EP2628474A1 - Bag for storing and dispensing a liquid additive under aseptic conditions - Google Patents
Bag for storing and dispensing a liquid additive under aseptic conditions Download PDFInfo
- Publication number
- EP2628474A1 EP2628474A1 EP20120007290 EP12007290A EP2628474A1 EP 2628474 A1 EP2628474 A1 EP 2628474A1 EP 20120007290 EP20120007290 EP 20120007290 EP 12007290 A EP12007290 A EP 12007290A EP 2628474 A1 EP2628474 A1 EP 2628474A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- bag
- additive
- connection
- suspension
- removal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000654 additive Substances 0.000 title claims abstract description 65
- 230000000996 additive effect Effects 0.000 title claims abstract description 59
- 239000007788 liquid Substances 0.000 title claims description 15
- 239000000725 suspension Substances 0.000 claims abstract description 59
- 238000000034 method Methods 0.000 claims abstract description 17
- 230000002787 reinforcement Effects 0.000 claims description 21
- 238000005070 sampling Methods 0.000 claims description 15
- 238000002347 injection Methods 0.000 claims description 12
- 239000007924 injection Substances 0.000 claims description 12
- 238000004806 packaging method and process Methods 0.000 claims description 10
- 230000004888 barrier function Effects 0.000 claims description 8
- 238000003466 welding Methods 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 4
- 238000000275 quality assurance Methods 0.000 claims description 4
- 238000007789 sealing Methods 0.000 claims description 4
- 230000015572 biosynthetic process Effects 0.000 claims description 3
- 230000003014 reinforcing effect Effects 0.000 claims description 3
- 239000000047 product Substances 0.000 description 18
- 238000010168 coupling process Methods 0.000 description 8
- 108090000790 Enzymes Proteins 0.000 description 7
- 102000004190 Enzymes Human genes 0.000 description 7
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 7
- 229940088598 enzyme Drugs 0.000 description 7
- 239000008101 lactose Substances 0.000 description 7
- 230000008569 process Effects 0.000 description 7
- 230000008878 coupling Effects 0.000 description 6
- 238000005859 coupling reaction Methods 0.000 description 6
- 244000052616 bacterial pathogen Species 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 230000007704 transition Effects 0.000 description 4
- 108010005774 beta-Galactosidase Proteins 0.000 description 3
- 239000005038 ethylene vinyl acetate Substances 0.000 description 3
- 238000010438 heat treatment Methods 0.000 description 3
- 230000007062 hydrolysis Effects 0.000 description 3
- 238000006460 hydrolysis reaction Methods 0.000 description 3
- 230000036512 infertility Effects 0.000 description 3
- 230000001954 sterilising effect Effects 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 102100026189 Beta-galactosidase Human genes 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- WQZGKKKJIJFFOK-FPRJBGLDSA-N beta-D-galactose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-FPRJBGLDSA-N 0.000 description 2
- 238000003776 cleavage reaction Methods 0.000 description 2
- 239000003086 colorant Substances 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 239000000796 flavoring agent Substances 0.000 description 2
- 235000019634 flavors Nutrition 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 239000011888 foil Substances 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 230000005484 gravity Effects 0.000 description 2
- 150000002632 lipids Chemical class 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 235000015097 nutrients Nutrition 0.000 description 2
- 239000006041 probiotic Substances 0.000 description 2
- 230000000529 probiotic effect Effects 0.000 description 2
- 235000018291 probiotics Nutrition 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 230000007017 scission Effects 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 108010059881 Lactase Proteins 0.000 description 1
- 230000004323 axial length Effects 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- DQXBYHZEEUGOBF-UHFFFAOYSA-N but-3-enoic acid;ethene Chemical compound C=C.OC(=O)CC=C DQXBYHZEEUGOBF-UHFFFAOYSA-N 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 235000013365 dairy product Nutrition 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000008571 general function Effects 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 238000005304 joining Methods 0.000 description 1
- 229940116108 lactase Drugs 0.000 description 1
- 230000001795 light effect Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
- 235000013336 milk Nutrition 0.000 description 1
- 210000004080 milk Anatomy 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000011179 visual inspection Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1462—Containers with provisions for hanging, e.g. integral adaptations of the container
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1475—Inlet or outlet ports
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2205/00—General identification or selection means
- A61J2205/20—Colour codes
Definitions
- the invention relates to a bag for storing and removing a liquid additive under aseptic conditions, wherein the additive removed from the bag is dosed under aseptic conditions into a base product, with a bag arranged on the first port for filling the bag with the additive and a second connection to Removal of the additive, with means for suspending the bag in a suspension position, which are positioned so that a gravitational feed of the additive to the second connection takes place, with a removal arrangement, on the one hand for the purpose of removal of the additive from the bag to the second port fluid is connected and the other ends in a hypodermic needle for dosing in the base product and a feasible with the bag method.
- Liquid additives such as enzymes, flavors, colors, lipids, probiotic bacteria and other nutrients are dosed into a basic food product to provide it with special properties. Since these additives can be sensitive to heat, the supply of these additives into the base product takes place directly before its filling and after its heat treatment to kill unwanted germs, for example an ultra-high-temperature treatment (UHT heat treatment), and preferably within the framework of a so-called. line dosing. The dosing must be carried out under aseptic conditions and with a sterile additive also stored under aseptic conditions, so that the basic product produced without germs during the heat treatment is not infected with germs in the dosing phase.
- UHT heat treatment ultra-high-temperature treatment
- lactose-reduced or lactose-free products A widespread application, in which an enzyme is used as an additive, is the production of lactose-reduced or lactose-free products.
- lactase is used for the enzymatic cleavage of lactose. These products are mainly consumed by people who lack of ß-galactosidase in the digestive tract.
- lactose-reduced milk and related substances is the market for calorie-reduced products. Lactose cleavage produces one molecule each of D-glucose and ⁇ -D-galactose [T ⁇ PEL, 2004, p. 99 ; [1] JEKLE; Food Technology Seminar, Lactose Free and Reduced Dairy Products, 2004].
- each of these molecules has greater sweetening power than lactose, so that a much sweeter product can be produced with the same nutritional value.
- the enzyme ⁇ -galactosidase can be used in the production.
- processes have been developed in which the enzyme is added immediately before bottling [1].
- the dosage rate of the enzyme in question ranges from 0.2 to 4 ml of enzyme / liter of the base product.
- Tetra FlexDos TM flexible aseptic dosing system for liquid additives
- PD 10080 de 2007- 02 a metering device is described with the use of a bag of the generic type in which an additive of the in question standing stock type, an aseptic in-line dosage of this liquid additive is made into a base product.
- the ready-to-use 5 or 10-liter bag filled with the sterile additive under aseptic conditions which in turn is accommodated in a bucket-like outer packaging, is suspended in the metering device.
- a separate hose arrangement acting as a removal arrangement is used to transfer the additive from the bag into the base product, which tube is connected to the bag via a special adapter prior to dosing.
- Hose arrangement and bags are prepared and provided separately from each other, they are usually from different manufacturers and are brought together only in the metering device and firmly connected.
- an injection needle is arranged, via which the additive at an injection point by means of a hose pump acting on the hose assembly from the outside into the base product is metered.
- the injection point is located on a sealed by a sterile membrane pipe socket of a pipeline in which the base product flows.
- the known metering device with the bag used for the purpose and the separate hose arrangement have disadvantages, in particular in the area of the bag and the coupling of the hose arrangement, which can call into question the absolutely required safety of the sterility of the metering process.
- the extraction port on the bag may be exposed to harmful environmental influences and / or possible faulty actions prior to coupling the hose assembly, which may affect the sterility of the critical surfaces leading to the metered additive in the course of the coupling process. A sterilization of these critical surfaces after completion of the coupling process is no longer possible.
- the known bag does not provide a way to remove a sterile sample from the bag as part of a quality assurance. Sampling of the bag by means of proximal puncturing is ruled out since the sampled contents of the bag remain sustainably unadulterated and, if so desired, can still be safely supplied to a dosage after sampling. Furthermore, it has been found that the known bag can not be completely emptied.
- the inventive idea is that even before the filling of the bag with the additive, the removal arrangement with the removal serving second terminal is firmly and tightly connected.
- This connection can preferably be realized positively and / or non-positively, for example in the form of an elastically ductile coupling, so that a joining of the bag with the removal arrangement is given to a tight and tightly connected unit in the simplest way.
- the connection can also be made cohesively, for example by welding.
- the unit, consisting of the bag and the withdrawal device preferably fixed on it can be exposed in its entirety, for the purpose of sterilization, to a suitable treatment, for example by sterilizing radiation.
- This solution according to the invention certainly eliminates the otherwise existing possibility of impairing the sterility of the compound when the latter is prepared after filling the bag with the additive and before metering the additive into the base product.
- the bag according to an advantageous embodiment is provided with a third sampling port.
- This possibility may or may not be mandatory.
- this is closed by a sealing plug, which recloses after a sample removed by means of a sampling needle from the bag sample.
- a sealing plug which recloses after a sample removed by means of a sampling needle from the bag sample.
- Such plugs are well known in medical technology and have proven there. Since a contamination of the bag contents with proper sampling on the third port with its stopper is excluded, the sampled bag, if desired, the dosage can be supplied.
- the bag sampled according to the invention can also be stored as proof of a perfect batch of the additive since it is not permanently adulterated by the sampling.
- the respective connection namely that of the filling, the removal and the sampling, is designed in the form of a nozzle-shaped hose access.
- This is a structurally very simple and cost-effective solution that greatly simplifies the handling of the bag for the purpose of its filling and emptying by means of a hose assembly and the sampling of the stopper.
- Another proposal provides that the filling serving first port is welded after the filling of the bag. This is a completely safe measure to create sustainable sterile conditions at this critical point.
- a further embodiment provides for a kink valve to be arranged in the second connection, by means of which a fluid-permeable connection between the catheter is made by irreversibly breaking a barrier at a predetermined breaking point Interior of the bag and the removal arrangement is made.
- the connection with the removal arrangement is made only shortly before the start of the dosage, so that the removal arrangement, consisting of a sampling tube, arranged in this filter, a latter in the flow direction of the additive downstream check valve and an injection needle, remains free from the additive until this time ,
- the invention also proposes that the means for suspending the bag are designed as a three-point suspension.
- the means for suspending the bag are designed as a three-point suspension.
- the three-point suspension is designed to be particularly stable, is further provided that they in one, based on the suspension position of the bag, molded at the top of the bag, the Edge education reinforcing grip plate is formed.
- the handle plate has a significantly different from the color of the bag color.
- the color coding of the handle plate can also serve to identify and recognize the respective additive.
- the invention also proposes for the design of the three-point suspension that the latter consists of two spaced suspension holes, which are preferably the same size, the line connecting their centers is oriented perpendicular to the suspension position of the bag by the suspension position, and that between the suspension holes, preferably centrally, a is provided in the direction of the connecting line extending slot-shaped recess having at its upper limit, preferably centrally, a bulge whose upper boundary is aligned with the respective upper boundary of the receiving openings.
- this results in a very stable three-point suspension, which fixes the bag safely and clearly in its required suspension position.
- a safe emptying of the bag contents is further favored in particular in the clearly fixed by the three-point suspension suspension position in that the bag, based on its suspension position, at its lower edge has a respective decreasing from outside to inside removal side inner contour, the additive from outside to inside to flow under the influence of gravity.
- a complete emptying of the bag ensures another proposal, which provides that the second port, based on the suspension position of the bag, opens at the lowest point of the discharge-side inner contour.
- first port used for filling and the third port for sampling do not have any emptying-critical significance, they are at the bottom edge of the bag in relation to the suspension position of the bag and each adjacent to the second terminal.
- the relatively short distance between the three ports makes it possible to additionally reinforce this penetration area of the bag by suitable measures, for example by welding together adjacent bag surfaces.
- Another proposal is to reinforce the bag in the area of its three-point suspension and on both sides of this area and in the area of its three connections and also on both sides of this area. This is achieved in that the bag has, based on its suspension position, at its upper edge an upper edge reinforcement and / or at its lower edge a lower edge reinforcement. This reinforcement can, for example, in turn be achieved by welding adjoining bag surfaces.
- a configuration favoring the emptying and the stability of the bag in its hanging position is ensured by the fact that the longitudinal axis forms the central axis of the second connection and at the same time, with the exception of the first and the third connection, the axis of symmetry of the bag. This leads, with the exception of the first and the third connection, to a completely symmetrical and thus advantageous in all respects bag.
- the bag is made of semi-transparent ethylene-vinyl acetate (EVA) with light protection.
- EVA semi-transparent ethylene-vinyl acetate
- the material EVA behaves neutrally with respect to the additives used, the light protection prevents damaging influences by light effect on the Additive and by the semi-transparent nature of the material can be performed at any time a visual visual inspection of the emptying process.
- a method that can be carried out with the bag according to the invention in its various embodiments is characterized by the steps a) to i) of claim 18 and is described in the following description of the figures and, where necessary, commented on.
- An advantageous embodiment of the method provides that for the purpose of quality assurance via the third port on the bag latter a sterile sample can be removed.
- the sampled bag may then be dosed or discarded.
- a bag 10, wherein it is in FIG. 1 is a first bag 10.1 with a capacity of, for example, 10 liters, for the sterile storage of liquid additives Z, such as enzymes, flavors, colors, lipids, probiotic bacteria and other nutrients is in its unfilled state, a flat, rectangular, from a suitable plastic existing structure, as it finds application in its basic form in medical technology.
- liquid additives Z such as enzymes, flavors, colors, lipids, probiotic bacteria and other nutrients
- a tubular film is used with a suitable diameter, which is assembled to a required axial length and then closed at the two open ends by welding, at or in these ends then the respective application-specific precautions, peculiarities or requirements are realized.
- the first bag 10, 10.1 preferably consists of semitransparent ethylene-vinyl acetate (EVA) with light protection. It has at a first upper edge 10.1a provided with a transverse and longitudinal ribs strip-shaped upper edge reinforcement 10.4, which is made by welding the two in contact with each other coming foil surfaces of the folded tube.
- this upper edge reinforcement 10.4 is preferably centrally an elongated, rectangular handle plate 22 fitted with appropriately rounded corners and molded, whereby an additional reinforcement of the upper edge 10.1 a is given.
- the presentation position of the first bag 10, 10.1 in FIG. 1 also corresponds to a suspension position A thereof, in which the removal of the additive Z takes place in the course of an aseptic dosing in a base product P.
- 22 means for suspension 20 in the form of a three-point suspension are formed in the formed in the upper edge reinforcement 10.4 handle plate 22. This consists of two spaced equally sized suspension openings 20.1, wherein the line connecting their centers is oriented perpendicular to the direction of suspension by the suspension position of the first bag 10, 10.1.
- suspension openings 20.1 In the middle between the suspension openings 20.1 is a slot-shaped extending in the direction of the connecting line Recess 20.2 provided centrally and at its upper boundary has an upwardly tapering, rounded-end bulge 20.2a, whose upper boundary is aligned with the respective upper boundary of the receiving openings 20.1.
- the suspension openings 20.1 and the recess 20.2 engage completely through the grip plate 22 and the upper edge reinforcement 10.1a of the first bag 10, 10.1 so that, for example, fork-shaped receiving means can reach through these openings 20.1, 20.2.
- the grip plate 22 expediently has a color which differs markedly from the color of the first bag 10, 10.1, for example yellow. This color coding makes it clear to the user of the first bag 10, 10.1 at first glance where the first bag 10, 10.1 is to be suspended.
- the special color coding of the handle plate 22 can also serve to mark the respectively stored in the first bag 10, 10.1 additive Z to make confusion easily recognizable or prevent it from the outset.
- the upper end of the lower edge reinforcement 10.5 borders a removal-side inner contour 10.3, which according to an advantageous embodiment in each case from outside to inside, in the direction of the longitudinal axis L drops.
- the longitudinal axis L simultaneously also forms the axis of symmetry of the first bag 10, 10.1, if one refers to its longitudinal axis L and disregards asymmetries in the range of the connections described below.
- Based on the receiving position A opens at the lowest point of the removal-side inner contour 10.3 of the removal of the additive Z serving second port 14, preferably in the form of a nozzle-shaped hose access is trained.
- a kinked valve 18 is arranged with the irreversible breaking a barrier at a predetermined breaking point a fluid possiblye connection between the interior of the first bag 10, 10.1 and a removal assembly 100 is made.
- the latter is in FIG. 1 indicated only schematically and in FIG. 2 not shown at all.
- the buckling valve 18 is in the FIGS. 1 and 2 shown only schematically.
- the removal arrangement 100 consists of a removal hose 100.1, which is firmly and tightly connected to the second connection 14 via a coupling 100.2. This may be a positive and / or non-positive or even a material connection.
- the withdrawal tube 100.1 At the end of the withdrawal tube 100.1 facing away from the coupling 100.2, it opens into an injection needle 100.5, with which the additive Z is metered under aseptic conditions into the base product P flowing in a conduit. Seen in the flow direction of the additive, the removal arrangement 100 in front of the injection needle 100.5 a check valve 100.4 and before a filter 100.3.
- the barrier of the kink valve 18 is only broken after the first bag 10, 10.1 has been attached via the three-point suspension 20 into the metering device and shortly before the start of the aseptic metering at the predetermined breaking point.
- the first bag 10, 10.1 and the dispenser assembly 100 secured thereto and fixed thereto are sterilized as a unitary unit by a suitable means. This happens according to the invention already before the filling of the first bag 10, 10.1 with the additive Z.
- a filling of the first bag 10, 10.1 serving preferably designed in the form of a nozzle-shaped hose access first port 12 is provided which is preferably welded after the filling of the first bag 10.
- the first bag 10, 10.1 in the lower edge reinforcement 10.5, adjacent to the second port 14 and the first port 12 opposite, if necessary, the sampling of the first bag 10, 10.1 serving preferably designed in the form of a nozzle-shaped hose access third port 16th on. This is preferably closed by a sealing plug 110, which recloses after a sample removed by means of a withdrawal needle from the first bag 10, 10.1.
- two fixing openings 24 are provided in the lower edge reinforcement 10.5, which are arranged on both sides of the longitudinal axis L oriented perpendicularly in the suspension position A of the first bag 10, 10.1.
- an additional fixation of the first bag 10, 10.1 is given during its filling, wherein in this filling the first bag 10, 10.1 is in an inclined position in which the three terminals 12, 14, 16 form the high point of the arrangement ,
- a second bag 10.2 with a relation to the first bag 10.1 lower capacity, for example, with a capacity of 5 liters shows FIG. 2
- the second bag 10.2 is preferably formed shorter than the first bag 10.1 perpendicular to its longitudinal axis L. This has only a minor effect on the formation of a second upper edge 10.2a and a second lower edge 10.2b, wherein the upper edge reinforcement 10.4 inevitably shorter and the lower edge reinforcement 10.5 is also shorter, and the second lower edge 10.2b preferably parallel to the removal side Inner contour 10.3 runs, while the relevant course in the first bag 10.1 is oriented perpendicular to the longitudinal axis L.
- the distance between the fixing openings 24 is adapted to the smaller transverse dimension of the second bag 10.2 and is smaller than in the case of the first bag 10.1.
- the vorg. Differences are only due to optimization aspects with regard to the shape design of the bags 10.1, 10.2 with their different capacities; they have no influence on the storage with the additive Z and on the general function of the respective bag 10.1, 10.2 in the aseptic dosing process.
- the second bag 10.2 adequately corresponds to that of the first bag 10.1.
- the above description of the first bag 10.1 is therefore fully applicable to the second bag 10.2.
- FIG. 3 shows his front view
- FIG. 3a shows his top view
- FIG. 3b shows a meridian section through the buckling valve 18 according to a in FIG. 3 with CD marked cutting course.
- the buckling valve 18 is, based on the presentation position, in its upper part of a closed end, smaller diameter first portion 18a and in its lower part of a larger diameter second portion 18b, both in an axially relatively short transition region between the large and the small Diameter are interconnected cohesively.
- an inner passage 18c which extends into the first part and ends there and undergoes a discontinuous reduction in its diameter in the region of the transition between the second and the first part 18b, 18a.
- the diameter reduction of the inner passage 18c is matched to the outer diameter of the second and the first part 18b, 18a so that both have a sufficient wall thickness in the predominant axial extent of the inner passage 18c.
- the area of the discontinuously reduced diameter of the inner passage 18 c is placed in such a way to the transition area of the outer diameter, that at the end of the transition region facing the first part 18 a results in a locally limited, circumferential, significant constriction of the wall thickness of the kink valve 18.
- This Einschnürstelle acts as a predetermined breaking point B.
- a sufficient bending moment transverse to the longitudinal axis of the kinked valve 18 leads to a complete breakage of the kinking valve 18 at this point, so that the first part 18a and the second part 18b are separated and the inner passage 18c the second part 18b completely and permeates through the fluid.
- the buckling valve 18 is, with the free end of the first part 18 a first introduced into the second port 14 and there axially displaced so far that after breaking the buckling valve 18 at the predetermined breaking point B of the singly smaller diameter first part 18 a in the first or the second Bag 10.1, 10.2 arrives, so that unimpeded access from the interior of the first or second bag 10.1, 10.2 is ensured via the internal passage 18c to the removal arrangement 100.
- the second part 18b is designed in the region of its free end in the form of a fastening part 18d.
- This attachment part 18d is in the second port 14, which is preferably designed in the form of a nozzle-shaped hose access, positively and / or non-positively and / or materially secured.
- this form and / or adhesion is achieved by thread-shaped beads trapezoidal cross-section and one of them axially spaced, perpendicular to the longitudinal axis of the kink valve 18 annular circumferential projection. It is crucial in the formation of the fastening part 18d that after introducing the kink valve 18 in the hose access a hermetic seal between the outside of the fastening part 18d and the inside of the hose access is made at this point.
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- Packages (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Basic Packing Technique (AREA)
Abstract
Description
Die Erfindung betrifft einen Beutel zur Bevorratung und Entnahme eines flüssigen Zusatzstoffes unter aseptischen Bedingungen, wobei der dem Beutel entnommene Zusatzstoff unter aseptischen Bedingungen in ein Basisprodukt dosiert wird, mit einem am Beutel angeordneten ersten Anschluss zur Befüllung des Beutels mit dem Zusatzstoff und einem zweiten Anschluss zur Entnahme des Zusatzstoffes, mit Mitteln zur Aufhängung des Beutels in einer Aufhängeposition, die so positioniert sind, dass eine schwerkraftseitige Zufuhr des Zusatzstoffes zum zweiten Anschluss erfolgt, mit einer Entnahmeanordnung, die einerseits zum Zwecke der Entnahme des Zusatzstoffes aus dem Beutel mit dem zweiten Anschluss fluidgängig verbunden ist und die andererseits in eine Injektionsnadel zur Dosierung in das Basisprodukt ausmündet sowie ein mit dem Beutel durchführbares Verfahren.The invention relates to a bag for storing and removing a liquid additive under aseptic conditions, wherein the additive removed from the bag is dosed under aseptic conditions into a base product, with a bag arranged on the first port for filling the bag with the additive and a second connection to Removal of the additive, with means for suspending the bag in a suspension position, which are positioned so that a gravitational feed of the additive to the second connection takes place, with a removal arrangement, on the one hand for the purpose of removal of the additive from the bag to the second port fluid is connected and the other ends in a hypodermic needle for dosing in the base product and a feasible with the bag method.
Flüssige Zusatzstoffe wie Enzyme, Aromen, Farben, Lipide, probiotische Bakterien und andere Nährstoffe werden in ein als Basisprödukt fungierendes Lebensmittel dosiert, um dieses mit besonderen Eigenschaften zu versehen. Da diese Zusatzstoffe hitzeempfindlich sein können, erfolgt die Zuführung dieser Additive in das Basisprodukt direkt vor dessen Abfüllung und nach dessen Wärmebehandlung zur Abtötung unerwünschter Keime, beispielsweise einer Ultra-Hoch-TemperaturBehandlung (UHT-Wärmebehandlung), und vorzugsweise im Rahmen einer sog. In-Line-Dosierung. Die Dosierung muss unter aseptischen Bedingungen und mit einem unter gleichfalls aseptischen Bedingungen bevorrateten sterilen Zusatzstoff erfolgen, damit das im Zuge der Wärmebehandlung keimfrei hergestellte Basisprodukt nicht in der Phase der Dosierung mit Keimen infiziert wird.Liquid additives such as enzymes, flavors, colors, lipids, probiotic bacteria and other nutrients are dosed into a basic food product to provide it with special properties. Since these additives can be sensitive to heat, the supply of these additives into the base product takes place directly before its filling and after its heat treatment to kill unwanted germs, for example an ultra-high-temperature treatment (UHT heat treatment), and preferably within the framework of a so-called. line dosing. The dosing must be carried out under aseptic conditions and with a sterile additive also stored under aseptic conditions, so that the basic product produced without germs during the heat treatment is not infected with germs in the dosing phase.
Ein weitverbreiteter Anwendungsfall, bei dem ein Enzym als Zusatzstoff Verwendung findet, stellt die Herstellung lactosereduzierter oder lactosefreier Produkte dar. Hier wird Lactase zur enzymatischen Spaltung der Lactose eingesetzt. Konsumiert werden diese Produkte vor allem von Menschen, die an einem Mangel an ß-Galactosidase im Verdauungstrakt leiden. Eine weitere Einsatzmöglichkeit für lactosereduzierte Milch und verwandte Substanzen ist der Markt für kalorienreduzierte Produkte. Bei der Lactosespaltung entsteht je ein Molekül D-Glucose und β-D-Galactose [TÖPEL, 2004, S.99; [1] JEKLE; Lebensmitteltechnologisches Seminar, Lactosefreie und -reduzierte Milchprodukte, 2004]. Jedes dieser Moleküle hat eine größere Süßkraft als Lactose, so dass bei unverändertem Nährwert ein wesentlich süßeres Produkt hergestellt werden kann. Um eine nahezu vollständige Hydrolyse der Lactose zu gewährleisten, kann z.B. das Enzym ß-Galactosidase bei der Produktion eingesetzt werden. Um die Prozesskosten der Hydrolyse reduzieren zu können, wurden Verfahren entwickelt, bei denen das Enzym unmittelbar vor der Abfüllung zugegeben wird [1]. Man hat hierbei den Vorteil, dass die Distributionsphase als Hydrolysezeit genutzt werden kann und so geringere Enzymdosagen realisierbar sind. Die Dosierungsrate des in Rede stehenden Enzyms bewegt sich in einem Bereich von 0,2 bis 4 ml Enzym/Liter Basisprodukt.A widespread application, in which an enzyme is used as an additive, is the production of lactose-reduced or lactose-free products. Here, lactase is used for the enzymatic cleavage of lactose. These products are mainly consumed by people who lack of ß-galactosidase in the digestive tract. Another possible use for lactose-reduced milk and related substances is the market for calorie-reduced products. Lactose cleavage produces one molecule each of D-glucose and β-D-galactose [TÖPEL, 2004, p. 99 ; [1] JEKLE; Food Technology Seminar, Lactose Free and Reduced Dairy Products, 2004]. Each of these molecules has greater sweetening power than lactose, so that a much sweeter product can be produced with the same nutritional value. To ensure almost complete hydrolysis of the lactose, for example, the enzyme β-galactosidase can be used in the production. In order to be able to reduce the process costs of hydrolysis, processes have been developed in which the enzyme is added immediately before bottling [1]. One has the advantage here that the distribution phase can be used as the hydrolysis time and thus lower enzyme dosages can be realized. The dosage rate of the enzyme in question ranges from 0.2 to 4 ml of enzyme / liter of the base product.
In der Druckschrift der Firma Tetra Pak Processing GmbH, Tetra FlexDos™, Flexibles aseptisches Dosiersystem für flüssige Zusatzstoffe, PD 10080 de 2007-02, ist eine Dosiereinrichtung beschrieben, mit der unter Verwendung eines Beutels der gattungsgemäßen Art, in dem ein Zusatzstoff der in Rede stehenden Art bevorratet ist, eine aseptische In-Line-Dosierung dieses flüssigen Zusatzstoffes in ein Basisprodukt vorgenommen wird. Zu diesem Zweck wird der unter aseptischen Bedingungen mit dem sterilen Zusatzstoff gefüllte gebrauchsfertige 5- oder 10-Liter-Beutel, der seinerseits in einer eimerartigen Umverpackung Aufnahme findet, in die Dosiereinrichtung eingehängt. Im Zuge der Dosierung wird zur Überführung des Zusatzstoffes aus dem Beutel in das Basisprodukt eine als Entnahmeanordnung fungierende separate Schlauchanordnung verwendet, die vor der Dosierung über einen speziellen Adapter an den Beutel angeschlossen wird. Schlauchanordnung und Beutel werden getrennt voneinander her- und bereitgestellt, sie stammen im Regelfall von unterschiedlichen Herstellern und werden erst in der Dosiereinrichtung zusammengeführt und miteinander fest verbunden. An dem dem Adapter abgewandten Ende der Schlauchanordnung ist eine Injektionsnadel angeordnet, über die der Zusatzstoff an einem Injektionspunkt mittels einer auf die Schlauchanordnung von außen einwirkenden Schlauchradpumpe in das Basisprodukt eindosiert wird. Der Injektionspunkt befindet sich an einem durch eine sterile Membran verschlossenen Rohrstutzen einer Rohrleitung, in der das Basisprodukt strömt.In the document Tetra Pak Processing GmbH, Tetra FlexDos ™, flexible aseptic dosing system for liquid additives, PD 10080 de 2007- 02, a metering device is described with the use of a bag of the generic type in which an additive of the in question standing stock type, an aseptic in-line dosage of this liquid additive is made into a base product. For this purpose, the ready-to-use 5 or 10-liter bag filled with the sterile additive under aseptic conditions, which in turn is accommodated in a bucket-like outer packaging, is suspended in the metering device. In the course of dosing, a separate hose arrangement acting as a removal arrangement is used to transfer the additive from the bag into the base product, which tube is connected to the bag via a special adapter prior to dosing. Hose arrangement and bags are prepared and provided separately from each other, they are usually from different manufacturers and are brought together only in the metering device and firmly connected. At the end of the hose assembly facing away from the adapter, an injection needle is arranged, via which the additive at an injection point by means of a hose pump acting on the hose assembly from the outside into the base product is metered. The injection point is located on a sealed by a sterile membrane pipe socket of a pipeline in which the base product flows.
Die bekannte Dosiereinrichtung mit dem zur Anwendung kommenden Beutel und der separaten Schlauchanordnung weisen insbesondere im Bereich des Beutels und der Ankopplung der Schlauchanordnung Nachteile auf, die die absolut erforderliche Sicherheit der Sterilität des Dosierprozesses in Frage stellen können. Der Entnahmeanschluss am Beutel kann vor der Ankopplung der Schlauchanordnung schädlichen Umgebungseinflüssen und/oder möglichen fehlerhaften Handlungen ausgesetzt sein, die die Sterilität der im Zuge des Kopplungsvorganges zusammengeführten, den zu dosierenden Zusatzstoff führenden kritischen Flächen beeinträchtigen können. Eine Sterilisierung dieser kritischen Flächen nach Vollzug des Kopplungsvorganges ist nicht mehr möglich. Da sich der Beutel und die Schlauchanordnung getrennt voneinander jeweils in einer Umverpackung befinden, ergibt sich allein durch diese Aufbewahrungs- und Handhabungssituation eine relativ kostspielige und wenig anwenderfreundliche Ausgangslage sowie eine nicht nur theoretische Möglichkeit zur Kontamination der kritischen Flächen mit Keimen. Darüber hinaus bietet der bekannte Beutel keine Möglichkeit, im Rahmen einer Qualitätssicherung eine sterile Probe aus dem Beutel zu entnehmen. Eine Beprobung des Beutels durch naheliegendes Anstechen scheidet dabei aus, da der beprobte Beutelinhalt nachhaltig unverfälscht bleiben und, falls dies gewünscht ist, einer Dosierung nach der Probenahme noch bedenkenlos zugeführt werden können muss. Des Weiteren hat sich gezeigt, dass der bekannte Beutel nicht vollständig entleeren lässt.The known metering device with the bag used for the purpose and the separate hose arrangement have disadvantages, in particular in the area of the bag and the coupling of the hose arrangement, which can call into question the absolutely required safety of the sterility of the metering process. The extraction port on the bag may be exposed to harmful environmental influences and / or possible faulty actions prior to coupling the hose assembly, which may affect the sterility of the critical surfaces leading to the metered additive in the course of the coupling process. A sterilization of these critical surfaces after completion of the coupling process is no longer possible. Since the bag and the hose assembly are separated from one another in each case in an outer packaging, resulting solely by this storage and handling situation a relatively expensive and less user-friendly starting position and a not only theoretical possibility for contamination of the critical surfaces with germs. In addition, the known bag does not provide a way to remove a sterile sample from the bag as part of a quality assurance. Sampling of the bag by means of proximal puncturing is ruled out since the sampled contents of the bag remain sustainably unadulterated and, if so desired, can still be safely supplied to a dosage after sampling. Furthermore, it has been found that the known bag can not be completely emptied.
Es ist Aufgabe der vorliegenden Erfindung, einen Beutel der gattungsgemäßen Art sowie ein mit dem Beutel durchführbares Verfahren derart weiterzuentwickeln, dass sich der gesamte Dosierprozess und die Handhabung seiner Komponenten sicherer und anwenderfreundlicher gestalten und darüber hinaus Beutel und Entnahmeanordnung gegenüber solchen nach dem bekannt gewordenen Stand der Technik kostengünstiger sind.It is an object of the present invention to develop a bag of the generic type as well as a feasible with the bag method such that the entire dosing process and the handling of its components make safer and more user-friendly and beyond bag and removal arrangement against such after the become known state of Technology are cheaper.
Die Aufgabe wird durch einen Beutel mit den Merkmalen des Anspruchs 1 gelöst. Vorteilhafte Ausgestaltungen des Beutels gemäß der Erfindung sind in den Unteransprüchen beschrieben. Ein mit dem erfindungsgemäßen Beutel durchführbares Verfahren ist Gegenstand des abhängigen Anspruchs 18. Eine vorteilhafte Ausgestaltung des Verfahrens ist in Unteranspruch 19 angegeben.The object is achieved by a bag having the features of claim 1. Advantageous embodiments of the bag according to the invention are described in the subclaims. A feasible with the bag according to the invention method is the subject of
Der erfinderische Grundgedanke besteht darin, dass bereits vor der Befüllung des Beutels mit dem Zusatzstoff die Entnahmeanordnung mit dem der Entnahme dienenden zweiten Anschluss fest und dicht verbunden ist. Diese Verbindung kann vorzugsweise form- und/oder kraftschlüssig verwirklicht sein, beispielsweise in Form einer elastisch duktilen Kupplung, sodass ein Fügen des Beutels mit der Entnahmeanordnung zu einer fest und dicht verbundenen Einheit auf einfachste Weise gegeben ist. Die Verbindung kann aber auch stoffschlüssig ausgeführt werden, beispielsweise durch Verschweißung. In jedem Falle kann die Einheit, bestehend aus dem Beutel und der auf diesem vorzugsweise fixierten Entnahmeanordnung, in Gänze zum Zwecke ihrer Sterilisierung einer geeigneten Behandlung, beispielsweise durch eine sterilisierende Bestrahlung, ausgesetzt werden. Diese erfindungsgemäße Lösung beseitigt sicher die ansonsten bestehende Möglichkeit der Beeinträchtigung der Sterilität der Verbindung, wenn letztere nach der Befüllung des Beutels mit dem Zusatzstoff und vor der Dosierung des Zusatzstoffes in das Basisprodukt hergestellt wird.The inventive idea is that even before the filling of the bag with the additive, the removal arrangement with the removal serving second terminal is firmly and tightly connected. This connection can preferably be realized positively and / or non-positively, for example in the form of an elastically ductile coupling, so that a joining of the bag with the removal arrangement is given to a tight and tightly connected unit in the simplest way. But the connection can also be made cohesively, for example by welding. In any case, the unit, consisting of the bag and the withdrawal device preferably fixed on it, can be exposed in its entirety, for the purpose of sterilization, to a suitable treatment, for example by sterilizing radiation. This solution according to the invention certainly eliminates the otherwise existing possibility of impairing the sterility of the compound when the latter is prepared after filling the bag with the additive and before metering the additive into the base product.
Zu Zwecken der Qualitätssicherung durch Probung des Beutelinhalts ist der Beutel gemäß einer vorteilhaften Aufführungsform mit einem dritten Anschluss zur Probenahme ausgestattet. Diese Möglichkeit kann, muss jedoch nicht zwingend genutzt werden. Hinsichtlich eines sterilen Zugangs zum dritten Anschluss wird weiterhin vorgeschlagen, dass dieser durch einen Verschlussstopfen verschlossen ist, der sich nach einer mittels einer Entnahmenadel aus dem Beutel entnommenen Probe wiederverschließt. Derartige Verschlussstopfen sind aus der Medizintechnik hinlänglich bekannt und haben sich dort bewährt. Da eine Verkeimung des Beutelinhalts bei sachgerechter Beprobung über den dritten Anschluss mit seinem Verschlussstopfen ausgeschlossen ist, kann der beprobte Beutel, wenn dies erwünscht ist, der Dosierung zugeführt werden. Der erfindungsgemäß beprobte Beutel kann aber auch, da er durch die Beprobung nicht nachhaltig verfälscht ist, als Nachweis einer einwandfreien Charge des Zusatzstoffes aufbewahrt werden.For purposes of quality assurance by sampling the bag contents, the bag according to an advantageous embodiment is provided with a third sampling port. This possibility may or may not be mandatory. With regard to a sterile access to the third connection is further proposed that this is closed by a sealing plug, which recloses after a sample removed by means of a sampling needle from the bag sample. Such plugs are well known in medical technology and have proven there. Since a contamination of the bag contents with proper sampling on the third port with its stopper is excluded, the sampled bag, if desired, the dosage can be supplied. However, the bag sampled according to the invention can also be stored as proof of a perfect batch of the additive since it is not permanently adulterated by the sampling.
Es ist weiterhin vorgesehen, dass der jeweilige Anschluss, nämlich jener der Befüllung, der Entnahme und der Probenahme, in Form eines stutzenförmigen Schlauchzuganges ausgebildet ist. Dies ist eine konstruktiv sehr einfache und auch kostengünstige Lösung, die die Handhabung des Beutels zum Zwecke seiner Befüllung und Entleerung mittels einer Schlauchanordnung und die Beprobung über den Verschlussstopfen sehr vereinfacht. Ein weiterer Vorschlag sieht vor, dass der der Befüllung dienende erste Anschluss nach der Befüllung des Beutels verschweißt ist. Dies ist eine absolut sichere Maßnahme, um an dieser kritischen Stelle nachhaltig sterile Bedingungen zu schaffen.It is furthermore provided that the respective connection, namely that of the filling, the removal and the sampling, is designed in the form of a nozzle-shaped hose access. This is a structurally very simple and cost-effective solution that greatly simplifies the handling of the bag for the purpose of its filling and emptying by means of a hose assembly and the sampling of the stopper. Another proposal provides that the filling serving first port is welded after the filling of the bag. This is a completely safe measure to create sustainable sterile conditions at this critical point.
Um auch im Bereich des zweiten Anschlusses nach der Befüllung des Beutels mit dem Zusatzstoff nachhaltig sterile Bedingungen herzustellen, sieht eine weitere Ausführungsform vor, dass im zweiten Anschluss ein Knickventil angeordnet ist, mit dem durch irreversibles Brechen einer Barriere an einer Sollbruchstelle eine fluidgängige Verbindung zwischen dem Innenraum des Beutels und der Entnahmeanordnung hergestellt wird. Die Verbindung mit der Entnahmeanordnung wird erst kurz vor der Inbetriebnahme der Dosierung hergestellt, sodass die Entnahmeanordnung, bestehend aus einem Entnahmeschlauch, einem in diesem angeordneten Filter, einem letzterem in Strömungsrichtung des Zusatzstoffes nachgeordneten Rückschlagventil und einer Injektionsnadel, bis zu diesem Zeitpunkt frei vom Zusatzstoff bleibt.In order to produce sustainable sterile conditions in the region of the second connection after the bag has been filled with the additive, a further embodiment provides for a kink valve to be arranged in the second connection, by means of which a fluid-permeable connection between the catheter is made by irreversibly breaking a barrier at a predetermined breaking point Interior of the bag and the removal arrangement is made. The connection with the removal arrangement is made only shortly before the start of the dosage, so that the removal arrangement, consisting of a sampling tube, arranged in this filter, a latter in the flow direction of the additive downstream check valve and an injection needle, remains free from the additive until this time ,
Um eine sichere Aufhängung und eindeutige Lagefixierung zu erreichen, die insbesondere eine störungsfreie Entleerung des Beutels sicherstellt, schlägt die Erfindung weiterhin vor, dass die Mittel zur Aufhängung des Beutels als Dreipunktaufhängung ausgebildet sind. Damit diese Dreipunktaufhängung besonders stabil ausgestaltet ist, ist weiterhin vorgesehen, dass sie in einer, bezogen auf die Aufhängeposition des Beutels, am oberen Rand des Beutels eingeformten, dessen Randausbildung verstärkenden Griffplatte ausgebildet ist. Um die Griffplatte mit der dort integrierten Dreipunktaufhängung auch optisch unverkennbar zu gestalten und dadurch die Handhabung des Beutels im Zuge seiner Aufhängung sicherer zu machen, sieht ein weiterer Vorschlag vor, dass die Griffplatte eine sich von der Farbe des Beutels deutlich unterscheidende Farbe aufweist. Die farbliche Kennzeichnung der Griffplatte kann aber auch zur Kenntlichmachung und Erkennung des jeweiligen Zusatzstoffes dienen.In order to achieve a secure suspension and clear positional fixation, which ensures in particular a trouble-free emptying of the bag, the invention also proposes that the means for suspending the bag are designed as a three-point suspension. For this three-point suspension is designed to be particularly stable, is further provided that they in one, based on the suspension position of the bag, molded at the top of the bag, the Edge education reinforcing grip plate is formed. To make the handle plate with the built-in three-point suspension and visually unmistakable and thereby make the handling of the bag in the course of its suspension safer, provides a further proposal that the handle plate has a significantly different from the color of the bag color. The color coding of the handle plate can also serve to identify and recognize the respective additive.
Die Erfindung schlägt zur Ausgestaltung der Dreipunktaufhängung weiterhin vor, dass letztere aus zwei beabstandeten Aufhängeöffnungen besteht, die vorzugsweise gleichgroß sind, wobei die Verbindungslinie ihrer Mittelpunkte senkrecht zur durch die Aufhängeposition vorgegebenen Aufhängerichtung des Beutels orientiert ist, und dass zwischen den Aufhängeöffnungen, vorzugsweise mittig, eine sich in Richtung der Verbindungslinie erstreckende schlitzförmige Ausnehmung vorgesehen ist, die an ihrer oberen Begrenzung, vorzugsweise mittig, eine Ausbuchtung aufweist, deren obere Begrenzung mit der jeweiligen oberen Begrenzung der Aufnahmeöffnungen fluchtet. Insbesondere in Verbindung mit der Griffplatte ergibt sich dadurch eine sehr stabile Dreipunktaufhängung, die den Beutel sicher und eindeutig in seiner erforderlichen Aufhängeposition fixiert.The invention also proposes for the design of the three-point suspension that the latter consists of two spaced suspension holes, which are preferably the same size, the line connecting their centers is oriented perpendicular to the suspension position of the bag by the suspension position, and that between the suspension holes, preferably centrally, a is provided in the direction of the connecting line extending slot-shaped recess having at its upper limit, preferably centrally, a bulge whose upper boundary is aligned with the respective upper boundary of the receiving openings. In particular, in conjunction with the handle plate, this results in a very stable three-point suspension, which fixes the bag safely and clearly in its required suspension position.
Eine sichere Entleerung des Beutelinhalts wird insbesondere in der durch die Dreipunktaufhängung eindeutig fixierten Aufhängeposition weiterhin dadurch begünstigt, dass der Beutel, bezogen auf seine Aufhängeposition, an seinem unteren Rand eine jeweils von außen nach innen abfallende entnahmeseitige Innenkontur aufweist, die den Zusatzstoff von außen nach innen unter dem Einfluss der Schwerkraft strömen lässt. Eine restlose Entleerung des Beutels stellt ein anderer Vorschlag sicher, der vorsieht, dass der zweite Anschluss, bezogen auf die Aufhängeposition des Beutels, an der tiefsten Stelle der entnahmeseitigen Innenkontur ausmündet.A safe emptying of the bag contents is further favored in particular in the clearly fixed by the three-point suspension suspension position in that the bag, based on its suspension position, at its lower edge has a respective decreasing from outside to inside removal side inner contour, the additive from outside to inside to flow under the influence of gravity. A complete emptying of the bag ensures another proposal, which provides that the second port, based on the suspension position of the bag, opens at the lowest point of the discharge-side inner contour.
Da dem der Befüllung dienenden ersten Anschluss und dem der Probenahme dienenden dritten Anschluss keine entleerungskritische Bedeutung zukommt, sind diese, bezogen auf die Aufhängeposition des Beutels, am unteren Rand des Beutels und jeweils benachbart zum zweiten Anschluss angeordnet. Der relativ kurze Abstand zwischen den drei Anschlüssen schafft die Möglichkeit, diesen Durchdringungsbereich des Beutels durch geeignete Maßnahmen, beispielsweise durch Verschweißung aneinanderliegender Beutelflächen, zusätzlich zu verstärken.Since the first port used for filling and the third port for sampling do not have any emptying-critical significance, they are at the bottom edge of the bag in relation to the suspension position of the bag and each adjacent to the second terminal. The relatively short distance between the three ports makes it possible to additionally reinforce this penetration area of the bag by suitable measures, for example by welding together adjacent bag surfaces.
Ein weiterer Vorschlag sieht vor, den Beutel im Bereich seiner Dreipunktaufhängung und beiderseits dieses Bereichs sowie im Bereich seiner drei Anschlüsse und ebenfalls beiderseits dieses Bereichs zu verstärken. Dies wird dadurch erreicht, dass der Beutel, bezogen auf seine Aufhängeposition, an seinem oberen Rand eine obere Randverstärkung und/oder an seinem unteren Rand eine untere Randverstärkung aufweist. Diese Verstärkung kann beispielsweise wiederum durch Verschweißung aneinanderliegender Beutelflächen erreicht werden.Another proposal is to reinforce the bag in the area of its three-point suspension and on both sides of this area and in the area of its three connections and also on both sides of this area. This is achieved in that the bag has, based on its suspension position, at its upper edge an upper edge reinforcement and / or at its lower edge a lower edge reinforcement. This reinforcement can, for example, in turn be achieved by welding adjoining bag surfaces.
Um den Beutel unter der Wirkung oder mit zusätzlicher Hilfe der Schwerkraft leichter befüllen zu können, ist er vorzugsweise in eine Schräglage zu verbringen, in der zumindest der zweite Anschluss einen Hochpunkt der Anordnung darstellt. Zur Unterstützung der Fixierung dieser Anordnungslage sieht ein weiterer Vorschlag vor, dass in der unteren Randverstärkung zwei Fixieröffnungen vorgesehen sind, die beiderseits einer in der Aufhängeposition des Beutels senkrecht orientierten Längsachse angeordnet sind.In order to fill the bag more easily under the action or with the aid of gravity, it is preferable to spend it in an inclined position in which at least the second connection represents a high point of the arrangement. To support the fixation of this arrangement situation provides a further proposal that two fixing holes are provided in the lower edge reinforcement, which are arranged on both sides of a vertically oriented in the suspension position of the bag longitudinal axis.
Eine die Entleerung und die Stabilität des Beutels in seiner Aufhängeposition begünstigenden Ausgestaltung wird nach einem anderen Vorschlag dadurch sichergestellt, dass die Längsachse die Mittelachse des zweiten Anschlusses und gleichzeitig, mit Ausnahme des ersten und des dritten Anschlusses, die Symmetrieachse des Beutels bildet. Dies führt, mit Ausnahme des ersten und des dritten Anschlusses, zu einem vollständig symmetrisch ausgebildeten und damit in allen Belangen vorteilhaften Beutel.According to another proposal, a configuration favoring the emptying and the stability of the bag in its hanging position is ensured by the fact that the longitudinal axis forms the central axis of the second connection and at the same time, with the exception of the first and the third connection, the axis of symmetry of the bag. This leads, with the exception of the first and the third connection, to a completely symmetrical and thus advantageous in all respects bag.
Es hat sich als besonders vorteilhaft herausgestellt, wenn der Beutel aus halbtransparentem Ethylenvenylazetat (EVA) mit Lichtschutz besteht. Das Material EVA verhält sich neutral gegenüber den zum Einsatz kommenden Zusatzstoffen, der Lichtschutz verhindert schädigende Einflüsse durch Lichteinwirkung auf den Zusatzstoff und durch die halbtransparente Beschaffenheit des Materials kann jederzeit eine augenfällige optische Kontrolle des Entleerungsvorganges durchgeführt werden.It has been found to be particularly advantageous if the bag is made of semi-transparent ethylene-vinyl acetate (EVA) with light protection. The material EVA behaves neutrally with respect to the additives used, the light protection prevents damaging influences by light effect on the Additive and by the semi-transparent nature of the material can be performed at any time a visual visual inspection of the emptying process.
Ein mit dem erfindungsgemäßen Beutel in seinen vielfältigen Ausführungsformen durchführbares Verfahren ist durch die Schritte a) bis i) des Anspruchs 18 gekennzeichnet und wird in der nachfolgenden Figurenbeschreibung beschrieben und, wo notwendig, kommentiert.A method that can be carried out with the bag according to the invention in its various embodiments is characterized by the steps a) to i) of
Eine vorteilhafte Ausgestaltung des Verfahrens sieht vor, dass zum Zwecke der Qualitätssicherung über den dritten Anschluss am Beutel letzterem eine sterile Probe entnommen werden kann. Der beprobte Beutel kann alsdann der Dosierung zugeführt oder er kann verworfen werden.An advantageous embodiment of the method provides that for the purpose of quality assurance via the third port on the bag latter a sterile sample can be removed. The sampled bag may then be dosed or discarded.
Eine eingehendere Darstellung der Erfindung ergibt sich aus der folgenden Beschreibung und den beigefügten Figuren der Zeichnung sowie aus den Ansprüchen. Während die Erfindung in den verschiedensten Ausführungsformen eines Beutels realisiert ist, werden in der Zeichnung ein erster und ein zweiter Beutel mit unterschiedlichem Fassungsvermögen jeweils in einer bevorzugten Ausführungsform beschrieben. Es zeigen
- Figur 1
- in der Vorderansicht einen erfindungsgemäßen ersten Beutel mit einem Fassungsvermögen von beispielweise 10 Liter;
- Figur 2
- gleichfalls in der Vorderansicht einen erfindungsgemäßen zweiten Beutel mit einem Fassungsvermögen von beispielsweise 5 Liter und
- Figuren 3, 3a, 3b
- eine in
Figur 1 mit "X" gekennzeichnete Einzelheit, die ein Knickventil zeigt, das in einem der Entleerung dienenden zweiten Anschluss Aufnahme findet.
- FIG. 1
- in front view, a first bag according to the invention with a capacity of, for example, 10 liters;
- FIG. 2
- also in the front view of a second bag according to the invention with a capacity of, for example, 5 liters and
- FIGS. 3, 3a, 3b
- one in
FIG. 1 with "X" marked detail, showing a kink valve, which takes in a serving for emptying second port recording.
Ein Beutel 10, wobei es sich in
Der erste Beutel 10, 10.1 gemäß der Erfindung besteht vorzugsweise aus halbtransparentem Ethylenvenylazetat (EVA) mit Lichtschutz. Er weist an einem ersten oberen Rand 10.1a eine mit Quer- und Längsrippen versehene leistenförmige obere Randverstärkung 10.4 auf, die durch Verschweißung der beiden miteinander in Kontakt tretenden Folienflächen des gefalteten Schlauchs hergestellt wird. In diese obere Randverstärkung 10.4 ist vorzugsweise mittig eine langgestreckte, rechteckförmige Griffplatte 22 mit zweckmäßigerweise abgerundeten Ecken eingepasst und eingeformt, wodurch eine zusätzliche Verstärkung des oberen Randes 10.1 a gegeben ist.The
Die Darstellungslage des ersten Beutels 10, 10.1 in
Die Griffplatte 22 weist zweckmäßig eine sich von der Farbe des ersten Beutels 10, 10.1 deutlich unterscheidende Farbe, beispielsweise gelb, auf. Durch diese farbliche Kennzeichnung wird für den Verwender des ersten Beutels 10, 10.1 auf den erste Blick erkennbar, wo der ersten Beutel 10, 10.1 aufzuhängen ist. Die besondere farbliche Kennzeichnung der Griffplatte 22 kann aber auch dazu dienen, den jeweils im ersten Beutel 10, 10.1 bevorrateten Zusatzstoff Z zu kennzeichnen, um Verwechslungen leicht erkennbar zu machen oder von vornherein zu verhindern.The
Bezogen auf seine Aufhängeposition A weist der erste Beutel 10, 10.1 an einem ersten unteren Rand 10.1b eine untere Randverstärkung 10.5 auf, die durch im Wesentlichen quer zu einer Längsachse L des ersten Beutels 10, 10.1 orientierte Verstärkungsrippen, hergestellt beispielsweise durch Verschweißung der beiden miteinander in Kontakt tretenden Folienflächen des gefalteten Schlauchs, gebildet ist.Based on its suspension position A, the
Das obere Ende der unteren Randverstärkung 10.5 berandet eine entnahmeseitige Innenkontur 10.3, die gemäß einer vorteilhaften Ausführungsform jeweils von außen nach innen, in Richtung der Längsachse L, abfällt. Im Ausführungsbeispiel bildet die Längsachse L gleichzeitig auch die Symmetrieachse des ersten Beutels 10, 10.1, wenn man sich auf dessen Längsachse L bezieht und Asymmetrien im Bereich der nachfolgend noch beschriebenen Anschlüsse vernachlässigt. Bezogen auf die Aufnahmeposition A mündet an der tiefsten Stelle der entnahmeseitigen Innenkontur 10.3 ein der Entnahme des Zusatzstoffes Z dienender zweiter Anschluss 14 aus, der vorzugsweise in Form eines stutzenförmigen Schlauchzuganges ausgebildet ist. Durch die sich im Bereich des ersten unteren Randes 10.1b von außen nach innen verjüngende entnahmeseitige Innenkontur 10.3 und in Verbindung mit dem an der tiefsten Stelle der Innenkontur 10.3 ausmündenden zweiten Anschluss 14 ist in Verbindung mit der eindeutig lagefixierten Aufhängeposition A des ersten Beutels 10, 10.1 durch die Dreipunktaufhängung 20 eine störungsfreie und restlose Entleerung des ersten Beutels 10, 10.1 sichergestellt.The upper end of the lower edge reinforcement 10.5 borders a removal-side inner contour 10.3, which according to an advantageous embodiment in each case from outside to inside, in the direction of the longitudinal axis L drops. In the exemplary embodiment, the longitudinal axis L simultaneously also forms the axis of symmetry of the
Im zweiten Anschluss 14 ist, von außen am stutzenförmigen Schlauchzugang zugänglich, ein Knickventil 18 angeordnet, mit dem durch irreversibles Brechen einer Barriere an einer Sollbruchstelle eine fluidgängige Verbindung zwischen dem Innenraum des ersten Beutels 10, 10.1 und einer Entnahmeanordnung 100 hergestellt wird. Letztere ist in
In der unteren Randverstärkung 10.5 ist, benachbart zum zweiten Anschluss 14, ein der Befüllung des ersten Beutels 10, 10.1 dienender, vorzugsweise in Form eines stutzenförmigen Schlauchzuganges ausgebildeter erster Anschluss 12 vorgesehen, der nach der Befüllung des ersten Beutels 10. 10.1 vorzugsweise verschweißt wird. Weiterhin weist der erste Beutel 10, 10.1 in der unteren Randverstärkung 10.5, benachbart zum zweiten Anschluss 14 und dem ersten Anschluss 12 gegenüberliegend, einen im Bedarfsfall der Probenahme aus dem ersten Beutel 10, 10.1 dienenden, vorzugsweise in Form eines stutzenförmigen Schlauchzuganges ausgebildeten dritten Anschluss 16 auf. Dieser ist vorzugsweise durch einen Verschlussstopfen 110 verschlossen, der sich nach einer mittels einer Entnahmenadel aus dem ersten Beutel 10, 10.1 entnommenen Probe wiederverschließt. In der unteren Randverstärkung 10.5 sind außerdem zwei Fixieröffnungen 24 vorgesehen, die beiderseits der in der Aufhängeposition A des ersten Beutels 10, 10.1 senkrecht orientierten Längsachse L angeordnet sind. Mit diesen Fixieröffnungen 24 ist eine zusätzliche Lagefixierung des ersten Beutels 10, 10.1 während dessen Befüllung gegeben, wobei sich bei dieser Befüllung der erste Beutel 10, 10.1 in einer Schräglage befindet, in der die drei Anschlüsse 12, 14, 16 den Hochpunkt der Anordnung bilden.In the lower edge reinforcement 10.5 is adjacent to the
Einen zweiten Beutel 10.2 mit einem gegenüber dem ersten Beutel 10.1 geringeren Fassungsvermögen, beispielsweise mit einem Fassungsvermögen von 5 Liter, zeigt
Das vorstehend erwähnte Knickventil 18 im zweiten Anschluss 14 ist in den
Das Knickventil 18 wird, mit dem freien Ende des ersten Teils 18a zuerst, in den zweiten Anschluss 14 eingeführt und dort so weit axial verschoben, dass nach Brechen des Knickventils 18 an der Sollbruchstelle B der vereinzelte durchmesserkleinere erste Teil 18a in den ersten oder den zweiten Beutel 10.1, 10.2 gelangt, sodass ein unbehinderter Zugang vom Innenraum des ersten oder des zweiten Beutels 10.1, 10.2 über den Innendurchgang 18c zur Entnahmeanordnung 100 sichergestellt ist. Der zweite Teil 18b ist im Bereich seines freien Endes in Form eines Befestigungsteils 18d ausgeführt. Dieser Befestigungsteil 18d ist im zweiten Anschluss 14, der vorzugsweise in Form eines stutzenförmigen Schlauchzuganges ausgebildet ist, form- und/oder kraftschlüssig und/oder auch stoffschlüssig befestigt. Im Ausführungsbeispiel wird dieser Form- und/oder Kraftschluss durch gewindegangförmige Wulste trapezförmigen Querschnitts und einen davon axial beabstandeten, senkrecht zur Längsachse des Knickventils 18 ringförmig umlaufenden Vorsprung erreicht. Entscheidend ist bei der Ausbildung des Befestigungsteils 18d, dass nach Einbringen des Knickventils 18 in den Schlauchzugang eine hermetische Abdichtung zwischen der Außenseite des Befestigungsteils 18d und der Innenseite des Schlauchzuganges an dieser Stelle hergestellt ist.The buckling
Ein Verfahren zur Befüllung des Beutels 10 bzw. 10.1, 10.2 mit dem flüssigen Zusatzstoff Z, zur Bevorratung des Zusatzstoffes Z in dem Beutel 10.1, 10.2 und zur Entnahme des Zusatzstoffes Z aus dem Beutel 10.1, 10.2, jeweils unter aseptischen Bedingungen und durchgeführt mit einem Beutel 10.1, 10.2, wie er vorstehend beschrieben wurde, wird in den nachfolgend angegebenen Schritten a) bis i) durgeführt.
- a) Der Beutel 10.1, 10.2 und die mit diesem verbundene und auf diesem fixierte Entnahmeanordnung 100 werden in sterilisiertem Zustand, bezogen auf die Aufhängeposition A, mit dem oberen Ende des Beutels 10.1, 10.2 zuerst in einen auf einer Seite offenen, als Umverpackung dienenden Umverpackungsbeutel eingeführt. Ein
Ankoppeln der Entnahmeanordnung 100 an den Beutel 10.1, 10.2 in der Dosiereinrichtung und kurz vor der Inbetriebnahme der Dosierung mit den aus dem Stand der Technik bekannten Fehlerquellen wird vermieden. - b) Die Anordnung aus Umverpackungsbeutel und Beutel 10.1, 10.2 wird unter Fixierung über die beiden Fixieröffnungen 24 derart in eine Schräglage verbracht, dass wenigstens der erste
Anschluss 12 den Hochpunkt der Anordnung darstellt. - c) Der Beutel 10.1, 10.2 wird über den ersten
Anschluss 12 mit dem flüssigen Zusatzstoff Z befüllt. - d) Nach der vollständigen Befüllung des Beutels 10.1, 10.2 wird der erste
Anschluss 12 verschweißt. Der Zusatzstoff Z ist nun hermetisch und steril von dem Beutel 10.1, 10.2 umschlossen. - e) Der Umverpackungsbeutel wird durch Verschweißung seiner noch offenen Seite um den Beutel 10.1, 10.2 herum vollständig hermetisch abgeschlossen.
- f) Der umverpackte Beutel 10.1, 10.2 wird an eine Dosiereinrichtung verbracht, dort aus dem Umverpackungsbeutel entnommen und in der Dosiereinrichtung über die
Dreipunktaufhängung 20 in seiner Aufhängeposition A positioniert. Zum Schutz vor Beschädigungen beim Transport kann der Umverpackungsbeutel wiederum in einer Transportverpackung, beispielsweise in einem Karton, Aufnahme finden. - g) Die Injektionsnadel 100.5 am
Ende der Entnahmeanordnung 100 wird unter aseptischen Bedingungen in ihre Dosierposition verbracht, wo Dampf- oder Wasserdampfkondensat-Barrieren die aseptischen Bedingungen während des Dosierprozesses aufrechterhalten. - h) Zeitlich gesehen wird kurz vor der Dosierung des flüssigen Zusatzstoffes Z in das in einer Leitung strömende Basisprodukt P eine fluidgängige Verbindung zwischen dem Innenraum des Beutels 10.1, 10.2 und der
Entnahmeanordnung 100 durch Brechen der Barriere an der Sollbruchstelle B indem Knickventil 18 hergestellt. - i) Der flüssige Zusatzstoff Z wird von dem Beutel 10.1, 10.2 zur Injektionsnadel 100.5 durch von außen auf die
Entnahmeanordnung 100 einwirkende Mittel zwangsweise gefördert.
- a) The bag 10.1, 10.2 and the attached thereto and fixed thereto
removal assembly 100 are in sterilized state, based on the suspension position A, with the upper end of the bag 10.1, 10.2 first in an open on one side, serving as outer packaging bags introduced. A coupling of theremoval assembly 100 to the bag 10.1, 10.2 in the metering device and shortly before the start of the dosage with the error sources known from the prior art is avoided. - b) The arrangement of outer packaging bag and bag 10.1, 10.2 is placed under fixation on the two fixing
holes 24 in such a skew that at least thefirst terminal 12 represents the high point of the arrangement. - c) The bag 10.1, 10.2 is filled via the
first port 12 with the liquid additive Z. - d) After the complete filling of the bag 10.1, 10.2, the
first terminal 12 is welded. The additive Z is now enclosed hermetically and sterile by the bag 10.1, 10.2. - e) The overwrap bag is completely hermetically sealed by welding its still open side around the bag 10.1, 10.2.
- f) The repackaged bag 10.1, 10.2 is brought to a metering device, removed there from the outer packaging bag and positioned in the metering device via the three-
point suspension 20 in its suspension position A. In order to protect against damage during transport, the outer packaging bag can again be accommodated in a transport packaging, for example in a cardboard box. - g) The injection needle 100.5 at the end of the
extraction assembly 100 is placed under aseptic conditions in its dosing position where vapor or water vapor barrier barriers maintain the aseptic conditions during the dosing process. - h) In terms of time, a fluid-permeable connection between the interior of the bag 10.1, 10.2 and the
removal assembly 100 is prepared by breaking the barrier at the predetermined breaking point B in the bucklingvalve 18 shortly before the metering of the liquid additive Z in the flowing in a line base product P. - i) The liquid additive Z is forcibly conveyed from the bag 10.1, 10.2 to the injection needle 100.5 by means acting externally on the
removal arrangement 100.
- 1010
- Beutel, allgemeinPouch, general
- 10.110.1
- erster Beutelfirst bag
- 10.1a10.1a
- erster oberer Randfirst upper edge
- 10.1b10.1b
- erster unterer Randfirst lower edge
- 10.210.2
- zweiter Beutelsecond bag
- 10.2a10.2a
- zweiter oberer Randsecond upper edge
- 10.2b10.2b
- zweiter unterer Randsecond lower edge
- 10.310.3
- (entnahmeseitige) Innenkontur(removal side) inner contour
- 10.410.4
- obere Randverstärkungupper edge reinforcement
- 10.510.5
- untere Randverstärkunglower edge reinforcement
- 1212
- erster Anschluss (Befüllung)first connection (filling)
- 1414
- zweiter Anschluss (Entnahme)second connection (removal)
- 1616
- dritter Anschluss (Probenahme)third connection (sampling)
- 1818
- Knickventil (Brechkonus)Buckling valve (crushing cone)
- 18a18a
- erster Teilfirst part
- 18b18b
- zweiter Teilsecond part
- 18c18c
- InnendurchgangInterior passage
- 18d18d
- Befestigungsteilattachment portion
- 2020
- Mittel zur AufhängungMeans for suspension
- 20.120.1
- Aufhängeöffnungsuspension opening
- 20.220.2
- (schlitzförmige) Ausnehmung(slot-shaped) recess
- 20.2a20.2a
- Ausbuchtungbulge
- 2222
- Griffplattegrip plate
- 2424
- Fixieröffnungpegging
- 100100
- Entnahmeanordnungremoval arrangement
- 100.1100.1
- Entnahmeschlauchsampling hose
- 100.2100.2
- Kupplungclutch
- 100.3100.3
- Filterfilter
- 100.4100.4
- Rückschlagventilcheck valve
- 100.5100.5
- Injektionsnadelinjection needle
- 110110
- Verschlussstopfensealing plug
- AA
- Aufhängepositionhanging position
- BB
- SollbruchstelleBreaking point
- LL
- Längsachselongitudinal axis
- PP
- Basisproduktbase product
- ZZ
- Zusatzstoffadditive
Claims (19)
dadurch gekennzeichnet,
dass die Entnahmeanordnung (100) mit dem zweiten Anschluss (14) verbunden ist und Beutel (10; 10.1, 10.2) und Entnahmeanordnung (100) als Einheit bereits vor der Befüllung des Beutels (10; 10.1, 10.2) mit dem Zusatzstoff (Z) sterilisiert werden.A bag for storing and removing a liquid additive under aseptic conditions, wherein the additive (Z) removed from the bag (10; 10.1, 10.2) is dosed under aseptic conditions into a base product (P), with an additive (10; 10.1, 10.2 ) arranged to fill the bag (10; 10.1, 10.2) with the additive (Z) and a second connection (14) for removal of the additive (Z), with means for suspension (20) of the bag (10 10.1, 10.2) in a suspension position (A), which are positioned so that a gravitational feed of the additive (Z) to the second port (14), with a removal assembly (100), on the one hand for the purpose of removal of the additive ( Z) from the bag (10; 10.1, 10.2) is fluidly connected to the second connection (14) and, on the other hand, discharges into an injection needle (100.5) for metering into the base product (P),
characterized,
in that the removal arrangement (100) is connected to the second connection (14) and the bag (10; 10.1, 10.2) and removal arrangement (100) are already in the unit prior to the filling of the bag (10; 10.1, 10.2) with the additive (Z) be sterilized.
dadurch gekennzeichnet,
dass der Beutel (10; 10.1, 10.2) einen dritten Anschluss (16) zur Probenahme aufweist.Bag according to claim 1,
characterized,
that the bag (10; 10.1, 10.2) a third terminal (16) for sampling.
dadurch gekennzeichnet,
dass der dritte Anschluss (16) durch einen Verschlussstopfen (110) verschlossen ist, der sich nach einer mittels einer Entnahmenadel aus dem Beutel (10; 10.1, 10.2) entnommenen Probe wiederverschließt.Bag according to claim 2,
characterized,
in that the third connection (16) is closed by a sealing plug (110) which reseals after a sample removed from the bag (10; 10.1, 10.2) by means of a withdrawal needle.
dadurch gekennzeichnet,
dass der jeweilige Anschluss (12, 14, 16) in Form eines stutzenförmigen Schlauchzuganges ausgebildet ist.Bag according to one of the preceding claims,
characterized,
that the respective connection (12, 14, 16) is designed in the form of a nozzle-shaped hose access.
dadurch gekennzeichnet,
dass der erste Anschluss (12) nach der Befüllung des Beutels (10; 10.1, 10.2) verschweißt ist.Bag according to one of the preceding claims,
characterized,
that the first port (12) after filling of the bag (10; 10.1, 10.2) is welded.
dadurch gekennzeichnet,
dass im zweiten Anschluss (14) ein Knickventil (18) angeordnet ist, mit dem durch irreversibles Brechen einer Barriere an einer Sollbruchstelle (B) eine fluidgängige Verbindung zwischen dem Innenraum des Beutels (10; 10.1, 10.2) und der Entnahmeanordnung (100) hergestellt ist.Bag according to one of the preceding claims,
characterized,
in that a kink valve (18) is arranged in the second connection (14), by means of which a fluid-permeable connection between the interior of the bag (10; 10.1, 10.2) and the removal arrangement (100) is produced by irreversibly breaking a barrier at a predetermined breaking point (B) is.
dadurch gekennzeichnet,
dass die Mittel zur Aufhängung (20) des Beutels (10; 10.1, 10.2) als Dreipunktaufhängung ausgebildet sind.Bag according to one of the preceding claims,
characterized,
in that the means for suspending (20) the bag (10; 10.1, 10.2) are designed as a three-point suspension.
dadurch gekennzeichnet,
dass die Dreipunktaufhängung (20) in einer, bezogen auf die Aufhängeposition (A) des Beutels (10; 10.1, 10.2), am oberen Rand (10.1a; 10.2a) des Beutels (10; 10.1, 10.2) eingeformten, dessen Randausbildung verstärkenden Griffplatte (22) ausgebildet ist.Bag according to claim 7,
characterized,
in that the three-point suspension (20) in one, with respect to the suspension position (A) of the bag (10; 10.1, 10.2), at the upper edge (10.1a; 10.2a) of the bag (10; 10.1, 10.2) formed reinforcing its edge formation Handle plate (22) is formed.
dadurch gekennzeichnet,
dass die Griffplatte (22) eine sich von der Farbe des Beutels (10; 10.1, 10.2) deutlich unterscheidende Farbe aufweist.Bag according to claim 8,
characterized,
in that the grip plate (22) has a color which differs markedly from the color of the bag (10; 10.1, 10.2).
dadurch gekennzeichnet,
dass die Dreipunktaufhängung (20) aus zwei beabstandeten gleichgroßen Aufhängeöffnungen (20.1) besteht, wobei die Verbindungslinie ihrer Mittelpunkte senkrecht zur durch die Aufhängeposition (A) vorgegebenen Aufhängerichtung des Beutels (10; 10.1, 10.2) orientiert ist, und dass mittig zwischen den Aufhängeöffnungen (20.1) eine sich in Richtung der Verbindungslinie erstreckende schlitzförmige Ausnehmung (20.2) vorgesehen ist, die mittig und an ihrer oberen Begrenzung eine Ausbuchtung (20.2a) aufweist, deren obere Begrenzung mit der jeweiligen oberen Begrenzung der Aufnahmeöffnungen (20.1) fluchtet.Bag according to one of claims 7 to 9,
characterized,
in that the connecting line of its centers is oriented perpendicular to the suspension direction of the bag (10; 10.1, 10.2) predetermined by the suspension position (A), and that in the middle between the suspension openings (20) the three-point suspension (20) consists of two equally spaced suspension openings (20.1). 20.1) is provided in the direction of the connecting line extending slot-shaped recess (20.2) which has centrally and at its upper boundary a bulge (20.2a) whose upper boundary with the respective upper boundary of the receiving openings (20.1) is aligned.
dadurch gekennzeichnet,
dass der Beutel (10; 10.1, 10.2), bezogen auf seine Aufhängeposition (A), an seinem unteren Rand (10.1b; 10.2b) eine jeweils von außen nach innen abfallende entnahmeseitige Innenkontur (10.3) aufweist.Bag according to one of the preceding claims,
characterized,
in that the bag (10, 10.1, 10.2), relative to its suspension position (A), has at its lower edge (10.1b, 10.2b) a respective withdrawal-side inner contour (10.3) sloping from the outside to the inside.
dadurch gekennzeichnet,
dass der zweite Anschluss (14), bezogen auf die Aufhängeposition (A) des Beutels (10; 10.1, 10.2), an der tiefsten Stelle der entnahmeseitigen Innenkontur (10.3) ausmündet.Bag according to claim 11,
characterized,
that the second connection (14), based on the suspension position (A) of the bag (10; 10.1, 10.2), opens at the lowest point of the removal-side inner contour (10.3).
dadurch gekennzeichnet,
dass der erste Anschluss (12) und der dritte Anschluss (16), bezogen auf die Aufhängeposition (A) des Beutels (10; 10.1, 10.2), am unteren Rand des Beutels und jeweils benachbart zum zweiten Anschluss (14) angeordnet sind.Bag according to one of the preceding claims,
characterized,
in that the first connection (12) and the third connection (16), relative to the suspension position (A) of the bag (10; 10.1, 10.2), are arranged at the lower edge of the bag and in each case adjacent to the second connection (14).
dadurch gekennzeichnet,
dass der Beutel (10; 10.1, 10.2), bezogen auf seine Aufhängeposition (A), an seinem oberen Rand (10.1a; 10.2a) eine obere Randverstärkung (10.4) und/oder an seinem unteren Rand (10.1b; 10.2b) eine untere Randverstärkung (10.5) aufweist.Bag according to one of the preceding claims,
characterized,
in that the bag (10; 10.1, 10.2), based on its suspension position (A), has at its upper edge (10.1a; 10.2a) an upper edge reinforcement (10.4) and / or at its lower edge (10.1b; 10.2b) a lower edge reinforcement (10.5).
dadurch gekennzeichnet,
dass in der unteren Randverstärkung (10.5) zwei Fixieröffnungen (24) vorgesehen sind, die beiderseits einer in der Aufhängeposition (A) des Beutels (10; 10.1, 10.2) senkrecht orientierten Längsachse (L) angeordnet sind.Bag according to claim 14,
characterized,
in that two fixing openings (24) are provided in the lower edge reinforcement (10.5), which are arranged on both sides of a longitudinal axis (L) oriented perpendicularly in the suspension position (A) of the bag (10; 10.1, 10.2).
dadurch gekennzeichnet,
dass die Längsachse (L) die Mittelachse des zweiten Anschlusses (14) und gleichzeitig, mit Ausnahme des ersten und des dritten Anschlusses (12, 16), die Symmetrieachse des Beutels (10; 10.1, 10.2) bildet.Bag according to claim 14,
characterized,
in that the longitudinal axis (L) forms the central axis of the second connection (14) and at the same time, with the exception of the first and the third connection (12, 16), the axis of symmetry of the bag (10; 10.1, 10.2).
dadurch gekennzeichnet,
dass das Material des Beutels aus halbtransparentem Ethylenvenylazetat (EVA) mit Lichtschutz besteht.Bag according to one of the preceding claims,
characterized,
that the material of the bag of semi-transparent Ethylenvenylazetat (EVA) having light protection.
gekennzeichnet durch die folgenden Schritte a) bis i):
characterized by the following steps a) to i):
dadurch gekennzeichnet,
dass zum Zwecke der Qualitätssicherung über den dritten Anschluss (16) am Beutel (10; 10.1, 10.2) diesem eine sterile Probe entnommen werden kann.Method according to claim 18,
characterized,
in that, for the purpose of quality assurance, a sterile sample can be taken from the bag (10; 10.1, 10.2) via the third connection (16).
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DK18151019.9T DK3326605T3 (en) | 2011-10-28 | 2012-10-24 | BAG FOR STORAGE AND DISPOSAL OF A LIQUID ADDITION UNDER ASEPTIC CONDITIONS |
EP18151019.9A EP3326605B1 (en) | 2011-10-28 | 2012-10-24 | Bag for storing and dispensing a liquid additive under aseptic conditions |
PL12007290T PL2628474T3 (en) | 2011-10-28 | 2012-10-24 | Bag for storing and dispensing a liquid additive under aseptic conditions |
PL18151019T PL3326605T3 (en) | 2011-10-28 | 2012-10-24 | Bag for storing and dispensing a liquid additive under aseptic conditions |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102011117268A DE102011117268A1 (en) | 2011-10-28 | 2011-10-28 | Bag for storing and removing a liquid additive under aseptic conditions |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP18151019.9A Division EP3326605B1 (en) | 2011-10-28 | 2012-10-24 | Bag for storing and dispensing a liquid additive under aseptic conditions |
EP18151019.9A Division-Into EP3326605B1 (en) | 2011-10-28 | 2012-10-24 | Bag for storing and dispensing a liquid additive under aseptic conditions |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2628474A1 true EP2628474A1 (en) | 2013-08-21 |
EP2628474B1 EP2628474B1 (en) | 2018-11-28 |
Family
ID=47088633
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP18151019.9A Active EP3326605B1 (en) | 2011-10-28 | 2012-10-24 | Bag for storing and dispensing a liquid additive under aseptic conditions |
EP12007290.5A Active EP2628474B1 (en) | 2011-10-28 | 2012-10-24 | Bag for storing and dispensing a liquid additive under aseptic conditions |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP18151019.9A Active EP3326605B1 (en) | 2011-10-28 | 2012-10-24 | Bag for storing and dispensing a liquid additive under aseptic conditions |
Country Status (6)
Country | Link |
---|---|
EP (2) | EP3326605B1 (en) |
DE (1) | DE102011117268A1 (en) |
DK (2) | DK2628474T3 (en) |
ES (2) | ES2712926T3 (en) |
PL (2) | PL2628474T3 (en) |
PT (2) | PT2628474T (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20210212894A1 (en) * | 2020-01-15 | 2021-07-15 | Fresenius Medical Care Holdings, Inc. | Flexible medical containers and related methods |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102022110499A1 (en) | 2022-04-29 | 2023-11-02 | Raumedic Ag | Bag for holding a medical or pharmaceutical medium, hose with a connector for connection to such a bag and arrangement with such a bag and with such a connector |
Citations (8)
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---|---|---|---|---|
GB1027288A (en) | 1962-07-23 | 1966-04-27 | Abbott Lab | Bag and method of making same |
DE3319633A1 (en) * | 1982-06-09 | 1984-01-05 | Miles Laboratories, Inc., 46515 Elkhart, Ind. | CANNULA CUTLERY |
DE8200215U1 (en) | 1982-01-07 | 1984-09-13 | Fresenius AG, 6380 Bad Homburg | Physiologically safe pouch that can be sterilized above 110 ° C |
DE3316615A1 (en) | 1983-05-06 | 1984-11-08 | Fresenius AG, 6380 Bad Homburg | Apparatus for enteral nutrition |
EP0223604A2 (en) | 1985-11-19 | 1987-05-27 | Coloplast A/S | A water bag for irrigating the colon |
WO1989003697A1 (en) * | 1987-10-22 | 1989-05-05 | Leonard Barry French | Collapsible solution container |
EP0315740A2 (en) | 1987-11-10 | 1989-05-17 | Baxter International Inc. | System for preservation, preparation and administration of infusion solutions for parenteral nutrition |
DE4317316A1 (en) | 1993-05-25 | 1994-12-01 | Fresenius Ag | Alimentation bag with welded-on pump pocket |
Family Cites Families (3)
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US4435179A (en) * | 1981-11-09 | 1984-03-06 | Biotest-Serum-Institut Gmbh | Blood bags with interconnecting system |
US4586928A (en) * | 1984-10-09 | 1986-05-06 | Miles Laboratories, Inc. | Pivoting frangible valve for plastic bags |
WO2005117802A1 (en) * | 2004-06-01 | 2005-12-15 | Gambro Lundia Ab | Container for medical solution |
-
2011
- 2011-10-28 DE DE102011117268A patent/DE102011117268A1/en not_active Ceased
-
2012
- 2012-10-24 EP EP18151019.9A patent/EP3326605B1/en active Active
- 2012-10-24 ES ES12007290T patent/ES2712926T3/en active Active
- 2012-10-24 ES ES18151019T patent/ES2847277T3/en active Active
- 2012-10-24 PT PT12007290T patent/PT2628474T/en unknown
- 2012-10-24 PL PL12007290T patent/PL2628474T3/en unknown
- 2012-10-24 PL PL18151019T patent/PL3326605T3/en unknown
- 2012-10-24 DK DK12007290.5T patent/DK2628474T3/en active
- 2012-10-24 PT PT181510199T patent/PT3326605T/en unknown
- 2012-10-24 DK DK18151019.9T patent/DK3326605T3/en active
- 2012-10-24 EP EP12007290.5A patent/EP2628474B1/en active Active
Patent Citations (8)
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GB1027288A (en) | 1962-07-23 | 1966-04-27 | Abbott Lab | Bag and method of making same |
DE8200215U1 (en) | 1982-01-07 | 1984-09-13 | Fresenius AG, 6380 Bad Homburg | Physiologically safe pouch that can be sterilized above 110 ° C |
DE3319633A1 (en) * | 1982-06-09 | 1984-01-05 | Miles Laboratories, Inc., 46515 Elkhart, Ind. | CANNULA CUTLERY |
DE3316615A1 (en) | 1983-05-06 | 1984-11-08 | Fresenius AG, 6380 Bad Homburg | Apparatus for enteral nutrition |
EP0223604A2 (en) | 1985-11-19 | 1987-05-27 | Coloplast A/S | A water bag for irrigating the colon |
WO1989003697A1 (en) * | 1987-10-22 | 1989-05-05 | Leonard Barry French | Collapsible solution container |
EP0315740A2 (en) | 1987-11-10 | 1989-05-17 | Baxter International Inc. | System for preservation, preparation and administration of infusion solutions for parenteral nutrition |
DE4317316A1 (en) | 1993-05-25 | 1994-12-01 | Fresenius Ag | Alimentation bag with welded-on pump pocket |
Non-Patent Citations (8)
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"Flex Dos injecte des principes actifs a travers l'emballage", PACKAGING FRANCE, 1 February 2006 (2006-02-01), XP055258880, Retrieved from the Internet <URL:http://www.packaging-france.com/emballages/metal/flex-dos-injecte-des-principes-actifs-a-travers-l-emballage-50374.html> |
"optiferm GmbH, 87466 Oy-Mittelberg", article "Beutel zur Bevorratung und Entnahme eines flüssigen Zusatzstoffes unter aseptischen Bedingungen" |
"Tetra FlexDos TM Flexibles aseptisches Dosiersystem fiir fliissige Zusatzstoffe Highlights Flexible Produktion", TETRA PAK, March 2006 (2006-03-01), pages 1 - 7, XP055263223 |
FLEMMING JORGENSEN; PETER LAMBERT: "Accurate Biopharmaceutical Dispensing: Peristaltic or Piston Pumps?", INNOVATIONS IN PHARMACEUTICAL TECHNOLOGY, pages 78 - 80, XP055258902 |
JAMES AGALLOCO ET AL: "Advanced Aseptic Processing Technology", 2010, INFORMA HEALTHCARE, article "Innovations in aseptic processing technology", pages: 28 - 35, XP055258889 |
JEKLE, LEBENSMITTELTECHNOLOGISCHES SEMINAR, LACTOSEFREIE UND -REDUZIERTE MILCHPRODUKTE, 2004 |
THOMAS WIESE: "Dosieren "just in time". FlexDos ermoglicht hochste aseptische Dosierprazision fur sensible Zusatzstoffe", LIBENSMITTE TECHIK, June 2007 (2007-06-01), pages 14 - 16, XP055258875, Retrieved from the Internet <URL:www.packaqinq-online.com> |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20210212894A1 (en) * | 2020-01-15 | 2021-07-15 | Fresenius Medical Care Holdings, Inc. | Flexible medical containers and related methods |
WO2021146369A1 (en) * | 2020-01-15 | 2021-07-22 | Fresenius Medical Care Holdings, Inc. | Flexible medical containers and related methods |
Also Published As
Publication number | Publication date |
---|---|
EP3326605B1 (en) | 2020-11-04 |
DK3326605T3 (en) | 2021-02-08 |
EP2628474B1 (en) | 2018-11-28 |
PT2628474T (en) | 2019-03-07 |
PL3326605T3 (en) | 2021-05-04 |
PL2628474T3 (en) | 2019-07-31 |
PT3326605T (en) | 2021-01-14 |
ES2847277T3 (en) | 2021-08-02 |
DE102011117268A1 (en) | 2013-05-02 |
EP3326605A1 (en) | 2018-05-30 |
DK2628474T3 (en) | 2019-03-25 |
ES2712926T3 (en) | 2019-05-16 |
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