Cold storage for pharmaceuticals

Abstract

To develop a cool box for pharmaceuticals in which the accommodated pharmaceuticals are hardly affected by vibration, and an influence of the vibration applied to the pharmaceuticals is small.SOLUTION: A cool box 1 for pharmaceuticals has a box body 2 having thermal insulation properties, and a refrigeration unit 7. The refrigeration unit 7 has a compressor 33, a condenser 35, expansion means 37 and an evaporator 38. The inside of the box body 2 is maintained at a prescribed temperature environment by the refrigeration unit 7, and pharmaceuticals 100 are accommodated in the box body 7. The compressor 33 and the condenser 35 are arranged outside the box body 2, the evaporator 38 is arranged in the box body 2, a rack plate member 5 is arranged in the box body 2, a placing plate 32 for placing the pharmaceuticals 100 is arranged on the rack plate member 5, and a vibration isolation member 31 for suppressing the transmission of vibration to the pharmaceuticals 100 from the box body 2 is arranged between the rack plate member 5 and the placing plate 32.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to a cold storage for pharmaceuticals for storing pharmaceuticals such as biopharmaceuticals, vaccines, and diagnostic agents.

Background Art

[0002] Some pharmaceuticals must be stored within a certain temperature range. Therefore, pharmaceuticals may be stored in a cold storage. For example, pharmaceuticals may be stored by accommodating them in a cold storage as disclosed in Patent Document 1 and maintaining the temperature inside the storage at a low and constant temperature within the range of 2 degrees Celsius to 8 degrees Celsius.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] There are pharmaceuticals containing proteins called biopharmaceuticals or antibody pharmaceuticals. These pharmaceuticals may be altered by heat and may be stored in a temperature-controlled cold storage. When the present inventors studied the cause of the alteration of pharmaceuticals containing proteins, it was found that the pharmaceuticals may be altered by vibration. That is, it was found that when a biopharmaceutical is subjected to vibration during storage, the protein as the main component may aggregate, which raises concerns about adverse effects on efficacy. Here, all commercially available cold storages vibrate more or less. According to the research of the present inventors, it was found that depending on the formulation of biopharmaceuticals, proteins may aggregate due to the vibration of commercially available cold storages.

[0005] Based on the above-mentioned prior art findings, the objective of this invention is to develop a pharmaceutical refrigerator that minimizes vibrations affecting the contained pharmaceuticals and reduces the vibrations transmitted to the pharmaceuticals. [Means for solving the problem]

[0006] An embodiment for solving the above-mentioned problems is a pharmaceutical refrigerator comprising a heat-insulating enclosure and a refrigeration device, wherein the refrigeration device comprises a compressor, a condenser, an expansion means, and an evaporator, the inside of the enclosure is maintained at a predetermined temperature by the refrigeration device, and pharmaceuticals are stored inside the enclosure, wherein the compressor and the condenser are located outside the enclosure, the evaporator is located inside the enclosure, there are shelf members inside the enclosure, there is a mounting plate on the shelf members for placing the pharmaceuticals, and a vibration damping member is provided between the shelf members and the mounting plate to suppress the transmission of vibrations from the enclosure to the pharmaceuticals.

[0007] According to the inventors' research, most vibrations in refrigerators originate from the compressor. In this embodiment of the pharmaceutical refrigerator, the compressor is located outside the casing, so vibrations from the compressor are less likely to be transmitted to the casing. In this embodiment of the refrigerated storage unit for pharmaceuticals, there are shelf members inside the enclosure, and a mounting plate is placed on top of them, on which pharmaceuticals are placed directly or indirectly. Furthermore, in this embodiment of the pharmaceutical refrigerator, a vibration-damping member is provided between the shelf member and the mounting plate. In this embodiment of the pharmaceutical refrigerator, a vibration-damping member is provided between the shelf member and the mounting plate to suppress the transmission of vibrations from the housing to the pharmaceuticals. Therefore, even if the housing vibrates, the vibrations of the housing are less likely to be transmitted to the pharmaceuticals, resulting in less vibration of the pharmaceuticals. Thus, in this embodiment, the refrigerated storage unit for pharmaceuticals has minimal vibration of the casing, and furthermore, the vibration of the casing is not easily transmitted to the pharmaceuticals, resulting in minimal vibration of the stored pharmaceuticals.

[0008] In the above-described embodiment, a shelf support member is provided on the inner surface of the housing, and the shelf plate member is installed on the shelf support member. It is also desirable that a vibration damping member is interposed between the shelf support member and the shelf plate member to suppress the transmission of vibrations from the housing to the pharmaceutical product.

[0009] In this embodiment of the pharmaceutical refrigerator, there is a vibration damping member between the shelf support member and the shelf plate member. As a result, vibrations from the housing are less likely to be transmitted to the pharmaceuticals, and the vibrations of the pharmaceuticals are reduced.

[0010] Another embodiment for solving the above-mentioned problems is a pharmaceutical refrigerator comprising a heat-insulating enclosure and a refrigeration device, the refrigeration device comprising a compressor, a condenser, an expansion means, and an evaporator, wherein the inside of the enclosure is maintained at a predetermined temperature by the refrigeration device, and pharmaceuticals are stored inside the enclosure, wherein the compressor and the condenser are located outside the enclosure, the evaporator is located inside the enclosure, there are shelf members for placing the pharmaceuticals inside the enclosure, there are shelf support members on the inner surface of the enclosure, the shelf members are installed on the shelf support members, and a vibration damping member is interposed between the shelf support members and the shelf members to suppress the transmission of vibrations from the enclosure to the pharmaceuticals. It is also conceivable to interpose a vibration-damping member between the side surface of the shelf member and the inner wall of the housing.

[0011] In this embodiment of the refrigerated storage unit for pharmaceuticals, the compressor is located outside the casing, so vibrations from the compressor are less likely to be transmitted to the casing. In this embodiment of the pharmaceutical refrigerator, there is a vibration damping member between the shelf support member and the shelf plate member. As a result, vibrations from the housing are less likely to be transmitted to the pharmaceuticals, and the vibrations of the pharmaceuticals are reduced. [Effects of the Invention]

[0012] The pharmaceutical refrigerator of this invention minimizes vibrations affecting the stored pharmaceuticals, resulting in less vibration of the pharmaceuticals themselves. Therefore, it can suppress deterioration of the stored pharmaceuticals caused by vibrations. [Brief explanation of the drawing]

[0013] [Figure 1] Perspective view of the refrigerator for pharmaceuticals according to an embodiment of the present invention. [Figure 2] Cross-sectional view taken along line A-A in FIG. 1. [Figure 3] Perspective view of the refrigerator for pharmaceuticals in FIG. 1 with the door open. [Figure 4] Enlarged cross-sectional view of the periphery of the shelf member of the refrigerator for pharmaceuticals in FIG. 1. [Figure 5] Refrigerator for pharmaceuticals according to another embodiment of the present invention, which is a perspective view with the door open. [Figure 6] Enlarged cross-sectional view of the periphery of the shelf member of the refrigerator for pharmaceuticals in FIG. 5.

Mode for Carrying Out the Invention

[0014] Hereinafter, embodiments of the present invention will be described. As shown in FIGS. 1 and 2, the refrigerator 1 for pharmaceuticals in the present embodiment is divided into a main body part (housing) 2 and a machine room 3. The main body part 2 is a heat-insulating housing installed above the machine room 3, and a shelf member 5 is provided inside. And a mounting plate 32 supported by a vibration damping member 31 is provided on the shelf member 5. The refrigerator 1 for pharmaceuticals has a refrigeration device 7 by which the inside of the main body part 2 is adjusted to a predetermined temperature environment. Hereinafter, each member will be described.

[0015] The main body part 2 is a heat-insulating housing and is a box having a door 10. That is, the main body part 2 is composed of a main body box 11 and a door 10. Both the main body box 11 and the door 10 constituting the main body part 2 incorporate heat-insulating materials. The main body part 2 has a framework and reinforcing members (not shown). Also, the surface is covered with a metal plate or a resin plate.

[0016] The main body box 11 of the main body part 2 has a top wall 12, a bottom wall 15, a rear wall 17, and left and right side walls 18, and is a box body with an opening at the front. That is, the main body box 11 is surrounded by the top wall 12, the bottom wall 15, the rear wall 17, and the left and right side walls 18.

[0017] In this embodiment, there is a shelf receiving member 20 inside the main body box 11, and the shelf board member 5 is installed inside the main body box 11 via the shelf receiving member 20. That is, in this embodiment, as shown in FIGS. 3 and 4, a plurality of shelf receiving members 20 are provided on the left and right side walls 18. The shelf receiving member 20 is a long member extending from the opening side to the back side of the main body box 11. The shelf receiving member 20 has, for example, an "L" - shaped cross - sectional shape, and the shelf receiving member 20 has a connecting portion 22 and a shelf receiving portion 23. The connecting portion 22 of the shelf receiving member 20 is in contact with the left and right side walls 18 inside the main body box 11, and the shelf receiving portion 23 is in a horizontal posture. And the shelf board member 5 is placed on the shelf receiving portion 23. The shelf board member 5 is plate - shaped or net - shaped, and objects can be placed on it.

[0018] In the cold storage 1 for pharmaceuticals of this embodiment, a vibration damping member 31 and a placement plate 32 are provided on the shelf board member 5. The placement plate 32 is a member for placing pharmaceuticals. The vibration damping member 31 is a member for preventing the vibration of the shelf board member 5 from being transmitted to the placement plate 32. The vibration damping member 31 only needs to have a function of suppressing the transmission of vibration, and its material and mechanism are not limited. For example, the vibration damping member 31 may be rubber, resin, an air spring, etc. As one form of the air spring, there is one in which a gas is filled in a diaphragm. Also, the vibration damping member 31 may be a mechanical spring such as a coil spring. The vibration damping member 31 may have a structure in which a spring or resin and a damper are combined. The same applies to other vibration damping members described later, and the material and mechanism are not limited.

[0019] The vibration damping member 31 also functions as a support portion for supporting the placement plate 32. In this embodiment, the vibration damping member 31 constitutes the entire support portion for supporting the placement plate 32, but not limited to this configuration. The vibration damping member 31 may constitute a part of the support portion for supporting the placement plate 32. For example, the vibration damping member 31 may be provided at the middle portion of the support portion for supporting the placement plate 32. In this embodiment, the mounting plate 32 is supported by four vibration-damping members 31, but the number of vibration-damping members 31 is arbitrary.

[0020] The refrigeration system 7 includes a compressor 33, a condenser 35, an expansion means 37, and an evaporator 38, which are connected in a ring shape by piping (not shown), and contains a refrigerant that undergoes a phase change. By driving the compressor 33, the gaseous refrigerant is compressed, and the refrigerant is cooled and liquefied in the condenser 35. The liquid refrigerant then enters the evaporator 38 via the expansion means 37 and vaporizes. In the process, heat of vaporization is absorbed, and the surface temperature of the evaporator 38 decreases. The vaporized refrigerant returns to the compressor 33 and is compressed again.

[0021] In this embodiment, the refrigeration unit 7 is installed across the machine room 3 and the main body (casing) 2, as shown in Figure 2. In other words, the three components of the refrigeration unit 7—the compressor 33, the condenser 35, and the expansion means 37—are located inside the machine room 3. On the other hand, the evaporator 38 is installed inside the main body (casing) 2. That is, in the pharmaceutical refrigerator 1 of this embodiment, the compressor 33 and the condenser 35 are located outside the main body (casing) 2, while the evaporator 38 is located inside the main body (casing) 2.

[0022] In the pharmaceutical refrigerator 1 of this embodiment, the main body (casing) 2 is placed on top of the machine room 3, as shown in Figures 1 and 2. In this embodiment, a vibration damping member 40 is interposed between the machine room 3 and the main body (casing) 2.

[0023] In this embodiment, the temperature of the main body (casing) 2 of the pharmaceutical refrigerator 1 is maintained within a certain range by the refrigeration device 7. Specifically, there is a temperature sensor (not shown) inside the main body (casing) 2, and the temperature detected by the temperature sensor is fed back to the refrigeration device 7 to maintain a constant temperature environment inside the main body (casing) 2. In the pharmaceutical refrigerator 1 of this embodiment, the evaporator 38 is located inside the main body (casing) 2, so the temperature inside the main body (casing) 2 is regulated by the evaporator 38.

[0024] On the other hand, in the pharmaceutical refrigerator 1 of this embodiment, the compressor 33 and condenser 35 are located outside the main body (casing) 2, so the main body (casing) 2 is less susceptible to vibrations from them. Furthermore, in this embodiment, a vibration damping member 40 is interposed between the machine room 3 and the main body (casing) 2, so vibrations from the machine room 3 are less likely to be transmitted to the main body (casing) 2.

[0025] In the pharmaceutical refrigerator 1 of this embodiment, pharmaceuticals 100 are housed inside the main body (casing) 2 as shown in Figures 2, 3, and 4. In this embodiment, the pharmaceuticals 100 are housed inside the main body (casing) 2 while placed on a mounting plate 32 which is installed via a vibration-damping member on a shelf member 5. Since the mounting plate 32 is supported by the vibration-damping member 31, the mounting plate 32 experiences extremely little vibration.

[0026] In other words, the source of vibration is the compressor 33 of the refrigeration unit 7, but since the compressor 33 is located outside the main body (casing) 2, the vibration of the main body (casing) 2 is smaller compared to conventional refrigerated storage units. Furthermore, the pharmaceuticals 100 are placed on the mounting plate 32 via a vibration-damping member 31, and since the vibration-damping member 31 is located between the shelf member 5 and the pharmaceuticals 100, vibrations from the main body (casing) 2 are less likely to be transmitted to the pharmaceuticals 100, and the vibration of the pharmaceuticals 100 is extremely small. Therefore, drug 100 is stored in an environment that is less susceptible to vibration.

[0027] Of the components of the pharmaceutical refrigerator 1 described above, the mounting plate 32 and the vibration isolation member 31 may be integrally constructed. That is, the vibration isolation member 31 may be integrally attached to the lower part of the mounting plate 32, and the two together may constitute an independent vibration isolation platform.

[0028] The pharmaceutical refrigerator 1 described above prevents the pharmaceuticals 100 from vibrating by interposing a vibration-damping member 31 between the shelf member 5 of the main body (casing) 2 and the pharmaceuticals 100 to suppress the transmission of vibrations from the main body (casing) 2 to the pharmaceuticals 100. However, the present invention is not limited to this configuration. The pharmaceutical refrigerator 50 shown in Figures 5 and 6 has a vibration-damping member 51 on the shelf support portion 23 of the shelf support member 20 to suppress the transmission of vibrations from the main body (housing) 2 to the pharmaceuticals 100, and a shelf plate member 5 is installed on top of the vibration-damping member 51. The vibration-damping member 51 may be present across the entire surface of the shelf support portion 23, or it may be arranged in a point-like manner. Furthermore, the vibration-damping member 51 may constitute the entire support portion that supports the shelf plate member 5, or it may constitute a part of the support portion that supports the shelf plate member 5. For example, the vibration-damping member 51 may be located in the middle of the support portion that supports the shelf plate member 5. In this embodiment, the pharmaceutical refrigerator 50 has a vibration damping member 51 interposed between the main body (casing) 2 and the shelf member 5 to prevent the pharmaceuticals 100 from vibrating.

[0029] In this embodiment, the pharmaceutical refrigerator 50 has a vibration damping member 51 between the main body (casing) 2 and the shelf member 5, so that vibration of the shelf member 5 is reduced, and the pharmaceuticals 100 are stored in an environment that is less susceptible to vibration. The other components of the pharmaceutical refrigerator 50 are the same as those of the pharmaceutical refrigerator 1 described above, so their explanation will be omitted.

[0030] In the pharmaceutical refrigerators 1 and 50 described above, the main body (casing) 2 is placed on top of the machine room 3, and a vibration-damping member 40 is interposed between the machine room 3 and the main body (casing) 2. However, the present invention is not limited to this configuration, and a machine room 3 independent of the main body 2 may be arranged on the side or back of the main body (casing) 2. Furthermore, the vibration-damping member 40 between the machine room 3 and the main body (casing) 2 may be omitted.

[0031] Next, we will describe the experiments conducted by the inventors. The inventors placed a simulated pharmaceutical product 100 in pharmaceutical refrigerators 1 and 50 and measured the vibrations the pharmaceutical product 100 experienced. As a result, there was no significant difference between the two types of pharmaceutical refrigerators 1 and 50, and the vibration of pharmaceuticals 100 was 0.0027G in both cases. In contrast, among the commercially available refrigerators surveyed, the one with the lowest vibration was 0.0060G.

[0032] Next, a pseudo-biopharmaceutical was prepared, and the biopharmaceutical was placed in a commercially available refrigerator and in the pharmaceutical refrigerators 1 and 50 of this embodiment, and the state of protein aggregation was observed. An example of the results is shown in the following table.

[0033] [Table 1]

[0034] As shown in the table, the amount of protein aggregation of the imitation drug stored in pharmaceutical refrigerators 1 and 50 after two months was 3.9 percent, while the amount of protein aggregation of the imitation drug stored in a conventional refrigerator was 7.0 percent. These experimental results showed that when pharmaceuticals are stored in the pharmaceutical refrigerators 1 and 50 of this embodiment, the amount of protein aggregation is significantly reduced, and the quality can be maintained over a long period of time. Furthermore, the experimental results suggest that if the vibration applied to the drug is 0.004G or less, the amount of protein aggregation is small, and if the vibration is 0.003G or less, protein aggregation can be suppressed even more significantly. This finding indicates that, for pharmaceutical refrigerators, it is desirable that the vibrations acting on pharmaceuticals be 0.004G or less, and a more recommended vibration level is 0.003G or less.

[0035] When biopharmaceuticals are stored using the pharmaceutical refrigerators 1 and 50 of this embodiment, protein aggregation is suppressed, allowing them to be stored without deterioration for extended periods. Since aggregation due to vibration is suppressed when using the pharmaceutical refrigerators 1 and 50 of this embodiment, vibration-sensitive pharmaceuticals such as biopharmaceuticals can be safely stored for long periods. The pharmaceutical refrigerators 1 and 50 of this embodiment are not limited to protein-based pharmaceuticals, but can be applied to pharmaceuticals that are susceptible to vibration, such as vaccines, and can suppress deterioration caused by vibration. Furthermore, the pharmaceutical refrigerators 1 and 50 of this embodiment can also be applied to regenerative medicine products.

[0036] The pharmaceutical refrigerator 1 described above has a vibration-damping member 31 provided between the shelf member 5 and the mounting plate 32, and the pharmaceutical refrigerator 50 has a vibration-damping member 51 between the main body (housing) 2 and the shelf member 5, but of course, both can be combined. That is, a configuration in which a vibration-damping member 31 is provided between the shelf member 5 and the mounting plate 32, and a vibration-damping member 51 is also provided between the main body (housing) 2 and the shelf member 5. In this case, protein aggregation can be further suppressed.

[0037] From the perspective of suppressing the transmission of vibrations from the main body (casing) 2 to the shelf board member 5, it is conceivable to have a structure in which a gap is left between the side surface of the shelf board member 5 and the inner wall of the main body 2. That is, the shelf board member 5 is placed on the shelf support 23, but the side surface of the shelf board member 5 does not come into contact with the inner wall of the main body 2. With this structure, since there is a gap between the side surface of the shelf board member 5 and the inner wall of the main body 2, there is no vibration transmission via the side surface of the shelf board member 5.

[0038] For a similar purpose, it is also conceivable to interpose a vibration-damping member between the side surface of the shelf board member 5 and the inner wall of the main body 2. For example, the shape of the vibration-damping member 51 shown in Figure 6 is changed to an "L" shape in cross-section. Then, one side of the "L" shape is placed between the shelf support 23 and the shelf board member 5, and the other side is placed between the side surface of the shelf board member 5 and the inner wall of the main body 2. With this structure, since the vibration-damping member is placed between the side surface of the shelf board member 5 and the inner wall of the main body 2, vibration transmission via the side surface of the shelf board member 5 is suppressed. [Explanation of symbols]

[0039] 1, 50 Pharmaceutical cold storage 2. Main unit (casing) 5 Shelf board components 7 Refrigeration equipment 20 Shelf support members 31 Vibration isolation member 32 Mounting plate 33 Compressor 35 Condenser 38 Evaporator 37. Expansion means 38 Evaporator 40 Vibration isolation member 51 Vibration isolation member 100 Pharmaceuticals

Claims

1. It has an insulated casing and a refrigeration device, The refrigeration apparatus comprises a compressor, a condenser, an expansion means, and an evaporator. A refrigerated storage unit for pharmaceuticals, wherein the inside of the enclosure is maintained at a predetermined temperature by the refrigeration device, and pharmaceuticals are stored inside the enclosure. The compressor and the condenser are located outside the housing, and the evaporator is located inside the housing. The enclosure contains a shelf member, and on the shelf member there is a mounting plate for placing the pharmaceutical product. A refrigerated storage unit for pharmaceuticals, characterized in that a vibration-damping member is provided between the shelf member and the aforementioned mounting plate to suppress the transmission of vibrations from the housing to the pharmaceuticals.

2. The enclosure has a shelf support member on its inner surface, and the shelf board member is installed on the shelf support member. The pharmaceutical refrigerator according to claim 1, further characterized in that a vibration damping member is interposed between the shelf support member and the shelf board member to suppress the transmission of vibrations from the housing to the pharmaceuticals.

3. It has an insulated casing and a refrigeration device, The refrigeration apparatus comprises a compressor, a condenser, an expansion means, and an evaporator. A refrigerated storage unit for pharmaceuticals, wherein the inside of the enclosure is maintained at a predetermined temperature by the refrigeration device, and pharmaceuticals are stored inside the enclosure. The compressor and the condenser are located outside the housing, and the evaporator is located inside the housing. The enclosure contains shelf members for placing the pharmaceuticals, The enclosure has a shelf support member on its inner surface, and the shelf board member is installed on the shelf support member. A refrigerated storage unit for pharmaceuticals, characterized in that vibration-damping members are interposed between the shelf support member and the shelf board member, and between the side surface of the shelf board member and the inner surface of the housing to suppress the transmission of vibrations from the housing to the pharmaceuticals.

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