HOUSING FOR A FLEXIBLE CONTAINER

Description

[0001] The present invention relates to a housing for a flexible container for transporting liquids, in particular pharmaceuticals. In addition to pharmaceuticals, other liquids encountered in the (bio)pharmaceutical production process can also be transported by means of a flexible container in such a housing.

[0002] Packaging for liquids does, of course, exist in principle, as can be seen, for example, in DE 2258163 A1, EP 1396440 A1, or NL 8501555 A. The DE and EP patent applications disclose housings for flexible containers that are at least partially lined with an elastic foam for impact protection. However, none of these packages are adapted to the requirements of the aforementioned (bio)pharmaceutical production process.

[0003] Flexible containers used to transport medications in a single package are also called "single-use bags." This is usually done in a frozen state, with the flexible container placed inside the package before freezing. The liquid is then frozen by cooling the package.

[0004] The volume expansion during freezing (approximately 8%) creates considerable pressure on the housing and the flexible container. This introduces the risk of mechanical damage and, subsequently, leaks in the mechanical container.

[0005] The object of the present invention is to reduce the mechanical stress on the flexible container and the housing during freezing compared to the prior art.

[0006] This object is achieved by a housing having the features of claim 1.

[0007] This is achieved by an elastic foam - in other words: by at least one body made of elastic foam - with which the housing is lined.

[0008] In particular, this can at least partially compensate for the volume expansion of the container arranged in the housing that occurs during freezing.

[0009] According to the invention, the housing is essentially cuboid-shaped. This can facilitate easy stacking of the housings.

[0010] According to the invention, the housing's cover surfaces are made of steel. In particular, in contact cooling systems, the housing's cover surfaces rest on cooled surfaces, whereby steel cover surfaces result in improved heat transfer compared to the prior art.

[0011] Protection is also sought for an arrangement comprising a housing according to the invention and a flexible container arranged therein and filled with a liquid, in particular a medicament.

[0012] Furthermore, protection is sought for the use of a housing according to the invention, wherein a liquid, in particular a medicament, is filled into the flexible container, the filled container is arranged in the housing and the liquid is frozen by cooling the arrangement of the housing and container.

[0013] Examples of liquids that can be transported in flexible containers include protein solutions, end products of purification, antibody solutions and other high-value intermediates in the pharmaceutical production cycle, as well as, of course, the pharmaceuticals themselves.

[0014] Advantageous embodiments of the invention are defined in the dependent claims.

[0015] The housing can optionally be lined with the foam in such a way that any volume expansion of the container arranged in the housing that occurs during freezing is essentially completely compensated by the foam.

[0016] A preferred embodiment may be one in which the foam exhibits decreasing elasticity as the temperature drops below freezing. It may also be provided that the foam essentially hardens at a temperature between 0°C and -30°C, preferably between -5°C and -25°C, and particularly preferably between -10°C and -20°C. These measures can contribute to the flexible container resting in a precisely adapted "bed" within the housing. All forces acting on the flexible container and the housing are thus absorbed by larger surfaces. Damage caused by clamping or the like is thus at least reduced, if not completely eliminated.

[0017] In a particularly preferred embodiment, the foam is designed so that the curing process is reversible. When the temperature of the assembly is increased after transport, the elasticity of the foam is restored, thus providing a certain degree of protection against impacts on the flexible container when it is removed from the housing. Furthermore, the reversible process essentially allows the housing to be reused if desired.

[0018] The curing of the foam can also be referred to as solidification. This is not the hardening process that occurs during foam production, but rather the change in elastic properties under the influence of cold.

[0019] In a particularly preferred embodiment, the housing can be lined with foam in such a way that the container—preferably including any attachments—is completely surrounded by the foam when the container is arranged in the housing. This allows for even better protection not only for the flexible container but also for the attachments against damage.

[0020] Since attachments for such flexible containers often have different shapes, for example because they consist of deformable hoses and the like, a foam block in the housing can be advantageous, which can accommodate the attachments (by deformation).

[0021] It may also happen that containers need to be transported that are not completely filled. In this case, an additional layer of foam can be used, creating a "bed" for the flexible container that fills the volume of the housing.

[0022] Further advantages and details of the invention are apparent from the figures and the accompanying description. These show: Fig. 1 is a sectional side view of a housing according to the invention with a flexible container arranged therein, and Fig. 2 is a sectional plan view of the same.

[0023] As can be seen from the Figures 1 and 2As can be seen, the flexible container 2 is arranged within the housing 1. The housing 1 is lined with foam 3 and a foam block 5. If the liquid inside the container 2 freezes, the container 2 expands. This volume expansion is absorbed by the foam 3 and the foam block 5, so that no - or at least negligible - tension arises between the container 2 and the housing 1. Attachments 4, e.g. hoses and valves and the like, are arranged above or within the foam block 5, which can absorb these due to its elasticity or flexibility.

[0024] In the present embodiment, the housing 1 is designed to be completely enclosing. The housing 1 can be made of plastic and / or metal. In the present embodiment, the cover layers are each made of stainless steel, and the side walls are made of polyethylene (specifically, high-density polyethylene, HDPE).

[0025] The completely enclosed design of the housing 1 ensures protection against access to the container 2. Theoretically, a closure or seal could also be applied, which would prevent or at least make visible any manipulation during the transport process or in storage.

[0026] The foam 3 can preferably be designed such that it is relatively yielding and flexible at room temperature (and slightly negative temperatures) and hardens at lower temperatures (-15°C and below), enclosing the container 2 arranged in the housing 1 and protecting it from relative movement. The container 2 thus protected cannot be bent or compressed because relative movement to the housing 1 is prevented. This can prevent breakage and leakage in the container 2, which may be made of plastic, for example.

[0027] For example, so-called visco-elastic foam can be used as foam, which hardens at certain negative temperatures.

[0028] Freezing of the assembly consisting of housing 1 and filled container 2 can be achieved, for example, by contact cooling systems or recirculating air cooling systems, or by other means. In contact cooling systems, the cover surfaces of housing 1 (also referred to as the "shell") rest on cooled surfaces. In recirculating air cooling systems, the housings 1 are flushed with cooled air.

[0029] The individual sides of the housing 1, in particular the cover surfaces (i.e. top and bottom), can be made of relatively thin material, in particular steel, in order to achieve rapid heat conduction (or cold conduction).

[0030] As already mentioned, the housings 1 according to the invention can be reused, especially if the foam 3 is designed such that curing is reversible at low temperatures. Of course, a single-use use of the housing 1 is also conceivable. For this purpose, the housing 1 can be easily disassembled for simple recycling measures.

Claims

1. Housing for a flexible container (2) for transporting liquids, in particular medicines, which is at least partially lined with an elastic foam (3, 5), characterized in that the housing (1) is of a in essence cuboidal shape and is lined with the foam (3, 5) in such a way that an increase in volume of the container (2) arranged in the housing (1) that occurs upon freezing is at least partially compensated by the foam (3, 5), wherein cover surfaces of the housing (1) being made of steel.

2. Housing according to claim 1, characterized in that the housing (1) is lined with the foam (3, 5) in such a way that an increase in volume of the container (2) arranged in the housing (1) that occurs upon freezing is in essence completely compensated by the foam (3, 5).

3. Housing according to one of the preceding claims, characterized in that the foam (3, 5) has decreasing elasticity with decreasing temperature below freezing point.

4. Housing according to one of the preceding claims, characterized in that the foam (3, 5) in essence hardens at a temperature between 0°C and -30°C, preferably between -5°C and -25°C and particularly preferably between -10°C and - 20°C.

5. Housing according to claim 4, characterized in that the hardening process is reversible.

6. Housing according to one of the preceding claims, characterized in that the housing (1) is lined with the foam (3, 5) in such a way that the container (2) - preferably together with any attachments (4) - is completely surrounded by the foam (3, 5) when the container (2) is arranged in the housing (1).

7. Housing according to claim 6, characterized in that a foam block (5) is provided in the housing (1) for receiving the attachments (4).

8. Arrangement comprising a housing according to one of the preceding claims and a flexible container (2) arranged therein filled with a liquid, in particular a medicine.

9. Use of a housing according to one of the claims 1 to 8, wherein a liquid, in particular a medicine, is filled into the flexible container (2), the filled container (2) is arranged in the housing (1) and the liquid is frozen by cooling the arrangement comprising the housing (1) and the container (2).

10. Use according to claim 9, characterized in that at least one additional layer of foam (3, 5) is arranged in the container (2) when the flexible container (2) is filled only to a part of its capacity.