EP3384219A1 - Bouchon pour un récipient destiné à être utilisé lors de la cryodessiccation et arrangement d'un bouchon et d'un récipient - Google Patents

Bouchon pour un récipient destiné à être utilisé lors de la cryodessiccation et arrangement d'un bouchon et d'un récipient

Info

Publication number
EP3384219A1
EP3384219A1 EP17769107.8A EP17769107A EP3384219A1 EP 3384219 A1 EP3384219 A1 EP 3384219A1 EP 17769107 A EP17769107 A EP 17769107A EP 3384219 A1 EP3384219 A1 EP 3384219A1
Authority
EP
European Patent Office
Prior art keywords
plug
container
sealing
sealing body
drying
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP17769107.8A
Other languages
German (de)
English (en)
Other versions
EP3384219B1 (fr
Inventor
Jan Kirchner
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.)
Kisiko Kirchner Simon and Co GmbH
Original Assignee
Kisiko Kirchner Simon and Co GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kisiko Kirchner Simon and Co GmbH filed Critical Kisiko Kirchner Simon and Co GmbH
Publication of EP3384219A1 publication Critical patent/EP3384219A1/fr
Application granted granted Critical
Publication of EP3384219B1 publication Critical patent/EP3384219B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
    • 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
    • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D39/0052—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in more than one piece
    • B65D39/0076—Plastic closures other than those covered by groups B65D39/0058 - B65D39/007
    • 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
    • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D39/0052—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in more than one piece
    • B65D39/0094—Glass, ceramic or metal stoppers for perfume bottles or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2539/00—Details relating to closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D2539/001—Details of closures arranged within necks or pouring opening or in discharge apertures, e.g. stoppers
    • B65D2539/008—Details of closures arranged within necks or pouring opening or in discharge apertures, e.g. stoppers with coatings or coverings
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • 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

Definitions

  • Plug for a container for use in freeze drying and placement of a plug and a container
  • the invention relates to a plug for a container for use in freeze-drying, also referred to as lyophilization. Furthermore, the invention relates to an arrangement of a plug and a container for use of the arrangement in freeze-drying.
  • a solution with appropriate ingredients is prepared and then dried this solution in a freeze-drying plant.
  • the solvent used to prepare the solution is typically water and the solution is accordingly an aqueous solution.
  • other solvents or mixtures thereof with aqueous systems can also be used, for example an alcohol, in particular ethanol, or an organic solvent.
  • the solution is first filled into a container, for example a glass cuvette or glass bottle, for the purpose of freeze-drying.
  • a plug inserted into the container to completely close this for freeze-drying partially or after freeze-drying.
  • the plug is designed such that the freeze-drying process gas exchange between the interior of the container and the environment is possible. This can be achieved, for example, in that, in a drying position, the plug is only partially inserted into the container during the process of freeze-drying, and thus the container is not yet sealed. In this way, during the freeze-drying process, the solvent, in particular water, can be removed from the solution in order to dry the ingredients of the solution. Following the freeze-drying process, the plug is typically pushed further into the container with the aid of a device formed in the freeze-drying unit, so that the plug is in the sealing position in which the plug closes the container in a fluid-tight manner.
  • the term "fluid" is used below as a common name for gases and for liquids.
  • fluid-tight is accordingly understood to mean that penetration of gases and / or liquids, in particular of water vapor or oxygen, into the interior of the container and escape of substances from the interior of the container is prevented in the sealing position.
  • a fuse closure is then attached to the container to secure the plug.
  • This securing closure may be, for example, a crimp cap or a screw cap.
  • plugs are usually formed in one piece.
  • a one-piece plug for use in a freeze-drying process is known for example from the document DE 20 201 1050413 U1.
  • the piston plug has an upper side and a lower side, with the lower side facing the upper side in an axial direction.
  • the piston plug has, in the area of the underside, at least one outwardly open, open cavity for gas exchange during freeze-drying, which is open in an axial direction downwards and in a radial direction.
  • US Pat. No. 4,306,357 A discloses a cap arrangement for a vessel for freeze-drying
  • the cap assembly comprises a one-piece plug for insertion into an opening of a freeze-drying vessel, the plug being formed with ribs on its shaft so that in a drying position of the plug when a cap flange is spaced from a vessel flange, the fins with an inner surface of the flange of the vessel form ventilation channels to allow fluid communication, with respect to freeze-drying, in particular gas exchange, between the interior of the vessel and the outside.
  • the probe is used to measure physical parameters, such as temperature, during freeze-drying.
  • the device comprises a one-piece plug, wherein a guide tube is arranged in a plug passing through the central opening of the plug, wherein this guide tube extends when plugged into a container opening plug into the container interior.
  • the guide tube serves to receive the probe in order to arrange it centrally and at a certain height in the container interior.
  • the plug has at least one further plug passing through the opening, which allows gas exchange when plugged into the container plug between the container interior and the container environment.
  • the at least one further opening is preferably designed such that the gas exchange with plug introduced in the container is similar or identical to a gas exchange of a conventional freeze-drying plug in a drying position of the freeze-drying plug.
  • the device or the plug of the device is not intended for this purpose nor suitable for closing the container in a fluid-tight manner following freeze-drying.
  • the currently used in the field of freeze-drying plug also as lyophilisate!
  • On ssto pf or freeze-drying stoppers are usually made a butyl rubber, also referred to as butyl rubber, for example, bromobutyl rubber or chlorobutyl rubber.
  • butyl rubber for example, bromobutyl rubber or chlorobutyl rubber.
  • the production of the plug as a rubber molded part is relatively expensive, since on the one hand, the material costs are relatively high and also must vulcanize the rubber mixture in a heated mold, whereby the cycle times and the energy consumption during production are relatively high.
  • a plug which comprises an element or central core of a rigid material which is opaque, transparent or translucent, such as glass, this element or central core having a head and an axial core Body includes.
  • the plug further comprises a sleeve-shaped element made of plastic, wherein the sleeve-shaped element surrounds the axial body.
  • the sleeve-shaped plastic element has on its peripheral surface at least one bead or a sealing rib for contacting the inner surface of a container neck of the container to be closed.
  • the bead or the sealing rib is designed such that it can deform freely during the closing process.
  • freeze-drying stoppers which are formed in two parts, wherein the two parts of the plug are made of different materials.
  • a plug having the features of the preamble of claim 1 is known from the document DE 1 942 347 A.
  • the plug has an insertable portion insertable into the container, the inserting portion having a side surface and a bottom surface, the bottom surface of a top surface of the plug being opposed in an axial direction of the plug.
  • the insertion section in turn has a sealing portion for fluid-tightly sealing the container to an environment of the container in a sealing position of the plug and an abutting axially from the top surface in the direction of the bottom surface of the sealing portion abutment portion for holding the plug in a drying position of the plug during freeze-drying
  • the abutment portion has at least one passage opening for gas exchange between an interior of the container and the environment of the container during the freeze-drying, wherein this passage opening extends from the side surface into the bottom surface.
  • the plug has a sealing body and a Basic body, which are interconnected.
  • the sealing body is formed by an upper part of the plug and the base body is formed by a lower part of the plug, wherein outer surfaces of the sealing body in the region of the Dichtab- cut form the side surface of the insertion and the main body in the region of the sealing portion is formed within the sealing body .
  • the contact section is formed by the main body. Accordingly, the side surface of the insertion portion in the region of the abutment portion and the bottom surface of the insertion portion are formed by outer surfaces of the main body.
  • the base body consists of a material which has a higher hardness than a material of which the sealing body consists.
  • detent lugs of the main body rest directly on a container wall of the container.
  • An arrangement of a plug and a container for use of the arrangement in freeze-drying having the features of the preamble of claim 15 is also known from DE 1 942 347 A.
  • Object of the present invention is to provide a stopper having the features of the preamble of claim 1, such that the plug still has a particularly good sealing property and / or barrier property and / or chemical resistance at lower material costs and lower production costs and also a has sufficient stiffness for ease of handling and yet avoids damage to plugs or containers when inserting the plug into or removing the plug from the container. It is another object of the invention to develop an arrangement having the features of the preamble of claim 15, such that this arrangement has the aforementioned advantages.
  • the plug proposes a plug, which is formed according to the features of claim 1.
  • the invention proposes an arrangement of a container and a plug having the features of claim 15.
  • the plug according to the invention is designed such that in the region of the contact portion regions of the side surface of the insertion, which contact an inner surface of a container wall of the container in the drying position and / or the sealing position, are formed by outer surfaces of the sealing body, wherein the base body in the region of the contact section within Accordingly, only outer surfaces of the softer sealing body come into contact with the inner surface of the container wall in the region of the insertion section.
  • the reduction of the wall thickness of the sealing body by the formation of the base body within the sealing body leads to a reduction of the material requirement for the sealing body, whereby the manufacturing costs are reduced, since a lower cost compared to the material of the sealing body material can be used for the main body.
  • the sealing body can be made of a softer material, each having the desired material properties, for example, the necessary elasticity or sealing effect.
  • the base body which does not come into contact with the container wall due to the design of the insertion section in the region of the insertion section, can be produced from a harder, more cost-effective material, for example polypropylene (PP).
  • PP polypropylene
  • the main body in the area of the plant Section is formed within the sealing body, also has the contact portion on the necessary for the secure holding of the plug in the drying position stiffness. Due to the fact that only the softer sealing body and not the harder body directly contacted the container, the insertion of the insertion is facilitated in the container and yet ensures a secure fit. Also, damage, such as breakage or abrasion of the base body or the container, in particular in the case of a thin-walled glass container, avoided, as in direct contact between the hard body and container, in particular during insertion of the plug in or pulling the plug out of the Container, could occur.
  • the formation of the plug with a formed inside the sealing body body made of a harder material also with regard to a manufacturing process of the plug to be considered advantageous.
  • material of the sealing body and the base of the plug by means of a multi-component injection molding process, in particular by means of a two-component injection molding process can be produced, being stiffened by the relative to the sealing body harder base body of the plug, whereby a demolding of the plug from a Injection molding tool is facilitated.
  • an ejector during removal from an injection molding tool at least not only presses into the softer material of the sealing body, but also presses into the harder material of the body or even acts exclusively on the body, thereby facilitating the demolding and damaging the plug is avoided in the process of demolding.
  • the safe handling of the plug when inserting the plug in facilitating an opening of the container or pulling the plug out of the opening since an excessive deformation of the plug, in particular in the region of the sealing portion due to the stiffening of the plug by the harder body is avoided when a force on the plug for insertion of the plug.
  • Such a deformation may, for example, lead to the sealing section in the sealing position of the plug not sealing the container in a fluid-tight manner or the deformation being so strong that damage to the plug or the container occurs.
  • outer surfaces of the sealing body in the area of the contact section form the side surface of the insertion section.
  • This embodiment is based on the surprising finding that for many solvents, in particular for water, and / or substances stored in the container, direct contact between these solvents or these substances and the base body only insignificantly or not at all affect the sealing effect of the plug and any contamination of the container interior with material of the base body is avoided if it is ensured that in the region of the insertion, the areas of the side surface of the insertion, which contact an inner surface of a container wall of the container in the drying position and / or the sealing position, by outer surfaces of the Seal body are formed.
  • the bottom surface or portions of the bottom surface of the Einogniabrab- section is formed by an outer surface or outer surfaces of the body.
  • the material of the body is resistant to the solvent or solvents used and the substances stored in the container.
  • the material of the body is resistant to the solvent or solvents used and the substances stored in the container.
  • the material of the body is resistant to the solvent or solvents used and the substances stored in the container.
  • the material of the body is resistant to the solvent or solvents used and the substances stored in the container.
  • the stiffening of the contact portion and the sealing portion of the base body is preferably formed as a solid body.
  • the base body is preferably at least in the region of the insertion substantially circular cylindrical.
  • the base body has an outer surface, wherein at least a portion of this outer surface is not covered by the sealing body in the axial direction of the plug.
  • the base body in the axial direction is mechanically accessible from the outside, so that a force can be applied directly to the base body, without acting directly on the sealing body.
  • an ejector of an injection mold for the purpose of demolding the plug press directly on the body.
  • the base body protrudes in the axial direction relative to the sealing body, or the corresponding outer surface of the sealing body ends flush with this outer surface of the base body. This avoids that acting in this direction from the outside forces act directly on the sealing body. But it is also quite conceivable that the sealing body protrudes in the axial direction relative to the base body.
  • the outer surface of the base body forms at least a portion of the bottom surface and / or the top surface.
  • the bottom surface and / or the top surface is formed exclusively by the basic body.
  • the sealing body covers the base body in the axial direction, it is considered to be particularly advantageous if the covering region of the sealing body has a relatively small axial dimension.
  • a ratio of this axial dimension to a radial dimension of the sealing section, in particular the diameter of the sealing section, is between 0.02 and 0.10, in particular between 0.02 and 0.06.
  • outer surfaces of the sealing body form the side surface and the bottom surface of the insertion section.
  • the sealing body which comes into contact with the container and the contents of the container can be made of a material which in each case opposes the desired material properties, for example the necessary elasticity, chemical resistance and / or barrier property the substance stored in the container or the substances stored in the container and / or the solvent used in the solution.
  • the base body can be made of a different material.
  • a material can be selected for the sealing body that has a good barrier effect and / or chemical resistance to substances stored in the container interior or the solvent used and for the body a, usually cheaper, material to be selected, which has a less good barrier effect and / or chemical resistance to these substances or the solvent used, since these substances or the solvent does not come into direct contact with the body.
  • the sealing body is cup-shaped or substantially pot-shaped.
  • the sealing body is formed in the region of the insertion section as a hollow cylinder or substantially as a hollow cylinder with a preferably closed bottom surface.
  • the blocking effect of the plug to be stored in the container substances and / or the solvent used and / or the ambient atmosphere can be adjusted in a simple manner.
  • a material can be selected for the sealing body that has a good blocking effect and / or chemical resistance to materials stored in the container interior, for example an organic solvent
  • a material is selected which has a good blocking effect and / or chemical resistance to substances present in the environment of the container, for example oxygen or water. This can be achieved by a Material selection a contamination of the contents of the container by substances from the environment, such as oxygen, avoided or at least reduced.
  • the sealing body and the base body are connected directly to each other. It is therefore not necessary in this embodiment to glue them together by means of an additional adhesive.
  • the sealing body and the base body are connected to one another directly by material engagement. These direct, in particular direct cohesive connection between the sealing body and the main body these are inextricably linked, whereby the plug is quasi one piece. Due to the quasi-one-piece design of the plug, the use of the plug, in particular with regard to an automated freeze-drying method in which the mechanical insertion of the plug is automated, is facilitated.
  • the sealing body from the body dissolves and example, the sealing body remains in the process of opening the container in the container or it during insertion of the Stopfens by a relative movement of the sealing body to the base body to a bead formation on the sealing body comes, which adversely affects the sealing effect of the plug.
  • the cohesive connection preferably takes place without an additional method step in that the sealing body is injection-molded onto the base body or the base body is injection-molded onto the sealing body by means of an injection molding method.
  • a cross-section of the plug is formed with a circular outer contour in the region of the sealing portion perpendicular to the axial direction of the plug.
  • the sealing section in the sealing position in this area comes to rest against the inner surface of the container wall delimiting the opening and seals the container.
  • the sealing body in the region of the sealing portion perpendicular to the axial direction of the plug has an annular cross-section.
  • a ratio of an outer radius of the annulus to an inner radius of the annulus 1, 1 to 2.5.
  • the plug has a blocking body or a barrier layer.
  • a blocking body or a barrier layer By means of the blocking body or the barrier layer, for example, a diffusion of oxygen through the stopper into the interior of the container can be prevented or at least reduced.
  • the material of the blocking body or the barrier layer may be, for example, a plastic, for example vinyl alcohol copolymer (EVOH), or aluminum, in particular an aluminum foil.
  • the barrier layer and / or the blocking body forms the top surface.
  • the blocking body and / or the barrier layer is preferably formed between the main body and the sealing body. As a result, the barrier layer or the blocking body is particularly well protected against damage from external forces.
  • the blocking body or the barrier layer is materially connected to the base body and / or materially connected to the sealing body.
  • an outer surface of the base body forms the top surface of the plug, wherein the top surface covers the sealing body in the axial direction.
  • the stopper has a cover section adjoining the insertion section in the axial direction, in particular the cover section has the cover surface, and wherein a radial dimension of the cover section is at least as large, in particular greater, than the radial dimension of the insertion section ,
  • the embodiment of the cover section with a larger radial dimension is considered to be advantageous in that the insertion depth of the plug into the container in the sealing position of the plug is limited by the cover section.
  • the cover portion may well be formed as a circumferential flange. It is considered advantageous if an outer surface of the sealing body forms a bearing surface of the cover section facing away from the cover surface. This bearing surface comes into contact with the outer surface of the container during insertion of the stopper into the container, whereby this bearing surface contributes to the sealing effect of the stopper.
  • the base body has a first projection formed in the radial direction in the region of the cover section, the first projection being in particular designed as a circumferential first projection. jump is formed.
  • This projection may serve to hold the plug in an additional closure attachable to the container.
  • This closure may be, for example, a crimp cap or a screw cap.
  • such an additional closure is attached to the container following the freeze-drying process to secure the plug. It is quite conceivable that the complete insertion of the plug into the container takes place by attaching the closure to the container.
  • the holding of the plug in the closure can take place, for example, in that a partial region of the closure engages behind the first projection on the side facing the container, for example the first projection is arranged in an undercut of the closure.
  • the connection between the closure and the plug ensures that the plug is pulled out of the container when the closure is removed from the container, for example when unscrewing a closure designed as a rotary closure.
  • the base body in an advantageous embodiment of the plug covers the sealing body in the region of the cover radially outward at least partially.
  • the base body in the area of the cover section, has a second projection formed radially on the outside, extending from the cover surface in the direction of the bottom surface, the second projection at least partially covering the sealing element radially outside in the region of the cover section.
  • the sealing body is radially enclosed by the second projection.
  • a partial region of the sealing body extending from the bottom surface in the direction of the top surface is radially enclosed by the base body. As a result, the contact area between the sealing body and the base body is increased, which is advantageous to the stability of the connection between them.
  • the base body has a through channel extending from the top surface in the direction of the bottom surface.
  • This passage allows, for example, by means of a syringe or the like to remove contents from the container without removing the plug from the container.
  • a needle or the like can be introduced into the through-channel, whereby the bottom surface of the sealing body is pierced in the region adjacent to the through-channel and thus the contents of the container become accessible.
  • a partial region of the sealing body extending from the bottom surface in the direction of the top surface is formed in the through-channel.
  • the design of the base body with a passage is also to be regarded as advantageous with respect to a production of the plug by injection molding.
  • a base body can first be injection-molded with a through-channel and subsequently the sealing body can be injection-molded from the side facing the cover surface through the through-channel to the base body. This significantly simplifies the required tooling technology and makes the tool less expensive, more robust and more durable. It is considered to be particularly advantageous if the through-channel is formed centrally in the base body, whereby shape tolerances, in particular with regard to the roundness of the sealing body, can be reduced.
  • the insertion section in particular the sealing body, has at least one recess, wherein the at least one recess forms the at least one passage opening for the gas exchange.
  • a recess is open in the axial direction in the direction of the bottom surface and open in the radial direction. It is quite conceivable that an outer surface of the insertion section delimiting the recess is at least partially formed by the main body.
  • the sealing body consists of a material which has a hardness of Shore A 40 to 80, preferably a hardness of Shore A 50 to 70, according to the standard DIN ISO 7619-1: 2010 and / or the sealing body of a thermoplastic elastomer (TPE).
  • TPE thermoplastic elastomer
  • the base body consists of a material which has a hardness of Shore D 30 to 100, preferably a hardness of Shore D 40 to 85 according to DIN ISO 7619-1: 2010 and / / or the base consists of polypropylene (PP) or high-density polyethylene (HDPE).
  • PP polypropylene
  • HDPE high-density polyethylene
  • the abutment portion is free from opposite the sealing portion in the radial direction outwardly projecting portions. Accordingly, the abutment portion has no regions protruding from the sealing portion, such as locking lugs, beads or the like, which rest against the container wall in the drying position in the axial direction in order to keep the stopper in the drying position at a certain insertion depth.
  • the stopper is held only in that the contact section contacts the inner surface of the container wall.
  • Stoppers with locking lugs, beads or the like also have the disadvantage that due to the great deformation in the region of the locking lugs or beads when transferring the plug into the sealing position of the plug, these protruding areas or the container itself are damaged. Also, the extraction of the plug is made difficult by locking tabs or the like, as doing the locking tabs or beads are deformed in one of the deformation during insertion opposite direction. By the opposite load again there is the risk of damage or even shearing the locking tabs or beads.
  • the base body and / or the sealing body and / or the plug is symmetrical, in particular radially symmetrical, to an axis of symmetry and / or plane of symmetry running in the axial direction.
  • the plug is a plug made by a multi-component injection molding process, preferably by a two-component or a three-component injection molding process.
  • the plug is inserted into an opening of the container.
  • the plug has an insertion portion inserted into the container, the insertion portion having a side surface and a bottom surface, the bottom surface of a top surface of the plug being opposed in an axial direction of the plug.
  • the insertion section in turn, has a sealing portion for sealing the container against an environment of the container in a sealing position of the plug and an abutting portion axially adjacent the top surface toward the bottom surface for holding the plug in a drying position of the plug during freeze-drying , wherein the abutment portion has at least one passage opening for a gas exchange between an interior of the container and the environment of the container during the freeze-drying, wherein this passage opening from the side surface in the Floor area extends.
  • the stopper on a sealing body and a base body which are interconnected.
  • the main body consists of a material which has a higher hardness than a material of which the sealing body consists.
  • the main body is formed in the region of the sealing portion within the sealing body. Outer surfaces of the sealing body form in the region of the sealing portion, the side surface of the insertion.
  • the sealing portion In the drying position of the plug, the sealing portion is disposed outside of the container and the abutment portion contacts an inner surface of a container wall of the container, the at least one passage opening in the interior of the container and in the environment, whereby a gas exchange during the process of freeze-drying between the interior of the container and the environment is possible.
  • the plug In the sealing position of the plug, the plug is further inserted into the container relative to the drying position and the sealing portion is disposed within the container, the sealing portion circumferentially contacting the inner surface of the container wall, whereby the sealing portion closes the container in a fluid-tight manner.
  • areas of the side surface of the insertion section which contact the inner surface of the container wall of the container in the drying position and / or the sealing position are formed by outer surfaces of the sealing body and the main body is formed in the area of the abutment section within the sealing body.
  • the insertion of the insertion is facilitated in the container and yet ensures a secure fit. Also, damage, such as breakage or abrasion of material, of the base body or of the container, especially in the case of a thin-walled glass container, is avoided, as might occur in the case of direct contact between the hard base body and the container. Even small material abrasions of the plug or of the container, which can reach the interior of the container. lead to contamination of the substance stored in the container, which makes the substance useless for the intended use.
  • the plug of the assembly may also be formed according to the embodiments described with respect to the plug as such.
  • the plug of the arrangement according to the features of one or more of claims 1 to 14 is formed.
  • FIG. 1 a first embodiment of a plug and a container in an arrangement in which the plug is partially inserted into the container, in a side view, Fig. 2 of the plug and the container of FIG. 1 in an arrangement in which the
  • Plug is inserted as far as possible into the container, in a side view,
  • Fig. 8 shows a second embodiment of the plug in a view according to the
  • FIG. 10 shows a third embodiment of the plug in a view according to the
  • Fig. 12 shows a fourth embodiment of the plug in a view according to the
  • Fig. 15 shows a fifth embodiment of the plug in a view according to the
  • Fig. 17 shows a sixth embodiment of the plug in a view according to the
  • FIG. 19 shows a seventh embodiment of the plug in a view according to FIG.
  • Arrow XIX in Fig. 20, 20 shows the plug in a sectional view along the line XX-XX in Fig. 19,
  • FIG. 21 the container according to FIG. 1 in a sectional view according to the line XXI-XXI in FIG. 22, FIG. 22 the container in a view according to the arrow XXII in FIG. 21.
  • Figures 1 and 2 illustrate the upper end of a container 18 and a first embodiment of a plug 1 for use in a freeze-drying process, the plug being inserted into an opening 23 of the container 18 formed in the area of a container neck 19.
  • FIGS. 1 and 2 the container is cut in each case and the plug is shown in each case uncut.
  • Fig. 1 an arrangement of the container 18 and the plug 1 is shown, in which an insertion section 2 of the plug 1 is partially inserted into the neck 19 of the container 18. This position of the plug 1 corresponds to a drying position of the plug. 1
  • Fig. 2 shows an arrangement of the container 18 and the plug 1, in which the insertion section 2 of the plug 1 is fully inserted into the container neck 19 of the container 18 and in an axial direction Z of the plug 1 to the insertion section 2 adjacent cover portion 10th of the plug 1 rests against an outer surface 20 of the container neck 19. This position of the plug 1 corresponds to a sealing position of the plug. 1
  • the insertion section 2 has a side surface 3 and a bottom surface 4, wherein the bottom surface 4 of a formed in the region of the cover 10 top surface 5 of the plug 1 in the axial direction Z of the plug 1 is formed opposite.
  • the insertion section 2 has a sealing portion 1 6 for fluid-tight sealing of the container 18 relative to an environment of the container 18 in the sealing position the stopper 1 and an abutting axially from the top surface 5 in the direction of the bottom surface 4 to the sealing portion 1 6 abutment portion 17 for holding the plug 1 in the drying position of the plug 1 during freeze-drying, wherein the abutment portion 17 has four passage openings 6, wherein the Passage openings 6 are identical and each formed in the form of a recess 6.
  • the respective recess 6 extends from the side surface 3 in the bottom surface 4 and allows in the drying position of the plug, thus in a state in which the insertion section 2 of the plug 1 is only partially inserted into the container 18, a gas exchange between an interior 22nd the container 18 and the environment.
  • This state is shown in FIG. 1, wherein the abutment portion 17 of the plug 1 is partially formed outside the container neck 19, wherein the portion of the abutment portion 17 located outside the container 18 has a portion of the respective one open in a radial direction X, Y Passage opening 6 and in this way a gas exchange between the container interior 22 and the environment is possible. Consequently, in the drying position of the plug 1 shown in FIG. 1, a freeze-drying of a solution stored in the container 18 is possible.
  • the insertion section 2 has a substantially circular cylindrical outer contour, wherein the abutment portion 17 is free from respect to the sealing portion 1 6 in the radial direction X, Y protruding areas.
  • the stopper 1 has a sealing section 1 6 adjoining the contact section 17 in the direction of the cover surface 5, the sealing section 16 being circumferentially inserted on the inner surface 21 of the container neck 19 in a state in which the insertion section 2 is completely inserted into the container 18 rests and thus sealing the container 18 sealing.
  • the plug 1 has a sealing body 7 and a main body 8, wherein outer surfaces of the sealing body 7 in the region of the sealing portion 1 6 and the contact portion 17, the side surface 3 of the insertion section 2 and the bottom surface. 4 of the insertion section 2.
  • the sealing body 8 is substantially pot-shaped.
  • the main body 8 is formed in the region of the insertion section 2 within the sealing body 7, whereby only the sealing body 7 comes into contact with the inner surface 21 of the container 18 and the interior of the container 18.
  • the sealing body 7 and the base body 8 are materially connected to each other. Due to the cohesive connection of the sealing body 7 and the base body 8 are permanently connected to each other, so that the plug 1 is formed quasi one piece.
  • the cohesive connection is preferably produced by a multi-component injection molding process, in particular a two-component injection molding process.
  • the main body 8 and the sealing body 7 are made of different materials, wherein the base body 8 consists of a material which has a higher hardness than a material of which the sealing body 7 consists.
  • the sealing body 7 has in the region of the sealing portion 1 6 an annular cross section, wherein an outer radius R of the annulus is approximately twice an inner radius r of the annulus.
  • the sealing body 7 and the main body 8 are partially formed in the cover portion 10, wherein an outer surface of the base body 8 forms the top surface 5 and the top surface 5, the sealing body 7 in the axial direction Z covers.
  • the cover portion 10 has a radial dimension which is greater than a radial dimension of the insertion section 2.
  • a bearing surface 11 of the cover section 10 facing away from the cover surface 5 abuts the outer surface 20 of the container 18.
  • This support surface 1 1 of the cover 10 is formed by an outer surface of the sealing body 7.
  • Both the main body 8 and the sealing body 7 of the plug 1 are formed radially symmetrical to an axis of symmetry 18 of the plug 1 extending in the axial direction Z.
  • the main body 8 is formed substantially circular cylindrical both in the region of the insertion section 2 and in the region of the cover section 10, wherein the base body 8 in the region of the cover 10 has a larger diameter than in the region of the insertion section 2.
  • the main body 8 has the Further, in the region of the cover section 10, a circumferential first projection 12 formed in the radial direction X, Y. This first projection 12 may, for example, serve to hold the plug 1 in an additional closure attachable to the container 18.
  • the base body 8 in the second embodiment of the plug 1 shown in FIGS. 8 to 11 covers the sealing body 7 in the region of the cover section 10 radially outside partially.
  • the base body 8 in the region of the cover 10 has a radially outwardly extending, extending from the top surface 5 in the direction of the bottom surface 4 second projection 13, wherein the second projection 13, the sealing body 7 in the region of the cover 10 radially outward partially covering.
  • the third embodiment of the plug 1 shown in FIGS. 10 and 1 1 differs from the embodiment shown in FIGS. 8 and 9 essentially in that the plug 1 in the form of a blocking body 9 formed between the base body 8 and the sealing body 7 a barrier layer 9, in order to improve the blocking effect of the plug 1, for example against oxygen diffusion.
  • the barrier layer 9 and / or the blocking body 9 may for example consist of ethylene-vinyl alcohol copolymer (EVOH) or aluminum.
  • the locking body 9 and / or the barrier layer 9 is materially connected to the base body 8 and / or materially connected to the sealing body 7.
  • a plug 1 can be produced, for example, by means of a three-component injection molding process. But it is also quite conceivable that the blocking body 9 and / or the barrier layer 9 between the base body 8 and the sealing body 7 is clamped or positively held.
  • the fourth exemplary embodiment of the stopper 1 illustrated in FIGS. 12 to 14 differs from the first exemplary embodiment essentially in that the base body 8 has a central through-passage 15 extending from the top surface 5 in the direction of the bottom surface 4, wherein a formed from the bottom surface 4 in the direction of the top surface 5 extending portion 14 of the sealing body 7 in the passage 15, whereby the base 8 encloses this subregion 14 of the sealing body 7 radially.
  • the passageway 15 allows removal of the contents of the container without removal of the plug 1 from the container 18, for example, by inserting a needle into the passage 15 and the sealing body 7 is pierced in the insertion of the needle.
  • such an embodiment of the plug 1 is particularly simple and inexpensive to produce by first the main body 8, for example by means of an injection molding process is prepared and then the sealing body 7 is molded onto the base body 8, wherein the injection molding of the sealing body 7 through the passage 15 of the main body 8 takes place. Due to the centrally formed passage 15 and thus the central gating of the sealing body 7 to the main body 8 also shape tolerances of the plug 1 are reduced.
  • the fifth embodiment of the stopper 1 shown in FIGS. 15 and 16 differs from the first embodiment essentially in that the base body 8 has an outer surface, wherein a portion of this outer surface in the axial direction Z of the stopper 1 is not penetrated by the sealing body 7 is covered.
  • this outer surface of the main body 8 forms a portion of the bottom surface 4, wherein the corresponding outer surface of the sealing body 7, which also forms a portion of the bottom surface 4, in the axial direction Z is flush with this outer surface of the base body 8.
  • the top surface 5 is formed in contrast to the first embodiment of the plug 1 by the sealing body 7.
  • the sixth embodiment of the plug 1 shown in FIGS. 17 and 18 differs from the first embodiment essentially in that the base body 8 has an outer surface, wherein a portion of this outer surface in the axial direction Z of the plug 1 not by the Sealing body 7 is covered.
  • this outer surface of the base body 8 forms a portion of the top surface 5, wherein the corresponding outer surface of the sealing body 7, which also forms a portion of the top surface 5, in the axial direction Z is flush with this outer surface of the base body 8.
  • the seventh embodiment of the plug 1 shown in FIGS. 19 and 20 differs from the fifth embodiment essentially in that the side surface 3 of the insertion section 2 is not formed exclusively by outer surfaces of the sealing body 7, but only the areas of the side surface 3 of the insertion section 2, which contact the inner surface 21 of the container wall 24 in the drying position and / or the sealing position, are formed by outer surfaces of the sealing body 7. Accordingly, in the drying position and / or the sealing position in the region of the insertion section 2, only outer surfaces of the softer sealing body 7 come into contact with inner surfaces 21 of the container wall 24. Subregions of the side surface 3 of the insertion section 2, in the present case a partial region of the side surface 3 bounding the respective recess 6, are formed by outer surfaces of the base body 8.
  • FIGS. 21 and 22 show the container 18 without plug 1.
  • the exemplary embodiments of the plug 1 illustrated in the figures have a conical outer contour in a region of the contact section 17 which has the bottom surface 4.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Ceramic Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Closures For Containers (AREA)

Abstract

L'invention concerne un bouchon (1) pour un récipient (18) destiné à être utilisé lors de la cryodessiccation, également appelée lyophilisation. L'invention concerne en outre un arrangement d'un bouchon (1) et d'un récipient (18). Le bouchon (1) possède une portion d'introduction (2) qui peut être introduite dans le récipient (18). La portion d'introduction (2) possède une portion d'étanchéité (16) servant à fermer le récipient (18) de manière étanche aux fluides par rapport à un environnement du récipient (18) dans une position d'étanchéité du bouchon (1) et une portion d'appui (17), limitrophe de la portion d'étanchéité (16) dans le sens axial depuis une surface de recouvrement (5) en direction d'une surface de fond (4), destinée à maintenir le bouchon (1) dans une position de séchage du bouchon (1) pendant la cryodessiccation. La portion d'appui (17) possède au moins une ouverture de passage (6) pour un échange gazeux entre un espace intérieur (22) du récipient (18) et l'environnement du récipient (18) pendant la cryodessiccation. Le bouchon (1) possède en outre un corps d'étanchéité (7) et un corps de base (8) qui sont reliés l'un à l'autre. Le corps de base (8) se compose d'un matériau qui présente une dureté supérieure à celle d'un matériau duquel se compose le corps d'étanchéité (7). Des zones d'une surface latérale (3) de la portion d'introduction (2) qui, dans la position de séchage et/ou la position d'étanchéité, entrent en contact avec une surface intérieure (21) d'une paroi de récipient (24), sont formées dans la zone de la portion d'appui (17) par des surfaces extérieures du corps d'étanchéité (7). Dans la zone de la portion d'appui (17), le corps de base (8) est formé à l'intérieur du corps d'étanchéité (7).
EP17769107.8A 2016-12-06 2017-09-26 Bouchon de récipient destiné à être utilisé lors de la lyophilisation Active EP3384219B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16202437.6A EP3333523B1 (fr) 2016-12-06 2016-12-06 Bouchon de récipient destiné à être utilisé lors de la lyophilisation
PCT/EP2017/074314 WO2018103906A1 (fr) 2016-12-06 2017-09-26 Bouchon pour un récipient destiné à être utilisé lors de la cryodessiccation et arrangement d'un bouchon et d'un récipient

Publications (2)

Publication Number Publication Date
EP3384219A1 true EP3384219A1 (fr) 2018-10-10
EP3384219B1 EP3384219B1 (fr) 2020-11-18

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EP16202437.6A Active EP3333523B1 (fr) 2016-12-06 2016-12-06 Bouchon de récipient destiné à être utilisé lors de la lyophilisation
EP17769107.8A Active EP3384219B1 (fr) 2016-12-06 2017-09-26 Bouchon de récipient destiné à être utilisé lors de la lyophilisation

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP16202437.6A Active EP3333523B1 (fr) 2016-12-06 2016-12-06 Bouchon de récipient destiné à être utilisé lors de la lyophilisation

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US (1) US11434050B2 (fr)
EP (2) EP3333523B1 (fr)
WO (1) WO2018103906A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3333523B1 (fr) 2016-12-06 2019-09-04 KISIKO Kirchner, Simon & Co. GmbH Bouchon de récipient destiné à être utilisé lors de la lyophilisation
US11345505B2 (en) * 2020-08-19 2022-05-31 Innovative Distilling Technologies, Inc. Capped barrel system and methods
US11957790B1 (en) 2022-01-31 2024-04-16 Thomas John Harkins, JR. Combination lyophilization and dispensing syringe assembly and methods of using same
US20240083645A1 (en) * 2023-08-02 2024-03-14 Huacheng Li Container sealing plug and container

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Publication number Priority date Publication date Assignee Title
US2889951A (en) * 1954-10-22 1959-06-09 Bunder Glas G M B H Bottle closures
US2820564A (en) * 1956-06-11 1958-01-21 Coty Inc Bottle neck stoppers
US2927709A (en) * 1959-07-07 1960-03-08 Faultless Rubber Co Bottle stopple
US3292342A (en) * 1964-01-16 1966-12-20 Copiague Res And Dev Company Device for vacuum sealing
FR1479255A (fr) * 1965-11-25 1967-05-05 Bouchon pour récipients tels que flacons ou analogues
DE1942347A1 (de) 1969-08-20 1971-03-04 Wimmer Pharma Gummi Gmbh Stopfen fuer Flaschen,bei denen eine Gefriertrocknung vorgenommen wird
US4040421A (en) * 1975-04-04 1977-08-09 Becton, Dickinson And Company Hypodermic syringe and attached needle assembly
US4306357A (en) * 1978-06-05 1981-12-22 Merck & Co., Inc. Tamperproof container
DE3736343C2 (de) * 1987-10-27 1996-07-18 Wasserburger Arzneimittelwerk Injektionsspritze
CA2006584C (fr) * 1988-12-27 1998-11-10 Gabriel Meyer Flacon de stockage et de transfert pour stocker un composant d'une substance medicamenteuse
US5377854A (en) * 1993-04-16 1995-01-03 International Technidyne Corp. Stopper apparatus for a test tube or similar article
US5596814A (en) * 1995-11-06 1997-01-28 W. L. Gore & Associates, Inc. Vented vial stopper for processing freeze-dried products
US5689895A (en) * 1996-10-31 1997-11-25 S.P. Industries, Inc., The Virtis Division Probe positioning device for a flask freeze drying
JPH1147234A (ja) * 1997-07-29 1999-02-23 Naniwa Rubber Kogyo Kk 医療用ゴム栓
DE202011050413U1 (de) 2011-06-10 2012-09-11 Helvoet Pharma Belgium N.V. Kolbenstopfen für eine Lyophilisations-Einheit
US9199768B1 (en) * 2015-02-11 2015-12-01 Ryan M. Casey Two-piece stopper
EP3333523B1 (fr) 2016-12-06 2019-09-04 KISIKO Kirchner, Simon & Co. GmbH Bouchon de récipient destiné à être utilisé lors de la lyophilisation

Also Published As

Publication number Publication date
US20190389630A1 (en) 2019-12-26
EP3333523A1 (fr) 2018-06-13
WO2018103906A1 (fr) 2018-06-14
EP3333523B1 (fr) 2019-09-04
EP3384219B1 (fr) 2020-11-18
US11434050B2 (en) 2022-09-06

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