US 20030084679 A1
This invention relates to shipping containers and methods for the transportation perishable or temperature-sensitive materials at stable temperatures. Materials within the container are maintained in a narrow temperature range by a passive temperature control device. The device and the perishable materials are placed in the container, separated by a structured barrier. Structured barriers comprise materials of predefined thickness and placed so that perishable materials do not come into direct contact with the temperature-control device, but has a plurality of notches that allow for limited air circulation. Preferably the assembled container is covered with a fitted lid to minimize temperature transfer between the outside and inside of the container.
1. A shipping container comprising:
a container have a single opening leading to an inner chamber;
a structured barrier within the inner chamber that allows for limited air circulation across said structured barrier;
a temperature-control device placed in the chamber on one side of the barrier; and
a fitted lid that securely covers said opening.
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13. A shipping container comprising:
a container means to house an inner chamber;
a barrier means within the inner chamber that allows for limited air circulation across said barrier means;
a temperature-control means to control temperature in said chamber; and
a covering means to cover said inner chamber.
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20. A method for transporting temperature-sensitive materials comprising:
placing said materials within a container;
placing the structured barrier on top of said materials;
placing the temperature-controlling device on top of the barrier; and
securely closing said container with the fitted lid.
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32. A method of maintaining materials at a temperature range of 17° C.+/−7° C. for at least 3 days comprising placing said materials in a container comprising a structured barrier and a temperature control device.
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 This application claims priority to U.S. Provisional application No. 60/306,865, entitled “Shipping Containers and Methods for the Transportation of Materials at Stable Temperatures,” filed Jul. 23, 2001.
 1. Field of the Invention
 The present invention relates to shipping containers and methods for the transportation of biological materials at stable temperatures. In particular, the invention relates to shipping containers and methods for the transportation of biological materials at relatively constant, stable temperatures.
 2. Description of the Background
 Biological and other materials are often transported over long distances using common carriers such as mail and express courier services using land sea or air. Sending and receiving locations can be miles or even continents apart with transportation being by land (road or rail), sea or air carrier. All forms of transportation carry a risk that the materials being transported might be damaged or destroyed. With biological materials such as blood, tissue and organs for transplantation, the risk is considerably magnified and, the longer the distance, the higher the risk. In addition, the shipping materials themselves can pose a health risk if, for example, the materials contain an infectious or hazardous substances.
 There are many regulations from local and federal government and international bodies, which seek to define safe shipping standards. Pertinent federal regulations in the United States include those set forth in titles 29, 39, 42 and 49 of the Code of Federal Regulations. Particular agencies whose mission is concerned with safe packaging and shipping standards are the International Civil Aviation Organization/International Air Transport Association (ICAO/IATA), United States Department of Transportation (DOT), U.S. Center of Disease Control (CDC), U.S. Occupational Safety and Health Administration (OSHA), United Nations (UN), and World Health Organization (WHO). Specific standards that must be followed include: Dangerous Goods Regulations of the International Air Transport Association, 38th Edition, Jan. 1, 1997; Code of Federal Regulations Title 49, Transportation Subtitle B, Other Regulations Relating to Transportation, U.S. Dept. of Transportation Parts 172, 173, 176 and 178, Oct. 1, 1996; Biosafety in Microbiological and Biomedical Laboratories, U.S. Dept. of Health and Human Services Public Health Service (CDC and NIH), 3rd Edition May, 1993; Code of Federal Regulations Title 42, Public Health U.S. Dept. of Health and Human Services Part 72 Interstate Shipment of Etiologic Agents Mar. 2, 1995; Hazardous Material Regulations Transportation Safety Act of 1974, Consolidation of 1976 Pocket Guide, 1991; U.S. Dept. of Health and Human Services Center for Devices and Radiological Health, U.S. Food and Drug Administration, Generic Standard Operating Procedure “Handling, Packaging, Transportation, Storage and Sterilization of Medical Devices” October, 1994; U.S. Dept. of Health and Human Services Occupational Safety and Health Administration Section 3, Final Rules on Occupational Exposure to Blood borne Pathogens; American Society for Testing and Materials Proposed Documents for ISO/TC 150/WG5 “Retrieval and Analysis of Implantable Medical Devices;” United Nations Documents Requirements for Transportation of Hazardous Goods.
 When transporting hazardous items, even if in full compliance with all appropriate regulation, problems can arise as to durability, rigidity, size, weight, cost, reusability, and temperature stability of the container. These issues are especially significant when the containers are required to be leak proof, pressure resistant and/or maintain a proscribed temperature range. Durability problems exist with rigid containers due to the inevitable bangs, scrapes, dents and other permanent distortions that can occur in handling during transport. Durability can also be adversely affected by external environmental conditions such as rain, snow and sun, which can compromise the integrity in the container. In some cases, containers are required to be discarded after one use or simply are unable to hold up to normal wear and tear. To make such container reusable, expensive process would be required to refurbish the container for reuse to meet original specifications, performance criteria and/or appropriate regulations.
 One example of a shipping container suitable for use in the transportation of hazardous materials is proposed in U.S. Pat. No. 5,996,799, which is incorporated herein by reference. In at least one embodiment, the container comprises a multi-component non-rigid, flexible structure to accommodate the particular item or items to be transported. The container can be sized to specific sizes and shapes of the items to be transported. This allows for a smaller, less cumbersome, reduced weight container that costs less, is easier to handle, and takes less space to store. The container's non-rigid, flexible design enhances its durability, possibly reducing damage caused during transport and increasing the probability of reusability. Further, as the container can be adaptable to have a closer net shape of the items to be transported, costs associated with transportation and delivery. The container can also be significantly more resistant to external environmental depending on the materials used for its construction.
 Another problem is that containers can be very large in comparison to the material or specimens to be transported. This creates unnecessary manufacturing and materials cost as well as increased costs for transportation. Lack of ability to match a performance oriented container size to the size of the materials/specimen can cause the transport to be unwieldy, heavier than necessary, difficult to store and too large for its intended purpose. More importantly, the increased size, which may be necessitated by dry ice or other materials designed to keep the materials at a constant temperature require additional space which causes significant temperature fluctuations within the container.
 Containers with lids have the general characteristic of top-down cooling (when considering the transportation of cooled materials), which means that more heat seeps into the container from the top as opposed to through the walls of the container, so that the coolest areas of the container are opposite the lid in the depths of the internal space of the container. This creates uneven and uncontrollable temperature gradients between the top and bottom of the container. Of course, this can present serious problems when temperature directly affects the material being transported. Top-down cooling also produces hot spots, wide temperature swings and severe temperature gradients throughout the container.
 The most common manner to transport heat-sensitive materials is in refrigerated containers. Although large quantities of such materials can be transported by artificial refrigeration for prolonged periods of time, the costs of such apparatus and the weight penalties incurred when air mail/freight is involved, are prohibitive for anything but bulk transport. For smaller quantities of materials, containers may be passively cooled, such as by packing the container with cooling elements such as water ice or dry ice (U.S. Pat. No. 6,119,465). Although effective for short periods of time, long-distance transportation is a problem and the weight of the cooling element adds considerably to the cost of delivery through conventional delivery services.
 One example of a passively cooled, self-contained transportation container has been proposed for the transportation of equine semen (U.S. Pat. No. 4,530,816 which is incorporated herein by reference). In this arrangement, a specimen is enclosed in a plastic bag and placed in a metal cup sandwiched between bags of liquid, such as water, that act as so called thermal ballast. The lower portion of the container is filled with a refrigerant such as ice or gelatinized ice. A thermal insulating layer, made of a vulcanized rubber, is disposed between the refrigerant and the metal cup in which the sample and the thermal ballast bags are disposed. The optimum steady state temperature is close to, but slightly greater than, freezing, with a temperature range of from 4° C. to 10° C.
 Thus, there is a strong need for a shipping container and related method that can transport materials that require stable temperatures and must be maintained within a defined temperature window. Such a container and method preferably should meet both general and specific requirements and testing protocols of national and international regulations for modes of transportation for air, sea, rail and highway. Such a container should be durable, lightweight, and preferably reusable, with the capability of transporting hazardous and/or potentially infectious materials in leak proof container that meets applicable criteria.
 The present invention overcomes the problems and disadvantages associated with current strategies and designs and provides new containers for shipping materials at stable temperatures. In particular, the invention relates to containers for shipping biological and other perishable materials at temperatures whereby the materials are not damaged.
 One embodiment of the invention is directed to a shipping container for the transportation of perishable or temperature-sensitive materials at relatively constant temperatures. Materials within the container are maintained in a narrow temperature range by a passive temperature control device. Such devices are commercially available, but may be custom designed for a particular container or material. The device and the perishable materials are placed in the container, separated by a structured barrier. Structured barriers are of a predefined thickness so that the perishable materials therein do not come into direct contact with the temperature control device, but allow for limited air circulation. Preferably, the structured barrier contains a plurality of notches for air circulation. The container is covered and, preferably, the lid is fitted to minimize the possibility of accidental opening and temperature transfer between the outside and inside of the container.
 Another embodiment of the invention is directed to methods for the transportation of temperature-sensitive materials. Methods comprise placing the materials in a container of suitable size and structure, and having one opening which leads into an inner chamber. Within the container is also placed a temperature-control device at a predetermined temperature, which is separated from the materials by a pouch made of insulative material. The pouch allows for limited air circulation, and prevents direct contact between the device and the materials. Once the contents are assembled within, a lid, preferably fitted, is placed over the one opening. Now completely assembled, the container can be delivered to a desired location.
 In a preferred embodiment, the invention provides a shipping container comprising: a container have a single opening leading to an inner chamber; a structured barrier within the inner chamber that allows for limited air circulation across said structured barrier; a temperature-control device placed in the chamber on one side of the barrier; and a fitted lid that securely covers said opening.
 Preferably, the container is composed of styrofoam.
 Preferably, the structured barrier is comprised of a light-weight materialn selected from the group consisting of foam, neoprene, plastics, cardboard, rubber, styrofoam and combinations thereof.
 Preferably, the structured barrier contains a plurality of notches or openings that allows limited air circulation between a plurality of inner chambers of the container.
 Preferably, the structured barrier contains three notches.
 Preferably, air circulation across the structured barrier is less than 25%.
 Preferably, the temperature-controlling device is an ice pack, liquid pack ,a gel pack, or a temperature generating device.
 In another preferred embodiment, the invention provides a method for transporting temperature-sensitive materials comprising: placing said materials within the container of the instant invention; placing the structured barrier on top of said materials; placing the temperature-controlling device on top of the barrier; and securely closing said container with the fitted lid.
 In a preferred embodiment, the container maintains said materials within a temperature range of 17° C.+/−7° C. for at least 3 days.
 In another preferred embodiment, the invention provides a shipping container comprising: a container means to house an inner chamber; a barrier means within the inner chamber that allows for limited air circulation across said barrier means; a temperature-control means to control temperature in said chamber; and a covering means to cover said innerchamber.
 Other embodiments and advantages of the invention are set forth in part in the description which follows, and in part, will be obvious from this description, or may be learned from the practice of the invention.
 Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.
 The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate a presently preferred embodiment of the invention, and, together with the general description given above and the detailed description of the preferred embodiment given below, serve to explain the principles of the invention. Thus, for a more complete understanding of the present invention, the objects and advantages thereof, reference is now made to the following descriptions taken in connection with the accompanying drawings in which:
FIG. 1 An open shipping container of one embodiment displaying components of the invention: a styrofoam container, vials of blood, a leak proof bag, a structured barrier, a gel pack and a fitted lid.
FIGS. 2a, 2 b, 2 c Perspectives of a preferred container.
FIG. 3A top perspective of a preferred container.
FIGS. 4a, 4 b, 4 c Perspectives of a preferred lid.
FIG. 5a, 5 b Perspectives of a preferred barrier.
FIG. 6A schematic of a preferred arrangement of: container; barrier; biological material; temperature controlling device; and lid.
FIG. 7 Test of frozen gel packs to maintain internal temperature range (ITR).
FIG. 8 Kit configuration incorporating a neoprene pouch to maintain internal temperature range (ITR).
 As embodied and broadly described herein, the present invention is directed to containers for shipping materials at stable temperatures. In particular, the invention relates to containers for safely shipping biological materials such as blood and other perishable materials within predetermined temperature ranges.
 Biological and other perishable materials are often transported over long distances using common carriers. For materials that must remain cool or cold, bulk refrigeration is generally required. Many materials cannot be transported by bulk, and require individually cooled containers. In most cases, these containers are passively cooled using frozen gel packs or other commercially available devices. Although effective, the increased costs associated with inclusion of the cooling materials are considerable. In addition, many materials have a limited life in such containers. The temperature window or temperature range at which the materials must be maintained is fairly narrow and often above freezing. This is particularly true with regard to biological specimens that are required to be sent to distant laboratories for medical testing.
 It was surprisingly discovered that, utilizing the shipping container and method of the invention, temperature-sensitive materials can be transported over long distances within passive temperature controls. Temperature control is achieved by incorporating a temperature-control device (e.g. a gel pack, ice pack, neoprene, warm pack or other temperature producing device), structured barrier that allows for limited air circulation and prevents direct contact between the materials and the temperature-control device, and a container with a single opening secured with a fitted lid.
 In a preferred embodiment of the invention, the temperature-sensitive materials are placed at the bottom of an appropriately sized container. Containers should be designed to have a minimum of open space, such that substantially all space within the container contains materials for transportation with little free space. Any size or configuration of container may be used, and preferably is configured for the contents being transported. The most typical configuration is square or rectangular.
 The desired material to be transported may be contained in a biohazard bag or other flexible pouch for safety reasons, and/or to prevent contact with air, water or water vapor.
 A structured barrier, preferably comprising a light-weight material that allows for air circulation around the barrier is placed on top of the materials substantially filling the cross-sectional area of the inner chamber of the container.
 Suitable materials that can be used for the barrier include, but are not limited to, cardboard, rubber, neoprene, foam (of appropriate density), paper, wood, styrofoam, composites, plastic and the like. The barrier prevents direct contact of the temperature-sensitive materials to the passive-cooling device.
 In a preferred embodiment, the barrier is appropriately structured with ventilation openings to allow for a limited amount of air circulation across the barrier. Openings may represent up to 20% of the cross-sectional area of the container. Openings preferably represent less than 20%, more preferably less than 10% of the cross-sectional area of the container.
 Structured barriers may have a single opening or a plurality of openings at various points over the barrier. For example, a square or rectangular barrier may have a plurality of notched corners representing an opening for air circulation.
 In a preferred embodiment, the barrier comprises notched corners for air circulation across the barrier. Preferably, there are three notched corners and one un-notched corner. The notches are formed of a sufficient size and shape to permit limited air circulation, but still allow the barrier to effectively shield the temperature-sensitive materials from the temperature-controlling device. In this manner, temperatures within the container are held relatively constant (temperature windows), for example, over a 20° C. range, over a 15° C. range, over a 5° C. range, and preferably over a 10° C. range (e.g. 0° C.+/−5° C.; 17° C.+/−10° C.; 24° C.+/−15° C.; 37° C.+/20° C.), for the appropriate period of time.
 Generally, transportation times for using the container of the invention, over which temperature windows can be maintained, are greater than one day, and preferably greater than two days.
 A temperature-controlling device such as, for example, foam, chemical warming or cooling devices, liquid pack or a gel pack, all of which are commercially available, or other passive temperature-controlling device may be placed on top of the barrier.
 The container is secured with a lid, preferably a fitted lid. The fitted lid minimizes the risk of accidental opening of the container, and also minimizes the amount of air circulation, and therefore temperature transfer, between the outside and inside of the closed container. The lid may be removable or, alternatively, hingedly or lachingly attached to the container. Other materials, such as shipping, regulatory or other documents or indicia may be placed on or in the container as desired.
 Temperature-sensitive materials that can be transported using the shipping container of the invention include, but are not limited to, tissues, cells, bodily fluids such as blood, whole organisms, artificial implants, pathogens, bacteria, organs, infectious substances, and temperature-sensitive chemicals and toxins, and pharmaceutical products such as drugs and vaccines, and combinations thereof.
 Preferably, containers are designed for a broad spectrum of users and require no special skill or training for assembly. Directions may be included in or with containers to provide preferred assembly instructions and instructions for emergency situations such as accidental leaks or punctures of the container. Thus, shipping containers of the invention are very useful for obtaining biological specimens from patients in a home, clinic or hospital setting. Nurses or other healthcare practitioners can obtain a desired biological specimen from the patient and immediately package the specimen for delivery to a clinical testing or other facility for analysis. For example, blood and urine is often collected from patients for routine physicals and insurance examinations. Once isolated, vials of blood and urine, may be packaged in a flexible biohazard pouch for protection from accidental leakage and biohazard containment as may be required by governmental regulation. Alternatively, vials may be placed in support structures (which may also be encased in a flexible pouch as desired) such as tube holders, tray holders and the like, which may form a part of the interior of the container or be separate components. The specimens are next placed into the bottom of a shipping container. On top of the specimen is placed a structured barrier for maintaining a near constant temperature environment within the container.
 Thickness of the barrier is determined by insulative properties of the container and the temperature requirements of the materials being shipped. The thickness of the barrier is generally between about 2 and 50 mm, and preferably between about 10 mm about 20 mm. The barrier substantially fills the cross sectional area of the inner chamber of the container and further contains a plurality of notches or openings allowing limited air circulation. For square or rectangular containers, barriers may also be rectangular or square. Preferably, such barriers have three notched corners, representing an opening of between about less than 20% of the cross-sectional area of the container, allowing limited air circulation across the barrier. A temperature-control device is placed on top of the barrier which may be a cooling device, such as, for example, a frozen or cooled gel pack for when outside temperatures are elevated above a desired range, or a room temperature gel pack to maintain a relatively constant temperature within the container when outside air temperatures are cooler than the desired temperature range. Alternatively, vials may be placed in a neoprene pouch to maintain a narrow temperature range during transportation. After assembly, the container is covered with a fitted lid to secure the contents and limit air circulation. Once fully assembled, containers can be transported over long distances without significant risk to the integrity of the contents.
 The preferred embodiments of the present invention and its advantages are understood by referring to the Figs. of the drawings, wherein like numerals being used for like and corresponding parts of the various drawings.
FIG. 1 depicts a preferred embodiment of the invention which is an open shipping container displaying components of the invention: a styrofoam container 60, vials of blood 61, a leak proof bag 62, a structured barrier 63, a gel pack 64 and a fitted lid 65. In this way, the invention also includes kit for transporting biological materials. Accordingly, the kit may contain written material for safe and effective use of the instant container. For example, the barrier may include instructions indicting that the barrier is be placed between the specimen and the temperature control device. Also, bag 62 may preferably contain instructions, warnings or other indicia 66 related to storing, using, or transporting any desired biological material to be transported. Similarly, in a preferred embodiment, the invention also includes instructions or other indicia 67 on storing, using, or transporting the instant container or its contents. The instructions may fit inside the container or be attached to the container or barrier.
FIGS. 2a, 2 b, 2 c, and FIG. 3 show different perspectives of container 1 has a body portion 2. The body may be constructed of any suitable material such as styrofoam having outer wall 8 and inner wall 9. Alternatively, body portion 2 may be a double-walled, blow-molded construction having outer wall 8 and inner wall 9, between which may be an insulation material. In the example, container 1 also comprises a floor portion 68 which is also formed by outer wall 8 and inner wall 9.
 It will be appreciated that FIG. 2c is a cross sectional view of the container across the line defined by A and A′.
 The body walls, floor and lid define a container volume or chamber 16 for retaining articles such as a desired biological material.
 A lip portion 69 is formed around an opening 70 to chamber 16 for securely holding a fitted lid that covers opening 70.
 Another preferred embodiment is shown with reference to FIGS. 4a, 4 b, and 4 c, wherein different perspectives of the instant lid portion are depicted. Specifically, the lid 71 may be formed of the same or different material than the container portion 1 (FIGS. 2a, 2 b, 2 c, and FIG. 3), and is defined by a body 75 having an inner surface 73 and an outer surface 74. The lid also may comprise a rim portion 69 formed on the inner surface 73 for securely holding the lid 71 on container portion 1. FIG. 4c is a cross sectional view of the lid across the line defined by B and B′.
 Another preferred embodiment is shown with reference to FIGS. 5a and 5 b, wherein different perspectives of the instant barrier are depicted. The barrier 76, may be any material that allows for air circulation around the barrier and is placed on top of the materials substantially filling the cross-sectional area of the inner chamber of the container. Preferably, materials that are suitable for the barrier include cardboard, rubber, neoprene, foam (of appropriate density), paper, wood, styrofoam, composites, plastic and the like. The barrier prevents direct contact of the temperature-sensitive materials to the passive-cooling device. The thickness of the barrier 77 is generally between about 2 and 50 mm, and preferably between about 10 mm about 20 mm.
 Specifically, FIG. 5a shows a preferred embodiment wherein the barrier 76 further comprises a plurality of notches or openings 77 allowing limited air circulation. Preferably, such barriers have three notched corners 77, representing an opening of between about 5% and 15% of the cross-sectional area of the container, allowing limited air circulation across the barrier. In the depicted embodiment, the barrier 76 is rectangular or square for a corresponding square or rectangular container. FIG. 5b is a cross sectional view of the lid across the line defined by C and C′. The barrier substantially fills the cross sectional area of the inner chamber of the container and notches or openings 77 allowing limited air circulation.
 A particularly preferred embodiment of the instant invention is shown in FIG. 6. It will be appreciated that FIG. 6 is a cross sectional view of the container across the line defined by A and A′ in FIG. 2b, and shows a preferred arrangement of the container, barrier, temperature-controlling device, lid and any desired biological material to be transferred. Specifically, a biological material such as vials of blood 78 are placed inside the container 1 on top of floor portion 68. A barrier 76 as is placed on top biological material 78. The barrier preferably has three notched corners 77, representing an opening of between about 5% and 15% of the cross-sectional area of the container, allowing limited air circulation (shown by arrows) across barrier 76.
 Next, a temperature-control device, such as a frozen or cooled gel pack 79, is placed on top of the barrier 76. A lid 71 then may be securely fitted on container portion 1. Besides being removable, the lid 71 may also be hingedly and latchingly attached to container portion 1.
 Attached hereto as Appendix A is a “User's Guide” describing and explaining the method of use for one embodiment of the invention.
 The following examples illustrate embodiments of the invention, but should not be view as limiting the scope of the invention.
 Blood specimens from 20 volunteers were exposed to various temperatures to determine the specific range of temperature to which a sample could be exposed without affecting viability. A temperature range of 50° to 75° Fahrenheit was identified as the range of temperature that specimens could be exposed. Several types and sized containers were evaluated to achieve maximum insulation. Containers evaluated included: Different weights of Styrofoam, polyurethane, thermos containers, and thermal bags. Proto-types were tested by using continuous recording temperature monitors. Styrofoam appeared to have very good stability maintaining the identified range of temperature when exposed to outside temperatures of 40° to 80° Fahrenheit.
 In order to maintain the identified internal temperature range (ITR) when exposed to external temperatures above 80° Fahrenheit a cooling device was employed. Several types of frozen gel packs were tested to maintain the ITR (See FIG. 7). During this testing it was identified that placing the frozen gel directly on the blood specimens caused damaged. A barrier between the frozen gel and specimens was needed. Various types of materials were tested. Materials tested included cardboard and various widths of Styrofoam. Potassium was identified as the most sensitive analyte when exposed to cold temperatures. Therefore potassium values were used to evaluate the effectiveness of the barriers.
 One inch Styrofoam proved to be good for allowing airflow while preventing temperatures of the frozen gel pack to affect specimens. However, When the Styrofoam barrier was cut to fit the inside dimensions of the Styrofoam container, it did not allow enough cooling to pass through to the blood specimens. Various types of holes and notches in the Styrofoam barrier were tried. After various trials, placing notches in three corners of the barrier allowed for very good passive cooling without negatively affecting analytes.
 At outside temperatures of 40° Fahrenheit or below the Kit was unable to maintain the ITR. Several devices were evaluated for providing heat or better insulation. Examples of devices evaluated included: chemical heat packs, isothermal molecular insulation, containers made of neoprene, and foam. Heat packs evaluated provided too much heat initially, and did not maintain needed temperatures for the duration of transport. Use of various insulators could not maintain stability. Neoprene of various thickness' were tested. At a thickness of 5 mm a pouch made of neoprene with a Velcro closure could maintain the ITR when blood was placed in the pouch immediately after it was drawn.
 The use of a frozen gel pack when temperatures are above 80° F. can be cumbersome and in some cases not feasible for nurses in the field. A secondary kit configuration addressed this by incorporating a neoprene pouch. By inserting specimens into the neoprene pouch the ITR remains stable at outside temperatures of up to 90° F. In addition, use of a chemical cooling pack maintains the ITR at temperatures above 90° F. (See FIG. 8).
 Additional advantages, features and modifications will readily occur to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details, and representative devices, shown and described herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents.
 As used herein and in the following claims, articles such as “the”, “a” and “an” can connote the singular or plural.
 All references cited herein, including all publications, and all U.S. and foreign patents and patent applications as well as the priority document, U.S. provisional application No. 60/306,865, are specifically and entirely incorporated herein by reference. It is intended that the specification and examples be considered exemplary only, with the true scope and spirit of the invention indicated by the following claims.