WO2018020505A1 - Procédé de fermeture de flacons, structure de support pour supporter des éléments de fermeture de flacon et contenant de transport ou d'emballage - Google Patents

Procédé de fermeture de flacons, structure de support pour supporter des éléments de fermeture de flacon et contenant de transport ou d'emballage Download PDF

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Publication number
WO2018020505A1
WO2018020505A1 PCT/IN2016/000196 IN2016000196W WO2018020505A1 WO 2018020505 A1 WO2018020505 A1 WO 2018020505A1 IN 2016000196 W IN2016000196 W IN 2016000196W WO 2018020505 A1 WO2018020505 A1 WO 2018020505A1
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WO
WIPO (PCT)
Prior art keywords
vials
stopper members
supporting
supporting structure
receptacles
Prior art date
Application number
PCT/IN2016/000196
Other languages
English (en)
Inventor
Anil Narayan Narvekar
Pratul Prakash Potdar
Original Assignee
Schott Kaisha Pvt. Ltd.
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 Schott Kaisha Pvt. Ltd. filed Critical Schott Kaisha Pvt. Ltd.
Priority to PCT/IN2016/000196 priority Critical patent/WO2018020505A1/fr
Publication of WO2018020505A1 publication Critical patent/WO2018020505A1/fr

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2821—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers applying plugs or threadless stoppers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/008—Racks for supporting syringes or needles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2842—Securing closures on containers
    • B65B7/285—Securing closures on containers by deformation of the closure

Definitions

  • the present invention relates in general to the processing of a batch of vials for use in pharmaceutical, medical or cosmetic applications and relates in particular to a supporting structure (also named nest) provided for holding stopper members, such as elastic plugs or plunger stopper members, at predermined positions, for use in a process for closing or stoppering such vials. Further aspects of the present invention relate to a nest and tub assembly accommodating at least one supporting structure supporting a plurality of such stopper members, which can be directly fed on existing filling and stoppering machine set-ups for simultaneously processing a plurality of vials. Further aspects of the present invention relate to a stoppering process and to an integrated filling and stoppering process for processing a plurality of vials.
  • vials are closed by feeding stopper members, such as elastic plugs or plunger stopper members, individually to a closing machine and closing the vials individually, as disclosed e.g. in US 2014/0069062 Al .
  • stopper members such as elastic plugs or plunger stopper members
  • the stopper members are singulated using vibratory bowls and transported using vibratory chutes. The vibratory bowl and chutes contact the stopper members, the surfaces of which will eventually be in direct contact with the product inside the vial.
  • it is generally considered necessary to steam sterilize the vibratory bowls and chutes.
  • US 2012/0248057 Al discloses a capping system method for sealing pharmaceutical vials.
  • a plurality of vials are disposed upright in a tub, which also accommodates a respective stopper member assembly for each vial comprising a preassembled elastomeric stopper and a retainer member,
  • Each stopper member is placed on the neck of its associated vial so that a portion of the stopper partially closes the opening of the vial, Thereafter a force is applied to each of the stopper member assemblies to cause the retainer members to snap-fit on the flanged neck of their associated vial so that portions of their associated stopper seal the opening in their associated vial.
  • This approach makes it easier to seal the vials under aseptic conditions.
  • the outer periphery of the upper tray for stopper members includes a generally V-shaped projection which is arranged to be disposed on a ledge of the sidewall of the bottom tray for vials so that each vial has a respective closure assembly disposed above and axially aligned with it.
  • WO 2015/023924 A2 A process for filling pharmaceutical containers that uses a similar capping system is disclosed in WO 2015/023924 A2.
  • the process uses nests that are configured to allow multiple stopper members and containers to be simultaneously aligned concentrically, and closed simultaneously.
  • Spring-loaded retaining structures on the stopper member nest allow it to releasably retain multiple stopper members above the corresponding multiple containers.
  • the retaining structures used are, however, still complicated and it is not easy to use this approach in the existing machinery of pharmaceutical fillers.
  • WO 2013/181552 A2 discloses another vial storage and transportation assembly, including a vial tray, a transport lid and a processing lid.
  • the transport lid and the processing lid are interchangeably engageable with the vial tray to house a plurality of vials therein, to shift the assembly between a transport configuration and a processing configuration, SUMMARY OF INVENTION
  • a stoppering process or an integrated filling and stoppering process for processing a plurality of vials using a supporting structure for holding a plurality of stopper members there is provided a supporting structure for holding a plurality of stopper members.
  • a supporting structure for holding a plurality of stopper members such as elastic plugs, at precisely defined positions, for use in the process for closing or stoppering vials.
  • a transport or packaging container accommodating at least one nest for stopper members configured so that the nest accommodating the stopper members can be directly fed on existing filling and stoppering machine set-ups for processing vials.
  • a supporting structure for stopper members according to the present invention for use in the stoppering process or an integrated filling and stoppering process, is configured for releasably supporting a plurality of stopper members for closing vials for use in pharmaceutical, medical or cosmetic applications, wherein the stopper members consist of a resilient material and comprise a disk-like cap portion from which a plug projects.
  • the supporting structure for stopper members comprises a planar supporting plate having a plurality of tubular receptacles for accommodating the stopper members at least partially, for concurrently supporting a plurality of stopper members at the supporting plate at precisely defined positions.
  • the receptacles are formed by circumferential side walls disposed in a regular arrangement at the supporting plate and protruding from the supporting plate, wherein the receptacles are configured for accommodating the stopper members at least partially.
  • the receptacles comprise retaining structures for releasably engaging with the disk-like cap portions of the stopper members for retaining the stopper members in the receptacles.
  • the supporting structure for stopper members allows to releasably hold a plurality of stopper members exactly in the same two-dimensional arrangement as a supporting structure used for supporting a plurality of vials, i,e. the same total number of vials.
  • the present invention enables using the existing tub and nest format widely used in the market with existing as well as new filling and stoppering machines. Furthermore, the supporting structure according to the present invention can be used to efficiently store and supply a plurality of stopper members in a predetermined geometrical arrangement under sterile conditions, using the tub and nest format widely used in the market.
  • the receptacles may accommodate the stopper members fully or only partially, depending on the circumstances of the further processing of the stopper members and vials.
  • the supporting plate is preferably made of a plastic material, e,g, by plastic injection molding, and offers sufficient strength, stiffness and mechanical stability, although these requirements are usually easy to fulfill, because the stopper members to be accommodated are light-weight and only small forces are usually exerted on the supporting plate during further processing,
  • the stopper members may be accommodated in the receptacles solely by friction.
  • the stopper members are made of or comprise an elastic (resilient) material
  • inserting the stopper members into the receptacles might involve imposing a slight elastic deformation of the stopper members so that the stopper members abut resiliently against the circumferential side walls of the receptacles.
  • the stopper members are light-weight, a reliably accommodation of the stopper members would usually require only a small degree of deformation of the stopper members, which corresponds to small forces required only for inserting or removing the stopper members into and out of the receptacles.
  • the side walls of the receptacles are preferably straight side- walls defining cylindrical receptacles that are not tapered.
  • the receptacles comprise retaining structures that releasably engage with the stopper members for retaining the stopper members in the receptacles.
  • the retaining structures engage with the stopper members in a form-fitting manner.
  • This form- fitting engagement may be implemented at the upper and bottom ends of the stopper members, or at any other suitable positions, such as at the bottom ends and at central portions of the stopper members.
  • the retaining structure may slightly protrude into the interior of the receptacles or may be formed as a recess or groove to retain the stopper members.
  • the protrusions are formed on the inner sides of the circumferential side walls of the receptacles, which may be easily accomplished by integrally forming protrusions or recesses or grooves with the side-walls of the receptacles, e.g. by plastic injection molding,
  • the protrusions may be configured to mate to the outer contour of the stopper members.
  • the protrusions may be formed at equal angular distances along the inner sides of the circumferential side walls of the receptacles, e.g. as small spotlike protrusions. According to an alternative embodiment, however, the protrusions may also be formed as circumferential protrusions on the inner sides of the circumferential side walls of the receptacles. According to a further embodiment upper ends of the receptacles comprise are chamfered, to thereby form a slanted insertion portion facilitating insertion of the stopper members from above the supporting plate into the receptacles thereof.
  • a transport or packaging container for accommodating a plurality of stopper members for closing vials for use in pharmaceutical, medical or cosmetic applications
  • the transport or packaging container is box-shaped and comprises: a bottom, which is closed or sealed by a seal, upstanding lower side-walls extending essentially perpendicularly from said bottom, a circumferential supporting step extending horizontally from said lower side-walls, and upper side-walls extending upward from said supporting step, wherein a circumferential flange is formed at upper ends of the upper side-walls.
  • at least one supporting structure for stopper members as disclosed in the present application is accommodated in the transport or packaging container, wherein the plurality of stopper members are accommodated in the receptacles of the at least one supporting structure for stopper members.
  • the transport or packaging container for stopper members enables the storage and transport of a plurality of stopper members in exactly the same format as the existing tub and nest format widely used in the market for the storage and transport of vials so that it may be used easily with existing as well as new filling and stoppering machines without the necessity of changing the whole setup thereof.
  • the edge of the bottommost planar supporting plate of the supporting structure for stopper members accommodated in the transport or packaging container may be supported directly on the circumferential supporting step or the transport or packaging container.
  • a plurality of supporting structures for stopper members may be accommodated together inside the transport or packaging container stacked one above the other.
  • spacers might be provided on the bottom sides of the supporting plates, for preventing a direct contact of the receptacles (or of the stopper members accommodated in these receptacles) with an underneath supporting stracture or the bottom of the transport or packaging container.
  • this is usually not required, because usually the bottom ends of the receptacles of an upper stopper member nest may rest directly on the top surface of another stopper member nest, because the outer diameter of the receptacles is larger than the inner diameter of the receptacles, so that the receptacles of the upper stopper member nest cannot enter the receptacles of another stopper member nest.
  • it might be of advantage if the upper ends of the stopper members are fully accommodated in the receptacles and disposed at a certain minimum distance to the upper ends of the receptacles.
  • the transport or packaging container is closed or sealed by a protective foil against the environment, the protective foil being bonded to the circumferential flange.
  • the protective foil may be impermeable to gas, thus implementing completely sterile conditions during storage and transport of the stopper members.
  • the protective foil may be a gas-permeable plastic film enabling a sterilization of the interior of the transport or packaging container through the protective foil by a flow of a sterilization gas, such as ethylene oxide.
  • a sterilization gas such as ethylene oxide.
  • the protective foil may be made of a web of synthetic fibers such as polypropylene fibers (PP) or a Tyvek® protective film for this purpose.
  • a method for closing a plurality of vials for use in pharmaceutical, medical or cosmetic applications said vials having a filling opening at an upper end thereof, said method comprising: providing a supporting structure for stopper members as disclosed in the present application accommodating a plurality of stopper members in the receptacles in a regular arrangement, at precisely defined positions; providing a supporting structure for vials comprising a supporting plate having a plurality of openings or receptacles disposed in the same regular arrangement as in the supporting structure for stopper members and a plurality of supporting devices for supporting the vials on the supporting plate as the vials are inserted into the openings or receptacles; disposing the supporting structure for stopper members above the supporting structure for vials, preferably in an environment with reduced pressure, so that the receptacles of the supporting structure for stopper members are aligned with the receptacles of the supporting structure for vials; and pushing the stopper
  • the nest accommodating the stopper members can be directly fed on existing filling and stoppering machine set-ups for processing presterilized vials.
  • the method according to the present invention can be implemented easily for vials of different lengths, because this requires just an adjustment of the distance between the supporting structure for stopper members and the supporting structure for vials, which can be accomplished by a simple vertical adjustment of either supporting structure, which does not change the exact alignment of the receptacles of both supporting structures.
  • the supporting structure for vials is held by a bottom holding frame, whereas the supporting structure for stopper members is held by an upper holding frame, wherein the bottom holding frame and the upper holding frame are disposed at a fixed spacing and aligned with each other by alignment devices.
  • one of the holding frames may be provided with alignment devices, such as protrusions, rods or the like, that cooperate with corresponding alignment devices, such as holes or recesses, provided on the other holding frame.
  • alignment devices such as protrusions, rods or the like
  • corresponding alignment devices such as holes or recesses
  • the intermediate supporting surface can be used to adjust the distance between the upper ends of the vials and the bottom ends of the receptacles of the supporting structure for stopper members, but may also serve to transfer forces exerted onto the vials during the stoppering process by pushing down the stopper members into the filling openings of the vials onto the intermediate supporting surface rather than onto the supporting devices of the supporting plate of the supporting structure for vials.
  • the vials may be supported directly on the supporting surface rather than on the supporting devices of the supporting plate of the supporting structure for vials such that the upper ends of the vials are released by the supporting devices in an elevated processing position during the stoppering process.
  • This offers a high degree of freedom when selecting the specific type of supporting structure for supporting the vials on the supporting plate.
  • the supporting devices are holding tabs formed at upper ends of resilient holding arms, wherein the holding tabs are matched to the vials such that the vials rest loosely on upper sides of the holding tabs with widened upper rims formed at upper ends of the vials, or wherein the holding tabs embrace the widened upper rims formed at upper ends of the vials, preferably so that the via!s are held by the holding tabs with a radial clearance or with radial and axial clearance.
  • Various different types of supporting types may be used as well for this purpose.
  • the upper holding frame may be disposed at such a distance to the bottom holding frame that the upper ends of the vials are in direct contact with or at a small distance to bottom ends of the tubular receptacles of the supporting structure for stopper members so that the stopper members may be directly guided into the open upper ends of the vials if pushed down out of the receptacles of the supporting structure for stopper members.
  • this configuration during processing helps to further minimize the risk of dust and pollutants entering the interior of the vials via the filling openings at upper ends thereof.
  • the supporting structures for stopper members and/or the supporting structures for vials may be supplied under sterile conditions, e,g. to a pharmaceutical filler, in transport and packaging containers as outlined in the following in more detail.
  • the method according to the present invention may involve additional processing steps, particularly a step of filling the plurality of vials with a pharmaceutical, medical or cosmetic product, which can be performed in any suitable sequence, particularly row-wise or simultaneously for all vials supported by a supporting structure.
  • this step of filling the plurality of vials with the pharmaceutical, medical or cosmetic product may be performed while the supporting structure for vials is held in the same bottom holding frame used during stoppering.
  • the vials after closing the vials with the stopper members in a gas-tight manner, the vials may be protected further against the intrusion of contaminants into the vial, for example by crimping a metal protective foil, as is known from the prior art. This crimping process may be performed while the vials are accommodated in the openings or receptacles of the supporting plate of the supporting structure for vials.
  • Figs, 1a - lc show details of a supporting structure for stopper members for vials according to a first embodiment of the present invention
  • Figs. 1d - 1f show the accommodation of stopper members in the receptacles of a supporting structure for stopper members for vials according to a further embodiment of the present invention
  • Figs, 1g - lh show perspective exploded views of a supporting structure for stopper members for vials with stopper members according to two preferred embodiments of the present invention
  • Fig. 1i shows a perspective top view of a supporting structure for stopper members for vials with stopper members being accommodated in receptacles thereof;
  • Figs. 2a - 2d show a transport or packaging container together with the supporting structure of Fig. la (tub and nest assembly for stopper members) for accommodating a plurality of stopper members for vials, at various stages of providing the transport or packaging container for stopper members;
  • Fig. 3a is a perspective view of a vial and of a stoppering member before performing the stoppering process
  • Fig. 3b is a perspective view of a vial sealed by a stoppering member after performing the stoppering process according to the present invention
  • Fig. 4a is a perspective top view of a supporting structure for vials for use in a method according to the present invention
  • Fig. 4b is a top view of the supporting structure of Fig. 4a;
  • Fig. 4c is a bottom view of the supporting structure of Fig. 4a
  • Fig. 4d is an exploded perspective view of the supporting structure of Fig. 4a together with vials to be supported;
  • Fig. 4e is a perspective top view of the supporting structure of Fig. 4a showing how the vials are supported;
  • Fig. 4f is perspective top view of a tub and nest assembly for vials, in which the supporting structure of Fig. 4a is accommodated, with a sealing lid removed;
  • Fig. 4g is an exploded perspective view of the tub and nest assembly for vials of
  • Fig. 4h is a sectional view of the supporting structure of Fig. 4e showing how the vials are supported inside the receptacles of the supporting structure for vials;
  • Fig. 5 shows a method according to the present invention for simultaneously closing (stoppering) a plurality of vials in a schematic sectional side view
  • Fig, 6 is a schematic top view of a processing station for processing and sealing vials using the supporting structure for stopper members according to the present invention in a filling process;
  • Fig. 7 is a perspective top view showing the supporting structure for vials with sealed vials after processing in a process according to the present invention as shown in Fig, 5.
  • a supporting structure in the following nest for vials or vial nest) in the sense of the present invention is used for concurrently supporting a plurality of vials, preferably of pre-sterilized vials or sealed vials, for use in pharmaceutical, medical or cosmetic applications,
  • vials including pen vials, by-pass vials and dental vials, are a commonly-used packaging solution for drug delivery systems, e.g. insulin administration, pen systems, pump systems, auto- injectors and needle free injectors.
  • drug delivery systems e.g. insulin administration, pen systems, pump systems, auto- injectors and needle free injectors.
  • personalized designs are available on the market.
  • Vials available on the market may be made of glass material, particularly of Fiolax® glass from SCHOTT AG, or of plastic material and offer fixed volumes for drug delivery of e.g. 1.0 ml, 1.5 ml and 3.0 ml, Different volumes usually correspond to different axial lengths of the vials.
  • An example of such medication containers embodied as vials is schematically shown in Fig. 3a in a perspective view.
  • a cylindrical basic shape having a cylindrical side wall 50 with - within tolerances - constant inner and outer diameters, which project vertically from a flat vial bottom 50a, and is followed by a shoulder portion 51 , which merges in a constricted neck portion 52 of a relatively short axial length near the upper open end of the vial and then merges in an expanded upper rim 53 (so-called rolled edge), which has a larger outer diameter than the associated neck portion 52 and is configured for connection to a closure member 200.
  • the underside of the rolled edge 53 may extend basically in horizontal direction or may be slanted and extend downward under a small acute angle and towards the constricted neck portion 52.
  • the neck portion 52 can be formed with smooth walls and without an external thread or may be provided with an external thread for screwing on a closure member.
  • Such vials are radially symmetric and are made of a transparent or colored glass or of a suitable plastic material by blow molding or plastic injection molding techniques, and in general can be internally coated so that the material of the vial emits minimal impurities to the agent to be received.
  • the stopper 200 generally comprises a disk-like cap portion 201 from which a plug 203 projects, which may be inserted into the filling opening of the vial.
  • the disk-like cap portion 201 is connected with the upper rim 53 of the vial in a gas-tight manner and protected against the intrusion of contaminants into the vial, for example by crimping a metal protective foil (beaded cap or cramp), often made from an aluminum sheet.
  • the cap portion 201 may be formed by a cylindrical side- wall 201a of a predetermined axial length, from which two leg portions 203 project substantially perpendicularly, forming the plug of the stopper 200, wherein a recess 202 is formed between the two leg portions 203 for facilitating piercing of the stopper 200 and enabling venting the interior of the vial via the recess 202 if the stopper 200 is only partially inserted into the filling opening of the vial.
  • a semi-circular radial protrusion 204a can be formed on the outer side of the two leg portions 203 for enhancing the sealing tightness if the stopper 200 is inserted into the filling opening of the vial.
  • FIG. 3b shows the vial with the stopper 200 inserted into the filling opening thereof.
  • Fig, la shows a supporting structure for stopper members (in the following nest for stopper members or stopper nest) in a perspective bottom view, which comprises a planar supporting plate 60 having rounded corners 64 and a plurality of tubular receptacles 61 disposed in a regular arrangement, which extend downward from the bottom side of the planar supporting plate 60.
  • the tubular receptacles 61 are formed by circumferential side-walls 62 protruding from the bottom side of the supporting plate 60.
  • these side-walls 62 are of cylindrical shape for accommodating the stopper members 200, although other shapes, such as elliptic shapes might also be possible.
  • These receptacles 61 are disposed in the same regular two-dimensional arrangement as for the supporting structure for vials set forth below, preferably at equidistant spacing.
  • Fig. lb shows the supporting structure for stopper members in a perspective top view
  • Fig. lc shows how the stopper members 200, such as elastic plugs, are accommodated in the receptacles 61 of the stopper nest 2.
  • the stopper members 200 are inserted from above or below into the receptacles 61 to a desired extent, preferably until they are fully accommodated in the receptacles 61 and the bottom ends of the stopper members 200 are substantially flush with the bottom ends of the side- walls 62 of the receptacles 61 as defined by the retaining structures inside the receptacles 61, which will be explained in more detail hereinafter.
  • the receptacles 61 are of cylindrical shape, wherein the upper rim 65 may be chamfered to ease insertion of the stopper members 200 into the receptacles from above the supporting plate 60. Below the chamfered upper rim 65 the side-walls of the receptacle 61 may extend perpendicularly to the top surface of the supporting plate 60 to form a cylindrical insertion portion 66, which may have the same diameter as the receptacles 61 at their bottoms ends. As shown in Fig.
  • a radial protrusion 67 preferably a circumferential radial protrusion 67, is formed below the insertion portion 66, which forms a constriction having a smaller inner diameter than the inner diameter of the receptacle 61.
  • the radial protrusion is followed by a circumferential groove or recess 68 formed on the inner side of the side-walls 62.
  • the axial length of the groove 68 corresponds to the axial length of the cap portion 201 of the stopper member 200 to be accommodated.
  • the receptacles 61 comprise retaining structures 67, 68 for j-eleasably engaging with the stopper members 200 for retaining the stopper members 200 in the receptacles 61.
  • the retaining structures correspond to the radial protrusion 67 and to the circumferential groove 68 respectively formed on the inner sides of the circumferential side walls 62 of the receptacles 61 and configured to cooperate with the disk-like cap portions 201 of the stopper members 200 in a form-fitting manner.
  • the axial lengths and/or the inner diameters of the grooves 68 may be equal to or slightly larger than the axial lengths and/or outer diameters of the cap portions of the stopper members
  • stopper members 200 may also be retained loosely, i.e. even with radial and/or axial play, by the two retaining structures 67, 68 or at least with minor friction only.
  • Figs. Id and I f show how further embodiments of stopper members 200 for vials are retained in the stopper nest. As shown in the. enlarged sectional view of Fig.
  • the stopper member 200 may further comprise a circumferential radial protrusion 204a and a circumferential groove 204b formed on the central plug portion 205 of stopper member 200, which is chamfered at a bottom end thereof.
  • the central plug portion may also be formed by two leg portions 203 disposed on diametrically opposite sides, each having a chamfered bottom end 203a, a central recess 202 being formed between the two leg portions 203, e.g. for venting the interior of a vial if the stopper member 200 is only partially inserted into the filling opening of a vial.
  • Additional recesses 201b my also be formed on the upper surface of the stopper member 200, e.g. to render the cap portion 201 more flexible.
  • the central plug portion may also be provided with an additional horizontal venting channel 206 for venting the interior of a vial if the stopper member is only partially inserted into the filling opening of a vial.
  • Figs, 1g to 1h show perspective exploded top views of a supporting structure for stopper members for vials with stopper members according to two different embodiments of the present invention.
  • Fig. 1 i shows a perspective top view of a supporting structure for stopper members for vials with stopper members being accommodated in receptacles thereof. As shown in Fig.
  • a transport or packaging container 3 a (hereinafter also named tub for stopper members) is used as schematically shown in Fig. 2a.
  • the transport or packaging container 3a has basically the same configuration as described below with reference to Fig.
  • the 4f is essentially box-shaped or tub-shaped and has a base 30a, a circumferential side wall 31a protruding essentially in vertical direction therefrom, a supporting step 32a protruding essentially rectangular therefrom, a circumferential upper side wall 33a and an upper rim 34a which is formed as a flange.
  • the corners 35a of the transport or packaging container 3a are suitably formed rounded, particularly near the supporting step 32a.
  • the upper side wall 33a is formed inclined at a small angle of inclination with respect to a vertical to the base 30a in order to ease the insertion of the stopper nest 2.
  • Such a transport or packaging container 3a is preferably formed from a plastics material, particularly by plastic injection molding, and is preferably formed of a clear transparent plastic in order to enable a visual inspection of the nest 2 accommodated in the transport or packaging container 3 a and of the stopper members accommodated in it.
  • the rounded corners 64 of the supporting plate 60 mate to the inner rounded corners 36a of the tub 3a, at least if disposed at the bottom end of the upper side walls 33 a. As shown in Fig.
  • a plurality of stopper nests 2 (in this example five stopper nests 2) can be accommodated inside the same transport or packaging container 3 a stacked one above the other, in the stacked configuration, the lower ends of the side-walls of an upper of two adjacent supporting plates 60 may rest directly on the upper surface of the lower of two adjacent supporting plates 60. If the outer diameter of the receptacles 61 is larger than the inner diameter of the receptacles 61, the side-walls 62 will not penetrate into the insertion portions 66 of the receptacles 61. Thus, no spacers are required between adjacent supporting plates 60, which contributes to optimizing the packing density.
  • spacers may be provided on the upper surface of lower surface of the supporting plates 60 to thereby prevent a direct contact betweeen the bottoms ends of the receptacles of an upper supporting plate 60 and the upper surface of an underneath supporting plate 60 in the stacked configuration.
  • Fig. 2b shows the tub and nest assembly 4a for stopper members with all stopper nests inserted into the tub 3a for stopper members, i.e. in the stacked configuration.
  • the stopper members are omitted in Figs. 2a and 2b.
  • a gap 39a is formed between the edges of the supporting plate 60 and the upper side- walls 33a of tub 3a by spacer webs 38a, which will ease insertion and removal of the stopper nests.
  • Fig, 2 c shows a further stage of sealing the tub and nest assembly 4a of Fig.
  • the protective foil 6a is a gas- permeable plastic film, in particular a web of synthetic fibers such as polypropylene fibers (PP) or a Tyvek® protective film, which enables a sterilization of the interior of the transport or packaging container 4a by a flow of a sterilizing gas through the protective foil 6a.
  • PP polypropylene fibers
  • Tyvek® protective film a gas- permeable plastic film
  • Fig. 2d shows the tub and nest assembly 4a of Fig. 2c sterile sealed against the environment.
  • the stopper members may be stored and transported under sterile conditions.
  • the tub and nest assembly 4a for stopper members may be packaged additionally in at least one gas -impermeable sterile plastic bag (not shown).
  • a supporting structure for vials 1 (in the following nest for vials or vial nest) comprises a planar supporting plate 10 having a plurality of openings or receptacles 11 disposed in a regular arrangement.
  • the receptacles 11 may be formed by cylindrical side- walls 14, which extend downward from the bottom side of the planar supporting plate 11.
  • these side- walls 14 are of cylindrical shape for accommodating the vials, although other shapes, such as polygonal shapes, are also possible.
  • These receptacles 1 1 are disposed in a regular two-dimensional arrangement, at equidistant spacing.
  • FIG. 4h the top view of Fig.
  • virtual connecting lines between the centers of directly adjacent receptacles 1 1 respectively may form a hexagon with a further receptacle 11 disposed at a center of the respective hexagon.
  • the receptacles may also be disposed at equidistant spacing along two mutually orthogonal directions.
  • the inner diameter of the receptacles 1 1 is slightly larger than the outer diameter of the vials to be accommodated.
  • the supporting plate 10 comprises rounded corners 12. Furthermore, extensions 13 extend beyond two opposite edges of the earner plate 10, which may be used as spacer members to ensure a proper spacing between the supporting plate 10 and side-walls of the transport and packaging container if inserted therein.
  • resilient holding arms 17 are associated with respective receptacles 61 in a configuration with a three-fold point symmetry. This results in a symmetrical force distribution when holding the vial by means of the holding arms 17.
  • the holding arms 17 thus result in an advantageous three-point bearing of the vials in the openings or receptacles 1 1 , so that the vials are automatically supported centered with respect to a center line of the respective opening or receptacle 11.
  • Holding tabs 17a which are flag-like are formed at the upper ends of the holding arms 17. These holding tabs 17a are each provided with a holding nose 17b protruding inward in radial direction, as shown in more detail in the cross-section through this holding structure shown in Fig.
  • the holding tabs 17a are connected with the supporting plate 10 via a resilient base 17 protruding perpendicularly from the upper side of the supporting plate 10.
  • a resilient base 17 protruding perpendicularly from the upper side of the supporting plate 10.
  • the holding nose 17b passes over into a slanted insertion surface extending slanted upward, which connects with the upper end of the holding arm 17.
  • the vials can be inserted selectively either from above or from below into the apertures of the supporting plate 10 and taken out again,
  • the vials are inserted from above into the apertures, at first the bottoms or bottom ends of the vials get in contact with the slanted insertion surfaces of the holding tabs 17a. Upon further insertion of the vials the bottom ends or the bottoms of the vials slide downwards along the slanted insertion surfaces and thereby resiliently spread the holding arms 17 increasingly apart or flap or pivot them back. Upon further insertion of the vials finally the cylindrical side walls 50 of the vials (see Fig. 4h) get in contact with the holding noses 17a and slide there along, until eventually the undersides of the expanded upper rims 53 of the vials rest loosely on the holding noses 17b of the holding tabs 71a.
  • the vials can be removed from the apertures of the supporting plate 10 upward with reversed motion sequence and with resilient bending of the holding arms 17.
  • the containers are inserted from below into the apertures, at first the upper ends of the vials get in contact with the curved portions on the bottom side of the holding tabs 17a.
  • the uppers ends of the vials slide upwards along the curved portions and thereby resiliently spread the holding arms 17 increasingly apart or flap or pivot them back.
  • the undersides of the expanded upper rims 53 of the vials slide beyond the holding noses 17b of the holding arms 17 and finally rest loosely on the holding noses 17b.
  • the vials can be removed from the apertures of the supporting plate 10 e.g. upward without resilient bending of the holding arms 17.
  • recesses 20 and/or corresponding protrusions 21 are formed along the side edges of the supporting plate 10.
  • the recesses 20 have a frustro-tri angular shape, if viewed in a top view, and are formed by upright side-walls projecting perpendicularly from the top surface of the supporting plate 10, namely by a central side- wall 20a and two inclined side-walls 20b, which intersect the central side-wall 20a under an acute angle,
  • the inclined side- walls 20b are followed by lateral extensions 20c.
  • the protrusions 21 have a corresponding frustro-triangular shape, if viewed in a top view, and are formed by upright side- walls projecting perpendicularly from the top surface of the supporting plate 10, namely by a central side-wall 21a and two inclined side- walls 21b, which intersect the central side- wall 21a under an acute angle.
  • the inclined side- walls 21b are followed by lateral extensions 21c.
  • the protrusions 21 are disposed along an opposite side edge of the supporting plate 10.
  • stiffening webs 26, 27 may be provided on the bottom side of the supporting plate 10, connecting the side- walls 14 of the receptacles 1 1. More specifically, the stiffening webs 26 extend perpendicular to the long sides of the supporting plate 10, whereas the stiffening webs 27 extend perpendicularly therefrom, Additional stiffening webs may extend under an acute angle, to thereby interconnect the side -walls 14 of the receptacles 1 1.
  • the central portion of the supporting plate 10 including all receptacles 1 1 is enclosed by a circumferential side- wall 25 projecting perpendicularly from the bottom side of supporting plate 10.
  • a circumferential side- wall 25 projecting perpendicularly from the bottom side of supporting plate 10.
  • the short sides of the side- wall 25 are interconnected with each other by undulated stiffening webs 28 projecting perpendicularly from the bottom side of supporting plate 10, for further stiffening the supporting plate 10.
  • such a nest 1 will be made of a plastic material using plastic injection-molding techniques.
  • the supporting plate 10 may still be flexible to a certain extent, if required.
  • Fig. 4d is an exploded perspective view of the supporting structure of Fig, 4a together with vials to be supported.
  • Fig. 4e is a perspective view of the supporting structure of Fig. 4a showing how the vials are supported.
  • Fig. 4h is a sectional view of the supporting structure of Fig. 4e showing how the vials are supported inside the receptacles of the vial nest 1. In the holding position shown in Fig.
  • the bottoms 50a of the vials project beyond the bottom ends of the side- walls 14 of the supporting plate and the circumferential side- wall 25 so that the bottoms 50a are freely accessible from the bottom side of the vial nest 1 for handling or processing while the vials are supported on the vial nest,
  • the upper rims 53 of the vials do not extend beyond the front ends of the holding arms 17, but are slightly displaced downward, In this position the vials can be displaced easily in axial direction upward toward a raised position and without bending of the holding arms 17 by a distance that corresponds basically to the axial length of the neck portion 52 of the vials.
  • the upper ends and the filling openings 53 of the vials are freely accessible for processing, e.g. for performing a filling operation as shown in Fig. 5.
  • a transport or packaging container 3 (hereinafter also named tub for vials) is used as schematically shown in Fig. 4f.
  • the transport or packaging container 3 is essentially box-shaped or tub-shaped and has a base 30, a circumferential side wall 31 protruding essentially in vertical direction therefrom, a supporting step 32 protruding essentially rectangular therefrom, a circumferential upper side wall 33 and an upper rim 34 which is formed as a flange.
  • the corners 35 of the transport or packaging container 3 are suitably formed rounded, particularly near the supporting step 32.
  • the upper side wall 33 is formed inclined at a small angle of inclination with respect to a vertical to the base 30 in order to ease the insertion of the vial nest 1.
  • a transport or packaging container 3 is preferably formed from a plastics material, particularly by plastic injection molding, and is preferably formed of a clear transparent plastic in order to enable a visual inspection of the vial nest 1 accommodated in the transport or packaging container 3 and of the vials 5 supported by it.
  • the nest I can be positioned precisely in the transport or packaging container 3 and thus the plurality of vials 5 can be positioned and held in a regular array and at precisely defined positions in a transport or packaging container 3 with standardized dimensions.
  • it can be ensured in this way that all bottoms or bottom ends of the vials are positioned in a plane defined jointly and in parallel to the base 30 and that all upper ends are positioned in a plane defined jointly and parallel to the upper rim 34 of the transport or packaging container 3.
  • the upper ends of the vials 5 do not extend beyond the upper rim 34 of the transport or packaging container 3 but are spaced apart to the upper rim 34.
  • a packaging unit (also named tub and nest assembly) formed by the transport or packaging container (tub) 3 and the nest 1 with the vials 5 accommodated therein is closed or sealed at least on the upper side by means of a protective foil or packaging foil 6 bonded onto the upper flange-like edge 34 of the tub 3.
  • a protective foil or packaging foil 6 bonded onto the upper flange-like edge 34 of the tub 3.
  • the protective foil 6 may be in particular a gas-permeable plastic film, in particular a web of synthetic fibers such as polypropylene fibers (PP) or a Tyvek® protective film, which enables a sterilization of the vials accommodated therein through the film 6.
  • the bottom side of the transport or packaging container (tub) 3 may also be formed open, e.g. in the manner of the tub 3 shown in Fig. 4g, i.e. in the manner that also the bottom side of the tub is provided with a flange-like bottom rim in the manner of the upper rim 34 so that the bottoms of the vials 5 may be freely accessible for processing steps also from the underside of the tub 3 if required.
  • access apertures 15 are formed on two longitudinal sides of the supporting plate 10, via which gripping arms or the like may grab the vial nest 1.
  • the access apertures 15 are partially surrounded by upright side- walls 16 projecting perpendicularly from the upper side of the supporting plate 10 to prevent a collision of the gripping arms or the like with the vials 5 accommodated.
  • the access apertures 15 are displaced relative to each other, e.g. by one row, which further facilitates an unambiguous positioning of vial nest 1 in tub 3,
  • a packaging unit as shown in Fig. 4g accommodating presterilized prefillable vials can be stored under save and sterile conditions and then supplied to pharmaceutical customers for further processing. Particularly, the pharmaceutical customers will then fill medicine or other liquids into the presterilized nested vials via the filling openings using conventional filling and stoppering machines, which may be any of the three following types of filling and stoppering machines: 1) manual machines, 2) semi automatic machines and 3) fully automatic machines. An example of such a filling operation is shown in Fig. 5 in a schematic cross- sectional view. At the time of delivery under sterile conditions, the packaging unit will be sealed by a lid or protective foil as outlined above (not shown), while the nest 1 will be supported on the supporting step 32 of tub 3.
  • the packaging unit may be packaged further in at least one sterile plastic bag.
  • the vials 5 will be accommodated upside-down in the receptacles of nest 1 so that their filling openings 54 face toward the upper end of tub 3 and the lid or protective foil (not shown).
  • the height level of the upper ends of vials 5 is thus precisely defined in relation to the level of the supporting plate 10, which is essentially equal to the level of supporting step 32 of tub 3, because the supporting plate 10 rests directly on supporting step 32.
  • the exemplary filling process shown in Figs. 5 and 6 considers that the supporting plate 10 rests directly on a rectangular holding frame 40 after removal from tub 3,
  • the inner free width of the holding frame 40 may also allow for a direct support of the outer side of supporting step 32 of tub 3 on the holding frame 40.
  • the height level of the upper ends of vials 5 is precisely defined in relation to the level of the holding frame 40.
  • the holding frame 40 is transferred at a precisely defined height level to a filling station 110 comprising a row of filling nozzles supported by a holding arm used for injecting a liquid, e.g. a medicine, via the filling openings into the vials supported by a vial nest.
  • a liquid e.g. a medicine
  • the height level of the bottom ends of filling nozzles is precisely defined so that a non-zero gap of well defined width ⁇ will be ensured between the upper ends of the vials and the bottom ends of filling nozzles.
  • the width ⁇ of this gap will be precisely adjusted before performing the process and will be part of the general settings of a processing station.
  • the width ⁇ of this gap will be adjusted in accordance with general safety regulations, in particular in accordance with GMP (Good Manufacturing Practice) guidelines requirements.
  • GMP Good Manufacturing Practice
  • vial nest 1 may be used for different types of vials 5 together with the vials 5 accommodated therein and they can be inserted into the packaging unit in the same manner and as the whole packaging unit and can be sealed and transported under sterile conditions to the pharmaceutical customers, according to the present invention it can be ensured that also the different types of vials may be processed under the same settings and conditions without the need of adjusting the general settings of the processing station. Furthermore, no additional hygienic permissions will be required for this purpose. Thus, according to the present invention different types of vials involving different axial lengths may be processed in the same way and under the same general conditions and settings. Thus, the present invention enables a cost-efficient processing of presterilized, sealed vials.
  • replacement of one type of vial nest by a different type of vial nest may be performed for compensating for different outer diameters of batches of different types of vials. More specifically, if a first batch of vials having a first outer diameter and a second batch of vials having a second outer diameter different to the first outer diameter needs to be processed by the same processing station, according to the invention only a first type of vial nest used for the first batch of vials and having receptacles of a diameter corresponding to the first outer diameter needs to be replaced by a second type of vial nest to be used for the second batch of vials and having receptacles of a diameter corresponding to the second outer diameter.
  • the aforementioned principle may also be applied if access to the bottom ends of the vials is required, because also the height level of the bottom ends of all vials accommodated by a vial nest is precisely defined in relation to the height level of the holding frame 40. This even applies if the tub 3 should be supplied to the pharmaceutical customer with an open bottom sealed by a lid or protective foil.
  • a bottom holding frame 80 For supporting and aligning a supporting plate 10 of a vial nest in a predetermined position and orientation, a bottom holding frame 80 is used, which comprises a central opening 84, whose contour corresponds exactly to the outer counter of the circumferential side-wall 25 on the bottom side of the vial nest (see Fig. 4c).
  • the upper ends of the vials 5 are positioned at a precisely defined height level relative to the machine holding frame 70, which may be part of a processing machine for the processing of containers and may be provided in a cleanroom or under sterile conditions, e.g. at a pharmaceutical company or filler.
  • spacer rods 72 are disposed on the machine holding frame 70 for precisely defining the position and orientation of the bottom holding frame 80, alignment tips may be provided at the front ends of the spacer rods 72 that engage with alignment holes formed in the bottom holding frame 80,
  • Fig. 5 further shows how the vial nest is accommodated and positioned in the central opening 84 of the bottom holding frame 80
  • spacer rods 82 are disposed on the upper side of bottom holding frame 80 for precisely defining the position and orientation of an upper holding frame 90 used for positioning and aligning a stopper nest above and relative to the underneath vial nest. Alignment tips may be provided at the front ends of the spacer rods 82 that engage with alignment holes formed in the upper holding frame 90 for proper alignment.
  • a plurality of openings or receptacles 92 formed as through holes are formed in the upper holding frame 90 in exactly the same geometric arrangement as the receptacles of the underneath vial nest. More specifically, the receptacles 92 are formed by side-walls 93 whose inner profile exactly match the outer profile of the side-walls 62 forming the receptacles 61 of the stopper nest. At the bottom ends of side-walls 93 protrusions 94 project radially inward enabling a firm support of the bottom ends of the receptacles 61 of the stopper nest.
  • a central opening may be formed in the upper holding frame 90 so that the outer rim of a supporting plate 60 may rest directly on the upper holding frame 90 while the receptacles 61 extend through the central opening of the upper holding frame 90 in precise alignment with the filling openings of the underneath vials 5.
  • Fig, 5 shows how the supporting plate 60 of a stopper nest is put onto the upper holding frame 90.
  • the supporting plate 60 of the stopper nest is put onto the upper holding frame 90 in such a manner that the bottom ends of the side-walls 62 of the receptacles 61 are in direct contact with or disposed slightly above the upper rims 53 of the vials.
  • the chamfered bottom ends of the side-walls 93 of the upper holding frame 90 substantially enclose the upper rims 53 of the vials 5 to thereby prevent any dust or pollutants from entering the vials 5 via the filling openings. More specifically, as shown in Fig. 5, the bottoms 50a of the vials 5 are directly supported on a supporting plate 76 that is disposed above the machine holding frame 70 at a distance precisely defined by the length of the spacer rods 75.
  • the lengths of the spacer rods 75 may be adjustable in order to lift the vials 5 from a position, in which the upper rims 53 of the vials 5 directly rest on the holding noses 17b of the holding tabs 17a, in axial direction upward toward the raised working position shown in Fig. 5, in which the upper rims 53 of the vials 5 are spaced apart from the holding noses 17b of the holding tabs 17a.
  • the set-up shown in Fig. 5 may be accomplished in a stoppering machine or in a combined filling and stoppering machine, in which case the bottom holding frame 80 could be identical with the holding frame 40 shown in Fig. 6 and the whole set-up will be disposed under reduced pressure or vacuum conditions at least while performing the stoppering process.
  • the lower ends of the cylindrical side- walls 93 of the receptacles 92 of the upper holding frame 90 are beveled inwards so that they can snuggle to the open upper ends of the vials 5, if required. These lower ends may be coated with a resin or plastic to reduce tension in this region.
  • a very narrow gap exists between the upper ends of the vials 5 and the lower ends of the cylindrical side-walls 93 of the receptacles 92 of the upper holding frame 90.
  • the stopper members 200 are pushed downward out of the receptacles 61 of the stopper nest and into the filling openings 54 at the upper ends 53 of the vials 5, while the vials 5 are accommodated in the receptacles 61 of the vial nest.
  • the stopper members 200 are pushed down by means of a plurality of adjustable pushing rods 121 of the stoppering machine 120. This stoppering process may be performed row- wise but can also be performed simultaneously for all stopper members 200 and vials 5 held by the nests.
  • both the supporting plate 10 of the vial nest and the supporting plate 60 of stopper nest are sufficiently stiff to ensure the above precise alignment of the stopper members 200 and vials 5 at all stages of the stoppering process.
  • Fig. 6 shows in a schematic top view an example of a processing apparatus or station for performing a process according to the present invention, as outlined above, under sterile conditions.
  • the processing apparatus 100 has a sterile inner volume 101 with an infeed section at the left-hand side and an outfeed section at the right-hand side thereof.
  • sterile packaging units as outlined above are fed, via the infeed section, into , the sterile inner volume 101.
  • the lids or protective foils of the packaging units are removed so that the tub and nest assemblies accommodating the presterilized vials and presterilized stopper members finally are disposed near the infeed position indicated by reference numeral 102.
  • the tub and nest assemblies are conveyed by a conveyer 106 along the direction of the arrow shown in Fig. 6 until finally reaching the outfeed position indicated by reference numeral 103.
  • the nests are accommodated by holdings frames 40 or similar holding tables or the tubs respectively accommodating a nest are accommodated by holdings frames 40 or similar holding tables.
  • the upper ends of the vials are fed to the processing stations 101 at precisely defined height levels.
  • the infeed and outfeed sections for the vials nests and the stopper member nests might be at different positions and particularly might be disposed at different height levels.
  • Fig. 6 shows the filling and stoppering of the vials accommodated by nests in the holding frames 40.
  • the nests or tub and nest assemblies for vials and for stopper members are first conveyed to the waiting position 104 and then to the filling and stoppering station 110, where the filling and stoppering process is usually performed row-wise, but may also be performed simultaneously for all vials and stopper members, After filling and stoppering the nests holding the filled and stoppered vials or the tub and nest assemblies accommodating the filled and stoppered vials are finally conveyed to the outfeed position indicated by reference numeral 103.
  • Fig. 7 is a perspective view showing the supporting structure for vials 1 with sealed vials 5 after processing in a process according to the present invention as shown in Fig. 5.
  • the upper rims of the stoppered vials 5 rest again directly on the holding noses 17b of the holding noses 17a (see Fig. 4h).
  • the direct support of the vials 5 on a stable supporting surface 76 ensures that both the precise centering and the height levels of the vials 5 will be maintained.
  • the above procedure may equally be performed for pre gassing or post gassing the vials.
  • gaps or flow channels may be provided to further support a proper gas flow for pre gassing or post gassing of the vials when the nest is accommodated in a tub, because a sterilizing gas may flow essentially unhindered from the upper side of the nest towards the bottom side of the nest, if accommodated in a tub.
  • the pre-sterilized vials are entirely of a known form and require no modification as compared to conventional pre- sterilized vials. Equally the tub is as currently employed in a known pre-sterilized vial handling system and it is only the nest for stopper members which has been modified properly.
  • the supporting structure for vials and stopper members according to the present invention may be used equally for a manual, semiautomatic or fully-automatic filling and stoppering process, as summarized below:
  • leg portion 203a chamfered front end of leg portion 203

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Abstract

Selon un procédé destiné à fermer une pluralité de flacons médicaux (5), une emboîture de fermeture destinée à supporter une pluralité d'éléments de fermeture est utilisée, comprenant une plaque de support plane comportant une pluralité de réceptacles tubulaires (61) et des structures de retenue pour recevoir de manière fiable les éléments de fermeture (200). Selon ce procédé, la pluralité de flacons médicaux (5) est supportée dans une emboîture de flacon correspondante. L'emboîture de fermeture est disposée au-dessus de l'emboîture de cartouche de telle sorte que les réceptacles de l'emboîture de fermeture s'alignent précisément sur les réceptacles de l'emboîture de flacon. Les éléments de fermeture (200) sont ensuite poussés vers le bas hors des réceptacles de l'emboîture de fermeture et dans les flacons (5), tandis que les flacons sont supportés par l'emboîture de flacon. L'emboîture de fermeture peut être directement acheminée sur des installations de machine de remplissage et d'arrêt existantes pour traiter des flacons préalablement stérilisés, essentiellement sans qu'il soit nécessaire de modifier l'installation.
PCT/IN2016/000196 2016-07-27 2016-07-27 Procédé de fermeture de flacons, structure de support pour supporter des éléments de fermeture de flacon et contenant de transport ou d'emballage WO2018020505A1 (fr)

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EP3851089A1 (fr) * 2020-01-20 2021-07-21 SCHOTT Schweiz AG Dispositif de support pour supporter une pluralité de récipients dans un engagement positif établi par un mouvement de déplacement
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WO2022136543A1 (fr) * 2020-12-23 2022-06-30 Bausch + Ströbel Maschinenfabrik Ilshofen Gmbh+Co. Kg Dispositif pour traiter des contenants pharmaceutiques et dispositif de fixation pour un dispositif de ce type
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WO2022161999A1 (fr) 2021-01-26 2022-08-04 Becton Dickinson France Nid pour l'emballage de bouchons-pistons avec des éléments d'empilement intégrés assurant un alignement fiable d'une pile de nids
CN115384923A (zh) * 2018-05-14 2022-11-25 肖特瑞士股份公司 用于同时支撑多个容器的支撑结构以及包括其的运输结构
WO2023012137A1 (fr) * 2021-08-05 2023-02-09 A. Raymond Et Cie Conditionnement pour dispositifs medicaux
CN116238741A (zh) * 2023-04-28 2023-06-09 帕克奇科技(杭州)有限公司 一种智能注射器灌装系统及工作方法
WO2023104461A1 (fr) * 2021-12-07 2023-06-15 A. Raymond Et Cie Systeme de conditionnement collectif pour dispositifs medicaux
US11679902B2 (en) * 2017-12-22 2023-06-20 West Pharmaceutical Services, Inc. Packaging system for small-volume aseptic filling
WO2023126084A1 (fr) * 2021-12-30 2023-07-06 A. Raymond Et Cie Ensemble de conditionnement pour capuchons et pour flacons a usage pharmaceutique et procede de remplissage et de fermeture desdits flacons
WO2023164771A1 (fr) * 2022-03-02 2023-09-07 Medisca Pharmaceutique Inc. Procédés et ensembles d'emballage de récipients pour des compositions contenant des ingrédients actifs
IT202200015549A1 (it) 2022-07-25 2024-01-25 Nuova Ompi S R L Unipersonale Dispositivo di supporto di una pluralità di contenitori per uso farmaceutico da movimentare in una linea di processazione

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CN115384923B (zh) * 2018-05-14 2023-08-15 肖特制药瑞士股份公司 用于同时支撑多个容器的支撑结构以及包括其的运输结构
CN115384923A (zh) * 2018-05-14 2022-11-25 肖特瑞士股份公司 用于同时支撑多个容器的支撑结构以及包括其的运输结构
EP3851089A1 (fr) * 2020-01-20 2021-07-21 SCHOTT Schweiz AG Dispositif de support pour supporter une pluralité de récipients dans un engagement positif établi par un mouvement de déplacement
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EP3967290A1 (fr) * 2020-09-11 2022-03-16 A. Raymond et Cie Systeme et procede d emballage de bouchons medicaux compose d'une coiffe et d'un obturateur
FR3114087A1 (fr) * 2020-09-11 2022-03-18 A. Raymond Et Cie Systeme et procede d’emballage de bouchons medicaux compose d’une coiffe et d’un obturateur
WO2022136543A1 (fr) * 2020-12-23 2022-06-30 Bausch + Ströbel Maschinenfabrik Ilshofen Gmbh+Co. Kg Dispositif pour traiter des contenants pharmaceutiques et dispositif de fixation pour un dispositif de ce type
WO2022155422A1 (fr) * 2021-01-15 2022-07-21 Oyster Point Pharma, Inc. Structures d'emboîtement pour le stockage, le transport et l'assemblage de distributeurs et de récipients de médicament
WO2022161999A1 (fr) 2021-01-26 2022-08-04 Becton Dickinson France Nid pour l'emballage de bouchons-pistons avec des éléments d'empilement intégrés assurant un alignement fiable d'une pile de nids
FR3125961A1 (fr) * 2021-08-05 2023-02-10 A. Raymond Et Cie Conditionnement pour dispositifs medicaux
WO2023012137A1 (fr) * 2021-08-05 2023-02-09 A. Raymond Et Cie Conditionnement pour dispositifs medicaux
WO2023104461A1 (fr) * 2021-12-07 2023-06-15 A. Raymond Et Cie Systeme de conditionnement collectif pour dispositifs medicaux
WO2023126084A1 (fr) * 2021-12-30 2023-07-06 A. Raymond Et Cie Ensemble de conditionnement pour capuchons et pour flacons a usage pharmaceutique et procede de remplissage et de fermeture desdits flacons
FR3131574A1 (fr) * 2021-12-30 2023-07-07 A. Raymond Et Cie Ensemble de conditionnement pour capuchons et pour flacons a usage pharmaceutique et procede de remplissage et de fermeture desdits flacons
WO2023164771A1 (fr) * 2022-03-02 2023-09-07 Medisca Pharmaceutique Inc. Procédés et ensembles d'emballage de récipients pour des compositions contenant des ingrédients actifs
EP4311562A1 (fr) 2022-07-25 2024-01-31 NUOVA OMPI S.r.l. Unipersonale Dispositif de support pour supporter une pluralité de récipients à usage pharmaceutique à manipuler dans une ligne de traitement
IT202200015549A1 (it) 2022-07-25 2024-01-25 Nuova Ompi S R L Unipersonale Dispositivo di supporto di una pluralità di contenitori per uso farmaceutico da movimentare in una linea di processazione
CN116238741A (zh) * 2023-04-28 2023-06-09 帕克奇科技(杭州)有限公司 一种智能注射器灌装系统及工作方法
CN116238741B (zh) * 2023-04-28 2023-08-04 帕克奇科技(杭州)有限公司 一种智能注射器灌装系统及工作方法

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