Packaging for biological samples

Abstract

A packaging and transport device for biological samples includes an insert, a securing strip, a securing element, a temperature sensor, a plurality of labels, a shipping pouch sized and shaped to receive a shipping document, and a transport bag configured to receive a sample container. The insert includes a plurality of cutouts sized and shaped to receive the securing strip, the securing element, and the temperature sensor; at least one of the plurality of tags includes patient information.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 356,788, filed on June 29, 2022, entitled “Packaging For Biological Samples,” the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present disclosure relates generally to packaging for biological specimens, and more particularly to packaging for securing biological specimens for shipping and transportation. Summary of the invention

[0004] One embodiment of the present disclosure provides a packaging and transport device for biological specimens, the packaging and transport device comprising an insert, a fixing strip, a fixing element, a temperature sensor, the insert having a plurality of cutouts sized and shaped to receive the fixing strip, the fixing element, and the temperature sensor, a plurality of labels, a shipping pouch sized and shaped to receive shipping documents, and a transport bag configured to receive a specimen container.

[0005] In some embodiments, the plurality of cutouts include a first cutout, a second cutout, and a third cutout. The first cutout of the insert may be configured to receive and store a fixation strip, the second cutout of the insert may be configured to receive and store a temperature sensor, and the third cutout of the insert may be configured to receive and store a fixation element.

[0006] In some embodiments, the insert is disposed between the shipping bag and the plurality of labels. The insert may be disposed between the shipping bag and the plurality of labels, and the shipping bag may be disposed between the shipping pouch and the insert.

[0007] In some embodiments, the inner shipping container is sized and shaped to receive the transport bag and the cooling engine, wherein the inner shipping container is smaller in size than the packaging and transport device. The plurality of labels may include a first label configured to be applied to the sample container and a second label configured to be applied to the inner shipping container. The retaining strip may be configured to leave a mark on the inner shipping container if removed or altered.

[0008] In some embodiments, the insert comprises three or more fixation strips.The three or more fixation strips may be arranged within a plurality of cutouts of the insert.

[0009] In some embodiments, the fixing strip is arranged in one of the plurality of cutouts of the insert. The insert may include four or more fixing elements. The four or more fixing elements may be arranged in the plurality of cutouts of the insert.

[0010] In some embodiments, the patient information includes identification patient information. The identification patient information may include the patient's name, date of birth, age, etc.

[0011] In some embodiments, the packaging and shipping device further comprises a cooling engine configured to maintain a temperature range of about -80°C to about 10°C upon activation of the cooling engine.

[0012] In some embodiments, the transport bag includes an absorbent sheet configured to absorb leakage of the sample container.The transport bag can be configured to withstand up to 95 kPa without leaking.

[0013] In some embodiments, the packaging and shipping device includes two or more labels.

[0014] In some embodiments, the temperature sensor is disposed within one of the plurality of cutouts of the insert.The insert may be disposed between the plurality of labels and one of the shipping pouch and the transport bag.

[0015] In some embodiments, the patient information includes de-identified patient information.

[0016] In some embodiments, the packaging and shipping further includes a kit container that houses the insert, the plurality of labels, the shipping pouch, and the transport bag.

[0017] Another embodiment of the present disclosure provides a packaging and transport device for biological specimens, the device comprising a packaging kit having an insert having a securing strip, a securing element, and a temperature sensor, wherein the insert comprises a plurality of cutouts sized and shaped to receive the securing strip, the securing element, and the temperature sensor, a plurality of labels comprising one or more of patient information and destination information, a transport bag configured to receive a specimen container containing a biological specimen, a shipping pouch, a cooling engine configured to maintain a temperature range of about 0° C. to about 10° C., an inner shipping container, and an outer shipping container sized and shaped to receive the inner shipping container, the cooling engine, and the packaging kit. In some embodiments, the inner shipping container comprises an area for receiving at least one of the plurality of labels, and the inner shipping container is sized and shaped to receive the cooling engine and the transport bag.

[0018] In some embodiments, the insert is disposed between the shipping bag and the plurality of labels.The shipping bag may be disposed between the shipping pouch and the insert.

[0019] Another embodiment of the present invention provides a method for packaging biological samples, the method comprising providing a packaging kit having a shipping bag and an insert for storing a fixing element, a fixing strip, and a temperature sensor; fixing a sample container with the fixing element, wherein the sample container includes a biological sample, applying a first label to the fixed sample container, the first label including at least one of patient information; inserting the labeled sample container into the shipping bag; placing the shipping bag in an inner shipping container, wherein the inner shipping container includes a cooling engine and a temperature sensor; closing the inner shipping container so that the shipping bag, the cooling engine, and the temperature sensor are arranged in the inner shipping container; fixing the inner shipping container in a closed position using a fixing strip so that attempts to enter the interior of the inner shipping container are obvious; and applying a second label to the inner shipping container, the second label including at least one of patient information and destination information.

[0020] In some embodiments, the packaging kit further comprises a shipping pouch and a plurality of labels, the labels comprising a first label and a second label. In the packaging kit, the insert can be arranged between the transport bag and the plurality of labels. In the packaging kit, the transport bag can be arranged between the shipping pouch and the insert.

[0021] In some embodiments, the method further includes removing the fixation strip from the first cutout of the insert, removing the temperature sensor from the second cutout of the insert, and removing the fixation element from the third cutout of the insert.

[0022] In some embodiments, the first cutout of the insert is configured to receive and store a fixation strip. The second cutout of the insert can be configured to receive and store a temperature sensor. The third cutout of the insert can be configured to receive and store a fixation element.

[0023] In some embodiments, the method further comprises activating the cooling engine such that the cooling engine is configured to maintain the inner shipping container within a predetermined temperature range when the activated cooling engine is disposed within the inner shipping container. The predetermined temperature range may be 0°C to 10°C.

[0024] In some embodiments, the method further includes transporting the inner shipping container with the second label to a destination.

[0025] In some embodiments, the method further comprises obtaining a biological sample from the patient.

[0026] In some embodiments, the method further comprises combining the biological sample with a transport medium, wherein the transport medium is configured to prevent degradation of the biological sample.The biological sample may include a plurality of tumor tissues obtained from a patient.

[0027] In some embodiments, the method further includes the transport bag including an absorbent configured to absorb leakage of the sample container.

[0028] In some embodiments, the securing strip is configured to leave a mark on the inner shipping container if removed or altered.

[0029] In some embodiments, the packaging kit includes three or more securing strips. The packaging kit may include four or more securing elements. The packaging kit may include two or more labels.

[0030] In some embodiments, the transport bag is configured to withstand up to 95 kPa without leaking.

[0031] In some embodiments, the patient information is de-identified patient information. The patient information may include identifying patient information. The patient information may include the patient's name, date of birth, and / or age.

[0032] In some embodiments, the packaging kit includes a kit container configured to receive and store the shipping bag and the insert.

[0033] Another embodiment of the present disclosure provides a method for packaging a biological sample, the method comprising receiving an outer shipping container having a cooling engine, an inner shipping container, and a packaging kit, wherein the packaging kit has a shipping bag, a shipping pouch, a plurality of labels, and an insert for storing a fixing element, a fixing strip, and a temperature sensor; removing the cooling engine, the inner shipping container, and the packaging kit from the outer shipping container; removing the shipping bag, the shipping pouch, the plurality of labels, and the insert from the packaging kit, wherein the insert includes a cutout sized and shaped to receive the fixing element, the fixing strip, and the temperature sensor; removing the fixing element, the fixing strip, and the temperature sensor from the insert; placing a biological sample in the sample container, the biological sample including tumor tissue and a transport medium; fixing the sample container with a fixing element; applying a first label of a plurality of labels to the fixed sample container, the first label including patient information and destination information at least one of; inserting a labeled sample container into a transport bag, the transport bag including an absorbent sheet configured to absorb leakage of the labeled sample container within the transport bag; starting a cooling engine, such that the cooling engine is configured to maintain the inner shipping container within a predetermined temperature range when the started cooling engine is disposed within the inner shipping container; placing the transport bag, the cooling engine, and the temperature sensor in the inner shipping container; closing the inner shipping container such that the transport bag, the cooling engine, and the temperature sensor are disposed within the interior of the inner shipping container; securing the inner shipping container in a closed position using a securing strip to prevent access to the interior of the inner shipping container, wherein the securing strip is configured to leave marks or residue on the inner shipping container if removed or altered; and applying a second label of a plurality of labels to the inner shipping container, the second label comprising at least one of patient information and destination information. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In conjunction with the exemplary embodiments Figure 1 The following detailed description of embodiments of a package for biological specimens will be better understood when read together with the accompanying drawings. It should be understood, however, that the disclosure is not limited to the precise arrangements and instrumentalities shown.

[0035] Figure 1 is a front perspective view of a packaging container according to an exemplary embodiment of the present disclosure;

[0036] Figure 2 is a top perspective view of a cooling block according to an exemplary embodiment of the present disclosure;

[0037] Figure 3 is a top perspective view of an inner shipping container according to an exemplary embodiment of the present disclosure;

[0038] Figure 4 is a top perspective view of a packaging kit according to an exemplary embodiment of the present disclosure;

[0039] Figure 5 According to an exemplary embodiment of the present disclosure Figure 4 An exploded view of the internal components of the packaging kit;

[0040] Figure 6 is a flow chart illustrating a method for packaging a biological specimen according to an exemplary embodiment of the present disclosure; and

[0041] Figure 7 is a flow chart illustrating a method for packaging a biological specimen according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION

[0042] Exemplary embodiments of the present disclosure provide packaging and transport devices for biological specimens. Figure 1-5 , an embodiment of the present disclosure is shown as an exemplary device. In use, a packaging and transport device ("device") 100 can be used for packaging and transporting (e.g., shipping) of biological samples. The device 100 can include an external shipping container 102, an internal shipping container 106, and a packaging kit 108 to package and transport biological samples. In some embodiments, the device 100 is used for packaging and transporting tumor tissue. For example, the device 100 can provide a packaging kit 108 for packaging and fixing one or more biological samples for shipping or transportation. The biological sample can be a tumor tissue collected from a patient. For example, a tumor tissue sample removed from a patient can be placed in a tumor tissue container or a sample container (such as a vial) for storage of the tumor tissue. In some embodiments, the tumor tissue sample is removed from a cancer patient. The tumor tissue can be combined with a medium / reagent to preserve the life of the tumor tissue and prevent contamination or degradation of the tumor tissue.

[0043] In some embodiments, the sample of tumor tissue is stored with a medium / reagent in a sample container. The medium can be a transport medium, such as a cryogenic transport medium configured to improve and prolong the preservation of biological materials (e.g., cells, tissues, organs). In some embodiments, the sample of tumor tissue is stored with a HypoThermosol in a sample container. The packaging kit 108 can then be used to seal and secure the sample container.

[0044] In use, the device 100 can be sent to a medical location (e.g., a hospital, an outpatient center, a surgery center, a doctor's office, a clinic, etc.). Tumor tissue can be extracted from a cancer patient at a medical location. The extracted tumor tissue can be packaged using the device 100 and sent to a processing facility for processing (e.g., cell amplification). For example, the tumor tissue can contain white blood cells (e.g., T lymphocytes or T cells). The tumor tissue can be sent to a processing facility for amplification of T cells. The amplified T cells can be sent back to the medical location and administered to the patient, for example, by infusion, to treat cancer.

[0045] In practice, the device 100 can be provided to a medical site to assist them in transporting the biological sample to another location, such as another medical site or a processing facility. The device 100 can provide the medical site with appropriate labels, monitors, sensors, packaging, and cooling components to protect and preserve the biological sample during transportation or shipment. The device 100 can include an external shipping container 102, a packaging kit 108, an internal shipping container 106, and a cooling engine 104. The cooling engine 104 can be arranged and contained in the internal shipping container 106. In some embodiments, when the device 100 is sent to the medical site for packaging biological samples, the packaging kit 108, the internal shipping container 106, and the cooling engine 104 are arranged in the external shipping container 102. For example, the cooling engine 104 can be arranged in the internal shipping container 106, and the internal shipping container 106 and the packaging kit 108 can be arranged in the external shipping container 102 of the device 100. The outer shipping container 102 can be sealed to secure the packaging kit 108 and the inner shipping container 106 containing the cooling engine 104 within the outer shipping container 102. In some embodiments, multiple packaging kits 108, inner shipping containers 106, and / or cooling engines 104 are arranged within the outer shipping container 102.

[0046] In some embodiments, the outer shipping container 102 is sent to a medical site and includes an inner shipping container 106, a packaging kit 108, and a cooling engine 104. The medical site can use the packaging kit 108 to fix the biological sample, and then place the packaging kit 108 containing the fixed biological sample and the cooling engine 104 in the inner shipping container 106. In some embodiments, the medical site uses the inner shipping container 106 to send the biological sample fixed by the packaging kit 108 and the cooling engine 104 to a manufacturing facility. For example, the inner shipping container 106 can be configured to receive the cooling engine 104 and the biological sample fixed via the packaging kit 108 to transport the fixed biological sample safely and securely to another medical site or processing facility. In some embodiments, the medical site can use the outer shipping container 102 to send the cooling engine 104 and the biological sample fixed via the packaging kit 108 to another medical site or processing facility.

[0047] In some embodiments, the packaging kit 108 includes one or more components for sealing, fixing and monitoring biological samples. Using the packaging kit 108, the biological sample can be sealed and fixed and placed in an internal shipping container 106 with a cooling engine 104. The cooling engine 104 can be configured to keep the biological sample within a specific temperature range. For example, the cooling engine 104 can be configured to keep the biological sample at a temperature of -80°C to 10°C to ensure the preservation of the biological sample during transportation and shipment of the device 100. In some embodiments, the cooling engine 104 is a container of dry ice or other cooling material configured to keep the biological sample (e.g., tumor tissue) at a temperature of -80°C to 10°C.

[0048] Reference Figure 1, the device 100 may include an external shipping container 102. The size and shape of the external shipping container 102 may be designed to receive the packaging kit 108, the internal shipping container 106, and the cooling engine 104. In some embodiments, the external shipping container 102 is configured to receive and secure the packaging kit 108, the internal shipping container 106, and the cooling engine 104. For example, the external shipping container 102 may store and secure the packaging kit 108, the internal shipping container 106, and the cooling engine 104 for shipment to a medical location. The external shipping container 102 may be configured to accommodate the packaging kit 108, the internal shipping container 106, and the cooling engine 104 to transport the packaging kit 108, the internal shipping container 106, and the cooling engine 104 to a medical location. The external shipping container 102 may allow the packaging kit 108, the internal shipping container 106, and the cooling engine 104 to be stored in a single package during transportation. The medical site can receive the outer shipping container 102, which includes the packaging kit 108, the inner shipping container 106, and the cooling engine 104, so that the medical site can fix the biological sample collected from the patient and safely transport the biological sample to another site, such as a processing facility. In some embodiments, the processing facility uses the inner shipping container 106 to transport the processed biological sample (e.g., expanded T cells) back to the source site of the device 100 (e.g., the medical site).

[0049] In some embodiments, the external shipping container 102 can be configured for multiple uses. For example, the external shipping container 102 can be configured to be sent to a medical location, and then can be used by the medical location to fix and transport the cooling engine 104 and the biological sample fixed using the packaging kit 108 to another location, such as a processing institution. The external shipping container 102 can be substantially rectangular. In some embodiments, the external shipping container 102 can be circular, octagonal, or any other suitable shape. In some embodiments, the external shipping container 102 is made of cardboard. In some embodiments, the external shipping container 102 can be made of polymers or metals.

[0050] refer to Figure 2, the device 100 may include a cooling pack or cooling engine 104. The cooling engine 104 may be configured to maintain items stored in the device 100 within a predetermined temperature range. The cooling engine 104 may be stored and contained within the internal shipping container 106. For example, when the internal shipping container 106 is transported in the external shipping container 102, the cooling engine 104 may remain in the internal shipping container 106. In some embodiments, the cooling engine 104 has an activated state and a deactivated state. In some embodiments, the cooling engine 104 is removed from the internal shipping container 106 only to activate or deactivate the cooling engine 104. The cooling engine 104 can be sent to a medical site in a deactivated state and can be activated by a user once a biological sample (e.g., a tumor tissue sample) is placed in the internal shipping container 106. For example, the external shipping container 102 can be sent to a medical site with the packaging kit 108 and the cooling engine 104 contained in the internal shipping container 106 and in a deactivated state. The user can then remove the cooling engine 104 from the internal shipping container 106, start the cooling engine 104, place the cooling engine 104 back into the internal shipping container 106, label and secure the biological sample using the packaging kit 108, and then place the biological sample in the internal shipping container 106 with the cooling engine 104 in the activated state. In practice, the device 100 can be sent to a medical location with the cooling engine 104 in the deactivated state. Once the biological sample is secured in the sample container using the packaging kit 108, the user can start the cooling engine 104, and then place the sample container in the internal shipping container 106 adjacent to the cooling engine 104. The user can then transport the internal shipping container 106 to another location. In some embodiments, the internal shipping container 106 is placed in the external shipping container 102, which is transported to another location. In some embodiments, the cooling engine 104 is configured to maintain the biological sample at a temperature of about 2° C. to about 8° C. In some embodiments, the cooling engine 104 can be configured to maintain the biological sample at a temperature of -80°C to about 10°C, about -75°C to about 0°C, or about -60°C to about -10°C.

[0051] refer to Figure 3, the device 100 may include an internal shipping container 106. The size and shape of the internal shipping container 106 may be designed to receive the cooling engine 104 and the biological sample fixed by the packaging kit 108. The size and shape of the internal shipping container 106 may also be designed to be arranged in the outer shipping container 102. The internal shipping container 106 can be sent to a medical site so that the medical site sends the cooling engine 104 and the biological sample fixed by the packaging kit 108 to another medical site or processing institution. The internal shipping container 106 can be substantially rectangular. In some embodiments, the internal shipping container 106 can be round, triangular, square, or any other suitable shape. The internal shipping container 106 can be made of a lightweight but sturdy material to easily transport the cooling engine 104 and the biological sample fixed by the packaging kit 108 while protecting the biological sample. In some embodiments, the internal shipping container 106 is made of cardboard. In some embodiments, the internal shipping container 106 can be made of a polymer, metal, or any other suitable material.

[0052] In some embodiments, the inner shipping container 106 includes an area 107. Area 107 can be an area on the outer surface of the inner shipping container 106. Area 107 can be configured to receive a label. The label can be arranged in the packaging kit 108 and can be obtained from the packaging kit 108 and placed on the area 107. In some embodiments, the user can handwrite or print on the area 107. The user can use a label, handwrite or print the destination of the biological sample fixed by the packaging kit 108. In some embodiments, the inner shipping container 106 is configured to be folded. For example, the inner shipping container 106 can be folded to be substantially similar to a rectangular box. In some embodiments, the inner shipping container 106 includes a top panel 125 and an extension 126 extending from the top panel 125. The extension 126 can have a flap 127 that can be received in the front wall 129. This allows the inner shipping container 106 to be self-sealed without the need for tape or other sealing instruments. In some embodiments, the inner shipping container 106 is composed of a single piece that can be folded into a rectangular box. In some embodiments, inner shipping container 106 and / or outer shipping container 102 include portions configured to receive personalized branding or other information.

[0053] refer to Figure 4-5, the packaging kit 108 may include a kit container 109. The kit container 109 may be configured to store and fix various components of the packaging kit 108. For example, the packaging kit 108 may include one or more labels, one or more fixed features, one or more monitors, one or more sensors and / or packaging, which may be stored in the kit container 109. In some embodiments, the kit container 109 is substantially rectangular. In some embodiments, the kit container 109 may be of any suitable shape. The size and shape of the kit container 109 may be designed to store all components of the packaging kit 108 therein, and the size and shape may be designed to be suitable for assembly in the outer shipping container 102 and / or the inner shipping container 106. For example, the size and shape of the kit container 109 may be designed so that the packaging kit 108 may be arranged in the outer shipping container 102 and / or the inner shipping container 106 during the transportation of the packaging kit 108 to / from the medical site.

[0054] In some embodiments, the kit container 109 is configured to be folded. For example, the kit container 109 can be folded to be similar to a thin rectangular box. The kit container 109 can have a thickness determined by the components arranged in the packaging kit 108. For example, the kit container 109 can have a thickness of about 1.5 inches. In some embodiments, the kit container 109 can have a thickness of about 0.5 inches to about 12 inches, about 1 inch to about 10 inches, about 2 inches to about 8 inches, about 3 inches to about 6 inches, greater than 12 inches or less than 0.5 inches. In some embodiments, the kit container 109 includes a top panel 131 and an extension 135 extending from the top panel 131. The extension 135 can have a flip cover 133 that can be received in the front wall 137. This makes the kit container 109 self-sealing without the need for adhesive tape or other sealing instruments. In some embodiments, the kit container 109 is composed of a single piece that can be folded into a rectangular box.

[0055] In some embodiments, the kit container 109 includes a slot 121. The slot 121 can be a cutout in the kit container 109 that is sized and shaped to receive and secure the label 124. For example, a portion (e.g., a corner) of the label 124 can be inserted into the slot 121 to secure the label 124 in place during movement or transportation of the packaging kit 108. In some embodiments, the kit container 109 includes a plurality of slots 121. For example, the kit container 109 can include a plurality of slots 121 corresponding to the number of labels 124, such that each label 124 is secured into its respective slot 121. The slots 121 can be arranged in the corners of the kit container 109 so that when the label is arranged in the kit container 109, the corner of the label 124 can be inserted into the slot 121 to secure the label 124.

[0056] In some embodiments, packaging kit 108 includes one or more components for securing one or more biological samples for transport. Figure 5 As shown, the packaging kit 108 may include one or more of the following: a shipping pouch 110, a transport bag 112, a fixing strip 114, a sensor 116, a fixing element 118, an insert 120, and a label 124. In some embodiments, the packaging kit 108 includes individual components stacked together for storage and transportation. For example, during the transportation of the packaging kit 108, the shipping pouch 110 may be arranged on the transport bag 112, the transport bag may be arranged on the insert 120, and the insert may be arranged on the label 124. Each component of the packaging kit 108 may be stacked together to reduce the overall size of the packaging kit 108. In some embodiments, the insert 120 may be arranged between the label 124 and the transport bag 112, and the transport bag 112 may be arranged between the shipping pouch 110 and the insert 120.

[0057] In some embodiments, the shipping pouch 110 is configured to receive one or more labels 124. For example, the shipping pouch 110 can be configured to receive one or more labels 124, on which the destination information can be arranged. In some embodiments, the packaging kit 108 includes two labels 124, one label 124 for the sample container and another label 124 for the inner shipping container 106. The labels 124 can be patient-specific labels, including information related to a specific patient. In use, one or more labels 124 can be configured to include destination information and can be placed in the shipping pouch 110, on the inner shipping container 106, and / or on the sample container. The shipping pouch 110 can be placed on the inner shipping container 106. For example, the shipping pouch 110 equipped with the label 124 or a shipping document (e.g., a waybill) can be placed on the area 107 of the inner shipping container 106. Placing the shipping pouch 110 with label 124 on area 107 makes it easy for the courier to see the destination of the internal shipping container 106. In some embodiments, the shipping pouch 110 has a width of six inches and a length of nine inches. In some embodiments, the shipping pouch 110 can have a width of 1 inch to 12 inches, 3 inches to 9 inches, or 6 inches to 8 inches, and can have a length of 1 inch to 15 inches, 3 inches to 12 inches, or 6 inches to 9 inches.

[0058] In some embodiments, the shipping pouch 110 is configured to receive a shipping document, such as a waybill. A user can insert the waybill into the shipping pouch 110 and seal the shipping pouch 110. The waybill can include the destination information of the location and the manner in which the inner shipping container 106 is to be transported. In some embodiments, the shipping document (e.g., waybill) is printed by the medical location. The medical location can pre-print the shipping document containing non-patient specific information.

[0059] In some embodiments, insert 120 is comprised of a foam material. In some embodiments, insert 120 may be comprised of cardboard, a polymer, or any other suitable type of protective material. Insert 120 may have a thickness of about 2 inches to about 0.1 inches, about 1.75 inches to about 0.5 inches, or about 0.75 inches to about 1 inch. In some embodiments, insert 120 has a thickness of about 0.75 inches.

[0060] In some embodiments, one or more securing strips 114, sensors 116, and one or more securing elements 118 are disposed within the insert 120. For example, the insert 120 may include cutouts 122a, 112b, and 122c that are sized and shaped to receive the securing strip 114, the sensor 116, and the securing element 118, respectively. In some embodiments, the cutout 122a is sized and shaped to secure the securing strip 114, the cutout 122b is sized and shaped to secure the sensor 116, and the cutout 122c is sized and shaped to receive the securing element 118. The cutouts 122a, 122b, and 122c are configured to secure the strip 114, the sensor 116, and the securing element 118 to prevent damage to the securing strip 114, the sensor 116, and the securing element 118 during transportation.

[0061] In some embodiments, the insert 120 may include three cutouts 122a, one cutout 122b, and two cutouts 122c. In some embodiments, the insert 120 may include any number of cutouts 122a, 122b, and 122c. For example, the insert 120 may include a plurality of cutouts 122a, 122b, and 122c corresponding to the number of the fixing strips 114, the sensors 116, and the fixing elements 118. In some embodiments, the cutout 122b is arranged between the two cutouts 122c, and one or more cutouts 122a are arranged below the cutouts 122b and 122c. The cutout 122c may be configured to receive more than one fixing element 118. In some embodiments, one or more cutouts 122c are each configured to receive four fixing elements 118. In some embodiments, the cutout 122c may be configured to receive any number of fixing elements 118. In some embodiments, each cutout 122a is configured to receive a fixing strip 114.

[0062] In some embodiments, one or more fixing elements 118 are configured to ensure the closure of the sample container receiving the biological sample. For example, as described above, the biological sample can be placed in the medium (e.g., transport medium) in the sample container. The sample container can be fixed with one or more fixing elements 118 to prevent leakage or contamination of the biological sample in the sample container. In some embodiments, the fixing element 118 is a flexible film or adhesive or a self-sealing thermoplastic. For example, the fixing element 118 can be a paraffin film, and once the biological sample and the medium are placed in the sample container, the paraffin film can be fixed around the sample container, such as adjacent to the opening of the sample container. In some embodiments, the fixing element 118 can be a sealing element of tape, cellophane, Teflon or any other suitable type. In some embodiments, the packaging kit 108 includes more than one fixing element 118. For example, the packaging kit 108 can include two, three, four, five, six, seven, eight, nine, ten or more than ten fixing elements 118.

[0063] In some embodiments, the transport bag 112 is configured to receive the biological sample and is configured to be fixed. For example, the transport bag 112 may include an adhesive portion containing an adhesive so that the transport bag 112 can be folded and the adhesive portion can be adhered to another portion of the transport bag 112, thereby sealing the transport bag 112. The transport bag 112 may include an absorbent sheet 111. The absorbent sheet 111 may be configured to indicate that the sample container containing the biological sample has leaked or damaged. The absorbent sheet 111 may be an absorbent pad configured to absorb liquid. In some embodiments, the absorbent sheet 111 is configured to indicate when it has absorbed liquid. For example, the absorbent sheet 111 may change color when absorbing liquid, thereby indicating that the sample container containing the biological sample has leaked or damaged during transportation. Once the sample container containing the biological sample is placed in the transport bag 112, the transport bag 112 can be placed in the inner shipping container 106 adjacent to the cooling engine 104, and the cooling engine is also arranged in the inner shipping container 106. The transport bag 112 can be a 95kPa liquid-tight transport bag. For example, the transport bag 112 is a 95 kPa liquid-tight transport bag, which allows the transport bag to withstand 95 kPa without leakage, thereby safely transporting sample containers containing biological samples. In some embodiments, the transport bag 112 can be any type of bag configured to withstand pressure and prevent leakage.

[0064] In practice, the medical site receiving device 100 may place the sample container containing the biological sample in a transport bag 112 having an absorbent sheet 111. The transport bag 112 may be placed within the inner shipping container 106 adjacent to the cooling engine 104. The medical site may transport or arrange for the transport of the inner shipping container 106 containing the transport bag 112 having the biological sample and the cooling engine 104. The recipient of the inner shipping container 106 (e.g., a processing facility) may analyze the absorbent sheet 111 to determine whether the sample container containing the biological sample is leaking or damaged during transport.

[0065] In some embodiments, packaging kit 108 includes securing strips 114. Securement strips 114 can be tamper-proof strips and can be used to secure inner shipping container 106. In some embodiments, inner shipping container 106 has an open position and a closed position. In the open position, the interior of inner shipping container 106 can be accessed. In the closed position, the interior of inner shipping container 106 cannot be accessed, and the components stored inside are secured. Packaging kit 108 can include one or more securing strips 114 to secure inner shipping container 106 in the closed position.

[0066] Securement strips 114 may be placed on inner shipping container 106 in a manner that prevents access to inner shipping container 106 and maintains inner shipping container 106 in a closed position. For example, once securement strips 114 are applied to inner shipping container 106 when inner shipping container 106 is in a closed position, the interior of inner shipping container 106 cannot be accessed without altering, damaging, or removing securement strips 114. In some embodiments, packaging kit 108 includes three securement strips 114 that are configured to be placed at different locations on inner shipping container 106 when inner shipping container 106 is in a closed position. Securement strips 114 may be placed on inner shipping container 106 such that once securement strips 114 are placed on inner shipping container 106 when inner shipping container 106 is in a closed position, access to the interior of inner shipping container 106 is prevented. In some embodiments, securing strips 114 are used to prevent inner shipping container 106 from being placed in an open position without removing securing strips 114 , thereby preventing access to the interior of inner shipping container 106 .

[0067] Securing strip 114 may be a tamper-evident strip or tamper-evident tape. For example, once securing strip 114 is placed, it may be difficult to remove it without causing visible damage to securing strip 114. In some embodiments, removal of securing strip 114 results in visible damage to inner shipping container 106, thereby indicating to an individual that inner shipping container 106 has been tampered with or entered. Removal of securing strip 114 may result in residue or markings being left on inner shipping container 106 to indicate that inner shipping container 106 has been tampered with.

[0068] The packaging kit 108 may include one or more labels 124. The labels 124 may be configured to include destination information, such as where the medical site intends to transport the biological sample, such as to a processing facility. The labels 124 may include de-identified information associated with the patient from whom the biological sample was obtained. The de-identified patient information may be a number associated with the patient, but does not reveal identifying information about the patient (e.g., name). Alternatively, the labels 124 may include identifying information about the patient (e.g., name, date of birth, age, etc.). In some embodiments, one label 124 is placed on a sample container containing the biological sample, and one label 124 is placed within the shipping pouch 110 and placed on the inner shipping container 106. In some embodiments, each label 124 includes different information. For example, one label 124 may include destination information adhered to the inner shipping container 106, while another label 124 may include de-identified patient information placed on the sample container containing the biological sample. In some embodiments, each label 124 includes de-identified patient information and destination information. In other embodiments, each label 124 includes identifying information about the patient (e.g., name). In other embodiments, one label 124 includes destination information to be inserted into a shipping pouch 110 placed on the inner shipping container 106, and another label 124 includes identifying information about the patient (e.g., name) to be placed on a specimen container containing the biological specimen.

[0069] In some embodiments, the label 124 includes an adhesive to facilitate attachment to the inner shipping container 106. The label 124 can be placed inside the shipping pouch 110 to protect the label 124 from damage. In some embodiments, the packaging kit 108 includes more than one label 124. For example, the packaging kit 108 can include two, three, four, five, six, seven, eight, nine, ten, or more than ten labels 124.

[0070] In some embodiments, packaging kit 108 includes sensor 116. Sensor 116 can be a temperature sensor configured to monitor the temperature of internal shipping container 106 during transportation of biological samples. In some embodiments, sensor 116 is configured to communicate with a remote server to notify individuals whether the temperature in internal shipping container 106 deviates from a predetermined range during transportation of biological samples. In some embodiments, sensor 116 is configured to record temperature data in internal shipping container 106 once activated. Sensor 116 can be configured to transmit a warning or alarm when the temperature in internal shipping container 106 deviates from a predetermined temperature range. Sensor 116 can be configured to couple and / or communicate with an electronic device (e.g., USB, Bluetooth, near field communication (NFC)). Sensor 116 can be configured to transmit the temperature detected during transportation of biological samples so that a user can determine whether the temperature deviates from a predetermined temperature range. Deviating from a predetermined temperature range can lead to degradation of biological samples.

[0071] In practice, a medical location can receive a device 100, which can include an inner shipping container 106, a cooling engine 104, and a packaging kit 108. Each of the inner shipping container 106, the cooling engine 104, and the packaging kit 108 can be removed from the outer shipping container 102. A biological sample can be obtained from a patient and added to a transport medium. The biological sample combined with the transport medium can be stored in a sample container. A label 124 containing one or more de-identified patient information and destination information can be added to the sample container. In some embodiments, a label 124 containing identifying patient information (e.g., name, date of birth, age, etc.) and destination information is added to the sample container. A fixing element 118 from the packaging kit 108 can be used to fix the sample container. The cooling engine 104 can be activated and placed in the inner shipping container 106 together with the sensor 116 from the packaging kit 108. The fixed sample container can be placed in a transport bag 112. The transport bag 112 can then be placed in the inner shipping container 106 adjacent to the activated cooling engine 104 and sensor 116. The inner shipping container 106 may be sealed and secured using the securing strip 114. Another label 124 containing one or more of de-identified patient information and destination information may be inserted into the shipping pouch 110, which may then be adhered to the inner shipping container 106. In some embodiments, the label 124 containing one or more of patient identification information (e.g., name, date of birth, age, etc.) and destination information is inserted into the shipping pouch 110, which is then adhered to the inner shipping container 106. The inner shipping container 106 containing the biological specimen and the cooling engine 104 may be transported to another location, such as another medical location or processing facility.

[0072] refer to Figure 6 , in some embodiments, the device 100 is used in a method for packaging a biological sample. In some embodiments, the method includes providing (201) a device 100, including an internal shipping container 106, a cooling engine 104, and a packaging kit 108. In some embodiments, a packaging kit 108 can be provided, and the packaging kit can include a transport bag 112 and an insert 120, the insert storing one or more fixing elements 118, one or more fixing strips 114, and a sensor 116 (e.g., a temperature sensor). In some embodiments, a sample container can be fixed (202) with the fixing element 118, and the sample container can include a biological sample that can be obtained from a patient. In some embodiments, the packaging kit 108 can include a plurality of labels 124. In some embodiments, the biological sample can be combined with a transport medium, and the transport medium can be configured to prevent degradation of the biological sample.

[0073] In some embodiments, a first label of the plurality of labels 124 is affixed (203) to a fixed sample container. In some embodiments, the first label may include at least one of patient information and destination information. In some embodiments, the labeled sample container may be inserted (204) into a transport bag 112 and the transport bag 112 may be placed (205) in an inner shipping container 106. In some embodiments, the transport bag 112 may include an absorbent sheet 111 configured to detect leakage of the labeled sample container within the transport bag 112. In some embodiments, the inner shipping container 106 may include a cooling engine 104 and a sensor 116, which may be a temperature sensor. In some embodiments, the inner shipping container 106 is closed (206) such that the transport bag 112, the cooling engine 104, and the sensor 116 are disposed within the inner shipping container 106. In some embodiments, the inner shipping container 106 may be secured (207) in a closed position using one or more securing strips 114, thereby preventing access to the interior of the inner shipping container 106. In some embodiments, one or more securing strips 114 are configured to leave a mark or residue on inner shipping container 106 if removed or altered. In some embodiments, a second label from among plurality of labels 124 is affixed 208 to inner shipping container 106. In some embodiments, second label can include patient information and destination information. In some embodiments, inner shipping container 106 can include the second label and be shipped to the destination.

[0074] refer to Figure 7, in some embodiments, the device 100 is used in a method of packaging a biological sample. In some embodiments, the method includes receiving (209) an outer shipping container 102 having a cooling engine 104, an inner shipping container 106, and a packaging kit 108. In some embodiments, the packaging kit 108 includes a transport bag 112, a shipping pouch 110, a plurality of labels 124, and an insert 120 storing a fixing element 118, a fixing strip 114, and a temperature sensor. In some embodiments, the cooling engine 104, the inner shipping container 106, and the packaging kit 108 are removed (210) from the outer shipping container 102. In some embodiments, the transport bag 112, the shipping pouch 110, the plurality of labels 124, and the insert 120 are removed (211) from the packaging kit 108, wherein the insert 120 includes a cutout sized and shaped to receive the fixing element 118, the fixing strip 114, and the temperature sensor. In some embodiments, the fixing element 118, the fixing strip 114, and the temperature sensor are removed (212) from the insert 120. In some embodiments, a biological sample is placed (213) in a sample container, the biological sample comprising tumor tissue and a transport medium. In some embodiments, the sample container is fixed (214) by the fixing element 118. In some embodiments, a first label of a plurality of labels 124 is applied (215) to the fixed sample container, the first label comprising at least one of patient information and destination information. In some embodiments, the labeled sample container is inserted (216) into a transport bag, the transport bag 112 comprising an absorbent sheet 111, the absorbent sheet being configured to absorb leakage of the labeled sample container within the transport bag 112. In some embodiments, the cooling engine 104 is started (217), such that the cooling engine 104 is configured to maintain the internal shipping container 106 within a predetermined temperature range when the started cooling engine 104 is arranged in the internal shipping container 106. In some embodiments, transport bag 112, cooling engine 104, and temperature sensor are placed (218) within inner shipping container 106. In some embodiments, inner shipping container 106 is closed (219) such that transport bag 112, cooling engine 104, and temperature sensor are disposed within the interior of inner shipping container 106. In some embodiments, inner shipping container 106 is secured (220) in a closed position using securing strip 114 such that access to the interior of inner shipping container 106 is prevented, wherein securing strip 114 is configured to leave a mark or residue on inner shipping container 106 if removed or altered. In some embodiments, a second label of plurality of labels 124 is applied (221) to inner shipping container 106, the second label comprising at least one of patient information and destination information.

[0075] In some embodiments, one or more securing strips 114 are removed from cutout 122a, sensor 116 is removed from cutout 122b, and one or more securing elements 118 are removed from cutout 122c. In some embodiments, cooling engine 104 may be activated such that cooling engine 104 is configured to maintain inner shipping container 106 within a predetermined temperature range when cooling engine 104 is activated and disposed within inner shipping container 106. In some embodiments, the predetermined temperature range may be 0° C. to 10° C.

[0076] In some embodiments, the outer shipping container 102 is received by a user and includes the cooling engine 104, the inner shipping container 106, and the packaging kit 108. In some embodiments, the user can remove the cooling engine 104, the inner shipping container 106, and the packaging kit 108 from the outer shipping container 102, and can remove the transport bag 112, the shipping pouch 110, the plurality of labels 124, and the insert 120 from the packaging kit 108.

[0077] The term "about" or "approximately" is used herein to provide textual support for the exact number after it and the number of the number after the term close to or approximating it. When determining whether a number is close to or approximates a specifically listed number, a number that is close to or approximates an unlisted number can provide a number that is substantially equal to the specifically listed number in the context in which it is presented. It should be understood that all numerical values ​​and ranges disclosed herein are approximate values ​​and ranges, whether or not "about" is used with it. It should also be understood that the term "about" combined with a number as used herein refers to a value that can be ±0.01% (including the end value), ±0.1% (including the end value), ±0.5% (including the end value), ±1% (including the end value), ±2% (including the end value), ±3% (including the end value), ±5% (including the end value), ±10% (including the end value) or ±15% (including the end value) of the number. It should also be understood that when a numerical range is disclosed herein, any numerical value falling within the range is also specifically disclosed.

[0078] Those skilled in the art will appreciate that changes may be made to the exemplary embodiments shown and described above without departing from the broad inventive concepts of the present invention. It should be understood that the embodiments and claims disclosed herein are not limited in their application to the details of the construction and arrangement of the components set forth in the specification and shown in the drawings. On the contrary, the specification and drawings provide examples of contemplated embodiments. The embodiments and claims disclosed herein are also capable of other embodiments and can be practiced and implemented in various ways.

[0079] Specific features of the exemplary embodiments may or may not be part of the claimed invention, and various features of the disclosed embodiments may be combined. Unless specifically set forth herein, the terms "a / an" and "the / said" are not limited to one element, but should be understood to mean "at least one". Finally, unless otherwise specified herein, the disclosed or claimed methods should not be limited to performing their steps in the order written, and those skilled in the art can readily understand that the steps can be performed in any practical order.

Claims

1. A packaging and transportation device for biological samples, the packaging and transportation device comprising: Inserts; Fixed strip; Fixing elements; a temperature sensor, wherein the insert includes a plurality of cutouts sized and shaped to receive the retaining strip, the retaining element, and the temperature sensor; a plurality of labels, wherein at least one of the plurality of labels includes patient information; A shipping pouch sized and shaped to receive shipping documents; as well as A transport bag configured to receive a sample container.

2. The packaging and shipping device of claim 1, wherein the plurality of cutouts comprises a first cutout, a second cutout, and a third cutout.

3. The packaging and transport device of claim 2, wherein: The first cutout of the insert is configured to receive and store the retaining strip, the second cutout of the insert is configured to receive and store the temperature sensor, and the third cutout of the insert is configured to receive and store the retaining element.

4. The packaging and shipping device of any one of claims 1-3, wherein the insert is disposed between the shipping bag and the plurality of labels.

5. The packaging and shipping device of any one of claims 1-3, wherein the insert is disposed between the shipping bag and the plurality of labels, and the shipping bag is disposed between the shipping pouch and the insert.

6. The packaging and transport device according to any one of claims 1 to 5, further comprising: An inner shipping container is sized and shaped to receive the transport bag and cooling engine, wherein the inner shipping container is smaller in size than the packaging and transport device.

7. The packaging and shipping device of claim 6, wherein the plurality of labels includes a first label configured to be applied to the sample container and a second label configured to be applied to the inner shipping container.

8. The packaging and transport device of claim 6 or 7, wherein the securing strip is configured to leave a mark on the inner shipping container if removed or altered.

9. The packaging and transport device of any one of claims 1-8, wherein the securing strip is disposed within one of the plurality of cutouts of the insert.

10. The packaging and transport device of any one of claims 1-9, wherein the insert comprises three or more securing strips.

11. The packaging and transport device of claim 10, wherein the three or more securing strips are disposed within the plurality of cutouts of the insert.

12. The packaging and transport device of any one of claims 1-11, wherein the insert comprises four or more securing elements.

13. The packaging and transport device of claim 12, wherein the four or more securing elements are disposed within the plurality of cutouts of the insert.

14. The packaging and shipping device of any one of claims 1-13, wherein the patient information includes identifying patient information.

15. The packaging and shipping device of claim 14, wherein the identifying patient information includes one or more of the patient's name, date of birth, age, etc.

16. The packaging and transport device according to any one of claims 1 to 15, further comprising: A cooling engine is configured to maintain a temperature range of about -80°C to about 10°C after activation of the cooling engine.

17. The packaging and transport device of any one of claims 1-16, wherein the transport bag comprises an absorbent sheet configured to absorb leakage of the sample container.

18. The packaging and shipping device of any one of claims 1-17, wherein the packaging and shipping device comprises two or more tags.

19. The packaging and transport device of any one of claims 1-18, wherein the temperature sensor is disposed within one of the plurality of cutouts of the insert.

20. The packaging and transport device of any one of claims 1-19, wherein the transport bag is configured to withstand up to 95 kPa without leaking.

21. The packaging and shipping device of any one of claims 1-20, wherein the patient information comprises de-identified patient information.

22. The packaging and shipping device of any one of claims 1-21, wherein the insert is disposed between the plurality of tags and one of the shipping pouch and the transport bag.

23. The packaging and transport device of any one of claims 1 to 22, further comprising: A kit container houses the insert, the plurality of labels, the shipping pouch, and the transport bag.

24. A packaging and transport device for biological samples, the device comprising: A packaging kit, the packaging kit comprising: an insert having a retaining strip, a retaining element, and a temperature sensor, wherein the insert includes a plurality of cutouts sized and shaped to receive the retaining strip, the retaining element, and the temperature sensor; a plurality of tags including one or more of patient information and destination information; a transport bag configured to receive a sample container containing the biological sample; Shipping pouches; a cooling engine configured to maintain a temperature range of about 0°C to about 10°C; Inner shipping container; and an outer shipping container sized and shaped to receive the inner shipping container, the cooling engine, and the packaging kit, Wherein the inner shipping container includes an area for receiving at least one of the plurality of labels, and the inner shipping container is sized and shaped to receive the cooling engine and the transport bag.

25. The packaging and shipping device of claim 24, wherein the insert is disposed between the shipping bag and the plurality of labels.

26. The packaging and transport device of claim 24, wherein the transport bag is disposed between the shipping pouch and the insert.

27. A method for packaging a biological sample, the method comprising: Providing a packaging kit having a transport bag and an insert for storing the fixing element, the fixing strip and the temperature sensor; fixing a sample container with the fixing element, wherein the sample container includes the biological sample; applying a first label to the fixed sample container, the first label including at least one of the patient information; inserting the labeled sample container into the transport bag; placing the transport bag in an inner shipping container, wherein the inner shipping container includes a cooling engine and the temperature sensor; closing the inner shipping container such that the transport bag, the cooling engine, and the temperature sensor are disposed within the inner shipping container; securing the inner shipping container in a closed position using the securing strips so that attempts to enter the interior of the inner shipping container are obvious; as well as A second label is applied to the inner shipping container, the second label including at least one of patient information and destination information.

28. The method of claim 27, wherein the packaging kit further comprises a shipping pouch and a plurality of labels, the plurality of labels comprising the first label and the second label.

29. The method of claim 28, wherein: Within the packaging kit, the insert is disposed between the shipping bag and the plurality of labels.

30. The method of claim 28 or 29, wherein: Within the packaging kit, the transport bag is disposed between the shipping pouch and the insert.

31. The method of any one of claims 27-30, further comprising: removing the securing strip from the first cutout of the insert; removing the temperature sensor from the second cutout of the insert; as well as The fixation element is removed from the third cutout of the insert.

32. The method of claim 31 , wherein the first cutout of the insert is configured to receive and store the retaining strip.

33. The method of claim 31 or 32, wherein the second cutout of the insert is configured to receive and store the temperature sensor.

34. The method of any one of claims 31-33, wherein the third cutout of the insert is configured to receive and store the fixation element.

35. The method of any one of claims 27-34, further comprising: The cooling engine is activated such that the cooling engine is configured to maintain the inner shipping container within a predetermined temperature range when the activated cooling engine is disposed within the inner shipping container.

36. The method of claim 35, wherein the predetermined temperature range is 0°C to 10°C.

37. The method of any one of claims 27-36, further comprising: The inner shipping container with the second label is transported to a destination.

38. The method of any one of claims 27-37, further comprising: The biological sample is obtained from a patient.

39. The method of any one of claims 27-38, further comprising: The biological sample is combined with a transport medium, wherein the transport medium is configured to prevent degradation of the biological sample.

40. The method of any one of claims 27-39, wherein the biological sample comprises a plurality of tumor tissues obtained from a patient.

41. The method of any one of claims 27-40, wherein the transport bag comprises an absorbent sheet configured to absorb leakage of the sample container.

42. The method of any of claims 27-41, wherein the securing strip is configured to leave a mark on the inner shipping container if removed or altered.

43. The method of any one of claims 27-42, wherein the packaging kit comprises three or more securing strips.

44. The method of any one of claims 27-43, wherein the packaging kit comprises four or more securing elements.

45. The method of any one of claims 27-44, wherein the packaging kit comprises two or more labels.

46. ​​The method of any one of claims 27-45, wherein the transport bag is configured to withstand up to 95 kPa without leaking.

47. The method of any one of claims 27-46, wherein the patient information comprises de-identified patient information.

48. The method of any one of claims 27-47, wherein the patient information includes identifying patient information.

49. The method of claim 48, wherein the patient information includes the patient's name, date of birth and / or age.

50. The method of any one of claims 27-49, wherein the packaging kit comprises a kit container configured to receive and store the transport bag and the insert.

51. A method for packaging a biological sample, the method comprising receiving an outer shipping container having a cooling engine, an inner shipping container, and a packaging kit having a shipping bag, a shipping pouch, a plurality of labels, and an insert storing a securing element, a securing strip, and a temperature sensor; removing the cooling engine, the inner shipping container, and the packaging kit from the outer shipping container; removing the transport bag, the shipping pouch, the plurality of labels, and the insert from the packaging kit, wherein the insert includes a cutout sized and shaped to receive the securing element, the securing strip, and the temperature sensor; removing the securing element, the securing strip, and the temperature sensor from the insert; placing the biological sample in a sample container, wherein the biological sample includes tumor tissue and a transport medium; Fixing the sample container with the fixing element; applying a first label of the plurality of labels to the fixed sample container, the first label including at least one of patient information and destination information; inserting the labeled sample container into the transport bag, the transport bag comprising an absorbent sheet configured to absorb leakage of the labeled sample container within the transport bag; activating the cooling engine such that the cooling engine is configured to maintain the inner shipping container within a predetermined temperature range when the activated cooling engine is disposed within the inner shipping container; placing the transport bag, the cooling engine, and the temperature sensor in the inner shipping container; closing the inner shipping container such that the transport bag, the cooling engine, and the temperature sensor are disposed within the interior of the inner shipping container; securing the inner shipping container in a closed position using the securing strips so that access to the interior of the inner shipping container is prevented, wherein the securing strips are configured to leave marks or residue on the inner shipping container if removed or altered; as well as A second label of the plurality of labels is applied to the inner shipping container, the second label including at least one of patient information and destination information.

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