DE102012103899B4 - Method and device for treating containers for storing substances for medical or pharmaceutical applications - Google Patents

Method and device for treating containers for storing substances for medical or pharmaceutical applications

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Publication number
DE102012103899B4
DE102012103899B4 DE102012103899.6A DE102012103899A DE102012103899B4 DE 102012103899 B4 DE102012103899 B4 DE 102012103899B4 DE 102012103899 A DE102012103899 A DE 102012103899A DE 102012103899 B4 DE102012103899 B4 DE 102012103899B4
Authority
DE
Germany
Prior art keywords
containers
carrier
container
receptacles
method according
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.)
Expired - Fee Related
Application number
DE102012103899.6A
Other languages
German (de)
Other versions
DE102012103899A1 (en
Inventor
Kai Wissner
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
Priority to DE102012103899.6A priority Critical patent/DE102012103899B4/en
Priority claimed from MX2014013171A external-priority patent/MX360701B/en
Priority claimed from EP13720925.0A external-priority patent/EP2844936B1/en
Publication of DE102012103899A1 publication Critical patent/DE102012103899A1/en
Application granted granted Critical
Publication of DE102012103899B4 publication Critical patent/DE102012103899B4/en
Application status is Expired - Fee Related legal-status Critical
Anticipated expiration legal-status Critical

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D25/00Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02Internal fittings
    • B65D25/10Devices to locate articles in containers
    • B65D25/108Devices, e.g. plates, presenting apertures through which the articles project
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00Supporting devices; Holding devices
    • B01L9/06Test-tube stands; Test-tube holders
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003Filling medical containers such as ampoules, vials, syringes or the like
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • B65B55/025Packaging in aseptic tunnels
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B63/00Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
    • B65B63/08Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for heating or cooling articles or materials to facilitate packaging
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B67OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
    • B67BAPPLYING CLOSURE MEMBERS TO BOTTLES JARS, OR SIMILAR CONTAINERS; OPENING CLOSED CONTAINERS
    • B67B3/00Closing bottles, jars or similar containers by applying caps
    • B67B3/02Closing bottles, jars or similar containers by applying caps by applying flanged caps, e.g. crown caps, and securing by deformation of flanges
    • B67B3/10Capping heads for securing caps
    • B67B3/14Capping heads for securing caps characterised by having movable elements, e.g. hinged fingers, for applying radial pressure to the flange of the cap
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B2220/00Specific aspects of the packaging operation
    • B65B2220/24Cooling filled packages
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00722Communications; Identification
    • G01N35/00732Identification of carriers, materials or components in automatic analysers
    • G01N2035/00742Type of codes
    • G01N2035/00782Type of codes reprogrammmable code
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • G01N2035/0401Sample carriers, cuvettes or reaction vessels
    • G01N2035/0403Sample carriers with closing or sealing means
    • G01N2035/0405Sample carriers with closing or sealing means manipulating closing or opening means, e.g. stoppers, screw caps, lids or covers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • G01N2035/0401Sample carriers, cuvettes or reaction vessels
    • G01N2035/0418Plate elements with several rows of samples

Abstract

A method of treating or processing containers (2) for storing or containing substances for cosmetic, medical or pharmaceutical applications, the containers (2) being open at one end and automated by means of a conveyor for handling or processing Process stations are passed or pass through, in which method a plurality of containers (2) is conveyed by the conveyor while they are held by a carrier (25; 134) together in a regular two-dimensional arrangement, wherein the carrier (25; 134) having a plurality of apertures or receptacles (32; 39; 87; 120) which provide the regular arrangement, and wherein the bottoms (3) of the containers (2) are at their closed ends from a first side of the carrier (25; 134) forth freely accessible, wherein a process station, a freeze-drying cabinet (220) with at least one Kühlfl che is, in which a freeze-drying process is executed, the bottoms (3) during the freeze-drying process in the freeze cabinet (220) are in a direct contact with the respective cooling surface while the containers (2) from the carrier (25; 134) or are received in a raised position in the openings or receptacles of the carrier (25; 134) and supported on the respective cooling surface.

Description

  • Field of the invention
  • The present invention generally relates to the simultaneous treatment or further processing of containers intended to contain these or those for preserving substances for cosmetic, medical or pharmaceutical applications, in particular vials with active ingredients or solutions of active substances, and more particularly concerns the simultaneous automated delivery and transfer of a plurality from containers to process stations, for example a filling or processing plant, a sterile tunnel, a freeze-dryer for lyophilizing a liquid containing active substance or the like.
  • Background of the invention
  • As containers for storage and storage of medical, pharmaceutical or cosmetic preparations in liquid form, in particular in pre-dosed quantities, medicament containers such as vials, ampoules or cartridges 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. For the most economical filling of the container under sterile conditions 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.
  • For this purpose, div. Transport and packaging containers are known from the prior art, in which at the same time a plurality of drug containers in a regular arrangement, for example, in a matrix array along rows and at right angles to extending columns, are arranged. 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. For this purpose, holding structures are used, in which at the same time a plurality of containers can be held in a predetermined regular arrangement. 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 8118167 B2 disclosed. The further processing of the container, however, always takes place in such a way that the holding structure from the transport and packaging container, the container is removed from the support 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. In particular, when separating the container by means of cellular wheels or the like, it always comes back to individual containers abut uncontrollably, resulting in undesirable abrasion and consequent contamination of the container interior or the process plant and to a deterioration of the external appearance of the container leads, which is undesirable.
  • US 8100263 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 kept in a regular arrangement. The individual medication containers are initially arranged loosely in receptacles which are formed in the holding structure. Subsequently, the support structure is inserted into the transport and packaging container and this surrounded with a gas-impermeable plastic tube. During the subsequent evacuation of the packaging unit formed in this way, the plastic tube is forced into the intermediate spaces between the medicament containers due to the negative pressure prevailing in the tube, which on the one hand stabilizes the position of the medicament container in the holding structure and, on the other hand, prevents further uncontrolled collision of adjacent medicament containers. When evacuating and the subsequent opening of the plastic tube, however, the drug container can slip sideways, which increases the automation effort for further processing of the drug container. Furthermore, the drug container after opening the plastic tube can still collide uncontrollably, which brings the aforementioned disadvantages. The medicine 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.
  • Other comparable transport and packaging containers and holding structures are in WO 2011/135085 A1 . US 2011/0277419 A1 . WO 2012/025549 A1 . WO 2011/015896 A1 . WO 2012/007056 A1 and WO 2009/015862 A1 disclosed.
  • DE 10 2007 042 218 A1 discloses a method for sterile or aseptic handling of containers. A support of the bottoms of the containers during a freeze-drying process in a freeze-drying cabinet in direct contact with the respective cooling surface of the freeze-dryer is not disclosed.
  • DE 10 2009 027 452 A1 discloses an apparatus and method for closing containers. Although the containers are filled while they are held on carriers. A support of the bottoms of the containers during a freeze-drying process in a freeze-drying cabinet in direct contact with the respective cooling surface of the freeze-dryer is not disclosed.
  • DE 3819095 A1 discloses a disposable syringe filling and sealing machine wherein carrier plates holding a plurality of disposable syringes in a matrix arrangement are used to fill the disposable syringes.
  • US 2007/0272587 A1 discloses a packaging arrangement for pharmaceutical containers consisting of a lid and a tray.
  • WO 2011/135085 A1 discloses a method of treating pharmaceutical containers in which the containers are first supplied sterile packaged in a transport container receiving a carrier with the containers held thereon. For treatment, the carrier is removed from the transport container in a sterile environment. Subsequently, the containers are lifted in rows by the carrier and further processed.
  • For further processing, however, the medicament containers usually have to be singulated each time. This is exemplified by the 1 which illustrates a schematic flow diagram of a conventional process for the freeze-drying of pharmaceutical preparations in drug containers, as described for example in US Pat US 5,964,043 is disclosed.
  • First, the process plant, a sterile tunnel, is charged with the vials. For this, the vials are hung upside down in transport frames, which are then conveyed through the process plant. For pretreatment, the vials held in the transport frame are first sterilized. Subsequently, the transport frames are turned with the vials stored therein and filled with a drug solution. Subsequently, a stopper is placed on the upper edge of the vials, in which a channel is formed, through which the interior of the bottle communicates during freeze-drying with the chamber of the freeze-drying cabinet.
  • For freeze-drying (also referred to as lyophilization or sublimation drying), the vials are then removed from the transport frame and placed individually in the freeze-drying cabinet. In this case, the bottoms of the vials to achieve a good cooling effect must be discontinued directly on a planar design cooling floor. If no full-surface immediate contact is ensured at this point, this leads to a considerable lengthening of the freeze-drying process, which leads to higher costs.
  • After lyophilization, the vials are removed from the freeze-drier, the plugs are depressed, and a metal lid is placed on the stopper and crimped or crimped. Such processed vials are then shipped, for example, in which a plurality of vials are picked up together by a carrier and the carrier is inserted into a transport and packaging container, which is then packaged sterile for delivery.
  • The immediate contact between the bottom of the medicine containers and the chilled bottom, which is necessary for freeze-drying, conventionally requires treating or processing individual containers, which increases the processing and packaging costs. A batchwise processing of drug containers is not possible conventionally.
  • In any case, a direct contact of the bottoms of the drug container, in particular the bottoms of vials, in the conventional holding structures is not possible.
  • Summary of the invention
  • The object of the present invention is to develop a method for treating or processing containers which serve for the storage of substances for cosmetic, medical or pharmaceutical applications, including a freeze-drying process in such a way that they are carried out even faster and more economically, better automatable and reliable can. According to another aspect of the present invention, there is provided a suitably designed apparatus for treating or processing such containers, including a freeze-drying process.
  • This object is achieved according to the present invention by a method having the features of claim 1 and solved by a device according to claim 27. Further advantageous embodiments are the subject of the dependent claims.
  • In a method of treating or processing containers which are open at one end and which serve to store or contain substances for cosmetic, medical or pharmaceutical applications, in particular vials, the containers are automated by means of a conveyor for handling or processing Process stations pass or pass therethrough, with a plurality of containers being conveyed by the conveyor while held together by a carrier in a regular two-dimensional array, and wherein the carrier has a plurality of openings or receptacles which define the array and wherein the bottoms of the containers are freely accessible at their closed ends from a first side of the carrier. In the method, a process station is a freeze-dryer cabinet having at least one cooling surface in which a freeze-drying process is performed. According to the invention, during the freeze-drying process in the freeze-drying cabinet, the trays are in direct contact with the respective cooling surface while the containers are being held by the carrier or while the containers are being held are received in a raised position in the openings or receptacles of the carrier and supported on the respective cooling surface.
  • Thus, according to the invention, the containers may be batch treated or processed in the freeze-drying process. One of the processes consuming making removal from the carrier and a separation does not need according to the invention. For this purpose, the carrier according to the invention is designed so that the carrier can be held on this form-fitting or frictionally engaged. In particular, the containers are held in openings or receptacles of the carrier that are suitably designed for this purpose.
  • Preferably, sidewall portions and / or the bottom of the containers, while held to the carrier, are in most cases accessible, so that the containers can be easily handled on the carrier. For example, the bottom of the containers may be completely or mostly accessible, that is not covered by a support structure or the like, while being held on the support. Thus, the carriers can be deposited with the containers, for example, on a cooling floor of a freeze-drying cabinet, so that a full-surface contact is ensured for efficient cooling. Appropriately, this all containers are held on the carrier to "same height".
  • According to a further embodiment, the carriers can be designed so that the containers can be displaced or rotated or moved or moved in a comparable manner while they are held by the carriers. This can be ensured in a simple manner by appropriate interpretation of the shape or frictional engagement. Thus, for example, the containers may be rotated to crimp or crimp a metal lid fitted on the upper edge thereof while being held on the carrier.
  • According to a further embodiment, the containers may be displaced for treatment or processing at or in the process station in the respective opening or receiving the carrier in the longitudinal direction in the raised position, in which the further treatment or processing is then facilitated. For example, in this raised position, the bottom of the containers may be fully accessible or the upper edge of the containers project well beyond the upper edge of the carrier or a shipping and packaging container so that treatment or processing is only possible in the raised position.
  • Conveniently, the containers are held in this elevated position in the region of their cylindrical side wall or a narrowed neck portion below the upper edge or at its upper edge, which may depend on the particular process station.
  • According to another embodiment, the containers are still received in the openings or receptacles of the carrier in the raised position, but are supported on an additional support surface or held by an additional holding or gripping device while being processed or processed at or in the process station. The holding means on the carrier are thus designed so that they do not hold the container in the raised position, at least not with the weight of the container corresponding sufficient holding force. However, even in this embodiment, the containers need not be completely removed from the carrier, so that they can continue to be treated batchwise or processed, but can still be transferred more quickly to a subsequent process step. The aforementioned holding or gripping device may, for example, be a robot arm of a fully automatic controlled process system.
  • The abovementioned support surface may in particular also be guide surfaces which suitably guide the further conveyance of the containers through the process plant. These guide surfaces can also be curved or ramp-shaped, for example, in order to predetermine such elevations of the containers during their conveyance through the process plant. In particular, such a support surface may also be provided with a turntable or be formed as such to rotate individual containers, while these are still received in the openings or receptacles of the wearer. Suitably, for this purpose, the carrier is designed so that the holding force exerted by the holding means can be adjusted in a simple manner, namely between a first holding position in which the containers are held with sufficient force form or frictionally on the carrier, and a second holding position, in which the holding force is completely or at least sufficiently reduced. This can be accomplished for example by adjusting the opening width of the openings or recordings of the carrier in a simple manner.
  • According to a further embodiment, edge portions of the carrier, in particular a baseplate thereof, may be removed or swung away to reduce the overall area of the carrier as the containers are handled or processed in or at the process station. This leads to significant cost savings, especially in the freeze-drying of a plurality of containers held in a carrier.
  • According to a first aspect of the present invention, the containers are frictionally held in the carrier (support structure). For force or frictional mounting of cylindrical containers is a variety of holding means available. Force or frictional connections are known to require only sufficient normal force on the surfaces to be joined together. The mutual displacement between the container and the carrier is thus prevented as long as caused by the static friction between the carrier and the container counterforce is not exceeded. The force or friction is lost and the surfaces slip on each other when the tangential load force is greater than the static friction force. The latter, however, is unlikely with the comparatively low weights of the containers to be received in the carrier, but may be exploited to shift the containers axially from a first position to a second position in which they are stored in the carrier in which they are stored can, for example, the openings are closed with a stopper or on the plug an outer closure (for example crimp cap or staple), often made of aluminum sheet, is applied.
  • The force or friction is expediently either below the flared upper edge of the container, d. H. in their narrow neck or neck area below the upper edge, or in the region of the cylindrical side wall. According to the invention, a bottom-side support of the containers is fundamentally not required, so that access to the undersides (bottoms) of the containers held in the carrier is basically possible. This makes it possible, according to the invention, for the containers, while they are accommodated in the carrier, to be further processed, as explained below. In other words, the containers can be further processed batchwise in carriers, but remain reliably and collision-free in or on the carriers during further processing, which allows considerable speed advantages and advantages in the automation of processing plants and thus overall even more economical and cost-effective processes leads. Furthermore, a direct glass-glass contact of adjacent containers is reliably prevented, which effectively prevents abrasion and contamination within the processing plant and thus allows significantly longer runtimes and maintenance intervals of the systems. Furthermore, scratches or the generation of particles on or in the containers can be effectively prevented.
  • The carrier according to the invention expediently allows the removal of the container up or down. Since the position of the force or frictional connection between the container and holding structure can be varied easily, the holding structure according to the invention can be used very flexibly also for containers with different external dimensions, as long as a sufficient normal force for the frictional engagement can be ensured. In particular, the containers in the carrier can be easily displaced in the axial direction so that containers of different heights can be held in or on the same carrier. The axial mobility of the container also allows easy tolerance compensation.
  • According to a second aspect of the present invention, the containers are held in a form-fitting manner in the holding structure. For the positive retention of cylindrical containers is a variety of holding means available. The mutual displacement between the container and the support structure is prevented as long as one connection partner stands in the way of the other connection partner, ie blocks it.
  • The positive connection is advantageously carried out either below the flared upper edge of the container, ie in the region of the narrow neck or neck region and immediately below the upper edge, or at the lower end of the container, for example at a bottom of the container. Suitably, the flared upper edge or the lower end or the bottom of the container is directly supported on the interlocking elements of the support structure. Alternatively, the upper edge or the lower end or the bottom of the container can also be positively gripped or engaged behind.
  • Another aspect of the present invention further relates to a transport and packaging container having at least one support structure as set forth above and further disclosed in detail below.
  • Another aspect of the present invention further relates to a transport and packaging container with measures for plagiarism protection, in particular for identification and / or tracking, as explained below.
  • LIST OF FIGURES
  • The invention will now be described by way of example and with reference to the accompanying drawings, from which further features, advantages and objects to be achieved will result. Show it:
  • 1 a flow chart of a conventional method for treating or processing containers, including a freeze-drying process;
  • 2a a carrier according to a first embodiment for holding a plurality of containers for use in a method according to the present invention;
  • 2 B - 2c a transport and packaging container with the carrier according to the 2a in a plan view and a perspective partial section;
  • 2d - 2e the inclusion of the container in a variant of the carrier according to the 2a in two different positions of the wearer;
  • 3a - 3d a process station for crimping a metal lid on an upper edge of a plurality of containers in a method according to the present invention;
  • 3e in an enlarged partial view of the procedure for flanging a metal lid on an upper edge of containers at the process station according to the 3a to 3d ;
  • 3f and 3g two further variants for process stations for flanging a metal lid on an upper edge of a plurality of containers in a method according to the present invention;
  • 4a - 4b a transport and packaging container with a carrier according to another embodiment of the present invention;
  • 5a - 5d a transport and packaging container with a carrier according to another embodiment of the present invention;
  • 6a - 6c a transport and packaging container with carriers according to another embodiment of the present invention;
  • 7a - 7b a transport and packaging container with a carrier according to another embodiment of the present invention;
  • 8a - 8e a transport and packaging container with a carrier according to another embodiment of the present invention;
  • 9a a transport and packaging container with a carrier according to another embodiment of the present invention;
  • 9b a transportation and packaging container according to another embodiment of the present invention;
  • 10 a transportation and packaging container according to another embodiment of the present invention;
  • 11a - 11e a transportation and packaging container according to another embodiment of the present invention;
  • 12 a flow chart of a method for treating or processing containers according to the present invention, including a freeze-drying process;
  • 13 in a schematic plan view of the application of a method according to the present invention for the freeze-drying of a substance in the containers;
  • 14 in an enlarged partial section, the arrangement of the containers on a cooling floor of a freeze-dryer cabinet in a method according to the 13 ;
  • 15a and 15b a further variant of a process station for flaring a metal lid on an upper edge of a plurality of containers in a method according to the present invention;
  • 16a - 16e a further variant for a process station in a method according to the present invention; and
  • 17a - 17b Measures for identification and / or tracking in a transport and packaging container according to the present invention.
  • In the figures, identical reference numerals designate identical or substantially equivalent elements or groups of elements.
  • Detailed description of preferred embodiments
  • A support structure (carrier) and a transport and packaging container accommodating such a support structure, according to the present invention, as described below, simultaneously holding a plurality of containers for storing substances for cosmetic, medical or pharmaceutical applications in a regular arrangement , in particular in a matrix arrangement at regular intervals of the containers to each other, along two different spatial directions, preferably along two mutually orthogonal spatial directions or a regular rows, which are arranged offset relative to each other.
  • An example of such drug container in the form of vial is in the 4b shown schematically in a longitudinal section. These have a cylindrical basic shape, with a cylindrical side wall with - within the tolerances - constant inner and outer diameter of a flat-shaped bottle bottom 3 protrudes vertically and near the upper open end of the vial in a narrowed neck section 5 of comparatively small axial length and then in a widened upper edge 6 merges, which has a larger outer diameter than the associated neck portion 5 and designed for connection to a closure element. The neck section 5 can be formed smooth-walled without external thread or can be provided with an external thread for screwing a closure element. For example, in the inner bore of the neck portion 5 and the upper edge 6 a plug (not shown) can be inserted whose upper end with the upper edge 6 the vial is gas-tight and protected against the ingress of contaminants into the vial with the top edge 6 is connected, 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.
  • Another example of containers in the context of the present application are ampoules, cartridges or syringe or injection containers. Ampoules or cartridges are containers for pharmaceuticals for the most parenteral administration (injection), for cosmetics and other substances and are usually cylindrically shaped with a full tip (spit or head) and a flat bottom or with two solid tips at both ends.
  • These can be designed in particular as crushing ampoules with an annular predetermined breaking point around the ampoule neck or as an OPC ampoule (one-point-cut ampoule) with a scratched into the glass crushing ring. Syringes or injection containers, also referred to as injection vials, punctured ampoules or reusable ampoules, are cylindrical, bottle-like shaped containers made of glass or plastic, usually in relatively small nominal volumes (eg 1 ml, 10 ml). They are closed with a rubber stopper with septum (puncture rubber). To protect the septum and fix the rubber stopper is still an outer closure (crimp cap or staple), often made of aluminum sheet applied. In a carpule, the liquid is in a cylinder, which is closed at one end with a thick rubber or plastic stopper. This acts as a piston when the contents are squeezed out with a Karpulenspritze. At the other end, the cylinder is closed only with a thin membrane that is pierced in use by the rear end of the cartridge needle (a cannula ground on both sides). Cylinder ampoules are often used in dentistry for local anesthesia. Special cylindrical ampoules with a specially designed front part (eg thread) are used for insulin therapy in insulin pens.
  • For the purposes of the present invention, 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. Especially with glass containers storage periods can be many years, which in particular of the hydrolytic resistance of the used glass type depends. While 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.
  • Inevitably, such containers have manufacturing tolerances, which may be just one or more tenths of a millimeter, especially in glass containers. In order to compensate for such manufacturing tolerances and at the same time to ensure that all bottle bottoms 3 can be arranged in a plane, the glass containers are fixed in a method according to the present invention by means of a positive connection or a frictional connection to a support structure or carrier. This form or frictional connection can be in the area of the narrowed neck section 5 the container, on the cylindrical side wall portion 4 or in the area of the lower end of the container 2 , especially on the ground 3 the container 2 will be realized.
  • The 2a shows a holding structure (carrier) 25 according to a first embodiment, with frictional retention of the container. The holding structure has a plurality of mutually parallel transverse webs 35 on, the arranged at regular intervals to each other S-shaped connecting webs 36 connected to each other, which are substantially perpendicular to the transverse webs 35 run. More precisely, the connecting bridges 36 over curved in opposite directions front and rear ends 37 . 38 with the crossbars 35 connected. The connecting bridges 36 are made of a plastic, preferably of a flexible plastic. The crossbars 35 preferably have a greater rigidity than the connecting webs 36 on. Due to the S-shaped shape of the connecting webs 36 are the crossbars 35 each offset in the longitudinal direction by a constant distance, so that the support structure 35 is formed overall as a parallelogram, with a base in the region of the lower edge of the in the 2a shown holding structure 25 and two imaginary edge lines inclined thereto at an acute angle, which are the forward ends of the transverse webs 35 connect with each other. In the right part of the picture 2a illustrated relaxed starting position, the container 2 free and without contact with the webs 35 . 36 or at least with little effort in the of the webs 35 . 36 trained elongated support shots 39 be introduced. The holding shots 39 have a substantially square cross section, so on the diameter of the container 2 is agreed that this is in a second position of the support structure 25 be frictionally fixed with sufficient force, in particular can be clamped.
  • To the holding structure 25 from the in the 2a shown first position in the in 2 B To convert shown second position, the transverse webs 35 each shifted in the longitudinal direction so that finally in the 2 B illustrated rectangular or square support structure 25 is trained. How to compare the 2a and 2 B can be removed, this bend the connecting webs 36 slightly. The second position according to the 2 B can by the interaction of the in the support structure 25 trained access openings 29 with correspondingly formed counter elements of the container 10 be fixed or by the interaction of centering 27 (see. 11a ) with correspondingly formed centering pin 17 a holding frame, not shown, which the holding structure 25 receives.
  • The enlarged partial view in the 2a you can see that the containers 2 in the first position according to the 2a loose in the holding shots 39 are included. The enlarged partial view according to the 2 B you can see that the containers 2 in the second position according to the 2 B from central sections of the connecting webs 36 frictionally fixed, in particular clamped, be. To the crossbars 35 may continue to exist a certain game, but is preferably minimal or vanishing.
  • The 2c shows the thus formed packaging unit 1 in a perspective partial section, wherein it can be seen that in this embodiment, the transverse webs 35 immediately on the level 13 of the container 10 trained supporting surface are supported. The frictional fixing of the container is in the partial section according to the 2d recognizable. The 3a and 3b show the support structure according to the second embodiment in a schematic plan view and a perspective view in the aforementioned second position.
  • As stated above, in the second embodiment, all the side walls of the receptacles become 39 when moving the crossbars 35 coordinated from the first position to the second position adjusted, by pivoting the upper end of the support structure 25 (see. 2a ) relative to the base at the lower end of the 2a represented parallelogram. In the aforementioned first position, the containers can thus be inserted into the support structure and precisely positioned, in particular arranged at a predetermined height level so that all bottoms of the container are flush and arranged in a common plane. By coordinated adjustment of the support structure in the aforementioned second position then all containers simultaneously frictionally fixed and precisely positioned in a regular arrangement.
  • The holding structure according to the 2a to 2c is preferably formed in one piece from a plastic. However, a similarly acting holding structure can also be assembled from a plurality of identical basic units, as described below.
  • The 2d and 2e show in greatly enlarged partial representations of another variant of the support structure according to the 2a - 2c , It shows the 2d the area of a receptacle of the support structure in the aforementioned second position in which the container 2 are held in the recordings of the support structure. Deviating from the 2a - 2c are in this embodiment at the connecting webs 36 on the two sides in each case a concave trained section 36a formed, wherein the radius of curvature of the two concave seats of the sections 36a on the radius of the container 2 is tuned. In the second position according to the 2d in which the connecting webs 36 inclined to the crossbars 35 extend, nestle the concave shots 36a to the cylindrical side wall of the container 2 so that the containers can be kept even more reliable and controlled. In the first position according to the 2e in which the connecting webs 36 perpendicular to the transverse webs 35 extend are the concave shots 36a no longer opposite to the cylindrical side wall of the container 2 arranged so that the containers unhindered, at least with significantly reduced effort, in the of the webs 35 . 36 trained recordings and can be taken out of these. Ideally, the bridges are 35 . 36 in the first position according to the 2e not at all on the side walls of the containers 2 at.
  • The 3a to 3d show a crimping station as an example of a process station for treating or processing medication containers 180 for simultaneous beading of metal lids on the upper edges of containers 2 in a carrier, as described above with reference to 2a to 2c described, recorded or held. Not shown here is the conveyor, such as a conveyor belt or a roller train in a sterile tunnel. The crimping station 180 is on a rack frame 181 arranged, which is located below the conveyor and and is as far as possible separated from the process plant as possible. The crimping station 180 has a holding arm 183 or cover on, the or of lifting rods 185 is passed through, at the upper end of each turntable 186 is mounted rotatably, that of the associated rotary drive 182 and about the transmission 184 can be turned.
  • Above the container is a holder 190 , at which a plurality of centering discs 191 and flanging discs 192 are held, whose position can be adjusted precisely, in adaptation to the regular arrangement of the containers to be processed, their arrangement by the transverse webs 35 and recordings of the wearer.
  • While the carriers in the configuration according to the 2 B be promoted upstream of the process station, so for example in a transport and packaging container according to the 2c with frictionally retaining the container 2 , the carrier is removed from the transport and packaging container and in the position according to 2a transferred, in which the frictional engagement between the transverse webs 35 and the containers 2 is largely or completely repealed. So that the containers do not slip out of the recordings of the wearer down uncontrollably, are in the area of the crimping station 180 suitable support and guide surfaces (not shown) are provided. Alternatively, the containers 2 in the position of the carrier according to the 2a clamped only with little force, so they in the shots of the wearer readily by raising the lifting rods 185 can be pushed up into a raised position. In this raised position, the upper edges of the containers 2 sufficiently freely accessible for crimping. How to the cross section according to the 3b can take only a few of the container 2 by means of the lifting rods 185 pushed up. In the raised position, the frictional engagement between the transverse webs 35 of the vehicle and the containers 2 preferably completely canceled.
  • How to the enlarged view according to the 3e can be seen in the raised position, the upper edge of the container 2 with the plug inserted therein 195 and a metal lid 193 , For example, an aluminum cap, in an associated centering 191 recorded to the rotational movement of the container when turning the turntable 186 to center. When turning one reaches the arm 190 mounted flanging disk 192 in contact with the metal lid 193 and crimping it around by forming, so as to seal the container sterile.
  • If all containers 2 of a carrier have been processed in the manner described above, the carrier from the region of the crimping station 180 removed and further promoted in the process plant (not shown). For this purpose, the container in the openings or receptacles of the carrier can be pushed back into its normal position and the carrier again in the position according to the 2 B be transferred for example, by insertion into a transport and packaging container to be further promoted. The processing in the flanging station is thus batchwise, without the containers needing to be completely removed from the carrier in any case. The crossbars 35 At any time during processing, the carrier prevents a collision of immediately adjacent containers, which prevents undesirable abrasion and contamination of the process equipment.
  • With the help of a carrier according to the 2a or as described below, according to the invention, a plurality of containers can thus be treated or processed simultaneously or in batches, while these are held on a carrier or at least guided. According to further embodiments of the invention, such a treatment or processing can also take place while the carrier is arranged with the containers held by this in a transport and packaging container, as this example in the 2c is shown. For this purpose, the carrier 25 (see. 2c ), for example via the access openings 29 be lifted properly, but without the transport and packaging container 1 to be taken. If, despite all precautionary measures, a container is broken or if contamination occurs during treatment or processing in any other way, these contaminants are in any case retained in the transport and packaging container, thus in any case not getting into the actual process plant.
  • The 3f and 3g show further variants of the crimping station according to the 3a , Thus, in the crimping station according to the 3f the centering discs 191 on a central support arm 190 stored while the flanging discs 192 in parallel with this extending support arms 190a . 190b are mounted, the distance and orientation relative to the central support arm 190 can be suitably adjusted, for example, in adaptation to the respective container type to be processed with different dimensions. In the variant according to the 3g This adjustment of the appropriate adjustment of the pivotally movable on the central support arm 190 mounted lateral support arms 190a . 190b ,
  • In the method according to the invention, the crimping discs are always located only over already closed with the aid of a plug containers. An ingress of contaminants or abrasion in the container interior can thus be reliably excluded according to the invention.
  • While stated above, the holding structure on the of the stage 13 Supported near the upper edge bearing surface is according to the embodiment of the 4a the holding structure 25 directly on the ground 11 of the transport and packaging container 10 supported. This works in principle for all holding structures that have a certain axial length, be it that the bottoms of the container 2 directly on the ground 11 of the container 10 rest or on bottoms of elongated shots 39 the holding structure 25 , In the illustrated embodiment according to the 4a is the holding structure 25 by a plurality of transverse webs crossing at right angles 35 formed having a plurality of elongated receptacles 39 form with square cross-section, the recordings 39 arranged in a matrix arrangement. Thereby the containers become 2 at its lower end frictionally engaged by the transverse webs 35 or an insert provided thereon made of a flexible plastic. The 4b shows a schematic partial section through this support structure. The example shows the clamping of containers 2 with different height. Basically, the holding structure 25 also in one piece with the ground 11 of the container 10 be educated.
  • The 5a to 5c show a further embodiment of a support structure (carrier), to which a plurality of containers 2 can be held positively. Here are according to the 5a in the flat transport plate 25 a plurality of openings 39 for receiving the containers 2 educated.
  • The openings are in annular form-locking elements 137 trained, either in the openings 39 are inserted, in particular engaged in the peripheral edge or are clipped, or integral with the flat carrier 25 are formed, for example by 1K or 2K plastic injection molding.
  • The schematic longitudinal section according to the 5b Summarizes several different variants for positive locking elements 137 in a comparative representation. In the fixed state, the interlocking elements support 137 the containers immediately below the upper edge 6 and in the area of the narrowed neck 5 ,
  • Although in the 5a the floor 11 of the container 10 as closed and integral with the side wall 12 is shown formed, the lower end of the container 10 also be open in the manner of the upper end, in particular with a flange-like lower edge in the manner of the upper edge 15 Be provided so that the bottoms of the container 2 from the bottom of the container 10 forth freely accessible, for example, for processing steps in a sterile tunnel or in a freeze-drying cabinet, as explained in more detail below.
  • The 6a to 6c show a further embodiment of a transport and packaging container 1 , According to the 6a is the holding structure 25 designed as a box, with circumferential side walls 168 , This box 168 is formed by a plurality of transverse webs extending parallel to one another and at regular intervals from one another 165 divided into several rectangular segments. On the surfaces of the transverse webs 165 are at the same height and at regular intervals to each other concave curved support arms 166 arranged, which are formed of an elastic plastic and either integral with the transverse webs 165 are formed or attached to this or molded. The holding arms 166 form recordings in which the containers can be introduced from the front so that the neck portions positively embraced and the upper edge can be supported on this, as in the 6c shown. In the longitudinal direction of the container 2 considered there is a frictional connection. By applying a suitable axially acting force, the containers 2 but in the of the holding arms 166 trained recordings are moved axially, for example, in a raised position, as described above with reference to 3a to 3d described.
  • The 7a shows a further embodiment for a transport and packaging container 1 with a holding insert, which is formed by two telescoping parts, the common elongated, rectangular in profile and parallel to each other holding receptacles 120 train in which the containers 2 are recorded and fixed by friction. More specifically, in the right sliding part 116 from the guide walls 117 a plurality of rectangular mounts extending parallel to each other 120 are formed and are in the left sliding part 115 from the side walls 118 formed appropriate elongated recordings. The guide walls 117 are formed slotted, as the sectional view according to the 7b can take. In the longitudinal slots of the guide walls 117 are the correspondingly formed side walls 118 the left sliding part 115 slidably guided and recorded. The two sliding parts 115 . 116 can be pushed into each other until the front or rear ends 123 the recordings 120 directly to the in the shots 120 recorded container 2 abut, so that the container 2 from the side walls of the recordings 120 clamped together. Basically, the side walls of the shots 120 with retaining projections or depressions corresponding to the container 2 be formed so that the container 2 Do not touch each other directly when these are in the shots 120 are received, but spaced apart in the projections formed by the recesses or receptacles are added to each other.
  • According to a preferred further embodiment, the side walls 118 . 122 the left sliding part 115 in the longitudinal direction of the recordings 120 considered wedge-shaped, so that the opening width between the side walls 117 the right sliding part 116 is increasingly reduced until the containers 2 in the elongated shots 120 frictionally fixed, in particular clamped. The 7b is a schematic sectional view and shows the recording of containers with different heights in recordings 120 with different heights (left and right part of the picture).
  • The top or the top and bottom of a support structure 25 according to the present invention or even a transport and packaging container 1 According to the present invention may be covered by a sterile, gas-permeable protective film which is glued and peeled off if necessary. This is exemplary in the 10 for a packaging unit represented by a transport container open on both sides and a holding structure accommodated therein according to the 6a is formed and on the top and bottom by means of a on the edge 15 glued on protective or protective or packaging film 130 is closed. For the protective film 130 it may in particular be a gas-permeable plastic film, in particular a web of synthetic fibers such as polypropylene fibers (PP) or a Tyvek ® -Schutzfolie, the sterilization of the support structure 25 picked up and packed containers 2 through the foil 130 through it.
  • The 9a shows a further variant in which the aforementioned edge portion of the base plate is very narrow, so that the side walls 63 the holding structure 60 directly in the correspondingly formed edge section 58 of the insert 54 are included, as in the sectional view according to the 9b shown. In the assembled state according to the 9b is also a transport and packaging unit 1 formed, which can be hermetically sealed against the outside environment. According to the 9b are the floors 3 the container directly on the base plate 61 supported and the containers 2 near its lower end in the elongated receptacles formed by the transverse webs 65 fixed by friction.
  • In a further embodiment according to the 8a are the containers 2 directly on a protective or packaging film 130 arranged on which a transport and packaging container 10 as above with reference to 2a described by way of example, is placed on the bottom of the container 10 arranged transverse webs 55 an immediate contact of the side walls 4 prevent the container. At its upper end, the containers can through the transverse webs 55 also frictionally fixed, in particular clamped. At the slide 130 it may in particular be a sterile, but gas-permeable film, in particular a plastic mesh, such as Tyveck ® .
  • The 8c to 8e show a further variant of this embodiment, in which in the transport and packaging container 10 received container by blowing a gas through the film 130 be sterilized through. So that incoming gases into the interior of the container 2 can flow in between the ground 11 of the transport and packaging container 10 and the top of the container 2 spacer 59 provided so that the containers are not directly on the ground 11 rest.
  • These spacers 59 can start from the corners of a particular shot 56 diagonally to the center of each shot 56 extend. The cross-shaped spacer webs 59 However, they are not connected to each other, so in the middle of each recording 56 the upper edge of the container is freely accessible. The 8e shows a plan view of the bottom of the transport and packaging container 10 trained insert, which can also be removable.
  • According to another embodiment according to the 11a to 11e is used to hold a plurality of containers at the same time 2 a flat transport plate 25 provided, which is formed of a plastic, for example, punched or injection-molded, and from a plurality of circular eyelets 30 exists that are interconnected. The eyelets 30 are sufficiently flexible or expandable so that the containers 2 from above or from below into the openings of the eyelets 30 can be introduced. This allows a plurality of containers 2 in the area of her narrowed neck sections 5 be frictionally fixed. This is in the schematic longitudinal sections according to the 11c to 11e shown in more detail.
  • In most embodiments described above, the bottoms of the containers are fully accessible from the bottom when held together on the carrier. This allows, for example, the batchwise freeze-drying of a plurality of containers in a freeze-drying cabinet while they are held together on the carrier. This will be explained below with reference to 12 to 14 be described in more detail.
  • The 12 shows a schematic flow diagram of such a process step, wherein, in contrast to a conventional process step, as described above with reference to 1 described, a plurality of containers in the process steps S1 to S9, at least in the process steps S5 to S7 held together on a support or at least taken by this guided.
  • This is schematically in plan view according to the 13 shown. The carriers 25 with the containers held by them in a regular two-dimensional arrangement are conveyed by means of the conveyor 221 , For example, a conveyor belt or a roller conveyor, in the direction of the arrow in the direction of a freeze-drying oven 220 promoted. This can for example be arranged laterally to a main conveyor of a process system, not shown, of which the carrier 25 on the conveyor 221 implemented or diverted and towards a freezer 220 be encouraged. In front of the freezer-drying oven 220 is a transverse to the conveyor 221 extending shelf on which the carriers are collected. This collection of vehicles 25 in front of the freezer-drying oven 220 can also be done on several levels, corresponding to the levels of the freezer 220 ,
  • To the base of the carrier 25 To further reduce, it may be advantageous for this, if edge sections 150 the carrier (cf. 5d ) or, as in the 5d shown, can be swung away. For this purpose, the edges 150 about hinges 151 with the carrier 134 according to the 5d connected. On the top of the carrier 134 and the edges 150 are block-shaped stops at corresponding positions 153 provided, the mutual stop a coplanar alignment of the edges 150 and the vehicle 134 establish. According to a further embodiment (not shown), the edges 150 also from the carrier 134 be removed. The edges 150 Of course, along all four longitudinal sides of the vehicle 134 be provided.
  • This simple measure increases the achievable packing density of the container 2 when loading the freezer 220 (see. 13 ) further. The 14 shows an enlarged partial section through a freeze-drying cabinet. As you can see, the floors are 3 the container 2 directly on the cooling floors 223 on, so that an optimal cooling effect can be achieved. The cooling floors 223 are arranged on several floors.
  • The 17a and 17b show a further variant of a crimping station for crimping a metal lid on an upper edge of a plurality of containers in a method according to the present invention. The centering discs 191 with their turning centers 194 are together on a rectangular plate 190 stored, on which also the flanging discs 192 are stored, whose positions can be precisely adjusted. In this variant, all containers of a carrier, or a portion thereof, are crimped in two process steps, since the lifting rods 185 alternating every other one of the containers 2 raise and lower.
  • The 16a to 16d show a further variant for a crimping station 180 for crimping a metal lid on the upper edge of containers in a method according to the present invention. Here are the drive motors 182 arranged with associated rotating means above the plane of the conveyor and the carrier. The carriers are in the assembly line process at the crimping station 180 passed by, while these from the transverse webs 35 the carrier are frictionally held, expediently in the position according to the 2a in which the frictional engagement between the transverse webs 35 and the containers 2 is completely or at least sufficiently waived. In the area of the crimping station 180 extends in the conveying direction a ramp-like support and guide surface 201 which the containers 2 be raised in turn in a raised position. The clear width between the lower end of the crossbars 35 and the conveyor is sufficient that the transverse webs 35 the support unhindered the ramp-like support and guide surface 201 can happen.
  • How to the enlarged view according to the 16e the upper edges of the containers are advised 2 in the raised position, ie during their bottoms on the ramp-like support and guide surface 201 are supported in the sphere of influence of the crimping station 180 so that the upper end of the container 2 applied metal lid can be crimped suitable.
  • Subsequently, the containers 2 continue along the ramp-like support and guide surface 201 until this finally returns to normal position in the of the transverse webs 35 the carrier trained recordings are lowered.
  • A corresponding raising and lowering of the containers, while they are held in carriers or at least guided in this, is advantageously also for the inspection of the container or its contents, in particular by means of optical inspection methods. As can be seen most of the representations of this application, the containers usually do not protrude beyond the upper edge of the associated carrier with their upper edge, so that they can not be optically tested and assessed. This is usually not reliable possible if the transport and packaging container is formed of a transparent plastic. However, in the raised position described above, the containers are accessible at least in their upper region for testing or inspection. This can be exploited if, for example, the containers in a conveyor by means of a ramp-like guide surface, as exemplified in the 16c and 16d shown, which engages in the path of the conveyor suitable, raises targeted and then lowered back into the recordings of the carrier.
  • The 17a and 17b show a further embodiment variant for a packaging unit 1 with one in the transport and packaging container 10 recorded holding plate 134 in which a plurality of containers 2 by means of ring elements 137 are frictionally fixed. The packaging unit 1 has provisions for identification and / or tracking as follows: As in the increased use of the 17a is shown in the area of the access recess 29 between the holding plate 134 and the side wall 12 and / or the stage 13 of the container 10 an electronically wireless (wireless) readable RFID chip or RuBee chip 175 arranged (a RuBee chip radiates on frequencies that can penetrate metal and water) through the side walls of the packaging unit 1 can be read out non-contact and on request information regarding the identity, important product properties (manufacturer, content, date of manufacture, expiration date, ...) etc. outputs. The chip 175 can in the packaging unit 1 be glued in place, even at a different location than shown in the figure. The chip 175 can be arranged so that in case of opening the packaging unit 1 or taking out the retaining plate 134 from the packaging unit 1 out the chip 175 is destroyed, for example, torn or disabled. Due to the missing answer of the chip 175 Upon request for a radio query, information is thus available which indicates that the packaging unit has been manipulated in some way since the previous packaging. Because the chip 175 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.
  • The destruction of the chip 175 especially when removing the carrier 134 take place during the initial loading of a process plant or a process station, or in a first pretreatment in the carrier 134 recorded container. The chip 175 may also be writable to write important information about, for example, processing in a process plant.
  • According to a further preferred embodiment, the RuBee or RFID chip 175 integrated in combination with other sensors, the important parameters of the transport and packaging container 1 time-dependent monitor which important quality or fastness properties in the transport and packaging container 1 concerning stored containers. These quality or fastness properties can be recorded periodically and in a chip 175 or sensor associated memory are stored. For the electrical power supply of these electronic components can in the transport and packaging container 1 a network-independent power supply may be provided, in particular a battery with small dimensions or inductively via a small conductor loop. As sensors according to the present application, in particular:
    • - A moisture sensor with or without memory (data logging), which measures the prevailing in the transport and packaging container humidity periodically and records as needed;
    • - A gas sensor with or without memory (data logging), the concentration of existing in the transport and packaging container gases, such as O 2 , ozone, CO 2 or disinfecting gases, such as. As ethylene oxide, formaldehyde, measures and records as needed;
    • - A temperature sensor with or without memory (data logging), which measures the temperature prevailing in the transport and packaging container periodically and recorded as needed;
    • - a UV sensor with or without memory (data-logging), which measures periodically in the transport and packaging container penetrating UV radiation and records as needed;
    • A gamma ray, electron beam or X-ray sensor with or without memory (data logging), which periodically measures the radiation entering the transport and packaging container and records it as required;
  • Furthermore, further precautions can be taken in the transport and packaging container, which concern plagiarism protection and reliable proof of the authenticity and authenticity of the vials stored in the transport and packaging container. For this purpose, in particular luminescence plagiarism protection can be provided, specifically in the form of phosphors applied at a suitable location in or on the transport and packaging container, which are conventionally also referred to as "phosphors". However, the phosphors which are preferably invisible to the human eye are characteristically distinguishable on the basis of different spectral emission spectra. The phosphors are preferably made of inorganic luminescent materials (eg microcrystals, nanocrystals and / or quantum dots) which fluoresce at certain wavelengths and / or phosphoresce. The different types of luminescence after the duration of illumination after the end of the excitation are divided into fluorescence (<1 msec) and phosphorescence (≥ 1 msec).
  • In such an embodiment, properties of the transport and packaging container can be interrogated in all process stations, or also in individual process stations of a process plant, preferably contactless by means of the RFID or RuBee chip or by excitation and (if necessary temporally resolved) detection of the fluorescence or luminescence spectrum. Thus, the authenticity and integrity of the carrier or the container received therein can be detected and queried. How to get the 17a can take the RFID chip 175 when removing the carrier 134 from the transport and packaging container 1 also be destroyed, which effectively prevents unauthorized manipulation of the carrier or the container received therein. After authorized treatment or further processing of the containers, for example after a successful filling of the containers with an authorized manufacturer, an RFID or RuBee chip can again be used 175 or a new identification or tracking means at a suitable location on the transport and packaging container 1 and / or the wearer 134 be attached, in particular in such a way that this is destroyed in the renewed removal or manipulation of the carrier.
  • The RFID or RuBee chip 175 can also be designed so that data can be written to it. Thus, a process station important parameters in the filling, such as filled in the container drug, its concentration, etc., are enrolled. This information is available again at a subsequent process station and can be read there.
  • In a corresponding manner, fluorescence or luminescence codes can also be written down on the carrier, the transport and packaging containers and / or the containers, which serve to prove the authenticity or to encode important parameters.
  • A corresponding raising and lowering of the containers while they are held in carriers or at least guided in these, as described above, is also advantageous for a coordinated transfer of the containers to downstream process stations. For example, the containers can be gripped individually or in rows in the raised position described above, in which the holding force in the receptacles or openings of the carrier is completely or at least sufficiently removed for their removal, with a gripper, for example in the upper edge, and be handed over in a coordinated manner.
  • The method according to the invention is based essentially on the fact that a plurality of containers are held together on a carrier and, while they are held on the carrier or at least guided, can be treated or further processed. As those skilled in studying the above description will be readily apparent, this approach is basically suitable for any process steps for the treatment or processing of containers for storing substances for cosmetic, medical or pharmaceutical applications.
  • The holding force exerted on the containers by the friction-locking or positively locking holding means of a carrier is sufficient to reliably hold the containers against the holding structure. In particular, the holding force exerted is greater than the weight of the container, possibly with content and plugs. According to further embodiments, the holding force can also be dimensioned by suitable design of the holding means so that it is greater than usual force in the handling, processing or treatment of the container in a process plant. As a result, a reliable mounting of the container is always guaranteed. Nevertheless, according to preferred further embodiments of the invention, the containers can be adjusted against this holding force in the openings or receptacles, in particular axially advanced or rotated. The force required for this must only be greater than the force exerted by the holding means.
  • To insert, remove or move the container on a carrier this holding force must be overcome first. This has the advantage that the container when exposed to a low force, such as vibrations of the process plant or funding of the same, continue to be reliably held on the carrier and not accidentally fall over. This considerably reduces the risk of unintentional contamination in process plants. For example, plugs introduced into the opening of containers frequently stick in the course of a treatment and can thereafter not be adjusted without shaking, for example in order to close or open a container. Traditionally, this has often led to a drop of containers and to an undesirable leakage of substances in process equipment. Since according to the invention the containers are held with a predetermined minimum holding force on the carriers, this risk is considerably minimized in a method according to the invention.
  • Conventionally, therefore, plugs or similar elastic closure parts were provided with a lubricious coating, resulting in undesirable impurities. According to the invention, it is basically possible to work without such lubricious coatings, so that active ingredients can be processed and treated in a purer form with a method according to the invention.
  • Of course, the support structure (the carrier) in the context of the present invention also be formed of a thermoplastic, thermosetting or elastomeric plastic, at least portions of the support structure and the carrier are provided with a reibreduzierenden coating to facilitate the insertion and removal of the container ,
  • According to another embodiment, the holding structure and / or the transport container, or portions thereof, be formed of a fiber-reinforced plastics or a plastic, which are added to increase its thermal conductivity ceramics or metals added. As is known, fiber reinforced plastics have a higher thermal conductivity up to 0.9 W / (Km) for 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. Thus, a thermal conductivity of 20 W / (Km) is achieved.
  • As will be readily apparent to those skilled in the art upon reading the foregoing description, the individual aspects and features of the above-described embodiments may be combined with one another in any manner, resulting in numerous other embodiments and modifications. As those skilled in the art will readily appreciate upon reading the present specification, it is intended that all such other embodiments and modifications be included in the present invention as long as they do not depart from the general spirit and scope of the present invention as defined in the appended claims ,

Claims (27)

  1. Method of treating or processing containers ( 2 ), which serve to store or contain substances for cosmetic, medical or pharmaceutical applications, the containers ( 2 ) are open at one end and automated by means of a conveyor for handling or processing be passed or pass through process stations, in which method a plurality of containers ( 2 ) is conveyed by the conveyor while it is being driven by a carrier ( 25 ; 134 ) are held together in a regular two-dimensional arrangement, wherein the carrier ( 25 ; 134 ) a plurality of openings or receptacles ( 32 ; 39 ; 87 ; 120 ), which dictate the regular arrangement, and wherein the floors ( 3 ) the container ( 2 ) at their closed ends from a first side of the carrier ( 25 ; 134 ) are freely accessible, wherein a process station a freeze-drying cabinet ( 220 ) with at least one cooling surface in which a freeze-drying process is carried out, wherein the bottoms ( 3 ) during the freeze-drying process in the freeze-drying cabinet ( 220 ) are in direct contact with the respective cooling surface while the containers ( 2 ) of the carrier ( 25 ; 134 ) or in a raised position in the openings or receptacles of the carrier ( 25 ; 134 ) are received and supported on the respective cooling surface.
  2. Method according to claim 1, wherein the supports ( 25 ; 134 ) in transport and packaging containers ( 1 ) and are removed for carrying out the freeze-drying process from the respective transport and packaging container.
  3. Method according to one of the preceding claims, wherein edge sections ( 68 ) of the carrier, in particular a base plate ( 61 ) thereof, to be removed or swung away so as to reduce the overall area of the carrier when handling or processing the containers in or at the process station.
  4. Method according to one of the preceding claims, wherein the containers ( 2 ) are moved in the respective opening or receiving the carrier in the longitudinal direction in the raised position for treatment or processing at or in another process station.
  5. The method of claim 4, wherein the containers in the raised position continue to be held in the openings or receptacles of the carrier to be processed or processed at or in the process station.
  6. The method of claim 4, wherein the containers in the raised position continue to be received in the openings or receivers of the carrier but are supported on an additional support surface or held by an additional holding or gripping means to be processed at or in the process station to become.
  7. The method of claim 6, wherein the additional support surface comprises at least one rotatably mounted and driven turntable on which the containers are rotated during or during processing or processing at the process station while still being received within the openings or receptacles of the carrier.
  8. Method according to claim 7, wherein the further process station comprises a crimping device ( 180 ) or a crimping station, wherein a metal lid is crimped or crimped on the upper edge of the container, wherein the crimping or crimping containers in the raised position are rotated about their longitudinal axis by the turntable while crimping or crimping the metal lid, and be pushed back into the openings or receptacles after crimping or crimping.
  9. Method according to claim 8, wherein the containers ( 2 ) for crimping or crimping in each case by means of a lifting rod ( 185 ) are raised in the raised position, wherein the respective turntable ( 194 ) is mounted on the lifting rod and wherein the upper edge ( 6 ) the container ( 2 ) with the metal lid ( 193 ) while rotating by means of a centering disc ( 191 ) is centered.
  10. Method according to one of the preceding claims, wherein the supports ( 25 ; 134 ) during treatment or processing in or at at least one of the process stations in transport and packaging containers ( 1 ) are arranged.
  11. Method according to one of the preceding claims, wherein the containers are each held in rows on the support and in each case in rows or moved by means of a gripping device for treatment or processing in or at a process station.
  12. Method according to one of the preceding claims, wherein the openings or receptacles of the carrier are associated with holding means, which the plurality of containers ( 2 ) to the carrier at the predetermined positions and in the regular two-dimensional arrangement, the holding means retaining the containers ( 2 ) on the carrier ( 25 ; 134 ) hold positively.
  13. The method of claim 12, wherein the retaining means as elastic annular positive locking elements, in particular as elastic eyelets ( 30 ) are formed, in which the containers are inserted and which the narrowed neck portions ( 5 ) The container engage around a form-fitting manner.
  14. Method according to claim 12, wherein the carrier ( 25 ) a plurality of parallel extending and at regular intervals arranged transverse webs ( 165 ), along which at regular intervals to each other a plurality of pairs of elastic, concave support arms ( 166 ) are arranged, which the upper edge ( 6 ) of the container received by a pair of holding arms ( 2 ) Fix each form fit, the containers are introduced by spreading the holding arms in this or withdrawn from these.
  15. Method according to claim 12, wherein the support has two support plates (3) mounted longitudinally displaceable relative to one another. 80 . 81 ) in which oval or elliptical openings ( 85 ) are formed, which together form an opening for holding a respective container, wherein for the arrangement of the container on the carrier or for removal from the carrier, the carrier plates are moved.
  16. Method according to one of claims 1 to 11, wherein the openings or receptacles of the support are assigned holding means, which the plurality of containers ( 2 ) to the carrier at the predetermined positions and in the regular two-dimensional arrangement, the holding means retaining the containers ( 2 ) on the carrier ( 25 ; 134 ) hold frictionally.
  17. The method of claim 16, wherein the holding means as circumferential and in the longitudinal direction of the container extending receptacles ( 39 ; 65 ) are formed and the side wall portions ( 4 ) the container ( 2 ) grip at least partially frictionally.
  18. A method according to claim 17, wherein the receptacles have a polygonal, in particular quadrangular or hexagonal cross-section, wherein the frictional engagement by the interaction of opposing side walls and the cylindrical side wall ( 4 ) the container is accomplished.
  19. Method according to claim 17 or 18, wherein the side walls ( 35 . 38 ; 46a ; 101 . 103 ) of the receptacles are formed of an elastic plastic or coated with such or provided.
  20. The method of claim 18 or 19, wherein all the side walls of the openings or receptacles are coordinated between a first position and a second position adjustable, wherein the container in the first position with little effort in the openings or receptacles are inserted or slidable and the container be frictionally fixed in the openings or receptacles in the second position.
  21. A method according to claim 20, wherein the carrier ( 25 ) in the second position is rectangular or square and the coordinated adjustment movement is a shearing motion from a first position, in which the carrier forms a parallelogram in plan view, into the second position.
  22. The method of claim 21, wherein the receptacles are formed from a plurality of identically formed and meshed basic units (16). 100 ) are formed, wherein side walls ( 101 . 103 . 107 ) of immediately adjacent basic units ( 100 ) cooperate with each other so that they are straightforward for the coordinated adjustment.
  23. A method according to any one of the preceding claims, wherein webs or sidewalls between the apertures or receptacles of the carriers prevent direct contact of adjacent containers received therein.
  24. Method according to one of the preceding claims, wherein at least some of the process stations are arranged and operated under sterile environmental conditions.
  25. Method according to one of the preceding claims, wherein at least one process station an identification or tracking means ( 175 ) is read to verify the authenticity or to read parameters, preferably an RFID chip or a RuBee chip.
  26. A method according to claim 25, wherein the identification or tracing means ( 175 ) so with the support structure ( 25 ) and / or a transport or packaging container ( 1 ) and / or a protective or packaging film ( 130 ) when opening the transport or packaging container ( 1 ) or when removing or manipulating the support structure ( 25 ) or the container ( 2 ) gets destroyed.
  27. Device for treating or processing containers ( 2 ), which serve to store or contain substances for cosmetic, medical or pharmaceutical applications, the containers ( 2 ) are open at one end, with a conveyor; and a plurality of process stations in or at which the containers ( 2 ) are each treated or processed, wherein a process station a freeze-drying cabinet ( 220 ) with at least one cooling surface in which a freeze-drying process is carried out; which device for treating or processing containers ( 2 ) is designed so that a plurality of containers ( 2 ) are automatically passed by the conveyor for treatment or processing to the process stations or go through it, while these by a carrier ( 25 ; 134 ) are held together in a regular two-dimensional arrangement, wherein the carrier ( 25 ; 134 ) a plurality of openings or receptacles ( 32 ; 39 ; 87 ; 120 ), which dictate the regular arrangement, and wherein the floors ( 3 ) the container ( 2 ) at their closed ends from a first side of the carrier ( 25 ; 134 ) are freely accessible, and the soils ( 3 ) during the freeze-drying process in the freeze-drying cabinet ( 220 ) are in direct contact with the respective cooling surface while the containers ( 2 ) of the carrier ( 25 ; 134 ) or in a raised position in the openings or receptacles of the carrier ( 25 ; 134 ) are received and supported on the respective cooling surface.
DE102012103899.6A 2012-05-03 2012-05-03 Method and device for treating containers for storing substances for medical or pharmaceutical applications Expired - Fee Related DE102012103899B4 (en)

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Application Number Priority Date Filing Date Title
DE102012103899.6A DE102012103899B4 (en) 2012-05-03 2012-05-03 Method and device for treating containers for storing substances for medical or pharmaceutical applications

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
DE102012103899.6A DE102012103899B4 (en) 2012-05-03 2012-05-03 Method and device for treating containers for storing substances for medical or pharmaceutical applications
MX2014013171A MX360701B (en) 2012-05-03 2013-05-02 Method and device for treating containers and substances stored therein for medical, pharmaceutical or cosmetic applications.
CN201510963173.8A CN105501503B (en) 2012-05-03 2013-05-02 Method and apparatus for handling or processing container
KR20147033551A KR20150009982A (en) 2012-05-03 2013-05-02 Method and device for treating containers and substances stored therein for medical, pharmaceutical or cosmetic applications
EP13720925.0A EP2844936B1 (en) 2012-05-03 2013-05-02 Method and device for treating containers and substances stored therein for medical, pharmaceutical or cosmetic applications
US14/398,541 US9522752B2 (en) 2012-05-03 2013-05-02 Process and apparatus for treating containers for storing substances for medical, pharmaceutical or cosmetic applications
EP14189484.0A EP2848882B1 (en) 2012-05-03 2013-05-02 Method and device for crimping containers for the storage of substances for medical, pharmaceutical or cosmetic uses
CN201380023284.XA CN104272049B (en) 2012-05-03 2013-05-02 Method for treating containers and substances stored therein for medical, pharmaceutical or cosmetic applications
PCT/EP2013/059183 WO2013164422A2 (en) 2012-05-03 2013-05-02 Method and device for treating containers and substances stored therein for medical, pharmaceutical or cosmetic applications
US14/995,927 US9828124B2 (en) 2012-05-03 2016-01-14 Process and apparatus for treating containers for storing substances for medical, pharmaceutical or cosmetic applications

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DE102013111600B4 (en) 2013-10-21 2018-04-05 Schott Ag Support structure for holding containers for substances for medical, pharmaceutical or cosmetic applications, as well as transport and packaging containers with the same
DE102013114404A1 (en) 2013-12-18 2015-06-18 Schott Ag Transport and packaging containers having a support structure for simultaneously holding a plurality of containers for medical, pharmaceutical or cosmetic applications, and methods and uses thereof
DE102014106197A1 (en) * 2014-05-05 2015-11-05 Schott Ag Method for packaging a plurality of containers for substances for medical, pharmaceutical or cosmetic applications, and packaging structure
DE102015012861A1 (en) 2015-10-05 2017-04-06 Angelika Traub Handling device for vials positioned within a nest
DE102016121086A1 (en) * 2016-11-04 2018-05-09 Schott Schweiz Ag Support structure for holding a plurality of containers for pharmaceutical, medical or cosmetic purposes and transport or packaging container with selbiger
DE102016123147A1 (en) 2016-11-30 2018-05-30 Schott Ag Support structure for simultaneously holding a plurality of vials, use thereof, and methods of treating such vials

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