EP3592322B1 - Plastic container product - Google Patents
Plastic container product Download PDFInfo
- Publication number
- EP3592322B1 EP3592322B1 EP18708942.0A EP18708942A EP3592322B1 EP 3592322 B1 EP3592322 B1 EP 3592322B1 EP 18708942 A EP18708942 A EP 18708942A EP 3592322 B1 EP3592322 B1 EP 3592322B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- container
- product according
- seam
- container product
- top membrane
- 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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- 239000004033 plastic Substances 0.000 title claims description 16
- 229920003023 plastic Polymers 0.000 title claims description 16
- 239000012528 membrane Substances 0.000 claims description 64
- 238000000034 method Methods 0.000 claims description 39
- 239000000463 material Substances 0.000 claims description 11
- 230000007704 transition Effects 0.000 claims description 7
- -1 polyethylene Polymers 0.000 claims description 6
- 230000003014 reinforcing effect Effects 0.000 claims description 6
- 239000004743 Polypropylene Substances 0.000 claims description 5
- 229920001155 polypropylene Polymers 0.000 claims description 4
- 230000002787 reinforcement Effects 0.000 claims description 4
- 239000004698 Polyethylene Substances 0.000 claims description 2
- 239000012611 container material Substances 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 229920000573 polyethylene Polymers 0.000 claims description 2
- 229920005606 polypropylene copolymer Polymers 0.000 claims description 2
- 238000000605 extraction Methods 0.000 claims 2
- 230000006835 compression Effects 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 230000008569 process Effects 0.000 description 35
- 238000007789 sealing Methods 0.000 description 15
- 239000000243 solution Substances 0.000 description 10
- 238000001802 infusion Methods 0.000 description 9
- 238000004519 manufacturing process Methods 0.000 description 9
- 238000000071 blow moulding Methods 0.000 description 8
- 238000011049 filling Methods 0.000 description 8
- 239000007924 injection Substances 0.000 description 8
- 238000002347 injection Methods 0.000 description 8
- 239000002245 particle Substances 0.000 description 6
- 238000000465 moulding Methods 0.000 description 5
- 229920000642 polymer Polymers 0.000 description 5
- 239000003814 drug Substances 0.000 description 4
- 241001631457 Cannula Species 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 3
- 229920001971 elastomer Polymers 0.000 description 3
- 239000000806 elastomer Substances 0.000 description 3
- 230000036512 infertility Effects 0.000 description 3
- 230000035515 penetration Effects 0.000 description 3
- 238000003466 welding Methods 0.000 description 3
- 230000008901 benefit Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
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- 235000016709 nutrition Nutrition 0.000 description 2
- 238000007493 shaping process Methods 0.000 description 2
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- 229920000089 Cyclic olefin copolymer Polymers 0.000 description 1
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
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- 239000000385 dialysis solution Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000013536 elastomeric material Substances 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
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- 230000036541 health Effects 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
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- 239000004702 low-density polyethylene Substances 0.000 description 1
- 229940127554 medical product Drugs 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
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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
-
- 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
- A61J1/1406—Septums, pierceable membranes
-
- 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
- A61J1/1412—Containers with closing means, e.g. caps
-
- 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
- A61J1/1412—Containers with closing means, e.g. caps
- A61J1/1418—Threaded type
-
- 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
- A61J1/1412—Containers with closing means, e.g. caps
- A61J1/1425—Snap-fit type
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
- B65D1/0207—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by material, e.g. composition, physical features
- B65D1/0215—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by material, e.g. composition, physical features multilayered
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D47/00—Closures with filling and discharging, or with discharging, devices
- B65D47/04—Closures with discharging devices other than pumps
- B65D47/06—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages
- B65D47/10—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages having frangible closures
- B65D47/103—Membranes with a tearing element
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D51/00—Closures not otherwise provided for
- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
Definitions
- the invention relates to a plastic container product, in particular manufactured by a blow molding, filling and sealing process, with a container body having a container content and an adjoining head part which delimits a removal area which is closed by a head membrane which has a connecting seam, which penetrates a plane spanned by the head membrane and separates penetrable areas on the free face of the head membrane for a removal process of the container contents.
- Plastic containers that are produced in a blow molding, filling and sealing process are used for food and luxury goods as well as in medicine with great advantage for the packaging of pharmaceuticals, diagnostics, enteral nutrition and medical products, e.g. rinsing and dialysis solutions.
- An essential advantage of such containers for these purposes is that the contents only come into contact with a polymer forming the container material, typically a polymer Plastic like LDPE, HDPE or PP.
- a polymer Plastic like LDPE, HDPE or PP typically a polymer Plastic like LDPE, HDPE or PP.
- Containers that are intended for injection, infusion, transfusion or enteral nutrition have a special shape of the head area for the formation of accesses to the container contents.
- the one-piece design of the container and head enables safe sterility of the filling material with particularly efficient implementation of the manufacturing process.
- Caps with elastomer sealing elements (DIN ISO 15759) are attached to the container head by welding or overmolding.
- a plastic container is known with preferred, thin-walled piercing positions for a cannula arranged on a defined lateral shoulder area of the container.
- Sufficient thinning can only be achieved here with a very complex tool technology, taking into account indented areas that make easy cleaning very difficult.
- a complete emptying of the container is not possible via these thin spots, since they are not located at the highest or lowest part of the container.
- U.S. 4,574,965 ( Fig. 1 and 3 ) shows - as well CN 85103261 A ( Fig. 1, 2 and 3 ) - in addition, a disadvantageous course of the mold parting line in the head area ( Fig. 1 and 3 : seam 18); as a result, the puncture point is very close to the edge of the container head and there is a great danger that the cannula will also unintentionally puncture the neck area of the container even if the angle of penetration is slightly different.
- Another disadvantage is the low central rigidity of the container head, which is shown in DE 10 2013 012809 picked up becomes.
- the EP 0621027 A1 shows in Figure 4 a container with a dividing line (42; "parting line”; column 8, lines 26ff) which extends in a straight line across the container body in an end view.
- a parting line typically results in blow molding due to the use of two-part molds.
- the dividing line results from the separations of the shaping two-part tool.
- the associated sealing or connecting seam in the head area has a minimal length and follows the course of the dividing line in a straight line.
- sealing seams are generally made as short as possible - not only with blow-molded containers - in order to minimize the risk of weak points, defects or even leaks, which in the case of filled containers with sterile filling material for medical purposes has very serious consequences for the health of the patient may have.
- the DE 10 2013 012 809 A1 relates to a container product in which, instead of a uniform head membrane, which has a uniform curvature the Spanning the end of the head part of the container body, different head surfaces are formed which form different curvatures at the head part end, so that an increased resistance to bending and easier piercing, cutting or penetration is achieved for the possible total removal area of the head membrane. Evasion of the head membrane during the removal process and the risk of leaks are thereby kept to a minimum and handling is possible in a safe manner even when using less sharp spikes, blades or thick cannulas.
- the invention is based on the object of creating a container product which is further improved compared to the known solutions, in particular with regard to the handling and the removal behavior for the container contents.
- a pertinent object is achieved by a container product with the features of claim 1 in its entirety.
- the connecting seam seen on the free face of the head membrane has a seam course which at least partially deviates from a fictitious straight course, which extends within this plane, which is longer than the straight course and which is penetrable
- At least partially encompassing areas, very thin-walled, penetrable areas can be formed which are supported by the extended connecting or sealing seam lying in the plane of the head membrane in such a way that it does not come into contact with the respective penetrable area during the removal or addition process of the container contents unintentionally denting of the entire head membrane with deteriorated removal behavior, in particular with regard to sterility, can occur.
- the handling of the plastic container product according to the invention as a whole is made easier for an operator and, moreover, a safe addition and / or removal process of the container contents is guaranteed in every case.
- the support and stiffening function for the addition or removal process via the connecting seam according to the invention is also ensured by the fact that, leaving the straight alignment, it at least partially encompasses the penetrable areas and thus further stiffens the edges. Due to the supporting and securing connection seam of the head part, it is therefore possible to reduce the wall diameter of the penetrable areas on the free face of the head diaphragm compared to the other wall parts of the head diaphragm, which further facilitates the mentioned addition and / or removal process.
- connection seam which is considerably lengthened compared to an otherwise straight course, using the known blow molding, filling and sealing process (BFS) in a routine production-safe manner results in thin areas as penetrable areas of 0.10 mm to 0 , 25 mm can easily be created without leaks at the connection seam, which is technically also referred to as a head seal seam or head weld seam, and without tearing at the thin spots when internal pressure loads occur in the temperature range above 110 ° C; Temperature ranges, such as those that arise during the sterilization of the filled container product as part of the necessary autoclave process.
- BFS blow molding, filling and sealing process
- the seam course of the connecting seam is designed as a kind of sealed or welded seam, which is created during the production of the head part within the scope of the blow molding, filling and sealing process (BFS), which continues along the same on opposite sides of the head part and merges into the mold parting line that is created during its production with multi-part, molding tools as part of the BFS process.
- BFS blow molding, filling and sealing process
- the mentioned penetrable areas with a reduced wall thickness compared to the average wall thickness of the head diaphragm also arise in the head membrane in the context of the manufacturing process mentioned.
- the sealed or welded seam extends completely through the head membrane in a sealed manner.
- the seam course in the head membrane merges at two opposite points into the corresponding dividing lines / seam course in the rest of the head part, which form a fictitious connecting straight line between them, on which the centers of the penetrable areas of the head membrane lie and / or outside, and that, in one embodiment, the fictitious straight line delimits at least one penetrable area in the manner of a tangent or this area assumes a predeterminable distance from the fictitious straight line.
- the penetrable areas can be arranged in a supported manner on the head membrane of the container product for a large number of applications in an operationally safe manner.
- the connecting seam similar or directly to the course of a sinusoidal wave on the head membrane, the wave trough and / or wave crest of which each receive a penetrable area of the head membrane and thus at least partially support it.
- the container body is preferably firmly connected via its head part and / or via a collar between the head part and the container body to a cap part which has externally releasable or released piercing parts which are congruent with are to be arranged in the assignable penetrable areas of the head membrane. Since the mentioned penetrable areas in the head membrane can be arranged off-center and the cap part with its piercing parts has to cover the penetrable areas for a removal process, it is possible according to the invention and advantageously provided to apply the cap parts to the container rotated by a predeterminable offset angle .
- the Fig. 1 shows a prior art ( DE 102013 012 809 A1 ) Verifiable plastic container product, which is manufactured according to the so-called blow molding, filling and sealing process (BFS) with a container body 10 having a container content (not shown) of the usual type and an adjoining head part 12 which delimits a removal area 14, which is closed by a head membrane 16, which has a connecting seam 18 which extends through a plane 20 spanned by the head membrane and for a removal process of the container contents according to the detailed illustration according to FIG Fig. 2 two penetrable regions 22, 24 separated from one another on the free end face 26 of the head membrane 16, which are shown idealized in a circular shape with their centers M1, M2. Components of the head part 12 are also a neck part 28 and a collar part 30.
- BFS blow molding, filling and sealing process
- the container product shown is an infusion bottle manufactured in one piece according to the BFS process, consisting of a plastic material, especially a polyolefin material.
- the head part 12 formed in the example shown according to the state of the art according to DIN ISO 15759: 2006-05 can be connected to cap parts 31 according to ISO 15759-BFS-A or ISO 15759-BFS-B by welding or overmolding on the collar part 30, such as this is exemplified in the Figures 9 and 10 is shown.
- the continuously running and uniformly convexly curved head membrane 16 for removal and / or addition processes which for example by means of a cannula (DIN EN ISO 7864) or a piercing part 34 (EN ISO 8536), as exemplified in the Fig. 9 shown, can be pierced in the direction of the arrow.
- a cannula DIN EN ISO 7864
- a piercing part 34 EN ISO 8536
- This fictitious rectilinear course 32 produces the shortest connection between two points E1 and E2, at which the known connecting seam 18 continuously merges into the adjoining mold separating line 19 in the head part 12.
- the connecting seam 18, which extends in the shape of a bow or tendon between the point-like points E1 and E2 follows the curvature of the head membrane 16 and, designed as a type of reinforcing rib, protrudes preferably by a predeterminable overhang over the free end face 26 of the head membrane 16.
- the mold parting lines 19 merge into a mold parting line 21 of the container body 10, which in the BFS process is typically formed with the aid of a two-part mold.
- the two opposing penetrable areas 22, 24 are then located, which for the sake of simplicity are shown as closed circles with their centers M1 and M2.
- the areas 22, 24 can, however, also have other circumferential geometries due to the manufacturing process have, for example, be elliptical, sickle-shaped or the like more.
- These areas 22, 24 which can be penetrated or pierced have, as indicated in FIG Fig. 9 results, reduced wall thicknesses, which turn out to be less than the other wall thickness of the head membrane 16.
- the diameter of the head diaphragm 16 can typically be 30 mm.
- the connecting seam 18, which is technically also referred to as a head seal seam, thus extends from one point E1 of the head part 12 to the opposite point E2 of the same head part and, as a reinforcement device in the form of a protruding rib, offers at least partially a resistance to unintentional pressing in of the entire head part.
- bran 16 when attaching a removal device such as a cannula or a piercing part 34 for a subsequent removal or addition process relating to the container contents. Without such a rib-like reinforcing device, if the piercing tool 34 hits it, as shown in FIG Fig.
- the connecting seam 38 according to the invention seen or arranged on the free end face 26 of the head diaphragm 16, has a seam course 36 deviating from the fictitious straight course 32, which extends within the plane 20 or within the protruding head diaphragm 16 as a surface, longer than the straight course 32 and which at least partially comprises the penetrable regions 22, 24.
- the non-straight course 36 of the connecting seam 38 according to the invention gives an operator an indication of the position or location of the respective penetrable area 22, 24 on the head membrane 16, since the connecting seam 38 encompasses approximately half of the respective penetrable area 22, 24.
- the connecting seam 38 running within the plane 20 of the head diaphragm 16 has an alternating, preferably curved course that forms a sinusoidal wave 40, the wave trough 42 of which and the associated wave crest 44 each receive a penetrable area 22 and 24 of the head diaphragm 16 and such at least partially included in half.
- the seam course 36 in the head membrane 16 again merges here at two opposite points E1, E2 into the rest of the seam course in the head part 12, with the two opposite points E1 and E2 forming the fictitious connecting straight line 32 between them, which follows the fictitious straight seam course 32 the Fig. 2 corresponds.
- the centers M1, M2 of the penetrable areas 22, 24 of the head membrane 16 lie on this fictitious connecting straight line 32.
- the head diaphragm 16 has a circular outer circumference and the said fictitious connecting straight line 32 defines with a further fictitious connecting straight line 48 which is perpendicular to the straight line 32, a fictitious center point Z through which the shaft 40 as shown in FIG Fig. 4 the connecting seam 38 according to the invention goes at the point of transition from wave valley 42 to wave crest 44.
- this tangent T includes an angle ⁇ of approximately 50 ° with the fictitious connecting straight line 32.
- Other angular dimensions ⁇ in the range of approx. 40 ° ( Fig. 8 ) up to 75 ° ( Fig. 5 ) are possible here depending on the embodiment of the connecting seam 38.
- the transition from wave trough 42 to wave crest 44 runs outside the central fictitious center point Z through the other center point Z + 1, through which then according to the representation according to the Fig. 4 the tangent would have to be laid. In this respect, however, nothing changes to the angle specifications ⁇ .
- the beginning P1 of the wave trough 42 and the beginning or the end P2 of the wave crest 44 of a wave 40 of the connecting seam 38 each merges into a section 50, which in turn, viewed from above, on the face 26 of the head membrane 16, along the fictitious connecting line 32 runs, the respective section 50 opening out at the edge into the opposite points E1, E2 on the head part 12.
- sections 50 selected in a straight line these can also have an arcuate course in continuation of the sine wave 40 or in the opposite direction to this wave course.
- the length of the undulating connecting seam 38 is preferably selected to be at least 30% longer than the diameter of the circular head membrane 16.
- the penetrable or pierceable areas 22, 24 on the head membrane 16 are in the embodiment according to FIGS Figures 3 and 4 chosen essentially the same size.
- the two penetrable areas 22, 24 on the head membrane 16 have wall thicknesses that are less than the other average wall thickness of the other head membrane 16, and the average wall thickness of a penetrable area 22, 24 is preferably between 0.15 mm and 0, 35 mm.
- the wall thicknesses for each penetrable area 22, 24 can also be selected differently so that, for example, one penetrable area is particularly suitable for introducing a puncture cannula and another penetrable area enables good accessibility for introducing a syringe needle.
- the two surfaces of the penetrable regions 22, 24 can be selected to be of different sizes, as shown by way of example in FIG Fig. 7 for a head diaphragm 16 modified in this respect, wherein in one embodiment a head diaphragm 16 according to FIG Fig. 8 the sequence from wave valley 42 to wave crest 44 is swapped in such a way that in the direction of view of the Fig. 8 seen first on the left side of the wave crest 44 before the wave valley 42 comes.
- the connecting seam 38 on the respective head membrane 16 can protrude in the manner of a reinforcing rib at least partially outward to the surroundings and / or in the direction of the interior of the container body 10, with a protrusion outward for the known solution according to the Fig. 2 is shown there.
- the head diaphragm 16 shown in the figures is shown as a curved surface in the form of the plane 20, which protrudes convexly outwards towards the surroundings.
- the head diaphragm 16 is a plane, that is to say an uncurved, planar plane (not shown).
- the container wall of the container according to the invention can have a multilayer structure (not shown) made of at least two materials.
- FIG DE 103 17 712 A1 A pertinent molding device for moving molding tools for the purpose of generating pertinent head geometries in plastic containers with link control is exemplified in FIG DE 103 17 712 A1 shown.
- the wave shape shown in the figures for the connecting seam 38 has proven to be particularly advantageous in terms of manufacturing technology.
- other wave forms can also be selected, for example in the form of an S-shaped arc with a different curve shape.
- meander-shaped seam courses or zigzag-shaped seam courses can be implemented if necessary.
- the seam course of the connecting seam 38 is selected in this way is that the respective penetrable regions 22, 24 are at least partially encompassed in order to sufficiently stabilize them during the puncturing. Furthermore, an improved reinforcement of the otherwise flexible plastic head membrane 16 is achieved overall due to the elongated seam course 36. It is also possible to attach more than two penetrable areas to the head membrane 16 (not shown).
- the upper side of the penetrable area 22 is tangent to the fictitious connecting straight line 32 and the further penetrable area 24 has a predeterminable axial distance from this connecting straight line 32.
- the tangent T applied to the wave trough 42 and wave crest 44, which goes through the center point Z, is steeper than in the embodiment according to FIG Fig. 4 .
- the connecting straight line 32 lies as a further tangent in the viewing direction Fig. 6 viewed at the top of the penetrable area 22 or at the bottom of the further penetrable area 24, both of which are approximately the same size in terms of area.
- the diameter of the penetrable area 24 is selected to be smaller than the penetrable area 22. Furthermore, as already explained, the course of the shaft 40 is offset off-center from the center point Z through the further center point Z + 1.
- the two penetrable areas 22, 24, which are approximately the same size, of the connecting straight line 32 is tangent and, as already explained, is the course from wave valley 42 to wave crest 44 according to the exemplary embodiments according to FIGS Figures 3 to 7 applied reversed.
- the cap part 31 is placed on the head part 12 in a manner known per se.
- the cap part 31 is preferably made of a rigid plastic material, which by and large has the shape of a circular cup with a bottom 52 and has detachable tabs 54, 56, of which as shown in FIG Fig. 9 the right flap 56 is removed for a removal process by means of the piercing tool 34.
- the cap part 31 is firmly attached at its lower edge to a flange part 58 which extends on the head part 12 between the collar part 30 and the neck part 28.
- the container body 10 is not shown, which is otherwise as shown in FIG Fig. 10 can also have a different shape than the container body 10 according to Fig.
- the cap part 31 there are two piercing parts 60, 62 which cover the respective penetrable areas 22, 24 in an assigned manner (see FIG. Fig. 9 ).
- the piercing parts 60, 62 each form a type of sealing part and are preferably formed from an elastomeric material that has a low rigidity and low hardness.
- Thermoplastic elastomers are preferably used for the piercing parts 60, 62, which can be connected to the cap part 31 in a simple manner in a materially bonded manner, for example by welding.
- cap alignment of the cap part 31 for a BFS bottle with its two accesses 60, 62 parallel to the axis 32 of the container 10; but also with other cap orientations, preferably between 0 ° to 50 °, to the longer transverse axis or connecting straight line 32 of the container bottle 10 according to the illustration according to FIG Fig. 10 .
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- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Ceramic Engineering (AREA)
- Hematology (AREA)
- Containers Having Bodies Formed In One Piece (AREA)
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- Blow-Moulding Or Thermoforming Of Plastics Or The Like (AREA)
Description
Die Erfindung betrifft ein Kunststoff-Behältererzeugnis, insbesondere hergestellt nach einem Blasform-, Füll- und Siegelverfahren, mit einem einen Behälterinhalt aufweisenden Behälterkörper und einem sich daran anschließenden Kopfteil, das einen Entnahmebereich begrenzt, der von einer Kopfmembran verschlossen ist, die eine Verbindungsnaht aufweist, die eine von der Kopfmembran aufgespannte Ebene durchgreift und für einen Entnahmevorgang des Behälterinhalts penetrierbare Bereiche auf der freien Stirnseite der Kopfmembran voneinander separiert.The invention relates to a plastic container product, in particular manufactured by a blow molding, filling and sealing process, with a container body having a container content and an adjoining head part which delimits a removal area which is closed by a head membrane which has a connecting seam, which penetrates a plane spanned by the head membrane and separates penetrable areas on the free face of the head membrane for a removal process of the container contents.
Kunststoffbehälter, die in einem Blasform-, Füll- und Siegelverfahren (BFS-Verfahren) hergestellt sind, wie es beispielsweise in der
Bei solchen Behältern - wie auch bei anderen Behältererzeugnissen für medizinische Zwecke, wie beispielsweise Injektionsfläschchen, Zylinderampullen oder Kunststoffbehältnissen für Injektionen (DIN EN ISO 15747:2012-07) - können z.B. beim Durchstechen mit Injektions-Kanülen oder Einstechteilen, Polymer-oder Elastomerpartikel aus dem Verschlussmaterial ausgestanzt werden. Diese losen Partikel können in der Kanüle, der Injektionsspritze, oder im Behälter selbst verbleiben. Dies kann unter anderem zu einem Verstopfen der Kanüle führen, was den Entnahme- und/oder den Injektionsvorgang unmöglich macht; auch können Partikel ins Füllgut gelangen.With such containers - as with other container products for medical purposes, such as injection vials, cylindrical ampoules or plastic containers for injections (DIN EN ISO 15747: 2012-07) - e.g. when piercing with injection cannulas or piercing parts, polymer or elastomer particles are punched out of the closure material. These loose particles can remain in the cannula, the injection syringe, or in the container itself. Among other things, this can lead to a clogging of the cannula, which makes the removal and / or injection process impossible; Particles can also get into the product.
Im Hinblick auf diese Problematik wurden demgemäß bei der Verwendung von Injektionsfläschchen mit elastomerem Verschluss in der EN ISO 8871- 5:2014 bereits Grenzwerte vorgegeben, ebenso in der US Pharmakopöe Kapitel 381. Um dieser Problematik - fachsprachlich auch als Fragmentation bezeichnet - Herr zu werden, wurden von Marinacci et al. im Stand der Technik (
Durch die
In der
Die
Insbesondere sind Siegelnähte bei Behältern mit mehrschichtigem Wandaufbau - beispielsweise beschrieben in
Die
Die
Ausgehend von diesem Stand der Technik liegt der Erfindung die Aufgabe zugrunde, ein Behältererzeugnis zu schaffen, das gegenüber den bekannten Lösungen weiter verbessert ist, insbesondere was die Handhabung und das Entnahmeverhalten für den Behälterinhalt anbelangt.Proceeding from this prior art, the invention is based on the object of creating a container product which is further improved compared to the known solutions, in particular with regard to the handling and the removal behavior for the container contents.
Eine dahingehende Aufgabe löst ein Behältererzeugnis mit den Merkmalen des Patentanspruchs 1 in seiner Gesamtheit.A pertinent object is achieved by a container product with the features of
Dadurch, dass gemäß dem kennzeichnenden Teil des Patentanspruchs 1 die auf der freien Stirnseite der Kopfmembran gesehene Verbindungsnaht einen von einem fiktiven geradlinigen Verlauf zumindest teilweise abweichenden Nahtverlauf aufweist, der sich innerhalb dieser Ebene verlaufend erstreckt, der länger als der geradlinige Verlauf ist und der die penetrierbaren Bereiche zumindest teilweise umfasst, lassen sich sehr dünnwandige, penetrierbare Bereiche ausbilden, die von der verlängerten, in der Ebene der Kopfmembran liegenden Verbindungs- oder Siegelnaht derart gestützt werden, dass es während eines des Entnahme- oder Zugabevorgangs des Behälterinhalts an dem jeweiligen penetrierbaren Bereich nicht ungewollt zu einem Einbeulen der gesamten Kopfmembran mit verschlechtertem Entnahmeverhalten, insbesondere betreffend die Sterilität, kommen kann. Da insoweit Fehlbedienungen ausgeschlossen sind, ist die Handhabbarkeit des erfindungsgemäßen Kunststoff-Behältererzeugnisses als Ganzes für eine Bedienperson erleichtert und im Übrigen ein sicherer Zugabe- und/oder Entnahmevorgang des Behälterinhalts in jedem Fall gewährleistet. Die Stütz- und Aussteifungsfunktion für den Zugabe- oder Entnahmevorgang über die erfindungsgemäße Verbindungsnaht ist auch dadurch gewährleistet, dass diese, die geradlinige Ausrichtung verlassend, die penetrierbaren Bereiche zumindest teilweise umfasst und derart weiter randseitig aussteift. Durch die stützende und sichernde Verbindungsnaht des Kopfteils ist es mithin möglich, die penetrierbaren Bereiche auf der freien Stirnseite der Kopfmembran vom Wanddurchmesser her gegenüber den sonstigen Wandteilen der Kopfmembran zu reduzieren, was den angesprochenen Zugabe- und/oder Entnahmevorgang weiter erleichtern hilft.In that, according to the characterizing part of
Es ist für einen Durchschnittsfachmann überraschend, dass sich durch die gegenüber einem sonst geradlinig ausgerichteten Verlauf wesentlich verlängerte Verbindungsnaht unter Einsatz des bekannten Blasform-, Füll- und Siegel-Verfahrens (BFS) in routineproduktionssicherer Weise Dünnstellen als penetrierbare Bereiche von 0,10 mm bis 0,25 mm ohne weiteres erzeugen lassen, ohne dass es dabei zu Undichtigkeiten an der Verbindungsnaht kommt, die fachsprachlich auch als Kopfsiegelnaht oder Kopfschweißnaht bezeichnet ist, und ohne dass es zum Einreißen an den Dünnstellen bei auftretenden Innendruckbeanspruchungen im Temperaturbereich oberhalb von 110°C kommt; Temperaturbereiche, wie sie beispielsweise bei der Sterilisation des befüllten Behältererzeugnisses im Rahmen des notwendigen Autoklaven-Prozesses entstehen. Hier scheint es einerseits durch die gegenläufig scherende Bewegung des noch heißen Polymers beim dritten Herstellschritt des BFS-Verfahrens, also bei der Versiegelung des Behälterkopfteils, zu einer offensichtlich günstigen Ausrichtung der Polymerketten und/oder einem vorteilhaften Spannungszustand im System Kopfmembran/Verbindungsnaht/pene-trierbare Bereiche zu kommen. Andererseits kommt, wie bereits erwähnt, auch der stützenden Wirkung der an die dünnen Durchstechflächen dicht heranreichenden Verbindungsnaht eine besondere Bedeutung zu.It is surprising for an average person skilled in the art that the connection seam, which is considerably lengthened compared to an otherwise straight course, using the known blow molding, filling and sealing process (BFS) in a routine production-safe manner results in thin areas as penetrable areas of 0.10 mm to 0 , 25 mm can easily be created without leaks at the connection seam, which is technically also referred to as a head seal seam or head weld seam, and without tearing at the thin spots when internal pressure loads occur in the temperature range above 110 ° C; Temperature ranges, such as those that arise during the sterilization of the filled container product as part of the necessary autoclave process. Here, on the one hand, the opposing shearing movement of the still hot polymer in the third manufacturing step of the BFS process, i.e. when sealing the container head part, seems to result in an obviously favorable alignment of the polymer chains and / or a advantageous state of tension in the head membrane / connecting seam / penetrable areas system. On the other hand, as already mentioned, the supporting effect of the connecting seam, which comes close to the thin piercing surfaces, is of particular importance.
Bei einer besonders bevorzugten Ausführungsform des erfindungsgemäßen Behältererzeugnisses ist der Nahtverlauf der Verbindungsnaht als eine Art Siegel- oder Schweißnaht ausgebildet, die bei der Kopfteilerstellung im Rahmen des Blasform-, Füll- und Siegelverfahrens (BFS) entsteht, die auf gegenüberliegenden Seiten des Kopfteils entlang desselben weiterverläuft und in die Formtrennlinie übergeht, die bei dessen Herstellung mit mehrteiligen, formgebenden Werkzeugen im Rahmen des BFS-Verfahrens entsteht. Bei der Herstellung der dahingehenden Siegelnaht für das Kopfteil entstehen auch im Rahmen des genannten Herstellverfahrens in der Kopfmembran die angesprochenen penetrierbaren Bereiche mit im Vergleich zur durchschnittlichen Wandstärke der Kopfmembran verringerter Wandstärke. Dabei durchgreift die Siegel- oder Schweißnaht in abgedichteter Weise vollständig die Kopfmembran.In a particularly preferred embodiment of the container product according to the invention, the seam course of the connecting seam is designed as a kind of sealed or welded seam, which is created during the production of the head part within the scope of the blow molding, filling and sealing process (BFS), which continues along the same on opposite sides of the head part and merges into the mold parting line that is created during its production with multi-part, molding tools as part of the BFS process. During the production of the pertinent sealing seam for the head part, the mentioned penetrable areas with a reduced wall thickness compared to the average wall thickness of the head diaphragm also arise in the head membrane in the context of the manufacturing process mentioned. The sealed or welded seam extends completely through the head membrane in a sealed manner.
Als weiter besonders vorteilhaft hat es sich erwiesen, dass der Nahtverlauf in der Kopfmembran an zwei gegenüberliegenden Stellen in den korrespondierenden Trennlinien/Nahtverlauf im sonstigen Kopfteil übergeht, die eine fiktive Verbindungsgerade zwischen sich bilden, auf der die Mitten der penetrierbaren Bereiche der Kopfmembran liegen und/oder außerhalb, und dass bei einer Ausführungsform die fiktive Gerade mindestens einen penetrierbaren Bereich in der Art einer Tangente begrenzt oder dieser Bereich einen vorgebbaren Abstand zu der fiktiven Geraden einnimmt. Dergestalt lassen sich bediensicher für eine Vielzahl von Anwendungsfällen die penetrierbaren Bereiche in abgestützter Weise auf der Kopfmembran des Behältererzeugnisses anordnen.It has also proven to be particularly advantageous that the seam course in the head membrane merges at two opposite points into the corresponding dividing lines / seam course in the rest of the head part, which form a fictitious connecting straight line between them, on which the centers of the penetrable areas of the head membrane lie and / or outside, and that, in one embodiment, the fictitious straight line delimits at least one penetrable area in the manner of a tangent or this area assumes a predeterminable distance from the fictitious straight line. In this way, the penetrable areas can be arranged in a supported manner on the head membrane of the container product for a large number of applications in an operationally safe manner.
In diesem Zusammenhang hat es sich weiter als besonders vorteilhaft erwiesen, die Verbindungsnaht ähnlich oder unmittelbar dem Verlauf einer sinusförmigen Welle auf der Kopfmembran auszubilden, deren Wellental und/oder Wellenberg jeweils einen penetrierbaren Bereich der Kopfmembran aufnimmt und derart zumindest teilweise stützend umfasst.In this context, it has also proven to be particularly advantageous to form the connecting seam similar or directly to the course of a sinusoidal wave on the head membrane, the wave trough and / or wave crest of which each receive a penetrable area of the head membrane and thus at least partially support it.
Bei einer weiteren besonders bevorzugten Ausführungsform des erfindungsgemäßen Behältererzeugnisses ist vorgesehen, dass der Behälterkörper über sein Kopfteil und/oder über einen Kragen zwischen dem Kopfteil und dem Behälterkörper mit einem Kappenteil vorzugsweise fest verbunden ist, das von außen freigebbare oder freigegebene Durchstechteile aufweist, die deckungsgleich mit den zuordenbaren penetrierbaren Bereichen der Kopfmembran anzuordnen sind. Da die angesprochenen penetrierbaren Bereiche in der Kopfmembran außermittig angeordnet sein können und das Kappenteil mit seinen Durchstechteilen die penetrierbaren Bereiche für einen Entnahmevorgang zu überdecken hat, ist es erfindungsgemäß möglich und in vorteilhafter Weise vorgesehen, die Kappenteile auf den Behälter entsprechend um einen vorgebbaren Versatzwinkel gedreht aufzubringen.In a further particularly preferred embodiment of the container product according to the invention, it is provided that the container body is preferably firmly connected via its head part and / or via a collar between the head part and the container body to a cap part which has externally releasable or released piercing parts which are congruent with are to be arranged in the assignable penetrable areas of the head membrane. Since the mentioned penetrable areas in the head membrane can be arranged off-center and the cap part with its piercing parts has to cover the penetrable areas for a removal process, it is possible according to the invention and advantageously provided to apply the cap parts to the container rotated by a predeterminable offset angle .
Weitere vorteilhafte Ausführungsformen des erfindungsgemäßen Behältererzeugnisses sind Gegenstand der sonstigen Unteransprüche.Further advantageous embodiments of the container product according to the invention are the subject of the other dependent claims.
Insgesamt ist mit der erfindungsgemäßen Lösung ein Behältererzeugnis geschaffen,
- das nach dem Blasform-, Füll- und Siegel-Verfahren mit geringem Leckagerisiko sicher und reproduzierbar herstellbar ist,
- dessen Behälterkopfgeometrie im Wesentlichen der DIN ISO 15759: 2006-05 entspricht,
- das bevorzugt zwei räumlich voneinander getrennte, gleichwertig penetrierbare Bereiche mit kontrolliert geringer Wandstärke aufweist, bei deren Durchstechen mit einer Standardkanüle (DIN EN ISO 7864) - wenn überhaupt - auch ohne Kappe nur sehr wenige Partikel mit ausgestanzt werden,
- das geringe Durchstechkräfte beim Durchstechen mit einem Einstechteil eines Infusionsgerätes gemäß EN ISO 8536-4:2013 ermöglicht, und
- das es ermöglicht, Kappenteile mit zwei Durchstechstellen auch in schräg verlaufenden Positionen auf den Behälterkörper aufzubringen.
- which can be safely and reproducibly manufactured using the blow molding, filling and sealing process with a low risk of leakage,
- whose container head geometry essentially corresponds to DIN ISO 15759: 2006-05,
- which preferably has two spatially separated, equally penetrable areas with controlled low wall thickness, when they are pierced with a standard cannula (DIN EN ISO 7864) - if at all - only very few particles are punched out even without a cap,
- that enables low piercing forces when piercing with a piercing part of an infusion device according to EN ISO 8536-4: 2013, and
- which makes it possible to apply cap parts with two piercing points to the container body in inclined positions.
Im Folgenden wird die erfindungsgemäße Lösung anhand von Ausführungsbeispielen eines Behältererzeugnisses näher erläutert. Dabei zeigen in prinzipieller und nicht maßstäblicher Darstellung die
- Fig. 1
- eine gegenüber einer praktisch realisierten Ausführungsform verkleinert gezeichnete perspektivische Ansicht eines Kunst-stoff-Behältererzeugnisses in Form eines Infusionsbehälters mit einem Kopfteil gemäß dem Stand der Technik nach DIN ISO 15759;
- Fig. 2
- eine vergrößerte Darstellung des Kopfteils des Behältererzeugnisses nach der
Fig. 1 ; - Fig. 3
- eine der
Fig. 2 entsprechende Darstellung eines geänderten Kopfteils für ein erfindungsgemäßes Behältererzeugnis; - Fig. 4
- eine stirnseitige Draufsicht auf eine Kopfmembran, wie sie für ein Kopfteil nach der
Fig. 3 eingesetzt ist; - Fig. 5 bis 8
- eine der
Fig. 4 jeweils entsprechende Darstellung einer Kopfmembran, jedoch mit jeweils anderen Verbindungsnahtverläufen und anderer Anordnung penetrierbarer Bereiche; - Fig. 9
- eine Schnittdarstellung durch ein Kopfteil einer weiteren Ausführungsform eines erfindungsgemäßen Behältererzeugnisses mit einer möglichen Kopfmembranausbildung nach einem der
Fig. 3 bis 8 mit einem aufgesetzten Kappenteil, wobei zur Durchführung eines Entnahmevorgangs des Behälterinhalts der Zustand während der Einstechbewegung mit einem Einstechteil dargestellt ist; und - Fig. 10
- eine perspektivische Darstellung des Kappenteils nach der
Fig. 9 mit kappenseitig abgedeckten Durchstechteilen, wobei das Kappenteil als Ganzes von seiner Lage her gegenüber der Längsausrichtung des nur teilweise dargestellten Behältererzeugnisses schräg verlaufend angeordnet ist.
- Fig. 1
- a reduced perspective view of a plastic container product in the form of an infusion container with a head part according to the state of the art according to DIN ISO 15759;
- Fig. 2
- an enlarged view of the head portion of the container product after
Fig. 1 ; - Fig. 3
- one of the
Fig. 2 corresponding representation of a modified head part for a container product according to the invention; - Fig. 4
- an end plan view of a head membrane, as it is for a head part according to the
Fig. 3 is used; - Figures 5 to 8
- one of the
Fig. 4 Corresponding representation of a head membrane, but with different connection seam courses and a different arrangement of penetrable areas; - Fig. 9
- a sectional view through a head part of a further embodiment of a container product according to the invention with a possible head membrane formation according to one of the
Figures 3 to 8 with an attached cap part, the state during the piercing movement with a piercing part being shown for carrying out a removal process of the container contents; and - Fig. 10
- a perspective view of the cap part after
Fig. 9 with piercing parts covered on the cap side, the cap part as a whole being arranged so as to run obliquely from its position relative to the longitudinal orientation of the container product, which is only partially shown.
Die
Das in
In Blickrichtung auf die
Die Verbindungsnaht 18, die fachsprachlich auch als Kopfsiegelnaht bezeichnet ist, erstreckt sich also von der einen Stelle E1 des Kopfteils 12 zu der gegenüberliegenden Stelle E2 desselben Kopfteils und bietet als Verstärkungseinrichtung in Form einer vorstehenden Rippe zumindest teilweise einen Widerhalt gegen ungewolltes Eindrücken der gesamten Kopfmem-bran 16 beim Ansetzen einer Entnahmeeinrichtung, wie einer Kanüle oder eines Einstechteils 34 für einen anschließenden Entnahme- oder Zugabevorgang betreffend den Behälterinhalt. Ohne eine solche rippenartige Verstärkungseinrichtung würde bei einem Auftreffen des Einstechwerkzeuges 34 gemäß der Darstellung nach der
Zwar bietet die rippenartige Verstärkungsnaht 18 gemäß den Darstellungen im Stand der Technik nach den
Bei der erfindungsgemäßen Lösung nach den
Wie sich des Weiteren aus den
Die Kopfmembran 16 hat einen kreisrunden Außenumfang und die genannte fiktive Verbindungsgerade 32 definiert mit einer weiteren fiktiven Verbindungsgeraden 48, die senkrecht auf der Geraden 32 steht, einen fiktiven Zentrumspunkt Z, durch den die Welle 40 gemäß der Darstellung nach der
Legt man weiter gemäß der Darstellung nach der
Wie sich weiter aus den
Die penetrierbaren oder durchstechbaren Bereiche 22, 24 auf der Kopfmembran 16 sind bei dem Ausführungsbeispiel nach den
Die Verbindungsnaht 38 auf der jeweiligen Kopfmembran 16 kann in der Art einer Verstärkungsrippe zumindest teilweise nach außen zur Umgebung und/oder in Richtung des Inneren des Behälterkörpers 10 vorstehen, wobei ein Überstand nach außen für die bekannte Lösung nach der
Für den Erhalt der wellenförmigen Verbindungsnaht 38 ist es notwendig, bei einer entsprechenden Formvorrichtung die Formwerkzeuge derart auszubilden, dass diese an ihren einander gegenüberliegenden Stirnseiten die notwendigen Formausnehmungen sowie Überstände aufweisen, um die Wellenform für das Kopfteil 12 zu erhalten. Eine dahingehende Formvorrichtung zum Bewegen von Formwerkzeugen zwecks Erzeugen von dahingehenden Kopfgeometrien bei Kunststoffbehältern mit Kulissensteuerung ist beispielhaft in der
Die weiteren Ausführungsformen der Kopfmembran 16 für ein erfindungsgemäßes Behältererzeugnis gemäß den Darstellungen nach den
Bei der Ausführungsform nach der
Bei der Ausführungsform nach der
Bei dem Ausführungsbeispiel nach den
Wie sich aus der Darstellung nach der
Claims (20)
- Plastic container product, particularly manufactured using a blow-fill-seal method, comprising a container body (10) with a container content and a top part (12) connected to said body, said top part delimiting an extraction region (14), which is sealed by a top membrane (16), which comprises a connecting seam (38), which passes through a plane (20) spanned by the top membrane (16) and separates at least two penetrable regions (22, 24) on the free end face (26) of the top membrane (16) from one another for an extraction process for the container content, characterised in that the connecting seam (38) seen on the free end face (26) of the top membrane (16) comprises a seam course (36) that at least partially deviates from a fictitious straight line course (32), said seam course extending and running within said plane (20), being longer than the straight line course (32) and at least partially enclosing the penetrable regions (22, 24).
- Container product according to claim 1, characterised in that the connecting seam (38) extends from a point (E1) on the top part (12) to an opposite point (E2) of said top part and, as a reinforcing device, at least partially offers resistance to undesirable compression of the top membrane (16).
- Container product according to claim 2, characterised in that the course of the connecting seam (38), or the reinforcing device respectively, provides an operating person with an indication of the position of the respective penetrable region (22, 24) on the top membrane (16).
- Container product according to any one of the preceding claims, characterised in that the connecting seam (38) running within the plane (20) of the top membrane (16) has a changing, preferably curved course.
- Container product according to any one of the preceding claims, characterised in that the curved course is substantially similar to an individual, preferably sinusoidal wave (40), the wave trough (42) and/or the wave crest (44) of said wave in each case incorporating and thus at least partially enclosing a penetrable region (22, 24) of the top membrane (16).
- Container product according to any one of the preceding claims characterised in that the seam course (36) of the connecting seam (38) is designed as a kind of separating line, which arises in the blow-fill-seal method when creating the top part, which continues to run (19) along the top part (12) on opposite sides thereof and transitions into a mould separating line (21) of the container body (10), which arises when said container body is manufactured from a multi-part mould as part of the same method.
- Container product according to claim 6, characterised in that the seam course (36) in the top membrane (16) transitions into the seam course (19) in the top part (12) at two opposite points (E1, E2), which form a fictitious connecting straight line (32) between one another, on which the centres (M1, M2) of the penetrable regions (22, 24) of the top membrane (16) are located and/or outside, and in that, in one embodiment, the fictitious straight line (32) delimits at least one penetrable region (22, 24) in the form of a tangent or this region is a pre-definable distance from the fictitious straight line (32).
- Container product according to any one of claims 5 to 7, characterised in that the top membrane (16) has a circular outer circumference and the fictitious connecting straight line (32), along with a further fictitious connecting straight line (48), which is perpendicular to said line, define a fictitious centre point (Z) at the point at which they cross, through which the wave (40) of the connecting seam (38) passes at the point of the transition from the wave trough (42) to the wave crest (44).
- Container product according to claim 8, characterised in that a tangent (T) applied to the wave trough (42) and/or the wave crest (44), which passes through the fictitious centre point (Z) or another centre point (Z + 1), encloses an angle α with the fictitious connecting straight line (32) of 10 to 90 degrees, preferably 30 to 70 degrees, or more preferably 40 to 60 degrees.
- Container product according to any one of claims 5 to 9, characterised in that the sequence of wave trough (42) to wave crest (44) is reversed.
- Container product according to any one of claims 5 to 10, characterised in that the start (P1, P2) of the wave trough (42) and/or wave crest (44) of a wave (40) of the connecting seam (38) transitions into a section (50), which, when viewed from above, on the end face (26) of the top membrane (16), runs along the fictitious connecting line (32) and which emerges in each case at the opposite points (E1, E2) on the top part (12).
- Container product according to any one of the preceding claims, characterised in that the length of the connecting seam (38) is at least 20%, preferably at least 30%, longer than the diameter of the top membrane (16), which has a preferably circular design, when viewed end on.
- Container product according to any one of the preceding claims, characterised in that the penetrable regions (22, 24) on the top membrane (16) comprise wall thicknesses that are smaller than the other average wall thickness of the top membrane (16), especially in the region of the connecting seam (38), and the average wall thickness of a penetrable region (22, 24) is between 0.10 mm to 0.40 mm, preferably between 0.15 mm and 0.3 mm.
- Container product according to any one of the preceding claims, characterised in that the wall thicknesses and/or the surface areas of the two penetrable regions (22, 24) on the top membrane (16) are different sizes.
- Container product according to any one of the preceding claims, characterised in that the connecting seam (38) on the top membrane (16) protrudes in the form of a reinforcement rib at least partially outwards towards the environment and/or in the direction of the inside of the container body (10).
- Container product according to any one of the preceding claims, characterised in that the container body (10) is preferably securely connected via its top part (12) and/or via a collar (30) between the top part (12) and the container body (10) to a cap part (31), which comprises piercing parts (60, 62) that can be released or are released from the outside, which are arranged to overlap with the assignable, penetrable regions (22, 24) of the top membrane (16).
- Container product according to claim 16, characterised in that, depending on the position of the penetrable regions (22, 24) in the top membrane (16), the application direction of the cap part (31) with its respective piercing parts (60, 62) is applied with an offset angle β of less than 70°, preferably less than 50°, more preferably less than 30° in relation to the fictitious connecting straight line (32) on the top part (12).
- Container product according to claim 16 or 17, characterised in that the cap part (31) is fixed to a reinforcing rib on the free end face (26) of the top membrane (16), which is preferably formed by the connecting seam (38).
- Container product according to any one of the preceding claims, characterised in that the top membrane (16) comprises a non-curved, planar or curved plane (20) which protrudes outwards towards the environment in a convex manner.
- Container product according to any one of the preceding claims, characterised in that a polyethylene, polypropylene, polypropylene copolymer or a polypropylene blend is used as the plastics material for the container material and/or in that the container wall of the container body (10) comprises a multi-layered structure made up of at least two materials.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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DE102017002401.4A DE102017002401A1 (en) | 2017-03-07 | 2017-03-07 | Plastic container product |
PCT/EP2018/054551 WO2018162255A1 (en) | 2017-03-07 | 2018-02-23 | Plastic container product |
Publications (2)
Publication Number | Publication Date |
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EP3592322A1 EP3592322A1 (en) | 2020-01-15 |
EP3592322B1 true EP3592322B1 (en) | 2020-11-18 |
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ID=61569233
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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EP18708942.0A Active EP3592322B1 (en) | 2017-03-07 | 2018-02-23 | Plastic container product |
Country Status (13)
Country | Link |
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US (1) | US11376192B2 (en) |
EP (1) | EP3592322B1 (en) |
JP (1) | JP7007387B2 (en) |
KR (1) | KR102511663B1 (en) |
CN (1) | CN110191697B (en) |
AU (1) | AU2018232417B2 (en) |
BR (1) | BR112019010889B1 (en) |
CA (1) | CA3054973A1 (en) |
DE (1) | DE102017002401A1 (en) |
MX (1) | MX2019010545A (en) |
RU (1) | RU2751496C2 (en) |
SG (1) | SG11201907438XA (en) |
WO (1) | WO2018162255A1 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102018124115A1 (en) * | 2018-09-28 | 2020-04-02 | Schott Schweiz Ag | Primary packaging for pharmaceutical substances |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1986006043A1 (en) * | 1985-04-12 | 1986-10-23 | Health Care Concepts, Inc. | Container with integrally formed piercing site |
Family Cites Families (28)
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US4254884A (en) * | 1978-10-20 | 1981-03-10 | Toppan Printing Co., Ltd. | Plug body for a container |
EP0044850A4 (en) | 1980-02-08 | 1983-07-04 | Baxter Travenol Lab | Plastic container with non-coring penetrable wall portion. |
US4419323A (en) * | 1980-02-08 | 1983-12-06 | Baxter Travenol Laboratories, Inc. | Method for manufacturing a plastic container with non-coring penetrable wall portion |
US4337025A (en) | 1980-08-25 | 1982-06-29 | Automatic Liquid Packaging, Inc. | Apparatus for molding a container with offset parting line |
US4513871A (en) | 1984-05-30 | 1985-04-30 | Health Care Concepts, Inc. | Container with integrally formed non-coring and non-leaking piercing site |
CN1004925B (en) | 1985-04-29 | 1989-08-02 | 身体护理意念公司 | Container with integraly formed non-coring and non-leaking piercing site |
US5238153A (en) * | 1991-02-19 | 1993-08-24 | Pilkington Visioncare Inc. | Dispenser for dispersing sterile solutions |
US5395365A (en) | 1993-03-22 | 1995-03-07 | Automatic Liquid Packaging, Inc. | Container with pierceable and/or collapsible features |
US5716348A (en) | 1995-10-19 | 1998-02-10 | Meridian Medical Technologies, Inc. | Anti-coring needle |
DE10317712A1 (en) | 2003-04-17 | 2004-11-11 | Bernd Hansen | molding machine |
CA2526902C (en) | 2003-04-23 | 2013-03-12 | Otsuka Pharmaceutical Factory, Inc. | Drug solution filling plastic ampoule and production method therefor |
DE10347908A1 (en) | 2003-10-15 | 2005-05-19 | Bernd Hansen | Method and device for producing at least one container filled with a medium |
ITBO20050483A1 (en) * | 2005-07-19 | 2007-01-20 | Brev Angela Srl | PERFORTABLE CLOSURE FOR A CONTAINER, MOLD AND METHOD TO REALIZE IT |
PL1775234T3 (en) * | 2005-10-14 | 2009-01-30 | Nestec Sa | Capsule for the preparation of a beverage |
US9649254B2 (en) | 2006-01-14 | 2017-05-16 | World Bottling Cap, LLC | Medical vial cap |
JP5078523B2 (en) | 2006-09-27 | 2012-11-21 | 株式会社大塚製薬工場 | Plastic ampules |
DE102007005407A1 (en) * | 2007-02-03 | 2008-08-07 | Fresenius Kabi Deutschland Gmbh | Cap for a container for holding medical fluids and container for receiving medical fluids |
FR2918874B1 (en) * | 2007-07-20 | 2009-10-09 | Philippe Perovitch | DEVICE FOR CONDITIONING AND ADMINISTERING SUB-LINGUAL OF ACTIVE PRINCIPLES |
DE102008009418B3 (en) | 2008-02-15 | 2009-04-09 | Spang & Brands Gmbh | cap |
JP5859201B2 (en) | 2008-04-25 | 2016-02-10 | 日本臓器製薬株式会社 | Plastic ampules |
DE102008060864A1 (en) * | 2008-12-09 | 2010-06-10 | Fresenius Kabi Deutschland Gmbh | Cap for containers for holding medical fluids and container for holding medical fluids |
EP2391329B1 (en) * | 2009-01-30 | 2017-06-28 | Biocompatibles UK Limited | Method for increasing the leakage resistance in a closed, pressurized system comprising a septum-sealed container |
EP2359799A1 (en) * | 2010-02-16 | 2011-08-24 | Fresenius Kabi Deutschland GmbH | Closure cap for a container for holding medicinal liquids and container |
DE102012021525A1 (en) * | 2012-10-31 | 2014-04-30 | Kocher-Plastik Maschinenbau Gmbh | Sealing arrangement and such an associated container |
US8944264B2 (en) * | 2013-02-04 | 2015-02-03 | World Bottling Cap, LLC | Medical vial cap |
DE102013012809A1 (en) | 2013-08-01 | 2015-02-05 | Kocher-Plastik Maschinenbau Gmbh | Head piece for a container that can be filled with a medium |
CN203564540U (en) * | 2013-11-01 | 2014-04-30 | 湖南乐福地医药包材科技有限公司 | Drug-mixing combination cover and infusion container with drug mixing combination cover |
SG11201700209PA (en) * | 2014-07-29 | 2017-02-27 | Kocher Plastik Maschinenbau Gmbh | Container having a head piece, which container can be or is filled with a medium |
-
2017
- 2017-03-07 DE DE102017002401.4A patent/DE102017002401A1/en not_active Withdrawn
-
2018
- 2018-02-23 BR BR112019010889-0A patent/BR112019010889B1/en active IP Right Grant
- 2018-02-23 RU RU2019129536A patent/RU2751496C2/en active
- 2018-02-23 CA CA3054973A patent/CA3054973A1/en active Pending
- 2018-02-23 KR KR1020197029245A patent/KR102511663B1/en active IP Right Grant
- 2018-02-23 JP JP2019542428A patent/JP7007387B2/en active Active
- 2018-02-23 CN CN201880006449.5A patent/CN110191697B/en active Active
- 2018-02-23 EP EP18708942.0A patent/EP3592322B1/en active Active
- 2018-02-23 US US16/468,328 patent/US11376192B2/en active Active
- 2018-02-23 AU AU2018232417A patent/AU2018232417B2/en active Active
- 2018-02-23 MX MX2019010545A patent/MX2019010545A/en unknown
- 2018-02-23 SG SG11201907438XA patent/SG11201907438XA/en unknown
- 2018-02-23 WO PCT/EP2018/054551 patent/WO2018162255A1/en active Application Filing
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1986006043A1 (en) * | 1985-04-12 | 1986-10-23 | Health Care Concepts, Inc. | Container with integrally formed piercing site |
Also Published As
Publication number | Publication date |
---|---|
KR20190121381A (en) | 2019-10-25 |
CN110191697B (en) | 2022-03-29 |
KR102511663B1 (en) | 2023-03-20 |
RU2019129536A3 (en) | 2021-05-26 |
WO2018162255A1 (en) | 2018-09-13 |
US11376192B2 (en) | 2022-07-05 |
MX2019010545A (en) | 2019-10-21 |
DE102017002401A1 (en) | 2018-09-13 |
US20200085688A1 (en) | 2020-03-19 |
AU2018232417A1 (en) | 2019-08-22 |
AU2018232417B2 (en) | 2023-05-25 |
JP7007387B2 (en) | 2022-01-24 |
SG11201907438XA (en) | 2019-09-27 |
CA3054973A1 (en) | 2018-09-13 |
RU2751496C2 (en) | 2021-07-14 |
RU2019129536A (en) | 2021-04-07 |
BR112019010889B1 (en) | 2023-03-28 |
JP2020510467A (en) | 2020-04-09 |
BR112019010889A2 (en) | 2019-10-01 |
EP3592322A1 (en) | 2020-01-15 |
CN110191697A (en) | 2019-08-30 |
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