EP3592322A1 - Plastic container product - Google Patents
Plastic container productInfo
- Publication number
- EP3592322A1 EP3592322A1 EP18708942.0A EP18708942A EP3592322A1 EP 3592322 A1 EP3592322 A1 EP 3592322A1 EP 18708942 A EP18708942 A EP 18708942A EP 3592322 A1 EP3592322 A1 EP 3592322A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- head
- container
- membrane
- seam
- product according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000004033 plastic Substances 0.000 title claims abstract description 18
- 229920003023 plastic Polymers 0.000 title claims abstract description 18
- 239000012528 membrane Substances 0.000 claims abstract description 83
- 238000000034 method Methods 0.000 claims abstract description 28
- 238000007789 sealing Methods 0.000 claims abstract description 21
- 238000011049 filling Methods 0.000 claims abstract description 12
- 238000000071 blow moulding Methods 0.000 claims abstract description 11
- 230000008569 process Effects 0.000 claims description 19
- 239000000463 material Substances 0.000 claims description 9
- 230000003014 reinforcing effect Effects 0.000 claims description 9
- -1 polyethylene Polymers 0.000 claims description 6
- 239000004743 Polypropylene Substances 0.000 claims description 5
- 238000000465 moulding Methods 0.000 claims description 4
- 229920001155 polypropylene Polymers 0.000 claims description 4
- 230000007704 transition 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
- 239000000243 solution Substances 0.000 description 10
- 238000001802 infusion Methods 0.000 description 9
- 238000004519 manufacturing process Methods 0.000 description 8
- 239000007924 injection Substances 0.000 description 6
- 238000002347 injection Methods 0.000 description 6
- 239000002245 particle Substances 0.000 description 6
- 238000003466 welding Methods 0.000 description 5
- 230000015572 biosynthetic process Effects 0.000 description 4
- 238000013461 design Methods 0.000 description 4
- 229920000642 polymer Polymers 0.000 description 4
- AIXMJTYHQHQJLU-UHFFFAOYSA-N chembl210858 Chemical compound O1C(CC(=O)OC)CC(C=2C=CC(O)=CC=2)=N1 AIXMJTYHQHQJLU-UHFFFAOYSA-N 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000036512 infertility Effects 0.000 description 3
- 230000008093 supporting effect Effects 0.000 description 3
- 230000008901 benefit Effects 0.000 description 2
- 238000005520 cutting process Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 239000000806 elastomer Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000013467 fragmentation Methods 0.000 description 2
- 238000006062 fragmentation reaction Methods 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 230000035764 nutrition Effects 0.000 description 2
- 235000016709 nutrition Nutrition 0.000 description 2
- 241001631457 Cannula Species 0.000 description 1
- 229920000089 Cyclic olefin copolymer Polymers 0.000 description 1
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 206010003549 asthenia Diseases 0.000 description 1
- 235000013361 beverage Nutrition 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 239000000385 dialysis solution Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 239000013536 elastomeric material Substances 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 238000007765 extrusion coating Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 229920002457 flexible plastic Polymers 0.000 description 1
- 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
- 239000007788 liquid Substances 0.000 description 1
- 229920001684 low density polyethylene Polymers 0.000 description 1
- 239000004702 low-density polyethylene Substances 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000002787 reinforcement Effects 0.000 description 1
- 239000012487 rinsing solution Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 238000010008 shearing Methods 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000010408 sweeping Methods 0.000 description 1
- 229920002725 thermoplastic elastomer Polymers 0.000 description 1
- 238000012549 training Methods 0.000 description 1
- 238000011144 upstream manufacturing Methods 0.000 description 1
- 208000016258 weakness Diseases 0.000 description 1
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
- A61J1/14—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
- A61J1/05—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
- A61J1/1412—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
- A61J1/1425—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
-
- 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
Definitions
- the invention relates to a plastic container product, in particular according to a blow molding, filling and sealing method, having a container body having a container body and an adjoining headpiece which delimits a removal region which is closed by a head membrane, which has a connecting seam, which passes through a plane spanned by the head membrane and separated areas for a removal operation of the container contents penetratable areas on the free end face of the head membrane.
- Plastic containers that in a blow molding, filling and sealing process are hergestel lt, as described for example in EP 2 269 558 A1 and in the art under the name bottelpack ® - system has become known used for food and beverages as well as in medicine with great advantage for the packaging of pharmaceuticals, diagnostics, enteral nutrition and medical devices, eg rinsing and dialysis solutions.
- a significant advantage of such containers for such purposes is that the contents are in exclusive contact with a polymer forming the container material, typically a plastic such as LDPE, HDPE or PP.
- the germ reduction / sterility of the contents can be ensured for longer periods of time.
- Bepatial- ter which are intended for injection, infusion, transfusion or enteral nutrition, have a special formation of the head area for the formation of access to the container contents.
- the one-piece design of container and head allows a secure sterility of the contents with particularly efficient implementation of the manufacturing process.
- Caps with elastomer sealing elements (DIN ISO 15759) are applied to the retaining head by welding or extrusion coating.
- WO 81/02286 discloses a plastic container with preferred thin-walled piercing positions for a cannula, which are arranged on a defined lateral shoulder region of the container. Sufficient thinning can only be achieved here by a very complex tool technology. At the expense of confiscated areas, which make easy cleaning very difficult. Moreover, a complete emptying of the container through these thin points is not possible because they are not at the highest or lowest part of the container.
- US Pat. No. 4,574,965 (Meierhoefer) discloses a container product manufactured according to a blow-molding, filling and sealing method with a specially designed double-dome geometry without thinning for the container head so as to pierce the container with a cannula for a removal operation to ensure a secure sealing and no particle formation. In this case, a small wall thickness in the piercing area is not necessary.
- US 4574965 (FIGS. 1 and 3) also shows - as well as CN 85103261 A (FIGS. 1, 2 and 3) - a disadvantageous profile of the mold parting line in the head region (FIGS. 1 and 3: seam 18);
- the piercing point is very close to the edge of the container head and brings the great danger even at slightly divergent Einstechwinkel with the cannula and the neck region of the container to pierce unintentionally.
- Another disadvantage is the low central rigidity of the container head, which is taken up in DE 102013012809.
- a large number of different dome-like head shapes with a plurality of head faces are proposed for stiffening the head area, the cap designs also adapted in detail.
- EP 0621027 A1 shows in Figure 4 a container with a dividing line (42, "Parting I ine", column 8, lines 26ff), which extends in a frontal view straight across the container body
- the parting line results from the separations of the forming two-part tool
- the corresponding 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 should be as short as possible to minimize the risk of weaknesses, imperfections or even leaks, which can have very serious consequences for the health of the patient in the case of filled sterile containers for medical purposes.
- sealing seams in containers with multilayer wall construction - for example described in EP 1616549 B1 and DE 10347908 A1 - are sensitive and prone to occurring leaks.
- DE 102013012809 A1 relates to a container product in which, instead of a uniform head membrane, which spans the end of the head part of the container body with uniform curvature, different top surfaces are formed which have different curvatures at the head end form, so that for the total possible removal area of the head membrane increased resistance to deflection and easier puncturing, cutting or penetration is achieved. Avoidance of the head membrane during the removal process and the risk of leaks are thereby kept to a minimum and the handling is also possible safely when using less sharp puncture spikes, cutting edges or thick cannulas.
- the present invention seeks to provide a container product that is further improved over the known solutions, in particular as regards the handling and removal behavior for the container contents.
- a related object solves a container product with the features of claim 1 in its entirety.
- the connecting seam seen on the free end face of the head membrane has a seam course at least partially deviating from a fictitious rectilinear course, extending within this plane, which is longer than the rectilinear course and At least partially encompassing the penetrable areas, it is possible to form very thin-walled, penetratable areas which are supported by the extended connecting or sealing seam lying in the plane of the head membrane in such a way that it is connected to the container during a removal or addition operation each penetrable area can not unintentionally come to a denting of the entire head membrane with worsened removal behavior, in particular concerning the sterility.
- 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 In any case, the container contents were taken care of.
- 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 this leaving the geradl inige orientation, at least partially encompasses the penetrable areas and so further stiffening edge. Due to the supporting and securing seam of the head part, it is therefore possible to reduce the penetrable areas on the free end face of the head membrane from the wall diameter with respect to the other wall parts of the head membrane, which further facilitates the mentioned addition and / or removal process.
- substantially elongated connecting seam using the known blow-molding, filling and sealing method (FSO) in a production-safe manner is thinner than penetrable ranges of 0, 1 0 mm to 0.25 mm can easily produce, without causing leaks at the seam, the fachcostl I also as a head seal seam or head weld is called, and without it for tearing at the Dünnstel len occurring internal pressure stresses in Temperature range above 1 1 0 ° C comes; Temperature ranges, such as those arising during the sterilization of the filled container product in the context of the necessary autoclave process.
- FSO blow-molding, filling and sealing method
- the seam course of the connecting seam is formed as a kind of sealing or welding seam, which arises during the head part creation in the context of the blow molding, filling and sealing process (BFS), which runs along on opposite sides of the head part along the same and merges into the mold parting line that results from its production with multi-part forming tools as part of the BFS process.
- BFS blow molding, filling and sealing process
- the addressed penetrable areas are also formed in the head membrane within the scope of the stated production method with reduced wall thickness compared to the average wall thickness of the head membrane. The seal or weld fully penetrates the head membrane in a sealed manner.
- the seam course in the head membrane merges at two opposite points in the corresponding parting lines / seam course in the other head part, which form a fictitious connecting straight line between them, on which the centers of the penetratable areas of the head membrane lie and / or outside, and that in one embodiment, the notional straight line limits at least one penetrable area in the manner of a tangent or this area occupies a predeterminable distance to the notional straight line. In this way, for a large number of applications, the penetrable areas can be arranged in a supported manner on the head membrane of the container product in a manner safe of use.
- the connecting seam similar or directly to the course of a sinusoidal wave on the top membrane, the wave trough and / or Wellenberg each receives a penetratable region of the head membrane and thus at least partially comprises supporting.
- the container body is preferably fixedly 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 to be arranged congruent with the assignable penetrable areas of the head membrane.
- Regions in the head membrane can be arranged eccentrically and the cap part with its piercing parts to cover the penetrable areas for a removal operation, it is possible and advantageously provided according to apply the cap parts rotated to the container by a predetermined offset angle.
- FIG. 1 shows a perspective view of a plastic container product in the form of an infusion container with a head part according to FIG. 1
- Fig. 2 is an enlarged view of the head portion of the container product of Fig. 1;
- FIG. 3 is a corresponding to Fig. 2 depicting development of an amended head portion for a container product according to the invention
- Fig. 4 is a frontal plan view of a head membrane, as used for a head part of FIG. 3;
- FIG. 1 shows a plastic container product that can be detected in the prior art (DE 1 0 201 3 01 2 809 A1), which is manufactured according to the so-called blow molding, filling and sealing method (BFS) with one Container contents (not shown) of a container body 10 of the type having a typical type and a head part 1 2 adjoining it, which delimits a removal area 14 which is closed by a head membrane 16 which has a connecting seam 18 which is one of the 2, two penetrable areas 22, 24 on the free end face 26 of the head membrane 1 6 separated from each other, the ideal statutory in a circular shape with their centers M1, M2 are dargestel lt. Parts of the head part 1 2 are further a neck part 28 and a collar part 30.
- the container product shown in FIG. 1 is an infusion bottle produced in one piece according to the BFS method, consisting of a plastic material, in particular a polyolefin material.
- DIN ISO blow molding, filling and sealing method
- head part 12 can be connected to cap parts 31 according to ISO 15759-BFS-A or ISO 15759-BFS-B by welding or encapsulation on the collar part 30, as shown by way of example in Figures 9 and 10.
- the continuous and uniformly convex curved head membrane 16 for example by means of a cannula (DIN EN ISO 7864) or a piercing 34 (EN ISO 8536), as exemplified in represented in Fig.9, in the indicated arrow direction is pierceable.
- the protruding thereon shown bulging connecting seam 18 follows a fictitious rectilinear curve 32, which is shown in dashed lines in Figure 2.
- This fictitious rectilinear course 32 establishes the shortest connection between two points E1 and E2, at which the known connecting seam 18 continuously merges into the adjoining shape-separating line 19 in the head part 12.
- the so far arcuate or tendon-shaped between the punctiform points E1 and E2 extending connecting seam 18 follows the curvature of the head membrane 16 and is designed as a kind of reinforcing rib preferably by a predetermined projection on the free end face 26 of the head membrane 16 before.
- the mold parting lines 19 merge into a mold parting line 21 of the container body 10, which is typically formed in the BFS process by means of a two-part mold.
- penetratable areas 22, 24 which, for the sake of simplicity, are considered to be closed. sene circles are shown with their centers M1 and M2. However, the regions 22, 24 can also have other peripheral geometries due to their production, for example elliptical, crescent-shaped or the like. These penetratable or pierceable areas 22, 24 have, as is suggested in FIG. 9, reduced wall thicknesses which are smaller than the other wall thickness of the head membrane 1 6.
- the reduced wall thicknesses for the penetratable areas 22, 24 as already stated, may actually have a slightly different shape than a circular shape, resulting from flow processes of the material during the manufacturing process by means of the BFS process; However, they can also be intentionally obtained by appropriate shaping via suitable tools in the head membrane 16. For the sake of completeness it should be mentioned that according to ISO 1 5759 the diameter of the head membrane 1 6 can typically be 30 mm.
- the connecting seam 18, which is also referred to as head seam seam in technical terms, thus extends from the one point E1 of the head part 12 to the opposite point E2 of the same head part and, as reinforcing means in the form of a protruding rib, at least partially provides resistance to unwanted impressions of the entire head membrane 1 6 when preparing a removal device, such as a cannula or a piercing part 34 for a subsequent removal or addition process concerning the container contents. Without such a rib-like reinforcing device, no puncturing by the head membrane 1 6 would essentially take place when the piercing tool 34 strikes as shown in FIG. 9, but rather would be arched inward with thin-walled formation and effective piercing or penetrating in this respect be prevented.
- the head membrane 1 6 If one then forms, which seems to be obvious, the head membrane 1 6 of its wall thickness according to thick, then the head membrane 1 6 then even a resistance even without bead-reinforced connection is approaching 18; All that is required is an increased force expenditure for the piercing operation by means of the piercing tool 34 and, in particular, the already mentioned fragmentation occurs, in which loose plastic particles increasingly pass from the thickened wall areas into the withdrawal channel (not shown) of the piercing tool 34, which is to avoid in any case.
- the rib-like reinforcing seam 18 according to the depictions in the prior art according to FIGS. 1 and 2 already provides a remedy for this problem; Nevertheless, it has been found in practice that this known solution for a functionally reliable and undisturbed removal process for a container, especially in the form of an infusion container, still leaves desires that lungs with the inventive solution according to the depicting according to FIGS. 3ff erfulf , The vol l Partinger devisber should be mentioned at this Stel le that for the removal process by means of a puncture of container contents from the container upstream of this an addition operation of at least one medium may be provided, for example in the form of a drug delivery in the already finished filling container with the container liquid , like an infusion fluid.
- the insertion tool 34 may be a diseased hypodermic needle of a syringe.
- inventive seam 38 has a deviating from the fictitious geradl inigen course 32 seam 36 which within the plane 20 respectively within the bulging head membrane 1 6 extends as a surface, is longer than the geradl inige course 32 and the at least partially encompasses the penetrable areas 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 position of the respectively penetratable part. Reichs 22, 24 on the head membrane 1 6, since the connecting seam 38 in about half of the respective penetratable region 22, 24 comprises.
- the connecting seam 38 extending within the plane 20 of the head membrane 16 has an alternating, preferably curved course which forms a sinusoidal shaft 40 whose wave trough 42 and the associated wave peak 44 each have a penetratable one Area 22 and 24 of the head membrane 1 6 receives and thus at least partially in half comprises.
- the seam course 36 in the head membrane 16 also passes here again at two opposite points E1, E2 in the other seam course in the head part 12, wherein the two opposite points E1 and E2 form the fictitious connecting line 32 between them, the fictitious straight seam 32 after of Fig. 2 corresponds.
- the centers M1, M2 of the penetratable regions 22, 24 of the head membrane 16 lie on this fictitious connection line 32.
- the head diaphragm 116 has a circular outer circumference and the said notional connecting straight line 32 defines, with another notional connecting straight line 48 perpendicular to the straight line 32, a fictitious center point Z through which the shaft 40, as shown in FIG the seam 38 of the invention at the point of transition from wave trough 42 to wave mountain 44 goes. If, as shown in FIG. 4, a tangent is applied to the wave trough 42 and the wave peak 44 through the center point Z, this tangent T with the imaginary connecting straight line 32 forms an angle ⁇ of approximately 50 °. Other angular dimensions ⁇ in the range of approximately 40 ° (FIG. 8) to 75 ° (FIG. 5) are possible here depending on the embodiment of the connecting seam 38. In the embodiment of FIG. 7 runs the
- the length of the wave-shaped connecting seam 38 is preferably selected to be at least 30% longer than the diameter of the circularly shaped head membrane 16.
- the penetrable or pierceable areas 22, 24 on the head membrane 16 are selected to be substantially equal in the embodiment of FIGS. 3 and 4. 9, the two penetrable areas 22, 24 on the head membrane 16 have wall thicknesses which are smaller than the other average wall thickness of the other head membrane 16 and the average wall thickness of a penetratable area 22, 24 lies preferably between 0.1 5 mm and 0.35 mm.
- the wall thicknesses for each penetrable area 22, 24 can also be chosen differently, so that, for example, a penetratable area is particularly suitable for introducing a puncture cannula and another penetrable area allows good accessibility for the introduction of a syringe needle.
- the two areas of the penetrable areas 22, 24 can be selected to be of different sizes, as shown by way of example in FIG. 7 for a head membrane 1 6 modified to that extent, wherein in one embodiment of a head membrane 1 6 according to FIG. 8, the sequence of wave trough 42 on Wellenberg 44 is exchanged such that seen in the direction of Fig. 8 first on the left side of the wave peak 44 comes before the wave trough 42.
- the connecting seam 38 on the respective head membrane 1 6 may protrude in the manner of a reinforcing rib at least partially outwardly to the environment and / or in the direction of the interior of the container body 10, wherein an outward projection for the known solution according to FIG. 2 is shown there ,
- the rib design was omitted in the illustration in FIGS. 3ff.
- the head membrane 1 6 shown in the figures is shown in each case as a curved surface in the form of the plane 20, which projects convexly outwards to the environment.
- the head membrane 1 6 as a plane, i. form uncurved, planar plane (not shown).
- the container body 10 is a polyethylene, a cycloolefin polymer, a polypropylene in question, as well as a cycloolefin copolymer, a polypropylene copolymer or a polypropylene blend.
- the container wall of the container according to the invention may have a multilayer structure (not shown) of at least two materials.
- the wave-shaped connecting seam 38 In order to obtain the wave-shaped connecting seam 38, it is necessary, with a corresponding molding device, to design the molding tools in such a way that they have the necessary mold recesses and projections on their opposite end faces in order to obtain the wave form for the head part 12.
- a pertinent molding device for moving molds for generating pertinent head geometries in plastic containers with slide control is exemplified in DE 103 1 7 712 A1.
- the waveform shown in the figures for the connection seam 38 has manufacturing technology as proved particularly advantageous. However, other wave forms can also be selected, for example in the form of an S-shaped arc with a different curve shape. Furthermore, meander-shaped seam courses or zig-zag-shaped seam courses can be implemented in case of need.
- the seam course of the connecting seam 38 is selected such that the respectively penetratable regions 22, 24 are at least partially covered in order to sufficiently stabilize them during the piercing. Furthermore, an improved overall reinforcement of the otherwise flexible plastic head membrane 1 6 is achieved overall due to the extended seam course 36. Furthermore, it is possible to also attach more than two penetratable areas on the head membrane 16 (not illustrated).
- the further embodiments of the head membrane 1 6 for a container product according to the invention in accordance with the depictions in FIGS. 5 to 8 are explained only insofar as they differ substantially from the preceding embodiments and if they have not already been adequately explained.
- the penetratable region 22 is tangent on its upper side by the imaginary connecting straight line 32, and the further penetratable region 24 has a predeterminable axial distance to this connecting straight line 32.
- the tangent T applied to world valley 42 and Wel lenberg 44 which passes through the center point Z, is steeper than in the embodiment according to FIG. 4.
- the connecting straight line lies as a further tangent Viewed in the direction of view on FIG. 6 at the top of the penetrable area 22 or at the bottom of the further penetrable area 24, both of which are roughly the same size in terms of area.
- the penetratable region 24 is chosen to be smaller in diameter than the penetratable region 22.
- the course of the shaft 40 goes off-center to the center point Z through the further center point Z + 1. sets arranged.
- the two penetrable areas 22, 24, which are approximately the same size, are affected by the connecting line 32 and, as already explained, the course of wave trough 42 to wave mountain 44 according to the embodiments of FIGS .3 to 7 reversed.
- the cap member 31 is mounted on the head part 12 in a conventional manner.
- the cap member 31 is preferably made of a rigid plastic material which generally has the shape of a circular cup 52 with bottom and releasable tabs 54, 56, of which, as shown in Figure 9, the right tab 56 is for a picking operation is removed by means of the plunge tool 34.
- the cap member 31 is integrally attached at its lower edge to a flange 58, which extends at the head portion 12 between the collar portion 30 and the neck portion 28.
- FIG. 9 does not show the container body 10, which, by the way, may also have a different shape than the container body 10 shown in FIG. 1.
- the cap part 31 has two piercing parts 60, 62, which cover the respective penetratable regions 22, 24 in an associated manner (see FIG.
- the piercing members 60, 62 each form a type of sealing member and are preferably formed of an elastomeric material having 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 by welding, for example, by welding.
- the transition in the form of the neck portion 28 between the other head portion 12 and the container top of the container body 1 0 has been omitted for the sake of simplicity.
- the cap portion 31 the penetratable areas 22, 24 assigned offset put on the head part 1 2.
- the two penetrable areas 22 and 24 on (Fig. 4) or outside (Fig. 5 - 8) of the notional connecting line 32 l lie, so far as the longitudinal axis 64 through the two tabs 54, 56 drawn with the notional straight line 32nd includes an offset angle ⁇ , which according to the embodiment of FIG. 1 0 can enclose in approximately 45 °; but may also readily have values between 0 ° (Fig. 4.) to about 30 ° (Fig. 5) and beyond.
- cap alignment of the cap member 31 for a BFS bottle with its two approaches 60, 62 parallel to the axis 32 of the container 1 0 align; 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, as shown in FIG. 10.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Ceramic Engineering (AREA)
- Hematology (AREA)
- Containers Having Bodies Formed In One Piece (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Blow-Moulding Or Thermoforming Of Plastics Or The Like (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
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 |
---|---|
EP3592322A1 true EP3592322A1 (en) | 2020-01-15 |
EP3592322B1 EP3592322B1 (en) | 2020-11-18 |
Family
ID=61569233
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP18708942.0A Active EP3592322B1 (en) | 2017-03-07 | 2018-02-23 | Plastic container product |
Country Status (13)
Country | Link |
---|---|
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 |
Family Cites Families (29)
Publication number | Priority date | Publication date | Assignee | Title |
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US4254884A (en) * | 1978-10-20 | 1981-03-10 | Toppan Printing Co., Ltd. | Plug body for a container |
US4419323A (en) * | 1980-02-08 | 1983-12-06 | Baxter Travenol Laboratories, Inc. | Method for manufacturing a plastic container with non-coring penetrable wall portion |
JPS57500050A (en) | 1980-02-08 | 1982-01-14 | ||
US4337025A (en) | 1980-08-25 | 1982-06-29 | Automatic Liquid Packaging, Inc. | Apparatus for molding a container with offset parting line |
US4574965A (en) * | 1984-05-30 | 1986-03-11 | Health Care Concepts, Inc. | Container with integrally formed piercing site |
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 |
PT1616549E (en) | 2003-04-23 | 2012-11-12 | Otsuka Pharma Co Ltd | Drug solution filling plastic ampoule and process for producing the same |
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 |
EP1775234B1 (en) * | 2005-10-14 | 2008-07-30 | Nestec S.A. | 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 |
CN102014845B (en) | 2008-04-25 | 2014-11-05 | 日本脏器制药株式会社 | Plastic ampule |
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 |
US9402784B2 (en) * | 2009-01-30 | 2016-08-02 | Biocompatabiles 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 |
PL3174812T3 (en) * | 2014-07-29 | 2019-11-29 | 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 SG SG11201907438XA patent/SG11201907438XA/en unknown
- 2018-02-23 EP EP18708942.0A patent/EP3592322B1/en active Active
- 2018-02-23 JP JP2019542428A patent/JP7007387B2/en active Active
- 2018-02-23 CA CA3054973A patent/CA3054973A1/en active Pending
- 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 CN CN201880006449.5A patent/CN110191697B/en active Active
- 2018-02-23 RU RU2019129536A patent/RU2751496C2/en active
- 2018-02-23 BR BR112019010889-0A patent/BR112019010889B1/en active IP Right Grant
- 2018-02-23 WO PCT/EP2018/054551 patent/WO2018162255A1/en active Application Filing
- 2018-02-23 KR KR1020197029245A patent/KR102511663B1/en active IP Right Grant
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JP7007387B2 (en) | 2022-01-24 |
KR102511663B1 (en) | 2023-03-20 |
US20200085688A1 (en) | 2020-03-19 |
WO2018162255A1 (en) | 2018-09-13 |
AU2018232417A1 (en) | 2019-08-22 |
DE102017002401A1 (en) | 2018-09-13 |
SG11201907438XA (en) | 2019-09-27 |
MX2019010545A (en) | 2019-10-21 |
CN110191697B (en) | 2022-03-29 |
EP3592322B1 (en) | 2020-11-18 |
BR112019010889A2 (en) | 2019-10-01 |
RU2751496C2 (en) | 2021-07-14 |
CA3054973A1 (en) | 2018-09-13 |
JP2020510467A (en) | 2020-04-09 |
RU2019129536A (en) | 2021-04-07 |
AU2018232417B2 (en) | 2023-05-25 |
US11376192B2 (en) | 2022-07-05 |
CN110191697A (en) | 2019-08-30 |
RU2019129536A3 (en) | 2021-05-26 |
KR20190121381A (en) | 2019-10-25 |
BR112019010889B1 (en) | 2023-03-28 |
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