EP2569225B1 - Closure for a receptacle and method for carrying out a freeze-drying process - Google Patents
Closure for a receptacle and method for carrying out a freeze-drying process Download PDFInfo
- 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
- Authority
- 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
Links
- 238000004108 freeze drying Methods 0.000 title claims description 26
- 238000000034 method Methods 0.000 title claims description 19
- 238000007789 sealing Methods 0.000 claims description 58
- 239000003708 ampul Substances 0.000 claims description 33
- 230000015572 biosynthetic process Effects 0.000 claims description 8
- 239000003814 drug Substances 0.000 claims description 8
- 238000005755 formation reaction Methods 0.000 claims description 8
- 238000001035 drying Methods 0.000 claims description 7
- 238000003780 insertion Methods 0.000 claims description 5
- 230000037431 insertion Effects 0.000 claims description 5
- 230000000994 depressogenic effect Effects 0.000 claims description 2
- 239000011324 bead Substances 0.000 description 11
- 206010053648 Vascular occlusion Diseases 0.000 description 10
- 230000002093 peripheral effect Effects 0.000 description 7
- 238000006073 displacement reaction Methods 0.000 description 4
- 239000004033 plastic Substances 0.000 description 4
- 238000011179 visual inspection Methods 0.000 description 4
- 230000004323 axial length Effects 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 230000002349 favourable effect Effects 0.000 description 2
- 230000003993 interaction Effects 0.000 description 2
- 239000008177 pharmaceutical agent Substances 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 229920002725 thermoplastic elastomer Polymers 0.000 description 1
Images
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)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Closures For Containers (AREA)
Description
Die Erfindung betrifft einen Verschluss für ein Behältnis, beispielsweise eine Ampulle, nach den Merkmalen des Obergriffes des Anspruches 1, wobei ein solcher Verschluss etwa aus der
Aus der
Verschlüsse ähnlicher Art sind bereits in verschiedenen Ausgestaltungen bekannt geworden. Es wird zunächst beispielsweise auf die
Aus der
Aus der
Bei diversen bekannten Verschlüssen werden die Verschlusskappen der Verschlüsse auf dem Behältnis zunächst in einer ersten Stellung angeordnet, in der über zum Inneren des Behältnisses gegebene Luftwege beispielsweise in einer Gefriertrocknungskammer eine Trocknung des in dem Behältnis aufgenommenen Medikamentes durchgeführt werden kann. Nach Beendigung der Gefriertrocknung werden die Verschlusskappen dann in eine zweite Stellung verbracht, in welcher sie an einem Mündungsrand des Behältnisses verrastet sind und in welcher der in der Verschlusskappe aufgenommene Verschlussstopfen dichtend in einen Behältnishals eingreift und/ oder mit einem Dichtflansch auf einer stirnseitigen Mündungsfläche des Behältnisses dichtend aufsitzt. Die Bewegung in die Verschlussstellung wird üblicherweise durch ein auf eine Vielzahl von mit derartigen Verschlüssen versehenen Behältnissen einwirkendes Plattenteil vorgenommen.In the case of various known closures, 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. After freeze-drying has ended, 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.
Das Plattenteil wirkt hierbei auf ein Schiebeteil ein, das sowohl - in der Regel: zunächst - relativ zu der Verschlusskappe bewegt wird, sowie dann zusammen mit der Verschlusskappe und dem in der Verschlusskappe aufgenommenen Verschlussstopfen in die rastende Verschlussstellung bewegt wird.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.
Im Hinblick auf die Einwirkung des vorrichtungsseitig vorgesehenen Plattenteils der Gefriertrocknungsanlage auf die Verschlüsse, um diese am Ende des Gefrier-Trocknungsvorgangs in die Verschlussstellung zu bringen, ist eine möglichst geringe Kraftbeaufschlagung erwünscht. So können eine große Anzahl von derartigen Behältnissen bei einer gegebenen Maximalkraft, die mit dem Plattenteil ausgeübt werden kann, gleichzeitig verschlossen werden. Andererseits ist eine gewisse Haltesicherheit der Verschlüsse in Bezug auf die Behältnisse gefordert, um zu vermeiden, dass die Verschlüsse während der Gefriertrocknung oder auf dem Weg in eine Gefrier-Trocknungskammer oder bei dem Transport und der Beaufschlagung innerhalb der Gefrier-Trocknungskammer von den Behältnissen abfallen.With regard to the action of the plate part of the freeze-drying system provided on the device side, in order to bring them into the closed position at the end of the freeze-drying process, the lowest possible force application is desirable. Thus, 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. On the other hand, 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.
Ausgehend von dem dargelegten Stand der Technik stellt sich der Erfindung die Aufgabe, einen Verschluss für ein Behältnis, insbesondere eine Ampulle, in dem ein Medikament aufgenommen ist, im Hinblick auf die Durchführung eines Gefrier-Trocknungsverfahrens günstig auszubilden.On the basis of the prior art set out, 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.
Diese Aufgabe ist mit der Gesamtheit der Merkmale des Anspruches 1 gelöst. Dadurch, dass der Verschlussstopfen nicht mit der Kappe, sondern relativ zu der Kappe in die Verschlussstellung verschoben wird, ist es möglich, die Kappe sogleich bei einem ersten Aufsitzen des Verschlusses auf dem Behältnis dort fest anzubringen, insbesondere fest zu verrasten. Im Zuge des Gefriertrocknens und des nachfolgenden endgültigen Verschlusses des Behältnisses ist eine weitere Bewegung der Verschlusskappe nicht mehr erforderlich. Der Verschlussstopfen ist dafür relativ beweglich zu der Verschlusskappe aufgenommen. Die Aufnahme des Verschlussstopfens kann in der Verschlusskappe selbst gegeben sein. Die Aufnahme des Verschlussstopfens kann aber auch zunächst nur vermittels des in der Verschlusskappe gehalterten Schiebeteils gegeben sein.This object is achieved with the entirety of the features of claim 1. Because the 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. For this purpose, 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.
Hinsichtlich des Verfahrens ist die Aufgabe beim Gegenstand des Anspruches 14 gelöst, wobei darauf abgestellt ist, dass nach Abschluss der Trocknung der getrennt von der Kappe und dem Schiebeteil hergestellte Verschlussstopfen, der einen Flansch aufweist und einen sich mit geringerem Durchmesser von dem Flansch nach oben erstreckenden Zentralbereich sowie einen sich von dem Flansch nach unten erstreckenden Einsteckabschnitt mittels einem an der Verschlusskappe verschieblich geführten Schiebeteil bei relativ zu dem Behältnis feststehender Kappe mittels Einwirkung auf das Schiebeteil in die Verschlussstellung versetzt wird.With regard to the method, the object is achieved with the subject matter of
Nach Abschluss des Gefriertrocknungsverfahrens wird nur noch das Schiebeteil relativ zu der Verschlusskappe bewegt. Es ist nicht erforderlich, nach Abschluss des Gefriertrocknungsverfahrens die Verschlusskappe noch relativ zu dem Behältnis zu bewegen. Der Verschlussstopfen kann allein durch Bewegung des Schiebeteils in die Verschlussstellung versetzt werden.After the freeze-drying process is complete, only the sliding part is moved relative to the closure cap. It is not necessary to move the closure cap relative to the container after the freeze-drying process has been completed. The sealing plug can be moved into the closed position simply by moving the sliding part.
Die Erfindung ist des Weiteren, bezüglich des Behältnisses, im Hinblick auf eine Ampulle (vial) beschrieben. Weiter vorzugsweise handelt es sich um ein Behältnis, beispielsweise eine Ampulle, aus Glas. Es kann sich aber auch jeweils um ein sonstiges Behältnis handeln. Vorzugsweise um ein solches, das im pharmazeutischen Bereich verwendet wird.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.
Es ist bevorzugt, dass die Verschlusskappe eine äußere Kappenwandung aufweist. Diese Kappenwandung kann auch außen bezüglich einer stirnseitigen, also in der Regel horizontal verlaufenden, Abschlussfläche einer Mündungsöffnung der Ampulle in Zuordnung zu der Ampulle angeordnet sein. Der Mündungsrand der Ampulle kann beispielsweise im Querschnitt wulstförmig gestaltet sein. Die Kappenwandung kann also außen bezüglich des Wulstes verlaufen. Die Ampulle kann sich weiter unterhalb des Wulstes zunächst nochmals in einen Ampullenhals verjüngen und sodann wieder verbreitern. Die in der Regel rotationssymmetrisch und in ihrem Bereich unterhalb des Halses jedenfalls zylindrisch bevorzugt ausgebildete Ampulle kann mit der Außenfläche ihres genannten Zylinderbereiches fluchtend oder nahezu fluchtend mit einer Außenfläche der Kappenwandung vorgesehen sein.It is preferred that 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 As a rule, 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.
Weitere Merkmale der Erfindung sind nachstehend, auch in der Figurenbeschreibung und in der Zeichnung, oftmals in ihrer bevorzugten Zuordnung zu den bereits vorstehend erläuterten Anspruchskonzepten beschrieben bzw. dargestellt, sie können aber auch in einer Zuordnung zu nur einem oder mehreren einzelnen Merkmalen, die hier beschrieben oder zeichnerisch dargestellt sind, insbesondere solchen der bereits abgehandelten Ansprüche, von Bedeutung sein.Further features of the invention are often described or illustrated below, also in the description of the figures and in the drawing, in their preferred association with the claim concepts already explained above, but they can also be associated with only one or more individual features which are described here or are shown in the drawing, in particular those of the claims that have already been settled, can be of importance.
Das Schiebeteil ist bevorzugt innenseitig der Kappenwandung geführt. Die Führung ist weiter bevorzugt an der Verschlusskappe gegeben. Es handelt sich bevorzugt um eine einzige, an der Verschlusskappe - zugleich die Außenfläche bildende - ausgebildete Kappenwandung.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.
Die Verschlusskappe und/oder das Schiebeteil sind bevorzugt im Kunststoffspritzverfahren hergestellte Kunststoff teile. Es handelt sich um Hartkunststoff. Dagegen ist der Verschlussstopfen bevorzugt ein Gummiteil oder besteht aus einem thermoplastischen Elastomer oder aus einem sonstigen gummiartigen Weichstoff, insbesondere Weichkunststoff.The closure cap and / or the sliding part are preferably plastic parts produced in the plastic injection molding process. It is hard plastic. In contrast, 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.
Die Verschlusskappe weist alternativ bevorzugt eine von der Kappenwandung gesonderte Führungswandung für den Verschlussstopfen auf. Die Führungswandung kann somit gezielt auf die Führungsaufgabe hin gestaltet sein. Insbesondere kann der Zusammenwirkungsbereich mit dem Verschlussstopfen in seiner Flächenausdehnung so gewählt sein, dass sich zwar zunächst, in einer ersten Stellung des Verschlussstopfens relativ zu der Mündung der Ampulle, also zur Durchführung des Gefrier-Trocknungsverfahrens, eine ausreichende Haftwirkung ergibt, die ein unbeabsichtigtes Verlagern des Verschlussstopfens ausschließt, andererseits aber eine darüber hinaus nicht zu große Kraftbelastung zur Verlagerung des Verschlussstopfens in die Verschlussstellung erfordert.As an alternative, 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. In particular 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.
Insbesondere ist auch bevorzugt, dass die Führungswandung als ein nach oben über die Kappenwandung hinausragender Kappenhals ausgebildet ist. Der Kappenhals hat bevorzugt einen deutlich geringeren Durchmesser als die Kappenwandung. Sowohl die Kappenwandung, wie auch der Kappenhals, sind weiter bevorzugt an einer Zylinderform orientierte Verschlusskappenteile. Sie sind bevorzugt rotationssymmetrisch, können jedoch außenseitig, etwa hinsichtlich der Kappenwandung, in Bezug auf eine Riffelung oder dergleichen auch abwechselnd über den Umfang gestaltet sein. Weiter kann die Außenwandung und/oder der Kappenhals in Bezug auf darin ausgebildete Durchtrittsöffnungen für eine Luftführung und/oder eine visuelle Überprüfbarkeit über den Umfang unterschiedlich gestaltetet sein. Hinsichtlich der Führungswandung bzw. des Kappenhalses können auch Unterbrechungen im Umfangsbereich vorgesehen sein. Etwa zur Anpassung an die erforderliche Größe des im Reibschluss zu dem Verschlussstopfen stehenden Wandungsbereiches.In particular, it is also preferred that 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. Furthermore, 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. With regard to the guide wall or the cap neck, 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.
Zwischen der Führungswand und der Kappenwandung können eine oder mehrere senkrecht orientierte Durchtrittsöffnungen ausgebildet sein. Diese Durchtrittsöffnungen ermöglichen den Durchgriff eines auf den Verschlussstopfen einwirkenden Teiles oder Bereiches des Verschlusses, insbesondere des Schiebeteils. Sie erlauben auch zunächst eine Sichtkontrolle hinsichtlich des in der Verschlusskappe aufgenommenen Verschlussstopfens.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.
Weiter bevorzugt ragt der Schiebefortsatz des Schiebeteils, das geeigneterweise zumindest teilweise oberhalb einer Durchtrittsöffnung angeordnet und mit der Verschlusskappe schiebeverbunden ist, in die Durchtrittsöffnung. Hierbei kann der Schiebefortsatz zunächst, in einer ersten Stellung, noch oberhalb der Durchtrittsöffnung oder geringfügig eingetreten in die Durchtrittsöffnung vorgesehen sein. Im Verschlusszustand nach Beendigung der Gefriertrocknung durchsetzt der Schiebefortsatz dann die Durchtrittsöffnung.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. In this case, 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.
Der in dem Verschluss vorgesehene Verschlussstopfen weist den Flansch auf, mit dem er im Verschlusszustand auf einer stirnseitigen Mündungsfläche der Ampullenöffnung aufliegt, und auf welchen der Schiebefortsatz einwirken kann. Weiter weist er einen sich von dem Flansch, mit geringerem Durchmesser als der Flansch, nach oben erstreckenden Zentralbereich auf. Darüber hinaus besitzt der Verschlussstopfen einen von dem Flansch sich nach unten erstreckenden Einsteckabschnitt. Der Einsteckabschnitt weist bevorzugt einen geringeren, an die Halsöffnung der Ampulle angepassten Durchmesser auf als der Flansch. Der Einsteckabschnitt greift im Verschlusszustand in dem Mündungsbereich des Behältnisses bzw. der Ampulle in das Innere der Ampulle ein und dichtet so die Ampulle durch Anlage an einer Innenfläche des Halsbereiches ab.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. In addition, 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.
Der Zentralbereich des Verschlussstopfens wirkt bevorzugt mit der genannten Führungswandung der Verschlusskappe, also insbesondere dem Verschlusskappenhals, zusammen. Er ist darin aufgenommen. Weiter ist er bevorzugt zylindrisch ausgebildet. Eine Zylinderaußenfläche wirkt entsprechend mit einer Innenfläche der Führungswandung zur Halterung und Führung zusammen. Das Schiebeteil wirkt weiter bevorzugt mittels des Schiebefortsatzes, von dem darüber hinaus bevorzugt mehrere über den Umfang verteilt vorgesehen sind, auf den Flanschbereich des Verschlusstopfens ein. Auf eine Oberseite des Flansches wird durch das Schiebeteil mittels des Schiebefortsatzes bzw. der Schiebefortsätze gedrückt, wodurch der Verschlussstopfen dann, relativ zu der Verschlusskappe bewegt, in die Verschlussstellung bezüglich der Ampulle versetzt werden kann.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.
Darüber hinaus ist auch bevorzugt, dass das Schiebeteil eine Oberseite der Verschlusskappe übergreift. Insbesondere auch einen gegenüber den Durchtrittsöffnungen radial äußeren Bereich der Verschlusskappe. Somit kann das Schiebeteil im Verschlusszustand hinsichtlich seiner Außenwandung fluchtend mit der Außenfläche der Kappenwandung verlaufen oder mit einem größeren Durchmesser der Außenwand übergreifend zu der Kappenwandung oder einem etwas geringeren Durchmesser als die Kappenwandung zurückversetzt bezüglich der Kappenwandung verlaufen.In addition, it is also preferred that the sliding part engages over an upper side of the closure cap. In particular also a region of the closure cap that is radially outer with respect to the passage openings. Thus, in the closed state, the sliding part 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.
Darüber hinaus ist auch bevorzugt, dass die Verschlusskappe bzw. das Schiebeteil nach Versetzen des Verschlussstopfens in die Verschlussstellung von einem Deckelteil abdeckbar sind.In addition, it is also preferred that the closure cap or the sliding part can be covered by a cover part after the closure plug has been moved into the closure position.
Das Deckelteil kann beispielsweise einrastbar an der Verschlusskappe vorgesehen sein. Es kann aber auch mit der Verschlusskappe etwa verschweißt werden.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.
Weiter ist bevorzugt, dass das Deckelteil unverlierbar einstückig mit der Verschlusskappe oder dem Schiebeteil ausgebildet ist. Bevorzugt ist eine einstückige Spritzteilausbildung mit dem Schiebeteil. Hierbei kann ein verdünnter Gelenkbereich im Übergang zwischen dem Schiebeteil und dem Deckelteil ausgebildet sein.It is further preferred that the 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. Here, a thinned joint area can be formed in the transition between the sliding part and the cover part.
Weiter können an der Verschlusskappe ein oder mehrere Verschlusszapfen, die nach oben freistehend herausragen, vorgesehen sein. Diese können in entsprechende Öffnungen des Deckelteils im Verschlusszustand eingreifen. Insbesondere können sie im Eingriffszustand zu den genannten Öffnungen auch mit diesen verschweißt sein.Furthermore, 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.
Nachstehend ist die Erfindung des Weiteren anhand der beigefügten Zeichnung, die jedoch lediglich Ausführungsbeispiele darstellt, erläutert. Hierbei zeigt:
- Fig. 1
- einen auf eine Ampulle aufgesetzten Verschluss erster Ausführungsform, bei offenem Deckel;
- Fig. 2
- den Verschluss gemäß
Fig. 1 in einer perspektivischen Ansicht von schräg unten; - Fig. 3
- den Verschluss gemäß
Fig. 1 bzw.Fig. 2 in einer Explosionsdarstellung, mit zugeordnetem Verschlussstopfen; - Fig. 4
- das Schiebeteil des Verschlusses gemäß
Fig. 1 , in einer Ansicht von oben; - Fig. 5
- das Schiebeteil gemäß
Fig. 4 in einer perspektivischen Ansicht von schräg unten; - Fig. 6
- die Verschlusskappe in einer Ansicht von oben;
- Fig. 7
- die Verschlusskappe in einer Ansicht von schräg unten;
- Fig. 8
- den Verschluss gemäß
Fig. 1 im Querschnitt in einer Gefrier- Trocknungsstellung; - Fig. 9
- eine Darstellung gemäß
Fig. 8 , jedoch bei in seine Dichtstellung verschobenem Verschlussstopfen; - Fig. 10
- eine perspektivische Ansicht eines weiteren Verschlusses;
- Fig. 11
- der Verschluss gemäß
Fig. 10 in einer perspektivischen Ansicht von schräg unten; - Fig. 12
- der Verschluss gemäß
Fig. 10 bzw.Fig. 11 in einer Explosionsdarstellung, mit zugeordnetem Verschlussstopfen; - Fig. 13
- das Schiebeteil des Verschlusses gemäß
Fig. 10 in einer Ansicht von oben; - Fig. 14
- einen Querschnitt durch den Gegenstand gemäß
Fig. 13 , geschnitten entlang der Linie XIV-XIV; - Fig. 15
- das Schiebeteil gemäß
Fig. 13 in einer Ansicht von unten; - Fig. 16
- die Verschlusskappe in einer Ansicht von oben;
- Fig. 17
- einen Querschnitt durch den Gegenstand gemäß
Fig. 16 , geschnitten entlang der Linie XVII-XVII; - Fig. 18
- einen Querschnitt durch den Verschluss gemäß
Fig. 10 , in einer Gefrier-Trocknungsstellung; und - Fig. 19
- eine Darstellung gemäß
Fig. 18 , bei in der Dichtstellung befindlichem Verschlussstopfen.
- Fig. 1
- a closure of a first embodiment placed on an ampoule, with the lid open;
- Fig. 2
- the closure according to
Fig. 1 in a perspective view obliquely from below; - Fig. 3
- the closure according to
Fig. 1 respectively.Fig. 2 in an exploded view, with associated sealing plug; - Fig. 4
- the sliding part of the closure according to
Fig. 1 , in a view from above; - Fig. 5
- the sliding part according to
Fig. 4 in a perspective view obliquely from below; - Fig. 6
- the cap in a view from above;
- Fig. 7
- the cap in an oblique view from below;
- Fig. 8
- the closure according to
Fig. 1 in cross section in a freeze-drying position; - Fig. 9
- a representation according to
Fig. 8 , but with the sealing plug moved into its sealing position; - Fig. 10
- a perspective view of another closure;
- Fig. 11
- the closure according to
Fig. 10 in a perspective view obliquely from below; - Fig. 12
- the closure according to
Fig. 10 respectively.Fig. 11 in an exploded view, with associated sealing plug; - Fig. 13
- the sliding part of the closure according to
Fig. 10 in a view from above; - Fig. 14
- a cross section according to the object
Fig. 13 , cut along the line XIV-XIV; - Fig. 15
- the sliding part according to
Fig. 13 in a view from below; - Fig. 16
- the cap in a view from above;
- Fig. 17
- a cross section according to the object
Fig. 16 , cut along the line XVII-XVII; - Fig. 18
- a cross section through the closure
Fig. 10 , in a freeze-drying position; and - Fig. 19
- a representation according to
Fig. 18 , with the sealing plug in the sealing position.
Dargestellt und beschrieben ist, zunächst mit Bezug zu den
Es handelt sich um einen Verschluss 1, der auf einem hier als medizinische Ampulle 9 ausgebildeten Behältnis aufsitzt. In der Ampulle 9 befindet sich, bevorzugt zunächst, das heißt vor einer gegebenenfalls durchzuführenden Gefriertrocknung, ein Medikament in flüssiger Form. Durch eine beispielsweise durchzuführende Gefriertrocknung kann es beispielsweise in Pulverform überführt werden.It is a closure 1, which is seated on a container designed here as a
Der Verschluss 1 besteht im Einzelnen aus einer Verschlusskappe 2 und einem Schiebeteil 3, das beim Ausführungsbeispiel teilweise oben bezüglich der Verschlusskappe 2 überstehend ausgebildet ist. Mit dem Schiebeteil 3 ist ein Deckel 4 verbunden.The closure 1 consists in detail of a
Wie sich weiter etwa aus den Querschnittsdarstellungen der
Die Verschlusskappe 2 weist weiter Rastausformungen 6 auf, mit denen sie einen Mündungswulst 7 der Ampulle 9 im Rastzustand untergreift. Wie insbesondere aus
Wie sich weiterhin aus einem Vergleich der
Der Verschlussstopfen besitzt einen Flansch 11 und einen Zentralbereich 12. Unterhalb des Flansches 11 ist weiter ein Dichtvorsprung 13 ausgebildet.The sealing plug has a
In der Verschlussstellung gemäß der
Aus der perspektivischen Darstellung der
Eine Umfangserstreckung eines Rastarmes 8 entspricht bevorzugt einem Umfangswinkel α von 2° bis 60°, wobei von den genannten sieben Rastarmen sich bevorzugt sechs Rastarme über einen Umfangswinkel von 30° bis 60° erstrecken und ein Rastarme 8" über einen Umfangswinkel zwischen 2° und 10°.A circumferential extent of a
Ein Umfangszwischenraum 18 zwischen zwei Rastarmen entspricht bevorzugt einem Umfangswinkel 1° bis 5°.A
Ein Rastarm 8" ist in seinem oberen, also dem Schiebeteil 3 zugewandten Bereich mit einem Fenster 19 versehen. Das Fenster 19 ermöglicht eine Sichtkontrolle des darin aufgenommenen Verschlussstopfens. Im unteren Bereich ist der Eingriffswulst 6 gleichwohl in Umfangsrichtung durchgehend geformt. Jedoch sind randseitig des durchgehend gebildeten Rastwulstes 6, der Außenwand zugeordnet, säulenartige Fortsätze 20 der Kappenwandung bis nach unten durchgeformt. Es ergibt sich also außenseitig eine torbogenartige Gestaltung dieses Rastarmes 8", die im oberen Bereich durchgehend geöffnet ist, im unteren Bereich jedoch bei durchgehenden Zargenabschnitten durch die Rückwand der Rastausformung 6 geschlossen.A locking
Diese Gestaltung des Rastarmes 8" ermöglicht zugleich eine werkzeugmäßig günstige Erfassung im Hinblick auf eine Aufbringung des Verschlusses in die Raststellung gemäß
Aus der Darstellung gemäß
Der Kappenhals 21 weist innenseitig einen oder mehrere Axialstege 24 auf, die zur bremsenden Zusammenwirkung mit einer Außenfläche des Zentralabschnittes 12 des Verschlussstopfens 5 dienen. Die Axialstege 24 stehen wulstartig innenseitig bezüglich einer Innenfläche des Kappenhalses 21 vor. Hiermit lässt sich der Verschlussstopfen 5 zuverlässig in der Stellung gemäß
Die genannten Axialstege können ergänzend oder alternativ auch an der Außenfläche des Zentralbereichs 12 des Verschlussstopfens 5 ausgebildet sein.The above-mentioned axial webs can additionally or alternatively also be formed on the outer surface of the
Das Schiebeteil 3, vgl. insbesondere
Unterseitig weist das Schiebeteil 3 Einrastfinger 31 auf, die im Querschnitt einen nach innen vorragenden Rastabschnitt 32 bilden, siehe etwa
Radial außen bezüglich der Einrastfinger 31 ist eine Wandung 34 vorgesehen, welche die Einrastfinger 31 aber nur auf einem Teil ihrer freikragenden Länge umgibt. Ein unterer Teil der Einrastfinger 31 liegt nach radial außen frei.A
Beim Ausführungsbeispiel sind umfangsverteilt insgesamt vier Einrastfinger 31 ausgebildet. Die Einrastfinger 31 erstrecken sich bevorzugt über einen Umfangswinkelbereich zwischen 10° und 60°.In the exemplary embodiment, a total of four latching
Im Umfangszwischenraum zwischen den Einrastfingern 31, zudem aber auch gegenüber einer Außenwandung der Einrastfinger 31 noch nach außen vorragend, sind die Schiebefortsätze 10 vorgesehen. Diese sind beim Ausführungsbeispiel im Querschnitt als ovalförmige Hohlformen ausgebildet. Die Schiebefortsätze 10 erstrecken sich vertikal. Die durch eine umlaufende Wandung gebildete Hohlform der Schiebefortsätze 10 erbringt über die Stirnfläche der Wandung, welche die Schiebekräfte überdeckt, eine günstige Krafteinleitung in den Verschlussstopfen 5.The sliding
Diese Schiebefortsätze 10 wirken auf den Verschlussstopfen 5, auf die Oberseite des Flansches 11, zum Verschieben in die Verschlussstellung ein.These sliding
Die Schiebefortsätze 10 sind einem zwischen dem Kappenhals 21 und der Kappenwandung 23 ausgebildeten Ringraum zugeordnet. Der Ringraum ist durch die sich diesbezüglich radial erstreckenden Radialstege 22 unterteilt. Die Radialstege 22 belassen sowohl Öffnungen 48 für einen Durchtritt der Schiebefortsätze 10, wie auch Öffnungen 49 für einen Durchtritt der Einrastfinger 31. Ersichtlich sind die Öffnungen 48 an die Außenkontur der Schiebefortsätze angepasst. Sie sind maßlich so vorgesehen, dass sich eine Gleitführung für die Schiebefortsätze 10 ergibt.The sliding
Mit Bezug zu den
Grundsätzlich besteht auch diese Bauform aus einem Kappenteil 36 und einem Schiebeteil 37. Im Inneren des Kappenteils 36 ist auch bei dieser Bauform ein Verschlussstopfen 38 aufgenommen.Basically, this type of construction also consists of a
Im Unterschied zu der vorher beschriebenen Ausführungsform ist zunächst gegeben, dass das Schiebeteil 37 eine äußere Schürzenwand 39 aufweist, die teilweise, über einen Teil ihrer Höhe, eine Außenwandung 40 des Kappenteils 36 überfängt, und zwar bereits in der Gefrier-Trocknungsstellung gemäß
Wie die Rastfinger der vorher beschriebenen Ausführungsform erstrecken sich auch die Rastfinger 41 dieser Bauform bevorzugt über einen Umfangswinkelbereich von 30° bis 60°.Like the locking fingers of the previously described embodiment, the locking
Einige der Rastfinger 41, bevorzugt jeder zweite Rastfinger 41, wobei insgesamt bevorzugt sechs Rastfinger 41 ausgebildet sind, weisen oberseitig, oberhalb der Rastwülste 42, aber unterhalb des Übergangs 28 in eine kreisringförmige Umfangswand 35 des Kappenteils 36, Durchgangsöffnungen 44 auf. Diese Durchgangsöffnungen 44 können zur Sichtkontrolle etwa im Hinblick auf den darin gehalterten Verschlussstopfen dienen.Some of the locking
Weiter sind oberhalb der Anbindung 28 der Rastfinger 41 an die genannte Umfangswandung 35 sich in Umfangsrichtung erstreckende Nuten oder Durchgriffsöffnungen 45, vorgesehen. Diese erstrecken sich kreisabschnittsförmig, bevorzugt über einen Umfangswinkel zwischen 10° und 40°.Furthermore, above the
In diese Umfangsnuten können im Verschlusszustand, siehe
Bezüglich beider Bauformen wird hinsichtlich des Gebrauchs beispielsweise wie folgt vorgegangen:
Zunächst werden getrennt die Kappe und das Schiebeteil sowie der Verschlussstopfen hergestellt. Der Verschlussstopfen wird sodann in die Kappe, oder, jedenfalls bevorzugt bei der Bauform der
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
In einem weiteren Schritt werden dann die so vorkonfektionierten Verschlüsse mit den mit einem Medikament gefüllten Ampullen in Verbindung gebracht. Dies kann etwa in einer Sternradvorrichtung einer Vereinzelungsanlage geschehen. Die Verbindung wird dadurch ausgeführt, dass die Kappen in die - zugleich auch schon endgültige - Raststellung auf die Ampulle gemäß
Die Ampullen werden in dieser Stellung der aufgebrachten Verschlüsse sodann in eine Gefrier-Trocknungsanlage verbracht. Hierbei wird bei Gefriertemperaturen eine Trocknung des in den Ampullen befindlichen Medikaments erreicht. Da die Verschlussstopfen nicht auf dem Mündungsrand der Ampulle aufsitzen oder gar in diesen eingreifen, und zudem Luftwege durch die Kappe in das Innere der Ampulle verblieben sind, kann eine effektive Trocknung erreicht werden.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.
Am Ende des Gefrier-Trocknungsvorganges wird ein Verschluss der Ampullen dadurch erreicht, dass jeweils das Schiebeteil in die Stellung gemäß
Schließlich kann noch der Deckel 4 auf das Schiebeteil aufgeklappt werden und mittels der Verschlusszapfen ein weiterer Verschluss insoweit erreicht werden. Dieser Verschluss kann insbesondere als Originalitätssicherung dienen.Finally, the
Von Bedeutung hinsichtlich der Bauform der
Claims (15)
- Closure (1) for a receptacle (9), for example an ampoule in which preferably a medicament is accommodated, having a closure cap (2) and a closure plug (5) accommodated in the closure (1), latching formations (6) being formed on the closure cap (2) for holding the closure (1) on the receptacle (9) in a latching manner, and a sliding part (3) being provided which can be moved relative to the closure cap (2) in order to displace the closure plug (5) from an open position into the closed position, the sliding part (3) being moved downwards relative to the closure cap (2) when in the closed position, it furthermore being possible to slide the closure plug (5) relative to the closure cap (2) by means of the sliding part (3, 37) in order to shift said plug into the closed position, and the depressed position of the sliding part (3, 37), in which position the closure plug (5) is in the closed position, being secured in a latching manner, characterised in that the closure plug (5) is manufactured separately from the closure cap (2) and the sliding part (3, 37), in that the closure plug (5) comprises a flange (11), a central region (12) which extends upwards from the flange (11) so as to have a smaller diameter, and an insertion portion which extends downwards from the flange (11), in that the sliding part (3, 37) comprises latching arms (47) and/or snap-in fingers (31) which engage in corresponding latching openings or latching recesses in the closure cap (2), the closure plug being acted on by means of sliding projections (10) formed on the sliding part (3) in order to slide said plug into the closed position, the sliding part (3) directly acting on the closure plug (5).
- Closure according to claim 1, characterised in that the sliding part (3) is guided on the inside of a cap wall of the closure cap (2).
- Closure according to claim 1, characterised in that the sliding part (3) is guided on the outside with respect to a cap wall of the closure cap (2).
- Closure according to any of the preceding claims, characterised in that the sliding part (3) engages over an upper edge of the cap wall in a U-shape.
- Closure according to any of the preceding claims, characterised in that the closure cap (2) comprises a guide wall for the closure plug (5), which guide wall is separate from the cap wall (23).
- Closure according to claim 5, characterised in that the separate guide wall is designed as a cap neck (21).
- Closure according to claim 6, characterised in that the cap neck (21) projects upwards beyond the cap wall.
- Closure according to either claim 6 or claim 7, characterised in that a cap neck wall is arranged so as to be radially inwardly offset from the cap wall, a passage opening preferably being formed between the guide wall and the cap wall.
- Closure according to claim 8, characterised in that a sliding projection (10) of the sliding part (3) projects into the passage opening (48).
- Closure according to any of claims 5 to 9, characterised in that the central region (12) cooperates with the guide wall.
- Closure according to either claim 9 or claim 10, characterised in that the sliding part acts on the flange (11) by means of the sliding projection (10).
- Closure according to any of the preceding claims, characterised in that the sliding part engages over an upper side of the closure cap (2).
- Closure according to any of the preceding claims, characterised in that the closure cap (2) or the sliding part (3) can be covered by a cover part (4), it being possible for the cover part (4) to be integrally connected to the sliding part (3).
- Method for carrying out a freeze-drying process for a medium, in particular a medicament, that is accommodated in a receptacle, in particular an ampoule (9), the receptacle (9) being closed by means of a closure plug (5) which seals in the region of a receptacle mouth, the closure plug (5) furthermore initially being held, in a cap (2) that is placed on the receptacle (9) before the start of drying process, in a position that is spaced apart from the region and being shifted into a sealing position after the drying process is complete, characterised in that, after the drying process is complete, the closure plug (5), which is manufactured separately from the cap (2) and the sliding part (3) and which comprises a flange (11), a central region (12) which extends upwards from the flange (11) so as to have a smaller diameter, and also an insertion portion which extends downwards from the flange, is shifted, by means of a sliding part (3) that is guided on the closure cap (2) in a sliding manner, into the closed position by the sliding part (3) being acted upon, with the cap (2) being fixed relative to the receptacle.
- Method according to claim 14, wherein a closure according to any of claims 1 to 13 is used.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102010016866.1A DE102010016866B4 (en) | 2010-05-10 | 2010-05-10 | Closure for a container and method for carrying out a freeze-drying method |
PCT/EP2011/057312 WO2011141376A1 (en) | 2010-05-10 | 2011-05-06 | Closure for a receptacle and method for carrying out a freeze-drying process |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2569225A1 EP2569225A1 (en) | 2013-03-20 |
EP2569225B1 true EP2569225B1 (en) | 2020-03-25 |
Family
ID=44119002
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP11722753.8A Active EP2569225B1 (en) | 2010-05-10 | 2011-05-06 | Closure for a receptacle and method for carrying out a freeze-drying process |
Country Status (5)
Country | Link |
---|---|
US (1) | US9540154B2 (en) |
EP (1) | EP2569225B1 (en) |
JP (1) | JP6013325B2 (en) |
DE (1) | DE102010016866B4 (en) |
WO (1) | WO2011141376A1 (en) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102011050983A1 (en) * | 2010-09-09 | 2012-03-15 | Helvoet Pharma Belgium N.V. | Closing plugs for pharmaceutical applications |
FR2967655B1 (en) * | 2010-11-24 | 2014-03-14 | Biocorp Rech Et Dev | DEVICE FOR CLOSING A CONTAINER, CONTAINER EQUIPPED WITH SUCH A DEVICE AND METHOD FOR CLOSING A BATCH OF SUCH CONTAINERS |
EP3295917A1 (en) * | 2013-07-03 | 2018-03-21 | SiO2 Medical Products, Inc. | Parenteral vial cap |
ITMI20132005A1 (en) * | 2013-12-02 | 2015-06-03 | Antonio Mutterle | CLOSING SYSTEM FOR BOTTLE, RELATIVE BOTTLE AND ASSEMBLY METHOD |
EP3494349B1 (en) * | 2016-08-05 | 2020-10-07 | Bachem AG | Lid for drying container |
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US1643285A (en) | 1926-05-10 | 1927-09-20 | William Orem | Stopper and sprinkler cap for bottles and the like |
US1949058A (en) * | 1932-09-29 | 1934-02-27 | Goodrich Co B F | Dispensing bottle stopper |
FR2036746A1 (en) | 1969-03-14 | 1970-12-31 | Transfusions Sanguines | Sterile uncorking and restoppering bottles - of plasma derivs for lyophilisation |
US4060911A (en) * | 1975-08-07 | 1977-12-06 | Behringwerke Aktiengesellschaft | Process for the preparation of a container closed under sterile conditions and containing lyophilized material |
US4194640A (en) * | 1977-05-06 | 1980-03-25 | The Upjohn Company | Vial and closure |
DE2900850A1 (en) | 1979-01-11 | 1980-07-24 | Sanner Kg Friedr | Plastics bottle cap assembly - comprises plastics stopper with passage and plug secured at outer end to form gap |
FR2674508B1 (en) | 1991-03-26 | 1993-07-02 | Prigent Henri | POURING-REDUCING CAP FOR LIQUIDS. |
US5314084A (en) | 1992-08-21 | 1994-05-24 | The West Company, Incorporated | Two piece all plastic seal |
DE69435255D1 (en) * | 1993-10-22 | 2010-01-07 | Abbott Lab | Test vials and methods for minimizing contamination |
DE69412291T2 (en) * | 1994-08-19 | 1998-12-03 | W.L. Gore & Associates, Inc., Newark, Del. | VENTILATED GLASS BOTTLE FOR FREEZING DRYING AND METHOD FOR REDUCING CONTAMINATION OF FREEZING DRY PRODUCTS |
US5901866A (en) * | 1998-02-13 | 1999-05-11 | Comar Inc. | Break away overcap |
US5819964A (en) * | 1996-09-27 | 1998-10-13 | Becton Dickinson And Company | Lyophilization closure assembly for a medicament container for use during a lyophilization process |
US5899349A (en) * | 1997-10-02 | 1999-05-04 | Beckman Instruments, Inc. | Cap/closure having a venting mechanism for use with centrifuge containers |
KR200182877Y1 (en) | 1999-12-30 | 2000-05-15 | 김종기 | Open and close device of sealing a receptacle for liquid |
US6659296B2 (en) * | 2000-01-26 | 2003-12-09 | Amersham Health As | Cap for container |
WO2004096113A2 (en) * | 2003-04-28 | 2004-11-11 | Medical Instill Technologies, Inc. | Container with valve assembly for filling and dispensing substances, and apparatus and method for filling |
WO2005000703A2 (en) | 2003-06-23 | 2005-01-06 | Helvoet Pharma Belgium N.V. | Closure for lyophilizing |
JP4883940B2 (en) * | 2005-05-31 | 2012-02-22 | シロウマサイエンス株式会社 | Container mouth closing mechanism |
FR2912384B1 (en) | 2007-02-09 | 2009-04-10 | Biocorp Rech Et Dev Sa | CLOSURE DEVICE FOR A CONTAINER, CONTAINER EQUIPPED WITH SUCH A DEVICE AND METHOD FOR CLOSING A LOT OF SUCH A CONTAINER |
US20090001042A1 (en) * | 2007-06-26 | 2009-01-01 | Robert Sever | Container-closure system for use in lyophilization applications |
AT506166B1 (en) | 2007-12-05 | 2010-02-15 | Gypser Stefan | CLOSURE |
DE102008051351A1 (en) * | 2008-10-10 | 2010-04-15 | Friedrich Sanner Gmbh & Co. Kg | Closure for pressing and locking with a container |
-
2010
- 2010-05-10 DE DE102010016866.1A patent/DE102010016866B4/en active Active
-
2011
- 2011-05-06 WO PCT/EP2011/057312 patent/WO2011141376A1/en active Application Filing
- 2011-05-06 EP EP11722753.8A patent/EP2569225B1/en active Active
- 2011-05-06 US US13/697,094 patent/US9540154B2/en active Active
- 2011-05-06 JP JP2013509517A patent/JP6013325B2/en active Active
Non-Patent Citations (1)
Title |
---|
None * |
Also Published As
Publication number | Publication date |
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US9540154B2 (en) | 2017-01-10 |
US20130055681A1 (en) | 2013-03-07 |
WO2011141376A1 (en) | 2011-11-17 |
DE102010016866B4 (en) | 2018-06-21 |
JP6013325B2 (en) | 2016-10-25 |
DE102010016866A1 (en) | 2011-11-10 |
EP2569225A1 (en) | 2013-03-20 |
JP2013526461A (en) | 2013-06-24 |
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