US20140034545A1

US20140034545A1 - Holding structure for simultaneously holding a plurality of containers for medical, pharmaceutical or cosmetic applications and transport or packaging container with holding structure

Info

Publication number: US20140034545A1
Application number: US13/886,714
Authority: US
Inventors: Edgar Pawlowski; Kai Wissner; Carmen Heiter; Bastian FISCHER; Ralph Lovis
Original assignee: Schott AG
Current assignee: Schott AG
Priority date: 2012-05-03
Filing date: 2013-05-03
Publication date: 2014-02-06

Abstract

A supporting structure for concurrently supporting a plurality of containers for substances for medical, pharmaceutical or cosmetic applications is disclosed, wherein the containers are open at least at one end and wherein the supporting structure comprises a plurality of openings or receptacles and a plurality of supporting means for supporting said containers in said openings or receptacles. According to the invention the supporting structure is formed by or comprises a plurality of subunits, wherein each of the subunits can be handled or processed separately together with the containers supported thereon.

The subunits make the transfer to processing stations of the process easier, but also serve for reliably positioning the containers during the process at positions, which are precisely determined by the positions of the supporting means.

Description

FIELD OF THE INVENTION

The present invention relates generally to the concurrent supporting of a plurality of containers for the storage of substances for medical, pharmaceutical or cosmetic applications, in particular of flasks (vials) and ampoules, and more particularly to the concurrent supporting of a plurality of containers in a supporting structure in such a manner that these, while they are supported in a supporting structure provided for this purpose, may be further processed in filling or processing units, in particular in a sterile tunnel, in a filling unit for liquid medical or pharmaceutical applications or in a freeze-dryer for lyophilizing a liquid including an agent or the like. A further aspect of the present invention relates to a process for the treatment of a plurality of such containers with a concurrent automated conveyance and transfer of a plurality of containers at processing stations.

BACKGROUND OF THE INVENTION

Medication containers, for example vials, ampoules or carpoules, are widely used as containers for preservation and storage of medical, pharmaceutical or cosmetic preparations to be administered in liquid form, in particular in pre-dosed amounts. These generally have a cylindrical shape, can be made of plastic or glass and are available in large quantities at low costs. In order to fill the containers under sterile conditions as efficiently as possible concepts are increasingly used according to which the containers are already packaged in a transport or packaging container at the manufacturer of the containers under sterile conditions, which are then unpacked and further processed at a pharmaceutical company under sterile conditions, in particular in a so-called sterile tunnel.
For this purpose, various transport and packaging containers are known from the prior art, in which a plurality of medication containers are concurrently arranged in an array configuration, for example in a matrix arrangement along rows and columns extending perpendicular thereto. This has advantages in the automated further processing of the containers since the containers can be passed to processing stations, for example to processing machines, robots or the like, at controlled positions and in a predetermined arrangement. For this purpose, supporting structures are used, in which a plurality of containers can be supported concurrently in a predetermined regular arrangement. For the transfer to a processing station it is just required to properly position and open the transport and packaging container. The downstream processing station will then know at what position and in what arrangement the containers to be processed further are arranged.
Such a transport and packaging container and a corresponding packaging concept are disclosed for example in U.S. Pat. No. 8,118,167 B2. The further processing of the containers is, however, always performed such that the supporting structure will be removed from the transport and packaging container, that the containers will be removed from the supporting structure and isolated and then individually placed on a conveyor, in particular on a conveyor belt, and passed to the processing stations for further processing. This limits the speed of processing that can be achieved. Particularly in the isolation of the containers by means of cell wheels or the like, it always occurs that individual containers abut uncontrolled, which results in an undesired abrasion and subsequently in a contamination of the interior volume of the containers or of the processing station and in an impairment of the outer appearance of the containers which is undesirable.
U.S. Pat. No. 8,100,263 B2 discloses a portable transport and packaging container that can be packaged in a sterile manner, in which a plate-shaped supporting structure can be inserted in which a plurality of medication containers are held in a regular arrangement. Firstly, the individual medication containers are placed loosely in receptacles, which are formed in the supporting structure. Then, the supporting structure is placed in the transport and packaging container and this is surrounded by a gas-impermeable plastic tube. Upon subsequent evacuation of the packaging unit thus formed, the plastic tube is pressed into the spaces between the medication containers due to the negative pressure prevailing in the tube, which, on the one hand, results in a stabilization of the position of the medication containers in the supporting structure and, on the other hand, in a prevention of further uncontrolled collisions of adjacent medication containers. During the evacuation and the subsequent opening of the plastic tube, however, the medication containers may slip sideways, increasing the efforts required for automation for processing further the medication containers. In addition, the medication containers may still collide uncontrolled after opening of the plastic tube, resulting in the aforementioned disadvantages. The medication containers cannot be processed further while being in the transport or packaging container or in the supporting structure, but must be isolated first in the conventional manner and transferred over to downstream processing stations.
Related transport and packaging containers and supporting structures are disclosed 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.
However, for a further processing the medication containers must always be isolated. This is explained by way of example for a conventional process for freeze-drying pharmaceutical substances in medication containers, as disclosed for example in U.S. Pat. No. 5,964,043. Firstly, the processing station, namely a sterile tunnel, is loaded with the vials. For this purpose, the vials are hung upside down in the transport frame, which is then conveyed through the processing station. For pretreatment, the vials supported in the transport frame are sterilized. Then the transport frames are turned together with the vials accommodated therein and filled with a drug solution. Subsequently a plug is placed on the upper rim of the vials, in which a channel is formed so that the interior of the respective vials communicates with the chamber of the freeze-dryer during the freeze-drying process.
For freeze-drying (also known as lyophilization, or sublimation drying), the vials are then removed from the transport frame and individually inserted into the freeze-dryer. Here, the bottoms of the vials must be placed directly on a planar cooling head to obtain a good cooling effect. If at this stage a direct contact over the entire bottom surface is not ensured, this results in a significant prolongation of the freeze-drying process, leading to higher costs.
After lyophilization, the vials are removed from the freeze-dryer, the plugs are pushed down and metal lids are placed onto the plugs, which are then beaded or crimped. Vials processed in this manner are then delivered, for example by inserting a plurality of vials into a common supporting base and by inserting the supporting base into a transport and packaging container, which is then sterile packaged for delivery.
The need for a direct contact between the bottoms of the medication containers and the cooling head for the freeze-drying process conventionally requires a treatment or processing of individual containers, which increases the costs for processing and packaging. Conventionally, a batch-wise processing of medication containers is not possible. In any case, a direct contact between the bottoms of the medication containers, in particular the bottoms of vials, is not possible in the conventional supporting structures.
U.S. Pat. No. 5,128,105 A, US 2005/0013745 A1 and US 2009/0238727 A1 disclose supporting structures for concurrently supporting a plurality of test tubes. DE 88 05 580 U1 and FR 2595667 discloses supporting structures for fragile containers.
U.S. Pat. No. 8,320,86A discloses a supporting structure made of a resilient metal strip, in which resilient holding receptacles are formed for accommodating containers therein. The metal strip can be mounted on the inside of a box. U.S. Pat. No. 2,598,492 discloses a similar supporting structure.
US 2011/0132797 A1 discloses a container for the transport of vials.

SUMMARY OF THE INVENTION

It is an object of the present invention to further enhance a supporting structure for containers for substances for medical, pharmaceutical or cosmetic applications such that a treatment or processing of the containers is made easier, particularly that it can be performed automated. According to further aspects there are to be provided a transport and packaging container comprising such a supporting structure and a process for the treatment or processing of such containers, wherein such a supporting structure is used.
According to the present invention these objects are achieved by a supporting structure according to claim 1, by a transport and packaging container according claim 11 and by a process according to claim 14. Further advantageous embodiments are the subject-matter of the dependent claims.
Accordingly, there is provided a supporting structure for concurrently supporting a plurality of containers for substances for cosmetic, medical or pharmaceutical applications, in particular vials and ampoules, said containers being open at least at one end, wherein the supporting structure comprises a plurality of openings or receptacles into which the containers can be inserted and a plurality of supporting means for supporting the containers in the openings or receptacles. According to the invention the supporting structure is formed by or comprises a plurality of subunits, wherein each of the subunits can be handled or processed separately together with the containers supported thereon.
The subunits thereby facilitate the transfer to processing stations used in the process, but also serve for a reliable positioning of the containers during the process at positions, which are precisely determined by the positions of the supporting means. The subunits serve as supporting structures (carriers) and can be handled individually, wherein the medication containers can be supported in these supporting structures preferably in a predetermined configuration. The containers can be inserted for example into such a subunit outside of a sterile processing plant. This is followed by a sterilization and further processing, each including gripping/handling of individual subunits or of inserts composed of such individual subunits for standard transport and packaging containers.
According to a further embodiment the subunits are detachably connected with each other to form the supporting structure. The coupling may be accomplished by friction or in a positive-fit manner using separate coupling members. Thus, the subunits can be assembled to larger subunits, which e.g. can be handled faster and in a more suitable manner, e.g. to form transport units that can be transported or sealed.
According to a further embodiment the subunits are connected with each other via a supporting frame. The supporting frame causes that the plurality of subunits have a higher mechanical stability, but may also serve to enable a concurrent handling of the plurality of subunits, for example for the simultaneous transfer of a plurality of subunits to a processing station or for storing the plurality of subunits in a transport and packaging container.
According to a further embodiment the supporting frame is configured as a transport and packaging container, which is open on one or two sides and into which each of the subunits can be inserted individually. Thus, a separate supporting frame is no longer necessary.
According to a further embodiment, the respective subunits comprise a supporting web by means of which the respective subunits are respectively retained in the supporting frame or by means of which the subunits are connected with each other. Particularly, the supporting web may be inserted directly into a transport and packaging container or into a supporting frame to be positioned there.
According to a further embodiment a plurality of resilient holding arms respectively project from the supporting web, which form openings or receptacles for supporting the containers at the subunits. By means of a suitable dimensioning and design of these holding arms the supporting of the containers at the supporting webs or subunits can be set as required in a simple manner. Particularly, by means of a suitable dimensioning and design of these holding arms a suitable frictional or positive-fit for supporting the containers or a suitable supporting of the containers at the subunits may be accomplished. Particularly, the holding or supporting of the containers is configured such that the containers can be rotated or displaced to a certain extent while being held at the subunits, e.g. that they can be displaced axially into a raised or lowered position and/or rotated about their longitudinal axis. The subunit, in particular the above-mentioned supporting web, may be mechanically retained in a processing station and the containers may be moved or displaced in a suitable manner for a further processing in the processing station. Subsequently, the subunits may be re-stored in a suitable manner, for example in a transportation and packaging container.
According to a further embodiment the supporting webs and the positions of the resilient holding arms are matched to the length of the containers such that bottoms of the containers are freely accessible for processing, while being held on the subunits. For example, the bottoms may rest directly on the entire surface of a cooling-finger for freeze-drying the contents of the containers.
For this purpose, it may be advantageous if the containers can be displaced in axial direction to a certain extent while they are supported on the subunits to enable a full-surface contact.
According to a further embodiment, the resilient holding arms are configured such that the containers respectively rest loosely with their bottoms on an expanded upper rim portion on the front free ends of the holding arms. In this manner, manufacturing tolerances of the dimensions of the containers can be easily compensated for.
According to a further embodiment, the respective subunits further comprise side walls which are detachably connected to the respective supporting web. By means of such side walls the subunits may be further covered or even completely closed, which can be of advantage, for example, for a further processing at or transfer to downstream processing stations.
According to a further embodiment the supporting webs and side walls of adjacent subunits can be caused so as to engage with each other for connecting respective adjacent subunits with each other. In this manner, the subunits can also be assembled to larger subunits or transport and packaging containers without using additional connecting or coupling members.
According to a further embodiment the supporting webs of the subunits are each configured such that they can be folded-up, so that respective rectangular subunits can be formed, if viewed in a plan view, wherein the subunits are connected or coupled with the supporting structure via a common connecting web. Suitably and optionally, the supporting webs can be coupled with the connecting web or separated from the latter again. If they are separated from the connecting web, the supporting webs can be re-deployed, for example, to form a linear supporting structure, in which all containers are held aligned with one another and spaced apart from each other at regular intervals. This facilitates, for example, further processing of the containers in an assembly line process, while these are supported by a supporting web. After further processing, the supporting webs can then be folded-up and/or assembled to a subunit, as described above.
According to a further aspect of the present invention there is provided a transport or packaging container for a plurality of containers for substances for cosmetic, medicalor pharmaceutical applications, in particular of vials, comprising at least one supporting structure as described above for concurrently supporting said plurality of containers in the transport or packaging container, wherein the supporting structure is accommodated in the transport or packaging container. Here, the transport or packaging container may also serve as a supporting frame, in principle, with which the individual subunits are coupled, for example, inserted in or engaged with the latter.
According to a further aspect of the present invention, there is provided a process for the treatment or processing of containers, which are used for the storage of substances for cosmetic, medical or pharmaceutical applications or contain such substances, wherein the containers are particularly of cylindrical shape and wherein the containers are open at least at one end, in which process a plurality of containers are inserted into openings or receptacles of subunits such that they are supported by supporting means, which are associated with the openings or receptacles, on the subunits; the containers are processed or treated while being held by a respective subunit; and a plurality of subunits together with the containers, which have been processed or handled and which are supported by said subunits, are inserted into a transport or packaging container or jointly form said transport or packaging container. The subunits thereby facilitate the transfer to processing stations used by the process, but also serve to enable a reliable positioning of the containers during the process at positions which are defined precisely by the positions of the supporting means.
According to a further embodiment, one of the processing stations is a flanging station or a crimping station, where a metal lid is beaded or crimped on the upper rim of the containers, wherein the containers are rotated by the turntable about their longitudinal axis in the raised position for beading or crimping while the metal lid is beaded or crimped, and are pushed back again into the openings or receptacles after beading or crimping. For beading or crimping the containers may be lifted to the raised position by means of a lifting rod, wherein the respective turntable is supported on the lifting rod and the upper rim of the container together with the metal lid put thereon is centered by means of a centering disc during the rotation. During the treatment or processing in or at at least one of the processing stations, the containers may be held in a subunit, as described above, and may be displaced in this position axially upward to the raised position for processing, may be processed in the raised position, and finally may be pushed back to a lowered position, where the containers are supported in the openings or receptacles of the subunit. Several such subunits can be combined to a transport and packaging container or to a supporting unit, as described below. Thus, the processing or handling of the containers can be made more flexible, especially while they are still supported reliably in such a subunit. Such processing or handling may be particularly a cleaning step, a sterilization step, for example a sterilization in a sterile tunnel, a filling process, a freeze-drying process or the like or may comprise such a step.
According to a further aspect, an identification or tracking sensor shall be present at least at one processing station to prove the authenticity of parameters or for reading out parameters, which can preferably read out RFID chips, RuBee chips or fluorescent labels.
According to a further aspect, the processing may be controlled by optical sensors and/or mechanical sensors. For this purpose, particularly labels on the vials or ampoules and/or on the transport or packing container may be used.
According to a further embodiment the transport or packaging container or also a subunit is sealed or closed to the environment by means of a foil or a cover.
According to a further aspect of the present invention that may also be claimed by means of an independent claim, a supporting structure, which is embodied as a transverse web, is provided for concurrently supporting a plurality of containers for substances for cosmetic, medical or pharmaceutical applications, in particular of flaks (vials), wherein a plurality of pairs of resilient holding arms are disposed on the front side of the transverse web, each of which comprises a central bulge in order to snuggle respectively to the neck of a container to be supported, in particular of a vial, and wherein the transverse web can be inserted from above into a transport container so as to be temporarily retained in the transport container in a vertical position. Such a supporting structure allows an advantageously simple and efficient processing or handling of the containers, because a plurality of containers or vials can be supported together by the supporting structure while being processed or handled, which acts as a subunit. The supporting structures may be configured as described in detail in the present application.

OVERVIEW ON DRAWINGS

The invention will now be described by way of example and with reference to the accompanying drawings, from which further features, advantages and problems to be solved will become apparent. In the drawings:

FIGS. 1 a-1 c show a transport and packaging container having a plurality of supporting structures according to a first embodiment of the present invention, wherein individual subunits of a supporting structure can be inserted in rows in the transport and packaging container and removed again;

FIG. 1 d shows a variant of the transport and packaging container according to FIG. 1 a, wherein the rows of supporting structures are individually inserted in a removable insert of the transport and packaging container;

FIGS. 2 a-2 d show different views of a matable insert according to a second embodiment of the present invention of a transport and packaging container;

FIG. 2 e shows in an enlarged partial section a part of a supporting structure according to a further embodiment of the present invention;

FIG. 2 f shows in an enlarged partial section the supporting structure of FIG. 2 e with a vial received therein;

FIGS. 3 a-3 d show different views of a collapsible insert according to a further embodiment of the present invention of a transport and packaging container, wherein the transverse webs are formed by a collapsible supporting web having holding arms formed thereon;

FIGS. 4 a-4 c show a transport and packaging container according to a further embodiment of the present invention which is configured to be open at both ends and which is closed at the open ends with a protective film; and

FIG. 5 is a schematic flow diagram of a method for the treatment or processing of containers 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

FIG. 1 a shows a transport and packaging container 1, into which a plurality of subunits embodied as transverse webs 165 are inserted, each supporting a plurality of vials 2. According to the present invention, the transport and packaging container serves for storing a plurality of containers for storage of substances for cosmetic, medical or pharmaceutical applications in an array configuration, in particular in a matrix configuration with regular intervals between the containers along two different directions in space, preferably along two mutually orthogonal spatial directions or in regular rows, which are displaced relative to each other.
An example of such medication containers embodied as vials is schematically shown in FIG. 1 c in a longitudinal sectional view. These have a cylindrical basic shape, having a cylindrical side wall with—within tolerances—constant inner and outer diameters, which project vertically from a flat vial bottom 3, which merges in a constricted neck portion 5 having a relatively short axial length near the upper open end of the vial and then merges in a widened upper rim 6, which has a larger outer diameter than the associated neck portion 5 and is configured for connection to a closure member. The neck portion 5 can be formed with smooth walls and without an external thread or may be provided with an external thread for screwing on a closure member. For example, a plug (not shown) may be inserted in the inner bore of the neck portion 5 and the upper rim 6, whose upper end is connected with the upper rim 6 of the vial in a gas-tight manner and protected against the intrusion of contaminants into the vial, for example by crimping or beading a metal protective foil which is not shown. Such vials are radially symmetric and are made of a transparent or colored glass or of a suitable plastic material by blow molding or plastic injection molding techniques, and in general can be internally coated so that the material of the vial emits minimal impurities to the agent to be received.
Another example of containers in the sense of the present application are ampoules, carpoules, syringes or injection containers. Ampoules or carpoules are containers for medication agents for usually parenteral administration (injection), for cosmetics and other agents and are usually cylindrical in shape with an extended tip (spear or head) and a flat bottom or also with two extended tips at both ends. These may be formed in particular as snap-off ampoules with an annular predetermined breaking point around the ampoule neck or as an OPC cartridge (One-Point-cut ampoule) having a breaking ring inscribed into the glass. Syringes or injection containers, also known as injection flask, vial or reusable ampoule, are cylindrical containers of glass or plastic shaped similar to a bottle, usually having a relatively small nominal volume (e.g. 1 ml, 10 ml). They are sealed with a rubber plug with septum (puncture rubber). For protecting the septum and fixing the rubber plug an outer closure (beaded cap or cramp), often made from an aluminum sheet, is necessary. In a carpoule the liquid is stored in a cylinder, which is closed at one end by means of a thick rubber or plastic plug. This acts as a piston when the content is pressed out using a carpoule syringe. At the other end the cylinder is closed only by means of a thin diaphragm, which is pierced from the rear end of the carpoule syringe (a cannula sharpened on both sides) in the application. Cylindrical ampoules are often used in dentistry for local anesthesia. Special cylindrical ampoules with a specially shaped front part (e.g. thread) are used for insulin therapy in insulin pens.
In the sense of the present invention, such containers are used for storage of substances or agents for cosmetic, medical or pharmaceutical applications, which are to be stored in one or several components in solid or liquid form in the container. Especially in the case of glass containers storage periods can amount many years, notably depending on the hydrolytic resistance of the glass type used. While, in the following, cylindrical containers are disclosed, it should be noted that the containers, in the sense of the present invention, may also have a different profile, for example a square, rectangular or polygonal profile.
Inevitably such containers have tolerances due to the production which can be of the order of one or several tenths of a millimeter in particular for glass containers. To compensate for such manufacturing tolerances, while ensuring that all vial bottoms 3 can be disposed in a plane, according to the present invention the glass containers are retained on a supporting structure or carrier by means of a positive-fit or friction or by it. This positive-fit or friction or this supporting may be implemented either in the region of the constricted neck portion 5 of the containers, at the side wall portion 4 or in the region of the bottom end of the containers 2, in particular at the bottom 3 of the containers.
According to FIGS. 1 a and 1 c, the transport and packaging container 1 comprises a closed, rectangular bottom 11, a side wall 12 projecting substantially perpendicular from the bottom and an upper rim 15, which projects substantially perpendicular from the side wall. The transport and packaging container 1 is formed open at the top so that the transverse webs 165 together with the vials 2 can be inserted from above and removed again individually as subunits. The transport and packaging container 1 can be closed by means of a foil or cover, as described below with reference to FIG. 4. Although, in FIG. 1 a, the bottom 11 of the transport and packaging container 1 is shown to be closed and formed integrally with the side wall 12, the lower end of the transport and packaging container 1 can also be formed open in the manner of the upper end, in particular it may be provided with a flange-like bottom rim in the manner of the upper rim 15 so that the bottoms of the containers 2 are freely accessible from the underside of the transport and packaging container 1, for example, for processing steps in a sterilizing tunnel or in a freeze-dryer.
As can be seen from FIGS. 1 a and 1 b, protrusions or ridges 169 are formed on the inner surface of the lower side wall 12 spaced apart from each other at regular intervals, which extend perpendicular to the bottom of the transport and packaging container 1, wherein a channel is formed between two respective directly adjacent projections 169, into which the side edge of the respective transverse web 165 can be inserted. These channels are preferably formed as guiding and clamping channels, in which the transverse webs are held clamped. Thus, the transverse webs 165 can be temporarily retained in their horizontal as well as vertical positions in the transport and packaging container 1.
Retaining the positions of the transverse webs 165 may also be implemented in the transporting and packing container 1 by means of the positive-fit cooperation of the side edges of the transverse webs 165 and the guide and clamping channels. For example, at least one protrusion or at least one recess may be formed along the side edges and a corresponding recess or projection may be formed on the inner side of the protrusions 169, which enable the positive locking for retaining the positions of the transverse webs 165 on the side walls 12 of the transport and packaging container 1. For this purpose, the transport and packaging container 1 and the transverse webs 165 are preferably formed of a plastic material, which is sufficiently resilient.
In this way, the transverse webs 165 may be held in the transport and packaging container 1 spaced apart from each other at constant intervals. The distances between the transverse webs 165 are dimensioned such that a packing density as high as possible can be achieved, i.e. that the gap between the rows of vials and the adjacent transverse webs 165 is as narrow as possible. The transverse webs 165 prevent direct collisions of vials 2 of directly adjacent rows.
Referring to FIGS. 1 a and 1 b, resilient holding arms 166 are disposed on one side of the transverse webs 165 spaced apart from each other at regular intervals, which serve as supporting means for supporting the vials 2. Preferably, the holding arms 166 are formed integrally with the transverse webs 165, for example by injection molding, and are arranged in alignment with each other at a given level of the transverse webs 165. The distances between adjacent pairs of holding arms 166 are dimensioned such that a direct collision of adjacent vials is prevented, i.e. that the outer surfaces of the vials 2 are kept undamaged.
The resilient holding arms 166 have a central bulge that snuggle each to the neck of the vial 2 to be supported. The holding arms 166 are each matched to the vials 2 and dimensioned such that the vials 2 are held by the holding arms 166 at an appropriate position by friction or in a positive-fit manner. Here, a processing and handling of the vials 2 may be continued even while being held at the transverse webs 165, because most of the vials 2 are still accessible while being supported. As can be seen in FIG. 1 a, the vials 2 are freely accessible from above while being supported, and their bottoms are freely accessible from the bottom side of the transverse webs 165 (which is important for the cooling by means of a cooling finger, which is in contact) and the entire front side is freely accessible, when the transverse webs 165 are removed from the transport and packaging container 1. Furthermore, the holding arms 166 may also be configured such that the vials 2, while they are supported by the holding arms 166, may be rotated and/or displaced in axial direction. For this purpose there is provided a suitable friction pairing with the material of the vials 2 by means of a suitable choice of the material of the resilient holding arms 166, so that the vials 2 are, on the one hand, reliably held by the holding arms 166, i.e. that they do not slip due to their own weight, but, on the other hand, may be moved with not too high force while they are held by the holding arms 166. This possibility of freely rotating the vials 2 can be used for example for beading a metal lid mounted on the upper rim of the vial 2, as described in more detail below with reference to FIG. 5.
As an example, the supporting of the vials 2 at a transverse web 165 is shown in FIG. 1 c. The vials 2 are supported in the region of the constricted neck portion 5 and beneath the widened top rim 6 (the edge roll) so that the vials 2 are supported by the holding arms 166 so as to be secured in axial direction. The bottoms 3 of the vials 2 project beyond the bottom edge of the transverse webs 165, but this is not absolutely necessary. According to further embodiments, the upper rims of the vials 6 may protrude beyond the upper edge of the transverse webs 165.
In the sense of the present invention, the transverse webs represent subunits 165, each of which may be handled or processed individually together with the vials 2 supported, but which at the same time represent individual supporting structures for supporting a plurality of vials 2 in a suitable manner. The transverse webs 165 may be gripped, for example, individually (for example by means of grippers) and processed further or treated. Here, the bottoms of the vials 2 are fully accessible from below, when the transverse webs 165 are removed from the transport and packaging container 1.
In the embodiment of FIGS. 1 a and 1 b transverse webs 165, which serve as subunits, are inserted individually into the transport and packaging container 1 and are connected or coupled with each other by means of the transport and packaging container. However, the individual transverse webs 165 may also be inserted together in a supporting frame or supporting box and held by the latter, which then can be inserted into the transport and packaging container 1 as a unit and removed therefrom.
This is exemplified in FIG. 1 d, where the projections 169 for retaining the transverse webs are not formed directly on the lower side walls 12 of the transport container and packaging container 1 but on the side walls of a frame-like or box-like insert, which can be inserted into the transport and packaging container 1. The transverse webs 165 may be inserted into the frame-like or box-like insert in a similar manner as described above and removed therefrom, irrespective of whether the latter is in the transport and packaging container 1 or outside thereof. The underside of the frame-like or box-like insert can be formed closed or open.
FIG. 2 a shows a further embodiment of a supporting structure, wherein the subunits 170 are each formed box-shaped and can be closed. The subunits 170 are composed of a basic supporting base which is formed by two side walls 165 b, a rear wall 165 e and a bottom 165 d. Basically, the two side walls 165 b and the bottom 165 d may be formed integrally with the rear wall 165 e.
Alternatively, the two side walls 165 b and/or the bottom 165 d may be connected or coupled to the rear wall 165 e, for example by insertion or clipping, in which case the rear wall 165 e practically can be handled as a transverse web according to the embodiment of FIGS. 1 a-1 d. As a whole, the supporting structure thus formed is L-shaped in cross section. On one side of the rear wall 165 e holding arms 166 are disposed spaced apart from each other and at regular intervals for supporting the vials 2, as described above. The vials 2 can be inserted from the front side or from above into the receptacles formed by the holding arms 166.
Each of the subunits 170 may be sealed and transported individually. For this purpose, grooves are formed at the upper end of the side walls 165 b in which the upper cover 165 c can be inserted. Furthermore, the front partition wall 165 a may be inserted into corresponding grooves on the front side of the side walls 165 b. The connection or coupling with the upper cover 165 c and the front partition wall 165 a may also be accomplished in any other manner, in particular by friction or in a positive-fit manner.
Individual subunits may also be assembled together to form an insert 25 for a transport and packaging container. For this purpose protrusions may be formed on the rear of the rear partition walls 165 e, which can be inserted into the grooves on the front side of the side walls 165 b. Or spring-like locking projections 172 may be formed on the front end side of the side walls 165 b, which can be inserted into corresponding receptacles from above or below (in the manner of a tongue-and-groove-coupling or dovetail coupling), which are formed on the rear face of the side walls 165 b of a directly adjacent subunit 170. The front subunit 170 can then be closed by means of the front side wall 165 a. Thus, an insert 25 is formed, which could be packaged individually, for example in a sterile packing tube, which, however, may also be inserted into a transport and packaging container 1 (cf. FIG. 1 a). The subunits 170 themselves can be transported and closed individually.
FIG. 2 b shows the insert 25 according to FIG. 2 a in a plan view. FIGS. 2 c and 2 d show the supporting of the vials 2 in the insert 25 in a partial sectional view along the lines A-A and B-B, respectively, in FIG. 2 a.
FIG. 2 e shows a further variant of supporting means for supporting the vials (not shown) in an enlarged partial sectional view, which can be used in all embodiments of the present invention. To this end, resilient retaining tongues 140 are provided on a transverse web, as described above (not shown), instead of the resilient holding arms 166, which project vertically from a horizontal supporting base 134 provided on the transverse web and extend from the top of the horizontal supporting base 134 arcuately inwardly into the opening 135. The retaining tongues 140 are preferably formed of a sufficiently flexible or resilient plastic. Alternatively, however, the tongues 140 may also be relatively stiff, but they may be movably mounted on the top of the supporting base 134 such that they are resiliently pivoted from the opening 135 or folded back upon insertion of the containers.
In this embodiment the supporting of the vials is implemented in the transition region between the constricted neck portion 5 and the expanded upper rim 6, as exemplified in the greatly enlarged partial sectional view of FIG. 2 f. In particular, the undersides of the rims of the containers 6 are supported loosely on the upper ends of retaining tongues 140 in the transition region to the constricted neck portion, wherein the vials are nevertheless supported so as to be secured in axial direction. According to a first embodiment the vials may be inserted into the openings 135 of the supporting base 134 from below. Upon insertion of the vials into the openings 135, a resilient bending of the resilient retaining tongues 140 is caused. According to a further embodiment, in principle the vials may also be inserted from above into the openings 135 of the supporting base 134 to be supported on the transverse web.
As can be seen in FIG. 2 f, there is an air gap between the retaining tongues 140 (see left-hand side of the drawing) and the constricted neck portion 5, allowing a radial play. Because of this supporting of the vials with radial play there exists the further possibility to displace vials supported by the retaining tongues 140 in axial direction, depending on the specific design of the vials, i.e. in the longitudinal direction of the vials, for example, until the bottoms 3 of all vials supported by the transverse web are supported under the same distance from the transverse web, in order to jointly span a plane.
According to the FIG. 2 f, the vial is inserted into the opening 135 to such an extent that the expanded rim 6 is supported on the front ends of the retaining tongues precisely in the transition region between the constricted neck portion 5 and the expanded upper rim 6. This can be accomplished, for example, by insertion of the vials from below into the openings 135 of the supporting base 134 and by subsequently pushing down the vials, specifically until the front ends of the retaining tongues precisely abut to the transition region between the constricted neck portion 5 and the expanded upper rim 6. In the supporting position shown in FIG. 2 f, a certain radial distance between the step-like transition region between the upper rim 6 and the constricted neck portion 5 and the front ends of the retaining tongues 140 is provided at least for the great majority of the retained vials. In this manner, manufacturing tolerances of the vials in the axial direction as well manufacturing tolerances in the radial direction can be compensated for to some extent, and thus also vials with different diameters may be supported by one and the same transverse web in the region of the constricted neck portion 5.
FIG. 3 a shows in a schematic plan view a collapsible subunit 300 according to a further embodiment. This is formed in the manner of a foldable web 300 and comprises a plurality of regions 301, along which resilient holding arms 166, as described above, are provided or formed spaced apart from each other and at regular intervals. In FIG. 3 a it is shown, that vials 2 are inserted into some of the receptacles formed by the holding arms 166. Between the regions 301 respective regions 302 without such holding means are provided. In the transition regions between regions 301 and 302 lines of weakness or thinner wall sections (folding lines) may be formed so that the web 300 can be selectively collapsed or folded up at these positions. The subunit 300 according to FIG. 3 a can be handled and processed separately together with the vials 2 supported by it. While in FIG. 3 a the subunit 300 is shown in a plan view and with an L-shaped profile, the web may be suitably configured by suitably folding in the transition regions, for example as a linear basic unit, which supports a plurality of vials spaced apart from each other and at regular intervals.
Referring to FIGS. 3 b and 3 c, in the following it will be described, how an insert 25 for a transportat and packaging container, as described above, may be formed by a plurality of such subunits 300. According to the plan view onto the insert 25 according to FIG. 3 c it is formed by five subunits according to FIG. 3 a, each of which is folded in a U-shape. For this purpose, lines of weakness or folding lines are formed in the transition regions between the regions 301 having the holding arms 166 and the regions 302 without these holding arms (see insert on the right-hand side of FIG. 3 b). In the folded state, the rear faces of two directly adjacent webs 301 abut each other, wherein the front faces of the webs 301 are inserted or locked in receptacles, which are formed by vertical protrusions 306 on a locking rail 305. These projections 306 may be formed as described above with reference to FIG. 1 b. The projections 306 thereby retain the positions of the webs 301 and the subunits thus formed at the locking rail 305. This is clearly shown in the enlarged insert in the left-hand part of FIG. 3 b.
According to a variant, the web 300 may be also collapsed or folded like an accordion to form a plurality of transverse webs. A collapsed or folded web 300 results in an insert 25, which is suitably held together, for example, by means of a locking rail 305, and may be inserted for storage and transport, for example, in a transport and packaging container, as shown in FIG. 1 a. However, such an insert 25 may also be closed against the environment by means of a lid and a bottom, for example in the manner as described above with reference to FIG. 2 a for the box-like units, or may be sealed by a protective foil as described below with reference to FIG. 4.
FIG. 3 d shows the supporting of the vials 2 in such an insert in a schematic partial sectional view taken along the line A-A according to FIG. 3 c.
The top or the top and bottom of an insert 25, as described above, or also of a transport and packaging container 1, as described by way of example with reference to FIG. 1 a, may be covered by a sterile, gas-permeable protective foil, which is adhesively bonded and can be removed as needed. This is exemplified in FIG. 4 for a packaging unit which is formed by a transport container that is open at both sides and by a supporting structure according to FIG. 1 a accommodated therein and which is closed on the upper and lower side by means of a protective or packaging foil 130 adhesively bonded to the flange-like edge 15. The protective foil 130 may be in particular a gas-permeable plastic foil, in particular a web of synthetic fibers such as polypropylene fibers (PP) or a Tyvek® protective film, which enables a sterilization of the containers 2 accommodated and packaged in the supporting structure 25 through the film 130.
The vials 2 may also be stored and sealed in such a transport and packaging container 1 temporarily without filling. A gas may penetrate through the gas-permeable protective film 130 into the interior of the transport and packaging container 1, for sterilization of the yet open vials. Such a transport and packaging container 1 can be re-opened later in a processing station or in a sterile tunnel to continue handling or processing the vials.
Hereinafter, with reference to FIG. 5 a process for the treatment or processing of containers will be described schematically, which are used for the storage of substances for cosmetic, medical or pharmaceutical applications or contain such substances. Firstly, in step S1 the subunits of the supporting structure are loaded with vials. These may in principle already be filled, in which case the vials are, for example, sealed in the subsequent process steps or their contents are first freeze-dried. However, FIG. 5 assumes that the vials are to be filled, while being supported on the subunits.
In process step S2, the vials are further processed, for example, washed and subsequently dried and/or sterilized while being supported on the subunits. This process step is optional.
Subsequently, in process step S3 the vials are filled either with a liquid containing an active ingredient or a powder. Then the vials are sealed in process step S4, for example by a plug or metal lid that may also be beaded or crimped. These process steps S3 and S4 are carried out, while the vials are supported on the subunits.
In the optional process step S5 that may also be carried out before step S4, the vials can be processed further, while they are supported on the subunits. Such a process step may be, for example, a freeze-drying process, during which the subunits are transferred to a freeze-dryer in which the freeze-drying process is performed. Suitably, the subunits are configured such that all bottoms of the vials are freely accessible from the underside while they are supported on the subunits so that they can rest directly on the entire surface of a cooling finger of the freeze-dryer. Of course, such a process step may also be represented by any other processing step, such as a thermal treatment or irradiation. It is advantageous that the containers are mostly freely accessible in the subunits in the sense of the present invention and as described above, in particular from the upper and lower sides and from the front of the subunits as described above, for example, with reference to FIGS. 1 a to 3 c.
In the subsequent process step S6, the subunits are inserted into a transport and packaging container, for example as shown in FIGS. 1 a and 1 d. Or all subunits together form such a transport and packaging container as shown e.g. in FIGS. 2 a, 2 b and 3 b.
Thus, according to the invention the vials can be treated or processed in batches. A removal from the supporting base and a separating step, which conventionally makes the processes complicated, is not required. For this purpose, according to the invention the subunits are configured such that the vials may be supported by friction or in a positive-fit manner. Specifically, the vials are supported in openings or receptacles of the subunits, which are shaped in a suitable manner for this purpose. The subunits may be configured such that the vials, while being supported, may be displaced or rotated or moved or displaced in a similar manner. This may be ensured easily, for example, by means of an appropriate design of the supporting of the vials, e.g. of the support by friction or in a positive-fit manner. Thus, the vials may, for example, be rotated, while they are supported at a subunit, for beading or crimping a metal lid which is mounted on their upper rim.
For a treatment or processing at or in a processing station the vials may be displaced in the respective opening or receptacle of a subunit in the longitudinal direction to a raised position in which the further treatment or processing is then facilitated. For example, in this raised position, the bottoms of the vials may be completely accessible or the upper rims of the vials may protrude suitably beyond the top edge of a subunit or of a transport and packaging container, so that a treatment or processing is possible only in the raised position. Advantageously, the vials are supported in this raised position in the region of its cylindrical side wall or of a constricted neck portion below the upper rim or at its upper rim, which may depend on the particular processing station.
In the raised position the vials may still be accommodated in the openings or receptacles of a subunit, but be supported on an additional supporting surface or supported by means of an additional holding or gripping device while they are treated or processed at or in the processing station. The supporting means at a subunit are configured for this purpose such that they do not support the vials in the raised position, at least not with a holding force sufficient to correspond to the weight of the vials. However, also in such an embodiment the vials do not need to be removed completely from a subunit so that their treatment of processing may be continued in batches, but that, nevertheless, they can be transferred to a subsequent process step more rapidly.

Claims

What is claimed is:

1. A supporting structure for concurrently supporting a plurality of containers for substances for medical, pharmaceutical or cosmetic applications,

said supporting structure being configured as a transverse web, wherein

a plurality of pairs of resilient holding arms are disposed on the front side of the transverse web, and

each of the resilient holding arms comprises a central bulge in order to respectively snuggle to the neck of a container to be supported, wherein

the transverse web can be inserted from above into a transport container so as to be temporarily retained in the transport container in a vertical position.

2. The supporting structure of claim 1, wherein each of the resilient holding arms is matched to the container to be supported such that it is supported by friction or in a positive-fit manner on the transverse web.

3. The supporting structure of claim 2, wherein the resilient holding arms are configured such that the containers can be rotated and/or displaced axially while being held by the holding arms.

4. The supporting structure of claim 1, wherein the transverse web and the positions of the resilient holding arms are matched to the length of the containers to be supported such that bottoms of the containers to be supported are freely accessible for a processing, while they are supported on the transverse web.

5. The supporting structure of claim 1, wherein the resilient holding arms are configured such that

the containers are supported in the region of the neck and below an expanded upper rim that follows the neck, and

the containers are held by the resilient holding arms so as to be secured in axial direction.

6. The supporting structure of claim 1, wherein the resilient holding arms are configured such that the containers respectively rest loosely with their bottoms on an expanded upper rim portion on the front free ends of the holding arms.

7. The supporting structure of claim 1, wherein distances between adjacent pairs of resilient holding arms are dimensioned such that a direct collision of adjacent containers is prevented.

8. The supporting structure of claim 1, wherein the resilient holding arms are disposed on the front side of the transverse web spaced apart from each other and at regular intervals.

9. The supporting structure of claim 1, wherein the resilient holding arms are formed of a plastics material and integrally with the transverse web.

10. The supporting structure of claim 1, wherein the resilient holding arms are disposed aligned with one another at a given level of the transverse web.

11. A transport or packaging container for a plurality of containers for substances for medical, pharmaceutical or cosmetic applications in said transport or packaging container, comprising

at least one supporting structure for concurrently supporting a plurality of containers for substances for medical, pharmaceutical or cosmetic applications,

said supporting structure being configured as a transverse web, wherein

said at least one supporting structure is inserted from above into said transport or packaging container or into a frame-like or box-shaped insert so as to be temporarily retained in the transport container in a vertical position.

12. The transport or packaging container of claim 11, wherein the transport or packaging container has a closed bottom and a side wall projecting perpendicularly, wherein

pairs of protrusions or ridges are formed on the inner surface of the side wall spaced part from each other and at regular intervals and extending in parallel with each other for respectively forming a guide and clamping channel extending vertically, and

side edges of the respective transverse web are inserted into two guide and clamping channels, which are disposed on opposite portions of the side wall of the transport or packaging container, for retaining the respective transverse web.

13. The transport or packaging container of claim 11, wherein the respective transverse web is held on the inner surface of the side wall of the transporting or packing container in a positive-fit manner.

14. The transport or packaging container of claim 11, wherein the transport or packaging container is sealed by a sterile, gas-permeable protective foil.

15. A process for the treatment or processing of containers, which are used for the storage of substances for medical, pharmaceutical or cosmetic applications or contain such substances, using a transport or packaging container comprising at least one supporting structure for concurrently supporting a plurality of containers in said transport or packaging container, wherein

said supporting structure is configured as a transverse web,

each of the resilient holding arms comprises a central bulge in order to respectively snuggle to the neck of a container to be supported, in which process:

a transverse web is removed from said transport or packaging container while said plurality of containers are supported on said transverse web;

said containers are processed or handled while being supported by the respective transverse web; and

said transverse web together with the containers, which have been processed or handled and which are retained by said transverse web, are inserted again into the transport or packaging container.

16. The process of claim 15, wherein

the containers are displaced in a longitudinal direction into a raised position to be treated or processed in the respective receptacle of the transverse web at or in a processing station,

a further treatment or processing of the containers is performed in said raised position, and

the transport or packing container is sealed or closed from the surroundings by means of a foil or a cover, after said treatment or processing of the containers.

17. A supporting structure for concurrently supporting a plurality of containers for substances for medical, pharmaceutical or cosmetic applications, said containers being open at least at one end, wherein the supporting structure comprises

a plurality of openings or receptacles and

a plurality of supporting means, wherein

the openings or receptacles are configured such that containers can be inserted into them, and

the supporting means are configured for supporting the containers in the openings or receptacles of the supporting structure, wherein

the supporting structure is formed by or comprises a plurality of subunits, and

each of the subunits can be handled or processed individually together with the containers supported thereon.

18. The supporting structure of claim 17, wherein the subunits are detachably connected with each other to form the supporting structure.

19. The supporting structure of claim 17, wherein the subunits are connected with each other via a supporting frame.

20. The supporting structure of claim 19, wherein the supporting frame is configured as a transport and packaging container, wherein

the transport and packaging container is open on one or two sides, and

each of the subunits can be inserted separately into the transport and packaging container.

21. The supporting structure of claim 19, wherein the respective subunits comprise a supporting web, wherein

the supporting web is configured to retain the respective subunits in the supporting frame or to connect the subunits with each other.

22. The supporting structure of claim 21, wherein a plurality of resilient holding arms respectively project from the supporting web and wherein the openings or receptacles of the supporting structure are formed by the resilient holding arms.

23. The supporting structure of claim 22, wherein the supporting webs and the positions of the resilient holding arms are matched to the length of the containers such that bottoms of the containers are freely accessible for processing, while being held on the subunits.

24. The supporting structure of claim 22, wherein the resilient holding arms are configured such that the containers respectively rest loosely with their bottoms on an expanded upper rim portion on the front free ends of the holding arms.

25. The supporting structure of claim 22, wherein the respective subunits further comprise side walls which are detachably connected to the respective supporting web.

26. The supporting structure of claim 25, wherein the supporting webs and side walls of adjacent subunits can be caused to engage with each other for connecting respective adjacent subunits with each other.

27. The supporting structure of claim 22, wherein the supporting webs of the subunits are each foldable, so that respective rectangular subunits can be formed, if viewed in a plan view,

wherein the subunits are connected with the supporting structure via a common connecting web.

28. A transport or packaging container for a plurality of containers for substances for medical, pharmaceutical or cosmetic applications, comprising at least one supporting structure for concurrently supporting said plurality of containers in the transport or packaging container, wherein

said at least one supporting structure is accommodated in said transport or packaging container,

said containers are open at least at one end, wherein the supporting structure comprises

a plurality of openings or receptacles and

a plurality of supporting means, wherein

the supporting structure is formed by or comprises a plurality of subunits, and

29. A process for the treatment or processing of containers, which are used for the storage of substances for medical, pharmaceutical or cosmetic applications or contain such substances, wherein the containers are open at least at one end, in which process:

a plurality of containers are inserted into openings or receptacles of subunits such that they are supported by supporting means, which are associated with the openings or receptacles, on the subunits;

a plurality of subunits together with the containers, which have been processed or handled and which are supported by said subunits, are inserted into a transport or packaging container or jointly form said transport or packaging container.