Method and apparatus for thermal stabilization of perishable biological samples

Abstract

The present invention provides a method and apparatus for performing temperature-controlled shipping of smaller temperature-sensitive payloads. The vacuum transporter may include a vacuum vessel and a PCM pack having an outer wall generally shaped to fit the vacuum vessel. The PCM package includes a payload cavity and may be pre-adjusted at an effective charge temperature for an effective charge time. A temperature sensitive payload is placed in the payload chamber. And the heat insulation plug is pressed into the opening part of the vacuum container. The vacuum transporter may then be transported to its destination by commercial delivery for an effective endurance time.

Description

Technical Field

[0001] The present application relates to systems and methods for transporting perishable and temperature sensitive materials including, but not limited to, whole blood. Background Art

[0002] Biological samples, such as but not limited to blood, are often required to be maintained within a specific temperature range to ensure the quality of the biological samples and any analytical or diagnostic tests performed on these samples. If not maintained within the appropriate temperature range, the composition of the sample may change, which may affect the accuracy of the test results. For example, too low a temperature may cause damage to the coating material (such as cells) due to the formation of intracellular ice, or the formation of particulate matter due to the aggregation of proteins and other dissolved materials. Conversely, increased temperatures may accelerate the degradation of proteins and coating materials because chemical reactions are more rapid at high temperatures.

[0003] The temperature of a biological sample may be controlled in a laboratory or other similar environment. However, at-home or other remote diagnostic testing may involve an individual collecting a biological sample at a location remote from where the analysis is to be performed (e.g., at their home) and shipping the sample to a testing facility. During transportation, a package containing a biological sample may be subject to extensive temperature changes and / or temperature fluctuations, resulting in similar changes in the temperature within the package and the temperature of any biological sample within such package, thereby affecting the quality of the biological sample. For example, the temperature in the cargo hold of a truck may rise to 60°C or drop to below -20°C, resulting in similar changes in the temperature within the package contained therein.

[0004] Typical temperature-controlled packaging systems are not well suited for transporting small, low-value payloads containing perishable materials. Small packaging systems using expanded polystyrene and cooling packs do not provide adequate performance to protect payloads from high or low temperatures over multi-day shipments, do not adequately protect specimens, and are not cost-effective for low-value payloads such as blood samples for routine diagnostic testing. Thicker insulation materials improve the performance of temperature-controlled packaging systems but add weight and volume, which increases freight costs based on shipping speed and the weight and volume combination of the package. Summary of the invention

[0005] Methods and apparatus are disclosed for performing temperature controlled transport of relatively small temperature sensitive payloads using mass produced vacuum bottles. Briefly, a vacuum transport container comprises a vacuum bottle, one or more PCM packs having outer walls that conform to the shape of the vacuum bottle. The PCM packs also include a payload cavity, such that the PCM packs can act as both a heat sink for thermal energy and as a secondary inner layer of thermal insulation. The PCM packs can be preconditioned at an effective charging temperature for a certain charging time. In some cases, the PCM packs can be cylindrical. The PCM packs can optionally include two or more subpacks, each subpack containing a different type of PCM. The preconditioned PCM packs are placed in the vacuum bottle, and the temperature sensitive payload is placed in the payload cavity. An insulating plug is pressed into the mouth of the vacuum bottle. The insulating plug can include a handle, a first plug having a diameter approximately equal to the inner diameter of the vacuum bottle, and a second plug having a diameter approximately equal to the diameter of the payload cavity. The vacuum transport container can then be transported to its destination by commercial courier within an effective endurance time.

[0006] The various embodiments described herein may include additional systems, methods, features, and advantages that may not necessarily be explicitly disclosed herein, but are apparent to one of ordinary skill in the art after reading the following detailed description and accompanying drawings. It is intended that all such systems, methods, features, and advantages be included in this disclosure and be protected by the following claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The description refers to the following drawings, in which the same reference numerals are used in different figures to indicate the same or similar components.

[0008] Figure 1 is a cross-sectional view of a temperature-controlled packaging system according to an embodiment.

[0009] Figure 2 is a cross-sectional view of another temperature-controlled packaging system according to an embodiment.

[0010] Figure 3 is a cross-sectional view of another temperature-controlled packaging system according to an embodiment.

[0011] Figure 4 Included is a cross-sectional view of another temperature-controlled packaging system according to an embodiment.

[0012] Figure 5 A disassembled temperature controlled packaging system is shown according to an embodiment.

[0013] Figure 6 A disassembled temperature controlled packaging system is shown according to an embodiment.

[0014] Figure 7 An assembled and disassembled temperature-controlled packaging system is shown according to an embodiment.

[0015] Figure 8 The summer and winter performance of two sub-package embodiments of a temperature controlled packaging system according to an embodiment are shown.

[0016] Fig. 9 The summer and winter performance of two sub-package embodiments of a temperature controlled packaging system according to an embodiment are shown.

[0017] Fig.10 The long term summer performance of a summer optimized embodiment of a temperature controlled packaging system according to an embodiment is shown.

[0018] Fig.11 A kit configuration including a temperature-controlled packaging system according to an embodiment is shown.

[0019] Fig.12 A collection and transportation workflow according to an embodiment is shown. DETAILED DESCRIPTION

[0020] The inventions described herein relate to the transport of perishable and temperature sensitive materials, including biological specimens. One such biological specimen is whole blood. The transport may be for laboratory analysis, such as diagnostic testing. For example, a biological specimen may be collected from a human or animal at a collection site and then transported to a centralized laboratory for diagnostic testing. The inventions may also be applied to the transport of perishable and temperature sensitive materials, such as food, chemicals, or vaccines.

[0021] Diagnostic tests may be performed on biological samples such as blood. In order to maintain the quality of biological samples for diagnostic testing and / or other analyses, biological samples such as blood and serum may be stored for a certain period of time or kept within a specific temperature range. Different samples may be kept within different temperature ranges when used for different types of analyses. For example, serum may be stored within a temperature range of 8-32°C for up to 48 hours for effective analysis of a specific analyte. Alternatively, serum may be stored within a temperature range of 2-8°C for up to 7 days. Alternatively, serum may be frozen at -20°C or lower for up to 1 month. Whole blood may be stored within a temperature range of 2-8°C, but only for 24 hours and may not be frozen. If not kept within the proper temperature range, the composition of the sample may change, particularly the composition of the liquid phase, resulting in inaccurate test results.

[0022] Temperature regulating packaging systems designed to address this challenge may include one or more phase change materials (PCMs) within an insulated container. PCMs such as water / ice, water / steam, dry ice, aqueous salts, paraffin waxes, and bio-oils can provide cooling and / or heating energy by releasing or absorbing heat of melting (or vaporization) at temperatures roughly around the melting or vaporization point of the PCM. The thermal storage that PCMs can provide against temperature changes far exceeds that of passive materials that rely solely on heat capacity. PCMs may require active cooling or heating to achieve the desired material phase in an initial state. For example, PCMs may need to be frozen by conventional refrigeration and then used in the temperature regulation of packaging materials. Because they can transition between liquid, solid, or gas phases, PCMs can be packaged in bags or other secondary containers.

[0023] In a temperature-controlled packaging system, an insulated container encloses one or more PCMs and a payload (e.g., biological specimens, perishable materials, etc.). The insulated container may include insulating materials such as expanded polystyrene, polyurethane foam, films containing air pockets, or vacuum insulation. A key parameter in the design of a temperature-controlled packaging system is the thermal resistance per unit thickness of the insulation material. Higher thermal resistance or thicker insulation can reduce the volume of the PCM and / or increase the protection time to provide a longer transportation time for the payload.

[0024] The optimal design of a temperature-controlled packaging system requires a balance between freight costs and the safety of the payload. In certain embodiments, the packaging system is configured to maintain the payload within a target temperature range when challenged with a target maximum heat load for a specified period of time.

[0025] The heat load can be expressed as the temperature difference that needs to be maintained between the outside of the packaging system and the payload. As a non-limiting example, the heat load can be expressed as the difference between an outside temperature of 30°C and an internal target temperature of no more than 8°C (a difference of 22°C).

[0026] The overall performance index of the packaging system can be expressed as the product of the heat load and the specified time period. As a non-limiting example, the packaging system can be designed to maintain a temperature difference of 22°C over 48 hours. The packaging system described herein provides a balance between a small and low-performance packaging system that must be shipped at expensive express or overnight air freight rates, and a large and high-performance packaging system that can be shipped at a slower and more economical rate. A compact packaging system with sufficient performance to cope with slower shipping speeds can be provided to make the transportation of high-value payloads cost-effective.

[0027] Systems, methods, and apparatus for providing temperature-controlled transport of small, temperature-sensitive payloads using vacuum insulated containers (e.g., vacuum bottles) are described herein. These inventions may be particularly useful when applied to the transport of low-value payloads where simplified handling procedures are desired. As a non-limiting example, the disclosed embodiments may be used to protect self-collected blood samples for transport for diagnostic testing. In certain embodiments, a temperature-controlled packaging system includes a container and one or more PCM bags that (i) are shaped to fit the container and (ii) define a cavity for a payload, such as, but not limited to, a biological sample. The PCM bag may serve as both a heat sink for thermal energy and an insulating secondary internal layer. In certain embodiments, the PCM bag is preconditioned for an effective charging time at an effective charging temperature. In various embodiments, the PCM bag includes a first portion and a second portion, wherein the first portion includes a first type of PCM and the second portion includes a second type of PCM different from the first type of PCM. The system may optionally include an insulating plug having at least one first plug and an optional second plug.

[0028] The basic method involves conditioning a structured PCM pack within a defined temperature range, placing the structured PCM pack and payload into a matching commercial vacuum bottle of the type commonly used to insulate beverages, pressing a suitably shaped insulating plug into the mouth of the vacuum bottle to secure the structured PCM pack in place, and transporting the assembly to the destination within a valid time period.

[0029] Figure 1 A temperature-controlled packaging system 100 according to an embodiment is shown. In the embodiment shown, the temperature-controlled packaging system 100 is a vacuum transporter 101 including a container 102 and one or more PCM bags. Figure 1 , the temperature controlled packaging system 100 includes a lower (or first) PCM bag 109 and an upper (or second) PCM bag 110. Although two PCM bags are shown, in other embodiments, the temperature controlled packaging system 100 may include a single PCM bag or multiple PCM bags. The vacuum transporter 101 may optionally include an insulating plug 103.

[0030] In some embodiments, the container 102 is a vacuum insulated container, and in one non-limiting embodiment, the container 102 is a vacuum container 102. The container 102 includes an outer wall 108 that extends generally vertically and forms an outer surface of the container 102. The outer wall 108 can have various shapes or contours as desired. In one non-limiting example, the outer wall 108 forms a generally cylindrical outer surface.

[0031] In addition to the outer wall 108, the container 102 also includes an inner wall 107 that defines a receiving area 121 of the container 102. In some embodiments, the top end 123 of the container 102 defines an opening or mouth that provides access to the receiving area 121. As discussed in detail below, when the vacuum conveyor 101 is required for transportation, the opening can be selectively closed or otherwise sealed or blocked. Figure 1 As shown, the inner wall 107 may have a taper such that the transverse dimension of the receiving area 121 near the top end 123 is different from the transverse dimension of the receiving area 121 near the bottom end 126 of the container 102. In some embodiments, such as Figure 1 As shown, the transverse dimension of the receiving area 121 near the top end 123 is greater than the transverse dimension of the receiving area 121 near the bottom end 126 of the container 102. In other embodiments, the inner wall 107 can have various tapers as needed. In some embodiments, the taper of the inner wall 107 can be from about 0.5° to about 3° relative to the vertical axis of the container 102, but in other embodiments, the taper can be other angles as desired. In some embodiments, the container 102 can optionally be a vacuum insulated container, and the diameter of its mouth leading to the receiving area 121 is not less than the diameter of the lower portion of the receiving area 121 of the container 102.

[0032] The first PCM pack 109 and the second PCM pack 110 may be placed within the receiving area 121 of the container 102. In certain embodiments, the taper of the inner wall 107 may facilitate placement of the PCM packs 109, 110 within the receiving area 121. In various embodiments, the PCM packs 109, 110 may be integrally formed, coupled and / or otherwise attached to form a single structure, but this need not be the case in other embodiments.

[0033] See also Figure 1 , the first PCM pack 109 includes a first PCM 112 within a lower shell 118. In certain embodiments, the lower shell 118 defines a lower portion 125 of the payload cavity 115. Optionally, a bottom bracket 116 extends from the lower shell 118, and when the bottom bracket 116 is included, the bottom bracket 116 can allow an air gap 128 to be formed between the bottom of the lower shell 118 and the bottom of the inner wall 107. When such an air gap 128 is included, additional thermal insulation can be provided within the receiving area 121. Optionally, the lower edge 114 protrudes outwardly from the lower shell 118 and can contact the inner wall 107 of the vacuum bottle. The contact between the lower edge 114 and the inner wall 107 can position the first PCM pack 109 within the container 102 and can form an air gap 130 between the sides of the lower shell 118 and the sides of the inner wall 107. Such an air gap 130 can provide additional thermal insulation within the receiving area.

[0034] The second PCM pack 110 includes a second PCM 111 within an upper housing 117. In certain embodiments, the second PCM 110 is different from the first PCM 112. As a non-limiting example, the first PCM 112 may have a higher melting point than the second PCM 111, such that heat entering the receiving area 121 through a mouth or opening (e.g., through the thermal plug 103) is first absorbed by the second PCM, thereby preferentially melting under high temperature conditions or preferentially freezing under low temperature conditions. This configuration may be beneficial to maximize the protection of the payload under cold external conditions. Conversely, in another non-limiting example, the first PCM 112 may have a lower melting point than the second PCM 111 to provide different temperature control characteristics. This configuration tends to reduce temperature gradients under high temperature external conditions, which may be beneficial to maximize the protection of the payload under high temperature external conditions. For example, a second PCM having a peak melting point of about 18°C ​​and a wide melting temperature range of 10°C to 25°C can be paired with a first PCM having a peak melting point of about 14°C and a wide melting temperature range of 8°C to 20°C to prevent the payload from exceeding about 20°C in hot summer conditions for 72 hours.

[0035] Similar to the first PCM pack 109, the second PCM pack 110 may optionally include an upper edge 113 extending outwardly from the upper shell 117. Figure 1 As shown, the upper housing 117 may define a second portion 127 of the payload cavity 115. Optionally, the second PCM pack 110 may have an annular shape having a central cavity to form the second portion 127 of the payload cavity 115.

[0036] When the insulating plug 103 is assembled with the container 102, the insulating plug 103 is configured to close or otherwise block the mouth of the receiving area 121. Optionally, when assembled with the container 102, the insulating plug 103 seals the receiving area 121. Figure 1 As shown, the insulated plug 103 includes a plug 105 having a side wall 106, which can match the diameter and / or taper of the inner wall 107 of the vacuum bottle. The plug 105 and the mouth of the container 102 can form a friction fit, thereby retaining the insulated plug 103 in the mouth of the container 102. In some embodiments, the insulated plug 103 can optionally include a handle 104 to facilitate carrying the vacuum transporter 101. The handle 104 can optionally have an outer diameter, which can be approximately equal to the outer diameter of the container 102. In such an embodiment, the handle 104 can serve as a stop and indicate when the insulated plug 103 is properly positioned in the container 102. In other embodiments, the handle 104 can include other diameters and / or shapes as desired.

[0037] like Figure 1As shown, the second PCM pack 110, the first PCM pack 109, and a portion of the optional plug 103 together form the wall of the payload cavity 115, in which the perishable load 119 can be placed. The temperature of the payload cavity can be affected by the phase change of the first PCM 112 and the second PCM 111. In some aspects, the temperature of the payload cavity 115 can tend to be between the melting temperatures of the first PCM and the second PCM. One or more PCMs in the vacuum conveyor can alternately undergo phase changes over a wide temperature range. For example, a PCM can gradually change from a liquid to a solid state over a temperature range of about 8°C to about 18°C. When using a vacuum conveyor to protect the payload from high and low external temperatures, a PCM with a wide phase change temperature range can be advantageous. In other embodiments using a single PCM pack, the PCM pack can achieve bidirectional thermal control using a PCM with a wide phase change temperature range. In some embodiments, the phase change temperature range can be within the desired effective mean motion temperature range, and the insulation temperature can be within the phase change temperature range. As a non-limiting example, a single PCM may have a melting temperature of approximately 37° C. and a soaking temperature range of approximately 37° C. to 60° C. As previously mentioned, in other embodiments, other configurations and / or types of PCM packages having one or more types of PCM materials may be used as desired.

[0038] The second PCM bag 110, the first PCM bag 109 and the load 119 can be fixed in place by the plug 103 and prevented from moving during transportation. In some embodiments, the plug 105 can contact the top of the second PCM bag 110 to prevent and / or minimize relative movement of the second PCM bag and other items in the vacuum transporter 101.

[0039] Figure 2 An example of another temperature controlled packaging system 200 according to an embodiment is shown. Similar to the temperature controlled packaging system 100, the temperature controlled packaging system 200 is a vacuum conveyor 201. The vacuum conveyor 201 is substantially similar to the vacuum conveyor 101 except for the contents discussed below.

[0040] In one aspect, vacuum conveyor 201 includes a thermal plug 203 substantially similar to thermal plug 103, but it additionally includes a second plug 232 extending from plug plug 105. In such an embodiment, as shown in FIG. Figure 2 As shown, the second plug 232 can partially extend into the payload cavity 115. In these embodiments, the second plug 232 extending into the payload cavity 115 can allow a portion of the second PCM pack 110 to serve as additional insulation for the payload cavity. The second plug 232 can also accommodate any sample placed in the payload cavity 115.

[0041] like Figure 2As shown, the second PCM pack 110 and the first PCM pack 109 can capture an upper air bag 234, a lower air bag 236, and a bottom air bag 238. When these air bags are included, they can provide additional thermal resistance to the payload cavity 115. The air bag 236 can have various shapes or sizes as desired. As a non-limiting example, the thickness of the air bag 236 can be between about 0.2 mm and about 5 mm.

[0042] Compared to the vacuum conveyor 101, the second PCM pack 110 and the first PCM pack 109 respectively include at least two PCMs and / or form at least two PCM phases within the housings 117, 118. In some embodiments, during the melting process, the first PCM contained in the second PCM pack 110 may form a first low-density phase 240 and a first high-density phase 242. The first high-density phase 242 may be at a lower or higher temperature than the first low-density phase 240. As a non-limiting example, partially frozen water may form a low-density (ice) phase at 0°C and a high-density (liquid) phase at 4°C.

[0043] In other embodiments, the first low density phase 240 may represent a unique PCM that has a lower density and is insoluble than the high density phase 242. As a non-limiting example, a hydrophobic oil-based PCM may have a lower density than a water-based PCM and may float on the former. As shown, the upper portion 127 of the payload cavity 115 may have a temperature closer to the first high density phase, which may be advantageous.

[0044] Similarly, the second PCM contained in the first PCM package 109 can form a second low density phase 244 and a second high density phase 246, and / or the second low density phase 244 can be a unique PCM with a lower density than the second high density phase 246. As a non-limiting example, a hydrophobic oil-based PCM can have a solid portion that is denser than a (warmer) liquid portion. As shown, the lower portion 125 of the payload cavity 115 can have a temperature closer to the second low density phase. The differentiation of the PCM during freezing or melting can therefore be exploited to regulate the temperature of the payload cavity, especially if the vacuum transport device is preferably transported upright.

[0045] exist Figure 2 In the illustrated embodiment, the second PCM pack 110 and the first PCM pack 109 are separate components that are coupled together. In certain embodiments, the alignment between the second PCM pack 110 and the first PCM pack 109 can be facilitated by alignment grooves 248 and alignment ribs 250. The cooperation of the alignment grooves 248 and the alignment ribs 250 can reduce air infiltration into the payload cavity 115, which can further improve thermal insulation performance.

[0046] Figure 3An example of another temperature controlled packaging system 300 according to an embodiment is shown. Similar to the temperature controlled packaging system 100, the temperature controlled packaging system 300 is a vacuum conveyor 301. The vacuum conveyor 301 is substantially similar to the vacuum conveyor 101 except for the contents discussed below.

[0047] Compared with the vacuum transporter 101, the vacuum transporter 301 includes three PCM bags: a first PCM bag 309, a second PCM bag 110, and a third PCM bag 352. The first PCM bag 309 is substantially similar to the first PCM bag 109, but the first PCM bag 309 omits the bottom bracket 116. The second PCM bag 110 may have an annular shape, but in other embodiments, the second PCM bag 110 may have other shapes or contours as desired. The third PCM bag 352 may be shaped to form an upper barrier between the payload cavity 115 and the plug 105.

[0048] exist Figure 3 In the illustrated embodiment, the third PCM package 352 may include a third PCM 354. Optionally, the third PCM 354 is different from at least one of the first PCM 112 and / or the second PCM 111. In some embodiments, the melting point of the second PCM 111 may be between the first PCM 112 and the third PCM 354. As a non-limiting example, the melting point of the first PCM 112 may be approximately 0° C., the melting point of the second PCM 111 may be approximately 10° C., and the melting point of the third PCM 354 may be approximately 18° C. In certain embodiments, the payload cavity 115 may be maintained at a temperature close to the melting point of the second PCM 111 when the external ambient temperature is cold or hot.

[0049] Figure 4 An example of another temperature controlled packaging system 400 according to an embodiment is shown. Figure 4 In the embodiment of the present invention, the temperature controlled packaging system 400 includes a vacuum transporter 401 having a narrow-mouth vacuum container 402, an insulating plug 403, a central PCM package 456 and a peripheral PCM package 458.

[0050] The central PCM pack 456, the peripheral PCM pack 458 and the wall of the plug 405 of the insulation plug 403 form a payload cavity 415. The vacuum container 402 includes a mouth 460 and a body 462. In this embodiment, the inner diameter of the mouth 460 is smaller than the inner diameter of the body 462. Figure 4 As shown, the plug 405 of the plug 403 can be inserted into the mouth 460 with minimal residual play.

[0051] The central PCM package 456 may include a central PCM 464, and the peripheral PCM package 458 may include a peripheral PCM 466. The directions of the peripheral PCM package 458 and the central PCM package 456 are as follows: Figure 4 460. As shown in the cross-sectional schematic diagram of FIG. 461 . In some embodiments, the central PCM pack 456 is shaped so that it can be removed from the vacuum transporter 401 through the mouth 460. As a non-limiting example, the diameter of the central PCM pack 456 can be equal to or less than the diameter of the mouth 460. The diameter of the peripheral PCM pack 458 can also be less than the diameter of the mouth to facilitate insertion into the vacuum transporter 401. The peripheral PCM pack 458 can optionally be permanently attached to the interior of the vacuum container 402. In various embodiments, the vacuum transporter 401 can be prepared for use by removing the plug 403, then inverting the vacuum container 402 and pouring out the central PCM pack 456. The central PCM pack 456 can then be charged for an effective period of time by refrigeration and then placed back into the vacuum container 402. The plug 403 can then be reinserted into the vacuum container 402 to facilitate temperature control.

[0052] Figure 5 A disassembled embodiment of a temperature controlled packaging system 100 according to an embodiment is shown, wherein the insulating plug 103 and the second PCM pack 110 form an upper assembly 501. In this embodiment, the plug 103 may be connected (permanently or temporarily) to the second PCM pack 110. Connecting the plug 103 and the second PCM pack 110 may facilitate maintaining the upper assembly 501 at ambient temperature when the refrigeration of the first PCM pack 109 is completed. For example, the first PCM pack 109 may be placed in a freezer at a temperature of about -20°C for 10 hours, while the upper assembly 501 is maintained at room temperature during the same 10 hours. The payload 119 may then be placed in the lower portion 125 of the payload cavity 115 within the lower PCM pack 109 as shown. The first PCM pack 109 may be placed in the container 102 before or after receiving the payload 119. Finally, the assembly 501 may be placed on the payload 119 and placed into the receiving area 121, thereby sealing the vacuum transporter 101 and initiating temperature control. The payload 119 can then be maintained at an intermediate temperature between room temperature and the temperature of the lower PCM pack 109. For freezing sensitive materials such as blood, this configuration can prevent overcooling of the payload 119 by providing a warmer thermal reservoir to balance the initial <0°C temperature of the first PCM pack 109.

[0053] Figure 6 1 shows a disassembled embodiment of a temperature controlled packaging system 100 according to an embodiment, wherein a first PCM pack 109 and a second PCM pack 110 form a lower assembly 601. In this embodiment, the lower assembly 601 includes the second PCM pack 110 permanently or temporarily connected to the first PCM pack 109. The lower assembly 601 includes a payload cavity 115 formed by the walls of the first PCM pack 109 and the second PCM pack 110. Figure 6In an embodiment, the lower assembly 601 may facilitate holding the second PCM pack at the same temperature as the first PCM pack. For example, the lower assembly 601 may be held in a commercial freezer at about 3°C ​​for 10 hours. This period of time may be sufficient to cure the PCM within the first PCM pack 109, but not the second PCM pack 110. The payload may then be placed in the payload cavity 115, and the lower assembly 601 may then be placed in the container 102. The plug 103 may then be placed in the container 102 to seal it. Thus, the lower assembly 601 may be adjusted to withstand both high and low external conditions.

[0054] Various other subassemblies may be formed using the components of the temperature controlled packaging system described herein, and the above examples should not be considered limiting. In addition, as previously mentioned, the specific arrangement of PCM packages having different PCMs and / or different PCM phases within the container should not be considered limiting, and in various embodiments, PCM packages may be provided in various arrangements as needed to achieve the desired temperature control and / or provide the desired insulation properties.

[0055] Figure 7 Another example of an assembled temperature-controlled packaging system 700A, a first disassembled temperature-controlled packaging system 700B, and a second disassembled temperature-controlled packaging system 700C is shown.

[0056] The temperature-controlled packaging system 700A is substantially similar to the temperature-controlled packaging system 100 , and includes a container 702 and a plug 703 .

[0057] The temperature controlled packaging system 700B includes a container 702, a plug 703, and a PCM assembly 701 including a first PCM pack 709 and a second PCM pack 710. In this embodiment, the payload cavity is defined by the first PCM pack 709 and the second PCM pack 710 similar to the temperature controlled packaging system 100. In one non-limiting example, the temperature controlled packaging system 700B can be configured for small blood tubes (or any other desired payload).

[0058] The temperature-controlled packaging system 700C includes a container 702 and a plug 703 (not shown). Compared to the temperature-controlled packaging system 700B, the temperature-controlled packaging system 700C includes a single PCM bag 768, and when inserted into the container 102, forms a side-by-side payload cavity 715 within the receiving area 121. In some embodiments, the PCM bag 768 can have a semicircular cross-section as shown, and in various aspects, the PCM bag 768 can fill more than half of the receiving area 121 in a plan view. In such embodiments, the PCM bag 768 occupying more than half of the receiving area can facilitate the positioning of the PCM bag 768 within the receiving area 121.

[0059] Figure 8Shows the variation of the internal temperature over time of an embodiment of a temperature-controlled packaging system when exposed to warm (constant at 30 °C) conditions (line 801) or cold (equivalent to ISTA-7D winter standard) conditions (line 803). A 30-ounce vacuum bottle was used as the container of the temperature-controlled packaging system, with a 2-inch thick expanded polystyrene insulation plug. The PCM package was overnight in a commercial refrigeration environment before being inserted into the stoppered vacuum bottle. In both cases, as shown by line 805, the performance criteria were met, with the temperature remaining below approximately 25 °C and above 0 °C. The average moving temperature also remained below 20 °C within 72 hours. In this example, water was used as the second PCM, and Puretemp 18 mixed with mineral oil was used as the first PCM.

[0060] Fig. 9 Shows the variation of the internal temperature over time of two embodiments of a temperature-controlled packaging system when exposed to warm (constant at 30 °C) conditions 801 or cold (equivalent to ISTA-7D winter standard) conditions 803. In this example, a 20-ounce vacuum bottle was used as the container of the temperature-controlled packaging system, and a 1-inch thick expanded polystyrene plug was used as the insulation plug. The PCM package was overnight exposed to a commercial refrigeration environment before being inserted into the stoppered vacuum bottle. Under both external conditions, for both PCM combinations, the performance criteria were met, with the temperature remaining below approximately 25 °C and above 0 °C. The average moving temperature also remained below 20 °C within 72 hours. In this example, water or Templok 5 was used as the second PCM (represented by line 907), and Puretemp 18 mixed with mineral oil or un-mixed Puretemp 18 was used as the first PCM (represented by line 909). The combination of vacuum insulation and the additional thermal resistance provided by the PCM elements themselves produced a two-way performance result, which was unexpectedly strong considering the size of the protective packaging (diameter approximately 9 inches by 3 inches). A traditional expanded polystyrene packaging system of similar size was expected to last less than 24 hours.

[0061] Fig.10 Shows the variation of the internal temperature over time of an embodiment of a temperature-controlled packaging system when exposed to warm (constant at 30 °C) conditions 803. A 30-ounce vacuum bottle was used as the container of the temperature-controlled packaging system, and a 2-inch thick expanded polystyrene plug was used as the insulation plug. The PCM package was overnight exposed to a commercial freezing environment at approximately -20 °C before being inserted into the stoppered vacuum bottle, and the performance is represented by line 1011. The performance criteria were met, with the temperature remaining below approximately 25 °C within 120 hours. The average moving temperature also remained below 20 °C within 120 hours. In this example, Puretemp 18 was used as both the first PCM and the second PCM.

[0062] Fig.11A prototype home collection kit layout 1170 is shown, including a portable centrifuge 1172 , a temperature-controlled packaging system 700B (eg, a vacuum transporter), and a blood self-collection kit 1174 with a transport container 1176 .

[0063] Fig.12 The workflow of self-collection, centrifugation and transportation of blood samples according to an embodiment of the present disclosure is shown.

[0064] The invention described herein is particularly suitable for the transport of whole blood samples or blood-derived samples such as serum or plasma for laboratory testing. For many diagnostic tests, whole blood must be kept above the freezing point of water (0°C) and below about 37°C during transportation to avoid invalid results. For many applications, lower average temperature ranges such as 0-8°C, such as 2-8°C, such as 0-15°C, such as 2-15°C, such as 0-20°C, such as 2-20°C, such as 0-25°C, and / or such as 0-25°C. In order to maintain these temperature ranges in summer or winter climate conditions, different PCM combinations with different melting point (or other phase transition temperature) ranges can be used. For example, a PCM with a melting point range between -2°C and 20°C or preferably between 0°C and 15°C can be used in the second PCM package. A PCM with a melting point range between 0°C and 25°C or preferably between 5°C and 20°C can be used in the first PCM package. To extend acceptable transport time, in some non-limiting examples, it may be advantageous to use a relatively lower melting point PCM in the upper position (where heat first penetrates through the plug of the vacuum transporter) and a relatively lower melting point PCM in the lower position. Such an orientation of the PCMs provides strong cold weather protection in the winter, lower initial payload temperatures in summer conditions, and a longer time before absolute thermal limits are breached in summer conditions. Because the typical difference between average summer temperatures and optimal biological storage conditions is greater than average winter conditions in temperate climates, a larger amount of the first PCM may be used compared to the upper "freeze-proof" PCM. As a non-limiting example, a ratio of 2:1 to 10:1 between the first PCM and the second PCM may be employed.

[0065] Another way to achieve both summer and winter protection is to use a single PCM with a wide phase change temperature range that is conditioned within that range prior to use. As a non-limiting example, a PCM that gradually phase changes between 0°C and 20°C can be pre-cooled at 2-8°C, the result being a partially phase changed mixture that can resist both low and high temperatures. A gradual phase change can be achieved by mixing materials with different melting points such as a mixture of olefins or waxes, or a mixture of salt hydrates. Alternatively, certain salt hydrate mixtures such as sodium chloride and sodium sulfate decahydrate can themselves have a wide phase change temperature range.

[0066] The payload temperature may be maintained within acceptable temperature limits and / or within an effective mean motion temperature range. An effective temperature limit is a high or low temperature threshold at which even brief exposure may deteriorate the payload. As a non-limiting example, brief exposure of a blood sample to temperatures below -2°C or above 40°C may invalidate laboratory analytical results. The effective mean motion temperature range for a given sample is typically narrower than the acceptable temperature limits and reflects that the sample must be maintained within that range to avoid deterioration during the effective transport time. Liquid blood, serum, or plasma samples are typically maintained within a temperature range of approximately 2°C - 8°C, which is similar to commercial refrigeration, or within a temperature range of 20°C - 25°C, which is generally considered controlled room temperature. However, blood samples at 2°C - 8°C exhibit higher rates of hemolysis (i.e., rupture of red blood cells) over time than blood samples at 20°C - 25°C. Conversely, blood samples at 20°C - 25°C exhibit higher rates of chemical degradation of laboratory analytes than blood samples at 2°C - 8°C. For transport times between 8 hours and 1 week, a non-typical temperature range of 9°C - 19°C can be beneficial in maintaining blood quality for general analytical testing. A properly configured vacuum transporter can maintain a temperature range of 9°C - 19°C for up to 1 week under typical ambient conditions.

[0067] The following provides a collection of exemplary embodiments, including at least some explicitly listed as "examples", providing additional descriptions of various example embodiments according to the concepts described herein. These examples are not mutually exclusive, exhaustive, or limiting; the content disclosed herein is not limited to these examples, but includes all possible modifications and variations within the scope of the issued claims and their equivalents.

[0068] Example 1. A temperature-controlled packaging system for a biological specimen, the system comprising a container and a PCM bag that (i) is shaped to fit within the container and (ii) defines a payload cavity for the biological specimen.

[0069] Example 2. A temperature-controlled packaging system for a biological specimen, the system comprising a container and a PCM bag, the PCM bag being preconditioned at an effective charging temperature for an effective charging time, the PCM bag further defining a payload cavity for the biological specimen.

[0070] Example 3. A temperature-controlled packaging system for a biological specimen, the system comprising a container and a PCM bag, the PCM bag comprising a first portion and a second portion, the first portion comprising a first type of PCM, the second portion comprising a second type of PCM different from the first type of PCM, the PCM bag defining a payload cavity for the biological specimen.

[0071] Example 4. A temperature-controlled packaging system for a biological specimen, the system comprising a container, a PCM bag defining a payload cavity, and a thermal plug comprising a first plug and a second plug.

[0072] Example 5. A temperature-controlled packaging system for biological specimens comprises a vacuum flask, a cylindrical PCM bag, the PCM bag (i) being shaped to fit within the vacuum flask and (ii) comprising a payload cavity, such that the PCM bag acts both as a heat sink for thermal energy and as an insulating secondary inner layer.

[0073] Example 6. A method of transporting a biological specimen comprises providing a vacuum transport container, placing a pre-conditioned cylindrical PCM bag into the vacuum transport container, and placing a temperature sensitive payload into a payload cavity defined by the PCM bag.

[0074] Example 7. The method of any preceding or subsequent example or combination of examples, further comprising transporting the vacuum shipping container to a destination within a valid durability time via commercial courier.

[0075] Example 8. A temperature control device, comprising: a vacuum bottle, an insulating plug and a main PCM bag; wherein the vacuum bottle comprises a vacuum insulating portion, a mouth, an outer wall substantially vertical relative to the mouth and an inner wall tapering inwardly at 0-5 degrees relative to the vertical; wherein the insulating plug comprises a handle and a plug frictionally fitted with the mouth; wherein the thickness of the insulating plug is at least 20 mm; wherein the outer wall of the main PCM bag is adapted to the inner wall of the vacuum bottle; wherein a payload cavity with a volume of at least 3 ml configured to accommodate a perishable payload is formed by the wall of the main PCM bag; wherein the payload cavity is at least partially surrounded by the main PCM bag.

[0076] Example 9. In the apparatus of any preceding or following example or combination of examples, wherein the main PCM bag further comprises a rim; wherein the bag outer wall and the rim capture a 0.2 mm to 5 mm thick air pocket between itself and the inner wall of the vacuum bottle.

[0077] Example 10. In the apparatus of any preceding or following example or combination of examples, wherein the payload cavity is centered on the vertical axis of the vacuum bottle.

[0078] Example 11. In the apparatus of any preceding or following example or combination of examples, wherein the payload cavity is shaped as a vertical cylinder.

[0079] Example 12. In the apparatus of any preceding or following example or combination of examples, wherein the plug further comprises a sub-plug centered on the vertical axis of the vacuum bottle and having a diameter substantially equal to that of the payload cavity.

[0080] Example 13. In the apparatus of any preceding or following example or combination of examples, further comprising a secondary PCM pack; wherein the secondary PCM pack comprises a second phase change material.

[0081] Example 14. In the apparatus of any preceding or following example or combination of examples, wherein the secondary PCM pack is located vertically above the primary PCM pack; and wherein the payload cavity is further at least partially surrounded by the secondary PCM pack.

[0082] Example 15. In the device of any preceding or following example or combination of examples, wherein the phase change temperature of the first phase change material is lower than the phase change temperature of the second phase change material.

[0083] Example 16. In the device of any preceding or following example or combination of examples, wherein the phase change temperature of the second phase change material is in the range of -2°C to 15°C, and wherein the phase change temperature of the first phase change material is in the range of 5°C to 25°C.

[0084] Example 17. In the device of any preceding or following example or combination of examples, wherein the phase change temperature of the second phase change material is in the range of 10°C to 25°C, and wherein the phase change temperature of the first phase change material is in the range of 8°C to 20°C.

[0085] Example 18. In the apparatus of any preceding or following example or combination of examples, wherein the first phase change material undergoes a phase change over a wide temperature range rather than at a precise temperature, and wherein a target temperature range for the payload overlaps the wide temperature range.

[0086] Example 19. In the device of any preceding or following example or combination of examples, wherein the first phase change material comprises an inorganic hydrated salt.

[0087] Example 20. In the device of any preceding or following example or combination of examples, wherein the second phase change material comprises sodium sulfate decahydrate.

[0088] Example 21. In the apparatus of any preceding or following example or combination of examples, wherein the primary PCM pack and the secondary PCM pack are permanently bonded together.

[0089] Example 22. In the apparatus of any preceding or following example or combination of examples, wherein the secondary PCM pack is permanently bonded to the thermal plug.

[0090] Example 23. In the apparatus of any preceding or following example or combination of examples, wherein the payload cavity is completely surrounded by the primary PCM pack and the secondary PCM pack.

[0091] Example 24. In the apparatus of any preceding or following example or combination of examples, further comprising a third level PCM pack; wherein the third level PCM pack comprises a third phase change material.

[0092] Example 25. In the device of any preceding or following example or combination of examples, wherein the overall length of the device is less than 305 mm and the diameter is less than 100 mm.

[0093] Example 26. In the device of any preceding or following example or combination of examples, wherein the outer wall of the vacuum bottle further includes printed instructions for using the device.

[0094] Example 27. In the device of any preceding or following example or combination of examples, wherein the insulating plug comprises a single integral element made of expanded polystyrene, extruded polystyrene, closed cell polyurethane foam, open cell polyurethane foam, or polyisocyanurate foam.

[0095] Example 28. In the device of any preceding or following example or combination of examples, wherein the thermal plug comprises a hollow plastic portion.

[0096] Example 29. In the device of any preceding or following example or combination of examples, wherein the insulating plug further comprises insulating material within the hollow plastic portion.

[0097] Example 30. The device of any preceding or following example or combination of examples, further comprising a transport box, wherein the plug is constrained within the vacuum bottle by the structure of the transport box.

[0098] Example 31. A method for transporting materials using an apparatus of any preceding or subsequent example or combination of examples, the method comprising the steps of: insulating a main PCM bag at an effective insulation temperature for an effective insulation time; placing the main PCM bag in a vacuum bottle; placing perishable materials in a payload cavity; pressing an insulating plug into the mouth of the vacuum bottle; transporting the apparatus to a destination within an effective transportation time while maintaining a set of tolerable internal temperature limits and an effective average motion temperature range.

[0099] Example 32. The method of any preceding or following example or combination of examples, wherein step (a) is accomplished by using a commercial refrigerator and the effective holding temperature is in the range of 0°C to 10°C.

[0100] Example 33. In the method of any preceding or subsequent example or combination of examples, wherein the effective transport time ranges from 48 hours to 120 hours.

[0101] Example 34. The method of any preceding or following example or combination of examples, wherein the set of effective internal temperature limits are between 0°C and 25°C.

[0102] Example 35. In the method of any preceding or following example or combination of examples, wherein the effective average motion temperature range is between 2°C and 20°C.

[0103] Example 36. A method for transporting materials, comprising the following steps: insulating a PCM bag at an effective insulation temperature for an effective insulation time; wherein the PCM bag includes a first phase change material and a payload cavity; wherein the payload cavity is at least partially surrounded by the PCM bag; placing the PCM bag in a vacuum bottle; wherein the PCM bag also includes an outer bag wall that conforms to the inner wall of the vacuum bottle; placing a perishable payload in the payload cavity; pressing an insulated plug into the mouth of the vacuum bottle; wherein the insulated plug forms a friction fit with the mouth; transporting the assembled vacuum bottle, PCM bag, perishable payload and insulated plug to a destination while maintaining a set of tolerable internal temperature limits and an effective average motion temperature range.

[0104] Example 37. The method of any preceding or subsequent example or combination of examples, further comprising the step of placing the assembled vacuum bottle, PCM bag, and insulating plug into a shipping box having an interior length equal to the length of the assembled vacuum bottle, PCM bag, and insulating plug.

[0105] Example 38. The method of any preceding or subsequent example or combination of examples, further comprising the step of placing the perishable payload into a secondary bag.

[0106] Example 39. The method of any preceding or subsequent example or combination of examples, further comprising the step of cleaning and sterilizing the vacuum flask and PCM bag for reuse.

[0107] Example 40. The method of any preceding or following example or combination of examples, wherein step (a) is achieved by using a commercial refrigerator and the effective insulation temperature range is between 0°C and 10°C.

[0108] Example 41. The method of any preceding or subsequent example or combination of examples, wherein the effective shipping time is in the range of 8 hours to 1 week.

[0109] Example 42. The method of any preceding or subsequent example or combination of examples, wherein the effective transport time is in the range of 48 hours to 120 hours.

[0110] Example 43. The method of any preceding or following example or combination of examples, wherein the set of effective internal temperature limits is between 0°C and 25°C.

[0111] Example 44. The method of any preceding or following example or combination of examples, wherein the effective average motion temperature range is between 2°C and 20°C.

[0112] Example 45. The method of any preceding or following example or combination of examples, wherein the effective average motion temperature range is between 9°C and 19°C.

[0113] Example 46. The method of any preceding or subsequent example or combination of examples, wherein the effective average motion temperature range is between 2°C and 8°C.

[0114] Example 47. The method of any preceding or following example or combination of examples, wherein the outer wall of the vacuum flask is substantially vertical relative to the mouth.

[0115] Example 48. The method of any preceding or following example or combination of examples, wherein an inner wall of the vacuum flask tapers relative to the mouth at an angle of about 0° to about 5° relative to vertical.

[0116] Example 49. The method of any preceding or following example or combination of examples, wherein the thickness of the thermal plug is at least 30 mm.

[0117] Example 50. The method of any preceding or following example or combination of examples, wherein the PCM package further comprises a second phase change material.

[0118] Example 51. The method of any preceding or following example or combination of examples, wherein the first phase change material is located below the second phase change material.

[0119] Example 52. The method of any preceding or following example or combination of examples, wherein the phase change temperature of the second phase change material is between 10°C and 25°C, and the phase change temperature of the first phase change material is between 8°C and 20°C.

[0120] Example 53. The method of any preceding or following example or combination of examples, wherein the thermal plug further comprises a plug PCM, and the thermal plug is maintained at a second effective maintenance temperature during step (a).

[0121] Example 54. The method of any preceding or following example or combination of examples, wherein the insulating plug comprises a single integral element of expanded polystyrene, extruded polystyrene, closed cell polyurethane foam, open cell polyurethane foam, or polyisocyanurate foam.

[0122] Example 55. The method of any preceding or subsequent example or combination of examples, wherein the total length of the assembled vacuum flask, PCM bag, perishable payload, and thermal plug is less than 305 mm and the total diameter is less than 100 mm.

[0123] Example 56. The method of any preceding or following example or combination of examples, wherein the total weight of the assembled vacuum flask, PCM bag, perishable payload, and thermal plug is less than 2.5 pounds.

[0124] Example 57. The method of any preceding or subsequent example or combination of examples, wherein the PCM bag further comprises a rim; wherein when placed, the outer wall and rim of the PCM bag form an air pocket of 0.2 mm to 5 mm thick between itself and the inner wall of the vacuum bottle.

[0125] Example 58. The method of any preceding or following example or combination of examples, wherein the perishable payload is blood, serum, or plasma.

[0126] Example 59. The method of any preceding or subsequent example or combination of examples, wherein the perishable payload is living cells.

[0127] The subject matter of the embodiments is described herein with specificity to meet statutory requirements, but such description is not necessarily intended to limit the scope of the claims. The claimed subject matter may be embodied in other ways, may include different elements or steps, and may be used with other existing or future technologies. Unless the order of the various steps or the arrangement of the elements is explicitly described, this description should not be interpreted as implying any specific order or arrangement between the various steps or elements. Directional references such as "upper", "lower", "top", "bottom", "left", "right", "front", and "rear" are intended to refer to the directions in the illustrations and descriptions. In this specification and the illustrations, the same reference numerals are intended to represent the same elements. Throughout this disclosure, reference numerals with letters represent specific instances of elements, while reference numerals without accompanying letters represent general references or collections of elements. Therefore, as an example (not shown in the figure), device "12A" represents an instance of a device class, which can be collectively referred to as device "12", any of which can be generally referred to as device "12". Except where the context clearly requires, the meanings of "one", "an", and "the" used herein include singular and plural references.

[0128] All ranges disclosed herein should be understood to include any and all sub-ranges contained therein. For example, the range of "1 to 10" should be considered to include any and all sub-ranges between 1 and 10 (including 1 and 10); that is, all sub-ranges with a minimum value of 1 or greater, such as 1 to 6.1, and sub-ranges with a maximum value of 10 or less, such as 5.5 to 10.

[0129] The aspects described above are merely examples of possible embodiments and are proposed only for a clear understanding of the principles of the present disclosure. Many changes and modifications may be made to the above-described embodiments without substantially departing from the spirit and principles of the present disclosure. All of these modifications and changes are intended to be included within the scope of the present disclosure, and all possible claims for single aspects or elements or step combinations are intended to be supported by the present disclosure. In addition, although specific terms are used herein and in the claims that follow, they are used only in a general and descriptive sense and are not intended to limit the embodiments described or the claims that follow.

Claims

1. A temperature-controlled packaging system for a biological specimen, the system comprising a container and a PCM bag, the PCM bag (i) being shaped to fit within the container and (ii) defining a payload cavity for the biological specimen.

2. The temperature controlled packaging system of claim 1, wherein the PCM pack is preconditioned at an effective charging temperature for an effective charging time.

3. The temperature-controlled packaging system of claim 1 , wherein the PCM package comprises a first portion and a second portion, the first portion comprising a first type of PCM, the second portion comprising a second type of PCM different from the first type of PCM, the PCM package defining a payload cavity for a biological specimen.

4. The temperature-controlled packaging system according to claim 1, further comprising a thermal insulation plug, wherein the thermal insulation plug comprises a first plug and a second plug.

5. The temperature controlled packaging system of claim 1, wherein the PCM pack acts as both a heat sink for thermal energy and as a secondary inner layer for insulation.

6. The temperature controlled packaging system according to claim 1, further comprising a heat insulating plug, in: The container comprises a vacuum bottle, the vacuum bottle comprising a vacuum insulation portion, a mouth, an outer wall substantially vertical relative to the mouth, and an inner wall tapering inwardly at 0-5 degrees relative to the vertical; The thermal insulation plug includes a handle and a plug frictionally engaged with the mouth, wherein the thermal insulation plug has a thickness of at least 20 mm; The outer wall of the PCM bag is adapted to the inner wall of the vacuum bottle; as well as The payload cavity comprises a volume of at least 3 cubic centimeters and is formed by walls of the PCM pack, wherein the payload cavity is at least partially surrounded by the PCM pack.

7. The temperature-controlled packaging system according to claim 1, wherein the PCM bag further comprises an edge and an outer wall of the bag, wherein the outer wall of the bag and the edge form an air pocket with a thickness of 0.2 mm to 5 mm between themselves and the inner wall of the container.

8. The temperature controlled packaging system of claim 1, wherein the payload cavity is centered on a vertical axis of the container.

9. The temperature-controlled packaging system according to claim 8 further includes an insulating plug, wherein the insulating plug also includes a sub-plug, the sub-plug is centered on the vertical axis of the container, and the diameter of the sub-plug is approximately equal to the diameter of the payload cavity.

10. The temperature controlled packaging system of claim 1, wherein the PCM pack is a primary PCM pack comprising a first phase change material, and wherein the temperature controlled packaging system further comprises a secondary PCM pack comprising a second phase change material.

11. The temperature-controlled packaging system of claim 10, wherein the secondary PCM pack is located vertically above the primary PCM pack, and the payload cavity is also at least partially surrounded by the secondary PCM pack.

12. The temperature-controlled packaging system according to claim 10, wherein a phase change temperature of the first phase change material is lower than a phase change temperature of the second phase change material.

13. The temperature-controlled packaging system according to claim 10, wherein the phase change temperature of the second phase change material is in the range of -2°C to 15°C, and the phase change temperature of the first phase change material is in the range of 5°C to 25°C.

14. The temperature-controlled packaging system according to claim 10, in: The primary and secondary PCM packs are permanently bonded together; and / or The secondary PCM pack is permanently bonded to the thermal plug.

15. The temperature-controlled packaging system according to claim 1, in: The container comprises a vacuum bottle, the vacuum bottle comprising a vacuum insulation portion, a mouth, an outer wall substantially vertical relative to the mouth, and an inner wall tapering inwardly at 0-5 degrees relative to the vertical; The temperature-controlled packaging system further comprises an insulating plug, wherein the insulating plug comprises a handle and a plug frictionally engaged with the mouth, wherein the insulating plug has a thickness of at least 20 mm; The PCM bag comprises an outer bag wall adapted to the inner wall of the vacuum bottle; The payload cavity comprises a volume of at least 3 cubic centimeters and is formed by the walls of the primary PCM pack; and The payload cavity is at least partially surrounded by the main PCM package.

16. A method of transporting a biological specimen, comprising providing a vacuum transporter, placing a pre-conditioned cylindrical PCM bag into the vacuum transporter, and placing a temperature sensitive payload into a payload cavity defined by the PCM bag.

17. The method of claim 16, wherein the PCM packets comprise primary PCM packets, and the method further include: Keep the main PCM bag warm at the effective insulation temperature for an effective insulation time; Place the main PCM bag into the vacuum transporter; as well as Press the insulation plug into the mouth of the vacuum conveyor.

18. The method according to claim 17, wherein the effective holding temperature is in the range of 0°C to 10°C.

19. The method of claim 16, further comprising transporting the device to a destination within an effective transport time while maintaining a set of tolerable internal temperature limits and an effective mean motion temperature range.

20. The method of claim 19, wherein the effective mean motion temperature ranges from 2°C to 20°C, and the effective transport time ranges from 48 hours to 120 hours.

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