EP3326605B1 - Sac destiné à approvisionner et à extraire un additif liquide sous conditions aseptiques - Google Patents
Sac destiné à approvisionner et à extraire un additif liquide sous conditions aseptiques Download PDFInfo
- Publication number
- EP3326605B1 EP3326605B1 EP18151019.9A EP18151019A EP3326605B1 EP 3326605 B1 EP3326605 B1 EP 3326605B1 EP 18151019 A EP18151019 A EP 18151019A EP 3326605 B1 EP3326605 B1 EP 3326605B1
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- EP
- European Patent Office
- Prior art keywords
- bag
- port
- bag according
- suspended position
- suspension
- 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.)
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- 239000000654 additive Substances 0.000 title claims description 42
- 230000000996 additive effect Effects 0.000 title claims description 36
- 239000007788 liquid Substances 0.000 title claims description 11
- 239000000725 suspension Substances 0.000 claims description 34
- 230000002787 reinforcement Effects 0.000 claims description 21
- 238000005070 sampling Methods 0.000 claims description 15
- 230000007704 transition Effects 0.000 claims description 9
- 239000000463 material Substances 0.000 claims description 6
- 239000005038 ethylene vinyl acetate Substances 0.000 claims description 4
- 230000009467 reduction Effects 0.000 claims description 4
- 238000007789 sealing Methods 0.000 claims description 4
- 230000003014 reinforcing effect Effects 0.000 claims description 3
- 239000012530 fluid Substances 0.000 claims description 2
- 230000007423 decrease Effects 0.000 claims 1
- 238000000034 method Methods 0.000 description 10
- 238000010168 coupling process Methods 0.000 description 9
- 238000002347 injection Methods 0.000 description 8
- 239000007924 injection Substances 0.000 description 8
- 238000004806 packaging method and process Methods 0.000 description 8
- 108090000790 Enzymes Proteins 0.000 description 7
- 102000004190 Enzymes Human genes 0.000 description 7
- 230000008878 coupling Effects 0.000 description 7
- 238000005859 coupling reaction Methods 0.000 description 7
- 229940088598 enzyme Drugs 0.000 description 7
- 230000008569 process Effects 0.000 description 7
- 238000003466 welding Methods 0.000 description 7
- 239000008101 lactose Substances 0.000 description 6
- 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 5
- 230000004888 barrier function Effects 0.000 description 5
- 244000052616 bacterial pathogen Species 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000000605 extraction 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
- 238000000275 quality assurance Methods 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 108010005774 beta-Galactosidase Proteins 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 239000003086 colorant Substances 0.000 description 2
- 239000000796 flavoring agent Substances 0.000 description 2
- 235000019634 flavors Nutrition 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 230000005484 gravity Effects 0.000 description 2
- 238000010438 heat treatment Methods 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
- 239000000243 solution Substances 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 102100026189 Beta-galactosidase Human genes 0.000 description 1
- 201000008892 GM1 Gangliosidosis Diseases 0.000 description 1
- 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-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 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
- 230000015556 catabolic process Effects 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 235000013365 dairy product Nutrition 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
- 239000011888 foil Substances 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
- 229940116108 lactase Drugs 0.000 description 1
- 230000007774 longterm 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
- 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
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
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- 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 filling and dispensing a liquid additive according to the appended claims.
- Liquid additives such as enzymes, flavors, colors, lipids, probiotic bacteria and other nutrients are dosed into a food that acts as a basic product in order to give it special properties. Since these additives can be heat-sensitive, these additives are added to the base product directly before it is filled and after it has been heat-treated to kill undesirable germs, for example an ultra-high temperature treatment (UHT heat treatment), and preferably as part of what is known as an internal Line dosing. Dosing must take place under aseptic conditions and with a sterile additive that is also stored under aseptic conditions, so that the basic product, which has been produced aseptically in the course of the heat treatment, is not infected with germs in the dosage 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 breakdown of lactose. These products are mainly consumed by people who suffer from a deficiency of ⁇ -galactosidase in the digestive tract.
- Another possible application for low-lactose milk and related substances is the market for low-calorie products.
- lactose is broken down, one molecule each of D-glucose and ⁇ -D-galactose is produced [ T ⁇ PEL, 2004, p.99; [1] JEKLE; Food Technology Seminar, Lactose-Free and Lactose-Reduced Dairy Products, 2004].
- each of these molecules has a greater sweetening power than lactose, so that a much sweeter product can be made with the same nutritional value.
- the enzyme ⁇ -galactosidase for example, can be used in production.
- processes have been developed in which the enzyme is added immediately before filling [1]. The advantage here is that the distribution phase can be used as a hydrolysis time and thus lower enzyme dosages can be achieved.
- the dosage rate of the enzyme in question moves in a range from 0.2 to 4 ml enzyme / liter of basic product.
- Tetra FlexDos TM Flexible Aseptic Dosing System for Liquid Additives
- PD 10080 de 2007-02 a dosing device is described with which, using a bag of the generic type in which an additive of the in question standing type is stored, an aseptic in-line dosing of this liquid additive is carried out in a basic product.
- the ready-to-use 5 or 10 liter bag which is filled under aseptic conditions with the sterile additive and which in turn is held in a bucket-like outer packaging, is placed in the Dosing device suspended.
- a separate hose arrangement functioning as a removal arrangement is used to transfer the additive from the bag into the basic product, which is connected to the bag via a special adapter before the dosing.
- the hose arrangement and the bag are manufactured and provided separately from one another; they usually come from different manufacturers and are only brought together and firmly connected to one another in the metering device.
- an injection needle is arranged, via which the additive is metered into the base product at an injection point by means of a hose wheel pump acting on the hose arrangement from the outside.
- the injection point is located on a pipe socket, closed by a sterile membrane, of a pipeline in which the basic product flows.
- WO 2005/117802 A1 describes a bag with removable kink valves.
- the known dosing device with the bag used and the separate hose arrangement have disadvantages, particularly in the area of the bag and the coupling of the hose arrangement, which can jeopardize the absolutely necessary safety of the sterility of the dosing process.
- the extraction connection on the bag can be exposed to harmful environmental influences and / or possible incorrect actions before the coupling of the hose arrangement, which can impair the sterility of the critical surfaces carrying the additive to be dosed which are brought together in the course of the coupling process. It is no longer possible to sterilize these critical areas after the coupling process has been completed.
- the known bag does not offer any possibility of taking a sterile sample from the bag as part of quality assurance. Sampling the bag by piercing it close by is ruled out, since the sampled bag contents remain unchanged in the long term and, if so desired, it must still be possible to dispense safely after sampling. Furthermore, it has been shown that the known bag cannot be completely emptied.
- the object of the present invention is to further develop a bag of the generic type in such a way that the entire dosing process and the handling of its components are safer and more user-friendly and, moreover, the bag and removal arrangement are more cost-effective than those according to the known prior art.
- the basic idea of the invention is that the removal arrangement is firmly and tightly connected to the second connection used for removal even before the bag is filled with the additive.
- This connection can preferably be implemented positively and / or non-positively, for example in the form of an elastically ductile coupling, so that the bag can be joined to the removal arrangement to form a firmly and tightly connected unit in the simplest way.
- the connection can, however, also be made with a material fit, for example by welding.
- the unit consisting of the bag and the removal arrangement preferably fixed thereon are entirely subjected to a suitable treatment, for example by means of sterilizing radiation, for the purpose of their sterilization.
- This solution according to the invention safely eliminates the otherwise existing possibility of impairing the sterility of the connection if the latter is produced after the bag has been filled with the additive and before the additive is added to the base product.
- the bag is equipped with a third connection for sampling.
- This option can, but does not necessarily have to be used.
- this be closed by a sealing stopper, which closes again after a sample has been taken from the bag by means of a sampling needle.
- sealing plugs are well known from medical technology and have proven themselves there. Since the contents of the bag cannot become contaminated with proper sampling via the third connection with its stopper, the sampled bag can be dispensed if desired.
- the bag sampled according to the invention can, however, since it has not been permanently falsified by the sampling, be kept as evidence of a faultless batch of the additive.
- connection namely that of the filling, the removal and the sampling
- the respective connection is designed in the form of a nozzle-shaped hose access.
- This is a structurally very simple and also inexpensive solution, which greatly simplifies the handling of the bag for the purpose of its filling and emptying by means of a hose arrangement and the sampling via the closure plug.
- the first connection serving for filling is welded after the bag has been filled. This is an absolutely safe measure to create sustainably sterile conditions at this critical point.
- a further embodiment provides that a kink valve is arranged in the second connection, with which a fluid-permeable connection between the can be established by irreversibly breaking a barrier at a predetermined breaking point Interior of the bag and the removal assembly is made.
- the connection with the dispensing arrangement is only established shortly before the start-up of the dosing, so that the dispensing arrangement, consisting of a dispensing hose, a filter arranged in this, a non-return valve downstream in the flow direction of the additive and an injection needle, remains free of the additive up to this point .
- the invention further proposes that the means for suspending the bag are designed as three-point suspension. So that this three-point suspension is designed to be particularly stable, it is also provided that it is formed in a grip plate which is formed on the upper edge of the bag and which reinforces its edge formation, based on the suspension position of the bag.
- a further proposal provides that the handle plate has a color that is clearly different from the color of the bag. The colored one Identification of the grip plate can also serve to identify and identify the respective additive.
- the invention further proposes that the latter consists of two spaced-apart suspension openings, which are preferably of the same size, the connecting line of their midpoints being oriented perpendicular to the hanging direction of the bag specified by the suspension position, and that between the suspension openings, preferably in the middle, a Slit-shaped recess extending in the direction of the connecting line is provided, which has a bulge at its upper limit, preferably in the center, the upper limit of which is aligned with the respective upper limit of the receiving openings.
- this results in a very stable three-point suspension that securely and clearly fixes the bag in its required suspension position.
- first connection used for filling and the third connection used for sampling are not critical for emptying, they are at the lower edge of the bag in relation to the hanging position of the bag and each arranged adjacent to the second connection.
- the relatively short distance between the three connections creates the possibility of additionally reinforcing this penetration area of the bag by suitable measures, for example by welding together bag surfaces.
- the bag is reinforced 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, in relation to its hanging position, has an upper edge reinforcement on its upper edge and / or a lower edge reinforcement on its lower edge. This reinforcement can again be achieved, for example, by welding together bag surfaces.
- a further proposal provides that two fixing openings are provided in the lower edge reinforcement, which are arranged on both sides of a longitudinal axis which is oriented perpendicularly in the hanging position of the bag.
- the bag is made of semi-transparent ethylene vinyl acetate (EVA) with light protection.
- EVA semi-transparent ethylene vinyl acetate
- the EVA material behaves neutrally towards the additives used, the light protection prevents damaging influences from the effects of light on the additive and the semi-transparent nature of the material means that the emptying process can be visually checked at any time.
- a method that can be carried out with the bag according to the invention in its various embodiments is characterized by 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 a sterile sample can be taken from the bag via the third connection on the bag for the purpose of quality assurance.
- the sampled bag can then be added to the dosage or it can be discarded.
- a bag 10, which is in Figure 1 is a first bag 10.1 with a capacity of 10 liters, for example, for 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 one suitable plastic existing structure, as it is used in its basic form in medical technology.
- liquid additives Z such as enzymes, flavors, colors, lipids, probiotic bacteria and other nutrients
- a tubular film with a suitable diameter is usually used, which is tailored to the required axial length and then closed by welding at the two open ends, with the respective application-specific precautions, special features or requirements being implemented at or in these ends.
- the first bag 10, 10.1 preferably consists of semi-transparent ethylene vinyl acetate (EVA) with light protection.
- EVA semi-transparent ethylene vinyl acetate
- this upper edge reinforcement 10.4 there is preferably an elongated, rectangular grip plate 22 with appropriately rounded corners fitted and molded, whereby an additional reinforcement of the upper edge 10.1 a is given.
- the position of the first bag 10, 10.1 in Figure 1 also corresponds to a suspension position A of the same, in which the removal of the additive Z takes place in the course of aseptic dosing into a basic product P.
- means for suspension 20 in the form of a three-point suspension are formed in the grip plate 22 molded into the upper edge reinforcement 10.4. This consists of two spaced-apart suspension openings 20.1 of the same size, the connecting line of their center points being oriented perpendicular to the suspension direction of the first bag 10, 10.1 predetermined by the suspension position A.
- a slot-shaped recess 20.2 which extends in the direction of the connecting line and which has an upwardly tapering bulge 20.2a which is rounded at the end and whose upper limit is aligned with the respective upper limit of the receiving openings 20.1 .
- the suspension openings 20.1 and the recess 20.2 extend completely through the grip plate 22 and the upper edge reinforcement 10.la of the first bag 10, 10.1, so that fork-shaped receiving means, for example, can reach through these openings 20.1, 20.2.
- the grip plate 22 expediently has a color which is clearly different from the color of the first bag 10, 10.1, for example yellow. This color coding makes it possible for the user of the first bag 10, 10.1 to see at a glance where the first bag 10, 10.1 is to be hung.
- the special color coding of the grip plate 22 can also be used to identify each to identify the additive Z stored in the first bag 10, 10.1 in order to make confusion easily recognizable or to prevent it from the outset.
- the first bag 10, 10.1 has a lower edge reinforcement 10.5 on a first lower edge 10.1b, which is produced by reinforcing ribs oriented essentially transversely to a longitudinal axis L of the first bag 10, 10.1, for example by welding the two together coming into contact film surfaces of the folded tube is formed.
- the upper end of the lower edge reinforcement 10.5 borders an inner contour 10.3 on the removal side, which, according to an advantageous embodiment, slopes from the outside inwards, in the direction of the longitudinal axis L.
- the longitudinal axis L also simultaneously forms the axis of symmetry of the first bag 10, 10.1 if one refers to its longitudinal axis L and neglects asymmetries in the area of the connections described below.
- a second connection 14 which is used to remove the additive Z and is preferably designed in the form of a nozzle-shaped hose access, opens out at the lowest point of the inner contour 10.3 on the removal side.
- a kink valve 18 is arranged, with which by irreversible breaking a barrier at a predetermined breaking point, a fluid-accessible connection between the interior of the first bag 10, 10.1 and a removal arrangement 100 is established.
- the latter is in Figure 1 only indicated schematically and in Figure 2 not shown at all.
- the kink valve 18 is in the Figures 1 and 2 only shown 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 can be a form-fitting and / or non-positive connection or a material connection.
- the withdrawal arrangement 100 has a check valve 100.4 in front of the injection needle 100.5 and a filter 100.3 in front of it.
- the barrier of the kink valve 18 is only broken after the first bag 10, 10.1 has been suspended via the three-point suspension 20 in the metering device and shortly before the aseptic metering is started at the predetermined breaking point.
- the first bag 10, 10.1 and the removal arrangement 100 firmly connected to it and fixed on it are sterilized as a unit that belongs together with a suitable means. According to the invention, this takes place before the first bag 10, 10.1 is filled with the additive Z.
- a first connection 12 is provided, which is used to fill the first bag 10, 10.1, preferably in the form of a nozzle-shaped hose access and which is preferably welded after the first bag 10, 10.1 has been filled. Furthermore, the first bag 10, 10.1 has in the lower edge reinforcement 10.5, adjacent to the second connection 14 and opposite the first connection 12, a sampling device from the first bag 10, 10.1 serving, preferably designed in the form of a nozzle-shaped hose access third connection 16. This is preferably closed by a stopper 110, which closes again after a sample has been taken from the first bag 10, 10.1 by means of a sampling needle.
- two fixing openings 24 are provided in the lower edge reinforcement 10.5, which are arranged on both sides of the longitudinal axis L, which is perpendicularly oriented in the hanging position A of the first bag 10, 10.1. These fixing openings 24 provide an additional positional fixation of the first bag 10, 10.1 while it is being filled, the first bag 10, 10.1 being in an inclined position during this filling, in which the three connections 12, 14, 16 form the highest point of the arrangement .
- the second bag 10.2 is preferably shorter than the first bag 10.1 perpendicular to its longitudinal axis L. This only has a slight influence on the formation of a second upper edge 10.2a and a second lower edge 10.2b, the upper edge reinforcement 10.4 being shorter and the lower edge reinforcement 10.5 also being shorter, and the second lower edge 10.2b preferably parallel to the removal side Inner contour 10.3 runs, while the course in this regard in the case of 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 previous Differences are only due to optimization aspects with regard to the shape of the bags 10.1, 10.2 with their different capacities; they have no influence on the supply of 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 correspond to those of the first bag 10.1.
- the above description of the first bag 10.1 in this regard can therefore be transferred without restriction to the second bag 10.2.
- the aforementioned kink valve 18 in the second port 14 is in the Figures 3, 3a and 3b shown.
- Figure 3 shows his front view
- Figure 3a shows its top view
- Figure 3b shows a meridional section through the kink valve 18 corresponding to one in Figure 3 Cutting line marked with CD.
- the kink valve 18 consists, based on the position shown, in its upper part of a closed end, smaller-diameter first part 18a and in its lower part of a larger-diameter second part 18b, both in an axially relatively short transition area between the large and small Diameter are firmly connected to each other.
- an inner passage 18c engages in the second part 18b, which extends into the first part and ends there and which experiences a discontinuous reduction in 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 that both have a sufficient wall thickness in the predominantly axial extent of the inner passage 18c.
- the area of the discontinuously reduced diameter of the inner passage 18c is placed in relation to the transition area of the outer diameter in such a way that a locally limited, circumferential, significant constriction of the wall thickness of the kink valve 18 results at the end of the transition area facing the first part 18a. This constriction acts as a predetermined breaking point B.
- a sufficient bending moment transverse to the longitudinal axis of the kink valve 18 leads to a complete breakage of the kink valve 18 at this point, so that the first part 18a and the second part 18b are isolated and the inner passage 18c penetrates the second part 18b completely and in a fluid-permeable manner.
- the kink valve 18, with the free end of the first part 18a first, is inserted into the second connection 14 and axially displaced there so far that after the kink valve 18 has broken at the predetermined breaking point B, the isolated first part 18a of smaller diameter enters the first or second Bag 10.1, 10.2 arrives, so that unimpeded access from the interior of the first or the second bag 10.1, 10.2 via the inner passage 18c to the removal arrangement 100 is ensured.
- the second part 18b is designed in the area of its free end in the form of a fastening part 18d.
- This fastening part 18d is fastened in the second connection 14, which is preferably designed in the form of a nozzle-shaped hose access, with a positive and / or non-positive fit and / or material fit.
- this form fit and / or force fit is achieved by means of thread-like beads of trapezoidal cross-section and an axially spaced-apart projection that runs around the longitudinal axis of the kink valve 18 in a ring shape.
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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)
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Claims (14)
- Sac pour l'approvisionnement et la distribution d'un additif liquide, comprenant des moyens de suspension (20) pour le sac (10 ; 10.1, 10.2) dans une position de suspension à l'extrémité supérieure du sac, comprenant au moins un premier raccord (12) disposé sur le sac (10 ; 10.1, 10.2) et un deuxième raccord (14) disposé à l'extrémité inférieure du sac (A) dans la position de suspension, pour la communication fluidique avec un dispositif d'extraction, une soupape de limitation de pression (18) disposée dans le deuxième raccord (14) avec une zone de rupture théorique (B),
dans lequel la soupape de limitation de pression (18) consiste au niveau de sa partie supérieure en une partie à diamètre plus petit (18a) fermée à son extrémité et au niveau de sa partie inférieure en une deuxième partie à diamètre plus grand (18b), lesquelles sont reliées entre elles par le biais d'une région de transition courte, dans lequel un passage intérieur (18c) s'engage dans la deuxième partie (18b) par en dessous, lequel s'étend jusqu'à l'intérieur de la première partie (18a) et se termine à cet endroit et lequel présente une réduction discontinue de son diamètre dans la région de la région de transition, la réduction de diamètre du passage intérieur (18c) est adaptée de telle façon au diamètre extérieur des première et deuxième parties (18a, 18b), que celles-ci présentent toutes deux une épaisseur de paroi suffisante dans la région de transition dans la région d'extension axiale du passage intérieur, la région du diamètre réduit de façon discontinue du passage intérieur (18c) est placée de telle façon par rapport à la région de transition des diamètres extérieurs, qu'un rétrécissement significatif périphérique limité localement de l'épaisseur de paroi de la soupape de limitation de pression (18) est formé à l'extrémité de la région de transition tournée vers la première partie (18a), lequel sert de zone de rupture théorique (B), la soupape de limitation de pression est tout d'abord introduite avec l'extrémité libre de la première partie (18a) dans le deuxième raccord (14) et la deuxième partie (18b) est conçue sous la forme d'une partie de fixation (18d) dans la région de son extrémité libre, laquelle est conçue sous la forme d'une entrée de tuyau en forme d'embout dans le deuxième raccord (14) et fixée par liaison de force, dans lequel, après l'introduction de la soupape de limitation de pression (18) dans l'entrée de tuyau, une étanchéité hermétique est réalisée à cet endroit entre le côté extérieur de la partie de fixation (18d) et le côté intérieur de l'entrée de tuyau,
caractérisé en ce que
la soupape de limitation de pression (18) est introduite si loin dans le deuxième raccord, et axialement décalée, qu'après la rupture de la soupape de limitation de pression (18) au niveau de la zone de rupture théorique (B), la première partie à diamètre plus petit (18a) isolée parvient dans le sac (10.1, 10.2), de manière à garantir un accès libre depuis l'espace intérieur du sac (10.1, 10.2) au dispositif d'extraction (100) par le biais du passage intérieur (18c). - Sac selon la revendication 1,
caractérisé en ce que
le sac (10 ; 10.1, 10.2) présente un troisième raccord (16) pour l'échantillonnage. - Sac selon la revendication 2,
caractérisé en ce que
le troisième raccord (16) est fermé par un bouchon de fermeture (110), lequel se referme une fois que l'échantillon a été prélevé du sac (10 ; 10.1, 10.2) à l'aide d'une aiguille de prélèvement. - Sac selon l'une des revendications 1 à 3,
caractérisé en ce que
le raccord respectif (12, 14, 16) est conçu sous la forme d'une entrée de tuyau en forme d'embout. - Sac selon l'une des revendications 1 à 4,
caractérisé en ce que
une suspension en trois points (20) est réalisée dans une plaque de préhension (22) formée sur le bord supérieur (10.1a ; 10.2a) du sac (10 ; 10.1, 10.2), par rapport à la position de suspension (A) du sac (10 ; 10.1, 10.2), renforçant le bord de celui-ci. - Sac selon la revendication 5,
caractérisé en ce que
la plaque de préhension (2) présente une couleur nettement différente de la couleur du sac (10 ; 10.1, 10.2). - Sac selon l'une des revendications 5 et 6,
caractérisé en ce que
la suspension en trois points (20) est constituée de deux ouvertures de suspension (20.1) espacées de la même taille, la ligne de liaison des points centraux de celles-ci étant orientée perpendiculairement à la direction de suspension du sac (10 ; 10.1, 10.2) prédéfinie par la position de suspension (A), et en ce qu'au centre entre les ouvertures de suspension (20.1), il est prévu une cavité (20.2) en forme de fente s'étendant dans la direction de la ligne de liaison, laquelle présente un bombement (20.2a) au centre et sur sa limite supérieure, dont la limite supérieure est alignée avec la limite supérieure respective des ouvertures de suspension (20.1). - Sac selon l'une des revendications 1 à 7,
caractérisé en ce que
le sac (10 ; 10.1, 10.2), par rapport à sa position de suspension (A), présente un contour intérieur côté extraction (10.3) incliné vers le bas respectivement de l'extérieur vers l'intérieur. - Sac selon la revendication 8,
caractérisé en ce que
le deuxième raccord (14), par rapport à la position de suspension (A) du sac (10 ; 10.1, 10.2), débouche sur le point le plus bas du contour intérieur côté extraction (10.3) . - Sac selon l'une des revendications 2 à 9,
caractérisé en ce que
le premier raccord (12) et le troisième raccord (16), par rapport à la position de suspension (A) du sac (10 ; 10.1, 10.2), sont disposés sur le bord inférieur du sac et respectivement à côté du deuxième raccord (14). - Sac selon l'une des revendications 1 à 10,
caractérisé en ce que
le sac (10 ; 10.1, 10.2), par rapport à sa position de suspension (A), présente un renforcement de bord supérieur (10.4) sur son bord supérieur (10.1a ; 10.2a) et/ou un renforcement de bord inférieur (10.5) sur son bord inférieur (10.1b ; 10.2b). - Sac selon la revendication 11,
caractérisé en ce que
deux ouvertures de fixation (24) sont prévues dans le renforcement de bord inférieur (10.5), lesquelles sont disposées des deux côtés d'un axe longitudinal (L) orienté verticalement dans la position de suspension (A) du sac (10 ; 10.1, 10.2). - Sac selon la revendication 12,
caractérisé en ce que
l'axe longitudinal (L) forme l'axe médian du deuxième raccord (14) et simultanément l'axe de symétrie du sac (10 ; 10.1, 10.2), à l'exception des premier et troisième raccords (12, 16) . - Sac selon l'une des revendications 1 à 13,
caractérisé en ce que
le matériau du sac est constitué d'éthylène-acétate de vinyle (EVA) avec photoprotection.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PL18151019T PL3326605T3 (pl) | 2011-10-28 | 2012-10-24 | Worek do przechowywania i pobierania płynnego dodatku w warunkach aseptycznych |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102011117268A DE102011117268A1 (de) | 2011-10-28 | 2011-10-28 | Beutel zur Bevorratung und Entnahme eines flüssigen Zusatzstoffes unter aseptischen Bedingungen |
EP12007290.5A EP2628474B1 (fr) | 2011-10-28 | 2012-10-24 | Sac destiné à approvisionner et extraire un additif liquide sous conditions aseptiques |
Related Parent Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP12007290.5A Division EP2628474B1 (fr) | 2011-10-28 | 2012-10-24 | Sac destiné à approvisionner et extraire un additif liquide sous conditions aseptiques |
EP12007290.5A Division-Into EP2628474B1 (fr) | 2011-10-28 | 2012-10-24 | Sac destiné à approvisionner et extraire un additif liquide sous conditions aseptiques |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3326605A1 EP3326605A1 (fr) | 2018-05-30 |
EP3326605B1 true EP3326605B1 (fr) | 2020-11-04 |
Family
ID=47088633
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP18151019.9A Active EP3326605B1 (fr) | 2011-10-28 | 2012-10-24 | Sac destiné à approvisionner et à extraire un additif liquide sous conditions aseptiques |
EP12007290.5A Active EP2628474B1 (fr) | 2011-10-28 | 2012-10-24 | Sac destiné à approvisionner et extraire un additif liquide sous conditions aseptiques |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP12007290.5A Active EP2628474B1 (fr) | 2011-10-28 | 2012-10-24 | Sac destiné à approvisionner et extraire un additif liquide sous conditions aseptiques |
Country Status (6)
Country | Link |
---|---|
EP (2) | EP3326605B1 (fr) |
DE (1) | DE102011117268A1 (fr) |
DK (2) | DK2628474T3 (fr) |
ES (2) | ES2712926T3 (fr) |
PL (2) | PL2628474T3 (fr) |
PT (2) | PT2628474T (fr) |
Families Citing this family (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 |
DE102022110499A1 (de) | 2022-04-29 | 2023-11-02 | Raumedic Ag | Beutel zur Aufnahme eines medizinischen oder pharmazeutischen Mediums, Schlauch mit Konnektor zum Anschluss an einen solchen Beutel sowie Anordnung mit einem solchen Beutel und mit einem solchen Konnektor |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3205889A (en) | 1962-07-23 | 1965-09-14 | Abbott Lab | Parenteral fluid container and port structure |
US4435179A (en) * | 1981-11-09 | 1984-03-06 | Biotest-Serum-Institut Gmbh | Blood bags with interconnecting system |
DE8200215U1 (de) | 1982-01-07 | 1984-09-13 | Fresenius AG, 6380 Bad Homburg | Physiologisch unbedenklicher und oberhalb 110°c sterilisierbarer Beutel |
US4530697A (en) * | 1982-06-09 | 1985-07-23 | Miles Laboratories, Inc. | Needle assembly |
DE3316615C2 (de) | 1983-05-06 | 1985-05-30 | Fresenius AG, 6380 Bad Homburg | Vorrichtung für die enterale Ernährung |
US4586928A (en) * | 1984-10-09 | 1986-05-06 | Miles Laboratories, Inc. | Pivoting frangible valve for plastic bags |
DK533085A (da) | 1985-11-19 | 1987-05-20 | Coloplast As | Vandbeholder til brug ved irrigation af tyktarmen hos colostomipatienter |
WO1989003697A1 (fr) * | 1987-10-22 | 1989-05-05 | Leonard Barry French | Recipient pour solution repliable sur lui-meme |
DE3738162A1 (de) | 1987-11-10 | 1989-05-24 | Baxter Travenol Lab | System zur aufbewahrung, zubereitung und applikation von infusionsloesungen fuer die parenterale ernaehrung |
DE4317316C2 (de) | 1993-05-25 | 1995-04-27 | Fresenius Ag | Beutelanordnugn für die enterale Ernährung |
WO2005117802A1 (fr) * | 2004-06-01 | 2005-12-15 | Gambro Lundia Ab | Recipient pour solution medicale |
-
2011
- 2011-10-28 DE DE102011117268A patent/DE102011117268A1/de not_active Ceased
-
2012
- 2012-10-24 EP EP18151019.9A patent/EP3326605B1/fr active Active
- 2012-10-24 ES ES12007290T patent/ES2712926T3/es active Active
- 2012-10-24 ES ES18151019T patent/ES2847277T3/es active Active
- 2012-10-24 PT PT12007290T patent/PT2628474T/pt unknown
- 2012-10-24 PL PL12007290T patent/PL2628474T3/pl unknown
- 2012-10-24 PL PL18151019T patent/PL3326605T3/pl unknown
- 2012-10-24 DK DK12007290.5T patent/DK2628474T3/en active
- 2012-10-24 PT PT181510199T patent/PT3326605T/pt unknown
- 2012-10-24 DK DK18151019.9T patent/DK3326605T3/da active
- 2012-10-24 EP EP12007290.5A patent/EP2628474B1/fr active Active
Non-Patent Citations (1)
Title |
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None * |
Also Published As
Publication number | Publication date |
---|---|
DK3326605T3 (da) | 2021-02-08 |
EP2628474B1 (fr) | 2018-11-28 |
PT2628474T (pt) | 2019-03-07 |
EP2628474A1 (fr) | 2013-08-21 |
PL3326605T3 (pl) | 2021-05-04 |
PL2628474T3 (pl) | 2019-07-31 |
PT3326605T (pt) | 2021-01-14 |
ES2847277T3 (es) | 2021-08-02 |
DE102011117268A1 (de) | 2013-05-02 |
EP3326605A1 (fr) | 2018-05-30 |
DK2628474T3 (en) | 2019-03-25 |
ES2712926T3 (es) | 2019-05-16 |
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