WO2008042939A2 - Récipient moulé équipé d'une tétine verticale et son procédé de fabrication - Google Patents

Récipient moulé équipé d'une tétine verticale et son procédé de fabrication Download PDF

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Publication number
WO2008042939A2
WO2008042939A2 PCT/US2007/080267 US2007080267W WO2008042939A2 WO 2008042939 A2 WO2008042939 A2 WO 2008042939A2 US 2007080267 W US2007080267 W US 2007080267W WO 2008042939 A2 WO2008042939 A2 WO 2008042939A2
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WO
WIPO (PCT)
Prior art keywords
wall
container
stopper
body portion
longitudinal axis
Prior art date
Application number
PCT/US2007/080267
Other languages
English (en)
Other versions
WO2008042939A3 (fr
Inventor
Richard Q. Poynter
Peter J. Decoste
Original Assignee
R.P. Scherer Technologies, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by R.P. Scherer Technologies, Inc. filed Critical R.P. Scherer Technologies, Inc.
Priority to JP2009531572A priority Critical patent/JP5199265B2/ja
Priority to BRPI0720340-3A priority patent/BRPI0720340B1/pt
Priority to DE602007011785T priority patent/DE602007011785D1/de
Priority to AT07843722T priority patent/ATE494235T1/de
Priority to EP07843722A priority patent/EP2066570B1/fr
Publication of WO2008042939A2 publication Critical patent/WO2008042939A2/fr
Publication of WO2008042939A3 publication Critical patent/WO2008042939A3/fr

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Classifications

    • 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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • B65D1/0223—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by shape
    • B65D1/023—Neck construction
    • B65D1/0238—Integral frangible closures
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents

Definitions

  • the invention relates to the field of molded containers, particularly to a blow-fill-seal (BFS) vial containing an internal elastomeric stopper, where the elastomeric stopper has a raised nipple that projects beyond the outer shell of the vial.
  • BFS blow-fill-seal
  • Small vials with elastomeric stoppers are traditionally used to contain small amounts of liquids, particularly liquid medications, or as storage and dispensing vessels for lyophilized medications that are reconstituted prior to use. Safe retention of the elastomeric stopper requires a foil over-cap, to prevent the expulsion of the stopper should pressure within the vial rise. Additionally, the elastomeric stoppers generally require siliconization as a lubricant to insert the stoppers in the vials during the manufacturing process, thus introducing a potentially additional chemical compound. Furthermore, glass vials are inherently liable to breakage. In the end, a stoppered glass vial requires at least three different structural compounds (glass, elastomers, and foil), and assembly requires numerous steps.
  • BFS low-fill-seal containers
  • resin is extruded and molded into a container, and the container is then filled and the resin container sealed, all is a series of automated steps, generally carried out in a continuous or near-continuous process in a sterile environment within the BFS molding machinery.
  • the evolution of this method of packaging is also well known in the art. Initially, various methods were described for blow molding a hollow thermoplastic article; for example, as seen in U.S. Pat. Nos. 3, 137,748 and 3,288,898. More complex process for manufacturing BFS containers are later seen in U.S. Pat. Nos.
  • the BFS manufacturing process traditionally includes sub-components such as a thermoplastic polymer storage and feeding system; an extruder with a parison head; a sterile air filling chamber; a specialized mandrel capable of filling the container, mold halves capable of opening and closing, and therein forming the container; and various downstream items of equipment, such as inspection and leak detection systems, labelers, and packaging machinery.
  • sub-components such as a thermoplastic polymer storage and feeding system; an extruder with a parison head; a sterile air filling chamber; a specialized mandrel capable of filling the container, mold halves capable of opening and closing, and therein forming the container; and various downstream items of equipment, such as inspection and leak detection systems, labelers, and packaging machinery.
  • Aseptic processing equipment such as tanks fitted with sterility filters, ensures that the BFS machinery is continuously provided with sterile product.
  • Thermoplastic polymer granules are typically fed via a vacuum tubing system into a hopper in the blow-fill-seal extruder, where they are heated to form a melt, typically at about 215° C.
  • the thermoplastic polymer melt is formed via a circular orifice into a plastic parison (hollow tube), which is held open by a stream of sterile filtered air.
  • the lower part of the divided mold halves then close to seal the bottom of the open parison and the parison wall is blown and/or compressed by vacuum to the cooled mold walls to form the lower part of the BFS container.
  • a filling mandrel fills a predetermined quantity of product into the container, and after withdrawal of the mandrel, the upper portion of the mold closes to form and seal the upper part of the BFS container.
  • an intermediate step includes placement of the insert in the correct position prior to encapsulation as part of the BFS process. Since multiple cavities may be built within a single mold, the rate of production is substantially related to the number of cavities in each BFS mold. Vials with encapsulated stoppers generally resemble the type of prior art construction as illustrated in FIG. 1. There are a number of problems with such a construction.
  • the relatively right angle shoulder where the encapsulated thermoplastic turns over the top of the stopper creates an area that is difficult to blow mold.
  • the need for a reproducible fracture area wherein the vial may be opened requires a weakened area for such a fracture area, which can be difficult to design into such packaging.
  • the designs owing to the fact that the stopper is encapsulated within the thermoplastic shell, result in a stopper surface that lies below the level of the shell.
  • the exposed surface of the stopper essentially lies in a hole, surround by a raised thermoplastic area, as seen in FIG. 2. This can make access to the stopper, such as for cleaning and disinfection difficult.
  • the instant invention overcomes these and many other shortcomings of contemporary BFS vial design.
  • the present invention advances the state of the art with a variety of new capabilities and overcomes many of the shortcomings of prior devices in new and novel ways.
  • the present invention is a molded container having a raised nipple, formed according to the traditional blow-fill-seal (BFS) methods described above.
  • the container comprises a cap portion, a body portion, and with an encapsulated stopper.
  • the body portion has a body portion wall having a wall shoulder portion with a distal aspect and a proximal aspect.
  • the body portion has an adjoining cap portion such that the body portion wall meets a cap portion wall at an engineered separation site, designed to represent an area of weakness in the walls of the container.
  • the container has a stopper enclosed within the container shell that prevents the transfer of contents from the body portion to the cap portion.
  • a portion of the stopper is enclosed within the body portion and a portion of the stopper is enclosed within the cap portion.
  • the stopper has a stopper wall and a stopper shoulder with a central raised nipple having a nipple top surface with an injection site and a nipple sidewall.
  • the engineered separation site is adjacent to the nipple sidewall such that when the cap portion is removed from the body portion at the engineered separation site, a portion of the nipple extends out of the body portion.
  • the instant invention allows all of the top surface of the nipple to be easily cleaned, if desired, and allows substantially all of the top surface of the nipple to be accessed by a needle, or other removal means, to puncture the stopper and access the container contents.
  • the body wall shoulder portion, adjacent to the cap portion may be configured at a non-orthogonal angle from the longitudinal axis of the container. This also has numerous advantages over the prior art, including but not limited to the following. It can be difficult, when the body wall should of a BFS vial comprises an orthogonal angle, to insure sufficient plastic at the bend to form a sufficiently strong container.
  • the wall shoulder portion further comprises at least one raised gusset, extending from the wall shoulder portion and having a lateral surface substantially parallel to the longitudinal axis of the container.
  • gusset(s) not only tend to strengthen the BFS vial, but cooperate with a variety of connectors. Extending the length of the lateral surface increases the surface area of interaction between the container and the interior surface of a needle-free container, and a larger surface area for interaction results in a more stable cooperation between the elements and a more positive centering of a needle-free connector.
  • the cap portion may have a cap portion wall formed with a grip enhancing feature such as a flattened tab (332), see FIGS 13 (a) and 13(b).
  • a flattened tab 332
  • Such a flattened tab may have relatively short lateral expanse such that the easiest means of removing the cap portion from the body portion is to use two hands, one to grip the body portion and another to twist off the cap portion. While one-handed removal of the cap portion in such a design is not impossible, it may require a degree of hand strength not universally found among those desiring to use the container.
  • the hand strength required for one-handed opening may be decreased by increasing the moment arm of the tab, that is, the larger the tab relative to the container, the less force that must be applied at a distal point on the tab to effect a rupture at the engineered separation site. This allows easier removal of the cap portion from the body portion by torquing the cap portion. Such relative elongation of the tab simply increases the leverage available for opening the container at the engineered separation site.
  • the engineered separation site comprises a line of discontinuity in shell thickness between the body portion wall and the cap portion wall.
  • the discontinuity creates a natural fracture zone between the adjoining body portion and cap portion
  • the engineered separation site is formed by a progressive attenuation of the thickness of the wall shoulder portion tapering from a maximum thickness at the distal aspect of the wall shoulder portion to reach a minimum thickness at the proximal aspect of the wall shoulder portion (221), see FIG. 7.
  • a container (10) with at least one diameter (12) and a longitudinal axis (14), comprising a container shell (50) comprising a body portion (200) with a body portion wall (220) having a wall shoulder portion (221) configured at a non-orthogonal angle from the longitudinal axis (14) of the container (10) having a distal aspect (222) and a proximal aspect (223) wherein the wall shoulder portion (221) further comprises at least one raised gusset (228) extending from the wall shoulder portion (221) and having a lateral surface (229) substantially parallel to the longitudinal axis (14) of the container (10) wherein the lateral surface (229) begins at the distal aspect (222) of the wall shoulder portion (221) and extends substantially parallel to the longitudinal axis (14) of the container at least 25% of the longitudinal distance from the distal aspect (222) to the injection site (135) measured along the longitudinal axis (14) of the container (10), and an adjoining cap portion (300) having a cap
  • a container (10) with at least one diameter (12) and a longitudinal axis (14), comprising a container shell (50) comprising a body portion (200) with a body portion wall (220) having a wall shoulder portion (221) configured at a non-orthogonal angle from the longitudinal axis (14) of the container (10) having a distal aspect (222) and a proximal aspect (223) wherein the wall shoulder portion (221) further comprises at least one raised gusset (228) extending from the wall shoulder portion (221) and having a lateral surface (229) substantially parallel to the longitudinal axis (14) of the container (10) wherein the lateral surface (229) begins at the distal aspect (222) of the wall shoulder portion (221) and extends substantially parallel to the longitudinal axis (14) of the container at least 25% of the longitudinal distance from the distal aspect (222) to the injection site (135) measured along the longitudinal axis (14) of the container (10), and an adjoining cap portion (300) having a cap
  • FIG. 1 is a cross section view of an embodiment of a prior art molded container
  • FIG. 2 is a cross section view of a prior art molded container with a cap portion removed;
  • FIG. 3 is a side elevation view of an embodiment of the instant invention.
  • FIG. 4 is a cross section view of the cap portion and a part of a body portion of the present invention.
  • FIG. 5 is a cross section view of a part of the body portion of the embodiment of the instant invention of FIG. 4, with the cap portion removed;
  • FIG. 6 is a cross section view of a stopper of the instant invention;
  • FIG. 7 is a cross section view of the cap portion, the stopper, and a part of the body portion of another embodiment of the molded container of the instant invention;
  • FIG. 8 is a cross section view of a part of the body portion of the embodiment of FIG. 5, and a needle-free connector;
  • FIG. 9a is a cross section view showing potential misalignment between the body portion of the embodiment of FIG. 5, and a needie-free connector;
  • FIG. 9b is a top plan view of an embodiment of the instant invention, showing raised gussets extending from a wall shoulder portion;
  • FIG. 10 is a cross section view of a part of the body portion of the BFS vial and a needle-free connector;
  • FIG. 1 1 is a cross section view of a part of the body portion of the embodiment of the instant invention with the needle- free connector inserted;
  • FIG. 12a is a top plan view of a prior art needle-free connector suitable for use with the instant invention.
  • FIG. 12b is a side elevation view of a prior art needle-free connector suitable for use with the instant invention.
  • FIG. 12c is a bottom plan view of a prior art needle-free connector suitable for use with the instant invention
  • FIG. 12d is a cross section view of a prior art needle-free connector suitable for use with the instant invention
  • FIG. 13a is a top plan view of an embodiment of the instant invention
  • FIG. 13b is a side elevation view of an embodiment of the instant invention
  • FIG. 14a is a top plan view of an embodiment of the instant invention
  • FIG. 14b is a side elevation view of an embodiment of the instant invention.
  • the molded container (10), see FIG. 4, of the instant invention enables a significant advance in the state of the art.
  • the detailed description set forth below in connection with the drawings is intended merely as a description of the presently preferred embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized.
  • the description sets forth the designs, functions, means, and methods of implementing the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and features may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
  • the instant invention comprises a molded container (10) with at least one diameter (12), see FIG.
  • the container (10) comprises a cap portion (300) and a body portion (200) with an encapsulated stopper (100).
  • the container has a container shell (50) comprising a body portion (200) with a body portion wall (220) having a wall shoulder portion (221) having a distal aspect (222) and a proximal aspect (223), best seen in FIG. 5.
  • distal and proximal are intended to represent positions relatively farther and relatively nearer, respectively, from the longitudinal axis (14) of the container (10).
  • the body portion (200) has an adjoining cap portion (300), seen in FIG. 4, having a cap portion wall (320), wherein the body portion wall (220) meets the cap portion wall (320) at an engineered separation site (400), seen in FIG. 4.
  • the engineered separation site (400) is designed to represent an area of weakness in the walls (220, 320) of the container, such that a uniform and repeatable breakage area is created for the removal of the cap portion (300) from the body portion (200).
  • the container (10) has a stopper (100), well seen in FIG. 5 and shown in detail removed from the container in FIG. 6, enclosed within the container shell (50), seen in FIG. 4, that prevents the transfer of contents from the body portion (200) to the cap portion (300).
  • a portion of the stopper (100) is enclosed within the body portion (200) and a portion of the stopper (100) is enclosed within the cap portion (300), as seen in FIG. 4.
  • the stopper (100) has a stopper wall (120) and a stopper shoulder (123), see FIG. 6, with a central raised nipple (130) having a nipple top surface (134) with an injection site (135) and a nipple sidewall (132), as seen in FIG. 5.
  • the engineered separation site (400), see FIG. 4, is adjacent to the nipple sidewall (132) such that when the cap portion (300) is removed from the body portion (200) at the engineered separation site (400) a portion of the nipple (130) extends out of the body portion (200), as seen in FIGS. 4 and 5.
  • the relatively small hole means that the care giver has only a very small surface area to hit with the needle, or other removal means, used to puncture the stopper and access the container contents.
  • the instant invention allows all of the top surface (134) of the nipple (130) to be easily cleaned, if desired, and allows substantially all of the top surface (134) of the nipple (130) to be accessed by a needle, or other removal means, to puncture the stopper (100) and access the container (10) contents.
  • the injection site (135) on the top surface (134) of the nipple (130) is bounded by a raised injection guide (136) to assist in correct placement of the needle or other removal means into the stopper (100).
  • the body wall shoulder portion (221), adjacent to the cap portion (300), may be configured at a non-orthogonal angle, seen in FIG. 5, from the longitudinal axis (14) of the container (10).
  • This also has numerous advantages over the prior art.
  • the traditional BFS vial such as the prior art examples seen in FIGS. 1 and 2, have shoulders over the embedded stoppers that are configured approximately orthogonally to a longitudinal axis of the container, resulting in approximately a right-angle bend at the most lateral portion of the shoulder area. It can be difficult, given such an orthogonal angle, to insure sufficient plastic at the bend, to form a sufficiently strong container, using traditional BFS methods.
  • the instant invention may also be configured so that the body portion wall (220) has an ingress preventer (224), seen in FIGS. 4 and 5, wherein the ingress preventer (224) cooperates with a stopper ingress preventer (124) formed in the stopper wall (120).
  • the ingress preventer (224) cooperates with a stopper ingress preventer (124) formed in the stopper wall (120).
  • a wall retention surface (226) on the body portion wall (220) cooperates with a stopper retention surface (126) on the stopper wall (120).
  • such cooperation may provide sufficient frictional fit so that the stopper (100) is less likely to be forced into, or expelled from, the container (10).
  • the wall retention surface (226) further comprises at least one wall egress preventer (227), wherein the wall egress preventer (227) cooperates with a stopper egress preventer (127) on the stopper retention surface (126).
  • the wall shoulder portion (221) further comprises at least one raised gusset (228), seen in FIGS. 9b and 10, extending from the wall shoulder portion (221) and having a lateral surface (229) substantially parallel to the longitudinal axis (14) of the container (10).
  • Such gusset(s) (228) not only tend to strengthen the BFS vial, but may cooperate with a variety of needle-free connectors, such as, by way of example only, the SMARTSITE® needle-free connector manufactured by Cardinal Health, Inc. of Dublin, Ohio, USA.
  • a larger surface area for interaction results in a more stable cooperation between the elements and a more positive centering of a needle-free connector, as will be discussed immediately below in relationship to FIGS. 8-11.
  • FIGS. 8-1 The advantage of the at least one raised gusset design may be seen in FIGS. 8-1 1.
  • a needle free connector (500) see FIG. 12a, of the type, by way of example only, of the SMARTSITE® needle-free connector poised at the moment of puncture of the injection site (135), see FIG. 8, of the raised nipple (130).
  • FIG. 9a One skilled in the art can see, as would be confirmed by reference to FIG. 9a, that it is relatively easy for an operator to place the needle-free connector (500) eccentrically on the container (10), potentially leading to an unstable connection and an improper puncturing of the injection surface (135).
  • Typical features of a needle-free connector (500) may be seen in FIGS. 12a- 12d, as well as in FIGS. 8, 9a, and 10-1 1.
  • some of the features of a typical needle-free connector include a connector male end fluid port ingress regulator (523), essentially shaped as a spike-like means for puncturing the stopper (100) at the injection site (135) and a connector male end fluid port interlock (524), essentially configured as resilient clips that allow the needle-free connector (500) to cooperate with various configurations of the body portion (200) of the container (10).
  • the raised gusset (228) design particularly embodiments employing a lateral surface (229) substantially parallel to the longitudinal axis of the container (10), may be appreciated by one skilled in the art as illustrated in FIG. 10.
  • the raised gusset(s) (228) As the needle-free connector approaches the top of the container (10), the raised gusset(s) (228), particularly the lateral edges (229), interacts with the clip-like sides of the needle-free connector. This tends to guide the needle- free connector to a proper central placement on the injection site (135).
  • the raised gusset(s) (228) tend to fill the interior volume of the needle-free connector and to insure a closer and more stable fit with the body portion (200) of the container (10).
  • FIGS. 12a-d The details of a typical needle-free container suitable for use with the instant invention are shown, by way of example only, in FIGS. 12a-d.
  • the cap portion (300) may have a cap portion wall (320) formed with a grip enhancing feature (330).
  • a grip enhancing feature (330) may be a flattened tab (332) having a lateral aspect (333).
  • Various embodiments employing different geometries maybe useful in facilitating the opening of the container (10) which is often of a relatively small size.
  • the grip enhancing features may be a flattened tab (332) attached to the cap portion (300), seen in FIGS. 13a-b and 14a-b.
  • a flattened tab (332) may have relatively short lateral expanse such that the easiest means of removing the cap portion (300) from the body portion (200) is to use two hands, one to grip the body portion (200) and another to twist off the cap portion (300).
  • Such a twisting motion is shown in FIG. 13b by the two-headed arrow indicating rotation that is shown on the cap portion (300). While one-handed removal of the cap portion (300) in such a design is not impossible, it may require a degree of hand strength not universally found among those desiring to use the container (10).
  • the hand strength required for one-handed opening may be decreased by increasing the moment arm of the tab (332) that is, the larger the tab (332) relative to the container (10), the less force that must be applied at a distal point on the tab (332) to effect a rupture at the engineered separation site (400).
  • a tab (332) is shown in FIGS. 7 and 14b formed such that a distance from a most distant point on the tab (332), at the lateral aspect (333), from a center of the injection site (135) is at least 50% of the largest of the at least one diameter (12) of the container (10). A similar construction may be seen in FIG. 14b.
  • the tab (332) is formed such that a distance from a most distant point on the tab (332), at the lateral aspect (333), from a center of the injection site (135) is at least 65% of the largest of the at least one diameter (12) of the container (10), as may be seen in FIG. 7 and FIG. 14b. Such relative elongation of the tab (332) simply increases the leverage available for opening the container (10) at the engineered separation site (400).
  • Clean and accurate removal of the cap portion (300) from the body portion (200) may also be facilitated by refinements in the engineered separation site (400) where the body portion wall (220) meets the cap portion wall (320).
  • a site (400) could comprise, by way of example, a score line in the shell wall (52).
  • the engineered separation site (400) comprises a line of discontinuity in shell thickness between the body portion wall (220) and the cap portion wall (320). The discontinuity creates a natural fracture zone between the adjoining body portion (200) and cap portion (300). As seen in FIG.
  • the engineered separation site (400) is formed by a progressive attenuation of the thickness of the wall shoulder portion (221), see FIG. 5, tapering from a maximum thickness at the distal aspect (222) of the wall shoulder portion (221) to reach a minimum thickness at the proximal aspect (223) of the wall shoulder portion (221).
  • the container with a raised nipple of the instant invention answers a long- felt need in the area of BFS containers having internally encapsulated stoppers.
  • the design of the invention allows a portion of the raised nipple to extend beyond the body portion of the container, after opening, such that it may be easily accessed and cleaned. Additional modifications, including the provision of an improved engineered separation site at the point of opening, and raised gussets that may provide a secure connection with various needle-free connectors improves the safety and efficiency found in this art.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Ceramic Engineering (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Containers Having Bodies Formed In One Piece (AREA)
  • Blow-Moulding Or Thermoforming Of Plastics Or The Like (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Auxiliary Devices For And Details Of Packaging Control (AREA)
  • Moulding By Coating Moulds (AREA)
  • Casting Or Compression Moulding Of Plastics Or The Like (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Abstract

La présente invention concerne un récipient qui comprend une coque de récipient dotée d'une partie corps, d'une partie bouchon adjacente et d'un dispositif d'obstruction installé à l'intérieur, ainsi qu'un site de séparation travaillé pour faciliter la séparation du corps et du bouchon. Le dispositif d'obstruction possède une tétine verticale installée sur celui-ci de telle sorte qu'une partie dudit dispositif se trouve enfermée dans la partie corps et une autre partie du dispositif est enfermée dans la partie bouchon. Lorsque la partie bouchon est retirée de la partie corps, une partie de la tétine sort de la partie corps et permet ainsi d'accéder facilement au dispositif d'obstruction pour nettoyer ou retirer le contenu. De plus, il y a un site de séparation qui comprend une atténuation partielle de l'épaisseur d'une partie de la paroi du récipient. Des soufflets verticaux sont prévus afin d'accroître la coopération entre l'invention et différents connecteurs dépourvus d'aiguilles déjà connus.
PCT/US2007/080267 2006-10-04 2007-10-03 Récipient moulé équipé d'une tétine verticale et son procédé de fabrication WO2008042939A2 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2009531572A JP5199265B2 (ja) 2006-10-04 2007-10-03 隆起ニップルを有する成型容器および使用方法
BRPI0720340-3A BRPI0720340B1 (pt) 2006-10-04 2007-10-03 Recipiente com ao menos um diâmetro e um eixo geométrico longitudinal e método para armazenar e dispensar uma substância fluxível no interior de um recipiente.
DE602007011785T DE602007011785D1 (de) 2006-10-04 2007-10-03 Formbehälter mit erhobenem nippel und verwendung
AT07843722T ATE494235T1 (de) 2006-10-04 2007-10-03 Formbehälter mit erhobenem nippel und verwendung
EP07843722A EP2066570B1 (fr) 2006-10-04 2007-10-03 Récipient moulé équipé d'une tétine verticale et son utilisation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/542,869 US20080083691A1 (en) 2006-10-04 2006-10-04 Molded container with raised nipple and method for use
US11/542,869 2006-10-04

Publications (2)

Publication Number Publication Date
WO2008042939A2 true WO2008042939A2 (fr) 2008-04-10
WO2008042939A3 WO2008042939A3 (fr) 2008-12-04

Family

ID=39271606

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/080267 WO2008042939A2 (fr) 2006-10-04 2007-10-03 Récipient moulé équipé d'une tétine verticale et son procédé de fabrication

Country Status (8)

Country Link
US (2) US20080083691A1 (fr)
EP (1) EP2066570B1 (fr)
JP (1) JP5199265B2 (fr)
CN (1) CN101600627A (fr)
AT (1) ATE494235T1 (fr)
BR (1) BRPI0720340B1 (fr)
DE (1) DE602007011785D1 (fr)
WO (1) WO2008042939A2 (fr)

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WO2018060333A1 (fr) * 2016-09-28 2018-04-05 Fresenius Kabi Deutschland Gmbh Capuchon de fermeture pour un contenant destiné contenir un liquide médical
US10086984B2 (en) 2009-06-30 2018-10-02 R.P. Scherer Technologies, Llc Molded container with opener and method for use

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US9918900B2 (en) 2014-10-29 2018-03-20 R.P. Scherer Technologies, Llc Inverse blow-fill-seal packaging
CA2991221A1 (fr) 2015-07-02 2017-01-05 Marc Andrew Koska Dispositif de distribution a usage unique pre-rempli d'un agent reconstituable
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10086984B2 (en) 2009-06-30 2018-10-02 R.P. Scherer Technologies, Llc Molded container with opener and method for use
WO2018060333A1 (fr) * 2016-09-28 2018-04-05 Fresenius Kabi Deutschland Gmbh Capuchon de fermeture pour un contenant destiné contenir un liquide médical
US11034491B2 (en) 2016-09-28 2021-06-15 Fresenius Kabi Deutschland Gmbh Sealing cap for a container for holding a medical liquid

Also Published As

Publication number Publication date
WO2008042939A3 (fr) 2008-12-04
EP2066570B1 (fr) 2011-01-05
US20080083691A1 (en) 2008-04-10
EP2066570A2 (fr) 2009-06-10
JP5199265B2 (ja) 2013-05-15
EP2066570A4 (fr) 2009-11-11
BRPI0720340B1 (pt) 2019-02-26
BRPI0720340A2 (pt) 2014-06-24
CN101600627A (zh) 2009-12-09
ATE494235T1 (de) 2011-01-15
DE602007011785D1 (de) 2011-02-17
US20090230077A1 (en) 2009-09-17
JP2010505710A (ja) 2010-02-25

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