EP3329997A1 - Structure de maintien permettant de tenir une multitude de flacons, utilisation d'une telle structure ainsi que procédé de traitement de telles flacons - Google Patents

Structure de maintien permettant de tenir une multitude de flacons, utilisation d'une telle structure ainsi que procédé de traitement de telles flacons Download PDF

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Publication number
EP3329997A1
EP3329997A1 EP17201410.2A EP17201410A EP3329997A1 EP 3329997 A1 EP3329997 A1 EP 3329997A1 EP 17201410 A EP17201410 A EP 17201410A EP 3329997 A1 EP3329997 A1 EP 3329997A1
Authority
EP
European Patent Office
Prior art keywords
vials
receptacles
support structure
openings
support
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.)
Pending
Application number
EP17201410.2A
Other languages
German (de)
English (en)
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 Pharma AG and Co KGaA
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 EP3329997A1 publication Critical patent/EP3329997A1/fr
Pending legal-status Critical Current

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Classifications

    • 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
    • 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
    • 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
    • B65D71/00—Bundles of articles held together by packaging elements for convenience of storage or transport, e.g. portable segregating carrier for plural receptacles such as beer cans or pop bottles; Bales of material
    • B65D71/70—Trays provided with projections or recesses in order to assemble multiple articles, e.g. intermediate elements for stacking
    • 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
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B21/00—Packaging or unpacking of bottles
    • B65B21/02—Packaging or unpacking of bottles in or from preformed containers, e.g. crates
    • 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
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/24—Cleaning of, or removing dust from, containers, wrappers, or packaging ; Preventing of fouling
    • 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
    • B65B63/00—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
    • B65B63/08—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for heating or cooling articles or materials to facilitate packaging
    • 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
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/22—Details
    • B65D77/24—Inserts or accessories added or incorporated during filling of containers
    • B65D77/26—Elements or devices for locating or protecting articles
    • 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
    • B65D85/00—Containers, packaging elements or packages, specially adapted for particular articles or materials
    • B65D85/30—Containers, packaging elements or packages, specially adapted for particular articles or materials for articles particularly sensitive to damage by shock or pressure
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • 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
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/025—Align devices or objects to ensure defined positions relative to each other
    • 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
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0829—Multi-well plates; Microtitration plates
    • 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
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
    • B01L2300/0835—Ampoules

Definitions

  • the present invention relates generally to the treatment of containers for substances for pharmaceutical, medical or cosmetic applications, and more particularly relates to a holding structure for simultaneously holding a plurality of vials, uses thereof and a method for treating such vials, in particular for lyophilizing substances for pharmaceutical or medical applications.
  • vials also referred to as vials or injection vials
  • vials are widely used. These generally have a cylindrical shape, can be made of plastics or glass and are available in large quantities at low cost.
  • lyophilization processes are used after bottling.
  • the vials must be unpacked at the bottler or a pharmaceutical company under sterile conditions and then further processed.
  • packaging solutions of vials that can be lyophilized in a nest and / or within the package.
  • Such support structures are in WO 2009/015862 A2 .
  • WO / 2014/009037 A1 discloses a holding structure according to the preamble of claim 1, wherein the holding means comprise at least two retaining tongues, which are provided at the edge of a respective opening or receptacle and are designed so that it is elastically pivoted away during insertion of the container into the openings or receptacles or folded away, and so matched to the vials that the vials are held by the retaining tongues with radial play.
  • the bottoms of the vials are freely accessible from the bottom of the support structure, allowing for a lyophilization process to be performed while the vials are held to the support structure.
  • the retaining tongues of the support structure are not always sufficiently stable, especially for holding large and heavy vials.
  • the vials between the retaining tabs also occurs some material abrasion, which is undesirable.
  • the tabs must be precise and designed with relatively tight tolerances so that the vials can be kept as intended with play.
  • the wearer may warp when using, due to process parameters such as temperature or humidity, dwindle, so that it may happen that the relatively tight tolerances can not be met and thus there is a relatively large, undesirable material abrasion occurs.
  • the bottleneck is not freely accessible.
  • process steps such as weighing, filling, setting plugs or crimping metal lids, the vials must therefore be raised, which requires appropriate equipment.
  • the vials are automatically removed from the holding structure or inserted into the prior art for further processing by means of robots or gripping devices.
  • it is difficult to remove or insert all the vials at the same time, since then relatively large forces act on the support structure, the example can lead to an uncontrolled bending of the support structure or even accidental falling out of the vials from the support structure. Therefore, in the prior art, usually only a subset of the vials are taken out or used with a robot or gripper, the total number of vials of that subset being dependent on what forces the support structure can accommodate without excessive deformation. This leads to delays and a higher cost in the further processing of the vials.
  • WO 2016/07564 A1 discloses a lyophilization process in which the bottoms of the containers are not in direct contact with a cooling surface.
  • WO 2016/166 769 A1 discloses a support structure for holding pre-crimped carpules Fig. 6a are shown, at the lower end of the receptacles annular projections are formed, on which the shoulders of the carpules are supported, without the crimp caps rest in this area. The ends of the carpules protrude from the Shots while the cartridges are supported. The holder of vials is not revealed.
  • WO 2010/062 602 A1 discloses the mounting of a plurality of sealing plugs. The holder of vials is not revealed.
  • EP 2 183 166 B1 discloses the mounting of vials in the manner that the bottoms of the vials held on the support structure are freely accessible from the underside of a carrier. However, the vials are always held at their upper ends, ie in the area of the neck or neck of the vials.
  • US 2013/0 048 531 A1 discloses a support structure for vials in which radial retention tabs on the lower ends of the receptacles support the bottoms of the vials.
  • the floors of the vials held on the support are not freely accessible within the meaning of the present application.
  • US 8 561 828 B2 discloses another vial support structure in which radial retention projections on the lower ends of the receptacles support the bottoms of the vials.
  • the floors of the vials held on the support are not freely accessible within the meaning of the present application.
  • a support structure for simultaneously holding a plurality of vials comprising a support having an upper side, a lower side facing the upper side, and a plurality of openings or receptacles into which the vials are at least partially insertable, to be supported therein on the support, the vials having a bottom forming a footprint, a cylindrical sidewall and an annular transition region between the footprint and the cylindrical sidewall.
  • At least one holding projection protrudes radially inwards into the respective opening or receiving at the lower end of a respective opening or receptacle in order to support the associated vial in cooperation with the transition area and outside the standing area of the vial in such a way that bottoms of the vials emerge from the openings or protrude receptacles of the carrier and are freely accessible from the underside of the carrier.
  • the transition region of the vials is preferably a curved edge section in a transition section between the respective floor or the standing surface to the cylindrical side wall of a vial, which is located outside the footprint of the vial.
  • the footprint of a vial is defined as the contact surface of the vial when placed on a flat surface. In the case where the bottom of a vial is flat, this contact surface is circular and represents the deepest portion of a vial when viewed in axial longitudinal section. In the case that the bottom of a vial is formed concavely, this contact surface is annular and is formed by lower vertexes of the vial, which are arranged distributed in a ring, when viewed from below the vial in a plan view.
  • the floors or bases of the vials are freely accessible, which in particular makes it possible to carry out a lyophilization process while the vials are held on the retaining structure.
  • the vials protrude substantially only over a distance from the openings or receptacles, which corresponds to an axial length of the holding projections (in a direction perpendicular to a plane spanned by the carrier).
  • This distance may be in the range of about 0.01 to 5.0 mm, preferably in a range between 0.01 and 2.0 mm, so that only small axial adjustment paths are required, for example, for a Lyophilticianslui a full-surface contact of the soil or To ensure that the vials have a cooling surface by simply lowering the support structure in the millimeter or submillimeter range, so that the vials stand freely on the cooling surface during the actual lyophilization process.
  • the holding structure can be kept even further spaced from the cooling surface, which further reduces the thermal mass during the Lyophilmaschinesvones.
  • the holding structure can also be simply lowered onto the cooling surface for the lyophilization process. The same applies to other processes that require free accessibility of the floors or floor space of the vials.
  • the vials at their lower ends not only the lower ends of the vials, so in particular the bottoms or surfaces, but also the upper ends of the container, in particular the narrowed neck portion or the filling opening, freely accessible, while the vials on the support structure are held, since a further support in this area is not required according to the invention.
  • the vials need not be lifted according to the invention, which helps to reduce the effort involved in processing the vials.
  • the retaining projections only slight forces occur at the retaining projections, so that the retaining projections cause self-centering of the vials in the openings or receptacles in particular, when the retaining projections are arranged as circumferentially formed projections or as a plurality of projections in a suitable symmetrical arrangement along the lower ends of the openings or receptacles.
  • the shape of the retaining projections is not particularly limited. These need only allow a support of the vials at the edge portions. Conceivable are thus flat, exactly horizontal (parallel to the plane spanned by the support of the support structure level) and radially inwardly extending projections, but also chamfered, concave or convex curved holding projections or holding projections with multiple holding levels. It is important only an intervention in edge portions or transition areas of the vials "above" the floors or standing surfaces of the vials, more preferably exclusively within a transition region between the floors or stand surfaces and cylindrical side walls of the vials, so for example within the curved transition region there.
  • the cylindrical sidewalls of the vials are automatically spaced from the sidewalls of the apertures or receptacles of the support structure, ie there is radial play in the region of the cylindrical sidewalls, which further favors the aforesaid self-centering of the vials in the apertures or receptacles, however also allows a frictionless insertion of the vials from the top of the carrier forth in the openings or recordings of the support structure, which reliably prevents the aforementioned material abrasion.
  • the retaining projections are adapted to the shape and dimensions of the edge portions of the vials, that the edge portions are supported exclusively by a positive connection, but not frictionally. This reliably prevents the aforementioned unwanted abrasion of material on the retaining projections.
  • Proper positive locking presupposes only that the holding projections protrude sufficiently far in the radial direction in order to sufficiently engage with the aforementioned transition regions or edge sections of the vials.
  • a coating with a relatively high coefficient of friction for example of a plastic, which may also be sprayed in two-component (2K) injection molding, may be provided on the retaining projections, in particular at their front ends, to prevent accidental slippage of the vials.
  • a suitable form-fit can be ensured in a simple manner in particular by the fact that the front ends the retaining projections with tight tolerances are adapted exactly to the geometry of the edge portions of the vials.
  • the surfaces of the retaining projections facing these edge portions may also be concave curved at least in sections, preferably with a radius of curvature corresponding to the radius of curvature of the aforementioned edge portions of the vials ,
  • the surfaces of the holding projections which face a respective transition region of a vial, are inclined at least in sections towards the underside of the carrier.
  • the angle of inclination corresponds expediently to the angle of inclination of a tangential to the transition region of the vials approximately in the region of the middle between the bottoms and the cylindrical side walls, viewed in a side view.
  • this angle of inclination can therefore be in the range of approximately 45 degrees.
  • this angle of inclination depends in particular on the size of the radius of curvature of the transition areas and is subject to a compromise between the two requirements that on the one hand the bottoms or lower ends of the vials for ease of accessibility should protrude as far as possible from the openings or recordings, but on the other hand, a reliable Supporting the vials must be ensured at the transition areas under all conceivable process conditions, in particular by a positive connection, while sufficient radial clearance between the side walls of the vials and the side walls of the openings or receptacles of the support structures must be during insertion and holding of the vials.
  • the optimum angles of inclination for this purpose can be calculated by simple calculations and numerical optimization in correspondence with the respective geometry of the aforementioned edge sections.
  • the surface of the holding projections facing the edge portions is inclined at a predetermined angle to a perpendicular to a plane spanned by the carrier to the underside of the carrier, said predetermined angle preferably being in the range of 10 to 70 degrees, more preferably in the range of 20 to 50 degrees ,
  • straight portions are additionally formed at front ends of the holding projections, which extend perpendicular to a plane spanned by the carrier plane.
  • These axially extending portions are thus disposed below the actual retaining projections and serve to sufficiently stiffen the retaining projections to effectively prevent unwanted bending of the retaining projections, which would result in an undesirable slippage of the vials.
  • This axial length depends essentially on the stiffness of the material of the holding projections and the carrier or the side walls of the carrier, as well as the weight and the exact geometry of the aforementioned transition region of the vials to be held and can be easily calculated and optimized.
  • the axial length of the aforesaid straight portions of the holding projections in a direction perpendicular to the plane defined by the carrier is in the range of 0.1 to 5.0 mm, more preferably in the range of 0.1 to 2.0 mm, in particular of the rigidity the material of the retaining projections and the carrier or the side walls of the carrier depends.
  • the predetermined radius of curvature of the transition sections of the vials is subject to very tight tolerances due to manufacturers' standards and general specifications, and is usually in the range of 1.0 to 10.0 mm, more preferably in the range of 1.5 to 4.0 mm.
  • the retaining projections are adapted to the shape of the transition region of the vials so that the bottoms or base surfaces of the vials protrude from the openings or receptacles of the support by a distance in the range of 0.01 to 5.0 mm, more preferably in the range 0.01 to 2.0 mm. This advantageously allows short adjustment paths of the containers according to the invention if the vials are to be accessible without force, for example to stand freely on a cooling surface. Thus, even shorter process times are possible according to the invention.
  • the retaining projection is designed to be circumferential at the lower end of a respective opening or receptacle.
  • at least two retaining projections are formed at equal angular intervals to each other at the lower ends of the openings or receptacles, wherein a circumferential length of interruptions between two adjacent retaining projections of an opening or receptacle is smaller than a circumferential length of the respective retaining projections.
  • the vials can thus be positioned and aligned even more precisely, in particular in such a way that the bottoms of all vials are likewise aligned exactly horizontally when the carrier is oriented horizontally, ie parallel to a likewise horizontal cooling surface of a freeze drier.
  • the receptacles are designed such that upper ends of the vials do not project beyond the upper side of the carrier.
  • the vials can therefore be completely absorbed in the recordings protected against mechanical impact.
  • the upper ends of the vials can be arranged essentially flush with the plane spanned by the upper side of the carrier, or at a very small distance therefrom, which distance can be appropriately smaller the aforementioned distance by which the bottoms or bases of the vials in the holding position protrude from the openings or recordings.
  • the treatment of the vials can be achieved by simple axial adjustment of the support structure by this distance to a support surface arranged below the same that the upper ends of the vials protrude by this distance from the recordings of the support structure, which is a gripping of the vials by robots or facilitate gripping or further processing of the upper ends of the vials, such as setting plugs and / or crimping a metal lid with septum.
  • the receptacles of circumferentially formed side walls are formed, which allows an even better mechanical protection of the side walls of the vials.
  • further intermediate spaces can be formed between the side walls of immediately adjacent receptacles, into which cooling fingers can protrude.
  • the retaining projections at the lower ends of the side walls are formed integrally therewith, in particular by means of a plastic injection molding process, which reduces the manufacturing costs and increases the mechanical reliability of the support structure, but also allows a higher precision in the production of the support structure, in particular the compliance very close tolerances.
  • slots are formed at the lower ends and on opposite sides of the side walls of the receptacles.
  • strip-like height adjusters may be engaged below the bottoms of the vials and aligned with these slots and may properly elevate the vials by height adjustment to facilitate removal and insertion of the vials from and into the receptacles of the support structure.
  • the slots allow the support structure to bend and thereby widen the lower ends of the receptacles, allowing the vials to be "released" down.
  • the carrier is designed as a flat, comparatively thin holding plate, in which the openings are formed directly, wherein at lower ends of the openings, the holding projections are formed integrally with the holding plate, in particular by means of a plastic injection molding process.
  • the vials in this embodiment are thus substantially not guided and secured laterally when they are held on the support structure. Depending on the process conditions, however, this may be sufficient, especially if it is to be assumed that the vials do not act on any significant forces during their treatment. In this alternative embodiment, optimal accessibility of virtually all sections of the vials is ensured.
  • Sectional guide elements are provided which extend perpendicular to the top of the holding plate to prevent contact of vials which are supported in immediately adjacent openings.
  • These guide elements can be provided, for example, as vertical pins or plates at the edge of the openings on the upper side of the carrier, expediently at uniform angular distances from each other. Gaps between these guide elements can continue to allow access to the side walls of the vials while they are held on the support structure.
  • the openings or receptacles are matched to an outer diameter of the vials supported therein, that a radial play exists above the aforementioned edge sections of the vials, ie to side walls of the openings or receptacles.
  • This radial clearance according to the invention allows a low-force and completely friction-free adjustment of the vials in the receptacles in a direction perpendicular to the top of the carrier, so in the axial direction of the vials, including preferably further supports the support of the vials exclusively due to a positive connection of the aforementioned transition regions or edge portions of the vials with the retaining projections.
  • the vials can thus be axially adjusted already by the action of very small forces, that is raised in the openings or receptacles of the support structure and lowered again.
  • a fluid gas and / or liquid
  • pressure pulses of low intensity may be sufficient.
  • the vials are received in receptacles of the holding structure, which are formed by circumferentially or substantially circumferentially formed side walls extending over a certain length of the vials, for example over at least 50% of the length of the vials, or over the entire Length of the vials extend, forming a comparatively narrow annular gap to the side walls of the container. Since the fluid flow can only escape from the receptacles through the comparatively narrow annular gap, even comparatively small fluid flows can also axially adjust heavy or long vials.
  • such a fluid flow can be used not only for lifting but also for cleaning the outer surface of the vials while the vials are received and held in the receptacles.
  • the aforementioned comparatively narrow annular gap between the side walls of the receptacles and the side walls of the vials leads to an intensification of the cleaning effects, because the cleaning fluid (liquid, gas or sprayed cleaning fluid) can flow only in the annular gap, but can not escape into the environment uncontrolled.
  • the vials are closed at their upper ends before such a cleaning step, for example by placing a plug. For safety reasons, for example, such a cleaning step may be necessary after the filling of certain medicaments (eg cytostatics).
  • Such gas pressure pulses acting from beneath the support structure may also be used to remove the vials by sufficiently lifting the vials until their tops are then gripped by a robot, gripper, or the like, and then the vials can be further removed.
  • gas pressure pulses acting from above the support structure may also be used to express the containers downwardly from the receptacles.
  • the gas pressure pulses must act sufficiently intense on the upper ends of the vials that the holding force exerted by the holding projections is suppressed, possibly with elastic widening or spreading of the retaining projections and / or the lower ends of the side walls of the receptacles of the support structure.
  • an intensification of gas pressure pulses, which act from above on the vials it may be advantageous for the aforementioned reasons, if the axial length of the receptacles is greater so that the axial length of the container.
  • Comparable fluid flows may also act on the tops of the vials for cleaning purposes while they are received in the seats and held to the support structure to clean the tops as well as the other exterior surfaces of the vials.
  • the vials are closed at such a cleaning step at their upper ends, for example by placing a plug.
  • corresponding fluid flows or fluid pressure pulses may also act on the upper and / or lower ends of the vials when the filling openings of the containers are not yet closed at their upper ends and while the vials are held to the support structure, such as the Interior surface of the vials to clean.
  • a nozzle or a pipe can also be introduced into the interior of the vials via the filling opening in order to introduce a cleaning fluid even more effectively into the interior of the containers.
  • Another aspect of the present invention relates to the use of a support structure as disclosed in the present application for simultaneously holding a plurality of containers for pharmaceutical or medical substances Applications, something during their treatment in a process plant, in particular a freeze-drying (lyophilization).
  • Another aspect of the present invention which may also be explicitly claimed as an independent invention by means of an independent claim, relates to a computer- or processor-readable file, also for transmission over networks, such as an in-house computer network or over the Internet, comprising instructions or control commands which, when loaded by a computer or processor, cause a 3D printer, under the control of the computer or processor, to provide a support structure, as disclosed in the present application, of a suitable material, particularly a plastic material, in three-dimensional Print form.
  • Another aspect of the present invention relates to a transport or packaging container for a plurality of vials, wherein the transport or packaging container is box-shaped and wherein a holding structure as disclosed in the present application is accommodated in the box-shaped transport or packaging container to hold the plurality of vials in the transport or packaging container.
  • Another aspect of the present invention relates to a method of treating vials having a bottom forming a footprint, a cylindrical sidewall, and an annular transition region between the footprint and the cylindrical sidewall, comprising the steps of: providing a support structure as in disclosed in the present application; Arranging the vials in the openings or receptacles of the support structure, so that the vials are supported by interaction of the transitional areas with the holding projections outside the standing surfaces so that the bottoms of the vials protrude from the openings or receptacles of the carrier and from the underside of the carrier are freely accessible; and treating the containers while they are held on the support structure and received in the openings or receptacles
  • the step of treating the vials comprises one or more of the following steps: freeze-drying (lyophilizing) a substance for pharmaceutical or medical applications in the vials; axial displacement of the vials in the apertures or seats by the action of a fluid flow acting on the bottoms or tops of the vials; Cleaning outsides of the vials by means of a fluid flow which flows into the receptacles of the support structure via a lower or upper end; Drying the outer sides of the vials by means of a gas flow, which flows via a lower or upper end into the receptacles of the support structure.
  • intermediate spaces are formed between the side walls of immediately adjacent receptacles of the support structure, protrude into the cooling fingers, which surround the receptacles of the support structure at least in sections.
  • the cooling surface is also flat and flat, so that the bottoms of the vials can be fully exposed to the at least one cooling surface during lyophilization.
  • a space may also be formed between the at least one cooling surface and the associated bottom of the vials during lyophilization, which in the latter case may also be realized by concave depressions on top of the cooling surface.
  • convex protrusions may also be formed on the upper side of the cooling surface on which the concavely bottoms of the vials rest directly.
  • FIG. 1a shows the geometry of typical 2R vials to 50R vials (4 ml to 62 ml capacity) summarized in Table 1 below.
  • Table 1 Typical geometry of 2R vials to 50R vials Type Volume [ml] a [mm] d1 mm d2 mm d3 mm max. d4 mm h1 mm h2 mm min. h3 mm r1 mm ⁇ r2 mm ⁇ s1 mm s2 mm min. t mm max. Tol. Tol. Tol. Tol. Tol. Tol. Tol.
  • this transition region 8 is considered as an edge section which, in the longitudinal direction of the vials, lies outside the actual standing surface of the vial 1, this base surface being defined as the contact surface of a vial 1 when placed on a flat base.
  • this contact surface is circular and represents the deepest portion of a vial 1, when viewed in an axial longitudinal section.
  • this contact surface is annular and is formed by the vertices 9 of the bottom 3 of the vial 1. These vertexes extend annularly along the edge of the bottom 3 when viewing the vial 1 in a bottom view.
  • Fig. 2b can refer to this transition region 9 or edge portion between the bottom 3 and the standing surface and the cylindrical side wall 2 of the vial 1 and is thus clearly delimited to both sections. While in the embodiment according to the Fig. 2a the cylindrical side wall 2 and the bottom 3, at least on the edge of the vial, are flat, the transition region or edge portion 8 is formed with a uniform curvature radius r2 uniformly curved.
  • this transition region or edge section 8 has a precisely predetermined geometry, which is utilized according to the invention to precisely match the geometry of holding projections 15 at the lower end of the side walls 14 of the holding structure receptacles to the geometry to tune the transition areas or edge portions 8 of the vials.
  • the retaining projections 15 are formed so that they interact exclusively with the transition regions or edge portions 8 of the vials, ie only within the aforementioned clearly defined transition region between the cylindrical side walls 2 and the bottom 3. In other words, the retaining projections 15 act exclusively with portions of the vials outside the respective footprint together, however, do not cooperate with the cylindrical side wall 2.
  • the holding projections 15 can support or hold these transition areas or edge sections by positive engagement or frictional engagement.
  • a purely form-fitting support of the transition regions or edge portions 8 by the holding projections 15 is preferred, for which it is sufficient that the holding projections 15 project sufficiently radially inwardly into the openings or receptacles of the holding structure to prevent downward slipping of the vials.
  • an evaluation of the typical geometrical conditions at the lower ends of vials, but also of other pharmaceutical containers, such as carpules has shown that it is possible to make holding projections 15 of suitable materials with sufficiently close tolerances so that such support is reliably ensured ,
  • FIG. 2b Shown is an overall tubular receptacle 12 which is formed by a circumferential side wall 14 of the support structure (not shown). The side wall 14 may extend vertically downwards (as shown schematically in FIG Fig.
  • 2a may also be uniformly inclined, radially inwardly inclined, about a relatively small angle relative to a bisector.
  • This angle may be, for example, in the range of about 1 degree to about 3 degrees, more preferably about 1 degree to about 2 degrees, in particular to allow demolding of the support structure from a mold in the case of its manufacture by means of an injection molding process.
  • At the lower edge of the side wall 14 at least one retaining projection 15 is formed, as in the Fig. 2b shown enlarged.
  • the bottom 3 of the vial 1 projects beyond the lower edge of the side wall 14, but the transition portion or edge portion 8 of the vial 8 is supported sufficiently to the total weight of the vial 1, including the contents and a closure (not shown), and to prevent slippage of the vial 1 from the receptacle 12. It can be clearly seen in the Fig. 2a Also that in the inventive type of support at the same time a gap between the inside of the side wall 14 and the outside of the cylindrical side wall 2 of the vial first is formed, which allows a frictionless insertion of the vial 1 in the receptacle 12 from above and an axial adjustment of the vial 1 within the receptacle 12 with very little force.
  • Fig. 2c greatly enlarged for an embodiment of a vial with a flat bottom 3 shown. It also specifies tolerances and dimensions in millimeters for 2R vials and 4R vials, and provides mathematical formulas for the dependence of important quantities of tolerances and geometric parameters.
  • the tolerance considerations indicate that the distance by which the retaining projections project radially into the openings or receptacles should be at least> 50% of the r2 value (rounding radius).
  • the retaining projections should taper towards the end (which is an advantage, but not essential).
  • the material thickness at the front end of the holding projections should be ⁇ 50% of the r2 value.
  • the max. The fit from Table 2 is equal to or less than 50% of the ground radius r2.
  • the holding structure can be realized inexpensively with sufficient accuracy by an injection molding process, by a deep drawing process or by 3D printing.
  • the carrier may also be formed of a fiber-reinforced plastic or a plastic, which are added to increase its thermal conductivity ceramics or metals.
  • fiber-reinforced plastics have a higher thermal conductivity of up to 0.9 W / (m * K) with the addition of carbon fibers. If ceramics or metals are added to the plastics, the thermal conductivity is further increased. The result is the so-called thermally conductive plastics.
  • a thermal conductivity of the material of the support structure of up to 20 W / (m * K) is achieved.
  • the Figures 3a-3b show two examples of a support structure 10 according to the present invention in plan view.
  • the individual openings or receptacles 12 in the carrier 11 are preferably arranged in a regular arrangement, for example in a matrix arrangement along rows and columns extending at right angles thereto (FIG. Fig. 3a ) or along rows crossing at an acute angle ( Fig. 3b ).
  • This has advantages in the automated further processing of the vials, since the vials can be transferred to processing stations in controlled positions and in a predefined arrangement, for example to process machines, robots or the like.
  • the separation between the openings or recordings can also be realized via individual webs.
  • Figures 3c-3e shows three examples of the shape of holding projections 15 of a holding structure according to the present invention in plan view.
  • Fig. 3c is a single retaining projection 15 formed as circumferentially formed, radial projection around the lower edge of the side wall 14.
  • two retaining projections 15 are arranged at uniform angular intervals to each other and with gaps 16 between them along the lower edge of the side wall 14 distributed.
  • Fig. 3e are a plurality of holding projections 15 at equal angular intervals to each other and with gaps 16 between them along the lower edge of the side wall 14 distributed, whereby a certain flexibility of the retaining projections 15 can be determined in a simple manner.
  • the retaining projections 15 By material and thickness of the retaining projections 15, these can be given sufficiently stable to reliably support the vials at their edge portions and thereby reliably prevent slippage of the vials.
  • the concrete shape of the retaining projections 15 also has an influence on the achievable holding force of the retaining projections.
  • the surface 17 of the holding projections 15 facing the transition region or edge section 8 can be inclined at a predetermined angle to a perpendicular to a plane spanned by the carrier towards the underside of the carrier, as in FIG Fig. 2c shown, wherein the angle is specifically matched to the geometry of the container to be held at its lower end, but is usually about 45 degrees and conveniently in the range 10 to 70 degrees, more preferably in the range 20 to 50 degrees.
  • the surface 17 of the holding projections 15 facing the transition region or edge section 8 can also be arched, in particular concavely curved, with a radius of curvature substantially corresponding to the aforementioned bottom radius r 2 of the vials to be held.
  • additional straight portions 18a may be formed, which extend perpendicular to a plane spanned by the carrier, ie in the longitudinal direction of the vials to be held, the axial length lz of the straight portions 18a in a direction perpendicular to the plane spanned by the carrier plane then substantially determines the flexural rigidity of the holding projections 15.
  • this axial length lz may be in the range 0.1 to 5.0 mm, more preferably in the range 0.1 to 2.0 mm.
  • Fig. 4a shows a support structure 10 according to a first embodiment of the present invention in a side view.
  • This is formed overall as a nest with a plurality of tubular receptacles for receiving the vials, preferably completely or over their entire length, and has an upper retaining flange 20, which is followed by an upper side wall 21 with a horizontal step 22 at its lower edge ,
  • the tubular receptacles for receiving the vials extend from this step 22 vertically downwards.
  • the space formed by the upper side wall 21 may be trough-shaped.
  • the upper ends of in the shots When the upper ends of in the shots When the inserted vials protrude into this space, the upper ends can be grasped in a simple manner, for example by robots or gripping devices, in order to remove the vials from the receptacles upwards or to insert the vials into the receptacles from above.
  • Slots 24 may be formed at the lower ends of the side walls 23 which are aligned with each other in predetermined directions, such as along a direction perpendicular to the longitudinal side of the support structure 10 as shown in FIG Fig. 4a shown.
  • strip-like height adjustment devices can engage in the slots 24, which are arranged below the bottoms of the vials and aligned with these slots 24 to raise and lower the vials suitable by height adjustment.
  • the slots 24 allow bending of the support structure 10 and thereby widening of the lower ends of the receptacles, whereby the vials can be "released" down.
  • Fig. 4b shows the inclusion of such a support structure 10 in a trough-shaped transport and packaging container 50 (also referred to as so-called. Tub).
  • the transport and packaging container 50 has a closed bottom 51, a substantially perpendicular projecting from this, circumferentially formed lower side wall 52, a subsequent this horizontal step 53, on which the upper retaining flange 20 of the support structure 10 is supported, an upper, in With respect to a perpendicular to the bottom 51 inclined upper side wall 54 and a flange 55 at the upper edge.
  • the transport and packaging container 50 can be closed by means of a protective or packaging film adhered to the upper edge 55.
  • the protective film may in particular be a gas-permeable plastic film, in particular a braid of synthetic fibers, for example of polypropylene fibers (PP), or also a Tyvek® protective film, which sterilizes the vials accommodated and packed in the holding structure 10 through the film allows.
  • PP polypropylene fibers
  • Tyvek® protective film which sterilizes the vials accommodated and packed in the holding structure 10 through the film allows.
  • the Fig. 5 shows a support structure 10 according to a second embodiment of the present invention in a perspective plan view.
  • This is designed as a flat retaining plate 11 of comparatively small thickness, preferably made of a plastic, as stated above.
  • the openings 12 are formed as through holes, at the lower end of the holding projections 15 in the formed above, preferably integrally with the holding plate 11 in order to support the vials sufficiently.
  • guiding elements 28 in the form of pegs may be provided at least in sections on the upper side of the holding plate 11 along edges of the openings 12 , Plates or the like, which extend perpendicular to the top of the holding plate 11.
  • FIGS. 6a-6d show examples of the use of a holding structure according to the present invention in freeze-drying, each in a schematic side view.
  • the cooling surface 30 is flat.
  • the bottoms of the vials 1 are in direct contact with the upper side of the cooling surface 30.
  • the holding structure 20 is also expediently located on the upper side of the cooling surface 30, so that the vials 1 are exposed on the cooling surface 30.
  • the holding structure 20 may also be raised by a small distance relative to the cooling surface 30, as long as the direct contact of the bottoms of the vials 1 with the top of the cooling surface 30 is ensured.
  • the bottoms 3 of the vials 1 are concavely curved in the center, so that an annular, convex gap is formed between the top of the cooling surface 30 and the bottoms 3, which may have a beneficial effect on a freeze-drying process.
  • an annular, convex gap is formed between the top of the cooling surface 30 and the bottoms 3, which may have a beneficial effect on a freeze-drying process.
  • between the side walls 14 of immediately adjacent receptacles 12 of the support structure spaces is formed, protrude into the cooling fingers 31, which surround the receptacles 12 of the support structure at least partially and preferably circumferentially. This can provide even faster and more effective cooling in freeze-drying.
  • the bottoms 3 of the vials 1 are formed concavely concave in the center, on the top of the cooling surface convex projections 33 are formed, with a radius of curvature, which is matched to the radius of curvature of the bottom 3, to a direct contact between the bottom 3 and top of the cooling surface 30 to ensure.
  • the bottoms 3 of the vials 1 are formed concavely concave in the center, on the top of the cooling surface concave depressions 34 are formed to the reduce thermal contact in this area, which may have a beneficial effect on a freeze-drying process.
  • Fig. 7a shows as an example of the use of a support structure according to the present invention, an internal cleaning of a vial 1, which is accommodated in a receptacle 12 of the support structure (not shown).
  • a nozzle or a pipe 40 is introduced by means of a height adjustment device 41 via the filling opening 7 into the interior of the vial 1 in order to spray a cleaning liquid (here: water) into the interior of the vial 1.
  • a cleaning liquid here: water
  • Fig. 7b As a further example of the use of a support structure according to the present invention, the cleaning of the outer sides of a vial 1, which is received in the receptacle 12 and supported on the holding projections 15.
  • a cleaning fluid preferably a cleaning liquid, such as water or steam, sprayed from below against the bottom of the vial 1. If this is done intensively enough, the vial 1 can thereby be lifted by the retaining projections 15 so that the vial 1 floats freely in the receptacle 12 ("levitation effect").
  • a flow temporarily forms in the annular gap between the outer wall of the vial 1 and the inner side of the side wall 14, which flows over the outer side of the vial 1 and cleans it.
  • a cleaning fluid preferably a cleaning fluid, such as, for example, water or steam, can also be sprayed from above into the receptacle 12 by means of an upper spraying device 42.
  • the fluid flow from below should in any case be sufficiently stronger than the fluid flow from above, preferably such that the bottom of the vial 1 is lifted by the holding projections 15, so that the vial 1 free in the recording 12 floats ("levitation effect").
  • Fig. 7c shows another example of the use of a support structure according to the present invention in raising and lowering the vials in receptacles of the support structure and for drying the outer sides of the container.
  • a gas for example nitrogen
  • a gas flow is formed temporarily in the annular gap between the outer wall of the vial 1 and the inside of the side wall 14, which flows over the outside of the vial 1 and dries it.
  • the gas flow exits at the upper end of the receptacles 12 again. If an entry of gas into the interior of the vial 1 is to be prevented, the filling opening 7 of the vial 1 is previously closed, for example with the aid of a plug.
  • a gas for example nitrogen
  • a gas for example nitrogen
  • the gas flow from below should in any case be sufficiently stronger than the gas flow from above, preferably such that the bottom of the vial 1 is lifted by the retaining projections 15, so the vial 1 floats freely in the receptacle 12 ("levitation effect") and all areas on the outside of the vial 1 can be dried.
  • FIGS. 7d and 7e show a treatment of vials according to the FIGS. 7b and 7c However, wherein on the upper ends of the container 1 so-called.
  • Press-fit caps are placed, which indeed cover the filler openings, but continue to ensure in a first position that the interior of the vials 1 is in communication with the gas environment, so During a freeze-drying process moisture and vapors can escape via the cap into the environment. Only when the caps are completely depressed to a second position, this connection is no longer so that the interior of the vials is then sealed gas-tight against the environment. The caps are thus completely depressed after the actual freeze-drying process. During the freeze-drying process, the caps are in the first position.
  • the injection of gas or a fluid from above into the receptacles 12 can according to the Fig. 8 also be used to push out the vials 1 down from the receptacles 12, while the holding force exerted by the retaining projections 15 must be suppressed.
  • the support of the support structure may be bent to suitably expand the lower ends of the receptacles 12. This expansion can take place to such an extent that the opening width of the holding projections 15 is greater than a maximum outer dimension of the vials 1 and the vials 1 can also be removed from the receptacles 12 downwards completely without friction.
  • slots 24 at the lower ends of the receptacles 12 facilitate bending of the support structure, as stated above.
  • the Fig. 9 shows a schematic flow diagram for a method according to the present invention for treating vials for substances for pharmaceutical or medical applications.
  • step S1 a transport and packaging container (see. Fig. 4b ), introduced into a sterile process environment and then peeled off a protective film from its upper edge.
  • step S2 the vials are then released. Before they are filled with a substance or liquid, they can be weighed (optional process step). Subsequently, in step S3, the vials are filled while they are held on the support structure. In this case, the holding structure can still be accommodated in the transport and packaging container, as in the Fig. 4b shown.
  • step S4 the vials are then released again. After filling the containers with a substance or liquid, they can be weighed again (optional process step).
  • step S5 plugs or special closures (press-fit caps) are inserted into the filling holes of the vials to close them. If a freeze-drying process is to be carried out subsequently, press-fit caps are inserted into the filler openings, which cover the filler openings to prevent the ingress of contaminants, but at the same time ensure that the interior of the vials is also protected by the attached cap continues to communicate with the environment. Such caps are in the FIGS. 7d and 7e shown.
  • the vials can also be used at this time in the receptacles or openings of the support structure in order to be further treated.
  • step S6 the holding structure is placed in a freeze dryer together with the vials held thereon. Subsequently, freeze-drying takes place in step S7, but this is not mandatory. In any case, after the freeze-drying step S7, the vials are closed in a gastight manner by pressing the press-fit closure caps against the environment.
  • step S8 the holding structure is removed again from the freeze dryer.
  • the vials remain in the recordings of the support structure.
  • step S9 metal caps are crimped / crimped onto the upper ends of the vials with the attached sealing plugs or caps (optional method step).
  • the vials remain in the recordings of the support structure.
  • step S10 the exterior of the vials is cleaned.
  • the vials remain in the recordings of the support structure. The cleaning is carried out as described above with reference to Fig. 7b described.
  • step S11 the outside of the vials is dried.
  • the vials remain in the recordings of the support structure. Drying is carried out as described above with reference to Fig. 7c described, or alternatively by means of heat, in particular by means of infrared radiation.
  • the vials may be labeled in step S12.
  • the vials can continue to be included in the recordings of the support structure. Or the vials were previously removed from the recordings of the support structure, as described above, in particular with reference to Fig. 7c ,
  • Transport or packaging container for a plurality of vials 1 according to the previous paragraph, wherein on the support structure, a plurality of vials 1 is supported or held.

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EP17201410.2A 2016-11-30 2017-11-13 Structure de maintien permettant de tenir une multitude de flacons, utilisation d'une telle structure ainsi que procédé de traitement de telles flacons Pending EP3329997A1 (fr)

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CN108116770A (zh) 2018-06-05
CN108116770B (zh) 2021-04-06
DE102016123147A1 (de) 2018-05-30
US20180148222A1 (en) 2018-05-31

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