines and injectable medications, and other pharmaceuticals may also have requirements for transportation and storage at certain temperatures. For example, the FluMistTM vaccine, which contains the live influenza virus, should be continuously stored at less than -1 5'C in order to maintain full potency. Additionally, transporting biological material requires that certain protocols and governing standards be met in order to prevent exposure, damage or contamination while in transit. Healthcare professionals try to solve this problem by transporting blood and blood products in a leak-proof primary container placed in a secondary container, such that the specimen is protected from inadvertent puncture or contamination. The blood and blood products are then packed on wet or dry ice or a chemical coolant to be transported in Styrofoam@ containers. In some parts of the world Styrofoam@ must exported back to its place of origin due to strict environmental regulations. {WP283777;3} 2 WO 2006/124149 PCT/US2006/013247 However, one of the limitations of this method of transportation is that wet ice is messy, often spills during transportation, and re-icing while in transit is sometimes challenging in remote areas. Dry ice offers its own complications as it can be hazardous; for example, loose dry ice can inadvertently touch the blood or blood product, causing it to freeze the blood or blood product at the area of contact and damage the entire product. Furthermore, if dry ice is placed in a non-vented container, it will explode, and so care must be taken to vent the container. Concentrations of CO 2 can also build up to harmful levels inside the container as the dry ice transforms to its gaseous form. Additionally, dry ice is sometimes unavailable in certain parts of the world, and is difficult to handle as it can burn the skin of a user. These factors only serve to further limit the ability to transport blood and blood products for prolonged periods. To alleviate this problem, frozen gel packs have been used to help maintain required temperatures. However, gel packs are susceptible to leaks and can therefore be unreliable. Additionally, it is difficult to maintain a consistent temperature within the entire blood or blood product with gel packs, since standard-sized gel packs are not customized and move around during shipment. Another limitation is that the blood and blood products and other biological material, biologics or certain pharmaceuticals need to be maintained at the required temperature over prolonged periods when transported. The same is true for other temperature controlled items, such as foodstuffs and chemicals which need to be maintained at predetermined temperatures in order to maintain freshness or potency. Conventional insulated shipping containers do not address this problem, which can be further complicated when the items are being transported internationally. Thus, there still exists a need to be able to transport temperature controlled items such as biological material, biologics, pharmaceuticals and other items efficiently and safely for periods lasting longer than eight to twelve hours without the use of either wet or dry ice, or standard gel packs in a durable, reusable container that is capable of maintaining and monitoring the temperature in transit for compliance with certain protocols and for support documentation of the lot numbers during transit for regulatory compliance. The transportation of platelet concentrates is particularly problematic, because of the need to keep such concentrates within a temperature range between 20'C and 24*C. Such temperature ranges are very difficult to maintain using dry or wet ice, or gel packs, which tend to {WP283777;3} 3 WO 2006/124149 PCT/US2006/013247 cool the product too much. The current solutions for the transportation of platelet products include packing the containers with gel packs that are warmed to room temperature, and surrounding the products with several layers of insulation. The resulting packages are bulky, and there is also no way to ensure that the temperature stays constant through different weather conditions (and varying ambient temperatures in hospitals and laboratories) that the package may be transported. Platelet concentrates are typically transported in lots of 5, with 5, 10, 15 or 20 as the usual shipment. There are additionally problems with the transportation of various foodstuffs, such as prepared food, fish and seafood, and other perishables including poultry, meats, and dairy products, in that food safety and taste can be severely compromised if the food is not transported at a reduced temperature. Fresh flowers are also typically transported at a reduced temperature in order to retain the freshness of the flowers for as long as possible. Various other products also need to be kept within a defined temperature range during transportation, and it is desirable to provide a suitable container for transport of all such products. SUMMARY OF THE INVENTION The invention is directed to a reusable container for transporting temperature controlled items such as biological material, pharmaceuticals, food, chemicals and other products, providing the ability to not only transport, but also to monitor and maintain the temperature controlled items at the necessary temperature range for more than (for example) twenty-four hours without the use of wet or dry ice, or standard gel packs. In one arrangement, the container comprises an outer case including a lid, an insulating layer substantially inside the outer case and the lid, and a generally rigid well located inside the insulating layer. A least one removable cooling element is included, the at least one cooling element being capable of maintaining temperature within a prescribed temperature range for predetermined periods of time upon being kept at a predetermined temperature prior to use, the at least one cooling element being disposable within the well and at least partially defining a receptacle area. A caddy is locatable in the receptacle area and designed to accommodate at least {WP283777;3} 4 WO 2006/124149 PCT/US2006/013247 one item to be transported, wherein the caddy is at least partially surrounded by the at least one cooling element. In another arrangement, a container for transporting temperature controlled items comprises an outer case including a lid, an insulating layer substantially inside the outer case and the lid, and at least two cooling elements, the cooling elements each being capable of maintaining temperature within a prescribed temperature range for predetermined periods of time upon being kept at a predetermined temperature prior to use, the cooling elements being disposed within the insulating layer and each defining a receptacle area designed to accommodate at least one temperature controlled item. Each cooling element is designed to maintain the item located within the receptacle area at a different predetermined temperature. In a further arrangement, a container for transporting temperature controlled items includes an outer case including a lid, an insulating layer substantially inside the outer case and the lid, and a flexible foil barrier positioned between the outer case and the insulating layer. At least one cooling element is included, the at least one cooling element being capable of maintaining temperature within a prescribed temperature range for predetermined periods of time upon being kept at a predetermined temperature prior to use, the at least one cooling element being disposed within the flexible foil barrier and at least partially surrounding a receptacle area. A receptacle is located in said receptacle area and designed to accommodate at least one temperature controlled item, wherein the receptacle is at least partially surrounded by the at least one cooling element. The container can include a waterproof outer case, which may be constructed from hard, durable, rustproof material or a soft, flexible, lightweight material that is durable and stain resistant. The outer case provides for varied means for lifting and towing the container, which may be singularly employed or in combination thereof, for example a reinforced handle on the top of the container, wheels, a telescopic handle, non-retractable handles and shoulder straps. The exterior of the container can contain at least one information sleeve adapted to hold identification information concerning the item being transported. For example, for the transport {WP283777;3} 5 WO 2006/124149 PCT/US2006/013247 of blood or blood products, a patient's name, social security or identification number, surgeon, blood type, date the blood or blood product left the blood bank, scheduled date of delivery, number of units of blood, delivery operating room number, surgeon, doctor and medical procedure can be documented and stored in the information sleeve. The cooling element is an important feature of the container in accordance with the present invention. The cooling element can include four modular units shaped and sized to securely fit the top, bottom and sides of the inner perimeter of the well and are adapted to form a receptacle area for housing an inner caddy. Alternatively, the cooling element can be in one piece and can include a bottom, side walls and at least one top portion, wherein the top portion is hinged to the side walls. The cooling element is responsible for keeping the inner caddy at the required temperature (for example, 1C to 6'C), and is made from strong, durable and lightweight material, such as ABS plastic. A cooling material is disposed in all or part of the cooling elements and may include a phase change material. The cooling element is adapted, when frozen and conditioned, to maintain the required temperature for extended periods of time, i.e. 24+ hours. The cooling elements can be frozen prior to each day's use in any standard or commercial freezer for up to 24 hours prior to each use. The cooling elements are stackable and provide for easy storage in a freezer. After removal from the freezer, the cooling elements can be conditioned prior to use and insertion into the container. The object of conditioning the cooling elements is to allow it to transition from the temperature of the freezer to a temperature proximal to the desired phase change temperature. This can be achieved simply by exposing the cooling elements to the ambient room temperature by placing it out on a counter (not in the insulated case), for approximately 30 to 60 minutes. The container can include an inner caddy, which provides for a bottom portion connected to sidewalls, a front wall, a back wall and a middle divider. Lifting means can be provided for lifting and removing the inner caddy from the container. Lifting means may include a handle, strap, tab, or anything that can be grasped or is generally known and used by those skilled in the arts. In one arrangement, the walls include one or more top portions that are hinged. The top portions may form a lid which opens outwardly from the receptacle area. In another arrangement, the inner caddy opens from front to back providing access to its contents. The inner {WP283777;3} 6 WO 2006/124149 PCT/US2006/013247 caddy is removable with cleaning vents, allowing for self-drainage and ease of cleaning. The inner caddy is conveniently sized such that it may be stored in a standard or commercial refrigerator with the item to be transported preloaded in the caddy until the item is ready for transport or use. The container can be further equipped with a receiving area for a temperature data logging device which comprises of at least one probe for monitoring, collecting and reporting data concerning the item being transported. Suitable temperature data-logging devices may include for example a Validator, which consists of proprietary technology currently available through American Thermal Wizard International, Inc. The temperature data-logging device is programmable to meet the compliance requirements and will continuously monitor the temperature of the item while it is housed in the container. The information once logged can be graphed or logged and is capable of being downloaded into Microsoft Word@ or Excel®. The temperature data-logging device can be programmed to either transmit an alarm or a page if the temperature range falls or exceeds the set parameters. The container can be further equipped with a GPS device and/or a cell phone or any other suitable position logging and/or communications devices so that the position of the container can be tracked, and optionally reported to a user in real time. In another arrangement of the invention, a container for transporting temperature controlled items includes an outer case including a lid, an insulating layer substantially inside the outer case and the lid, and a removable cooling element capable of maintaining temperature within a prescribed temperature range for predetermined periods of time upon being kept at a predetermined temperature prior to use. The cooling element is shaped so as to define a receptacle area therein, into which at least one item for transportation may be placed such that the item for transportation is substantially surrounded by the cooling element. The cooling element includes a bottom, side walls and at least one lid portion, the at least one lid portion being hingedly attached to at least one side wall to allow access to the receptacle area defined within the cooling element. The cooling element can include phase change material {WP283777;3} 7 WO 2006/124149 PCT/US2006/013247 disposed therein. The phase change material can be sealed within the cooling element. In one arrangement, the cooling element at least partially comprises an ABS plastic. In yet a further arrangement, the invention relates to a method of transporting temperature controlled items, the method including supplying a container having an outer case including a lid; an insulating layer substantially inside the outer case and the lid; at least one removable cooling element capable of maintaining temperature within a prescribed temperature range for predetermined periods of time, the at least one removable cooling element being disposed within the outer case and at least partially defining a receptacle area; and a caddy located in the receptacle area and designed to accommodate at least one item, with the caddy at least partially surrounded by the at least one cooling element. The method further includes removing the at least one removable cooling element from the container, cooling the at least one removable cooling element for a predetermined period of time in a freezer, refrigerator or other temperature controlled environment, and replacing the at least one removable cooling element in the container. The item to be transported is placed into the caddy, and the caddy is placed into the receptacle area, at least partially surrounded by the at least one cooling element. The container is closed so as to substantially surround the at least one cooling element by the insulating layer; and the temperature controlled items are transported. The at least one removable cooling element can be frozen for at least 24 hours prior to replacement in the container for use. The at least one removable cooling element can be conditioned after cooling and prior to replacement in the container for use, by placing the cooling element at room temperature for approximately 30 minutes. Preferably, the at least one cooling element comprises cooling material sealed therein, the cooling material comprising a phase change material. The method can also include the step of monitoring at least one of temperature within the caddy and location of the container during transportation of the container. {WP283777;3} 8 WO 2006/124149 PCT/US2006/013247 For a further and more fully detailed understanding of the present invention, various objects and advantages thereof, reference is made to the following detailed description and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS Further objectives and advantages of the invention will become more apparent from the following description and claims and from the accompanying drawings herein. Fig. 1 depicts a container for transporting temperature controlled items according to the present invention. Fig. 2 depicts an external view of one arrangement of the container for transporting temperature controlled items. Fig. 3 depicts an alternate arrangement of the container for transporting temperature controlled items. Figs. 4a and 4b depict arrangements of the cooling elements of the invention. Figs. 5a and 5b depicts arrangements of the inner caddy. Fig. 6 depicts an alternate arrangement of the container according to the invention for transporting vials of specimens. Figs. 7a and 7b depict alternate arrangements of the container according to the invention. Fig. 8 depicts an alternate arrangement of the container according to the invention. Fig. 9 depicts an alternate arrangement of the container according to the invention. {WP283777;3} 9 WO 2006/124149 PCT/US2006/013247 DESCRIPTION OF THE PREFERRED EMBODIMENTS The term "temperature controlled item" is intended to cover any product that must be kept within predetermined temperature ranges during transport and is not intended to be interpreted in a narrow or limiting manner. By reference to the exemplary drawings in detail wherein like numerals indicate like elements throughout the various views, there is shown in Fig. 1 an exemplary container 10 for transporting temperature controlled items in accordance with the invention. The container 10 can include an outer case 11 that may be formed from soft, flexible, lightweight material such as ballistic nylon, vinyl or canvas, or a hard rigid material for more durability, or any other suitable materials generally known and used by persons skilled in the art. The outer case 11 is preferably made of waterproof, stain resistant, rustproof material, which can be easily cleaned. The container 10 may be made in different sizes depending on the number of blood or blood product units that are being transported. In one arrangement, the container 1.0 can hold 1-2 units of blood or blood products. In another arrangement, the container 10 can hold 1-4 units of blood. Alternatively, the container 10 can hold 1-6, or more units of blood or blood products. Container 10 can also be modified to hold two bags of stem cells or bone marrow by removing the vertical divider, and only using one horizontal divider. Container 10 can also be modified to hold a caddy rack of serum specimens in transfer tubes. In the arrangement illustrated in Figs. 1-2, the outer case 11 comprises a base 12 which may be formed from a reinforced or stiff material, or of other suitable materials generally known and used by persons skilled in the art. In an alternate arrangement, illustrated in Fig. 3, the base 12 may include a rigid base insert covered with a flexible material. In the exemplary arrangement shown, the outer flexible material is ballistic nylon, but any suitable material may be employed. The outer case 11 further comprises ends 14 and 14' that are connected to the base 12, with sides 15 and 15' (not shown) extending between the ends 14 and 14'. {WP283777;3} 10 WO 2006/124149 PCT/US2006/013247 The container 10 provides for a lid 17, which can be hingedly attached to the side 15 or 15' (not shown) of the outer case 11 and may be closeable by twist latches 30, 30'. Preferably, at least one twist latch 30 is lockable. Alternatively, other suitable forms of closeable means such as hooks, loops, snap fasteners, buttons, Velcro or zippers may be employed to close the lid 17. Fig. 3 depicts one arrangement of the invention wherein the lid 17 is hingedly attached to one of the sides 15, and may be closable with at least one zipper 29 and 29'. Alternatively, the zipper 29 may extend around the entire periphery of the lid 17 such that the lid 17 is completely removable. In another arrangement of the invention, the lid 17 may have a zipper 29 extending around two ends 14, 14' and one (1) side 15 so that the lid 17 may be hinged at its attached side 15 providing maximum opening without being completely removable. However, it will be appreciated by those skilled in the art that any form of a lid 17 may be employed. In one arrangement, the lid's interior 13 comprises a closed cell PE foam insert that acts as insulation to prevent the transmittal of external heat, thus protecting the interior contents of the container 10. It will be appreciated that any suitable insulating material may be used in the lid's interior 13. The insulating material 13 may also act as a water barrier to protect the interior contents of the container 10. In another arrangement, a cooling module may be added to the lid's interior 13 in which coolant material may be disposed, further enhancing the performance of the container 11. As shown in Fig. 2, a wheel assembly 16, 16' and anchor screws 18, 18', 18" located on one of the opposing ends 14 can provide stabilizing means for the container 10 when stood on its end 14. The stabilizing means allow the container 10 to be placed flat on its base 12 without the container 10 tipping over. Other stabilizing means may include at least a foot, claw or any other stabilizing means that is generally known and used by persons skilled in the art. In one arrangement of the invention, a telescopic handle 19 may be provided adjacent to the base 12 for pulling the container 10 on the wheel assembly 16, 16'. The telescopic handle 19 is capable of gradually extending to the desired height from the top end 14' of the container 10 when a push button 20 is pressed. The push button 20 also serves to retract the telescopic handle 19 when pressed. {WP283777;3} .1 WO 2006/124149 PCT/US2006/013247 The container 10 also preferably comprises of at least one pair of non-retractable handles 30 and 30' (not shown) providing alternate means for picking up and carrying the container 10. As shown in Figs. 1 & 2, the outer case 11 provides rings 31 and 31' (not shown) for a shoulder strap 32 (not shown) to be attached for alternate means for picking up and carrying the container 10. Fig. 3 shows one arrangement of the invention where the shoulder straps are attached to the outer case 11. In certain arrangements of the invention, an additional reinforced handle can be attached to the top of the lid's exterior 22 providing yet another means for picking up and carrying the container. As shown in Fig. 1, the outer case 11 may include at least one identification sleeve 21 which is adapted to secure and hold documentation concerning the item or items being transported. For example, in the case of the transportation of blood or blood products, the documentation may include information such as a patient's name, social security or identification number, physician, blood type, date the blood or blood product left the blood bank, scheduled date of delivery, number of units of blood or blood product being transported, delivery destination, etc. The identification sleeve 21' can be made of a clear or transparent plastic with an opening 24 adapted with a finger notch 25 for easy insertion and removal of documentation. As shown in Fig. 2, in one arrangement of the invention the outer case 11 can have more than one identification sleeve 21, 21', one on the side 15 of the outer case 11, and the other on the lid's exterior 22. It is understood by those practicing the art that there can be as many identification sleeves 21, 21' as desired. As shown in Fig. 2, the identification sleeve 21 may be secured to the side of the container 10 by anchor screws 27, 27', 27", 27", or any other securing means that are generally known and used by those skilled in the pertinent arts, including but not limited to, screws, nails, bolts, paste, glue and Velcro. The lid's exterior 11 is adapted for provision of any desired logo or other identification marks or notations. The outer case 11 can be adapted to form a receptacle area for an insulating layer 37 made of suitable insulation materials to shield the interior contents of the container 10 from external temperature. Suitable insulation materials may include a substantially rigid insulating {WP283777;3} 12 WO 2006/124149 PCT/US2006/013247 material having a relatively low thermal conductivity and being relatively light weight, for example Minicel@, Volara@, Neoprene, Polystyrene (Styrene), Polyethylene, VIP (Vacuum Insulation Panel), ABS and Coroplast@, TempShieldTM and SPACE AGE@. Preferably the insulating layer 37 is formed from rigid polyurethane. Alternatively, the insulating layer 37 may be formed from closed cell PE foam, and may be formed of the same material as the lid's interior 13. The insulating layer 37 includes a bottom portion 38 (not shown) connected to walls 39 substantially surrounding the inner perimeter of the outer case 11. The insulated layer 37 has a predetermined height to substantially engage or abut the top of the container 10 while substantially minimize the air space remaining above the container 10. The container 10 can also include a substantially rigid waterproof open well 40, which may comprise PE plastic shaped to form a receptacle area 41 for cooling elements 46, 46', 47, 47'. The formed well 40 can substantially surrounds the insulated layer 37 and can include a bottom portion 43 connected to walls 44 in a seamless well for spill proofing and to receive the cooling elements 46. After the insulating layer 37 is placed in the outer case 11, the well 40 can be inserted in the outer case 11 to substantially engage the walls 39 and bottom portion so as to substantially seal the insulated layer 37 to the outer case 11. In one arrangement of the invention, the well 40 is secured to the outer case 11 by anchor screws 45. It is understood by those skilled in the art that other securing means such as nails, glue, nuts and bolts may be applied to secure the well 40 to the outer case 11, or that the well 40 may be removable from the outer case 11 for easy cleaning. Fig. 4a depicts an arrangement of the cooling elements of the present invention, which is responsible for keeping the inner caddy 50 (illustrated in Fig. 5) at the required temperatures of 1C to 6*C. The cooling element 45 can be formed of separate components 46, 46', 47, 47' that are made from strong, durable and lightweight material and comprise at least four modular units with refrigerant material disposed within each modular unit. The cooling elements 46, 46', 47, 47' can include two sides 46 and 46' and a top 47 and bottom 47'. The two sides 46 and 46' can {WP283777;3} 13 WO 2006/124149 PCT/US2006/013247 be sized and shaped to securely fit the interior sides of the insulation deck 40, while the top 47 and bottom 47' are sized and shaped to fit the bottom and top of the well 40. In another arrangement of cooling element 45, illustrated in Fig. 4b, the cooling element 45 is formed so as to define a receptacle 48 therein, with two hinged top portions 47 attached to side walls 46. The cooling element 45 may also include handles 49 and may be sized to fit within the well 40. The handles 49 enable the cooling element 45 to be easily placed into and out of the well 40. In a further arrangement of cooling element, the top portion 47 may be hinged along a long side thereof. The hinge may be formed of Lucite, fabric, or any other suitable material. The cooling element 45 in the arrangement shown is generally rectangular in form, as is the receptacle area 48. The walls of the cooling element 45 are relatively rigid so that it retains its shape through numerous cycles of freezing and thawing the phase change materials or other cooling materials disposed within the walls of cooling element 45. This enables several cooling elements 45 to be conveniently stacked in a freezer prior to use, thus ensuring ease of use. The cooling element may be formed of a single material that retains its temperature for a prolonged period of time, or may be formed from a combination of materials. In one arrangement, -1 C phase change coolant packs may be embedded in insulating material, such as Coroplast@ or ABS/Starboard plastic (Styrene). One or more OC phase change coolant packs may also be used, although such coolant packs do not maintain the desired temperature as long as the -1C phase change coolant packs. The phase change coolant packs may be completely sealed within the insulating material, or may be placed in suitable hollows created within the insulating material. When ABS plastic is used, a solvent may be employed to melt and fuse the plastic around the gel pack in order to prevent leakage thereof. By encasing the gel packs in relatively rigid plastic, the gel packs can be prevented from bulging due to their contents shifting during thawing and refreezing, which can otherwise encroach on the available storage space for the caddy 50. The cooling element 45 may have two phase change coolant packs located in both the top and bottom of the element, and one coolant pack in each side. The phase change materials are preferably gels that may be formed of any suitable material, such as carboxymethylcellulose, ethylene glycol, paraffins such as octadecane, n-dodecane, n-undecane, {WP283777;3} 14 WO 2006/124149 PCT/US2006/013247 phenols, salts (especially salt hydrides), fatty acids, esters, glycols, starches, alcohols, and acetones and aqueous and non-aqueous combinations thereof. It will be appreciated that cooling materials other than phase change gels may be employed, such as paraffin packs, paraffinic and naphthenic oils and oil mixtures, and aromatic hydrocarbon compounds. Synthetic oils, such as polyalpha olefins, polyalkylene glycols and polyalkylene glycol ethers, dialkyl ethers, acetals, and derivatives thereof may also be used. To use the cooling element 45, the element can be frozen in a commercial or home freezer at temperatures set at or below -10 C for at least 24 hours, and then conditioned (allowed to stand at room temperature for 30-60 minutes after removal from the freezer) prior to use. If the cooling element 45 is already partially frozen, twelve (12) hours of freezing should prove sufficient. The cooling elements 45 are stackable and easily stored in the freezer. After each use, the cooling element 45 can be removed from the container 10 and refrozen before each day's use. Once the cooling element 45 is frozen and conditioned, it may be inserted into the container 10. In the case of separate components, the bottom' 47' can be first placed in the bottom of the well 40 and the sides 46 and 46' can be inserted along the sidewall of the well 40 forming a receptacle area 48 for the inner caddy 50. After the inner caddy 50 is loaded and properly secured within the receptacle area 48, the top 47 can be placed on top of the inner caddy 50. In the case of a single cooling element 45, the cooling element can be placed in the well 40 by means of the handles 49, and the hinged top portions 47 can be opened ready to receive the inner caddy 50. In certain situations, a standby cooling element (not shown) may be employed. The standby cooling element may be sized and shaped to fit within the receptacle area 48 of the cooling element 45. The standby cooling element may be frozen along with the cooling element 45, and may be inserted into the receptacle area 48 prior to use. Such an arrangement can be useful if the container 10 is transported empty to pick up an item to be transported, or can be useful if the container 10 is stored ready to be used for emergency use, such as on an ambulance, helicopter, airplane or other emergency vehicle. The standby cooling element can help to retain the receptacle area 48 at the desired temperature for as long a time period as possible. The {WP283777;3} 15 WO 2006/124149 PCT/US2006/013247 standby cooling element is removed from the container 10 prior to insertion of the caddy 50 and the item(s) to be transported. Figs. 5a and 5b depict arrangements of the inner caddy 50 made to hold, transport and monitor the temperature of I to 6 units of blood or blood products at the required temperature range. Typically, one arrangement of the caddy may be sized to receive both 450 cc sized whole blood units, and 350 cc PRBC blood product units. It will be appreciated by those of skill in the art that different caddies may be sized differently for different payloads, as typically food, chemicals, pharmaceuticals, biologics, laboratory specimens, stem cells, bone marrow and organs are transported in different sized containers. The appropriately sized caddy can be selected for the item being transported. For example, different caddies to transport 2-6 units of blood, 2-3 units of stem cells or 1-2 units of bone marrow may be sized with the same external dimensions to fit inside a container 10. In this way, it is not necessary to carry a large stock of different sized containers 10 because the inner caddy 50 can be swapped out depending on the particular transport application. Additionally, in certain arrangements, the use of a caddy is not necessary, as the item to be transported may be placed directly into the receptacle area defined by the cooling elements. The inner caddy 50 is preferably constructed of clear, durable and lightweight material, such as Lucite or polycarbonate material or other like materials that are generally known and used by those skilled in the arts. However, it is understood that any material of like properties that is known and generally used by those skilled in the arts may be employed. The inner caddy 50 is removable and has cleaning vents 57, allowing for self-drainage and easy cleaning. The inner caddy 50 comprises of a bottom portion 58 connected to walls 59. Preferably, the inner caddy 50 defines a holding area 60 that can accommodate two or more items, such as units of blood or blood products or other biological material, vials of pharmaceuticals and the like, etc, for transportation at the required temperature range. As best seen in Fig. 5b, holding area 60 is defined by sidewalls 80, front wall 81 a back wall 82, and a middle divider 83. To store a unit of blood or blood products in the holding area 60, the unit can be inserted in an upright position in between one of the straight side walls 80 and the middle {WP283777;3} 16 WO 2006/124149 PCT/US2006/013247 divider 83. The sidewalls 80 and middle divider 83 can, for example, be sized and shaped to hold and secure a unit of blood or blood products placed between them. In one arrangement of the invention, the holding area 60 is adapted and sized to hold 1 to 2 units of blood products. In another arrangement, the holding area 60 is adapted to hold up to four units of blood or blood products. In yet another arrangement, the holding area 60 is adapted to hold six or more units of blood or blood products. It will be readily understood that the holding area 60 is sized appropriately to receive and securely hold any item that is to be transported. The sidewalls 80 can be hingedly connected to lids 85, 85', which either extend outwardly open from the holding area 60 to form gull wings or from front to back (not shown). Each lid 85, 85' is situated on an opposing side of the inner caddy 50. In one arrangement, lifting means 86 are provided for easy removal of the inner caddy 50 from the container 10. Lifting means may include a handle, strap, tab, or anything that can be grasped or is generally known and used by those skilled in the arts. In one arrangement, lids 85, 85' include an aperture 87 (not shown) adapted to receive the lifting means. The inner caddy may be kept refrigerated with the biological material or pharmaceutical stored therein prior to use for transportation purposes. In one arrangement of the invention, the lids 85, 85' can be adapted to receive tamper resistant security tags or clips. If the tamper resistant security tags are still in place at the destination address for the item being transported, then the recipient can be assured that the item was not removed from the container 10. The tamper resistant security tags provide an effective means of ensuring compliance with certain protocols. As shown particularly in Fig. 5a, the inner caddy 50 provides for a receiving area 90, which is sufficiently wide and deep enough to hold and secure a temperature data-logging device 91. In the preferred arrangement, the receiving area 90 is secured to the front wall 81 of the inner caddy 50. However, it is appreciated by those skilled in the arts that the receiving area 90 may be located anywhere on or near the inner caddy provided that the temperature data-logging device 91 is proximately located near the blood or blood units being transported for monitoring purposes. {WP283777;3} 17 WO 2006/124149 PCT/US2006/013247 The temperature data-logging device 91 can comprise at least one probe 92 for monitoring, collecting and reporting data concerning the items being transported. The probe 92 may be inserted into a protected channel formed in the caddy 50, proximate to the items being transported. The temperature data-logging device 91 can be pre-programmable and can be adapted to monitor the temperature of the items being transported for 24+ hours to meet the courier or recipient's protocols. In this manner, compliance and performance of the invention can be documented and verified. The temperature data-logging device 91 may include a connection point to enable it to be connected to a computer docking station for downloading the temperature data, or may connect with a computer wirelessly. Typically, the temperature data is downloaded into suitable software that can produce a graph showing the trend in temperature recorded by the probe 92 over time. In some arrangements, the temperature data-logging device 91 and/or the probe 92 may be incorporated into the caddy 50. After the cooling element 45 has been frozen, conditioned and placed in the container 10, the inner caddy 50 is removed from the refrigerator with the temperature controlled items to be transported and inserted into the receptacle area 48 formed by the cooling element 45 for receiving the inner caddy 50. The temperature data-logging device 91 is now ready for monitoring and can be positioned in the receiving area 90 with its probe inserted in the holding area 60 at or near the items being transported. The temperature data-logging device 91 may be activated by swiping it with a start magnet, or otherwise switched on. Thereafter, the temperature data-logging device 91 can continuously monitor the units of biological material or pharmaceutical during the entire time of transport for up to 24+ hours. The temperature data logging device 91 can be programmed to either transmit an alarm or a page if the temperature range is outside the set parameters. Alternatively, or in addition, a user can download data from the data-logging device 91 once the container 10 has reached its final destination, and can view the temperature information on a computer or can print out the information. Instead of placing the data-logging device 91 in the caddy 50, it may alternatively be placed in a receptacle created in the lid or side walls of the container 10, such that a display on the data logging device 91 may be viewed without opening the container 10. In this way, the {WP283777;3} 18 WO 2006/124149 PCT/US2006/013247 inside temperature of the container 10 as recorded by the probe 92 may be easily checked during transportation of the items without compromising the integrity of the interior of the container 10. The container 10 may also be equipped with a cell phone/GPS unit such that a user can call the cell phone in order to find out the location, speed of travel, temperature, etc of the unit. It will be appreciated that any suitable communications device may be used, and that a cell phone is used as an example only. For example, an email alert may be transmitted by a wireless communications device such as a BlackberryTM. Additionally, any suitable location detecting system may be employed, not limited to GPS systems. For example, in an alternative arrangement, the container 10 may be fitted with an REID tag, which may be read by sensors located at various points in its journey (or the container 10 may be fitted with a sensor capable of reading static RFID tags located at various points). This arrangement may be useful when used in combination with a courier or delivery company that has RFID tracking equipment at its warehouses and other locations along a delivery route. Yet a further alternative location tracking system can involve barcode labels provided on the outside of the container 10 that can be scanned as the container 10 is transported along a delivery route. It is possible to program geographical parameters outside which the container 10 should not travel, and have the cell phone/GPS unit or other location tracking system call or page a user if the container 10 is found to be outside this area. This arrangement can help to alleviate routing errors in transportation which cause the item to be in transit for longer than is desirable. The cell phone/GPS unit or other communications/tracking system may be incorporated into the temperature data-logging device 91, or may be separate therefrom. Preferably, the temperature data-logging device 91 sends temperature data to the cell phone/GPS unit so that the temperature information may be transmitted by the cell phone to a user. Preferably, the communication between the data-logging device 91 and the cell phone is carried out wirelessly. The antenna for the cell phone/GPS unit functions optimally when the exterior of the case 11 is formed of ballistic nylon or other suitable material that does not interfere with reception. Batteries for the cell phone/GPS unit are also included. Additionally, sensors may be included for monitoring opening of the container 10, and/or the caddy 50. A processor may be included. {WP283777;3} 19 WO 2006/124149 PCT/US2006/013247 An alarm system may be included, such that an alarm may sound at any point that the temperature recorded by the data-logging device 91 is outside the required range. The alarm system may include an audible alarm that may be heard by a person transporting the container 10, or may be connected to a communications device so that a user may be alerted by call, page, email or any other type of communications that the item being transported has been compromised. Steps may then be taken to immediately rectify the temperature of the item, such as by checking that the container 10 has not been opened, or to immediately send replacement items to the intended recipient of the items. Another arrangement of the invention is illustrated in Fig. 6 for transporting test tubes and vials of specimens. The container 100 of Fig. 6 may be smaller than the containers of Figs. 1-5, because. it may be sized to receive tubes or vials of specimens rather than bags of blood or blood products or other biological materials. The container 100 in figure 6 may comprise an outer layer 102 which may be formed material, a layer of phase change coolant (number not shown) that goes between 102 and 104, an inner layer 104 of formed plastic or non-reactive material that is attached to lid 108 so that any leakage of the coolant material will not react with the 102, 104, and 106. It is also preferred that all the components are sealed together. A cap 112 also can be included. The entire container 100 may be frozen for 24 hours prior to use. The test tubes or vials to be transported may be wrapped in a plastic, polyethylene or other suitable bag, or in bubble wrap, and are placed within the inner caddy 110. A further arrangement of the invention is illustrated in Fig. 7a. In this arrangement, the container 120 comprises an outer corrugated layer 122, a large flexible bag 124, which may be formed of Mylar or any suitable material, an insulating layer 126 of open cell or closed cell foam, or any other suitable material, a second smaller Mylar or other flexible bag 128, and container 100. The Mylar or other foil bags provide air barriers to aid with insulation. The bags 124 and 128 may be open at the top, and may be simply closed in an overlapping manner using a gift wrap type fold, meaning that a user does not need to use glue or tape to keep the bags closed. The insulating layer 126 may be formed as several separate pieces to surround the inner container 100, or may include fewer pieces that are folded or otherwise joined. Preferably at least the top of the insulating layer is removable from or hingedly attached to the walls so that {WP283777;3} 20 WO 2006/124149 PCT/US2006/013247 access to the interior of the container 120 may be easily gained. Container 100 is frozen prior to use, preferably for at least 24 hours. The container 100 can transport products for a minimum of 24-48 hours at the required temperature. Larger container 100 may be employed to transport larger volumes of specimens, foods, pharmaceuticals, and items that are bulkier than, for example, blood and blood products and other biological materials. Container 100 can also be used by itself to hold specimens at compliance temperature inside outer type containers such as laboratory specimen lock boxes used at physician offices for holding laboratory specimens awaiting courier pick-up. A further arrangement of the invention is illustrated in Fig. 7b. In this arrangement, the container 120 comprises an outer corrugated layer 122, a large flexible bag 124, which may be formed of Mylar or any suitable material, an insulating layer 126 of open cell or closed cell foam, or any other suitable material, a second smaller Mylar or other flexible bag 128, and several phase change material packs 130. The Mylar or other foil bags provide air barriers to aid with insulation of the gel packs 130. The bags 124 and 128 may be open at the top, and may be simply closed in an overlapping manner using a gift wrap type fold, meaning that a user does not need to use glue or tape to keep the bags closed. The insulating layer 126 may be formed as six separate pieces to surround the inner compartment, or may include fewer pieces that are folded or otherwise joined. Preferably at least the top of the insulating layer is removable from or hingedly attached to the walls so that access to the interior of the container 120 may be easily gained. In the illustrated arrangement, six -1 0 C coolant packs 130 are employed, and the gel packs 130 may have different sizes such that 2 larger packs may go on the top and bottom of a specimen to be transported, with 4 smaller packs around the sides of the specimen. The 4 smaller packs may be connected together to form a single wall that may be folded easily at the joins between the packs. Different phase change coolant packs 130 may be switched in and out of the container 120, depending on the type of specimen that is to be transported. For example, 18'C to -25'C phase change coolant, -50'C phase change coolant if ultra-low freezers are available, or +2'C to +5'C phase change coolant may be used, depending on the temperature at which the product is to be transported. The coolant packs are frozen prior to use, preferably for {WP283777;3} 21 WO 2006/124149 PCT/US2006/013247 at least 24 hours, and the product to be transported is surrounded by the coolant frozen packs. Alternatively, phase change coolant packs incorporated into cooling elements 45 may be used, with the cooling elements sized depending on the product that is to be transported. The product to be transported may be placed directly inside the compartment created by the coolant packs 130, or may be placed inside a material such as bubble wrap prior to being placed inside the container 120, in order to prevent any cold spots forming in the product in any location where the product may directly touch the coolant packs 130. The container 120 can transport products for a minimum of 48-96 hours at the required temperature. Larger containers 120 may be employed to transport pallets of products, for example for military or laboratory use, or for the transportation of food, chemicals or other bulky items. The container 100 of Fig. 6 may be used within the container 120 to provide additional temperature stability to the container 100. In another arrangement of the invention, illustrated in Fig. 8, different temperature zones may be created within the same container 140 for the transport of different products at the same time. For example, three different temperature zones such as ambient, refrigerated and frozen may be included. In order to do this, removable insulating dividers 141 may be arranged to create different temperature zones. In the illustrated arrangement, two dividers 141 can create three temperature zones. The dividers 141 may be used inside a rigid insert well 142, and an insulating layer 143 may be provided on the interior of the lid 144 of the container 140. The container 140 may have an outside document window 145 and pocket 146, and may have wheels (not shown) and an extendible handle 148 to enable transport of the container. Additional handles 149 may also be provided. The exterior of the container 140 may be of any suitable material, such as ballistic nylon, and the insulating layers (not shown) in the wall of the container 140, as well as the insulating layer 143, may be formed ofclosed cell foam or any other suitable insulation. A phase change cooling element (not shown) and optionally a caddy (not shown) can be used in each temperature zone created by the insulating dividers 141 to maintain required temperatures in the three different temperature zones. It will be appreciated that the number and size of the temperature zones may be varied by using different configurations of dividers 141, depending on the application. The temperature zones may be used to control the length of time that the container 140 may be used, such that the container 140 may be used for 12, 24, 48 or 72 hours depending on the initial temperature of the phase change coolant packs. {WP283777;3} 22 WO 2006/124149 PCT/US2006/013247 A further arrangement of the invention is illustrated in Fig. 9. In this arrangement, the container 150 may be sized to take up a half pallet (for example, having outside dimensions of 27" high, 26.5" wide and 22.5" deep). Alternatively, the container 150 may be sized to take up a whole pallet, or any other suitable size. An advantage of sizing the container to take up a half or whole pallet, is that the container 150 may be easily transported using commercial shipping companies, and may be particularly suitable for bulk deliveries, such as for food, medicines, vaccines and the like. The container includes an internal insulating layer 152 of PE foam, which may for example, be 3" thick. A removable insert well 154 formed of a strong, durable material may have handles 156 so that the well and its contents may be easily lifted out of the container 150. The cooling element 158 may be formed of any suitable material, such as ABS plastic with phase change material sealed therein. The cooling element 158 may have walls that are 2" thick, with an interior payload space 160 of 14" x 10" x 15". It will be appreciated that the sizes given herein are exemplary only, and that the invention is not intended to be limited in this regard. The cooling element 158 can be formed as a rectangular box 162, with a hinged lid 164 allowing access to the interior thereof. Alternatively the cooling element 158 may have a removable, unhinged lid. The container 150 may be equipped with a cellphone/GPS unit and/or a temperature logging device as in other arrangements. All the arrangements of the invention result in lightweight, reusable shipping containers for temperature controlled items and which keep the temperature of the items within predetermined ranges during transportation. Monitoring of the temperature may be used with any of the arrangements, by using a temperature data-logging device 91 inside any of the containers. All arrangements of the invention allow for complete cold-chain transportation solutions. It is possible, for example, to pool ownership of the containers and cooling elements so that delivery companies are able to lease containers and cooling elements separately: This would enable a delivery company to keep cooling elements pre-frozen at various points in the delivery route, and to change the cooling elements if necessary prior to final delivery of the item. For {WP283777;3} 23 WO 2006/124149 PCT/US2006/013247 example, in some applications it may be desirable to change the cooling element every 12 or 24 hours. Further modifications and alternative arrangements of various aspects of the invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the invention. It is to be understood that the forms of the invention shown and described herein are to be taken as the presently preferred arrangements. Elements and materials may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the invention may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of this description of the invention. Changes may be made in the elements and compositions described herein or in the features or in the sequence of features of the methods described herein without departing from the spirit and scope of the invention as described in the following claims. {WP283777;3} 24

Claims (40)

1. A container for transporting temperature controlled items comprising: an outer case including a lid; an insulating layer substantially inside the outer case and the lid; a generally rigid well located inside the insulating layer disposed in the outer case; at least one removable cooling element, the at least one cooling element being capable of maintaining temperature within a prescribed temperature range for predetermined periods of time upon being kept at a predetermined temperature prior to use, the at least one cooling element being disposable within the well and at least partially defining a receptacle area; and a caddy locatable in said receptacle area and designed to accommodate at least one item to be transported, wherein said caddy is at least partially surrounded by the at least one cooling element.

2. The container according to claim 1, further comprising a temperature data-logging device for monitoring, collecting and reporting data concerning the item being transported.

3. The container according to claim 1, wherein the cooling element comprises cooling material disposed therein, the cooling material comprising a phase change material.

4. The container according to claim 3, wherein the phase change material is sealed within the cooling element.

5. The container according to claim 1, wherein the cooling element at least partially comprises an ABS plastic.

6. The container according to claim 1, wherein the cooling element is shaped so as to substantially surround the caddy. {WP283777;3} 25 WO 2006/124149 PCT/US2006/013247

7. The container according to claim 6, wherein the cooling element comprises a bottom, side walls and at least one top portion, wherein the top portion is hingedly attached to the side walls.

8. The container according to claim 1, wherein the cooling element is removable from the container so as to be separately freezable prior to use.

9. The container according to claim 1, wherein the outer case further comprises means for lifting and towing the container.

10. The container according to claim 9, wherein the lifting and towing means comprises at least one of a reinforced handle, a wheel assembly, a telescopic handle, a non retractable handle, and a shoulder strap.

11. The container according to claim 1, wherein the outer case further comprises of at least one information sleeve adapted to hold identification information concerning the biological material or pharmaceutical being transported.

12. The container according to claim 1, wherein the lid is hingedly attached to the outer case and includes closing means for closing the container.

13. The container according to claim 12, wherein the closing means are selected from the group consisting of twist latches and at least one zipper.

14. The container according to claim 1, wherein the caddy is provided with at least one tamper resistant seal.

15. The container according to claim 1, wherein the insulating layer is formed of polyurethane material.

16. The container according to claim 1, wherein the well is formed of PE plastic. {WP283777;3} 26 WO 2006/124149 PCT/US2006/013247

17. The container according to claim 1, wherein the lifting means of the inner caddy includes a handle.

18. The container according to claim 2, further comprising a communications device capable of communicating temperature data to a user.

19. The container according to claim 2, further comprising an alarm to alert a user if the temperature recorded by the temperature data-logging device falls outside a predetermined range.

20. The container according to claim 1, further comprising a location detecting device for tracking the location of the container during transport.

21. The container according to claim 20, further comprising a communications device capable of communicating at least one of temperature and location data to a user.

22. A container for transporting temperature controlled items comprising: an outer case including a lid; an insulating layer substantially inside the outer case and the lid; and at least two cooling elements, the cooling elements each being capable of maintaining temperature within a prescribed temperature range for predetermined periods of time upon being kept at a predetermined temperature prior to use, the cooling elements being disposed within the insulating layer and each defining a receptacle area designed to accommodate at least one item to be transported, wherein each cooling element is designed to maintain an item located within the receptacle area at a different predetermined temperature.

23. The container according to claim 22, wherein each cooling element includes a phase change material. {WP283777;3} 27 WO 2006/124149 PCT/US2006/013247

24. The container according to claim 22, further comprising a temperature data logging device for monitoring, collecting and reporting data concerning the biological material or pharmaceutical being transported.

25. A container for transporting temperature controlled items comprising: an outer case including a lid; an insulating layer substantially inside the outer case and the lid; a flexible foil barrier positioned between the outer case and the insulating layer; at least one cooling element, the at least one cooling element being capable of maintaining temperature within a prescribed temperature range for predetermined periods of time upon being kept at a predetermined temperature prior to use, the at least one cooling element being disposed within the flexible foil barrier and at least partially surrounding a receptacle area; and a receptacle located in said receptacle area and designed to accommodate at least one item to be transported, wherein said receptacle is at least partially surrounded by the at least one cooling element.

26. The container according to claim 25, further comprising a second flexible foil barrier surrounding said receptacle.

27. The container according to claim 25, wherein the at least one cooling element includes a phase change material.

28. The container according to claim 27, wherein the phase change material is sealed within sealed within the cooling element.

29. The container according to claim 27, wherein the cooling element at least partially comprises an ABS plastic.

30. A container for transporting temperature controlled items comprising: an outer case including a lid; {WP283777;3} 28 WO 2006/124149 PCT/US2006/013247 an insulating layer substantially inside the outer case and the lid; and a removable cooling element capable of maintaining temperature within a prescribed temperature range for predetermined periods of time upon being kept at a predetermined temperature prior to use, wherein the cooling element is shaped so as to define a receptacle area therein, into which at least one item for transportation may be placed such that the item for transportation is substantially surrounded by the cooling element.

31. The container according to claim 30, wherein the cooling element includes a bottom, side walls and at least one lid portion, the at least one lid portion being hingedly attached to at least-one side wall to allow access to the receptacle area defined within the cooling element.

32. The container according to claim 30, wherein the cooling element comprises phase change material disposed therein.

33. The container according to claim 32, wherein the phase change material is sealed within the cooling element.

34. The container according to claim 30, wherein the cooling element at least partially comprises an ABS plastic.

35. A method of transporting temperature controlled items comprising the steps of: supplying a container having an outer case including a lid; an insulating layer substantially inside the outer case and the lid; at least one removable cooling element disposable within the outer case and at least partially defining a receptacle area that is at least partially surrounded by the at least one cooling element; removing the at least one removable cooling element from the container; cooling the at least one removable cooling element for a predetermined period of time in a freezer, refrigerator or other temperature controlled environment; replacing the at least one removable cooling element in the container; {WP283777;3) 29 WO 2006/124149 PCT/US2006/013247 placing the item to be transported in the receptacle area defined in the at least one cooling element; closing the container so as to substantially surround the at least one cooling element by the insulating layer; and transporting the biological material and/or pharmaceuticals.

36. The method according to claim 35, wherein the at least one removable cooling element is frozen for at least 24 hours prior to replacement in the container for use.

37. The method according to claim 35, wherein the at least one removable cooling element is conditioned after cooling and prior to replacement in the container for use, by placing the cooling element at room temperature for approximately 30 minutes.

38. The method according to claim 35, wherein the at least one cooling element comprises cooling material sealed therein, the cooling material comprising a phase change material.

39. The method according to claim 35, further comprising the step of monitoring at least one of temperature within the caddy and location of the container during transportation of the container.

40. The method according to claim 35, further comprising the step of inserting a standby cooling element into the receptacle to maintain internal temperature conditions prior to placing the item-to be transported into the receptacle. {WP283777;3} 30