EP2862809A2 - Structure de support de récipients pour substances destinées aux applications médicales, pharmaceutiques ou cosmétiques ainsi que récipient de transport ou d'emballage en étant équipé - Google Patents

Structure de support de récipients pour substances destinées aux applications médicales, pharmaceutiques ou cosmétiques ainsi que récipient de transport ou d'emballage en étant équipé Download PDF

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Publication number
EP2862809A2
EP2862809A2 EP20140189210 EP14189210A EP2862809A2 EP 2862809 A2 EP2862809 A2 EP 2862809A2 EP 20140189210 EP20140189210 EP 20140189210 EP 14189210 A EP14189210 A EP 14189210A EP 2862809 A2 EP2862809 A2 EP 2862809A2
Authority
EP
European Patent Office
Prior art keywords
carrier
holding
containers
holding part
openings
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
EP20140189210
Other languages
German (de)
English (en)
Other versions
EP2862809B1 (fr
EP2862809A3 (fr
Inventor
Gregor Fritz DEUTSCHLE
Edgar Pawlowski
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.)
Schott AG
Original Assignee
Schott AG
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 AG filed Critical Schott AG
Publication of EP2862809A2 publication Critical patent/EP2862809A2/fr
Publication of EP2862809A3 publication Critical patent/EP2862809A3/fr
Application granted granted Critical
Publication of EP2862809B1 publication Critical patent/EP2862809B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers
    • 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
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02—Internal fittings
    • B65D25/10—Devices to locate articles in containers
    • B65D25/108—Devices, e.g. plates, presenting apertures through which the articles project
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00—Supporting devices; Holding devices
    • B01L9/06—Test-tube stands; Test-tube holders
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/18—Transport of container or devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/021—Identification, e.g. bar codes
    • B01L2300/022—Transponder chips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/12—Specific details about materials
    • B01L2300/123—Flexible; Elastomeric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5085—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates
    • B01L3/50855—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates using modular assemblies of strips or of individual wells

Definitions

  • the present invention relates generally to the simultaneous mounting of a plurality of containers for storing substances for medical, pharmaceutical or cosmetic applications, in particular vials, ampoules, cartridges, dual-chamber cartridges, Syringes or dual chamber cartridges, and more particularly relates to the simultaneous mounting of a plurality of such containers in a support structure in a simple and reliable manner and in such a way that they, while they are held in a holding structure provided for this, in filling - Or processing plants can be processed or further processed, in particular in a sterile tunnel, a filling plant for liquid medical or pharmaceutical applications or a freezer-drying cabinet for this purpose. Furthermore, the present invention relates to a transport and / or packaging container with at least one such support structure and optionally with an integrated sensor and / or plagiarism protection.
  • medicine containers such as vials, for example
  • Ampoules or cartridges used These generally have a cylindrical shape, can be made of plastics or glass and are available in large quantities at low cost.
  • concepts are increasingly used in which the containers are packaged sterile sterile at the manufacturer of containers in transport and packaging containers, which then at a pharmaceutical company under sterile conditions, especially in a so-called. Sterile tunnel , unpacked and then processed further.
  • Transport and packaging containers are known from the prior art, in which a plurality of drug containers are arranged in a predetermined regular arrangement at the same time.
  • This has advantages in the automated further processing of the containers, since the containers can be transferred to processing stations in controlled positions and in a predetermined arrangement, for example to process machines, robots or the like.
  • To transfer to a processing station just needs the transport and packaging container to be properly positioned and opened.
  • the downstream processing station then knows in which position and arrangement the containers to be further processed are arranged.
  • Such a transport and packaging container and a corresponding packaging concept are for example in the US 8,118,167 B2 disclosed.
  • the further processing of the container always takes place in such a way that the holding structure is removed from the transport and packaging container and the containers are removed from the holding structure and separated and transferred to a conveyor, in particular a conveyor belt, individually to the processing stations and further processed there , This limits the achievable speed in further processing.
  • separating the container with the help of cellular wheels or the like, it always comes back to individual containers abut uncontrollably, resulting in an undesirable abrasion and consequent contamination of the container interior or the process plant, as well as to a deterioration of the external appearance of the Container leads, which is undesirable.
  • US 8,100,263 B2 discloses a sterile packable and transportable transport and packaging container, in which a plate-shaped support structure can be used, in which a plurality of drug containers are held in a regular array.
  • the medication containers can not be further processed in the transport or packaging container or in the holding structure, but must first be separated in the conventional manner and handed over to downstream processing stations.
  • WO 2009/015862 A1 discloses a solution with a nest as a support structure based on a firm connection with the vials via a frictional engagement ("... flaps fit against neck "). Due to the fact that plastic nests can never be made stress-free and the vials usually have different lengths, it follows that individual vials in the freeze drier lose ground contact during the process. The freeze-drying process can therefore be unstable and difficult to control.
  • the vials can not be reintroduced from above into the nest during in-process control.
  • many pharmaceutical manufacturers require strict avoidance of any ingress of particles from above into the vial filling holes.
  • recirculation of the vials measured or tested during processing back into the nest is desired.
  • freeze-drying process is one of the most expensive processes in the manufacture of pharmaceuticals. Since the costs essentially depend on the packing density that can be achieved during processing and freeze-drying, this must be optimized.
  • the existing packaging is not flexible enough to transport different vial sizes.
  • Most nest solutions use the outside diameter of the Vial as auxiliary contour for fixation. However, this is usually less standardized and, moreover, is often subject to comparatively high tolerances.
  • the vials in the support structure can not be held tension-free, which can lead to an undesirable bulging of the support structure, in particular during processing, for example in a freeze-drying cabinet.
  • the object of the present invention is to further improve the holding of containers which serve for the storage of substances for medical, pharmaceutical or cosmetic applications, so that these containers can be handled, transported and processed even faster and more economically, better automatable and reliable ,
  • a holding structure for simultaneously holding a plurality of containers, in particular of vials, for substances for medical, pharmaceutical or cosmetic applications provided with a flat, rectangular support having a plurality of openings or receptacles, and with at least one holding part, which is detachably connected to the carrier, wherein the respective holding part is designed to a plurality of containers to hold on the carrier by a positive connection.
  • the positive connection is formed or designed by coupling the respective holding part to the carrier such that the containers held on the carrier extend into the openings or receptacles of the carrier.
  • the containers extend into the openings of the carrier or, in particular, through these openings, the bottoms of the containers, even if they are held on the carrier, are freely accessible from the underside of the holding structure.
  • This offers considerable advantages in the processing or further processing of the containers, since they do not need to be removed from the holding structure and separated for processing or processing, but, while these are held on the holding structure, can be processed or processed.
  • the containers can be placed on an external support surface or brought into a full-surface and immediate contact with a cooling surface, for example with a cold finger of a freeze dryer.
  • the respective holding part is preferably designed so that tolerances of the container, in particular with respect to the outer radius or the outer contour of the container and their length, can be compensated in a simple manner.
  • tolerances with respect to the outer radius or the outer contour of the container can be compensated, for example, simply by a certain radial clearance with which the containers are held by the holding part or by a certain elasticity or deformability of the holding receptacles of the holding part.
  • Tolerances or differences in length between individual containers in the axial direction can be easily compensated by the fact that the respective holding part keeps the container secured with an axial play with a form fit in one direction only.
  • the positive connection is formed such that the containers are axially secured to the respective one in the region of a narrowed neck portion and below a widened upper edge adjoining the narrowed neck portion Holding part are held. In this way, a positive connection in only one direction can be realized in a simple manner.
  • positive engagement is formed so that the containers each rest with the underside of the widened upper edge loosely on the respective holding part or on holding means which are formed on the respective holding part.
  • the holding structure has a plurality of holding parts, which are in each case strip-shaped and extend along a longitudinal side of the carrier.
  • the containers can be held in a form-fitting manner along the longitudinal sides of these holding parts, wherein the regular geometric arrangement of the container can be specified in a simple manner.
  • the containers are hung in particular in the holding parts.
  • annular holding elements are formed on the holding parts, which are each designed to engage around the outer circumference of the container in a form-fitting manner.
  • the annular holding elements are preferably distributed at uniform intervals and along the respective holding part and the opening width of the annular receptacles is greater than the outer diameter of a narrowed neck portion of the container, but smaller than the outer diameter of an upper edge of the container, which narrowed Neck section connects. In this way, the containers with the underside of the upper edge of the container can rest loosely on the tops of the annular receptacles and are held with both radial and axial play on the holding parts.
  • the containers of respective pairs of adjacent holding parts on the carrier are held in rows or columns.
  • the holding parts may each be strip-shaped, with straight longitudinal sides on which the containers rest with the underside of the widened upper edge.
  • a plurality of semicircular recesses may be formed along at least one longitudinal side of the holding parts, which in cooperation with the semi-circular recesses of a directly adjacent arranged strip-shaped holding part form a plurality of annular receptacles in which the containers, as stated above, are held.
  • the semicircular recesses may in each case be offset relative to one another, in particular along mutually opposite longitudinal sides of the holding means, which may allow an even higher packing density.
  • a series processing of containers is greatly facilitated, in which a number of containers are inserted by means of a gripper row or the like in the recesses of a bar, then another bar is fed so that their recesses embrace the container also, then the two bars so far merged that a row of containers is reliably held by the two strips, and finally the two strips are clipped together in the carrier.
  • the recesses can also be designed as a semi-ellipse, so that containers with different outer dimensions can be processed with the same support structure.
  • the holding parts are each strip-shaped and hold respective pairs of adjacent holding parts, the plurality of containers on the carrier in rows or columns.
  • the holding parts each have two wings which are elastically braced against each other, that in a first position of the holding parts, in which the wings, preferably against an elastic restoring force, are moved towards each other, the holding parts in spaces between upper ends of rows or Columns of containers can be inserted, and that the upper ends of the wings in a second position of the holding parts, in which the wings, preferably due to the elastic restoring force, unfolded, keep the containers on the support in rows or columns, as stated above ,
  • the respective holding part is held by clamping on the carrier.
  • the holding parts can be easily removed from the support structure and attached to this again reliably and at predetermined positions.
  • the respective holding part is connected by means of a clip connection with the carrier.
  • the holding parts can be easily removed from the support structure and fixed again to this reliable and at predetermined positions, these positions by the for the clip connection used structures can be specified precisely.
  • at least one first detent element can be arranged on the carrier or the respective holding part, and at least one second detent element can be arranged on the respective holding part or the carrier, whereby the first and the second detent element engage with the respective holding part for connection of the carrier can be.
  • a plurality of openings are formed in the at least one holding part and the respective holding part is mounted displaceably parallel to the carrier relative to the carrier, wherein in a first position of the holding part relative to the carrier, the openings of the holding part with the openings or Receivers of the carrier are aligned, so that the upper ends of the container are each inserted into the openings of the holding part, and wherein the holding part is displaceable by parallel displacement relative to the carrier in a second position or can be adjusted, in which the positive connection by cooperation of the openings is effected in the holding part with the openings or receptacles in the carrier to hold the containers to the carrier.
  • a plurality of openings are formed, each associated with a plurality of holding means for holding the container, wherein the respective holding part is perpendicular to the top of the carrier adjustable.
  • the openings of the holding part can be aligned with openings or receptacles of the carrier, and in a first position in which the distance between the at least one holding part and the carrier greater than a predetermined minimum distance, the holding means associated with a respective opening of the holding means spaced from each other be arranged so that the upper ends of the container can be inserted respectively into the respective opening of the holding part.
  • the holding means associated with the openings of the holding means may be designed so that by reducing the distance between the at least one holding part and the carrier they are coordinated to be adjusted to a second position in which the upper ends of the containers are each held by the holding means.
  • the holding part and the carrier are arranged one above the other, wherein the holding means are designed as elastic holding arms and are arranged on the holding part and wherein the elastic holding arms so with the carrier cooperate to be adjusted in changing the distance between the holding part and the carrier coordinated between the first position and the second position.
  • the elastic support arms for coordinated adjustment in the openings or in slots formed in the support, guided or reach the elastic support arms when falling below the predetermined minimum distance between the holding part and the carrier in abutment with guide elements or edges of the openings of the Carrier to be coordinated in the second position to be adjusted.
  • the holding parts can also be clipped into the carrier, they can be held axially secured to the carrier and thus very reliably on the carrier, which considerably reduces the risk of uncontrolled slipping or falling out of the container from the carrier. This is especially true even if the holding parts themselves are designed so that the containers are held axially secured in the holding receptacles of the holding parts. This can be realized in a simple manner by suitable design of the positive connection in the retaining seats.
  • the holding parts on the upper side of the carrier are clipped into them so that the upper sides of the containers, in particular their filling openings provided there, are very easily accessible for further processing of the containers, for example for filling or closing the containers.
  • the edges of the openings simultaneously act as collision protection to prevent collision of immediately adjacent containers.
  • the holding parts can also be clipped into the underside of the carrier in the latter, so that the upper ends of the containers project up to the upper side of the carrier from the openings thereof.
  • the holding parts are each formed as annular holding parts to positively surround the outer periphery of the container, wherein the holding elements are each clipped directly or with the aid of a respective clip in the openings of the wearer.
  • the annular holding part surrounds the outer circumference of the container at least in sections, and particularly preferably substantially completely, apart from an approximately provided insertion opening for insertion and removal of the container in and out of the annular holding part.
  • the holding parts each have a plurality of receptacles, which are arranged at equal distances from each other and distributed along the respective holding part, so as to specify a regular arrangement of the container, which facilitates automated processing of the container.
  • the holding parts are each clipped into the carrier. The holding parts are thus easily releasably connected to the carrier, but reliably held in the clipped state at this.
  • the container is each received with radial play in the receptacles of the holding part whose inner diameter is greater than the outer diameter of the narrowed neck portion but smaller than the outer diameter of an upper edge of the container, which adjoins the narrowed neck portion.
  • the lower edge of the upper edge (in particular rolled edge) of the container is bevelled, a self-centering effect occurs, so that the container is automatically centered in the central opening of the holding part.
  • the handling of the holding parts can be facilitated if they have a bevelled edge in the region of the holding clips provided at the edges, which allows the formation of a wedge-shaped clearance into which a gripping or handling tool can be inserted to grip the holding part or to handle and release the clip connection with the carrier again.
  • the inner edges of the circular retaining seats of the respective holding part can be chamfered, which ensures further self-centering of the containers when they rest on the edge of the associated opening.
  • At least one predetermined breaking point or at least one weakened region is provided in the holding part in order to break apart the holding part.
  • the holding parts have identification or tracking means for identifying or tracking the holding structure with the containers held by the latter and / or a sensor for monitoring parameters of the holding structure, for example environmental parameters, such as temperature, lighting conditions or humidity, or depending on the time To monitor and record time-dependent.
  • the identification or tracking device and / or the sensor is preferably embedded in the formed of a plastic holding means, for example in the annular holding receptacles.
  • Another aspect of the present invention relates to a transport or packaging container for a plurality of containers for substances for medical, pharmaceutical or cosmetic applications comprising a box-shaped container in which at least one holding structure, as stated above, for simultaneously holding the plurality of containers is received in the transport or packaging container.
  • a holding structure as well as a transport and packaging container accommodating such a holding structure, according to the present invention, serves to hold a plurality of containers for storing substances for medical, pharmaceutical or cosmetic applications simultaneously, preferably in a regular manner, as described below Arrangement, in particular in a matrix arrangement at regular intervals of the container to each other and along two different spatial directions, preferably along two mutually orthogonal spatial directions or in regular rows, which are arranged offset relative to each other.
  • Fig. 1 An example of such drug containers in the form of vials is in the Fig. 1 shown schematically in a longitudinal section. These have a cylindrical basic shape, with a cylindrical side wall 4 with - within the tolerances - constant inside and outside diameter, which protrudes perpendicularly from a flat bottle bottom 3 and near the upper open end of the vial in a narrowed neck portion 5 of comparatively lower axial length and then into a widened upper edge 6 (also referred to as a rolled edge) merges, which has a larger outer diameter than the associated neck portion 5 and is designed for connection to a closure element. How to get the Fig.
  • the underside of the roll edge 6 may be formed chamfered and extend at an acute angle downwards and toward the narrowed neck portion 5.
  • the underside of the roll edge 6 may also be flat and extend at a right angle to the narrowed neck portion 5.
  • the neck portion 5 may be formed smooth-walled without external thread or may be provided with an external thread for screwing a closure element.
  • a plug (not shown) can be inserted whose upper end is connected to the upper edge 6 of the vial gas-tight and protected against the ingress of contaminants into the vial with the upper edge 6 , For example, by crimping or crimping a metal protective film, not shown.
  • Such vials are radially symmetrical and formed of a transparent or colored glass or by blow molding or plastic injection molding techniques of a suitable plastic material, and may in principle be internally coated, so that the material of the vial emits as little impurities to the male substance.
  • containers in the context of the present application are ampoules, cartridges or syringe or injection containers. Further examples of containers are also double-chamber cartridges and / or double-chamber syringes and / or bottle cartridges (vartridges).
  • such containers are used for storing substances or active substances for cosmetic, medical or pharmaceutical applications which are to be stored in one or more components in solid or liquid form in the container.
  • storage periods can be many years, which depends in particular on the hydrolytic resistance of the type of glass used.
  • containers are disclosed below which are cylindrical, it should be noted that the containers according to the present invention may also have a different profile, for example a square, rectangular or polygonal profile.
  • such containers have manufacturing tolerances, which may be just one or more tenths of a millimeter, especially in glass containers.
  • the containers are fixed according to the invention to a holding structure, as explained below.
  • the holder of the container is doing in the transition region of the narrowed neck portion 5 for widened upper edge 6 or realized in the region of the narrowed neck portion 5.
  • a holding element is arranged in the region of the narrowed neck portion 5, which engages with the narrowed neck portion 5 in a positive engagement or very particularly preferably receives it with a certain radial clearance to compensate for tolerances and different outside diameters of different container types.
  • This holding member may be part of or is formed by a holding means, which is clipped into a carrier according to embodiments of the invention, as described below, to form a holding structure for simultaneously holding a plurality of containers in openings or receptacles.
  • Fig. 2a shows in a perspective plan view of a strip-shaped holding plate 10, at the left and right longitudinal side, in each case at regular intervals from each other a plurality of semicircular recesses 11a, 11b are formed, which are each offset by half a diameter of the recesses to each other.
  • the holding plates 10 are mirror-symmetrical, so they can be reversed clipped in the same way in a carrier.
  • two such retaining plates 10, which contact each other along the contact line 14, form a retaining means, as in FIG Fig. 2b illustrated in which a plurality of circular openings 13 for holding the vial (Vial) 2 are formed.
  • the vials 2 are held positively in the circular retaining seats 13 in the region of their narrowed neck portion below the widened upper edge 6, can in principle also be held by friction, in particular clamped.
  • the upper edge 6 of the container 2 can also rest loosely on the holding plates.
  • the two holding plates 10 may be directly connected to each other, for example, be releasably locked together to form a subunit in which the vials are held reliably.
  • Fig. 2c shows a holding structure according to the present invention with two strip-shaped holding plates 10 according to the Fig. 2a which are clipped into a flat, rectangular support 30, in which in a regular arrangement openings 31 are formed whose opening width is greater than a maximum outer dimension of the vials 2.
  • the holding plates 10 are clipped into the top of the carrier 30 in this so that the recesses 11a, 11b are aligned with the openings 31 in the carrier 30 and the vials 2 through the openings 31 in the carrier 30 downwardly, so sodadss the bottoms of the vials 2 are completely accessible from the bottom of the carrier 30 and forth freely.
  • the clip 20 has a base 21 from which protrudes a latching or clamping hook 22, which together with the base 21 forms a receptacle 23 in which the edge of the carrier 30 is clamped.
  • the retaining clips 20, the carrier 30 and the holding plates 10 are made of suitable plastics, which have sufficient elasticity to the clipping of the holding plates in the carrier 30 and a release of the To enable clip connection.
  • the retaining clip may be similarly provided in the carrier 30 instead of the retaining plate 10.
  • differently shaped positive-locking elements can also be used.
  • the Fig. 2f shows a plan view of the support structure (carrier) according to the Fig. 2c ,
  • the Fig. 3a shows in a perspective view of a support structure according to another embodiment of the present invention.
  • openings 31 are formed in a regular arrangement whose opening width is greater than a maximum outer dimension of the vials 2, so that they are introduced into the openings 31 from above the carrier 30 as well as from below the carrier 30 can.
  • the width of this gap is preferably slightly larger than the outer dimension of the vial 2 in the neck portion 5 (see. Fig.
  • the vials 2 lie loosely on the upper sides of the strip-shaped holding plates 10 with the lower sides of their widened upper edges 6 and are thus secured axially in one direction on the carrier 30, without the vials 2 being kept clamped.
  • the vials 2 can also be attached to the carrier 30 be kept clamped, preferably in the region of the narrowed neck portion 5 (see. Fig. 1 ).
  • the strip-shaped holding plates 10 may be clipped into the carrier 30 in the manner described above or otherwise releasably secured thereto.
  • the strip-shaped holding plates 10 are kept clamped to the carrier 30.
  • 30 clamping webs 19 are provided along two opposite longitudinal sides of the carrier, which according to the Fig. 3a each form a plurality of rectangular receptacles 19c, which in the greatly enlarged sectional view according to the Fig. 3c is more apparent.
  • the clamping web 19 has a plurality of base portions 19a for connection to the carrier 30 and a plurality of pairs of vertically projecting from these side walls 19b, which the rectangular receptacles 19c (see. Fig.
  • spacers 18 are arranged with a rectangular cross-section on the top of the carrier 30.
  • These are preferably made of an elastic material, for example of an elastic plastic or rubber. According to the Fig. 3c the strip-shaped holding plates 10 are inserted into the gap between the spacers 18 and the clamping bar 19 and are kept clamped therein.
  • the upper edges 6 of the vials 2 also rest directly on the upper side of the carrier 30 if the outer diameter of the upper edges 6 of the vials 2 should be greater than the maximum outer dimension in the region of the side walls 4 (cf. Fig. 1 ).
  • the strip-shaped retaining plates 10 then rest on the upper edges 6 of the vials 2 to hold the vials 2 axially secured to the carrier 30 in two directions.
  • the height of the spacer elements 18 corresponds at least to the height of the widened upper edge 6 of the vials 2 (cf. Fig. 1 ), but may be larger than this. In this way, the axial clearance can be specified, with which the vials 2 are held positively on the carrier 30.
  • FIGS. 4a and 4b show in a schematic perspective view and in a sectional view of a holding structure according to another embodiment of the present invention in a state before the containers are held on the support structure.
  • the container 2 are inserted into the openings 31 of the carrier 30.
  • the containers may be temporarily supported on an external support surface 8, as schematically shown in FIG Fig. 4b shown.
  • the containers 2 are held by a holding device (not shown), for example the holding device of a process station, until the containers 2 are reliably held on the holding structure.
  • a holding device not shown
  • the upper edges 6 of the containers 2 protrude sufficiently out of the openings 31, so that the undersides of the widened upper edges 6 of the containers 2 for the holding plates 10 are accessible for support.
  • the holding plates 10 consist of two holding wings 10a, 10b, which together form a holding plate 10 and are connected to each other via a film hinge or the like, by pivoting about the common connecting line to each other and can be unfolded.
  • the holding plates are made of a plastic, in particular by means of a 1K or 2K injection molding process.
  • the holding plates 10 can be inserted into the interstices 9 until the upper ends of the holding wings 10a, 10b are slightly below the undersides the widened upper edges 6 of the container 2 are arranged.
  • FIGS. 4c and 4d show the thus formed holding structure in a schematic perspective view and in a sectional view in a state in which the containers 2 are held on the holding structure.
  • retaining wings 10a, 10b For refolding the retaining wings 10a, 10b, it is advantageous if they are elastically braced against each other by a restoring force, which can be accomplished in a simple manner by the design and the choice of the material of the retaining wings 10a, 10b and their connection area.
  • the relaxed rest position of the retaining wings 10a, 10b, the folded position according to the FIGS. 4a and 4b be, in which case the retaining wings 10a, 10b have to be unfolded against an elastic restoring force.
  • the weight of the container 2 may be sufficient.
  • the containers 2 are actively depressed relative to the holding plates 10 until the bottoms of the widened upper edges 6 of the containers 2 come into abutment with the upper ends of the holding wings 10a, 10b and unfold them upon further depression of the containers 2.
  • the retaining wings 10a, 10b are mechanically pressed apart to the position according to the FIGS. 4c and 4d take.
  • the relaxed rest position of the retaining wings 10a, 10b and the unfolded position according to the FIGS. 4c and 4d be, in which case the retaining wings 10a, 10b must be folded against an elastic restoring force to the position according to the FIGS. 4a and 4b
  • the folding and / or unfolding of the retaining wings 10a, 10b can be supported by mechanical intervention here as well.
  • FIGS. 5a and 5b show in a schematic sectional view of a holding structure according to another embodiment of the present invention in a state before the containers are held on the support structure, and in a state in which the containers are held on the support structure.
  • elastic support arms 90 are pivotally supported on the lower support plate 30a and extend through the openings 31b in the upper support plate 30b.
  • the elastic support arms 90 can also be laterally closed by extending slots or openings arranged through the openings 31b.
  • the containers 2 extend through the openings 31a, 31b of the lower and upper support plates 30a, 30b, with the elastic support arms 90 extending into the spaces 9 between the upper ends of the containers 2.
  • the elastic support arms 90 are pivoted away from the containers 2 so that they can be inserted into the openings or receivers 9 formed by the front ends 94 of the support arms 90.
  • the container 2 are suitably supported on an external support surface (not shown), comparable to Fig. 4b ,
  • the support arms 90 For adjusting the support arms 90 is in accordance with the Fig. 5b the distance between the support plates 30a, 30b changed. In this case, the support arms 90 slide at the edges of the openings 31b or the slots or openings, not shown, and are thereby inwardly, elastically pivoted toward the containers 2. In this position, the widened upper edges 6 of the container 2 are positively secured and axially.
  • wedge-shaped retaining projections 94 are provided at the upper ends of the support arms 90, each having an upper slope 92 and a lower slope 93 in order to facilitate the insertion or removal of the container 2 from the holding structure thus formed.
  • Fig. 5b can exist between the front ends of the retaining projections 94 and the narrowed neck portion 5 of the respective held container a gap 100, the containers 2 are thus supported with a certain radial play on the retaining projections 94.
  • the containers can also be held elastically clamped by the holding projections 94, or rectangular holding receptacles can be formed in the holding projections 94, which receive the widened upper edge 6 of the containers 2 in a form-fitting manner, be it with radial and / or axial Game or without such a game.
  • FIGS. 5c and 5d show a further variant of the embodiment according to the FIGS. 5a and 5b in which the aforementioned adjustment of the elastic retaining arms 90 additionally by a wedge shape of the support arms 90 is effected in cooperation with the openings 31b or the slots or openings 31c in the upper support plate 30b.
  • 90 slopes 98 are formed on the inside of the elastic support arms, so that the support arms 90 increasingly broaden from its lower end to the retaining projections 94.
  • These bevels 98 act as a control surface to effect the adjustment of the retaining arms 90 in cooperation with the apertures 31c in the upper support plate 30b, which may also be identical to the apertures 31b of the upper support plate 30b which serve to receive the containers.
  • the support structure consists of a lower support plate 30a with a plurality of openings 31a and an upper support plate 30b with a plurality of openings 31b, which are arranged in alignment with the openings 31a of the lower support plate 30a.
  • Cylindrical side walls 85 are disposed around the openings 31a on the upper surface of the lower support plate 30a, and elastic support arms 80 are respectively associated with the openings 30a, which are arranged at equal angular intervals with each other along the edge of the respective opening 31a.
  • the Fig. 6d shows a greatly enlarged partial section of the in Fig. 6c in a circle section. How to the partial section according to the Fig. 6d can take, protrude the support arms 80 substantially perpendicularly from the lower support plate 30a, wherein the front ends 81 of the support arms 80 arcuately project into the respective opening 31a. From the outside of each support arm 80, facing away from the respective opening 31 a, there is a latching nose 83. Between the underside of the detent 83 and the upper edge of the cylindrical side wall 85, a gap 84 is formed whose width corresponds to the thickness of the upper support plate 30b.
  • the upper ends 81 of the support arms 80 do not contact the upper support plate 30b. Furthermore, the support arms 80 are relaxed in this position.
  • the opening width of the receptacles formed by the holding arms 80 in the relaxed state is greater than a maximum outside diameter of the containers 2 in the region of the upper one Rands 6, so that the container 2 can be introduced from below the lower support plate 30a in any case, or from above the lower support plate 30a with spreading of the support arms 80th
  • the opening width of the holding arms 80 formed receptacles is larger in the relaxed state as a maximum outer diameter of the container 2 in the region of the cylindrical side wall 4, so that the container 2 can be introduced from above the lower support plate 30a without spreading of the support arms 80 in these recordings.
  • the containers 2 contained in the receptacles may be temporarily supported on an external support surface (not shown), comparable to Fig. 4b ,
  • the detents 83 completely slide over the edge of the openings 31b of the upper support plate 30b, as in FIGS FIGS. 6j and 6k shown. Because the width of the gap 84 (see FIG. Fig. 6d ) between the underside of the detents 83 and the upper edge of the cylindrical side walls 85 corresponds to the thickness of the upper support plate 30b or at least is greater than this, the detents 83 can be clipped into the upper support plate 30b. This leads to a maximum bending of the support arms 80 radially inwardly into the associated openings 31b of the upper support plate. In this position, therefore, the lower support plate 30a is connected by clipping the detents 83 in the openings 31b of the upper support plate 30b with the upper support plate 30b.
  • the widened upper edges 6 of the container 2 are supported on the elastic support arms 80.
  • the upper edges 6 of the container 2 can rest loosely on the elastic support arms 80, with a certain radial play, as stated above, or the front ends 81 of the elastic support arms 80 can rest against the narrowed neck portion 5 of the container 2 or press against it to keep the container 2 clamped.
  • a support of the container 2 on an external support surface comparable to Fig. 4b , not necessary anymore.
  • the holding structure formed in this way can be placed in a transport and packaging container, as exemplified in US Pat Fig. 8c imaged, introduced and stored and transported in this sterile.
  • the procedure is reversed.
  • the upper support plate 30b moved away from the lower support plate 30a or by force on the elastic support arms 80 and / or the detents 83 ensures that the detents 83 again out of engagement with the edges of the openings 31b in the upper support plate 30b arrive.
  • the elastic properties of the holding arms 80 contribute to this release of the engagement of the locking lugs 83 crucial.
  • the containers 2 can also be withdrawn individually from the openings 31a, 31b.
  • the holding structure consists of a lower support plate 30a with a plurality of openings 31a and an upper support plate 30b with a plurality of openings 31b, which in the position of the support plates 30a, 30b according to the FIGS. 7a to 7c are arranged in alignment with the openings 31a of the lower support plate 30a.
  • the containers 2 can be inserted into the openings 31a, 31b from below or above the lower support plate 30a in this position of the support plates 30a, 30b and be taken down or up again from these openings 31a, 31b.
  • the two support plates 30a, 30b can be displaced parallel to one another in the direction of one of the longitudinal sides, which leads to a reduction in the opening width of the openings formed together by the openings 31a, 31b in the adjustment direction, as in the plan view according to FIG Fig. 7d can be removed.
  • the opening width of the openings formed jointly by the openings 31a, 31b can thus be predetermined in a simple manner.
  • the projections 30 projecting at right angles on the underside of the lower support plate 30a and the edges of the openings 31b in the upper support plate 30b can keep the neck portions 5 of the containers clamped together when the opening width of the openings formed together by the openings 31a, 31b is exactly the outer diameter the narrowed neck portions 5 corresponds.
  • the opening width of the openings formed together from the openings 31a, 31b is somewhat larger, the widened upper edges 6 of the containers 2 may loosely rest on the edges of the openings 31b in the upper support plate 30b without keeping the containers 2 clamped.
  • the position of the two support plate 30a, 30b relative to each other can be secured by means of suitable connecting elements.
  • the two support plate 30a, 30b can be locked together in the desired holding position by means of locking elements.
  • Fig. 8a shows in a schematic sectional view of the holder of a vial 2 in the support structure according to the Fig. 2c ,
  • the vial 2 is in the area of the narrowed Neck portion 5 held positively.
  • the underside of the roll edge 6 of the vial loosely on the top of the holding plates 10, expedient while maintaining a certain radial clearance in the region of the narrowed neck portion fifth
  • Fig. 8b shows in a schematic sectional view of the holder of a vial in a variant of the support structure according to the Fig. 2c in which side walls 32 protrude vertically from the underside of the carrier 30, which at least partially surrounds the vial held in the opening of the carrier 30 in the circumferential direction, in order to prevent a collision of immediately adjacent containers.
  • a support structure as described above may be inserted and transported in a trough-shaped transport and packaging container 60, such as shown in FIG Fig. 8c shown.
  • the transport and packaging container 60 is substantially box-shaped or trough-shaped and has a bottom 61, a vertically projecting from this, circumferentially formed side wall 62, a substantially perpendicularly projecting from this step 63 and an upper edge 65 which is formed like a flange is.
  • Such a transport and packaging container 60 is preferably made of a plastic, in particular by plastic injection molding technology, and is preferably formed of a clear, transparent plastic to a visual visual inspection of the recorded in the transport and packaging container 60 holding structure and held by the latter To enable container 2.
  • the step 63 of the transport container 60 is formed as a circumferential, planar support surface, on which the support structure rests directly.
  • the support structure can be precisely positioned in the transport container 60 and the plurality of containers 2 can thus be arranged and held in a regular arrangement and at precisely defined positions in a transport container 10 with standardized dimensions.
  • it can be ensured in this way that all bottoms of the containers are arranged in a plane spanned jointly parallel to the bottom 61 or to the upper edge 65 of the transport container 10.
  • the transport container 60 has provisions for identification and / or tracking as follows: As in the enlarged use of Fig. 8c 1, an electronically wireless-readable RFID chip or RuBee chip 52 is disposed in the region of the access recess 63 between the support plate 30 and the side wall 62 and / or the step 63 of the container (a RuBee chip transmits to frequencies that Metal and water can penetrate), which can be read out without contact through the side walls of the packaging unit and on request information regarding the identity, important product properties (manufacturer, content, date of manufacture, expiration date, etc.) etc. issues.
  • the chip 52 may be glued into the packaging unit 1 at a suitable location, also elsewhere than shown in the figure.
  • the chip 52 may be arranged such that in the case of opening the packaging unit 1 or removing the holding plate 30 from the packaging unit, the chip 52 is destroyed, for example, torn or rendered inoperative. Due to the lack of response of the chip 52 to a radio interrogation, information is thus available which indicates that the packaging unit has been manipulated in some way since the previous packaging. Because the chip 52 does not respond to the radio query. This can serve, for example, to prove the authenticity and integrity of the packaging unit and the containers accommodated therein.
  • FIGS. 9a to 9c show in plan views holding means according to further embodiments according to the present invention.
  • a plurality of annular receptacles 43 are arranged distributed at regular intervals spaced from each other.
  • the receptacles 43 are formed by two semicircular ring segments 41, between which an insertion opening 42 is formed, through which the containers can be inserted radially inwardly.
  • Between The thus formed holding elements are spaces 44 formed so that the holding elements can be formed of relatively narrow plastic webs, which are flexible and resiliently bendable.
  • the retaining bar 40 is clipped in the manner described above in a carrier (not shown).
  • the circular receptacles 43 are formed only along one longitudinal side of the holding web 40.
  • predetermined breaking lines or weakening areas 45 are formed in the holding web 40 at regular intervals, where it can be broken apart into smaller subunits.
  • FIGS. 9d to 9f exemplify various basic forms of the holding receptacles 43.
  • the semicircular webs 41 are relatively strong and thus relatively little elastic.
  • the holding receptacle has a square cross-section, wherein the opening width of the receptacle 43 formed by the inner edges 47 is greater than the clear width between the edges 46 of the insertion opening 42.
  • a plurality of containers may be held together on a carrier and, while held or at least guided on the carrier, may be treated or further processed.
  • this approach is generally suitable for any process steps for treating or processing containers for storing substances for cosmetic, medical, or pharmaceutical applications.
  • the holding force exerted on the containers by the holding element is sufficient to reliably hold the containers in the holding element and on the holding structure.
  • the holding force exerted is greater than the weight of the container, possibly with content and plugs.
  • the holding force can also be dimensioned by suitable design of the holding means so that it is greater than a conventional force in handling, processing or treating the containers in a process plant. As a result, a reliable mounting of the container is always guaranteed.
  • the containers can be adjusted by simply gripping and adjusting the holding elements together with each held by these containers without much resistance in the openings or recordings, in particular axially advanced or rotated.
  • the containers For inserting, removing or moving the containers on a carrier, it is simply necessary for the containers to be suitably inserted into the receptacles of the holding elements and to be clipped into the carrier in such a way that the containers are inserted into the openings or receptacles of the carrier.
  • the resulting achievable mounting of the container is sufficiently stable, so that they continue to be held reliably on the carrier and not accidentally fall over when exposed to a low force, such as vibrations of the process plant or funding of the same. This considerably reduces the risk of unintentional contamination in process plants.
  • Another significant advantage of the present invention is that the containers can be inserted from above into the openings or receptacles of the carrier and can also be taken out of these again or axially adjusted. The risk of accidental penetration of particles into the internal volume of the container can thus be minimized.
  • the support structure (nest) and / or the transport and packaging container (tub) in the context of the present invention may be formed of a thermoplastic, thermosetting or elastomeric plastic, and / or provided at least portions of the support structure or the carrier with a reibredumpden coating be to facilitate the insertion and removal of the containers.
  • so-called cycloolefin copolymers (COC) or cycloolefin polymers (COP) can be used.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
EP14189210.9A 2013-10-21 2014-10-16 Structure de support de récipients pour substances destinées aux applications médicales, pharmaceutiques ou cosmétiques ainsi que récipient de transport ou d'emballage en étant équipé Active EP2862809B1 (fr)

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DE102013111600.0A DE102013111600B4 (de) 2013-10-21 2013-10-21 Haltestruktur zum Halten von Behältern für Substanzen für medizinische, pharmazeutische oder kosmetische Anwendungen, sowie Transport- und Verpackungsbehälter mit selbiger

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EP2862809A2 true EP2862809A2 (fr) 2015-04-22
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US (1) US10064787B2 (fr)
EP (1) EP2862809B1 (fr)
KR (1) KR101695065B1 (fr)
CN (1) CN104555014B (fr)
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MX (1) MX351586B (fr)

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EP2862809B1 (fr) 2016-10-05
US20150108034A1 (en) 2015-04-23
KR101695065B1 (ko) 2017-01-23
US10064787B2 (en) 2018-09-04
CN104555014A (zh) 2015-04-29
MX2014012707A (es) 2015-06-24
KR20150045905A (ko) 2015-04-29
DE102013111600B4 (de) 2018-04-05
MX351586B (es) 2017-10-20
DE102013111600A1 (de) 2015-04-23
EP2862809A3 (fr) 2015-12-23
CN104555014B (zh) 2017-06-30

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