EP2569225B1 - Fermeture pour un récipient et procédé pour mettre en oeuvre un procédé de cryodessication - Google Patents

Fermeture pour un récipient et procédé pour mettre en oeuvre un procédé de cryodessication Download PDF

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Publication number
EP2569225B1
EP2569225B1 EP11722753.8A EP11722753A EP2569225B1 EP 2569225 B1 EP2569225 B1 EP 2569225B1 EP 11722753 A EP11722753 A EP 11722753A EP 2569225 B1 EP2569225 B1 EP 2569225B1
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EP
European Patent Office
Prior art keywords
closure
cap
sliding part
wall
plug
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.)
Active
Application number
EP11722753.8A
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German (de)
English (en)
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EP2569225A1 (fr
Inventor
Ronny Prosper Elisabeth Vrijens
Reinhard Louis Jozef Waeben
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.)
Datwyler Pharma Packaging Belgium NV
Original Assignee
Datwyler Pharma Packaging International NV
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Publication of EP2569225A1 publication Critical patent/EP2569225A1/fr
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Publication of EP2569225B1 publication Critical patent/EP2569225B1/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
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/241—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/04—Closures with discharging devices other than pumps
    • B65D47/20—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge
    • B65D47/24—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge with poppet valves or lift valves, i.e. valves opening or closing a passageway by a relative motion substantially perpendicular to the plane of the seat
    • B65D47/245—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge with poppet valves or lift valves, i.e. valves opening or closing a passageway by a relative motion substantially perpendicular to the plane of the seat the valve being opened or closed by actuating a stopper-type element
    • B65D47/247—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge with poppet valves or lift valves, i.e. valves opening or closing a passageway by a relative motion substantially perpendicular to the plane of the seat the valve being opened or closed by actuating a stopper-type element moving linearly, i.e. without rotational motion

Definitions

  • the invention relates to a closure for a container, for example an ampoule, according to the features of the upper handle of claim 1, such a closure from approximately WO 01/49583 A1 is known.
  • the invention further relates to a method for carrying out a freeze-drying method according to the features of the preamble of claim 14.
  • Closures of a similar type have already become known in various configurations.
  • Closures of the generic type which have a closure and sliding part formed as a unitary part. By means of an enlarged outer handle on this one part, a displacement from and into the closed position is possible
  • the closure caps of the closures are initially arranged on the container in a first position, in which, for example, in an airway provided to the interior of the container Freeze-drying chamber can be used to dry the medicament contained in the container.
  • the closure caps are then brought into a second position, in which they are locked at an opening edge of the container and in which the closure plug accommodated in the closure cap engages in a sealing manner in a container neck and / or with a sealing flange on an end opening surface of the container sits sealingly.
  • the movement into the closed position is usually carried out by means of a plate part acting on a large number of containers provided with such closures.
  • the plate part acts on a sliding part, which is - as a rule: first - moved relative to the closure cap, and then is moved into the latching closure position together with the closure cap and the closure plug accommodated in the closure cap.
  • the lowest possible force application is desirable.
  • a large number of such containers can be closed at the same time with a given maximum force that can be exerted with the plate part.
  • the closures must be held securely in relation to the containers in order to prevent the closures from falling off the containers during freeze drying or on the way to a freeze-drying chamber or during transport and loading inside the freeze-drying chamber.
  • the object of the invention is to provide a closure for a container, in particular an ampoule, in which a medicament is accommodated, with a view to carrying out a freeze-drying process.
  • closure plug is not moved with the cap, but rather relative to the cap into the closed position, it is possible to attach the cap to the container immediately when the closure is first seated, in particular to lock it firmly in place. In the course of freeze-drying and the subsequent final closure of the container, a further movement of the closure cap is no longer necessary.
  • the sealing plug is received so that it can move relative to the sealing cap.
  • the sealing plug can be accommodated in the sealing cap itself. However, the sealing plug can initially only be received by means of the sliding part held in the sealing cap.
  • the object is achieved with the subject matter of claim 14, the focus being on the fact that after the drying is completed, the sealing plug, which is produced separately from the cap and the sliding part, has a flange and extends upward with a smaller diameter from the flange Central area as well as a different from that Inserting the flange downward is displaced into the closed position by means of a sliding part which is displaceably guided on the closing cap, with the cap being fixed relative to the container by acting on the sliding part.
  • the invention is further described with respect to the container with regard to an ampoule (vial). It is also preferably a container, for example an ampoule, made of glass. However, it can also be a different container. Preferably one that is used in the pharmaceutical field.
  • the closure cap has an outer cap wall.
  • This cap wall can also be arranged on the outside in relation to an end face, that is to say generally horizontally, of an end face of a mouth opening of the ampoule in association with the ampoule.
  • the mouth edge of the ampoule can, for example, have a bead-shaped cross section.
  • the cap wall can therefore run on the outside with respect to the bead.
  • the ampoule can initially taper further into an ampoule neck further below the bead and then widen again.
  • the ampoule which is preferably designed to be rotationally symmetrical and in its area below the neck in any case cylindrical, can be provided in alignment with the outer surface of its cylinder area or almost in alignment with an outer surface of the cap wall.
  • the sliding part is preferably guided on the inside of the cap wall.
  • the guidance is further preferably given on the closure cap. It is preferably a single cap wall formed on the closure cap, which at the same time forms the outer surface.
  • the closure cap and / or the sliding part are preferably plastic parts produced in the plastic injection molding process. It is hard plastic.
  • the sealing plug is preferably a rubber part or consists of a thermoplastic elastomer or some other rubber-like soft material, in particular soft plastic.
  • the sealing cap preferably has a guide wall for the sealing plug that is separate from the cap wall.
  • the guide wall can thus be designed specifically for the management task.
  • the area of interaction with the sealing plug can be chosen in such a way that initially, in a first position of the sealing plug relative to the mouth of the ampoule, that is to say for carrying out the freeze-drying process, there is a sufficient adhesive effect which prevents the sealing plug from being inadvertently displaced excludes, on the other hand, however, requires a force that is not too great to move the sealing plug into the closed position.
  • the guide wall is designed as a cap neck protruding upward beyond the cap wall.
  • the cap neck preferably has a significantly smaller diameter than the cap wall.
  • Both the cap wall and the cap neck are more preferably closure cap parts oriented on a cylindrical shape. They are preferably rotationally symmetrical, but can also be designed alternately over the circumference on the outside, for example with regard to the cap wall, with respect to corrugation or the like.
  • the outer wall and / or the cap neck can be designed differently with respect to the passage openings formed therein for air guidance and / or visual inspection.
  • interruptions can also be provided in the peripheral area. For example, to adapt to the required size of the wall area in frictional engagement with the sealing plug.
  • One or more vertically oriented passage openings can be formed between the guide wall and the cap wall. These passage openings enable the passage of a part or area of the closure acting on the closure plug, in particular the Sliding part. They also initially allow a visual inspection of the sealing plug accommodated in the sealing cap.
  • the sliding extension of the sliding part which is suitably arranged at least partially above a passage opening and is slidingly connected to the closure cap, more preferably projects into the passage opening.
  • the sliding extension can initially be provided in a first position, still above the passage opening or slightly entered into the passage opening. In the closed state after freeze-drying has ended, the sliding extension then passes through the passage opening.
  • the closure plug provided in the closure has the flange with which it rests in the closed state on an end face of the ampoule opening and on which the sliding extension can act. It also has a central region that extends upward from the flange, with a smaller diameter than the flange.
  • the plug has an insertion portion extending downward from the flange.
  • the insertion section preferably has a smaller diameter that is adapted to the neck opening of the ampoule than the flange. In the closed state, the insertion section engages in the mouth area of the container or the ampoule in the interior of the ampoule and thus seals the ampoule by contacting an inner surface of the neck area.
  • the central region of the sealing plug preferably interacts with the said guide wall of the sealing cap, that is to say in particular the neck of the sealing cap. He is included in it. It is also preferably cylindrical educated. A cylinder outer surface cooperates accordingly with an inner surface of the guide wall for holding and guiding.
  • the sliding part further preferably acts on the flange region of the closure plug by means of the sliding extension, of which several are preferably provided distributed over the circumference. An upper part of the flange is pressed by the sliding part by means of the sliding extension or the sliding extensions, whereby the sealing plug can then be moved relative to the sealing cap into the closed position with respect to the ampoule.
  • the sliding part engages over an upper side of the closure cap.
  • a region of the closure cap that is radially outer with respect to the passage openings.
  • the sliding part in the closed state, can run flush with the outer surface of the cap wall with respect to its outer wall or can extend with a larger diameter of the outer wall overlapping the cap wall or a slightly smaller diameter than the cap wall set back with respect to the cap wall.
  • closure cap or the sliding part can be covered by a cover part after the closure plug has been moved into the closure position.
  • the cover part can be provided, for example, in a snap-in manner on the closure cap. But it can also be welded to the sealing cap.
  • cover part is designed so that it cannot be lost in one piece with the closure cap or the sliding part.
  • a one-piece molded part formation with the sliding part is preferred.
  • a thinned joint area can be formed in the transition between the sliding part and the cover part.
  • one or more locking pins which protrude freely at the top, can be provided on the locking cap. These can engage in corresponding openings in the cover part in the closed state. In particular, they can also be welded to said openings in the engaged state.
  • a closure 1 which is seated on a container designed here as a medical ampoule 9.
  • a medicament in liquid form preferably initially, that is to say before any freeze-drying to be carried out. Freeze drying, for example, can be used to convert it into powder form.
  • the closure 1 consists in detail of a closure cap 2 and a sliding part 3 which, in the exemplary embodiment, is partially protruding above the closure cap 2.
  • a cover 4 is connected to the sliding part 3.
  • the closure cap 2 also has latching formations 6 with which it engages under a muzzle bead 7 of the ampoule 9 in the latched state. How especially out Fig. 8 can be seen, the latching formations are formed on elastically bendable latching arms 8, which can elastically spring outwards accordingly when the closure cap 2 is placed on the ampoule 9. (See the position shown in broken lines).
  • the plug 5 is by means of the sliding part 3 relative to the cap 2 from an open position according to Fig. 8 , in which freeze drying can be carried out, in a closed position according to Fig. 9 transferred.
  • the sliding part 3 In the closed position according to Fig. 9 the sliding part 3 is moved downward relative to the closure cap 2, the closure plug 5 being acted on by means of sliding extensions 10 formed on the sliding part for displacement into the closed position.
  • the sliding part 3 acts directly on the sealing plug via said sliding extensions.
  • the sealing plug has a flange 11 and a central area 12.
  • a sealing projection 13 is also formed below the flange 11.
  • locking arms 8 of different widths extending downward are formed on the closure cap 2.
  • a total of seven locking arms 8 are formed distributed over the circumference, of which three locking arms 8 'project less downward than the remaining locking arms.
  • a locking arm 8 has a cantilevered length 1 or 1 ', which is one third to two thirds based on the axial length L of the closure cap 2.
  • the axial length L is measured starting from the lower end of a latch arm 8 which projects the furthest downwards, up to the shoulder 16, that is to say exclusively excluding the height of the cap neck 21, which is described in detail below.
  • a circumferential extent of a latching arm 8 preferably corresponds to a circumferential angle ⁇ of 2 ° to 60 °, six of the seven latching arms preferably extending over a circumferential angle of 30 ° to 60 ° and one latching arm 8 ′′ over a circumferential angle between 2 ° and 10 °.
  • a circumferential gap 18 between two locking arms preferably corresponds to a circumferential angle of 1 ° to 5 °.
  • a locking arm 8 ′′ is provided with a window 19 in its upper region, that is to say toward the sliding part 3.
  • the window 19 enables a visual inspection of the sealing plug received therein.
  • the engagement bead 6 is nevertheless shaped continuously in the circumferential direction formed locking bead 6, the outer wall assigned, columnar extensions 20 of the cap wall formed down. This results on the outside in an arch-like configuration of this latching arm 8 ′′, which is continuously open in the upper region, but closed in the lower region by the rear wall of the latching formation 6 in the case of continuous frame sections.
  • This design of the locking arm 8 "at the same time enables a tool-favorable detection with regard to an application of the closure in the locking position according to Fig. 8 , before beginning freeze drying.
  • a cap neck 21 is formed radially on the inside toward an outer wall of the closure cap 2.
  • the cap neck 21 is formed in one piece with the outer cap wall 23 via radial webs 22.
  • the cap neck 21 partially projects upward beyond the shoulder 16, but is also partially formed within the cap wall 23 below the shoulder 16. Overall, it is a cylindrical body.
  • the inside of the cap neck 21 has one or more axial webs 24 which serve for braking interaction with an outer surface of the central section 12 of the sealing plug 5.
  • the axial webs 24 protrude on the inside in a bead-like manner with respect to an inner surface of the cap neck 21. This allows the sealing plug 5 to be reliably positioned in accordance with Fig. 8 to keep.
  • the cap neck 21 has horizontal locking grooves 25, which are designed as through openings in the exemplary embodiment. How about Fig. 8 results, these can serve to hold the sliding part 3 in an upper position (initially).
  • the above-mentioned axial webs can additionally or alternatively also be formed on the outer surface of the central region 12 of the sealing plug 5.
  • the sliding part 3, cf. in particular Figures 4 and 5 initially has, on the top side, an outer, vertically running peripheral wall 26.
  • the peripheral wall 26 merges into an upper end wall 27 which runs horizontally in the state of use and is preferably circular in the exemplary embodiment.
  • This end wall 27 is further preferably covered by a cover 4 in the closed state.
  • closure pins 29 are provided in the end wall 27, which pass through openings 30 of the cover part in the closed state. They then initially protrude upwards and can, for example, provide a weld-like seal by hot forming. But you can also have an enlarged head on the top, positively hold the lid 4 in the closed position.
  • the sliding part 3 has latching fingers 31, which in cross section form an inwardly projecting latching section 32, see for example Figures 8 and 9 .
  • latching section 32 With this latching section 32, the latching formations can engage in the latching openings 25 in a first position of the sliding part 3 relative to the closure cap 2. Due to the fact that the latching formations 32 are shaped like barbs, they can be moved into the position according to after the sliding part 3 has been pushed down further Fig. 9 , blocking under a lower grip section 33, which is further formed on the cap neck already described. A shifting back of the sliding part 3 relative to the cap part 2 is therefore no longer possible after reaching this locking position.
  • a wall 34 is provided radially on the outside with respect to the snap-in fingers 31, but surrounds the snap-in fingers 31 only over part of their cantilevered length. A lower part of the latching fingers 31 is exposed radially outward.
  • a total of four latching fingers 31 are formed around the circumference.
  • the latching fingers 31 preferably extend over a circumferential angle range between 10 ° and 60 °.
  • the sliding extensions 10 are provided in the circumferential space between the latching fingers 31, but also projecting outward from an outer wall of the latching fingers 31. In the exemplary embodiment, these are designed in cross section as oval hollow shapes.
  • the sliding extensions 10 extend vertically.
  • the hollow shape of the sliding extensions 10 formed by a circumferential wall provides a favorable introduction of force into the sealing plug 5 via the end face of the wall, which covers the sliding forces.
  • the sliding extensions 10 are assigned to an annular space formed between the cap neck 21 and the cap wall 23.
  • the annular space is divided by the radial webs 22 which extend radially in this regard.
  • the radial webs 22 leave both openings 48 for the sliding extensions 10 to pass through and openings 49 for the latching fingers 31 to pass through.
  • the openings 48 are adapted to the outer contour of the sliding extensions. They are dimensionally provided so that there is a sliding guide for the sliding extensions 10.
  • this type of construction also consists of a cap part 36 and a sliding part 37.
  • a plug 38 is also accommodated inside the cap part 36 in this type of construction.
  • the sliding part 37 has an outer apron wall 39 which partially, over part of its height, extends over an outer wall 40 of the cap part 36, specifically already in the freeze-drying position Fig. 18 to a larger extent in the closed position according to Fig. 19 .
  • the cap part 36 also has this design, cf. about in particular Fig. 11 , distributed over the circumference, a plurality of locking fingers 41. These locking fingers 41 have locking beads 42 projecting inwards. On the outside they have a continuation section 43 which projects downwards.
  • This continuation section 43 is formed in the form of a thin, circular section-shaped wall. It also extends only over a smaller circumferential extent than a locking finger 41. It can serve to limit the snap-on movement, according to the contact with the shoulder of the ampoule (see, for example Fig. 19 ).
  • the locking fingers 41 of this design preferably extend over a circumferential angle range from 30 ° to 60 °.
  • Some of the locking fingers 41 preferably every second locking finger 41, with a total of six locking fingers 41 preferably being formed, have through openings 44 on the upper side, above the locking beads 42, but below the transition 28 into an annular peripheral wall 35 of the cap part 36. These through openings 44 can be used for visual inspection, for example with regard to the sealing plug held therein.
  • grooves or penetration openings 45 extending in the circumferential direction are provided. These extend in a circular section, preferably over a circumferential angle between 10 ° and 40 °.
  • the procedure is as follows, for example: First, the cap and the sliding part as well as the sealing plug are made separately. The plug is then inserted into the cap, or, at least preferably in the design of the Figures 10 to 19 , first in the sliding part 37, pressed into a position according to Fig. 8 respectively. Fig. 18 .
  • the configuration of the Fig. 18 is preferably achieved by first inserting the sealing plug 5 into the sliding part 37 and then pressing the sliding part with the sealing plug 5 located therein into the cap part 36.
  • the sealing plug 5 is first inserted into the sealing cap or the cap part, the sliding part is placed on this composite from above.
  • the sliding part 37 is first brought into a first latching position according to Fig.
  • the pre-assembled closures are then connected to the ampoules filled with a medicament.
  • a medicament for example, in a star wheel device of a separating system.
  • the connection is carried out in such a way that the caps are in the - at the same time also final - locking position on the ampoule Fig. 8 respectively.
  • Fig. 18 be applied.
  • a suitable device can be used immediately act on the cap in each case, so that there is no relative displacement of the closure plug or of the sliding part relative to the cap in this processing step. The device does not act on the sliding part in this process step.
  • the ampoules are then placed in a freeze-dryer in this position of the applied closures. Drying of the medication in the ampoules is achieved at freezing temperatures. Since the sealing plugs do not sit on the mouth edge of the ampoule or even engage in it, and in addition airways remain through the cap into the interior of the ampoule, effective drying can be achieved.
  • the ampoules are sealed by moving the sliding part into the position according to Fig. 9 respectively.
  • Fig. 19 is pressed from above.
  • the cap remains visible in its previously assumed position relative to the ampoule.
  • the sealing plug is brought into its sealing position.
  • the depressed position of the sliding parts, in which the plugs are in the closed position, is also locked. Latching arms of the sliding part engage corresponding latching openings or latching recesses in the cap, and preferably there on the inside.
  • cover 4 can be opened onto the sliding part and a further closure can be achieved in this respect by means of the locking pins.
  • This closure can serve in particular as a tamper-evident device.
  • the sliding part 37 in a cross section, cf. about Fig. 18 overlaps an upper end edge of the outer wall 40 of the closure cap in a U-shape. That is, preferably on the outside by means of the skirt wall 39 and preferably on the inside by means of a latch arm 47.
  • the latch arms 47 are connected to the skirt wall 39 forming the outer wall here by a cover 50 of the sliding part 37.
  • cover 50 of the sliding part 37.
  • these are formed in the area of the ceiling wall 50 by radially oriented free cuts 51 with a ceiling area 52 extending approximately in the plane of the ceiling 50.
  • connection of the locking fingers 47 is given in a connection area 53 radially on the inside, while the locking fingers are radially on the outside, here submerged under the relevant ceiling edge 54, with the ceiling 50.

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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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)

Claims (15)

  1. Fermeture (1) pour un récipient (9), par exemple une ampoule, dans lequel est contenu de préférence un médicament, comprenant un capuchon de fermeture (2) et un bouchon de fermeture (5) reçu dans la fermeture (1), dans laquelle des formations d'encliquetage (6) sont formées sur le capuchon de fermeture (2) pour maintenir par encliquetage la fermeture (1) sur le récipient(9), et une pièce coulissante (3) mobile par rapport au capuchon de fermeture (2) est prévue pour déplacer le bouchon de fermeture (5) depuis une position d'ouverture dans la position de fermeture, dans laquelle, en position de fermeture, la pièce coulissante (3) est déplacée vers le bas par rapport au capuchon de fermeture (2), dans laquelle en outre le bouchon de fermeture (5) est déplaçable par rapport au capuchon de fermeture (5) pour être amené en position de fermeture au moyen de la pièce coulissante (3, 37) et la position abaissée de la pièce coulissante (3, 37) dans laquelle le bouchon de fermeture (5) est en position de fermeture, est verrouillée par encliquetage, caractérisé en ce que le bouchon de fermeture (5) est fabriqué séparément du capuchon de fermeture (2) et de la pièce coulissante (3, 37), en ce que le bouchon de fermeture (5) présente une bride (11) et une zone centrale (12) s'étendant vers le haut à partir de la bride (11) avec un diamètre plus petit et une partie d'insertion s'étendant vers le bas à partir de la bride (11), en ce que la pièce coulissante (3, 37) présente des bras d'encliquetage (47) ou des doigts d'encliquetage (31) qui s'engagent dans des ouvertures d'encliquetage ou des contre-dépouilles/retraits d'encliquetage correspondantes du bouchon de fermeture (2), dans lequel le bouchon de fermeture est sollicité en déplacement dans la position de fermeture par actionnement direct du bouchon de fermeture (5) par la pièce coulissante (3) par le biais d'appendices de coulissement (10) formées sur la pièce coulissante (3).
  2. Fermeture selon la revendication 1, caractérisée en ce que la pièce coulissante (3) est guidée du côté intérieur d'une paroi du capuchon de fermeture (2).
  3. Fermeture selon la revendication 1, caractérisée en ce que la pièce coulissante (3) est guidée à l'extérieur par rapport à une paroi du capuchon de fermeture (2).
  4. Fermeture selon l'une des revendications précédentes, caractérisée en ce que la pièce coulissante (3) recouvre en forme de U un bord supérieur de la paroi du capuchon.
  5. Fermeture selon l'une des revendications précédentes, caractérisée en ce que le capuchon de fermeture (2) présente une paroi de guidage pour le bouchon de fermeture (5) qui est séparée de la paroi du capuchon (23).
  6. Fermeture selon la revendication 5, caractérisée en ce que la paroi de guidage séparée est formée en tant que col de capuchon (21).
  7. Fermeture selon la revendication 6, caractérisée en ce que le col de capuchon (21) dépasse vers le haut de la paroi de capuchon.
  8. Fermeture selon l'une des revendications 6 ou 7, caractérisée en ce qu'une paroi de col de capuchon est agencée de manière décalée radialement vers l'intérieur par rapport à la paroi de capuchon, dans laquelle, de préférence, une ouverture de passage est formée entre la paroi de guidage et la paroi de capuchon.
  9. Fermeture selon la revendication 8, caractérisée en ce qu'un appendice de coulissement (10) de la pièce coulissante (3) pénètre dans l'ouverture de passage (48).
  10. Fermeture selon l'une des revendications 5 à 9, caractérisée en ce que la zone centrale (12) coopère avec la paroi de guidage.
  11. Fermeture selon l'une des revendications 9 ou 10, caractérisée en ce que la pièce coulissante agit sur la bride (11) par le biais de l'appendice de coulissement (10).
  12. Fermeture selon l'une des revendications précédentes, caractérisée en ce que la pièce coulissante vient en recouvrement sur un côté supérieur du capuchon de fermeture (2).
  13. Fermeture selon l'une des revendications précédentes, caractérisée en ce que le capuchon de fermeture (2) ou la pièce coulissante (3) peut être recouverte par une partie de couvercle (4), la partie de couvercle (4) pouvant être reliée en une seule pièce à la pièce coulissante (3).
  14. Procédé pour la mise en œuvre d'un procédé de lyophilisation d'un produit/substance, en particulier d'un médicament, reçu dans un récipient, en particulier une ampoule (9), dans lequel le récipient (9) est fermé au moyen d'un bouchon de fermeture (5) fermant de manière étanche la zone d'une embouchure du récipient, dans lequel en outre le bouchon de fermeture (5) est d'abord maintenu dans une position espacée de la zone dans un capuchon (2) placé sur le récipient (9) avant le début du séchage, et est déplacé dans une position de fermeture étanche après la fin du séchage, caractérisé en ce que, après la fin du séchage, le bouchon de fermeture (5), qui est fabriqué séparément du capuchon (2) et de la pièce coulissante (3) et qui présente une bride (11) et une zone centrale (12) s'étendant vers le haut à partir de la bride (11) avec un diamètre plus petit et une partie d'insertion s'étendant vers le bas à partir de la bride, est amené en position de fermeture par le biais d'une pièce coulissante (3) associée au capuchon de fermeture (2) de manière à être guidée en coulissement, en agissant sur la pièce coulissante (3) lorsque le capuchon est fixé par rapport au récipient.
  15. Procédé selon la revendication 14, dans lequel une fermeture selon l'une des revendications 1 à 13 est utilisée.
EP11722753.8A 2010-05-10 2011-05-06 Fermeture pour un récipient et procédé pour mettre en oeuvre un procédé de cryodessication Active EP2569225B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102010016866.1A DE102010016866B4 (de) 2010-05-10 2010-05-10 Verschluss für ein Behältnis und Verfahren zur Durchführung eines Gefrier-Trocknungsverfahrens
PCT/EP2011/057312 WO2011141376A1 (fr) 2010-05-10 2011-05-06 Fermeture pour un récipient et procédé pour mettre en œuvre un procédé de cryodessication

Publications (2)

Publication Number Publication Date
EP2569225A1 EP2569225A1 (fr) 2013-03-20
EP2569225B1 true EP2569225B1 (fr) 2020-03-25

Family

ID=44119002

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Application Number Title Priority Date Filing Date
EP11722753.8A Active EP2569225B1 (fr) 2010-05-10 2011-05-06 Fermeture pour un récipient et procédé pour mettre en oeuvre un procédé de cryodessication

Country Status (5)

Country Link
US (1) US9540154B2 (fr)
EP (1) EP2569225B1 (fr)
JP (1) JP6013325B2 (fr)
DE (1) DE102010016866B4 (fr)
WO (1) WO2011141376A1 (fr)

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DE102011050983A1 (de) 2010-09-09 2012-03-15 Helvoet Pharma Belgium N.V. Verschlussstopfen für pharmazeutische Anwendungen
FR2967655B1 (fr) * 2010-11-24 2014-03-14 Biocorp Rech Et Dev Dispositif de bouchage d'un recipient, recipient equipe d'un tel dispositif et procede de fermeture d'un lot de tels recipients
US10327986B2 (en) * 2013-07-03 2019-06-25 Sio2 Medical Products, Inc. Parenteral vial cap
ITMI20132005A1 (it) * 2013-12-02 2015-06-03 Antonio Mutterle Complesso di chiusura per flacone, relativo flacone e metodo di assemblaggio
EP3494349B1 (fr) * 2016-08-05 2020-10-07 Bachem AG Couvercle pour conteneur de séchage

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Also Published As

Publication number Publication date
US9540154B2 (en) 2017-01-10
US20130055681A1 (en) 2013-03-07
WO2011141376A1 (fr) 2011-11-17
EP2569225A1 (fr) 2013-03-20
DE102010016866B4 (de) 2018-06-21
JP6013325B2 (ja) 2016-10-25
JP2013526461A (ja) 2013-06-24
DE102010016866A1 (de) 2011-11-10

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