Thermal container for packaging

Abstract

The present invention describes a thermal container for packaging designed to be used to contain packages of pharmaceuticals and / or products which must be transported at a temperature which is maintained virtually constant (comprised at least between +2° and +8°) for at least 48 / 72 hours. The thermal container is composed of a primary container (2) provided to contain a secondary container (3) suitable for housing therewithin cold accumulators (4) and pharmaceuticals (6) and / or a possible auxiliary container (5) intended to receive the pharmaceuticals (6). The primary container is provided to delay the thermal balance between the interior (housing the pharmaceuticals) and the exterior (surrounding environment) for as long as possible. In particular, the secondary container (3) is composed of three reciprocally separate, independent boxes designed to be stacked in a clearly defined order, wherein the central box (30) is intended to house the pharmaceuticals (6) while the upper box (31) and the lower box (32) are provided to receive the refrigerating devices (4), which may be classic cold accumulators or dry ice, depending on the desired temperatures, and which are used to preserve the pharmaceuticals. The three boxes (30, 31 and 32) are configured to be arranged one on top of the other in the sequence stated earlier to form the secondary container (3) whose configuration is envisaged to allow the central box containing the pharmaceuticals to be "enveloped" on six sides by a temperature which is lower (due to the presence of the cooling devices) with respect to that of the central box and to dispense and distribute cold energy without the primary container having to intervene, which meanwhile, has the task of insulating the secondary container against the outer environment and against the temperature thereof since a plurality of passageways is created around the central box for the air, which is cooled by the cold accumulators and circulates around the central box, therefore the pharmaceutical temperature maintenance function exists and is active also when the secondary container is extracted from the primary container since the cold air continues to circulate inside the secondary container. The thermal container comprises a temperature device (9) for monitoring the temperature in the pharmaceuticals area and a security locking mechanism (10) for the primary container, which has the task of mutually fixing the box and lid in a secure way during transportation and enabling the end user to check and guarantee the fact that the container has not been tampered with or opened during the transportation operations, which could result in the risk of deterioration or theft of the products contained therein, and that the container has reached its destination in the same condition in which it left. To be able to open the primary container (2) and release the lid (25), it is necessary to break the locking mechanism (10), which essentially consists of a plate (11) located in the box and a plaque (12) with opening lock (120) designed to be engaged in the lid of the container, which are mutually secured by a locking element (13).

Description

Technical field

[0001] The present invention refers to a thermal container for packaging particularly designed to contain and to transport medicines, substances, products, or foods which need to be protected and isolated from the surrounding environment and maintained within a constant temperature range for a determined number of hours during transportation thereof.Background Art

[0002] As is known, pharmaceutical companies, as a rule, do not ship pharmaceuticals directly to the customers, but rather they assign them to pharmaceutical logistics facilities, which, in turn, are divided up over various levels down to the vans which supply, upon specific request, the individual pharmacies, hospitals, laboratories, etc.

[0003] At present, there are laws which stipulate that a pharmaceutical must be transported at a "controlled temperature". This means the vehicles designed for the transportation thereof, whether they are heavy goods vehicles or small vans, must be equipped with a refrigerated body.

[0004] Indeed, there are pharmaceuticals which must remain at temperatures contained within a very specific range, for example, a few degrees centigrade.

[0005] In particular, a pharmaceutical, which falls outside the required temperature limits en route, risks losing all the characteristics thereof and becoming ineffective and possibly even toxic and, consequently, becomes amenable to claim by the purchasers (pharmacies, hospitals, etc.); furthermore, the said pharmaceuticals must also to be protected against light, blows, and the environment so that the packages and the preparations cannot be damaged, altered, or contaminated. One need that is strongly felt at present is the need to be able to transport pharmaceuticals safely and with a strictly controlled temperature inside the container.

[0006] Nowadays, the most widespread packing system envisages that when the pharmaceutical is taken from the cold storage rooms, it is placed in a thermal or insulated container which is normally made of sintered expanded polystyrene, the latter being an excellent thermal insulator, featuring a determined blow-resistance, and offering a good barrier against light, but being unable to maintain pre-determined required temperatures over time.

[0007] At present, cold accumulators are inserted, together with the pharmaceutical, into the polystyrene containers so that the cold chain is not broken. These refrigerating devices are stored beforehand in freezers where they accumulate cold which in any case remains limited over time.

[0008] Both the pharmaceuticals and the cold accumulators before being placed in the polystyrene container are inserted into polyethylene bags, which are knotted by hand by an operative to contain humidity. Furthermore, appropriate air pillows are also inserted into the container to ensure that, during the transportation, there is no movement or overturning of the pharmaceuticals inside the box therefore both the pharmaceuticals and the cold accumulators are immobilised by the air pillows.

[0009] The container is then sealed by means of a lid which is secured to the container by means of various 'rounds' of adhesive tape applied around the entire perimeter of the joint between the container and lid.

[0010] The packing systems for the transportation of pharmaceuticals in use at present have encountered numerous problems in terms of both maintaining and distributing the necessary temperature for a determined number of hours and as regards the considerable amount of waste materials produced during each transportation and which are also highly polluting.

[0011] Indeed, as regards the temperature and the maintenance thereof over time, various problems have been encountered. In more detail, at the time of assembly of the container with the pharmaceuticals, the following situation is encountered by an operative: the pharmaceutical is at a temperature of 3 / 4°C, the cold accumulators are at -2, -3°C if they have been stabilised (the cold accumulator leaves the freezer at a much lower temperature than that required therefore the operative has to leave the cold accumulator at room temperature for several minutes so that the said accumulator loses coldness, warming up to a temperature in the vicinity of -2, -3°C so as not to damage the pharmaceuticals which are practically in contact with the cold accumulators, but the operative is unable to know the said temperature exactly as it is not measured) while the air in the work environment is 18 / 20°C and the air encountered inside the thermal container and the air pillows will be the same.

[0012] The different temperatures of the individual components, once inserted inside the container, as they come into reciprocal contact, tend to balance out.

[0013] This situation at the time the lid is placed on the thermal container triggers certain separate phenomena.

[0014] The first is due to the fact that the direct contact between the three different temperatures (pharmaceutical 3 / 4°C - accumulators -2 / -3°C - air 18 / 20°C) generates condensation which is not acceptable because it wears the packages containing the pharmaceuticals. The second is due to the fact that the components (pharmaceutical, cold accumulators, air pillows and air present) tend to reach a thermal balance inside the container with the transfer of energy which takes place from the hottest to the coldest area and therefore tends to increase the temperature of the pharmaceutical very quickly.

[0015] A further problem, also linked to temperatures, derives from the relationship between the temperatures inside the thermal container and those of the external environment.

[0016] As already mentioned early, the task of the insulated container is to delay the thermal balance between the interior thereof and the exterior (surrounding environment) for as long as possible.

[0017] Based on the concept that a hotter temperature transfers energy to colder bodies, the decreasing sequence of temperatures at play is as follows: air inside the thermal container and air pillows - pharmaceutical - accumulators.

[0018] Once a thermal balance has been reached inside the container, only the thickness of the walls thereof will slow down the transfer of the coldness to the exterior, therefore the diaphragm formed by the polystyrene wall of the container is the only element which divides the two temperatures still at play, i.e. the external temperature and the internal temperature.

[0019] In particular, in recent times, data loggers have often been inserted to monitor the temperature inside the container when it is open. Naturally, the data logger measures the temperature inside the container and not the specific temperature of the pharmaceuticals contained in the box.

[0020] Additionally, the data logger can only be read when the container is open, therefore it is not possible to monitor the temperature situation during transportation, and the storage condition of the pharmaceuticals can only be known once transportation is complete. At present, there are also data loggers which measure the temperature without opening the container, but have decidedly prohibitive costs and therefore are utilised in very rare cases.

[0021] Furthermore, there are further temperature measurement systems available (such as, for example, infrared devices), but also in this case they are exorbitant and measure the temperature inside the container and not the specific temperature of the pharmaceuticals, which is what needs to be known.

[0022] In addition to the above, the pharmaceutical is not protected against possible crushing by the cold accumulators as the cold accumulators and pharmaceuticals are inserted in the container loose and in a disorderly fashion and everything is covered with air pillows, which are provided to occupy the remaining space inside the container. In further cases, air pillows are not utilised because the pharmaceuticals are covered with further cold accumulators and it may happen that the packages are damaged by the weight exerted thereon or by deterioration due to humidity and the condensation which forms.

[0023] In particular, there is legislation in force which envisages that all the components which have been in contact with a pharmaceutical cannot be reused, resulting in enormous wastage of materials and ensuing handling and disposal costs.

[0024] From the description above, it is clear that the problems that must be tackled when preparing, packaging, and handling the containers are numerous and not insignificant. Indeed, the preparation of the containers is challenging due to the need for a person assigned to bagging both the pharmaceuticals and the cold accumulators, which take up space inside the container and are sometimes too close to one pharmaceutical and too far from another pharmaceutical, therefore the temperature is very often not uniform between the various zones inside the container and not always suitable for the pharmaceutical when there are, for example, different types of pharmaceuticals inside the same container. Additionally, with the configuration just described, a low insulation coefficient is encountered in addition to the fact that the cold accumulators are almost always neither salvaged nor reused, with considerable wastage of materials which are considered pollutants requiring disposal.

[0025] A further drawback emerges from the presence of the air pillows and the operations necessary to prepare them, which increases the time required to prepare the container and the costs of materials, in addition to the presence of further materials which must, then, be disposed of.

[0026] Containers such as those illustrated in patents US1843038A, JP2004 012754 A, US2006 / 191282Al and JP2014 000993A are known.

[0027] At present, there is a particularly strong need to be able to transport the pharmaceuticals without the drawbacks described above but, above all, by endeavouring to contain the time required to prepare the containers since both the containers and the cold accumulators can be salvaged and reused so as to reduce waste materials as much as possible, but above all to be able to monitor the actual temperature of the pharmaceutical.Disclosure of Invention

[0028] One object of the present invention is essentially to solve the problems of the prior art by overcoming the aforesaid difficulties by means of a thermal container for packaging which is able to maintain, for a predetermined time (at least 48 / 72 hours), a pre-set temperature inside the container with indirect cooling of the pharmaceutical exerted on six sides.

[0029] A second object of the present invention is to provide a thermal container for packaging which allows only the temperature of the pharmaceuticals to be measured at any time.

[0030] A third object of the present invention is to provide a thermal container for packaging which offers housing for the products / pharmaceuticals which is separate from the refrigerating components, prevents the presence of condensation around the packages containing the products, and maintains a constant, uniform temperature inside the product housing which is also checkable from outside.

[0031] A further object of the present invention is to provide a thermal container for packaging which makes the packaging stage fast, simple and automatable and is able to house any kind of product perfectly, without losing the characteristics thereof including practicality, fluid tightness, and safety.

[0032] A still further but not final object of the present invention is to provide a thermal container for packaging which is simple to make and works well.

[0033] These objects and others besides, which will better emerge over the course of the present description, are essentially achieved by means of a thermal container for packaging in accordance with the appended claims.Brief Description of Drawings

[0034] Further characteristics and advantages will become clearer in the detailed description that follows of a thermal container for packaging according to the according to the present invention, provided here below with reference to the appended drawings, provided in the form of illustrative and therefore non-limiting examples, in which: Figure 1 shows, schematically and in a perspective view, a thermal container for packaging according to the present invention; Figure 2 shows, schematically, an exploded view of the container in Figure 1; Figure 3 shows, schematically, an exploded view of components present in the container in Figure 1; Figure 4 shows, in a perspective exploded view, some of the components in Figure 3; Figure 5 shows, in a perspective, partially sectional, exploded view, the container in Figure 1; Figure 6 shows, schematically, a sectional view of the container in Figure 3; Figure 7 shows, in a perspective exploded view, a variant of the container in question; Figure 8 shows, in a perspective exploded view, a detail of the variant in Figure 7; Figure 9 shows, in a sectional, exploded view, the variant in Figure 7; Figure 10 shows, in a perspective exploded view, a second variant of the container according to the present invention; Figure 11 shows, in a sectional exploded view, the variant in Figure 10; Figure 12 shows, in a perspective frontal view, a component of the container in question; Figure 13 shows, in a perspective frontal view, the component in Figure 12 without a lid in an operating condition; Figure 14 shows, in a perspective rear view, the component in Figure 12 in an operating condition; Figure 15 shows, in a perspective frontal view, the component in Figure 13 in a resting condition; Figure 16 shows, in a perspective, partially exploded, rear view, the component in Figure 14 in a resting condition; Figure 17 shows an exploded view of the component in Figure 12; Figure 18 shows a sectional side view of the component in Figure 12; Figure 19 shows, schematically, further details of the component in Figure 12; Figure 20 shows, schematically and in a perspective view, a detail of the container according to the present invention; Figure 21 shows, schematically and in a perspective view, the lid of the container with a part of the detail in Figure 20; Figure 22 shows, schematically and in a perspective view, the container box with a part of the detail in Figure 20 in the installation step; Figure 23 shows, schematically and in a perspective view, the container box with a part of the detail in Figure 20 installed; Figure 24 shows, schematically and in a perspective view, a component of the detail in Figure 20; Figure 25 shows, schematically and in a perspective view, a different component of the detail in Figure 20; Figure 26 shows, schematically and in a perspective rear view, the element of the component in Figure 25; Figure 27 shows, schematically and in side view, the element of the component in Figure 26; Figure 28 shows, schematically, an exploded partial sectional view of the detail in Figure 20.

[0035] With reference to the aforesaid figures, and in particular to Figure 1, 1 denotes overall a thermal container for packaging according to the present invention designed to be utilised to contain packages of pharmaceuticals and / or products which must be transported maintaining a virtually constant temperature (comprised between at least +2° and +8°) for at least 48 / 72 hours.Best Mode for Carrying Out the Invention

[0036] The thermal container 1 is composed of a primary container 2 provided to contain a secondary container 3 suitable for housing therewithin cold accumulators 4 and pharmaceuticals 6 and / or a possible auxiliary container 5 intended to receive the pharmaceuticals 6. In turn, the primary container 2 may be inserted into an outer container 7 composed of a cardboard box sealed by a lid 70, as will be explained over the course of the description.

[0037] According to the present embodiment, the outer container 7 made of cardboard has - on the mutually opposing internal rear wall 71 and internal front wall 72 - a tab insert 710 and 720 provided to engage respectively in a first cavity 210 present on the external rear wall 21 of the primary container and in a second cavity 220 located in the external wall front 24 of the primary container as shown in Figure 5.

[0038] In particular, the two elements (box and lid) constituting the outer container 7 are self-locking with the primary container due to the presence of the two tab inserts.

[0039] Furthermore, on each side wall 73 of the outer container 7 there is a cleft 730 present designed for a belt 8 to be passed through, the said belt being fixed by a pin 80 outside at one end while the other end of the belt hooks onto the free end of the corresponding belt by means of a hooking element 82 on the opposite side to lock the lid 70 and permit convenient and easy conveying of the box. Furthermore, a first handle / grip 75 made of cardboard is provided which is secured to the belt to be able to move the box even more conveniently.

[0040] In particular, the outer container 7 allows a portion of the primary container to be visible, as will be explained later on.

[0041] The primary container 2 is composed of a structure constituted of a box made of sintered expanded polystyrene or further equivalent materials suitable to meet the same needs and formed of a base 20 - from which a rear wall 21, a couple of side walls 22 and 23, and a front wall 24 extend - and a lid 25.

[0042] According to the present invention, the secondary container 3 is composed of three reciprocally separate and independent boxes, as shown in Figure 4, designed to be stacked in a clearly defined order.

[0043] In more detail, the central box 30 is the box intended to house the pharmaceuticals 6 while the upper box 31 and the lower box 32 are provided to receive the refrigerating devices 4, which can be classic cold accumulators or dry ice (depending on the desired temperatures) and which are used for the preservation of the pharmaceuticals.

[0044] In particular, the central box 30 comprises a lateral inner wall 300 that enables a gap 301 to be created and the lid 302 thereof has a series of first clefts 303 near the perimeter which are at the space obtained between the outer wall and the inner wall.

[0045] Furthermore, the base of the box 30 has a second series of perimeter clefts 304 for the passaggio of air, as will emerge more clearly later on.

[0046] The lower box 32 has its own lid 320 endowed with a third series of perimeter clefts 321 provided for communicating and coupling with the second series of perimeter clefts 304 of the central box.

[0047] The upper box 31 has, on the base, a fourth series of perimeter clefts 311 provided for communicating and coupling with the first series of perimeter clefts of the central box on the side opposite the third series of perimeter clefts 321.

[0048] The three boxes 30, 31 and 32 are configured to be arranged one on top of the other with the sequence indicated earlier to obtain the secondary container 3, shown in Figure 4.

[0049] In addition to the above, at the time of the superimposition, the three boxes are kept together by means of a cardboard strip 35 whose movements are restricted by a pair of containing ribs that are respectively present on each outer side wall of the lower and upper boxes.

[0050] The strip is designed to be engaged at the free ends thereof by a second grip / handle 350 that has the task of fixing the strip and offering the user a practical and convenient grip when the secondary container has to be extracted from the primary one and transported. The configuration of the secondary container 3 is provided to enable the central box containing the pharmaceuticals to be "enveloped", on six sides, by a lower temperature (due to the presence of the cooling devices) than that of the central box and to dispense and distribute cold energy without the primary container having to intervene, the latter having, instead, the task of insulating the secondary container against the external environment and against the temperature thereof. Indeed, around the central box a plurality of passageways are created for the air, which is cooled by the cold accumulators and circulates around the central box.

[0051] A variant envisages that the central box 30 has a side wall which is open to receive and allow the extraction of the auxiliary container 5 containing the pharmaceuticals without having to disassemble and separate the three boxes 30, 31, and 32 and remove the cardboard strip 35, as shown in Figure 8.

[0052] With the configuration described, no component is in contact with the pharmaceuticals 6 except the central box 30, or the auxiliary container 5 in the variant, therefore all the further components are reusable and must not be disposed of as waste, unlike as occurs at present, resulting in considerable containment of polluting materials and better handling and more practical transportation.

[0053] Additionally, with the arrangement of the components according to the present invention, the pharmaceuticals are protected against crushing or possible contamination due to eutectic liquid leakage (breakage of cold accumulator). In particular, the pharmaceutical temperature maintenance function exists and is active also when the secondary container is extracted from the primary container since the cold air continues to circulate inside the secondary container.

[0054] In the present embodiment, the thermal container is equipped with a temperature device 9 which comprises a thermometer with a display 9a located on the wall front 24 of the container 2 and provided to allow the temperature present in the pharmaceuticals area to be measured, at any time, without having to open the container as the said thermometer is connected to a probe 90 located inside the secondary container 3 and, in particular, in the central box where the pharmaceuticals are housed, to measure the temperature in that specific area.

[0055] In more detail, the probe 90 remains deactivated and outside the space inside the central box while the primary container is open and being prepared while, when the said container is closed, the said probe is activated and autonomously enters the space where the pharmaceuticals are stored, so as to allow constant monitoring of the temperature in the pharmaceuticals area.

[0056] In this way, the temperature present in the central box which holds the pharmaceuticals is constantly visible from the outside of the container and it is not necessary to open the said box in order to check the temperature.

[0057] Indeed, the probe 90 only measures the temperature of the pharmaceuticals area and not, as occurs at present, the environment in which the pharmaceutical is located including the air pillows and cold accumulators.

[0058] According to the present embodiment, the temperature device 9 comprises a support 9b provided to be placed in a suitable niche in the primary container and designed to house a spring 95 which is tensioned by a notched pin 91 which interferes with a small toothed wheel 92 placed on a disc 93 equipped with a pin 930 located on the side opposite the toothed wheel 92, as shown in Figure 15. The support 9b has a slit 9c which has the task of acting as a guide and support for the toothed wheel 92.

[0059] Furthermore, the support 9b has a first upper wing 9d and a second lower wing 9e provided to engage a cursor 94, as shown in Figure 17.

[0060] In more detail, the probe 90 is activated from the outside when the primary container is locked through insertion of the notched pin 91, which couples to the small toothed wheel 92.

[0061] The downwards movement of the pin 91 makes the toothed wheel 92 turn, which moves the disc 93 which slides the pin 930 into a slot 940 in the cursor 94. This movement shifts the cursor to which the probe 90 is engaged, which is equipped with a small portion of cable 90a to take the probe into the space in the central box 30 where the pharmaceuticals are in order to be able to measure the temperature. At the other end of the cable is the digital thermometer with display 9a, as shown in Figure 19.

[0062] When the primary container needs to be opened, it is necessary to retract the probe and reposition it in the initial position inside the niche.

[0063] To carry out this operation, an operative - by removing the lid - releases the toothed pin 91, which rises again through the action of the spring 95 and the disc rotates in the opposite direction, making the cursor 94 retract, which drags the probe 90 out of the central box into a resting position. Every time the primary container is closed, the probe is reactivated.

[0064] In more detail, the cursor 94 has a base 941 on which the probe is fixed, as shown in Figure 17. The base, to be adaptable to any box dimension, is movable and can be placed in different positions on the cursor.

[0065] Furthermore, the temperature device 9 comprises an alarm system with a sound and / or light signal to signal temperature variations inside the pharmaceuticals box. The signal is not only displayable on the container but can be signalled on a mobile phone or computer, so as to be able to constantly monitor the pharmaceuticals temperature situation and be able to intervene promptly in the event of faults.

[0066] In addition to the above, the task of the primary container is to delay, for as long as possible, the thermal balance between the interior (housing of the pharmaceuticals) and the exterior (surrounding environment).

[0067] With the thermal container according to the present invention there are no fewer than three diaphragms opposing the passage of energy between the exterior and the interior and three temperatures at play: the external / environment temperature - the temperature of the lower and upper boxes and, finally, the temperature inside the central box that holds the pharmaceuticals, unlike as occurs at present, where the temperatures are only the internal / external temperatures.

[0068] In particular, the cooling system is indirect (therefore there is no formation of condensation), is on six sides (i.e. around the pharmaceuticals area), and there is no longer any need to stabilise the cold accumulators, as should be done at present (therefore it is also possible to insert the cold accumulators in the upper and lower boxes as soon as they have been removed from the freezer where they were placed to charge. With the present configuration it is possible to prepare the lower and upper boxes by ready-filling them with cold accumulators and placing them in the freezer. In this way, nobody touches frozen elements and assembly operations are sped up.

[0069] With the present thermal container for packaging it also becomes possible to transport pharmaceuticals which require temperatures of approximately -80°C. Indeed, secondary containers are used in which the upper and lower boxes are preloaded with dry ice in pellet form. In this configuration, the third and fourth series of slits are reduced to prevent the accidental passage of pellets. Furthermore, the central box does not have the double vertical wall since the division of temperatures is not necessary, but rather total, direct transfer of coldness to the area where is the pharmaceutical is held is required.

[0070] In addition to the above, the thermal container is equipped with a security lock mechanism which enables the final recipient to check and guarantee the fact that the container was not tampered with or opened during transportation with the risk of deterioration of the products contained therein or of theft and that it has arrived at destination in the same condition in which it left. Indeed, in order to be able to open the primary container and release the lid, it is necessary to break the mechanism.

[0071] According to the present invention, the primary container is provided with a locking mechanism 10 for mutually fixing the box and lid in a secure way during transportation and allow the end user to know whether or not the container was tampered with or there were attempts to open it before the said container reached its destination.

[0072] The locking mechanism 10 is essentially constituted of a plate 11 placed in the box and a plaque 12 with an opening lock 120 designed to be engaged in the container lid. Furthermore, a locking element 13 is provided which is designed to engage in the plate and in the plaque, locking the entire mechanism, as better described below.

[0073] In more detail, the plate 11 is provided to engage in a suitable seat 110 of a polystyrene peg 111 that is inserted into a niche 27 present in the inner wall of the primary container 2, as shown in Figure 22.

[0074] The plate 11 has a tab 11a which has the task of entering the polystyrene and being anchored, at a first portion 11b that is orthogonal to the tab and is provided to be inserted into the seat 110, at a second portion 11c that is orthogonal to the preceding portion and is designed to rest in the seat 110, and at a third portion 11d that is orthogonal to the preceding portion and parallel to the first portion, so as to straddle the thickness of the peg, as shown in Figure 24. Furthermore, in the first portion 11b there is a pair of orthogonal wings 11e that are reciprocally engaged by a joining bar 11f and the wings and bar make up a hooking seat for the locking element 13.

[0075] In the present embodiment, the locking element 13 has the lower end arranged to come to support the upper edge of the box while the other end, which is an arrow, is arranged to be inserted into a locking seat 125b present in the plaque 12.

[0076] In particular, the plaque 12 is composed of two elements: an open lock 12a and a connection 12b. The plaque has - near each corner - a plug 123 provided to penetrate the polystyrene of the container when the plaque is positioned in a suitable seat provided on the lid. A variant, shown in Figure 21, envisages that the plaque is positioned on a suitably shaped polystyrene peg 200 which is then inserted into a corresponding seat 201 present in the lid. The peg has a seat to receive the plate.

[0077] In more detail, the plugs 123 retain the plaque in the polystyrene, but have a main function of positioning inasmuch as the actual sealing is assigned to the connection 12b.

[0078] Additionally, the plaque 12 has - in the centre - a button 120 equipped with a central groove 120a placed along the diagonal which is used during the mechanism and the container opening step. The button has, on the edge thereof, diametrically with respect to the groove, a pair of small protrusions 120b which have the role of security seals to enable the end user to know whether or not there has been an attempt to open the container during transport.

[0079] Furthermore, on the inner part, the button has a ridge with an upper edge shaped so as to couple in an obligatory way with a corresponding profile on the connection. Finally, the button, also on the inner part, is equipped with an element 125 which extends perpendicularly and is provided with a tip 125a at the free end and a slot (locking seat) 125b just underneath the tip provided to receive and engage the arrow of the locking element 13.

[0080] In addition to the above, the plaque on the inner part has four protrusions 126 provided to be inserted into corresponding holes in the connection.

[0081] The connection consists of a cylinder with a shaped edge orthogonal endowed with a pair of loops positioned mutually diametrically opposed and located at the small protrusions on the button and the four holes which are engaged by the corresponding protrusions 126 present on the open lock of the plaque 12.

[0082] Finally, the locking element 13 consists of a pin which has, at one end thereof, an arrow 130 which is provided to be inserted into the slot / locking seat 125b immovably. Additionally, the locking element is designed to break when a user has to open the container.

[0083] Indeed, when the button is turned, the two small protrusions 120b which act as a security seal are broken, therefore it is possible to see the white of the underlying polystyrene and the end user will know that the container has been tampered with and there has been an attempt to restore or refit the mechanism. Furthermore when the protrusions are detached the button also detaches from the plate because the junction points break and the connection, by rotating, makes the button emerge, consequently also breaking the arrow. Once closed, the container can no longer be opened without breaking the mechanism.

[0084] Indeed, the locking mechanism in question, which is made of polystyrene glass, is for single use, while the container can be reused multiple times. The locking mechanism can be replaced by placing a new peg with a new mechanism in the container so that it is possible to reuse the container. Indeed, the mechanism is located on the polystyrene peg so as to be easily replaced in order to restore the box to a condition in which it can be closed and reused with a lock. In this way, the mechanism can be supplied in a kit together with the peg thereof since it is sufficient to insert a new peg into the container, which has a seat provided to receive it.

[0085] According to the present embodiment, the primary container has a perimeter recess on the lateral sides of the lid which receives a paper strip 15 which has the task of protecting the locking mechanism and of providing a surface for writing, such as instructions, information, symbols, messages, bar codes, etc. for correct use of the thermal container for packaging.

[0086] Furthermore, the strip is a further security seal since it is secured to the container and cannot be removed because it is inserted in an undercut fashion, which engages the strip between the box and the lid. In this way, the strip covers and protects the locking mechanism and to access the latter, the strip must be ripped or cut in a specific sector which covers the mechanism. If the strip is ruined, it means the box has been tampered with.

[0087] After the predominantly structural description, the operation of the invention in question will now be outlined.

[0088] When you have to transport products which need to be maintained at a pre-set temperature for a certain number of hours such as, for example, pharmaceuticals, a user simply has to insert the packages of pharmaceuticals into the central box, placing them in the space inside and, once this operation is complete, close the box lid and add the cold accumulators in the lower box and upper box, closing each one with the respective lids, or take a ready prepared upper and lower box and stack the three boxes, reciprocally securing them with the cardboard strip sealed by the handle. In this way, the secondary container is ready and may be inserted into the primary container which is then closed with the lid thereof after the cardboard strip has been inserted into the specific seat.

[0089] To close the container, it is sufficient to close the lid and, once the lid is in position, the lock is activated automatically because the locking element engages autonomously with the arrow in the locking seat present in the plaque.

[0090] If the central box has an opening, the auxiliary container in which the pharmaceuticals are arranged is used, and once closed, the said container is inserted into the suitable space in the central box. The further operations are the same as in the previous arrangement. Upon closure of the primary container lid, the probe for monitoring the temperature in the pharmaceuticals area is activated.

[0091] Once the thermal container has reached its destination, it is opened using the locking mechanism, therefore the secondary container can be extracted from the primary container and, by gripping the handle, can be handed over to the pharmacist, who will extract the pharmaceuticals from the central box. All the components of the thermal container - except the central box or the auxiliary container - can be reused for further transportation needs. The central box and the auxiliary container can be recycled.

[0092] The present invention thus achieves the objects proposed.

[0093] The thermal container for packaging in question is able to maintain a pre-set temperature inside the container for a predetermined time (at least 48 / 72 hours) with indirect cooling of the pharmaceutical on six sides. This system is managed on the basis of two temperatures (that of the pharmaceutical and that of the cold accumulator) which are not in mutual contact, unlike the temperatures in the systems according to the commonly known technique, which are in mutual contact, therefore a balance is reached very quickly and the heat from the air present in the box and in the air pillows is transferred quickly, with the consequence that there is not always a correct or ideal temperature for the pharmaceutical.

[0094] Furthermore, the subdivision and separation of the components make it possible to eliminate condensation, which has always created more than a few problems in terms of managing packages containing the pharmaceuticals and maintaining them in perfect conditions.

[0095] Advantageously, the thermal container according to the present invention makes it possible to prevent dissipation of the energy and coldness from the cold accumulators since it is no longer necessary to stabilise them as occurs with the containers according to the commonly known technique since they are inserted into their box immediately after being taken out of the freezer. This, in addition to a considerable energy saving, also speeds up the operations to prepare the containers, thereby preventing unreasonable wastages as occurs at present.

[0096] A further advantage of the thermal container for packaging emerges from the fact that it makes it possible to check, at any time, the temperature of the pharmaceuticals only without having to open the container and therefore be able to lodge a claim about the transportation and the contents, since is not possible to demonstrate what has happened once the container has been opened.

[0097] In addition to the above, the thermal container offers a housing for the products / pharmaceuticals which is separate from the refrigerating components, prevents the presence of condensation around the product packages, and maintains a uniform, constant temperature inside the area housing the products, which can also be verified from the outside.

[0098] Furthermore, the thermal container for packaging makes the operations for the preparation of the container and the packaging steps fast, simple, and automatable, in addition to being able to perfectly house any kind of product without losing the characteristics thereof such as practicality, fluid tightness, and safety.

[0099] A further advantage results from the fact that there is no longer absolutely any risk of contamination of the pharmaceuticals if there were any leakage of the eutectic liquid from the cold accumulators.

[0100] Furthermore but not finally, the thermal container in question makes it possible to eliminate the use of consumables since the components thereof can be entirely reused and / or recycled with considerable savings in materials and a dramatic reduction in polluting materials. Indeed, the only component which has to be disposed of because it contains the pharmaceuticals is the central box or the auxiliary container, but these are recyclable.

[0101] A further but not final advantage of the present invention is that it is considerably easy to use and to make, and works well.

Claims

1. Thermal container for packaging designed to be used to contain packages of pharmaceuticals and / or pharmaceutical products that have to be transported maintaining an almost constant temperature for at least 72 hours, consisting of: - a primary container (2) for containing a secondary container (3) suitable for housing inside cold accumulators (4) and pharmaceuticals (6) in which said primary container (2) consists of a structure consisting of a box made of sintered expanded polystyrene consisting of a base (20) from which a rear wall (21), a pair of side walls (22, 23) and a front wall (24) detach and of a closing / lid element (25), said primary container being provided to slow the thermal balance between the interior and the exterior, - a secondary container (3) consisting of three boxes that are separate from one another and independent of one another and set up to be joined and stacked according to a well-defined order, characterized in that - a central box (30) is assigned to house the pharmaceuticals (6) wherein said central box (30) comprises a lateral inner wall (300) that enables a gap (301) to be created and the lid (302) thereof has a series of first clefts (303) near the perimeter that are at the space obtained between the outer wall and the inner wall and the base of the box (30) has a second series of perimeter clefts (304) for the passage of air, - an upper box (31) that has, on the base, a fourth series of perimeter clefts (311) provided for communicating and coupling with the first series of perimeter clefts (303) of the central box on the side opposite the third series of perimeter clefts (321), and - a lower box (32) that has a lid (320) provided with a third series of perimeter clefts (321) provided for communicating and coupling with the second series of perimeter clefts (304) of the central box, - the upper box (31) and lower box (32) are provided for receiving the refrigerating devices (4), which are the classic cold or dry ice accumulators which are used to store the pharmaceuticals, said three boxes (30, 31 and 32) being configured to be arranged one on top of another with the sequence indicated previously to obtain the secondary container (3), the configuration of the secondary container (3) being provided to enable the central box to be "wrapped" on six sides that contains the pharmaceuticals at a temperature below, the temperature of the central box and cold energy to be dispensed and distributed without the primary container having to intervene, which on the other hand has the task of insulating the secondary container from the outer environment and from the temperature thereof because, around the central box, a plurality of passages is created for the air that takes cold from the cold accumulators and circulates around the central box so that maintenance of the temperature of the pharmaceutical is current and active even when the secondary container is extracted from the primary container because the cold air continues to circulate inside the secondary container, said thermal container operating with three temperatures at play: external / ambient temperature, lower and upper temperature of the boxes and, lastly, temperature inside the central pharmaceuticals box for the presence of several diaphragms that oppose the passage of energy between the exterior and the interior, - the three boxes (30, 31, 32) are configured to be arranged one on top of the other with the sequence indicated and at the moment of superimposition, the three boxes are kept together by a cardboard band (35) that is bounded in movements by a pair of containing ribs that are respectively present on each outer side wall of the lower and upper boxes, said band being set up to be engaged at the free ends by a second grip / handle (350) that has the task of fixing the band and offering the user a practical and convenient grip when the secondary container has to be extracted from the primary container and transported.

2. Thermal container for packaging according to claim 1, characterized in that the primary container (2) can be inserted into an outside container (7) consisting of a cardboard box closed by a lid (70) in which: - said outer cardboard container (7) has, on the rear wall (71) and inside front wall (72), which are opposite one another, a tab insert (710, 720) provided for engaging respectively in a first recess (20) present on the outer rear wall (21) of the primary container and in a second recess (22) placed in the outer front wall (23) of the primary container, so that the two elements that make up the outer container (7) are self-locking on the primary container because of the presence of the two tab inserts, - said outer container (7) has, on each side wall (73), a cleft (730) designed for a belt (8) to be passed that is fixed by a pin (80) to the outside at one end, whereas the other end of the belt hooks to the free end of the corresponding belt by a hooking element (82) on the opposite side to close the lid (70) and permit convenient and easy conveying of the box by a first cardboard handle / grip (75) that is closed on the belt to be able to move the box even more conveniently, - said outer container (7) enables a portion of the primary container to be seen.

3. Thermal container for packaging according to claim 1, characterized in that the central box (30) has an open side wall for receiving and extracting an auxiliary container (5) containing the pharmaceuticals without having to dismantle and separate the three boxes (30, 31, 32) and remove the strip of cardboard (35); in this manner, no component is in contact with the pharmaceuticals (6) except for the central box (30) or the auxiliary container (5) so that all the other components are reusable and do not have to be disposed of as waste, with significant limitation of polluting materials and better transport management and practicality.

4. Thermal container for packaging according to claim 1, characterized in that on the front wall (24) of the container (2) is placed a thermometer with display (9a) of a temperature device (9), said thermometer is provided to enable the temperature in the pharmaceuticals zone to be read at any moment without having to open the container because the container is connected to a probe (90) placed inside the secondary container (3) and, in particular, in the central box where the pharmaceuticals are housed to detect the temperature of that specific zone where the probe (90) remains inactive outside the inner space of the central box until the primary container (2) is opened and is equipped, whereas, when it is shut it is activated and enters autonomously the space in which the pharmaceuticals are kept so that it is thus possible to monitor constantly the temperature in the pharmaceuticals zone and the temperature present in the central pharmaceuticals box is visible constantly from outside the container.

5. Thermal container for packaging according to claim 4, characterized in that the temperature device (9) comprises a support (9b) provided for being placed in a suitable niche of the primary container (2) and suitable for housing a spring (95) that is tensioned by a notched pin (91) which interferes with a small toothed wheel (92) placed on a disc (93) provided with a pin (930) located on the side opposite the toothed wheel (92), said support (9b) has a slit (9c) that has the task of acting as a guide and support for the toothed wheel (92) and has a first upper wing (9d) and a second lower wing (9e) provided for engaging a cursor (94) which has a base (941) on which the probe is fixed, the said base, to be able to adapt to any box dimension, is movable and can be placed in different positions on the cursor.

6. Thermal container for packaging according to claim 1, characterized in that the primary container (2) is provided with a security lock mechanism (10) to fix together box and lid element (25) of in a constraining manner during transport and enable the final recipient to have a check and guarantee of the fact that the primary container (2) was not tampered with or opened during transport with the risk of deterioration of the products contained therein or of theft and that it has arrived at destination in the same condition in which it left and in order to be able to open the primary container (2) and release the lid (25) it is necessary to break the lock mechanism (10) which substantially consists of a plate (11) placed in the box and of a plaque (12) with opening lock (120) set up to be engaged in the lid (25) of the container and a locking element (13) is provided that is arranged to engage in the plate and in the plaque to lock the entire mechanism in which said plate (11) is provided to engage in a suitable seat (110) of a polystyrene peg (111) that is inserted into a niche (27) present in the inner wall of the primary container (2) and has a tab (11a) that has the task of entering the polystyrene and anchoring, from a first portion (11b) that is orthogonal to the tab and is provided for being inserted into the seat (110), from a second portion (11c) that is orthogonal to the preceding arranged for resting in the seat (110) and from a third portion (11d) that is orthogonal to the preceding and parallel to the first portion so as to straddle the thickness of the peg and, in the first portion (11b), a pair of orthogonal wings (11e) are present that are reciprocally engaged by a joining bar (11f) and wings and bar make up a hooking seat for the locking element (13) that has the lower end arranged to come to support the upper edge of the box whereas the other arrow end is set up to be inserted into a locking seat (125b) present in the plaque (12) which consists of two elements: an open lock (12a) and a connection (12b).

7. Thermal container for packaging according to claim 6, characterized in that said plaque has: - near each corner, a plug (123) for penetrating into the polystyrene of the container when the plaque is positioned in a suitable seat provided on the lid or the plaque is positioned on a shaped polystyrene peg (200) that is then inserted into a corresponding seat in the lid and said peg has a seat for receiving the plate, said plugs (123) being provided for retaining the plaque in the polystyrene, having the main function of positioning inasmuch as the actual sealing is assigned to the connection (12b), - in the centre, a button (120) is provided with a central groove (120a) placed along the diagonal used during the step of opening the mechanism and the container, said button having on the edge thereof, diametrically with respect to the groove, a pair of small protrusions (120b) that have the role of security seals to enable the end user to known whether, during transport, there has been an attempt or not to open the container and on the inner part the button has a ridge with an upper edge shaped to couple in an obligatory manner with a corresponding profile present in the connection also in the inner part said button is provided with an element (125) that detaches perpendicularly and is provided with a tip (125a) at the free end and with a slot (locking seat) (125b) just below the tip provided for receiving and engaging the arrow of the locking element (13), - has, on the inside, four protrusions (126) provided for being inserted at corresponding holes of the connection, which consists of a cylinder with a shaped orthogonal edge provided with a pair of loops placed diametrically opposite and located at small protrusions of the button and the four holes that are engaged by the corresponding protrusions (126) present in the opening block of the plaque (12).

8. Thermal container for packaging according to claim 6, characterized in that said locking element (13) consists of a pin that has, at one end, the arrow that is provided to be irremovably inserted into the locking slot / seat (125b), said locking element being set up to break when a user has to open the container given that when the button (120) is rotated, the two small protrusions (120b) that act as security seals break so that it is possible to detect that the container has been tampered with and, when the protrusions are detached also the button detaches from the plate because the junction plates break and the connection, by rotating, makes the button emerge, consequently breaking also the arrow because, once the container is closed, it can no longer open unless the mechanism is broken.

9. Thermal container for packaging according to claim 4, characterized in that said probe (90) is activated from the outside when the primary container is closed through the insertion of the notched pin (91) that is coupled with the small toothed wheel (92) and downward movement of the pin (91) rotates the toothed wheel (92) that moves the disc (93) which slides the pin (930) into a slot (940) of the cursor (94) and this movement translates the cursor with which the probe (90) is engaged, the said probe (90) being equipped with a small portion of cable (90a) to take the probe (90) inside the space of the central box (30) where there are the pharmaceuticals to be able to detect the temperature whereas, at the other end of the cable, there is the digital thermometer with the display (9a); when the primary container (2) has to be opened, the probe is deactivated and returned to the initial position inside the niche, removing the lid because the toothed pin (91) is freed, said pin (91) rising again through the action of the spring (95) while the disc rotates in the opposite direction, making the cursor (94) retract, said cursor (94) dragging the probe (90) outside the central box to a rest position.

10. Thermal container for packaging according to claim 4, characterized in that said temperature device (9) comprises an alarm system with a sound and / or light signal to signal temperature variations inside the box of the pharmaceuticals and this signal is not only displayable on the container but can be signalled on a mobile phone or computer so as to be able to monitor constantly the pharmaceuticals temperature situation and be able to intervene promptly in the event of faults.

11. Thermal container for packaging according to claim 1, characterized in that the cooling system is indirect, it is on six sides, around the pharmaceuticals zone, so there is no formation of condensation in the pharmaceuticals zone, the cold accumulators are configured to be inserted into the upper and lower boxes, also as soon as they are removed from the freezer, where they load up with cold and it is possible to prepare the lower and upper boxes already filled with cold accumulators and place the boxes in the freezer all complete, so that the frozen accumulators are not touched by an operator and assembly operations are speeded up.

12. Thermal container for package according to claim 1, characterized in that it enables pharmaceuticals to be transported that require temperatures of about - 80°C in which secondary containers are used where the upper and lower boxes are preloaded with dry ice in pellets and for this configuration the third and fourth series of clefts are reduced to prevent the accidental passage of pellet and the central box does not have the double vertical wall because no division of temperature is necessary but, on the contrary, total and direction transfer of cold is required to the zone where there is the pharmaceutical.

13. Thermal container for package according to claim 6, characterized in that said lock mechanism is made of crystal polystyrene, is disposable, and is replaceable by placing a new peg in the container with a new mechanism so that it is possible to reuse the container, said mechanism being placed on the polystyrene peg to be able to be easily replaced and the box to be returned to a condition in which it can be closed and reused, with a closure and mechanism with relative peg being provided in a kit as it is sufficient to insert a new peg into the container that has a seat designed to receive the new peg.

14. Thermal container for package according to claim 1, characterized in that said primary container (2) has a perimeter cutout on the lateral sides of the lid that receives a strip (15) made of paper that has the task of protecting the lock mechanism and supplying a surface for writing, instructions, information, symbols, messages, barcodes, etc, for correct use of the packaging thermal container and acting as a further security seal, inasmuch as it is constrained on the container, cannot be removed because it is inserted into an undercut that engages the strip between the box and lid so that said band covers and protects the lock mechanism and to access the latter, a suitable sector has to be torn or cut that goes to cover the mechanism and if the strip is damaged, this means that the box has been tampered with.

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