DEVICE FOR FILLING INFUSION BAGS

DE502020010927D1Active Publication Date: 2025-05-22HARRO HOFLIGER VERPACKUNGSMASCHEN
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Patent Information

Application Number
DE502020010927
Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
Filing Date
2020-05-06
Publication Date
2025-05-22
Estimated Expiration
2040-05-06

AI Technical Summary

Technical Problem

Existing devices for filling infusion bags under inert gas conditions are inefficient due to high nitrogen consumption, safety concerns from uncontrolled nitrogen drainage, and difficulties in achieving optimal laminar air flow, as well as complex cleaning processes and media handling.

Method used

A device with a filler needle and a base holder that includes a radially cantilevered connection flange, allowing for separate channels for inert gas and liquid, preventing media mixing and enabling simpler construction and effective cleaning. The device also features a movable nozzle that can be adjusted to ensure inert gas displaces ambient air, reducing oxygen exposure during filling.

Benefits of technology

The device allows for efficient filling of infusion bags with reduced residual oxygen content, decreased cycle times, and simplified cleaning processes, ensuring safe and economic operation while minimizing nitrogen consumption.

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Description

TECHNICAL FIELD

[0001] The invention relates to a device for filling infusion bags, in particular for filling infusion bags with a liquid. The infusion bags can be single-chamber bags or multi-chamber bags. Multi-chamber bags can, for example, also contain a powder and a liquid chamber. STATE OF THE ART

[0002] Filling infusion bags must generally be carried out under special conditions (called "low bioburden"), as the contents of the infusion bags are administered to a patient and therefore must not be contaminated. For critical ingredients, particularly cancer drugs or infusions for parenteral nutrition, filling the infusion bags under an inert gas atmosphere may be necessary, as the fluid being filled must not come into contact with atmospheric oxygen. Nitrogen is typically used as the inert gas.

[0003] Filling liquids under inert gas conditions can be achieved, for example, through roof-mounted gas flushing. In this case, the device for filling the infusion bags is placed in a constant flow of inert gas. However, this method consumes large quantities of nitrogen, resulting in considerable costs. Furthermore, it poses a safety issue, as the large quantities of nitrogen often escape uncontrollably due to the design. Furthermore, the critical bag area is shaded, which may prevent optimal laminar airflow in the critical area of ​​the filling hoses.

[0004] As an alternative to roof gassing, a special filling head can be used to fill infusion bags under inert gas conditions. This allows for post-gassing with nitrogen. Evacuation of the filling hoses before the actual filling would also be possible in this way. However, cleaning such a filling head for multiple media is very difficult. However, intensive cleaning of the filling head is essential, particularly due to the possibility of residual liquid being drawn into the vacuum circuit. Using the filling needle for vacuum and / or nitrogen gassing in addition to its actual use for filling the infusion bags with a liquid requires the filling needle to be completely emptied before changing applications. Taking into account the intended filling media, this is undesirable and technically very complex.The remaining quantities of the filling media must be collected and disposed of separately, as disposal via wastewater is not possible.

[0005] US Pat. No. 3,299,603 discloses a device for filling infusion bags with a liquid. The device comprises a filling needle and a base holder. The base holder extends around the filling needle, with a circumferential gap between the base holder and the filling needle. Furthermore, a gas connection is provided through which inert gas can be passed through the filling needle. A similar device is also known from WO 2012 / 061359 A1.

[0006] From EP 1 411 023 A1 and DE 10 2015 106 125 B3, devices for filling beverages are known which also have a filling needle and a base holder. PRESENTATION OF THE INVENTION

[0007] Based on this prior art, the invention is based on the object of providing an improved device for filling infusion bags, in which filling under inert gas conditions is possible in a process-reliable manner.

[0008] The device according to the invention for filling infusion bags is defined by the features of main claim 1. Useful developments of the invention are the subject of further claims following this claim.

[0009] The device according to the invention for filling an infusion bag comprises a filling needle and a base holder that extends around the filling needle in such a way that a circumferential gap exists between the filling needle and the base holder. Furthermore, at least one gas connection for inert gas is provided, through which inert gas can be fed into the circumferential gap between the filling needle and the base holder. At the lower end of the base holder is a movable nozzle that is mounted for longitudinal displacement and, in its rest position, protrudes beyond the lower end of the filling needle.

[0010] According to the invention, the filling needle has a radially projecting connecting flange. This connecting flange allows the filling needle to be connected to a filling device. The base holder also has a radially projecting connecting flange, allowing the base holder to be attached to the filling needle via the respective connecting flanges.

[0011] According to the invention, the filling needle itself is thus used solely for filling the infusion bags with the fluid to be filled. The media used (inert gas or fluid to be filled) are therefore routed through different channels, preventing mixing of the media. This results in a comparatively simple machine design. The inventive design of the device for filling infusion bags therefore enables effective and reliable cleaning of the device, in particular the filling needle.

[0012] By using the device according to the invention, single-chamber and multi-chamber bags with a significantly reduced residual oxygen content in the headspace can be produced. Significantly reduced cycle times can be achieved, thus enabling safe and economical operation of the device according to the invention.

[0013] The leading, movable nozzle can, in particular, be spring-loaded and mounted for longitudinal displacement by means of a compression spring. Such a design is simple and economical to implement and can be easily replaced if necessary.

[0014] The shape of the filling needle itself, especially the lower end of the filling needle that is inserted into the infusion bag, is not restricted by the device according to the invention. Thus, different external geometries of the filling needle are still possible, allowing, for example, the filling needle to be adapted to the shape of the infusion bag connection.

[0015] Typically, the infusion bag to be filled is flushed with inert gas, particularly nitrogen, at an upstream station. The flushed infusion bag is then emptied, and the infusion bag's filling tube is clamped off. A section of filling tube remains above the clamp. This section of filling tube can come into contact with the ambient air and thus cause unacceptably high oxygen levels during filling of the infusion bag.

[0016] When filling an infusion bag, initially only the inert gas can be passed through the surrounding space and the movable nozzle. In this way, inert gas can be fed into the filling tube of the infusion bag that remains above the clamp in order to displace the ambient air from the filling tube. The movable nozzle can then be pushed back upwards a little. Preferably, the movable nozzle can be pushed back far enough so that it is above the lower end of the filling needle. This allows the filling needle to be brought into direct contact with the filling tube of the infusion bag for filling the infusion bag with the liquid to be filled, so that no contact between the liquid to be filled and the ambient air should be possible.

[0017] In a first embodiment, a stop element can be provided to move the movable nozzle upwards from its rest position. If the device is height-adjustable, contact with the stop element can initially occur when the device is lowered, allowing the movable nozzle to be moved upwards accordingly as the device is lowered further. In a second embodiment, the movable nozzle can be moved upwards from its rest position by a motor or pneumatic drive. Such a design would be independent of any possible height adjustability of the device.

[0018] In principle, a single inert gas connection may be sufficient to fill the surrounding space with inert gas and discharge sufficient inert gas through the movable nozzle. However, several, particularly three, gas connections can preferably be provided, arranged circumferentially. This allows for an even distribution of the inert gas within the surrounding space and also ensures that the filling hose above the clamp is quickly flooded with inert gas.

[0019] Further advantages and features of the invention can be found in the features further specified in the claims and in the following exemplary embodiment. SHORT DESCRIPTION OF THE DRAWING

[0020] The invention is described and explained in more detail below with reference to the exemplary embodiment shown in the drawing. In the drawings: Fig. 1 a cross section through the device according to the invention for filling infusion bags in the rest position of the movable nozzle, and Fig. 2 a cross section according to Fig. 1 , in which the movable nozzle was moved upwards by centering jaws. WAYS TO CARRY OUT THE INVENTION

[0021] The device 10 according to the invention for filling infusion bags is shown in Fig. 1 and 2The device 10 has a filling needle 20. The lower end 22 of the filling needle 20 can be brought into contact with a corresponding attachment of an infusion bag—in particular with the filling tube of the infusion bag—so that the liquid to be filled can be poured into the infusion bag through the interior 24 of the filling needle. The filling needle 20 has a radially projecting connecting flange 26 at its upper end. The filling needle 20 can be attached to a filling device (not shown here), in particular to a filling head, via the connecting flange 26. The attachment can preferably be effected via one or more screws.

[0022] A base holder 30 with its radially projecting connection flange 32 is attached to the connection flange 26 of the filling needle 20. The base holder 30 has a pipe socket 34 that extends outside the filling needle 20. A circumferential gap 36 is present between the pipe socket 34 of the base holder 30 and the filling needle 20.

[0023] In the present example, the filling needle 20 has an approximately circular cross-section, and the tube socket 34 of the base holder 30 also has a circular cross-section. Accordingly, the circumferential intermediate space 36 is annular in the present example. In principle, the cross-sectional shape of the filling needle 20, in particular of the lower end 22 of the filling needle 20, can be freely selected in the device according to the invention. This allows the lower end 22 of the filling needle 20 to be adapted to different connections of an infusion bag and to different cross-sectional shapes of the filling tubes of an infusion bag. Depending on the selected shape of the filling needle 20, the shape of the tube socket 34 of the base holder 30 can also be adapted. The tube socket 34 can therefore, for example, also have a rectangular, square, or oval cross-section.

[0024] In the present example, a gas connection 38 is provided at the upper edge of the pipe socket 34. The gas connection 40 is located directly below the connection flange 32. The gas connection 38 allows the circumferential space 36 between the pipe socket 34 and the filling needle 20 to be flooded with an inert gas, in particular nitrogen. In addition to the gas connection 38, further gas connections may be provided, which should be distributed around the circumference so that the circumferential space 36 can be evenly flooded with inert gas. Furthermore, the individual gas connections 38 should each be provided at the upper edge of the pipe socket 34 of the base holder so that the circumferential space 36 can be flooded with inert gas over its entire longitudinal direction, if possible, and no residues of the ambient air remain in the upper edge areas of the circumferential space 36.

[0025] The lower end 40 of the pipe socket 34 of the base holder 30 is located slightly above the lower end 22 of the filling needle 20. The filling needle 20 thus projects slightly beyond the base holder 30. In the present example, the lower end 40 of the base holder 30 has an inwardly projecting circumferential shoulder formation 42. A movable nozzle 44 is located on this circumferential shoulder formation 42 in its Fig 1 In the rest position 46 shown, the nozzle 44 has a circumferential projection 48. The movable nozzle 44 extends the circumferential gap 36 downwards. In its rest position 46, the movable nozzle 44 projects downwards beyond the lower end 22 of the filling needle 20.

[0026] The filling needle 20, together with the base holder 30 and the movable nozzle 44, can be adjusted in its longitudinal direction 50 and thus be designed to be height-adjustable. In this way, the filling needle 20, together with the base holder 30 and the movable nozzle 44, can be continuously lowered in the longitudinal direction 50 in the present example. During this lowering of the filling needle 20, the filling tube of the infusion bag remaining above the clamp is simultaneously flooded with inert gas. During the lowering, the lower end 52 of the movable nozzle 44 comes into contact with two centering jaws 54, 56 (see Fig. 2). The two centering jaws 54, 56 thus serve as a stop for the movable nozzle 44 and prevent the movable nozzle 44 from being lowered any further. The centering jaws 54, 56 move the movable nozzle 44 upwards from its rest position 46, so that when the device 10 is lowered further, the lower end 22 of the filling needle 20 is located below the lower end 52 of the movable nozzle 44. The circumferential collar 48 of the movable nozzle 44 slides along the inside 58 of the pipe socket 34. As soon as the lower end 22 of the filling needle 20 has been lowered far enough to make contact with the filling tube of the infusion bag, the actual filling process can begin.

[0027] In the present example, a compression spring 60 is present in the circumferential space 36. The compression spring 60 runs along the inner side 58 of the pipe socket and presses the movable nozzle 44 into its rest position 46. When the movable nozzle 44 is deflected from its rest position 46, the compression spring is tensioned, so that after the deflecting force is removed, the compression spring presses the movable nozzle back into its rest position.

[0028] Instead of continuously lowering the device, it would also be possible to provide one or more waiting positions during the lowering of the device. In this case, the filling hose could be flooded particularly during the waiting positions.

Claims

1. Device (10) for filling an infusion bag with a liquid - having a filling needle (20), - having a base holder (30), which extends around the filling needle (20) in such a way that an encircling intermediate space (36) is present between the filling needle (20) and the base holder (30), - having at least one gas connection (38) for inert gas, through which inert gas is able to be conducted into the encircling intermediate space (36) between the filling needle (20) and the base holder (30), - characterized in that - the filling needle (20) has a radially projecting connection flange (26) at its upper end, - the filling needle (20) is able to be connected by way of its connection flange (26) to a filling device, - the base holder (30) has a tubular connecting piece (34) which extends around the outside of the filling needle (20), - a radially projecting connection flange (32) is present at the upper edge region of the tubular connecting piece (34), - the connection flange (32) of the base holder (30) is able to be fastened to the connection flange (26) of the filling needle (20), - the gas connection (38) for inert gas is present directly below the connection flange (32) of the base holder (30), - a movable nozzle (44) which is fastened in a longitudinally displaceable manner to the lower end (40) of the base holder (30) is present, wherein the movable nozzle (44) projects in its rest position (46) beyond the lower end (22) of the filling needle (20).

2. Device according to Claim 1, - characterized in that - the movable nozzle (44) is mounted in a longitudinally displaceable manner by means of a compression spring (60).

3. Device according to Claim 1 or 2, - characterized in that - the movable nozzle (44) is present in its retracted position above the lower end (22) of the filling needle (20).

4. Device according to one of Claims 1 to 3, - characterized in that - the movable nozzle (44) is displaceable upwards out of its rest position (46) by way of a motorized or pneumatic drive.

5. Device according to one of the preceding claims, - characterized in that - the filling needle (20) is designed so as to be adjustable in height together with the base holder (30) and the movable nozzle (44).

6. Device according to one of the preceding claims, - characterized in that - at least three gas connections (38) for inert gas, through which inert gas is able to be conducted into the encircling intermediate space (36) between the filling needle (20) and the base holder (30), are present.