Device for blow molding and filling containers

The device addresses the challenge of rapid, contamination-free filling of blow-molded containers by using a protective device within a sterile chamber to guide the filling tube, achieving efficient and safe filling processes for medical containers.

DE102023004512A1Pending Publication Date: 2025-05-08ROMMELAG ENGINEERING GMBH
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Patent Information

Application Number
DE102023004512
Authority / Receiving Office
DE · DE
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-11-08
Publication Date
2025-05-08

AI Technical Summary

Technical Problem

Existing solutions for blow-molding and filling containers, particularly those with a nominal filling volume of more than 30 ml, face challenges in rapid filling with minimal risk of particulate and microbiological contamination.

Method used

A device featuring a blow mandrel accommodated in a mandrel holder with a sterile chamber, where a protective device guides the filling tube to create a sterile space for low-contamination, rapid filling. The device includes separating mechanisms to maintain sterility and allows for simultaneous movement of the filling tube with the rising fluid level.

Benefits of technology

The solution enables high-speed production of filled and sealed containers while ensuring minimal contamination risk, particularly effective for medical applications involving liquids, emulsions, or suspensions with increased density.

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Abstract

Device for blow molding and filling containers, in particular within the framework of a blow molding, filling and closing process, at least consisting of - a blow molding device (10) with a blow mandrel (12), - a filling device (14) with a filling tube (16), and - an actuating device (18) for moving the blow mold (10) and filling device (14), wherein the blow mandrel (12) is at least partially received in a mandrel holder (20) which has a sterile chamber (22) in which a protective device (24) is longitudinally guided by means of the actuating device (18), which in each travel position comprises parts of the filling tube (16) which has a fluid guide (26) for a filling material for filling the container.
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Description

[0001] The invention relates to a device for blow molding and filling containers, in particular within the scope of a blow molding, filling and closing process, at least consisting of - a blow molding device with a blow mandrel, - a filling device with a filling pipe, and - an actuating device for moving the blow molding and filling device.

[0002] In the process, which has now been introduced worldwide under the protected name "bottelpack" by the patent holder, a tube is extruded in the first step and taken over by an open blow mold. The main part of the blow mold closes and a specially shaped blow mandrel filling unit is placed in the neck area, sealing the actual container area to the not yet fully formed neck area. The actual container is then inflated via this blow mandrel with a gas, preferably sterile air, and a gas pressure of up to 5 bar. Containers with a filling volume of up to 30 ml, such as ampoules, can only be formed using a vacuum. The part of the tube remaining outside the mold remains hot and plastically soft during this process. After the blow molding process, the filling material is poured into the respective container via suitable filling mandrels.After the blow mandrel filling unit is lifted, a head jaw of the mold closes and hermetically seals the filled container. At the same time, a desired head or closure contour is formed using a vacuum, and when the blow mold is opened, the filled, finished container leaves the device; and the next production cycle begins anew (Blow Molding of Plastic Hollow Parts, Karl Hanser Verlag, Munich, 2006, pages 143 and 144).

[0003] German Auslegeschrift 1 283 141 further discloses a filling mandrel for a device for forming and filling an easily deformable container made of thermoplastic material and located in a production mold, comprising two coaxial tubes forming a filling channel and a gas channel, which are axially displaceable relative to one another and whose outlet ends form a valve closing the annular channel thereof, and comprising a valve body arranged in the channel of the inner tube, which acts in a leading or lagging manner relative to the annular channel valve and which, when the outer tube is held in place, is axially displaceable relative to the outer and inner tubes by means of an actuating device and has a driver which is used for the leading or lagging opening or closing.Closing the annular channel is movable between two stops on the inner tube, wherein the filling material supply line is connected to the channel in the inner tube, which is coupled to the shaft of the valve body via a compression spring acting on the driver and acting on the valve in the opening direction, wherein the shaft has an outward-opening valve body and is connected to a lifting and lowering device which serves to open and close the valves. This makes it possible to move the inner tube and the shaft together as required, independently of the outer tube, with the aid of the actuating device as soon as the outer tube comes into contact with the container, wherein it is possible to allow the level of the filling material to rise above the outlet opening of the shaft or to raise the outlet opening to approximately the same extent as the level of the filling material, so that the filling material has hardly any opportunity to mix with air after it has discharged from the filling mandrel.

[0004] Based on this prior art, the object of the invention is to improve the known solutions, in particular to provide a device and a method for quickly filling containers, in particular blow-molded bottles (ie containers with a nominal filling quantity / a nominal filling volume of more than 30 ml) made of plastic for medical purposes, with minimal risk of particulate and / or microbiological contamination (hereinafter also referred to as contamination for short).

[0005] A device having the features of patent claim 1 in its entirety, or a method having the features of patent claim 11, solves this problem.

[0006] Because, according to the characterizing part of patent claim 1, the blow mandrel is at least partially accommodated in a mandrel holder which has a sterile space in which a protective device is guided so as to be longitudinally displaceable by means of the actuating device, which protective device in each displacement position comprises parts of the filling tube which has a fluid guide for a filling material for filling the container, a low-contamination, rapid filling with fluids, in particular for medical purposes, for the previously blow-molded container is achieved.Because the filling tube of the filling device is at least partially surrounded by a protective device, preferably arranged coaxially around the filling tube, usually in the form of a protective tube, the interior of which forms a clean space under gas overpressure, which interacts logically with the sterile space in the mandrel holder. The tubular protective device can be moved synchronously together with the filling tube of the filling device. The interior of the protective device, together with the sterile space in the mandrel holder, forms a filling tube sterile space, thus creating a sterile space of variable size that ensures low-contamination filling of the respective blow-molded container. Despite this additional design effort to maintain an additional filling tube sterile space, very high output rates of formed, filled, and sealed containers can be achieved.This is helped by the fact that the filling tube of the filling device can be moved downwards from a blowing position relative to the blowing mandrel toward the bottom of the bottle to be filled. This allows filling with the filling material to begin near the bottom of the container in a lower filling position. During the filling process, the filling tube is moved upwards continuously or in steps as the fluid level in the container rises. This simultaneous upward movement of the filling tube with the rising fluid level in the container enables, in particular, safe filling with liquids, emulsions, or suspensions of increased density. At the same time, the expanded filling tube sterile space ensures fluid filling with minimal risk of particulate and microbiological contamination.

[0007] In a preferred embodiment of the device according to the invention, it is provided that a separating device is present which, at least during blow molding of the container, blocks a fluid path from the interior of the blow mandrel towards the filling tube sterile space and opens it during filling of the molded container, and that a further separating device is present by means of which a further fluid path between the filling tube sterile space and the environment can be blocked. In this way, during the blow molding process of the respective container, the sterile space in the mandrel holder is separated from the supply of blow air towards the container to be molded. During the subsequent filling of the blow-molded container in its mold using the filling mandrel, both separating devices are in their open position and the air displaced during filling of the container can be displaced to the outside after passing through the sterile space in the mandrel holder.If the sterile space in the mandrel holder is to be cleaned or sterilized, only the additional separating device at the beginning of the sterile space in the mandrel holder is closed and the supply of the cleaning and sterilizing medium takes place via an independent fluid guide within the protective device, which is part of the additional separating device, in the direction of the blowing mandrel and through it, for which purpose the one separating device on the blowing mandrel remains open.

[0008] In a further preferred embodiment of the device according to the invention, it is provided that one separating device has a sealing part which surrounds the filling tube and is fixedly guided thereto so as to be longitudinally movable in the blowing mandrel and can be brought into tight contact with a further sealing part which is stationary within the mandrel holder. It is preferably further provided that the further separating device has a sealing element which is a component of the protective device and which can be moved by means of the actuating device into tight contact with a further sealing element which is stationary on parts of the mandrel holder. The preferably conical design of parts of the two separating devices ensures functionally reliable sealing even during long-term operation of the device.

[0009] In a further preferred embodiment of the device according to the invention, it is provided that the protective device can be retracted into the sterile space over a large part of its entire length by means of the actuating device, and that, when the protective device is retracted as far upwards as possible, both separating devices can be effectively brought into their blocking, sealing position. This creates a prerequisite for the sterile space in the mandrel holder to be cleaned and / or sterilized separately from the other components. Sterilization can be carried out, as is generally known, with sterilizing gases, for example, with gaseous hydrogen peroxide; however, steam is preferably used.

[0010] Furthermore, the device can be used to move the filling tube downwards from a blowing position relative to the blowing mandrel towards the shaped base of the container to be filled, so that filling can begin near the container base in a lower filling position and, during the filling process, the filling tube can be moved upwards continuously or in steps as the fluid level rises. The tubular protective device, together with the filling tube, is inserted into the preferably cylindrical recess of the mandrel holder, which forms the additional sterile space. Sterile air can flow through the protective device as well as the sterile space in the mandrel holder. A simultaneous upward movement of the filling tube with the rising fluid level thus enables fast and safe filling with liquids, emulsions or suspensions with a density of more than 1.015 g / ml.

[0011] Preferably, the protective device is arranged concentrically to the filling tube and has a fluid guide for supplying and / or removing sterile air and / or cleaning media, which, when the separating devices are blocked, enable separate cleaning and sterilization of the sterile space in the mandrel holder, which together with the fluid guide in the protective device forms the extended filling tube sterile space.

[0012] In a preferred embodiment of the device according to the invention, the mandrel holder can be connected to a blowing air supply via a channel guide and to an outlet for media, such as sterile and / or cleaning media, via another channel guide. This achieves a substantially loss-free supply and removal of various types of media.

[0013] In a further preferred embodiment of the device according to the invention, the mandrel holder is accommodated between two receptacles, one of which is designed as a carrier and, at least in one of its positions, is used for contact with the mandrel holder by means of the actuating device, while the other receptacle serves for temperature control, in particular for cooling. Overall, a type of slide guide is implemented for the mandrel holder, which can be moved along a column guide into its individual functional positions by means of the actuating device. Particularly when filling temperature-sensitive products, cooling allows for reliable filling of fluid into containers.

[0014] In a further preferred embodiment of the device according to the invention, the actuating device comprises a machine frame with a column guide, with at least one actuator for moving the mandrel holder and for further moving the protective body with the filling tube, relative to the mandrel holder, into at least one filling position. Thanks to the actuating device with the machine frame and the respective actuator, a reliable movement of the movable components of the device into their respective functional positions is achieved without delay.

[0015] In a particularly preferred embodiment of the device according to the invention, the blowing mandrel and filling tube can be sealed off from the environment by means of an attachable and removable cover during cleaning and / or sterilization. In this way, cleaning and / or sterilization media can be introduced into the interior or into a functional space of the cover via the media path between the protective device, sterile chamber, and blowing mandrel, with the separating device on the blowing mandrel open and the separating device on the protective device closed. The cover, which is mounted on the underside of the mandrel holder, comprehensively accommodates parts of the blowing mandrel and the filling device.

[0016] In the following, the device according to the invention is explained in more detail using an exemplary embodiment according to the drawing. The drawings show, in principle and not to scale, the Fig. 1 to 3 partly in view, partly in section, the essential components of the device in a basic or starting position, at the start of a production process with the blow mandrel attached, and during the actual production step with so-called sub-surface filling; Fig. 4 and Fig. 5 each shows a longitudinal section through the mandrel holder with the blowing mandrel inserted and with a representation of one separating device in the release or blocking position; Fig. 6 to 9 the further separating device in different functional positions; Fig. 10 and Fig. 11 the protective device in perspective view from below or in longitudinal section; and Fig. 12 a section of a lower part of the device according to the Fig. 1 with cover attached.

[0017] The Fig. 1 to 3 essentially show the device as a whole in various functional positions. The device is used for blow molding and filling containers (not shown), in particular within the scope of a blow molding, filling, and closing process. To this end, the device comprises a blow molding device 10 with a blow mandrel 12. Furthermore, a filling device 14 with a filling tube 16 is provided. It is understood that the illustration with only one blow mandrel 12 and only one filling tube 16 is only exemplary and that, in particular, projecting into the respective plane of the drawing, several blow and filling mandrels can be present in a series arrangement, which corresponds to the usual design of such devices.Furthermore, an actuating device 18 is provided for moving the blow mold 10 and filling device 14 with their respective blow mandrels 12 and filling tubes 16, which is also verifiable in the prior art, so it will not be discussed in more detail here. As can be further seen from the . Fig. 1 to 3, the blowing mandrel 12, viewed in the direction of the figures, is partially received with its upper end in a mandrel holder 20, which forms a block, for example, is designed in the shape of a cuboid and can thus offer space for several blowing mandrels 12 arranged one behind the other together with filling tubes 16. The block-shaped mandrel holder 20 has a sterile space 22, which is introduced into the mandrel holder 20 from above as a hollow cylindrical recess. In the mandrel holder 20, a protective device 24 is guided longitudinally by means of the actuating device 18 or parts thereof, which in each of its travel positions, as shown in the Fig. 1 to 3, comprises parts of the filling tube 16, which has a fluid guide 26 for a filling material for filling the respective container. The tubular protective device 24 in question is shown in more detail in the Fig. 10 and Fig. 11 shown.

[0018] As can be seen from the Fig. 4 and Fig. 5, a separating device 28 is provided which, at least during the blow-molding of the container, blocks a fluid path 30 from the interior 32 of the blow mandrel 12 in the direction of the sterile space 22, which in the Fig. 5. However, during the subsequent filling of the blow-molded container, the separating device 28 is moved according to the illustration after the Fig. 4 is released, and air or another medium displaced from the container during filling can be displaced from the interior 32 of the blow mandrel 12 in the direction of the sterile space 22 when the separating device 28 is released.

[0019] For this purpose, one separating device 28 has a sealing part 34 which surrounds the filling tube 16 and is fixedly guided thereon so as to be longitudinally movable in the blowing mandrel 12. The sealing part 34, which is movable in this way, can be brought into a tight fit with a further sealing part 36 which is arranged stationary within the mandrel holder 20. The one sealing part 34 is provided on its side facing the further sealing part 36 with a sealing cone 38 which, in the blocking position, is in a tight fit with a contact cone 40 of the further sealing part 36, which is particularly important in the Fig. 5. The sealing parts 34, 36 are preferably formed from a sealing material, such as an elastomer material.

[0020] As can be seen from the Fig. 4 and Fig. 5, the outer circumference of the blowing mandrel 12 is securely received in the mandrel holder 20 via a plurality of sealing devices and, to this extent, the interior 32 of the blowing mandrel 12 is sealed from the environment in the region of the receptacle in the mandrel holder 20. At least in the release position according to the illustration according to the Fig. 4, the outer diameter of the sealing part 34 is selected to be somewhat smaller than the inner diameter of the blowing mandrel 12 at this point, so that at least in the released position between the sealing part 34 and the blowing mandrel 12, a gap guide in the form of an annular gap 42 is created, along which in the open position of the separating device 28 after the Fig. 4 Blowing air or another blowing medium can flow through the interior 32 of the blowing mandrel 12 in the direction of the sterile chamber 22. In the blocking position according to the illustration after the Fig. 5, the corresponding fluid path is blocked by the separating device 28.

[0021] For the blowing media supply to the blowing mandrel 12, the mandrel holder 20 is provided with an internal channel guide 44, which opens at one free end into an annular groove 46 on the outer circumference of the blowing mandrel 12, which is delimited on the outside by wall parts of the mandrel holder 20. The annular groove 46 in question typically has an annular gap (not shown) that allows the supply of blowing medium, such as blowing air, under pressure via the channel guide 44 and the annular groove 46 into the interior 32 of the blowing mandrel 12.

[0022] The additional sealing part 36 is fitted in the transition area to the sterile chamber 22 by means of at least one seal 48, comparable to the sealing fit of the blowing mandrel 12. Furthermore, a further seal 50 is provided on the lower, free end face of the additional sealing part 36, against which the sealing cone 38 of the sealing part 34 can be applied on the inner circumference for improved sealing in a closed position. Both seals 48, 50 are preferably designed as O-rings.

[0023] As can be seen from the Fig. 4 and Fig. 5, the filling tube 16 is penetrated centrally by a valve rod 52, which serves to mechanically control a closing valve 54, which in particular according to the illustration according to the Fig. 12 shows that when actuated accordingly, the closing cone of the closing valve 54 can release or block the lower free end of the filling tube 16, whereby in the Fig. 12 shows the valve position releasing the filling tube 16. In this respect, the free fluid guide 26 for the supply of the fluid to be filled runs in an annular space 55 or annular gap between the outside of the valve rod 52 and the inner circumferential side of the filling tube 16. The illustration according to the Fig. 4 and Fig. 5 further shows the upper fixing edge of a cover 56, as it is shown in its entirety in the Fig. 12. Otherwise, if the cover 56 is omitted, the functional position corresponds to the Fig. 5, with the separating device 28 locked, the basic position after the Fig. 1 and the start of production, in which the blow mandrel cone 57 rests on a container neck at its free lower end and serves to supply blowing air via the channel guide 44, during which the container is blow-molded. The open position for the separating device 28 after the Fig. 4, however, concerns the filling of the container, in particular in the form of a sub-surface filling as shown in the Fig. 3. Furthermore, the Fig. 4 the opened separating device 28 with the cover 56 again fitted as shown in the Fig. 12.

[0024] As in particular the Fig. As shown in Figures 6 to 9, the device according to the invention has a further separating device 58, by means of which a further fluid path 60 between the sterile chamber 22 and the environment can be shut off. It is understood that, where the term "environment" is mentioned, this particularly includes sterile chambers in which the device as a whole with its components is accommodated. In particular, the Fig. 1 to 3, the device shown in FIGS. 1 to 3 may comprise a filling sterile chamber in the travel range of the blowing mandrel 12 and filling tube 16, as shown in part by way of example in DE 196 48 087 C2. However, for the sake of simplicity of illustration, such sterile chamber arrangements will not be discussed further. The further separating device 58 comprises a sealing element 60, which is preferably an integral component of the protective device 24, which can be moved by means of the actuating device 18 into a tight fit with a further sealing element 64, which is arranged stationary on parts of the mandrel holder 20. The tight fit of the two sealing elements 60, 64 against one another is shown in FIGS. Fig. 8 and Fig. 9, where the Fig. 9 an enlarged image section in Fig. 8, which is enclosed by a circle and labelled B.

[0025] The mentioned protective device 24 is in the Fig. 10 and Fig. 11. The protective device 24 is designed in particular as a solid cylinder with individual channel guides that extend along the longitudinal axis of the cylinder. Thus, the protective device 24 has a central channel 66, into which, according to the illustrations according to the Fig. 1 to 3, the upper parts of the filling device 14 with filling tube 16 and valve rod 52 guided centrally therein are accommodated. Furthermore, four outer channels 68 are grouped around the central channel 66, which are combined in pairs at one point in the solid cylinder of the protective device 24 and serve to supply sterile and / or cleaning media from a receiving plate 70. All outer channels 68 as well as the central channel 66 open into the sterile chamber 22 at the bottom. Furthermore, the upper part of the channels 66, 68 opens into individual channel lines 72 in the receiving plate 70, which serve to supply the aforementioned media for the outer channels 68, wherein, viewed in the direction of the Fig. 10 and Fig. 11, a pair of channel lines 72 on each side supplies a pair of external channels 68, which merge into the respective channel lines 72 at the head end, separated from one another. The respective channel line 72 leads out of the mounting plate 70 via a corresponding connection, wherein the respective connection serves to connect the channel line 72 and the associated external channels 68 to a suitable media supply (not shown). In any case, via the arrangement of the protective device 24, various sterile and / or cleaning media can be introduced via the individual channel guides 68, 72 from the mounting plate 70 into the sterile chamber 22 in order to clean or sterilize it.

[0026] The cylinder of the protective device 24 is conically widened at the bottom from the outer circumference and forms the sealing element 62 with the correspondingly conical surface. As can be seen in particular from the Fig. 1 to 3, the protective device 24 can be retracted into the sterile room 22 over a large part of its entire length by means of the actuating device 18, which is particularly evident from the illustration according to the Fig. 3; however, it can also be moved back completely to a position according to the Fig. 1, which corresponds to the cut-off or blocking position according to Fig. 8 and Fig. 9, in which the further fluid path 60 is blocked.

[0027] The further sealing element 64, according to the present embodiment, consists of an elastomeric sealing ring or O-ring, which is clamped between two parts 74 of the mandrel holder 20 with a predeterminable projection into the further fluid path 60. A further O-ring 76 is similarly fixed, in particular clamped, between one of the parts 74, in particular the lower part 74, and an upper side of the mandrel holder 20. The illustration according to the Fig. 7 shows an enlarged image section in the Fig. 6, which is designated as a circular image section with A. As can be seen from the Fig. 6 and Fig. 7, the protective device 24 with its conically projecting sealing element 62 is in a slightly lowered position, so that the conical wall surface of the sealing element 62 comes into contact neither with the O-ring of the further sealing element 64 nor with the additional O-ring 76, which in this area only secures the possible transition between the sterile space 22 via the further fluid path 60 into the environment.

[0028] The position releasing the further fluid path 60 is assumed by the protective device 24 if, during the blow molding process, an excess of sterile or blowing air is to escape into the environment or sterile space via the interior 32 of the blow mandrel 12 and the first separating device 28 and the subsequent sterile space 22 via the further separating device 58. However, if a container is to be filled subsequently by means of the filling device 14, the protective device 24 assumes its Fig. 8 and Fig. 9, in which the conical sealing element 62 comes into sealing engagement with the O-ring-shaped further sealing part 64. To this extent, the corresponding further fluid path 60 is then blocked off and the free lower end of the seat cone of the sealing element 62 opens out somewhat below the O-ring sealing ring 76, viewed in the horizontal direction, while maintaining a predeterminable radial distance.

[0029] In addition to the previously mentioned channel guide 44 for the blowing air supply, there is another channel guide 78 in the mandrel holder 20, which provides a drain for media such as sterile and / or cleaning media. Furthermore, the block-like mandrel holder 20 is in the filling position after the Fig. 3 is arranged between two receptacles, the upper of which is designed as a carrier 80 and serves to move the filling device 14 with protective device 24 by means of the actuating device 18. The other receptacle 82 is designed in the manner of a so-called cold plate and thus serves for cooling. Additionally or alternatively, the receptacle 82 can also be equipped with a heating device (not shown). The plate-shaped carrier 80 is penetrated at its free corner areas to receive a column guide 84, which is part of a machine frame 86, by means of which individual components of the device such as mandrel holder 20, protective device 24 and the blow molding device 10 together with the filling device 14 can be moved up and down, which can be seen in particular from the illustrations according to the Fig. 1 to 3 results.

[0030] In addition to the actuating device 18, there is a further actuating device 88 which can be controlled independently of the first actuating device 18 and which has individual lifting cylinders 90 which, in turn, are arranged on a carrier plate 92 and allow the lifting and lowering of the carrier 80 by means of the actuating device 18. The Fig. 1 to 3, the device shown essentially as a whole comprises at least one actuator 94 as part of the actuating device 18, which is fixed within the column guide 84 on an upper cross member 96. The actuator 94 has an actuating rod 98 on the output side, by means of which the individual components are moved into their respective functional positions according to the Fig. 1 to 3. Furthermore, a control cylinder 100 is arranged between the lifting cylinders 90 on the longitudinally movable support plate 92, which actuates the valve rod 52 accordingly. Fig. 1, the functional position of the components is such that the carrier plate 92 with the receiving plate 70 are arranged above a further cross member 102 on the column guide 84, which corresponds to the initial or basic position of the device, whereas in the blowing position after the Fig. 2 both the receiving plate 70 and the carrier plate 92 are arranged below the further cross member 102. In a lower filling position after the Fig. 3, the protective device 24 is accommodated in its lowest position in the sterile room 22 and the respective lifting cylinders 90 are in their extended position, which leads to a lowering of the receiving plate 70 with the protective device 24.

[0031] To ensure easy cleaning and (steam) sterilization of the protective tube interior of the protective device 24 within the scope of the invention, which is typically carried out with superheated steam at 121°C, the protective device 24 is preferably formed from a solid cylinder, which is preferably rigid and internally pressure-resistant and made of a metallic material, such as stainless steel. Furthermore, the protective device 24 preferably has a smooth inner wall. The cylinder 24 is therefore thick-walled and provided with longitudinal bores forming the outer channels 68, which can serve as inlets for sterile fluid and / or a cleaning fluid. The sterile fluid can also consist of sterile air.

[0032] For an internal cleaning of the filling tube sterile space, formed at least from the outer channels 68 in the protective device 24 and the actual sterile space 22 in the mandrel holder 20, a seal from the sterile space 22 to the protective device 24 is provided via the further separating device 58 already described. During production, i.e. when filling containers, this separating device 58 is opened with its sealing elements 62, 64, so that sterile air can escape through the thus released opening in the form of the further fluid path 60. As further Fig. 5 shows, the interior 32 of the blowing mandrel 12 can be sealed off from the filling tube sterile space during the blowing process by means of a mandrel sealing cone as one sealing part 34, which is arranged stationary on the filling tube 16, and a corresponding sealing bush as the further sealing part 36, which is attached to the end of the blowing mandrel 12, or can be opened to discharge displaced air from the container during fluid filling.

[0033] Preferably, below-level filling is provided, i.e., the filling tube 16, starting from a blowing position relative to the blowing mandrel 12, is moved downwards toward the bottom of the bottle to be filled, allowing filling to begin near the container bottom in a lower filling position. During the filling process, the filling tube 16 is moved upwards continuously or in steps in the opposite direction as the liquid level in the container rises, but is held below the filling material level. In this case, the protective device 24, together with the filling tube 16, is immersed in the preferred cylindrical recess of the mandrel holder 20, which forms the sterile space 22. Sterile air can flow through the protective device 24 and the sterile space 22.

[0034] A simultaneous upward movement of the filling tube 16 with the rising liquid level enables safe and rapid filling with liquids, emulsions and / or suspensions with a significantly higher density than water, i.e. a density of more than 1.015 kg / l at 25 °C. These include colloidal infusion solutions, for example infusion solutions containing more than 2% polygelin (trade names Haemaccel and Emagel) or more than 5% hydroxyethyl starch (trade names including Vitafusal; Haessteril 6%; Tetraspan 10%) and crystalloid solutions, which typically contain several mineral salts, such as Ringer's acetate solution, Ringer's lactate solution and solutions containing 5% or more glucose.

[0035] The device and method according to the invention have also proven effective in filling solutions for topical disinfection of skin and mucous membranes for wound disinfection, which contain 2-phenoxyethanol and / or the hydrochloride of octenidine (N-octyl-1-[10-(4-octyliminopyridin-1-yl)decyl]pyridine-4-imine). Trade names include Octenisept (with phenoxyethanol) and Octeniderm (with 1-propanol and 2-propanol).

[0036] For cleaning and sterilization, follow the instructions in the Fig.12, the cover 56 is sealingly placed on the receptacle 82, which is preferably designed as a cooling plate or cold plate. The seal 58 of the protective device 24 to the sterile space 22 of the mandrel holder 20 is closed, and the sealing point 28 between the blow mandrel 16 and the filling tube sterile space 22, 68 is opened. Via the receptacle plate 70 and through the external channels 68 in the cylindrical protective device 24, the entire enclosed space within the cover 56 can now be filled with cleaning fluid. This fluid can be drained off via a lower drain on the cover 56 if necessary. Sterilization then takes place by feeding in hot steam, preferably followed by drying using sterile air. The cover 56 is preferably screwed to the plate-shaped holder 82 in a detachable manner, so that a secure holder is guaranteed, even in the case of the excess pressure generated during steam sterilization. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] DE 196 48 087 C2

[0024]

Claims

[1] Device for blow-molding and filling containers, in particular within the framework of a blow-molding, filling and closing process, at least consisting of - a blow molding device (10) with a blow mandrel (12), - a filling device (14) with a filling pipe (16), and - an actuating device (18) for moving the blow mould (10) and filling device (14), characterized by in that the blow mandrel (12) is at least partially received in a mandrel holder (20) which has a sterile space (22) in which a protective device (24) is guided so as to be longitudinally displaceable by means of the actuating device (18), which protective device (24) in each displacement position comprises parts of the filling tube (16) which has a fluid guide (26) for a filling material for filling the container. [2] Device according to claim 1, characterized bythat a separating device (28) is provided which, at least during blow-molding of the container, blocks a fluid path (30) from the interior (32) of the blow mandrel (12) in the direction of the sterile space (22) and releases it when the formed container is filled, and that a further separating device (58) is provided by means of which a further fluid path (60) between the sterile space (22) and the environment can be blocked. [3] Device according to claim 1 or 2, characterized by that the one separating device (28) has a sealing part (34) which surrounds the filling tube (16) and is fixed thereto so as to be longitudinally movable in the blowing mandrel (12) and can be brought into tight contact with a further sealing part (36) which is arranged stationary within the mandrel holder (20). [4] Device according to one of the preceding claims, characterized bythat the further separating device (58) has a sealing element (60) which is a component of the protective device (24) which can be moved by means of the actuating device (18) into a tight fit with a further sealing element (64) which is arranged stationary on parts (74) of the mandrel holder (20). [5] Device according to one of the preceding claims, characterized by that the protective device (24) can be retracted into the sterile chamber (22) over a large part of its entire length by means of the actuating device (18) and that in a maximum extended position of the protective device (24) both separating devices (28, 58) can be effectively brought into their blocking sealing position. [6] Device according to one of the preceding claims, characterized bythat the protective device (24) is arranged concentrically to the filling tube (16) and has a fluid guide (68) for supplying and / or removing sterile air and / or media, in particular for sterilization and / or cleaning. [7] Device according to one of the preceding claims, characterized by that the mandrel holder (20) can be connected to a blown air supply by means of a duct guide and with a further duct guide (44) to an inlet and / or outlet for media, for sterilization and / or cleaning. [8] Device according to one of the preceding claims, characterized by in that the mandrel holder (20) is accommodated between two receptacles (80, 82), one of which is designed as a carrier (80), serves at least in one of its positions for contact with the mandrel holder (20) by means of the actuating device (18) and the other receptacle (82) serves for temperature control, in particular for cooling. [9] Device according to one of the preceding claims, characterized bythat the actuating device (18) has a machine frame (86) with a column guide (84), with at least one actuator for moving the mandrel holder (20) and for subsequently moving the protective device (24) with the filling tube (16), seen relative to the mandrel holder (20), into at least one filling position. [10] Device according to one of the preceding claims, characterized by that the blow mandrel (12) and the filling tube (16) can be separated from the environment by means of an attachable and removable cover (56) during cleaning and / or sterilization. [11] Method for low-contamination filling of containers using a device according to one of claims 1 to 10 with a filling material for medical purposes, characterized by that a sub-surface filling is carried out. [12] Method according to claim 11, characterized bythat a blow-moulded plastic bottle with a nominal filling volume of more than 30 ml is used in the container. [13] Method according to claim 11 or 12, characterized by that the density of the contents at 25°C is more than 1.015 kg / l. [14] Method according to claim 11 or 12, characterized by that the contents contain octenidine. [15] Method according to one of claims 11 to 13, characterized by that the contents are colloidal infusion solutions containing more than 2% polygelin or more than 5% hydroxyethyl starch, and / or solutions containing several mineral salts, and / or solutions containing 5% or more glucose.

Citation Information

Patent Citations

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