EP2861155A1 - Vorrichtung mit durchlässiger wand und verschlussnadel - Google Patents

Vorrichtung mit durchlässiger wand und verschlussnadel

Info

Publication number
EP2861155A1
EP2861155A1 EP13804794.9A EP13804794A EP2861155A1 EP 2861155 A1 EP2861155 A1 EP 2861155A1 EP 13804794 A EP13804794 A EP 13804794A EP 2861155 A1 EP2861155 A1 EP 2861155A1
Authority
EP
European Patent Office
Prior art keywords
septum
closure
penetrable
penetrable septum
filling
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.)
Withdrawn
Application number
EP13804794.9A
Other languages
English (en)
French (fr)
Other versions
EP2861155A4 (de
Inventor
Daniel Py
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dr Py Institute LLC
Original Assignee
Dr Py Institute LLC
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 Dr Py Institute LLC filed Critical Dr Py Institute LLC
Publication of EP2861155A1 publication Critical patent/EP2861155A1/de
Publication of EP2861155A4 publication Critical patent/EP2861155A4/de
Withdrawn legal-status Critical Current

Links

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
    • A61J1/05—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
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • 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
    • B65D2251/00—Details relating to container closures
    • B65D2251/0003—Two or more closures
    • B65D2251/0006—Upper closure
    • B65D2251/0015—Upper closure of the 41-type
    • 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
    • B65D2251/00—Details relating to container closures
    • B65D2251/0003—Two or more closures
    • B65D2251/0068—Lower closure
    • B65D2251/009—Lower closure of the 51-type

Definitions

  • the present invention relates to a device, such as a container, vial or dispenser, with a septum that is penetrable for filling a chamber with a substance therethrough, a closure that closes the penetrated septum and is itself penetrable for accessing the substance filled into the chamber, and a filling device for filling the chamber through the septum, and related methods.
  • a device such as a container, vial or dispenser, with a septum that is penetrable for filling a chamber with a substance therethrough, a closure that closes the penetrated septum and is itself penetrable for accessing the substance filled into the chamber, and a filling device for filling the chamber through the septum, and related methods.
  • a typical previously-known vial having a penetrable septum for filling therethrough leaves a residual injection aperture in the septum after a filling needle penetrates and withdraws therefrom.
  • Hermetically resealing the penetrated septum requires utilizing an external source such as radiation or chemicals. While such methods are effective, one drawback is that radiation or chemical resealing requires relatively expensive parts in a filling assembly line.
  • a typical previously-known filling needle includes a hollow stainless steel shaft, a non- coring, conically-pointed tip fixedly secured to the distal end of the shaft, and diametrically opposed fluid ports proximal to the tip and in fluid communication between the interior of the shaft and the ambient environment.
  • One drawback encountered with previously-known filling needles is that the interior of the needle, and any fluid contained therein or passing therethrough, can be exposed to the ambient environment via the open fluid ports.
  • regulatory agencies require control of the filling needle environment in order to protect against exposure of a sterile product to the environment and the resulting contamination of the product that might occur.
  • a device comprises a sealed chamber; a first penetrable septum in fluid communication with the chamber that is penetrable by a first needle or like injection member to fill the first chamber with a substance therethrough; and a second penetrable septum.
  • the second penetrable septum is movable between first and second positions. In the first position, at least a portion of the second septum is spaced away from the first septum to allow the needle or like injection member to penetrate the first septum and aseptically or sterile fill the chamber with a substance therethrough.
  • said at least a portion of the second septum overlies and mechanically seals a resulting injection aperture in the first septum after withdrawal of the first needle or like injection member therefrom, and is penetrable by a second needle to penetrate the first and second septums and withdraw a filled substance from the chamber.
  • the device further comprises a body defining the chamber and a first closure connected to the body and forming a fluid-tight seal therebetween.
  • the first closure includes the first penetrable septum.
  • the device further comprises a second closure connectable to the first closure and/or body.
  • the second closure includes the second penetrable septum.
  • the first and/or second penetrable septums are co-molded with the first and second closures, respectively.
  • the first penetrable septum is over-molded onto the first closure, and the second penetrable septum is over-molded onto the second closure.
  • the first and/or second penetrable septums are over-molded to the first and second closures, respectively, at the same time.
  • the second closure is connected to the first closure, and at least one of the first and second closures is movable relative to the other to position the second closure in the first or second positions.
  • the device further comprises a hinge coupled between the first and second closures to allow movement of the second closure from the first open position to the second closed position.
  • the hinge is a living hinge.
  • the first and second closures are injection molded as one part, and the first and second penetrable septums are over-molded to the first and second closures, respectively.
  • the first penetrable septum is formed of an elastic material.
  • the aperture formed in the first penetrable septum by the needle, injection or filling member substantially closes upon withdrawal of the needle, injection or filling member due to the elastic properties of the material.
  • the material is sufficiently elastic to substantially hermetically seal itself at a resulting penetration aperture after withdrawal of the first needle or like injection member therefrom.
  • the first septum is approximately dome or convex shaped. In some such embodiments, the first septum is approximately dome or convex shaped on a side thereof substantially opposite the side of the chamber.
  • the second penetrable septum is approximately dome or convex shaped.
  • the second septum is approximately dome or convex shaped on a side thereof substantially opposite or juxtaposed with respect to the upper side of the first septum in a way that the second septum and first septum provide a mechanical seal around an aperture left by a filling needle.
  • the first septum comprises a substantially homogeneous material, such as, for example, silicone.
  • the first septum defines a durometer within the range of about 5 Shore A to about 65 Shore A, such as within the range of about 25 Shore A to about 45 Shore A.
  • the first septum defines a thickness within the range about 1 ⁇ 2 to about twice the largest diameter of the needle or like injection member that penetrates the first septum to fill a chamber therethrough.
  • penetration of the first septum by the first needle or like injection member achieves at least about a 3 log reduction in bio-burden by wiping the tip of the first needle or like injection member. In some such embodiments, penetration of the first septum by the first needle or like injection member achieves at least about a 6 log reduction in bio- burden of the tip.
  • the first closure includes a first connecting member
  • the second closure includes a second connecting member
  • at least one of the first and second connecting members is engageable with the other to secure the second penetrable septum in the second position.
  • at least one of the first and second connecting members is receivable within the other to secure the second penetrable septum in the second position.
  • the first connecting member defines a recess
  • the second connector member defines a protrusion receivable within the recess to secure the second penetrable septum in the second position.
  • the protrusion defines a chamfer or beveled surface slideable against the recess to facilitate inserting the second connecting member into the first connector member.
  • the protrusion is engageable with an underside of the recess to secure the second connecting member to the first connecting member.
  • the recess extends angularly about the first connecting member, and the protrusion extends angularly about the second connecting member.
  • the second penetrable septum is entirely spaced away from the first penetrable septum in the first position.
  • the device further comprises a body defining the chamber and a closure overlying the first penetrable septum and connected to the body and forming a fluid-tight seal therebetween.
  • the second penetrable septum is slidably received in the closure.
  • the device further comprises a disk including the second penetrable septum.
  • the closure further defines a lateral slot therein for slidably receiving the disk therein, wherein the disk creates a dimensional interference fit with the slot, thereby creating a sliding, fluid-tight seal, therebetween.
  • the second septum comprises a first portion and a second portion, wherein said second portion defines said at least a portion of the second septum.
  • the first portion of the second septum sealingly overlies the first septum and the second portion of the second septum is spaced away from the first septum.
  • the second portion of the second septum sealingly overlies the first septum and the first portion of the second septum is spaced away from the first septum.
  • a device comprises a sealed chamber; first means in fluid communication with the chamber and penetrable by a first needle or like injection member for filling the first chamber with a substance therethrough; and second means movable between a first position, wherein at least a portion of the second means is spaced away from the first means for allowing the first needle or like injection member to penetrate the first means and fill the chamber therethrough, and a second position for sealing a resulting injection aperture in the first means after withdrawal of the first needle or like injection member therefrom, and penetrable by a second needle or like injection member for penetrating the first and second means and withdrawing a filled substance from the chamber and through the second needle or like injection member.
  • the first means is formed of an elastic material. In some embodiments, the first means is a first penetrable septum, and the second means is a second penetrable septum.
  • a device comprises a sealed chamber, and a penetrable septum, having a first portion and a second portion, in fluid communication with the chamber.
  • the penetrable septum is movable between (i) a first position, wherein the first portion is in fluid communication with the chamber to allow a first needle or like injection member to penetrate therethrough, and, in turn, fill the chamber with substance, and (ii) a second position, wherein the second, unpenetrated portion, sealingly overlies the chamber after withdrawal of the first needle or like injection member therefrom.
  • the second portion is penetrable in the second position by a second needle or like injection member to, in turn, withdraw substance from the chamber.
  • the device further comprises a body defining the chamber and a closure connected to the body and forming a fluid-tight seal therebetween, wherein the penetrable septum is slidably received in the closure.
  • the device further comprises a disk including the penetrable septum.
  • the closure further defines a lateral slot therein for slidably receiving the disk therein, wherein the disk creates a dimensional interference fit with the slot, thereby creating a sliding, fluid-tight seal, therebetween.
  • a filling device comprises a hollow filling member.
  • a tip is formed at one end of the filling member, at least one port is in fluid communication with the interior of the hollow filling member, and an annular shell extends radially and angularly about the filling member.
  • a closure is coupled to the annular shell, and at least one of the closure and the filling member is movable between (i) a first position wherein the closure closes the at least one port and forms a substantially fluid-tight seal between the fluid port and ambient atmosphere to facilitate maintaining sterility of the port and interior of the filling member, and (ii) a second position opening the at least one port and allowing a flow of substance through the port.
  • the closure is biased in a direction from the second position toward the first position to normally close the at least one port.
  • the filling device further comprises a biasing member biasing the closure in the direction from the second position toward the first position.
  • the closure is engageable with a penetrable septum to move at least one of the closure and filling member from the first position to the second position upon penetrating the septum with tip of the filling member.
  • at least one of the closure and filling member is movable from the second position to the first position during or upon withdrawing the filling member from the septum.
  • a distal end of the closure is engageable with a stop surface of the filling member to stop the closure in the first position and form a substantially fluid-tight seal between the closure and filling member.
  • the filling device further comprises a sealing member located between the distal end of the closure and the stop surface and forming a substantially fluid-tight seal therebetween in the first position.
  • the sealing member is integrally molded, such as by over molding, to the closure. In other embodiments, the sealing member is integrally molded, such as by over molding, to the stop surface.
  • the filling member is formed of plastic, such as any of numerous different thermoplastics, including the liquid crystal polymers (LCP) that are highly crystalline, thermotropic (melt-orienting) thermoplastics and sold under the trademark VECTRATM by Celanese Corporation.
  • LCP liquid crystal polymers
  • VECTRATM thermotropic (melt-orienting) thermoplastics
  • the annular shell forms a bellows.
  • the annular shell includes a one-way valve in fluid communication between the hollow filling member and ambient atmosphere.
  • the one-way valve vents out air and/or other gases from within the shell to the ambient atmosphere when the bellows is under compression.
  • a filling device comprises first means for providing a conduit for the passage of fluid therethrough; second means formed at one end of the first means for penetrating a septum; third means in fluid communication with the conduit for passage of fluid from the conduit therethrough; and fourth means for closing the third means. At least one of the fourth means and the first means is movable between (i) a first position wherein the fourth means closes the third means and forms a substantially fluid-tight seal between the third means and ambient atmosphere to facilitate maintaining sterility of the third means and an interior of the first means, and (ii) a second position opening the third means.
  • Some embodiments further comprise fifth means for forming a seal between the fourth means and at least one of the first and second means.
  • the first means comprises a filling member
  • the second means comprises a tip of the filling member
  • the third means comprises at least one port
  • the fourth means comprises a closure
  • the fifth means comprises a sealing member
  • a method comprises the following steps:
  • the method further comprises the steps of:
  • the method further comprises, prior to closing a resulting penetration aperture in the first septum with the second septum, sterilizing at least an exterior surface of the first penetrable septum defining the resulting penetration aperture and an interior surface of the second penetrable septum, such as with UV radiation (e.g., at a wavelength of about 254 nm), or low energy beta radiation, or by any sterilizing agent.
  • the sterilizing step includes applying radiation to said surfaces.
  • the step of sterilizing the sealed empty chamber is performed prior to penetrating the first penetrable septum.
  • the penetrating step further comprises wiping the first needle or like injection member with the first penetrable septum.
  • the wiping step comprises wiping the tip of the filling needle or like injection member with the first penetrable septum.
  • the wiping step comprises wiping the needle or like injection member with the first penetrable septum defining a durometer within the range of about 5 Shore A to about 65 Shore A.
  • the wiping step comprises wiping the needle or like injection member with the first penetrable septum defining a thickness within the range of about 1 ⁇ 2 to about two times the largest diameter of the needle or like injection member.
  • the wiping step comprises wiping the tip of the needle or like injection member, wherein the tip defines an included bevel angle within the range of about 30 degrees to about 50 degrees, such as about 40 degrees. In some such embodiments, the wiping step achieves at least about a 3 log reduction in bio-burden on the tip of the needle or like injection member.
  • the sealing step includes moving the second penetrable septum from a first position, wherein a first portion thereof overlies the first penetrable septum, to a second position, wherein a second portion thereof overlies and sealingly engages the first penetrable septum.
  • the sealing step includes moving the second penetrable septum from a first position spaced away from the first penetrable septum to a second position overlying and sealingly engaging the first penetrable septum.
  • a method comprises the following steps:
  • the substance can be introduced from the first needle or like injection member into the chamber after full perforation of the first penetrable septum or after part of the at least one filling port has passed through an interior surface of the first penetrable septum and is located within the chamber.
  • the method can further comprise the step of substantially sealing the at least one filling port and an interior of the needle or like injection member from ambient atmosphere in the closed position.
  • the method can also comprise, before or during the withdrawing step, moving at least one of the closure and the at least one filling port of the first needle or like injection member from the open position to the closed position.
  • the method can include substantially preventing any contact between the at least one filling port and the first penetrable septum.
  • the closure is interposed between the at least one filling port and first penetrable septum to substantially prevent any contact between the at least one filling port and the first penetrable septum.
  • One advantage of the present invention is that the device, such as a container to be filled, is mechanically self-closing. As a result, the present invention obviates the need to thermally, chemically or laser reseal the resulting penetration aperture, and thus obviates the need for such additional processing steps and equipment.
  • the septum is configured to wipe the tip of the filling needle or like injection member as it penetrates the septum to fill the chamber, and effectively de-contaminates and/or sterilizes the tip prior to entry into the chamber. Accordingly, another advantage of the present invention is that it can reduce the risk of contamination and/or reduce the controls over, or the need to control a filling needle environment.
  • the needle opens and closes automatically within the sterile or aseptic container.
  • the needle is always closed prior to being withdrawn from within the sterile container.
  • the needle is sealed during passage through the septum to prevent any contaminants on the septum or in the environment from contaminating the interior of the needle.
  • FIG. 1 is a side perspective view of a device in the form of a container
  • FIGS. 2A-2D sequentially show the assembly of the device of FIG. 1, in which the septa are over-molded onto the molded cap and the first closure is sealingly closed in place on the container;
  • FIG. 3A is a partial, side cross-sectional side view of the device of FIG. 1, with the second closure in the first, non-sealing position;
  • FIG. 3B is a side cross-sectional view of the device of FIG. 1 after the filling member has pierced the device septum and has been withdrawn leaving a hole in the device septum, with the second closure in the first, non-sealing position, and schematically showing sterilization of the first and second closures;
  • FIG. 4 is a side cross-sectional view of the device of FIG. 1, with the second closure in the second, sealing position;
  • FIG. 5 is a side perspective view of a filling device engageable with the device of FIG. 1 to aseptically or sterile fill a substance therein;
  • FIG. 6A is a side cross-sectional view of the filling device of FIG. 5, with the closure in the first or closed position, sealing the ports of the filling member from the ambient atmosphere;
  • FIG. 6B is a side cross-sectional view of the filling device of FIG. 5, with the closure in the second or open position, opening the ports of the filling member;
  • FIG. 7A is a partial, side cross-sectional view of the closure and tip of the filling device of FIG. 5 prior to engagement with the septum of the device of FIG. 1, with the closure in the first or closed position sealing the ports from ambient atmosphere;
  • FIG. 7B is a side cross-sectional view of the filling device of FIG. 5 upon penetration of the tip of the filling member through a septum of the type shown in FIG. 1, with the closure still in the first or closed position sealing the ports from contact with the penetrated septum;
  • FIG. 7C is a side cross-sectional view of the filling device of FIG. 5, where the tip of the filling member is penetrated through the septum, the closure is prevented from further movement through the septum, and the filling member is allowed to continue to move into the chamber relative to the fixed closure to expose the fluid ports to the chamber and allow the aseptic or sterile flow of substance through the open ports and into the aseptic or sterile chamber;
  • FIG. 8A is a side cross-sectional view of another embodiment of the distal end of the filling device of FIG. 5, including a seal over-molded to the stop surface formed at the tip of the filling member to facilitate forming a substantially fluid-tight or hermetic seal between the closure and filling device;
  • FIG. 8B is a side cross-sectional view of another embodiment of the distal end of the filling device of FIG. 5, including a seal over-molded to the distal end of the closure to facilitate forming a substantially fluid-tight or hermetic seal between the closure and filling device.
  • FIG. 9A is a top perspective view of a device in the form of a container, with the second closure in the first, non-sealing position;
  • FIG. 9B is a top perspective view the device of FIG. 9A with the second closure in the first, non-sealing position with a filling member positioned to pierce the first closure;
  • FIG. 9C is a side view of the device of FIG. 9A that has been filled, with the second closure in the second, sealing position and ready for sampling of substance in the chamber;
  • FIG. 9D is a side view of the filled device of FIG. 9C with a needle piercing the second closure into the chamber to permit withdrawal and sampling of substance from the chamber;
  • FIG. 9E is a side view of the device of FIG. 9C with all of the substance withdrawn from the chamber;
  • FIG. 10A is a cross-sectional view of the device and filling member shown FIG. 9B;
  • FIG. 10B is a cross-sectional view of the device of FIG. 9A with the tip of the filling member penetrating the septum of the first closure into the chamber and the closure of the filling member in the first or closed position, sealing the ports of the filling member from the ambient atmosphere;
  • FIG. IOC is a cross-sectional view of the device of FIG. 9A with the filling member further penetrating into the chamber with the closure of the filling member in the second or open position, opening the ports of the filling member;
  • FIG. 10D is a cross-sectional view of the device of FIG. 9A with the filling member partially withdrawn from the chamber and the closure of the filling member moved back to the first or closed position, re-sealing the ports of the filling member from the ambient atmosphere;
  • FIG. 11 is an exploded view of another embodiment of a device in the form of a container
  • FIGS. 12A-12D show sequential side cross-sectional views of the assembly, sterilization, filling and sealing of the device of FIG. 11 taken along section line A-A;
  • FIG. 13 is a perspective cross-sectional view of another embodiment of a device in the form of a container, prior to assembly of the second septum thereto;
  • FIG. 14 is a perspective cross-sectional view of the device of FIG. 13, with the second septum in a first, ready for filling, position;
  • FIG. 15 is a perspective cross-sectional view of the device of FIG. 13 during filling thereof;
  • FIG. 16 is a perspective cross-sectional view of the device of FIG. 13, with the second septum in a second, sealing, position;
  • FIG. 17 is a perspective cross-sectional view of another embodiment of a device in the form of a container, prior to assembly of the septum thereto;
  • FIG. 18 is a perspective cross-sectional view of the device of FIG. 17, with the septum in a first, ready for filling, position;
  • FIG. 19 is a perspective cross-sectional view of the device of FIG. 17 during filling thereof;
  • FIG. 20 is a perspective cross-sectional view of the device of FIG. 17 with the septum in a second, sealing, position;
  • FIG. 21 is an exploded view of another embodiment of a device in the form of a container
  • FIG. 22 is a perspective side view of the device of FIG. 21, with the closure in the first position, uncovering the filling septum; and [0072] FIG. 23 is a perspective side view of the device of FIG. 21, with the closure in the second position, uncovering the withdrawal septum.
  • a device is indicated generally by the reference numeral 10.
  • the device 10 is a container defining a sealed (with respect to the ambient atmosphere or environment) empty chamber 11 therein for aseptic or sterile filling with a substance, such as a medicament, pharmaceutical injectable, or vaccine.
  • a substance such as a medicament, pharmaceutical injectable, or vaccine.
  • the invention may be embodied in and otherwise may be applicable to any of numerous different types of devices that are currently known or that later become known, such as vials, syringes, delivery devices, dispensers and processing devices.
  • the devices may be filled with any of numerous different substances that are currently known or that later become known, such as medicaments, pharmaceutical injectables, vaccines, supplements, foods, beverages, liquid nutrition products, and industrial products, and in any of numerous different forms, including liquids, gels, powders and gases.
  • the container 10 includes a body 12 and a closure 14.
  • the body is substantially cylindrical and defines a substantially cylindrical sidewall 16 with an opening 18 at a top end thereof, for sealingly receiving the closure 14 thereon, as described further below.
  • the body 12 further includes an annular projection 20 spaced from the top end thereof and extending laterally outwardly from the sidewall 16.
  • the body 12 may be made of glass or plastic.
  • the body may be made of any of numerous different materials that are currently known or that later become known.
  • the body may be configured in any of numerous shapes to receive a closure.
  • the body may define a spool-like or "diabolo" shape such as disclosed in U.S. Patent No. 7,100,646, issued September 5, 2006, entitled “Sealed Containers and Methods of Making and Filling Same," which, in turn, claims benefit of similarly titled U.S. Provisional Patent Application No. 60/408,086, filed September 3, 2002, each of which is hereby expressly incorporated by reference in its entirety as part of the present disclosure.
  • the closure 14 comprises a first closure 22 and a second closure 24.
  • the first and second closures 22, 24 are angularly moveable with respect to one another.
  • the first and second closures are coupled via a living hinge 26.
  • the second closure may be connected to either of the first closure or body via any of numerous connections that are currently known or that later become known to allow movement of at least one of the closures relative to the other.
  • the first and second closures 22, 24 need not be connected in the open position, but rather may be connected only in the closed position when the second closure overlies and sealingly engages a penetration aperture in the first closure. Where the first and second closures 22, 24 are connected in the open position, they may be molded in one piece, as shown.
  • Both the first and second closures 22, 24, include first and second substantially centered recesses 28, 30 respectively, axially extending from the top surfaces of the closures for sealingly receiving therein first and second penetrable septums 32, 34, respectively.
  • the penetrable septums may be made of any material that is penetrable by a needle, injection or filling member.
  • the material may be a needle-penetrable elastomeric, rubber or rubber-like material that is sufficiently elastic to be penetrated by a needle.
  • the septum materials also are sufficiently elastic to substantially close a resulting penetration aperture after removal of a needle or like injection member therefrom.
  • the aperture or hole may sufficiently close to prevent leaking or passage of liquid through the septum, it may not close sufficiently to prevent passage of gases, e.g. air, or other contaminants, e.g., microbial forms, especially over time.
  • the material is sufficiently elastic to thereby hermetically reseal itself. In embodiments where the material is under internal compression, the compression stresses can assist in closing/resealing the hole.
  • the first and second penetrable septums 32, 34 are co-molded with the first and second closure portions 22, 24, respectively.
  • first and second penetrable septums 32, 34 are over-molded with the first and second closure portions 22, 24, respectively, e.g., at the same time, as shown in FIGS. 2A and 2B.
  • the second closure portion 24 can then be mounted onto the body 12 as shown in FIGS. 2C and 2D.
  • the penetrable septums may be mounted within the first and second recesses in any of numerous ways configured to sealingly mount the septums therein, and the container may be assembled in a different order.
  • the closure 14 may be mounted on the body 12, and then the septums 32, 34 joined with the first and second closure portions 22, 24.
  • the first closure 22 includes an annular sidewall 36 axially extending from the perimeter of the top surface thereof, defining an axially extending annular channel 38 between the annular sidewall 36 and the annular wall of the annular recess 28.
  • the annular channel 38 receives therein a portion of the top end of the cylindrical sidewall 16 of the body 12, when the first closure is mounted atop the body.
  • the top end of the cylindrical sidewall 16 of the body defines an annular tapered protuberance 40.
  • the tapered protuberance 40 defines a tapered surface 42 on an external side of the sidewall 16.
  • the body sidewall 16 defines a laterally extending annular recess 44, extending inwardly from the exterior of the sidewall.
  • the bottom end of the annular sidewall 36 of the first closure defines a corresponding annular tapered protuberance 46.
  • the tapered protuberance 46 defines a tapered surface 48 on the interior of the sidewall 36.
  • the sealed empty chamber 11 is defined within the body, and the first penetrable septum 32 is in fluid communication with the chamber. If the closure 14 and body 12 are sterilized, a sealed, empty, sterile chamber is thus defined therein. Sterilization of the closure, body and/or any component parts therein may be achieved in accordance with the teachings of any of the following patents and patent applications, each of which is hereby expressly incorporated by reference in its entirety as part of the present disclosure as if fully set forth herein: U.S. Patent Application No. 08/424,932, filed April 19, 1995, entitled "Process for Filling a Sealed Receptacle under Aseptic Conditions," issued as U.S.
  • the sealed empty chamber may be sterilized with a fluid sterilant prior to filling, as disclosed in U.S. Patent Application No.
  • the second closure 24 is moveable between a first position (shown in FIGS. 2D, 3A, 9A and 10A), spaced away from the first closure 22, and a second position (shown in FIG. 4), where the second closure 24 mounts atop the first closure 22.
  • the first position the second penetrable septum 34 is not sealingly engaging the first penetrable septum 32.
  • the second penetrable septum 34 sealingly overlies the penetrable portion of the first penetrable septum 32, thus creating a mechanical seal, as explained further below.
  • the second closure 24 includes an annular sidewall 52 axially extending from the perimeter of the top surface thereof, and is configured to fittingly receive the first closure 24 therein when in the second position.
  • the bottom end of the second closure annular sidewall 52 defines an annular tapered protuberance 54.
  • the tapered protuberance 54 defines a tapered surface 56 on the internal side of the sidewall 52.
  • the second axially-extending recess 30 of the second closure 24, containing the second penetrable septum 34 therein sealingly fits within the first penetrable septum 32, thereby sealingly engaging the second penetrable septum atop the penetrable portion of the first penetrable septum.
  • the first penetrable septum 32 is approximately dome or convex shaped on a side thereof opposite the chamber 11.
  • the second penetrable septum 34 is correspondingly approximately dome or convex shaped as well on a side thereof substantially opposite the first penetrable septum 32, in order to sealingly mate with the contour of the first penetrable septum.
  • a filling device penetrates the first penetrable septum 32, when the second closure 24 is in the second or open position.
  • An exemplary needle is disclosed in U.S. Patent Application No. 13/450,306, filed April 18, 2012, entitled “Needle with Closure and Method,” which, in turn, claims benefit of U.S. Provisional Patent Application No. 61/476,523, filed April 18, 2011, entitled “Filling Needle and Method,” each of which is hereby expressly incorporated by reference in its entirety as part of the present disclosure as if fully set forth herein.
  • a filling device 60 is utilized to fill the device 10.
  • the filling device 60 comprises a hollow filling member 62, a tip 64 formed at one end of the filling member, two ports 66 in fluid communication with the interior of the hollow filling member 62, a first or relatively rigid closure 68, and a second closure or relatively flexible annular shell 70.
  • the filling member 62 includes a boss 72 at approximately a middle portion thereof. As can be seen, the boss 72 defines an annularly and axially extending recess therein for receiving a proximal portion of the closure 68 and a biasing member 74 that engages and biases the closure, as described further below.
  • the two ports 66 are diametrically opposed relative to each other; however, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the filling device may define any number of ports that may define any of numerous different configurations and locations.
  • the closure 68 and/or the filling member 62 is movable between (i) a first position wherein the closure closes the ports 66, as shown typically in FIG. 6A, and (ii) a second position opening the ports 66, as shown typically in FIG. 6B. When in the closed position, the closure 68 forms a substantially fluid-tight seal between the ports 66 and ambient atmosphere.
  • the closure 68 is biased via the biasing member 74 in the direction from the second or open position toward the first or closed position to normally close the ports 66.
  • the biasing member 74 is a coil spring.
  • the closure may be biased in any of numerous different ways that are currently known or that later become known, using biasing members other than springs. Further, if a spring is used, any of numerous different springs or combinations of springs may be used.
  • the closure 68 is a "shutter" closure that slides axially over the filling member 62 between the normally closed and open positions.
  • the closure may take any of numerous different configurations that are currently known, or that later become known, for performing the function of the closure as described herein.
  • the closure 68 extends both annularly and axially about the filling member 62 and is slidably mounted on the filling member.
  • the closure 68 includes an annular flange 76 adjacent to a proximal end thereof that is engageable with the biasing member 74 for biasing the closure in the direction from the second or open position toward the first or closed position.
  • An opposing distal end 78 of the closure 68 is engageable with an annular stop surface 80 of the filling member tip 64 to stop the closure in the first or closed position.
  • the distal end 78 of the closure 68 tapers inwardly to define a perimeter substantially flush with the perimeter of the stop surface 80 and adjacent portion of the filling member tip 64. As shown in FIGS.
  • the closure 68 (FIG. 8B) and/or the filling member tip 64 (FIG. 8A) includes an annular seal 82, between the distal end 78 of the closure and the tip 64 of the filling member, to further ensure the formation of a fluid-tight seal at the junction of the closure and filling member.
  • the seal 82 is o-ring shaped and is over-molded to the filling member tip 64.
  • the O-ring shaped seal 82 is over-molded to the distal tip of the closure 68.
  • the seal may or may not be integral with the closure and may take the form of any of numerous different types of seals or sealing members that are currently known or that later become known, to facilitate the formation of fluid-tight seal at the juncture of the closure and filling member.
  • the proximal end of the closure 68 is slidably received within the annular recess of the boss 72 of the filling member 62, and the biasing member 74 is located between the rear wall 84 of the boss 72 and the annular flange 76.
  • the flexible closure or shell 70 sealingly encloses the boss 72 of the filling member 62.
  • the flexible shell forms a bellows to allow the shell to axially expand when moving into the first or closed position (FIG. 6A) and to axially contract when moving into the second or open position (FIG. 6B).
  • the flexible shell may take any of numerous different configurations that are currently known, or that later become known, for performing the function of the shell as described herein.
  • the flexible shell sealingly engages an outwardly projecting annular flange 86 of the boss 72 near the proximal end thereof, and sealingly engages an annular flange 88 of the closure 68 at the distal end thereof.
  • the closure annular flange 88 projects radially outwardly from an approximate mid-portion of the closure 68.
  • the portion of the flexible shell 70 proximally adjacent to the boss annular flange 86 includes an integrally the boss 72.
  • the boss 72 includes corresponding venting holes 92 located adjacent to the rear wall 84 that are normally sealed by the valve 90. The venting holes 92 are in fluid communication with the interior recess of the boss 72.
  • the interior of the boss 72 is in fluid communication with one or more annularly and axially extending channels formed between the closure 68 and filling member 62 which, as shown in FIGS. 7C and IOC, are in fluid communication with a chamber to be filled when the closure is located in the second or open position.
  • the biasing member 74 is compressed upon movement of the closure from the first position to the second position, sufficient fluid pressure within the boss 72 (i.e., at or above the venting valve opening pressure) will cause the the venting valve 90 to move radially outwardly relative to the holes 92 to thereby allow one-way venting of any such air or other gases into the ambient atmosphere.
  • any air or other gases e.g., nitrogen
  • the valve 90 resiliently returns to its sealing position overlying and engaging the holes 92.
  • the venting valve 90 allows one-way venting of air or other gases through the venting holes 92, and into the shell 72 when a vacuum is present therein.
  • the venting valve may take the form of any of numerous integral or non-integral valves, that are currently known or that later becomes known, capable of performing the function of the venting valve as described herein.
  • the filling device tip 64 is defined by a non-coring, conically-pointed tip; however, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the filling device tip may define any of numerous other tip configurations that are currently known, or that later become known, such as a trocar tip.
  • the spring force of the biasing member 74 is sufficient to allow the filling device 60 to penetrate a septum of an opposing device while maintaining the closure 68 in the closed position during penetration of the closure through the septum and until the annular flange 88 of the closure engages an exterior surface of the septum (or other exterior or stop surface of the device to be filled) to cause relative movement of the closure and filling member against the bias of the biasing member 74 from the normally closed position to the open position and, in turn, expose the sterile filling device ports 66, 66 within the sterile device chamber.
  • a filling line attachment fitting 94 is formed on a proximal end of the filling member 62.
  • the attachment fitting 94 is a barbed fitting for attachment to a filling line (not shown).
  • any of numerous different types of fittings, connections or connectors that are currently known, or that later become known, equally may be employed for connecting the filling device to a filling or other type of line or conduit.
  • the proximal end of the filling device may define a male or a female connector for aseptically or sterile connecting to the other of the male or female connector attached to a filling line, as disclosed in U.S. Patent Application No.
  • the filling device 60 may be used to aseptically or sterile fill fluids through the first penetrable septum 32 and into the chamber 11 of the device 10.
  • the closure 68 prior to penetrating the first septum 32, and when the filling device tip 64 is exposed to the ambient atmosphere, the closure 68 is in the closed position sealing the ports 66 with respect to ambient atmosphere to thereby maintain the sterility of the ports and of the interior of the filling device.
  • FIGS. 7B and 10B upon penetrating the first septum 32, the closure 68 remains interposed between the ports 66 and the first penetrable septum 32 to substantially prevent contact between the ports and the septum.
  • the bottom surface of the annular flange 88 of the closure engages the top surface of the first closure 22 and prevents further movement of the shutter closure 68 relative to the first closure 22.
  • Further penetration of the filling device 60 into the chamber of the device 10 causes the filling member 62 and filling device tip 64 to slide relative to the shutter closure 68 against the bias of the biasing member 74 to, in turn, move the ports 66 to the open position.
  • the biasing member 74 is compressed with further movement of the shutter closure from the closed position to the open position, any fluid pressure within the shell 72 above of the venting valve opening pressure is allow to flow through the venting valve 90 into the ambient atmosphere. In the open position of FIGS.
  • the fluid or other substance within the filling device is permitted to flow through the open ports 66 and into the chamber 11. Any fluid within the chamber 11 that is displaced by the substance flowing into the chamber is allowed to vent through the channels formed between the shutter enclosure 68 and filling device 62 and, in turn, through the venting valve 90. Since the sterile ports 66 are never exposed to the ambient atmosphere throughout the filling process, the ports, interior of the filling device, and fluid flowing therethrough, are not contaminated and/or are maintained aseptic or sterile as the fluid is injected or otherwise filled into the chamber 11.
  • the first septum 32 comprises a lower, i.e., base, layer having a relatively high durometer and an upper layer having a relatively lower durometer.
  • the upper layer is not bondable with the lower layer and is over-molded thereon.
  • the first septum 32 wipes the tip 64 of the filling member 62 and the shutter closure 68 of contaminants thereon during engagement and penetration of the septum by the tip to, in turn, prevent the tip and/or shutter closure from introducing such contaminants into the sterile interior of the chamber 11 and thereby maintain the chamber and any substance therein aseptic or sterile.
  • the effectiveness of such wiping during penetration of the septum is dependent, in part, upon the pressure applied by the septum onto the tip of the filling member as it penetrates through, as well as the coefficient of friction therebetween.
  • the first septum 32 is approximately dome or convex shaped.
  • the present inventor has determined that the dome or convex shape increases the internally directed pressure applied by the septum 32 onto the tip 64 from the beginning of piercing, as the tip inverts the convexity of the septum in order to penetrate therethrough.
  • the thickness of the septum (increasing the length of the wiping effect) and durometer thereof also affect the pressure applied by the septum onto the tip.
  • the durometer of the septum 32, or the layers thereof is within the range of about 5 Shore A to about 65 Shore A, such as, for example, within the range of about 20 Shore A to about 50 Shore A.
  • the durometer of the septum 32 is within the range of about 25 Shore A to about 45 Shore A. In some such embodiments, the septum thickness is within the range of about 1 ⁇ 2 to about two times the largest diameter of the tip 64 of the filling member 62.
  • the material of the filling member 62 and the septum 32 also may be selected to enhance the wiping effect.
  • the present inventor has determined that the use of a plastic filling member provides the appropriate friction coefficient range to enhance the wiping effect.
  • the plastic material is also easier to mold, and thus easier to manufacture and assemble.
  • a septum made of a homogeneous elastic material defining a substantially homogeneous density will enhance the wiping effect.
  • the filling member 62 is formed of plastic, such as any of numerous different thermoplastics, including the liquid crystal polymers (LCP) that are highly crystalline, thermotropic (melt-orienting) thermoplastics and sold under the trademark VectraTM by Celanese Corporation, or graphene.
  • LCP liquid crystal polymers
  • the first septum 32 is made of silicone. In other embodiments, the first septum 32 is made of a vulcanized rubber or a thermoplastic elastomer. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the filling member and septum may be made of any of numerous different materials that are currently known, or that later become known, to perform the functions of the filling member and septum disclosed herein.
  • the configuration of the filling member itself also enhances the effectiveness of the wiping effect.
  • the included angle of the tip 64 of the filling member affects the progressively increasing thickness of the tip, and the diameter of the filling device, i.e., the outer diameter of the shutter closure. As the filling member 62 penetrates through the first septum 32, the internal pressure applied by the septum onto the tip 64, and thereafter onto a portion of the rigid closure increases proportionally to the progressively increasing tip diameter, resulting from the included angle of the tip.
  • the included angle of the tip of the piercing member is within the range of about 20 degrees to about 40 degrees, and such as about 30 degrees.
  • the present inventor has determined that the wiping effect on a filling member tip by a septum having properties as aforementioned may achieve at least approximately a 3 log reduction in bio-burden when filling member tip penetrates a septum while immersed in a broth, which is about the reduction achieved by known UV pulse (5 second) sterilization techniques, and up to approximately a 6 log reduction in bio-burden. Therefore, one advantage of the present invention is that the wiping of the filling device tip allows substantially sterile filling of fluids within a non-aseptic, non-sterile or relatively low sterility assurance level (“SAL”) environment (e.g., about 6 log bio-burden or lower).
  • SAL sterility assurance level
  • the filling device 60 may sterile fill a substance into the device 10 without the need to decontaminate the septum of the device or the tip of the filling device prior to filling.
  • the combination of the maintained sterility of the ports 66 and interior of the filling device 60, as well as the wiping effect provided by the first septum 32 effectively sterilize the tip 64 of the filling member 62 upon penetration of the filling member through the septum. Therefore sterile filling is achieved without the need to take conventional sterilization steps, such as the application of UV radiation, for example.
  • an unclassified environment e.g., about log 6 or higher
  • an unclassified environment is an environment having a number and size of particles per volume greater than 100,000 particles per cubic meter of 0.5 ⁇ or larger in diameter, i.e., a class 100,000 environment.
  • the filling device 60 is withdrawn from the first septum 32.
  • the biasing member 74 biases the rigid closure 68 downwardly or in the direction of the septum 32. Therefore, as the filling member 62 is withdrawn, it is moved axially relative to the shutter closure 68 to, in turn, move the ports 66 into the closed position behind the closure.
  • the shutter closure 68 is configured to substantially prevent contact between the filling device eyes or ports 66, and as can be seen, the sliding shutter or closure is closed over the filling device eyes or ports prior to their passage through the septum and/or withdrawal therefrom.
  • the closure 68 sealingly closes the ports 66 and prevents contamination of the ports or interior of the filling device.
  • the first septum 32 is engineered in a manner known to those of ordinary skill in the pertinent art to self-close and thereby ensure that the head loss left by the residual filling device injection aperture 96 after the tip of the filling device is withdrawn substantially prevents fluid ingress therethrough. Thereafter, as shown in FIG. 4, the second closure portion 24 is moved from the first position, and snaps into the second position, and the unpenetrated second septum 34 overlies and seals the injection aperture 96 in the first septum 32 from the ambient atmosphere. This forms a filled, sealed device as shown in FIGS. 4 and 9C.
  • the exterior surface of the first closure 32 and/or the interior surface of the second closure 24 may be sterilized, such as is shown in the example of FIG. 3B, in order to prevent any contaminants from being trapped between the first and second septums 32 and 34, respectively, after closure of the second closure to the first closure.
  • Sterilization of these surfaces may be performed in any of numerous different ways that are currently known, or that later become known, including without limitation, by the application of radiation thereto, such as e-beam, laser or UV radiation, by the application of a fluid sterilant, such as vaporized hydrogen peroxide ("VHP”) or nitric oxide (“NO”), or by heated gas.
  • VHP vaporized hydrogen peroxide
  • NO nitric oxide
  • sterilization may be achieved in accordance with the teachings of any of the following patents and patent applications, each of which is hereby expressly incorporated by reference in its entirety as part of the present disclosure: U.S. Patent Application No. 08/424,932, filed April 19, 1995, entitled “Process for Filling a Sealed Receptacle under Aseptic Conditions," issued as U.S. Patent No. 5,641,004; U.S. Patent Application No. 09/781,846, filed February 12, 2001, entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Method for Filling Vial,” issued as U.S. Patent No. 6,604,561, which, in turn, claims benefit of U.S. Provisional Patent Application No.
  • a further closure may be applied over the second closure 24 and/or second septum 34, such as an adhesive-backed foil layer that overlies the second septum 24 and is adhesively attached to the second septum or second closure, to provide an additional barrier such as to prevent moisture- vapor transmission ("MVT").
  • MVT moisture- vapor transmission
  • the adhesive-back foil layer or other additional MVT barrier may be manually engaged and removed to expose the second septum. Then, as shown in FIG.
  • a syringe needle or like withdrawal device may be pierced through the first and second septums 32, 34 and placed into fluid communication with the interior chamber 11 and the fluid or other substance therein to withdraw the fluid or other substance from the chamber and into the syringe to, for example, inject the withdrawn substance into a person.
  • the first and second septums may be pierced one or more times as desired to withdraw substance from the chamber 11 until the chamber is empty as shown in FIG. 9E.
  • the second closure is initially a separate piece and is not connected to the first closure. After the first closure is pierced and the device is filled with a substance, the second closure is then fixedly secured, such as by a snap fit as described above, to the first closure to sealingly engage the first and second septums, and seal the resulting penetration aperture in the first septum.
  • the second closure can be pre- sterilized prior to assembly, or can be surface sterilized as described above prior to assembly to the first closure.
  • the second closure can be automatically assembled to the first closure with any of numerous different assembly devices that are currently known, or that later become known, such as a pick and place robotic assembly device, or other suitable fixture that can automatically assemble the second closure to the first closure.
  • a closure assembly station can be located downstream of the needle penetration and filling station to assemble the second closure to the first closure upon or following withdrawal of the filling needle from the first closure.
  • FIGS. 11-12D another device is indicated generally by the reference numeral 110.
  • the device 110 is substantially similar to the device 10 described above in connection with FIGS. 1-4 and 9A-10B, and therefore like reference numerals preceded by the numeral "1" are used to indicate like elements.
  • a primary difference of the device 110 in comparison to the device 10 is the design of the closure 114 and that the first penetrable septum 132 is not integrated into the closure 114. Rather, the first penetrable septum 132 is separate from the closure and seats into the opening 118 of the body 112.
  • An upper portion 124 of the closure 114 defines a laterally- extending slot 124a configured to slidably receive the second penetrable septum 134 therein, for sealing the first septum 132 after penetration thereof, as hereinafter described.
  • the body 112 includes an annular, laterally-extending flange 120 spaced from the opening 118, and a neck 113 extending upward from the periphery of the flange 120 to the opening 118.
  • the first septum 132 includes a corresponding annular, laterally- extending flange 132a dimensioned for engagement with the flange 120 of the body 112.
  • the septum 132 also includes an annular, axially-extending portion 132b, spaced radially inwardly relative to the flange 132a and projecting axially downwardly therefrom.
  • the portion 132b extends toward the chamber 111 of the device and sealingly engages the interior surface of the body sidewall 116 and the flange 132a engages the flange 120.
  • the closure 114 is mounted atop the first septum 132, and onto the body 112, to form a compression seal between the closure 114, first septum 132, and body 112.
  • the lower portion 122 of the closure 114 defines a substantially annular lateral slot 122a therein defining a substantially annular inner sidewall 136.
  • the ceiling 122b of slot 122a i.e., the base of the upper portion 124, defines a first aperture 128 extending between the lower and upper portions 122, 124.
  • the sidewall 136 of the slot 122a includes an annular lip 136a extending laterally inwardly from the base end of the sidewall 136.
  • the lip 136a is slightly smaller in diameter than the neck 113.
  • the lip 136a is flexed slightly outwardly by the larger neck 113 during mounting so it can slide over and past the neck 113. After the lip 136a slides past the bottom of the neck, the lip 136a resiliently returns to its original size and engages the bottom surface of the flange 120 of the body 112, in a snap-fit type engagement, to hold the closure 114 in place.
  • the neck 113 of the body 112 defines a slot (not shown) adapted to receive therein a corresponding tab (not shown) projecting from the interior surface of the the closure 114, such that the closure 114 only mounts onto the body 112 when the tab and slot align, in a key-and-groove type configuration. Thus, the closure 114 only mounts onto body 112 in a designated orientation relative thereto.
  • the height of the slot 122a i.e., the distance between the ceiling 122b and the lip 136a is approximately the same as the height of the neck 113. However, the height of the slot 122a is slightly less than the height of portion of the first septum 132 to be retained in the slot 122a.
  • the ceiling 122b of the slot 122a abuts the upper surface of the first septum 132 and compresses and/or depresses the first septum 132 into the neck 113 and, in turn, creates a compression seal between the closure 114, the septum 132 and the body 112.
  • the first septum 132 is approximately dome or convex shaped on the upper side thereof, opposite the chamber 111.
  • an approximately central portion of the convex upper surface of the septum 132 bulges through the aperture 128 and partially into the upper portion 124.
  • the upper portion 124 of the closure 114 defines the lateral slot 124a therein.
  • slot 124a includes the first aperture 128 in the base thereof, connecting to the slot 122a.
  • the slot 124a defines a second aperture 130, substantially vertically aligned with the first aperture 128, thereby exposing the first penetrable septum 132 for filling therethrough.
  • the slot 124a also defines an opening 124b in the sidewall thereof for receiving a disk 125 therethrough and into the slot 124a.
  • the disk 125 is shaped and configured to fit into and substantially mate with the corresponding interior shape of the slot 124a.
  • the disk 125 is dimensioned, relative to the interior dimensions of the slot 124a, to create a dimensional interference therewith.
  • the thickness of the slot 124a (perpendicular to the lateral extent of the slot 124a) is slightly less than the thickness of the disk 125, and therefore the disk 125 creates an interference fit with the slot 124a when inserted, e.g., wedged, therein.
  • the disk 125 forms a sliding, fluid-tight seal between itself and the interior surfaces of the walls of the slot 124a when inserted therein.
  • the disk 125 includes the second penetrable septum 134. Similar to the embodiment described above, the second penetrable septum 134 can be co-molded with the disk 125. Alternatively, the second septum 134 can be over- molded onto the disk 125.
  • the disk 125 is initially inserted into the slot 124a in a first position, as shown in FIG. 12B.
  • the disk 125 is mechanically inserted into the slot 124a, such as, for example, via a solenoid operated arm
  • the disk 125 is movable, i.e., slideable, within the slot 124a between the first position where the disk 125 is positioned away from the first septum 132 bulging through the first aperture 128, and a second position (FIG. 12D) where the disk 125 is positioned between the first and second apertures 128, 130, and the second septum 134 overlies the first septum 132.
  • the second septum 134 sealingly engages, i.e., overlies, the bulging portion of the first septum 132.
  • the portion of the first septum 132 bulging partially into the slot 124a narrows the thickness of the slot 124a at that location within the slot, corresponding to the location of the second position of the disk 125. Accordingly, when the disk 125 is moved into the second position, the second septum 134 compresses against the bulging portion of the first septum 134, and, in turn, forms a mechanical compression seal therewith.
  • the compression force on the disk 125 and second septum 134 assists in maintaining the disk in the second position, e.g., by friction or wedging, during storage and subsequent use.
  • the assembled device 110 i.e., the body 112, closure 114, disk 125, first and second septums 132, 134 and/or any component parts, can be sterilized with the disk 125 in the first position, as shown in FIG. 12B.
  • Sterilization of the device 100 may be performed in any of numerous different ways that are currently known, or that later become known, including without limitation, by the application of radiation thereto, such as e-beam, laser or UV radiation, by the application of a fluid sterilant, such as vaporized hydrogen peroxide ("VHP") or nitric oxide (“NO”), or by heated gas in accordance with the teachings of any of the patents and patent applications incorporated by reference above.
  • VHP vaporized hydrogen peroxide
  • NO nitric oxide
  • a filling device such as the filling device 60 disclosed above or in any of the patents and patent applications incorporated by reference above, can be advanced through the second aperture 130 to penetrate the first penetrable septum 132 and aseptically or sterile fill fluid into the sterile chamber 111 of the device 110 (FIG. 12C).
  • the first septum 132 wipes the tip of the filling member of contaminants thereon during engagement and penetration of the septum 132 by the tip, to, in turn, prevent the tip from introducing such contaminants into the sterile interior of the chamber 111, thereby maintaining the chamber 111 and any substance therein aseptic or sterile.
  • the filling device is withdrawn from the first septum 132.
  • the first septum 132 can be engineered in a manner known to those of ordinary skill in the pertinent art to self-close and thereby ensure that the head loss left by the residual filling device injection aperture 196 after the tip of the filling device is withdrawn substantially prevents fluid ingress therethrough.
  • the disk 125 is slidably pressed from the first position into the second position (FIG. 12D), such that the unpenetrated second septum 134 overlies and seals the injection aperture 196 in the first septum 132 from the ambient atmosphere in a similar manner as described in the above embodiment.
  • the disk 125 surrounding the second septum 134 remains in sealing engagement with the interior surfaces of the slot 124a.
  • the bulging surface of the first closure 132 can be re-sterilized in order to prevent any contaminants from being trapped between the first and second septums 132, 134.
  • the openings of the filled device 110 can be sealed, such as, for example, via shrink wrap, to provide an additional barrier.
  • a tamper-proof layer 115 can be applied over the closure 114 after filling.
  • the tamper-proof layer 115 is an adhesive-backed foil layer adhesively attached to the closure 114, overlying the second aperture 130 and the second septum 134.
  • the foil layer 115 also indicates whether the device 110 has been tampered with after filling thereof and prior to withdrawing the filled fluid therefrom.
  • a withdrawal device When ready for use, a withdrawal device may penetrate or pierce through the first and second septums 132, 134 to withdraw fluid from the chamber 111.
  • the second septum 134 is off-center within the disk 125, so that a withdrawal device penetrating through the second septum 134, e.g., through the center thereof, can penetrate through the first septum 132 at a previously unpenetrated location and not through the injection aperture 196.
  • FIGS. 13-16 another device is indicated generally by the reference numeral 210.
  • the device 210 is substantially similar to the device 110 described above in connection with FIGS. 11-12D, and therefore like reference numerals preceded by the numeral "2" are used to indicate like elements.
  • a primary difference of the device 210 in comparison to the device 110 is the second penetrable septum 234 is large enough to sealingly cover the first penetrable septum 232 in both the first and the second positions, as hereinafter described.
  • the second penetrable septum 234, within the disk 225 includes a first portion 234a and a second portion 234b.
  • the first portion 234a of the second septum 234 is positioned between the first and second apertures 228, 230, and sealingly overlies the bulging portion of the first septum 232 in similar manner as described above in the embodiment of device 110.
  • the assembled device 210 (FIG. 14), with the disk 225 in the first position, can be sterilized prior to filling. Similar to the embodiment of device 110 above, the disk 225 creates a dimensional interference with the slot 224a, thereby creating a sliding seal between the disk 225 and the slot 224a. The seal therebetween maintains the sterility of the second portion 234b of the second septum 234 in the first position, i.e., during filling. Thereafter, as shown in FIG.
  • a filling device such as, for example, the filling device 60
  • the filling device 60 can be advanced through the second aperture 230, and, in turn, penetrate both the first portion 234a of the second septum 234 and the first septum 232 to aseptically or sterile fill fluid into the sterile chamber 211 of the device 210.
  • the first portion 234a of the second septum 234 and the first septum 232 wipe the tip of the filling device of contaminants thereon during engagement and penetration of the septums thereby to, in turn, prevent the filling device from introducing such contaminants into the sterile interior of the chamber 211 and thereby maintain the chamber and any substance therein aseptic or sterile.
  • the disk 225 is slidably pressed from the first position (FIG. 15) into the second position (FIG. 16).
  • the first portion 234a of the second septum 234 is sealed off from the remainder of the device 210 when the disk 225 is moved from the first position into the second position.
  • the first portion 234a of the septum 234 defines a substantially concave upper surface.
  • the portions of the disk 225 and the second septum 234 surrounding the first portion 234a of the second septum and sealingly engaging the interior surfaces of the upper and lower walls of the slot 224a trap, i.e., seal off, any contamination residing on the first portion 234a in the pocket between the concave surface and the upper wall of the slot 224a, e.g., from contact with and wiping of the tip of the filling member 60.
  • the sterile, unpenetrated second portion 234b of the second septum 234 is positioned between the first and second apertures 228, 230, and sealingly overlies the bulging portion of the first septum 232.
  • the fluid within the chamber 211 is hermetically sealed.
  • the first septum 232 is covered by the second septum 234 before, during and after penetration thereof, and thus the upper surface of the first septum 232 is never exposed to the ambient atmosphere and remains substantially sterile, particularly in embodiments where the second septum 234 wipes the injection member 60. Therefore, no re- sterilization is required after filling.
  • a needle or like withdrawal device can thereafter penetrate the second portion 234b of the second septum 234 and the first septum 232 to withdraw liquid from the chamber 211, in a similar manner as described above.
  • FIGS. 17-18 another device is indicated generally by the reference numeral 310.
  • the device 310 is substantially similar to the devices 110, 210 described above in connection with FIGS. 11-16, and therefore like reference numerals preceded by the numeral "3" are used to indicate like elements.
  • a primary difference of the device 310 in comparison to the devices 110, 210 is that the device 310 includes a single penetrable septum 334.
  • the septum 334 defines a first portion 334a for filling therethrough when the disk 325 is located in the first position and a second portion 334b for sealing the contents of the device 310 and withdrawing substance therefrom when the disk 325 is located in the second position, as hereinafter described.
  • the device 310 comprises a body 312, a closure 314 and a disk 325 including the penetrable septum 334.
  • the closure 314 is sealingly mounted atop the upper end of the body 312.
  • the upper rim of the body 312 defines an annular spike 312a that sealingly engages the base surface of the closure 314.
  • the closure 314 includes an annular, axially- extending projection 314a, spaced radially inwardly relative to the perimeter of the closure 314 and projecting axially downwardly from the base of the closure 314.
  • the projection 314a is dimensioned to sealingly engage a portion of the body sidewall 316 adjacent the opening 318 thereof.
  • the diameter of the projection 314a is dimensioned, relative to the outer diameter of the body 312, to create a dimensional interference therewith, thereby creating a fluid-tight interference fit therebetween.
  • the closure 314 defines a lateral slot 324a.
  • the slot 324a defines a first aperture 328 in the base end thereof, connecting the slot 324a in fluid communication with the chamber 311 of the device 310.
  • the slot 324a also defines a second aperture 330 in the upper end thereof substantially vertically aligned with the first aperture 328.
  • the slot 324a has an opening 324b in the sidewall thereof for receiving the disk 325, with the penetrable septum 334, therethrough.
  • the disk 325 is shaped to mate with the corresponding interior shape of the slot 324a and is dimensioned to create a dimensional interference therewith.
  • the disk 325 forms a sliding, fluid-tight seal between itself and the interior surfaces of the slot 324a.
  • the disk 325 is initially inserted into the slot 324a into the first position, as shown in FIG. 18.
  • the first portion 334a of the penetrable septum 334 is positioned between the first and second apertures 328, 330 and forms a sealed, assembled device.
  • the sealed, assembled device 310, with the disk 325 in the first position can be sterilized prior to filling.
  • the seal between the disk 325 and the slot 324a maintains the sterility of the second portion 324b of the septum 334 while in the first position, e.g., during filling.
  • a filling device such as, for example, the filling device 60
  • the septum 334 wipes the tip of the filling device of contaminants thereon during engagement and penetration of the septum by the filling device to, in turn, prevent the filling device from introducing such contaminants into the sterile interior of the chamber 311.
  • the disk 325 is slidingly pressed from the first position into the second position (FIG. 20), such that the sterile, unpenetrated second portion 334b is positioned between the first and second apertures 328, 330. Because of the seal between the disk 325 and the slot 324a, and because the second portion 334b is unpenetrated, the fluid within the sterile chamber 311 is hermetically sealed. The first portion 334a of the septum 334 is also sealed off from the remainder of the device 310 when the disk 325 is moved from the first position into the second position.
  • the first portion 334a of the septum 334 defines substantially concave upper and lower surfaces, which function similar to the concave surface of the septum 234 of device 210. Accordingly, in the second position, the portions of the disk 325 and the septum 334 surrounding the first portion 334a of the septum and sealingly engaging the interior surfaces of the slot 324a, trap, i.e., seal off, any contamination, such as liquid residue, residing on the first portion 334a in the pockets between the concave surfaces of the first portion 334a of the septum 334 and the respective upper and lowers walls of the slot 324a.
  • FIGS. 21-23 another device is indicated generally by the reference numeral 410.
  • the device 410 is substantially similar to the devices 10, 110, 210, 310 described above in connection with FIGS. 1-20, and therefore like reference numerals preceded by the numeral "4" are used to indicate like elements.
  • a primary difference of the device 410 in comparison to the devices 10, 110, 210, 310 is that the device 410 includes a closure 414 that is rotatable relative to the body 412 to selectively expose a filling septum 432 and a withdrawal septum 434, as hereinafter described.
  • the device 410 includes a body 412, a septum assembly 433, and a closure 414.
  • the septum assembly 433 comprises a penetrable bottom septum layer 433a and an overlay layer 433b.
  • the overlay layer 433b defines two apertures, receiving therein corresponding projections of the septum layer 433a to define a penetrable filling septum 432 and a separate penetrable withdrawal septum 434.
  • the septum layer 433a, and thus the filling and withdrawal septums 432, 434 can be made of an elastomeric material, such as, for example, silicone, vulcanized rubber or a thermoplastic elastomer, as described above.
  • the septum assembly 433 is shaped and dimensioned to mount into the neck 413 and engage the flange 420 of the body 412.
  • the septum assembly includes diametrically opposed tabs 433c fittingly engageable with corresponding diametrically opposed slots 413a in the neck 413 of the body 412.
  • the septum assembly 433 is not rotatable within the neck 413.
  • the septum assembly and neck may have fewer (e.g., one) or more two tabs and slots, respectively, which in any case need not be diametrically opposed, or no tabs/slots at all.
  • the closure 414 mounts atop the body 412 and forms a compression seal between the closure 414, the septum assembly 433, and the body 412 in similar manner as described above with respect to the embodiment of device 110.
  • the closure 414 includes an aperture 428 in the upper surface thereof and is assembled onto the body 412 in a first position or orientation relative to the septum assembly such that the aperture 428 is positioned above or over the filling septum 432, as shown in FIG. 22. In the first position with the filling septum 432 exposed, the seal between the closure 414 and the remainder of the septum assembly 433 maintains the sterility of the remainder of the assembly 433.
  • the closure 414 is rotatable about the neck 413 from the first position into a second position, to, in turn, position the aperture 428 above withdrawal septum 434, as shown in FIG. 23. Due to the above-discussed compression seal, the seals between the body 412, septum assembly 433, and closure 414 are maintained during rotation. Once rotated into the second position, a tab 433d projecting upwardly from the overlay layer 433b engages a corresponding slot or recess in the upper end of the closure 414 (not shown), thereby substantially preventing reverse rotation of the closure 414 from the second position back toward the first position (or at least prevent inadvertent rotation).
  • the assembled device 410 can be sterilized in like manner prior to filling. Thereafter, with the closure 414 in the first position, a filling device, such as the filling device 60 disclosed above or in any of the patents and patent applications incorporated by reference above, can be advanced through the aperture 428 to penetrate the filling septum 432 and aseptically or sterile fill fluid into the sterile chamber 411 of the device 410.
  • a filling device such as the filling device 60 disclosed above or in any of the patents and patent applications incorporated by reference above, can be advanced through the aperture 428 to penetrate the filling septum 432 and aseptically or sterile fill fluid into the sterile chamber 411 of the device 410.
  • the filling septum 432 wipes the tip of the filling member of contaminants thereon during engagement and penetration of the septum 432 by the tip, to, in turn, prevent the tip from introducing such contaminants into the sterile interior of the chamber 411, thereby maintaining the chamber 411 and any substance therein aseptic or sterile.
  • the filling device is withdrawn from the filling septum 432.
  • the closure 414 is then rotated into the second position, covering and sealing off the penetrated filling septum 432, thereby hermetically sealing the fluid within the sterile chamber 411.
  • the unpenetrated, sterile withdrawal septum 434 is exposed.
  • a withdrawal device may thereafter penetrate through the septum 434 to withdraw the fluid from the chamber 411.
  • the components of the container or other device and the filling device may be made of any of numerous different materials that are currently known, or that later become known, for performing the function(s) of each such component.
  • the components of the container or other device and filling device may take any of numerous different shapes and/or configurations.
  • the filling device may be used to inject any of numerous different types of fluids or other substances into the container or other device for any of numerous different applications, including, for example, medicaments, pharmaceuticals, vaccines, liquid nutrition products, supplements, and numerous other products that are currently known, or that later become known. Accordingly, this detailed description of embodiments is to be taken in an illustrative, as opposed to a limiting sense.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP13804794.9A 2012-06-13 2013-06-13 Vorrichtung mit durchlässiger wand und verschlussnadel Withdrawn EP2861155A4 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261659382P 2012-06-13 2012-06-13
US201361799744P 2013-03-15 2013-03-15
PCT/US2013/045732 WO2013188703A1 (en) 2012-06-13 2013-06-13 Device with penetrable septum and closure needle

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EP2861155A1 true EP2861155A1 (de) 2015-04-22
EP2861155A4 EP2861155A4 (de) 2016-08-17

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EP (1) EP2861155A4 (de)
JP (1) JP2015519182A (de)
KR (1) KR20150034172A (de)
CN (1) CN104519805A (de)
AU (1) AU2013274132A1 (de)
BR (1) BR112014031326A2 (de)
CA (1) CA2876292A1 (de)
CO (1) CO7240420A2 (de)
IN (1) IN2014DN10606A (de)
RU (1) RU2015100517A (de)
WO (1) WO2013188703A1 (de)

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AU2013274132A1 (en) 2015-01-22
CA2876292A1 (en) 2013-12-19
CN104519805A (zh) 2015-04-15
CO7240420A2 (es) 2015-04-17
RU2015100517A (ru) 2016-08-10
JP2015519182A (ja) 2015-07-09
WO2013188703A1 (en) 2013-12-19
BR112014031326A2 (pt) 2017-06-27
KR20150034172A (ko) 2015-04-02
US20130333796A1 (en) 2013-12-19
IN2014DN10606A (de) 2015-09-11
EP2861155A4 (de) 2016-08-17

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