US20100038369A1

US20100038369A1 - Box for transporting samples

Info

Publication number: US20100038369A1
Application number: US12/510,539
Authority: US
Inventors: Manuel Rivas CaÑas; Myriam Fabre
Original assignee: Advancell Advanced In Vitro Cell Technologies SA
Current assignee: Advancell Advanced In Vitro Cell Technologies SA
Priority date: 2008-08-01
Filing date: 2009-07-28
Publication date: 2010-02-18

Abstract

The present invention relates to a box for transporting samples, conceived to maintain the temperature in its interior in a range between 15° C. and 25° C. for an extended time period and suitable for any product that requires thermal and mechanical resistance, particularly for biological samples. The transport box of the invention comprises a series of non-primary packaging of carefully selected dimensions, shape and materials, accumulating heat elements and, optionally, filling material.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is filed under the provisions of 35 U.S.C. §119(e) and claims the priority of U.S. Provisional Patent Application No. 61/085,433 filed on Aug. 1, 2008, which is incorporated by reference herein in its entirety.

DESCRIPTION

The present invention relates to a box for transporting samples, devised to maintain the temperature in its interior in a range between 15° and 25° C. for extended time periods.
The transport box of the invention is particularly suitable for transporting biological samples, although it is applicable in general to the transport of any product that requires extreme thermal and mechanical resistance.

BACKGROUND OF THE INVENTION

According to the ICAO (International Civil Aviation Organization), the specific definition of biological sample is any material of human or animal origin that includes, but is not limited to, excreta, secreta, blood and its components, tissues and their fluids, sent for diagnostic purposes, but excluding infected live animals. This definition includes all the typical samples used for the diagnosis or analysis carried out in clinical or experimental laboratories (blood, serum, saliva, urine, faeces, CSF, biopsies, histology, swabs, etc.).
In general, the transport of products always entails risks of thermal and mechanical type. Optimum packaging is that which effectively prevents both risks, thereby allowing the temperature of the biological sample to remain within an optimum range, as it is packaged at origin until it is received at its destination and protected from mechanical damages. An optimum temperature range is understood as that temperature range which guarantees the physical-chemical properties that ensure the feasibility and repeatability of the aforementioned experiments.
Due to being a biological sample, the packaging must also comply with certain biological protection requirements. The samples or biological products, in general, naturally entail an associated biological risk in accordance with the biological load they contain. Consequently the packaging, apart from preventing mechanical damage, is vital to the prevention of biological risk.
In general, the receptacles used to transport biological samples are comprised of a primary packaging and one or several non-primary packaging. Throughout this description, the definitions of the terms explained below shall be used.
A primary packaging is that which contains the biological product for diagnosis. Said packaging must be standardized and meet the requirements established in the packaging instructions. In this manner, normally, the primary packaging must fulfill two requirements: contain a plastic material that envelops and waterproofs the biological sample and contain printed information guaranteeing the standardized biological product in its interior.
Non-primary packaging are those which, at least, contain the primary packaging. They can be secondary, tertiary, etc. depending on whether they contain one, two or more packaging in their interior. These packaging do not need to be standardized.
In this manner, the biological sample may be introduced directly in a tube or a standardized receptacle, although said sample would normally be introduced in a standardized plastic bag with safety seal. Another possibility would be to place the biological sample inside a non-standardized plastic bag, with a safety seal, inside a more complex standardized receptacle with some type of coating for mechanical and/or thermal protection.
Filling material is understood to be the material which is disposed in the space between the different packaging. This material is fundamentally aimed at reducing mechanical and thermal stress, such as expanded polystyrene chips or different insulating materials of a highly plastic nature and with very low thermal conductivity, in addition to materials with low calorific capacity which, once heated or cooled at a determined temperature, help to maintain the surrounding space at a specific temperature. Additionally, filling of absorbent materials may be used (for example, cotton or vermiculite) to guarantee the suitable humidity conditions and/or to absorb, in case of accident, liquid material spills.
In the current state of the art there are different types of containers conceived to conserve biological samples within a pre-established temperature range, normally cold (between −20° C. and 4° C.). These include containers equipped with electrical systems fed by an external power supply, containers equipped with cold-accumulating elements and containers equipped with an autonomous mechanical system that distributes the cold evenly throughout the container.
The containers included in the State of the Art have certain deficiencies with respect to their use for transporting a sample at temperatures in a range between 15° C. and 25° C., such as the following:

- in extreme temperature conditions (T_external<10° C. or T_external>30° C.) they do not maintain the optimum temperature range even for short time intervals; and/or
- in non-extreme temperature conditions (15° C.<T_external<25° C.) they do not maintain the optimum temperature range during standard time intervals (16-24 hours).

On the other hand, the containers that could be suitable for maintaining the optimum temperature range during transport of the sample are expensive systems, with the drawbacks that this entails.
Consequently, a need exists for a suitable container for transporting biological samples that maintains the temperature in its interior within the optimum range for extended time periods, without the financial detriment associated to prior systems of the State of the Art.

DESCRIPTION OF THE INVENTION

The transport box of the invention has been devised to solve the previously expounded problems, maintaining the temperature in its interior in a range between 15° C. and 25° C. for an extended time period, understood within the context of this specification as a time period longer than 24 hours.
More specifically, the invention relates to a transport box according to independent claim 1. Advantageous embodiments are defined by means of the dependent claims.
Advantageously, the transport box of the invention is the most structurally simple and cheap solution to the aforementioned problem.
The transport box of the invention comprises a first non-primary packaging, a second non-primary packaging, a third non-primary packaging and heat accumulators. The first non-primary packaging is made of plastic material of high heat-insulating capacity, preferably polypropylene or other polymer of similar characteristics. With regard to its shape, the first non-primary packaging is preferably cylindrical in shape to contribute to evenly distribute the thermal gradient. In a preferred embodiment, the first non-primary packaging has a double layer, in such a manner that it closes hermetically and provides sufficient rigidity to protect the interior from possible blows. In a possible embodiment of the transport box of the invention, the interior of the first non-primary packaging has a metal lining.
The second non-primary packaging is made of high-density polystyrene. In an embodiment of the invention, the interior of the second non-primary packaging is lined with a heat-insulating material, for example a layer of cardboard, in order to increase its heat-insulating capacity.
The third non-primary packaging is made of cardboard and its purpose is to sustain the structure of the second non-primary packaging, in order to increase its thermal resistance and bear the necessary shipment labels and documents.
The second and third non-primary packaging shall preferably have a straight parallelepiped shape.
In an alternative embodiment, the second and third non-primary packaging may be combined in a single packaging with a polystyrene interior and cardboard exterior.
The transport box of the invention also comprises one or several heat accumulators, with the property that their temperature varies very slowly on exposure to external temperature gradients. These products generally have a gel or liquid form packed in a plastic material.
These heat accumulators, according to the type of product to be shipped, may be disposed inside the first non-primary packaging, between the first non-primary packaging and the second non-primary packaging or in both places.
Preferably, heat accumulators in liquid form enveloped in rigid plastic material or heat accumulators in gel form enveloped in flexible plastic material shall be used.
Additionally, in order to increase the thermal and mechanical resistance of the box, filling material may be disposed either in the interior of the first non-primary packaging, between the first non-primary packaging and the second non-primary packaging, or in both places. In a preferred embodiment, said material consists of porous plastic material chips approximately 1 cm³in volume.
As mentioned earlier, one of the objects of the invention is to provide a transport box capable of maintaining a sample disposed in its interior within an optimum temperature range between 15° C. and 25° C. For this purpose, the materials, dimensions and shapes of the different packaging must be carefully selected. The temperature in the interior of the first non-primary packaging (T₁) is a variable that depends on different factors but, for the sake of simplification, we can conclude that T₁depends fundamentally on the temperature in the interior of the second non-primary packaging (T₂).
However, the variables defining T₂are:

- the external ambient temperature,
- the inclusion or non-inclusion of heat accumulators between the first non-primary packaging and the second non-primary packaging,
- the initial temperature of the heat accumulators,
- the material of the non-primary packaging used,
- the shape and dimensions of this packaging,
- the inclusion or non-inclusion of filling material.

The variable that comprises the greatest number of interconnections between the different elements of the box is defined within this context as the relationship (R_μ) between the volume of air between the first non-primary packaging and the second non-primary packaging (V₁₂) and the total volume of the box (V_tot):
R _μ =V ₁₂ /V _tot,
with the exception that the thickness of the second non-primary packaging must also remain within a certain range.
In fact, given that air is a good thermal insulator, the volume of air between the first non-primary packaging and the second non-primary packaging must be sufficient in order to ensure suitable insulation. The volume of air between the first non-primary packaging and the second non-primary packaging increases as the size of the first non-primary packaging decreases and as the size of the second non-primary packaging increases. However, the size of both packaging is conditioned by the transport needs: the first non-primary packaging must be sufficiently large to contain the primary packaging with the biological sample in its interior, in addition to heat accumulating elements and/or filling material, if necessary, and the second non-primary packaging must not be so large as to hinder the handling and transport of the transport box.
On the other hand, as the thickness of the second non-primary packaging increases, so does the insulating capacity of the transport box. Nevertheless, excessive thickness entails certain drawbacks, such as a larger size of the transport box and an increase in expense associated to the amount of material used in its manufacture.
Consequently, a compromise must be found between both sizes when designing a transport box that suitably meets the needs of this technical sector.
Advantageously, the transport box according to the invention resolves the aforementioned drawbacks on defining an optimum range for the R_μ parameter and for the thickness of the second non-primary packaging. Specifically, in the transport box of the invention, the proportion R_μ of volume of air between the first non-primary packaging and the second non-primary packaging with respect to the total volume of the box is comprised within a range between 0.1 and 0.6, and the thickness of the second non-primary packaging is in a range between 4 and 6 cm.
In a preferred embodiment of the invention, the parameter R_μ is comprised in a range between 0.2 and 0.5 and, in a preferred embodiment, between 0.2 and 0.3.
In a preferred embodiment of the invention, the thickness of the second non-primary packaging is comprised in a range between 4.5 and 5.5. cm and shall be preferably 5 cm.
In a preferred embodiment of the invention, the transport box additionally comprises filling material, disposed in the interior of the first non-primary packaging, between the first non-primary packaging and the second non-primary packaging or in both positions.

DESCRIPTION OF THE DRAWINGS

For the purpose of complementing the description hereunder and to further explain the characteristics of the invention, a set of drawings in accordance with a preferred embodiment thereof has been included as an integral part of said description, in which the following figures have been represented in an illustrative and non-limitative manner:

FIG. 1 shows an exploded view of the transport box according to the invention;

FIG. 2 shows a time-temperature graph for an external temperature of 4° C. which compares the results of two embodiments of the first non-primary packaging of the transport box according to the invention with an embodiment of said first non-primary packaging representative of the state of the art;

FIG. 3 shows the time-temperature graph for a package sent via a first route from Barcelona on 15 Feb. 2005 and received in Tebubio on 16 Feb. 2005;

FIG. 4 shows the time-temperature graph for a package sent via a second route from Tebubio on 16 Feb. 2005 and received in Lyngby on 17 Feb. 2005;

FIG. 5 shows a comparative time-temperature graph of the two routes, the results of which are represented in FIGS. 3 and 4.

PREFERRED EMBODIMENT OF THE INVENTION

As shown in FIG. 1, the transport box (1) for transporting biological products according to the invention comprises a first non-primary packaging (2), a second non-primary packaging (3), a third non-primary packaging (4) and one or several heat accumulators (5).
The first non-primary packaging (2) is a hermetic receptacle manufactured from a high-capacity heat-insulating plastic material, to contain in its interior a primary packaging with the biological sample to be transported. In the embodiment of FIG. 1, the first non-primary packaging (2) has a cylindrical shape to contribute to the even distribution of the thermal gradient. Preferably, the first non-primary packaging (2) has a radius of approximately 11 cm and a height of between 13 and 18 cm.
The second non-primary packaging (3) contains the first non-primary packaging (2) and is manufactured in high-density polystyrene. In the embodiment exemplified in FIG. 1, the second non-primary packaging (3) has a straight parallelepiped shape, specifically a prism shape, formed by six polystyrene sheets. In a preferred embodiment, the parallelepiped is 30 cm in width×30 cm in length×20 cm in height. In an alternative embodiment, the parallelepiped is 40 cm in width×40 cm in length×30 cm in height.
The dimensions of and proportion between the first and second non-primary packaging (3) are selected in such a manner as to guarantee the maintenance of the biological sample within the desired temperature range for a time period longer than 24 hours.
The third non-primary packaging (4) contains the second non-primary packaging (3) to sustain the structure, increase its thermal resistance and bear the necessary labelling and is manufactured, preferably, from cardboard. Despite having been defined as two independent packaging, the second and third non-primary packaging (4) may be integrated to form a single packaging with polystyrene interior and cardboard or similar exterior, which allows identifying stickers and labels to be fixed thereon.
The transport box (1) visible in FIG. 1 also contains heat accumulating elements (5) which, disposed in a suitable number and temperature, inside the first non-primary packaging (2), between the first non-primary packaging (2) and the second non-primary packaging (3) or in both, contribute to maintain the interior of the first non-primary packaging (2) within the optimum temperature range.

Examples

In order to verify that the transport box (1) of the invention is suitable for transporting a biological sample in a reliable and secure manner, maintaining said sample within the optimum temperature range, between 15° C. and 25° C., for extended time periods, different experiments were carried out, described hereunder in the following examples:

Example 1

Resistance to a Constant External Temperature of 4° C.

Experimental studies of a transport box (1) according to the invention, with two different types of first non-primary packaging (2), were carried out with a constant external temperature of 4° C.:

- Type 2 packaging (NPT2): A hermetically sealed receptacle with a plastic interior and exterior.
- Type 3 packaging (NPT3): A hermetically sealed receptacle with a plastic exterior and stainless steel inner lining.
  Type 2 and 3 packaging were both cylinders of identical size (22 cm of external diameter and 13.5 cm in height), the only difference being the inner metal or plastic lining.

The second non-primary packaging (3) was an expanded polystyrene box with a cardboard exterior for sticking labels and lined in its interior with another cardboard layer to increase its heat-insulating capacity. The dimensions of the second non-primary packaging were 40 cm in width, 40 cm in depth and 30 cm in height, with a thickness of 5 cm. The R_μ parameter in these experiments was, therefore, 0.43. Additionally, in order to verify the advantages of the transport box (1) of the invention with respect to other containers, experiments were carried out for an additional type of first non-primary packaging (2), representative of those used normally in the state of the art, comprised of low-density expanded polystyrene sheets inside compressed cardboard packaging, of similar characteristics to the second non-primary packaging (3), but with much thinner walls and with less volume. This packaging has been termed type 1 (NPT1) in the experiment.
Additionally, filling material was disposed between the first non-primary packaging (2) and the second non-primary packaging (3) as well as heat accumulators (5).
Afterwards, each of the three types of packaging was disposed in the interior of the second non-primary packaging (3), the assembly was subjected to a constant external temperature of 4° C. and its calorific capacity was calculated in each of the three situations. The results are reflected in the time-temperature graph of FIG. 2, which shows that the calorific capacity of the system with type 1 first non-primary packaging (2) is clearly superior to the systems with type 2 or type 3 first non-primary packaging (2), due to which it is unsuitable for the purpose of the invention.
With regard to type 2 and type 3 packaging, the results reflected that both receptacles showed greater thermal resistance than the packaging used up until that moment.
Additionally, it was verified that the difference between type 2 and type 3 first non-primary packaging (2) stemmed from the fact that type 3, due to its inner conductive lining, had greater inertia for thermal change than type 2. In this manner, a change from a non-optimum to an optimum external temperature would affect type 2 first non-primary packaging (2) more quickly than that of type 3. Therefore, in most cases, the system that would best adapt to the needs raised is that which contains a type 2 first non-primary packaging (2).

Example 2

Study of the Shipment of Plates to validate Thermal and Mechanical Resistance Experimented on a Real Route

In order to complete the experiment, it was decided to validate a biotechnological product produced and distributed by Advanced In Vitro Cell Technologies, S.L., a kit comprised of plates with Caco2 cells cultivated as monolayers over a CacoReady™ porous membrane subjected to a transport process on a real route. Disposing of this type of material allowed us to carry out pre- and post-shipment quality controls against a negative control (plates which have not undergone the shipment process) and then draw conclusions. A special characteristic of said plates is that a culture medium which is solid at room temperature but becomes liquid at optimum culture temperatures (37° C.) is placed on these prior to being shipped. The experiment included the following stages: Barcelona—Tebubio (Paris)—Barcelona.
The data prior to the study were the following:

- Temperatures below 15° C. during relatively extended time periods negatively affect the cellular monolayer and, particularly, its barrier properties.
- Temperatures above 25° C. during relatively extended time periods affect the physical condition of the transport system, producing heterogeneous areas of different density that negatively affect the cellular monolayer and, particularly, its barrier properties.

Therefore, the study was based on the plates with a perfectly solid means of transport, maintained at a temperature of 20-22° C. at the time of shipment. The objective was to verify whether the transport box (1) according to the invention minimized the impact of variations in external temperatures, thereby guaranteeing that the plates remain within the optimum temperature range as long as possible. For this, two shipments were made articulated in the following manner:

- Shipment 1 (2 plates): Sent on 25 Jan. 2005 and received on 27 Jan. 2005.


T_max(° C.)	T_min(° C.)	T_mean(° C.)

Barcelona Airport	13	4	9
25 Jan. 2005
Paris Airport	6	1	4
26 Jan. 2005

- Shipment 2 (2 plates): Sent on 8 Feb. 2005 and received on 10 Feb. 2005.


T_max(° C.)	T_min(° C.)	T_mean(° C.)

Barcelona Airport	13	4	9
8 Feb. 2005
Paris Airport	7	1	4
9 Feb. 2005

In both cases the same type of second non-primary packaging (3) was used, the same filling material, the same type of heat accumulator with the same temperature (37° C.) and similar external temperatures. In shipment 1, a type 1 first non-primary packaging (2) was used and, in shipment 2, a type 2 first non-primary packaging (2) was used (see Example 1 for the definition of type 1 and type 2 first non-primary packaging (2)).
Upon the return of the plates these were liquefied and subjected to TEER (Trans-Epithelial Electric Resistance) and flow (%) on day 21 and 23 quality controls. The results were subjected to an internal plate satisfaction control which allows a maximum of 10% of deficient bowls within the sample space (teer >1000 ohm·cm²and flow (%) <1), followed by a statistical dispersion analysis. The results 15 were the following:

Shipment 1:

1) Plates 1 and 2 are satisfactory for teer control on day 21 (plate 1: 24/24, plate 2: 23/24).
2) Plate 1 is satisfactory and plate 2 is unsatisfactory for flow percentage control on day 21 (plate 1: 11/12, plate 2: 0/12).
3) Plates 1 and 2 are unsatisfactory for teer control on day 23 (plate 1: 7/12, plate 2: 4/12).
4) Plates 1 and 2 are unsatisfactory for flow percentage control on day 23 (plate 1: 7/12, plate 2: 7/12).
5) On day 21, the average teer of the bowls (optimum and non-optimum) of plates 1 and 2 is respectively 35.12% and 34.20% lower than the negative batch control (not shipped).
6) On day 23, the average teer of the bowls (optimum and non-optimum) of plates 1 and 2 is respectively 24.37% and 57.52% lower than the negative batch control (not shipped).
7) On day 21, the average flow (%) of the bowls (optimum and non-optimum) of plates 1 and 2 is respectively 20% and 700.24% higher than the negative batch control (not shipped).
8) On day 23, the average flow (%) of the bowls (optimum and non-optimum) is respectively 358.3% and 566.6% higher than the negative batch control (not shipped).

Shipment 2:

1′) Plates 1 and 2 are satisfactory for teer control on day 21 (plate 1: 24/24, plate 2: 24/24).
2′) Plates 1 and 2 are satisfactory for flow percentage control on day 21 (plate 1: 12/12, plate 2: 12/12).
3′) Plates 1 and 2 are satisfactory for teer control on day 23 (plate 1: 12/12, plate 2: 12/12).
4′) Plates 1 and 2 are satisfactory for flow percentage control on day 23 (plate 1: 12/12, plate 2: 12/12).
5′) On day 21, the average teer of the bowls (all are optimum) of plates 1 and 2 is respectively 8.5% and 4.2% lower than the negative batch control (not shipped).
6′) On day 23, the average teer of the bowls (all are optimum) of plates 1 and 2 is respectively 6.18% and 10.2% lower than the negative batch control (not shipped).
7′) On day 21, the average flow (%) of the bowls (all are optimum) of plates 1 and 2 is respectively 15% and 45.45% lower than the negative batch control (not shipped).
8′) On day 23, the average flow (%) of the bowls (all are optimum) of plates 1 and 2 is respectively 45.45% and 27.27% lower than the negative batch control (not shipped).

Conclusions:

- For external temperatures above 10° C. and below 30° C. the transport box (1) of the invention guarantees optimum internal temperatures for time periods longer than 96 hours.
- For temperatures between 5° C. and 10° C. the transport box (1) of the invention guarantees optimum internal temperatures during 12 hours.
- For temperatures between 0° C. and 5° C. the transport box (1) of the invention guarantees optimum internal temperatures during 4-6 hours.
- The transport box (1) of the invention has good thermal recovery, in such a manner that, when exposed to external temperatures of 20-25° C., the temperature inside the box rises from the initial 4° C. to 18-20° C. after two hours.

Example 3

Study of Shipment without Plates on the Barcelona-Tebubio-Denmark-Barcelona Route

This study was carried out to verify the conclusions mentioned in example 2.
For this reason it was decided to make a shipment without plates, measuring the temperature in the interior of the first non-primary packaging (2) of a transport box (1) according to the invention on the Barcelona-Tebubio-Denmark-Barcelona route.

1. Route 1. Barcelona-Tebubio:

- Package shipped on 15 Feb. 2005 and received on 16 Feb. 2005. The time-temperature graph of this route is shown in FIG. 3.


T_max(° C.)	T_min(° C.)	T_mean(° C.)

Barcelona Airport	14	5	9
15 Feb. 2005
Paris Airport	7	1	2
16 Feb. 2005

- Initial temperature of the heat accumulator=37° C.
- Duration of journey=16 hours.
- Time of permanence inside the first non-primary packaging (2) within the optimum temperature range of the product=10 hours.
- Time of permanence inside the first non-primary packaging (2) within the temperature range between 25° C. and 30° C.=6 hours.
- Time of permanence inside the first non-primary packaging (2) within the temperature range between 28° C. and 30° C.=2 hours.

Conclusions Route 1:

- The time of permanence inside the first non-primary packaging (2) within the temperature range between 28° C. and 30° C. is 2 hours, which is insufficient for the possible liquefaction of the solid transport medium.
- We can conclude that, during the whole route, the interior of the first non-primary packaging (2) maintained its optimum temperature conditions.

2. Route 2. Tebubio-Lyngby (Denmark)

- Package shipped on 16 Feb. 2005 and received on 17 Feb. 2005. The time-temperature graph for this route is shown in FIG. 4.


T_max(° C.)	T_min(° C.)	T_mean(° C.)

Paris Airport	7	1	4
16 Feb. 2005
Lyngby	2	−2	0
17 Feb. 2005

- Initial temperature of the gel (heat accumulator)=30° C.
- Duration of journey=22 hours.
- Time of permanence inside the first non-primary packaging (2) within the optimum temperature range of the product=18 hours.
- Time of permanence inside the first non-primary packaging (2) at temperatures below 15° C.=4 hours.
- Minimum temperature reached by the system=12° C.

Conclusions Route 2:

- There were no liquefaction problems with the solid transport medium because the temperature never rose above 26° C. (maximum temperature=25.9° C.).
- Despite the fact that the interior of the first non-primary packaging (2) maintained a temperature below 15° C. for 4 hours, this is not considered critical for the system (although it would be for temperatures below 10° C.).

The comparative time-temperature graph comparing the two routes is shown in FIG. 5.

Claims

1. A transport box (1) for transporting biological products that comprises:

a hermetic first non-primary packaging (2) manufactured from a high-capacity heat-insulating plastic material;

a second non-primary packaging (3) that contains the first non-primary packaging (2), manufactured from high-density polystyrene;

a third non-primary packaging (4) that contains the second non-primary packaging (3), to sustain the structure, increase thermal resistance and bear the labelling;

one or several heat accumulators (5) disposed in the interior of the first non-primary packaging (2) and/or between the first non-primary packaging (2) and the second non-primary packaging (3);

characterized in that the relation (R_μ) between the volume of air between the first non-primary packaging (2) and the second non-primary packaging (3) and the total volume of the box is in a range between 0.1 and 0.6 and the thickness of the second non-primary packaging (3) is in a range between 4 and 6 cm.

2. The transport box (1) for transporting biological products according to claim 1, characterized in that the first non-primary packaging (2) has an inner metal lining.

3. The transport box (1) for transporting biological products according to claim 1, characterized in that the interior of the second non-primary packaging (3) is lined with a layer of heat-insulating material.

4. The transport box (1) for transporting biological products according to claim 1, further comprising filling material, disposed in the interior of the first non-primary packaging (2), between the first non-primary packaging (2) and the second non-primary packaging (3), or in both.

5. The transport box (1) for transporting biological products according to claim 1, characterized in that the second non-primary packaging (3) and the third non-primary packaging (4) are combined, forming a single packaging with a polystyrene interior and cardboard exterior.

6. The transport box (1) for transporting biological products according to claim 1, characterized in that R_μ is in a range between 0.2 and 0.5.

7. The transport box (1) for transporting biological products according to claim 6, characterized in that R_μ is in a range between 0.2 and 0.3.

8. The transport box (1) for transporting biological products according to claim 1, characterized in that the thickness of the second non-primary packaging (3) is in a range between 4.5 and 5.5 cm.

9. The transport box (1) for transporting biological products according to claim 8, characterized in that the thickness of the second non-primary packaging (3) is 5 cm.

10. The transport box (1) for transporting biological products according to claim 1, characterized in that the first non-primary packaging (2) has a cylindrical shape.

11. The transport box (1) for transporting biological products according to claim 1, characterized in that the second non-primary packaging (3) is a parallelepiped 30 cm in width×30 cm in length×20 cm in height.

12. The transport box (1) for transporting biological products according to claim 1, characterized in that the second non-primary packaging (3) is a parallelepiped 40 cm in width×40 cm in length×30 in height.