WO2011094881A1

WO2011094881A1 - Sterile packaging of bottles and/or of bottle closures

Info

Publication number: WO2011094881A1
Application number: PCT/CH2011/000013
Authority: WO
Inventors: Christian Schütz
Original assignee: Schuetz Christian
Priority date: 2010-02-04
Filing date: 2011-02-02
Publication date: 2011-08-11
Also published as: CH702668A1; DE112011100439A5; CH702668B1

Abstract

A set packaging (10; 20) for packaging a plurality of bottles (40) or a plurality of bottle closures (30) in a sterile manner comprises an accommodating film (110; 20), which has a plurality of recesses (1110; 210), in each of which one of the plurality of bottles (40) or one of the plurality of bottle closures (30) is arranged. The set packaging (10; 20) allows the plurality of bottles (40) or bottle closures (30) to be distributed or used in a sterilized manner so that simple process control is possible in the aseptic filling and closing of the bottles. For example, the time-intensive process step of washing and possibly sterilizing can be omitted or at least simplified. Certain process steps such as gassing can also be additionally simplified, accelerated, and possibly automated as a result of the predefined arrangement of the bottles (40) and/or the bottle closures (30). The set packaging (10; 20) according to the invention thus allows the bottles (40) to be aseptically filled and closed in a relatively efficient and low-cost manner.

Description

STERILE PACKAGING OF VESSELS AND / OR OF

BOTTLE CLOSURES

Technical area

The invention relates to a set packaging according to the preamble of independent claim 1 and a closure device and a method for the sterile sealing of vials with vial closures. Such set packages can be used for the sterile packaging of vials or vial closures.

PRIOR ART In the aseptic filling of vials of various types, such as, for example, injection bottles or vials or prefilled syringes or carpules, plugs are often used today to close the vials at least temporarily. The filling process typically involves sterilizing and washing the vials, filling the vials, possibly sparging the filled vials with inert gas, closing the vials with one stopper each, and crimping the stopper. Although this filling process can also be carried out automatically or robotically, certain process steps, in particular the sterilization and washing of the vials, are relatively time-consuming. The crimping of the plug can be done for example by means of a respective cap, which is placed on the plug and then crimped with the vial. For example, EP-B1-1 971 531 describes a closure system for an injection bottle with a stopper and such a closure cap. The plugs themselves and also the caps are partly pre-sterilized packed in foil or bag sold especially in steam-sterilizable bags or in autoclaving bags.

So that the filling process can take place aseptically, the mentioned process steps are usually carried out at least partially in a clean room, which is relatively expensive. In particular, with relatively small batch sizes, such as those incurred in clinical investigational preparations, thereby the filling process per unit can be expensive and inefficient. In addition, for such batch sizes, the expenditure on equipment, for example for washing and depyrogenation steps or the sterilization of the primary packaging material and the filling or flanging machines, of these filling processes is relatively high, which in turn has negative effects on the costs and the efficiency of the filling processes. The present invention is therefore based on the object to propose an apparatus and / or a method which allows a relatively inexpensive and efficient aseptic filling and closing of vials, especially in the mentioned relatively small batch sizes.

Presentation of the invention

The object is achieved according to the invention by a set package as defined by the features of independent claim 1, and by a closing device and a method as defined by the features of independent claim 10 and the features of independent claim 19, respectively. Advantageous embodiments of the invention will become apparent from the dependent claims. The essence of the invention is as follows: A set package for the sterile packaging of a plurality of vials or a plurality of vial closures, comprises a receiving sheet having a plurality of wells in each of which one of the plurality of vials and one of the plurality of vial closures is disposed , As used herein, the term "vial" refers to, in particular, a medical container such as an injection vial, a vial, a pre-filled syringe, a cartridge, or the like.These vials are typically made of glass or plastic Closure for sealing such a vial understood and in particular a plug, a cap or a plug-cap combination. The set packaging according to the invention makes it possible for a plurality of vials or vial closures to be sterilized or used, so that simple process control is possible during the aseptic filling and closing of the vials. For example, the time-consuming process step of washing and possibly sterilizing can be omitted or at least simplified. Also, certain process steps such as fumigation by the predefined arrangement of the vials and / or vial closures can be further simplified, accelerated and possibly automated. The set packaging according to the invention thus enables a relatively efficient and cost-effective aseptic filling and closing of the vials.

The recesses of the receiving film of the set package may be tapered, for example, hemispherical or configured as a conical truncated cone, whereby the vials or the vial closures can be easily held by friction forces in the wells. The receiving film may be made of aluminum or in particular of plastic and in particular of a transparent plastic. The recesses of the receiving film can be closed by a push-through film, so that the individual vials or vial closures are packed in the wells. The depressions can also be designed to be open on both sides with a receiving opening and on an opposite side so that the held vials or vial closures can be accessed on both sides.

Preferably, the recesses of the receiving film in the direction of a receiving opening of the recesses are designed durchdrückbar. Thus, a vial or vial closure held in a well can be easy be solved again from the receiving film. The vials or the vial closures are preferably surrounded by a vapor-permeable and germ-proof packaging material, preferably also together with the set packaging. In particular, the vials or vial closures may be sealed together with the set package in clean room foil material or in an autoclave bag. Such a packaging allows on the one hand a simple and comfortable handling of the set packaging and on the other hand a simple sterilization of the vials or the vial closures or the entire set packaging in a filling process, for example by means of an autoclave. Preferably, the vials or the vial closures are sterilized, whereby a simple embodiment of the filling process is possible.

Preferably, the distance between adjacent in one direction depressions of the receiving film is the same. Such a regular arrangement of the wells and thus also of the vials or vial closures facilitates the further processing of the set packaging, in particular in a filling process, which can also be carried out automatically. The recesses of the receiving film are preferably arranged in several rows, in particular in five rows of ten recesses.

In a preferred embodiment, the set package includes vial closures each having a head portion and a body portion, the head portion having a larger diameter than the body portion such that for closing an opening of an associated vial, the body portion is insertable through the opening into the vial and the head portion can be arranged close to the opening. With such vial closures or plugs, the vials can be easily closed in a filling process. In this case, the set packaging preferably comprises a holding foil, which is provided with openings corresponding to the depressions of the receiving foil, wherein the openings are dimensioned and the holding foil is so connected to the receiving foil that the body portions of the vial closures each protrude through one of the openings of the holding foil and the head portions of the vial closures respectively abut an edge of one of the openings. With such a retaining film, the vial seals can be held efficiently and securely by locating the body parts inside the recesses of the receiving film and projecting the body parts out through the openings of the retaining film. The openings can be punched into the retaining film. In particular, the holding foil can be designed as a collar and / or push-through, at least in the edge region of the openings, so that the vial closures or the stoppers can be detached in a simple manner. Preferably, the set package is made of a material which is dimensionally stable in an autoclaving process for sterilization, in particular polypropylene (PP), polycarbonate (PC), cyclo-olefin copolymer (CoC) or polyoxymethylene (POM). Such a set package allows for efficient sterilization without compromising the function of holding the vials or vial closures.

Another aspect of the invention relates to a capping device for capping vials each having a vial closure having a vial holder having a plurality of receptacles and a vial closure holder having a plurality of corresponding receptacles. The vial closure holder is designed so that the wells of a set packaging with vial closures described above can be arranged in the receptacles of the vial closure holder. With such a closure device all vials arranged in the vial holder can be closed together in a simple manner. For example, in one filling process, all the vials placed in the vial holder can be filled and then sealed by squeezing the vial closure holder along with the vial-sealed set package onto the vial holder and thus the vials. In this pressing, on the one hand a vial closure can be arranged on the associated vial and on the other hand, at the same time, the vial closures can be detached from the receiving foil of the set packaging. Thus, the closure of the vials in a filling process can be performed quickly and efficiently. In addition, the vial closures and / or the Vials are sterilized as described above, which further simplifies the filling process under aseptic conditions and increases its efficiency. The vials can be arranged, for example, directly in the receptacles of the vial holder. The vial holder together with the vials and the vial closure holder together with the vial closure set package may each be surrounded by a vapor permeable and germproof packaging material as described above. This will efficiently sterilize the vial holder and vials, vial lock holder, and vial closures together. The receptacles of the vial holder and the vial closure holder can be configured as cavities or as blind holes.

In a preferred embodiment of the closure device according to the invention, the vial closure holder and the set packaging with vial closures are designed as one unit. They can be made of the same material in one piece. Such a unit may allow easy manufacture and ease of use. Preferably, the vial holder is configured such that the vents of a set vial pack as described above can be disposed in the vial holder receptacles, the vial set having vials corresponding to vial closures and correspondingly configured with vial closures. Corresponding vials in this context are vials that match the vial closures, so they can be closed by them. Corresponding set packages in this context are set packages which are matched to one another from the arrangement of their receptacles, so that the set packs with vials match the set packs with vial closures. Such a closure device enables efficient filling process management. According to the vial closure holder described above, in one embodiment, the vial holder may also be configured as a unit. Preferably, the vial holder and vial closure holder are each plate-shaped. In this way, the vial holder and vial lock holder can be easily implemented and handled easily and efficiently. In particular, such plates can also be handled relatively simply automated, for example robotic. For example, such plate-shaped vial holders and vial closure holders may have a length of about 25 cm and a width of about 20 cm or a length of about 23.02 cm and a width of about 1985 cm or a length of about 32.4 cm and a width of about 17 cm or a Have a length of about 19,845 cm and a width of about 12,964 cm.

Preferably, the closure device includes a spacer mountable between the vial holder and the vial closure holder, the spacer carrying the vial closure holder when the vial closure holder is disposed on the vial holder. In this case, the spacer can be designed in shape and size depending on the dead weight of the vial closure holder so that it can carry the vial closure holder together with the set packaging with the vial closures. Thus, the vial closure holder can be arranged and held in a simple manner, for example, in a filling process as intended on the vial holder. The spacer may, for example, be configured in the shape of a column and, in particular, as four columns that can be arranged, for example, in each case in a corner region of the vial closure holder and the vial holder. The spacer is preferably configured to yield at an actuation force acting on the vial closure holder and / or the vial holder in the direction of the vial holder or vial closure holder, respectively. Thus, the vial closure holder can only be placed on the vial holder as intended, possibly after that further process steps are performed on the vial and / or on the vial closures and then the vials are closed by attaching the actuating force. The spacer is preferably connectable to the vial holder. This connection can be used to replace the Distance holder after use be solvable. The connection can also be fixed, in particular if the spacer is designed to be elastic, for example.

Preferably, the closing device comprises a guide, by means of which the vial closure holder and the vial holder are guided to each other movable. Such guidance allows easy, controlled and secure closure of the vials. The guide may be a bore in the vial closure holder and / or the vial holder for receiving the spacer, in particular when the spacer is configured as one or more columns.

In a preferred embodiment, in each case a lid can be arranged in the receptacles of the vial closure holder in such a way that a vial-facing side of a vial closure arranged in the same receptacle faces away from the lid. Preferably, the recesses of the receiving film of the set packaging with vial closures are open on both sides, so that when closing the vial this receiving film is pressed so far on the vial that the lid can be arranged on the vial without this receiving film to remove previously. The covers can in particular be designed in each case as a closure cap as described above. With such lids, the vial closures can be crimped directly upon closure, which can be done in the same step with closing the vials or in a second subsequent step. Another further aspect of the invention relates to a method of vial-sealing vial-closure vials by means of a capping device as described above wherein vial holders are mounted in each vial holder in which the vial packaged vial packs are placed in the vial cap holders and squeezing the vial lock holder and the vial holder together so that each of the vials is closed with one of the vial closures. With such a method, a high efficiency can be achieved in particular under sterile and / or aseptic conditions. Preferably, the Vial filled before closing. In particular, they can be filled with liquid or a flowable product and then possibly additionally with an inert gas. Preferably, the process is carried out in a lyophilizer, thus allowing for efficient sterile sealing.

Brief description of the drawings

In the following the invention will be described in more detail with reference to the attached drawings by means of embodiments. Show it:

Fig. 1 is a schematic view of a part of a receiving sheet of a first

Embodiment of a set package according to the invention with vial closures;

Fig. 2 is a schematic side view of a portion of the receiving sheet of Fig. 1; FIG. 3 is a schematic cross-sectional view of a portion of the receiving sheet of FIG.

1 ;

Fig. 4 is a schematic view of a portion of a holding film of the set packaging

Vial closures of Fig. 1;

5 shows a schematic view laterally of a part of the holding foil of FIG. 4; FIG.

Fig. 6 is a schematic cross-sectional view of a part of the holding sheet of Fig. 4; Fig. 7 is a schematic view of a part of a receiving sheet of a first

Embodiment of a set package according to the invention

bottles;

FIG. 8 shows a schematic view laterally of a part of the receiving film of FIG. 7; FIG. 9 is a schematic cross-sectional view of a part of the receiving sheet of FIG.

7 with an embodiment of a vial;

Fig. 10 is a schematic view of a vial holder of a first

Embodiment of a closing device according to the invention;

Fig. 1 1 is a schematic cross-sectional view of the vial holder of Fig. 10 along line A-A with a second embodiment of a set package of vials according to the invention;

Fig. 12 is a schematic view of a vial closure holder of

Closing device of Fig. 10; 13 shows a schematic cross-sectional view of the vial closure holder of FIG. 12 along the line B - B with a second exemplary embodiment of a set package with vial closures according to the invention;

14 is a schematic cross-sectional view of Fiuchchenhaiterung and the

Vial closure holder of the closure device of Fig. 10;

Fig. 15 is a schematic view of another embodiment of a

Vial with an associated vial closure and associated closure cap;

16 is a schematic cross-sectional view of a third embodiment of a set package with vial closures according to the invention;

Fig. 17 is a schematic cross-sectional view of the set packaging of Fig. 16 with

Sealing caps of Fig. 15;

Fig. 18 is a schematic view of a portion of the set package of Fig. 17; 19 is a schematic cross-sectional view of a fourth embodiment of a set package according to the invention with vial closures;

Fig. 20 is a schematic cross-sectional view of the set packaging of Fig. 19 with

Vial closures of Fig. 15;

Fig. 21 is a schematic view of a portion of the set package of Fig. 20; Fig. 22 is a schematic cross-sectional view of a third embodiment of a set package of vials according to the invention;

FIG. 23 is a schematic cross-sectional view of the set package of FIG. 22 with FIG

Vial of Fig. 15; and

24 shows a schematic cross-sectional view of a second exemplary embodiment of a closing device according to the invention with the set packages of FIGS. 17, 20 and 23.

Way (s) for Carrying Out the Invention Certain terms will be used in the following description for convenience and are not intended to be limiting. The words "right,""left,""bottom," and "upper" designate directions in the drawings referred to, and portions therein. The terms "inward" and "outward" refer to directions toward or away from the geometric center the invention and named parts thereof. The terminology includes the words expressly mentioned above, derivatives thereof, and words of similar meaning. Fig. 1 shows a part of a receiving sheet 11 of a first embodiment of a set package with vial closures. On the left and on the upper side of Fig. 1, the edge termination of the receiving film 1 1 can be seen and on the right and on the lower side of the illustration of FIG. 1, the receiving film 1 1 continues. The receiving film 1 1 comprises a substantially circular recess 1 12 and a plurality of recesses 111, three of which are shown in Fig. 1. The recesses 11 1 are configured substantially circular in plan view and each have a hole 111 1.

The following definition applies to the entire further description. If reference signs are included in a figure for the purpose of clarity of the drawing, but are not mentioned in the directly related text of the description, their explanation will be referred to in the preceding description of the figures. If reference signs are also mentioned in the descriptive text directly related to a figure, which are not included in the associated figure, reference is made to the preceding figures.

In Fig. 2, a recess 11 1 of the receiving film 1 1 is shown from the side, which is configured substantially in the shape of an upwardly tapering or conical truncated cone. The recess 1 1 1 has on one side an opening 1 112 for receiving or dispensing a vial closure and on an opposite side of the hole 1 11 1. Fig. 3 shows the recess 1 1 1 with a stopper 3 disposed therein as a vial closure or as Part of a vial closure. The plug 3 comprises a body portion 32 with two legs and a head portion 31. The head portion 31 of the plug 3 has a larger diameter than the body portion 32, so that the head portion 31 projects beyond the body portion 32 to the outside. The head portion 31 and essential parts of the body portion 32 are disposed within the recess 1 1 1. The hole 1 1 11 is dimensioned so that the head portion 31 of the plug 3 can not be pushed, without deforming either the recess 1 1 1 of the receiving sheet 1 1 or the head portion 31 of the plug 3.

Fig. 4 shows, analogously to FIG. 1, a part of a holding foil 12 of the set packaging with vial closures. The holding film 12 comprises a substantially circular recess 122 and a plurality of openings 121, three of which are shown in Fig. 4. The openings 121 are configured substantially circular in plan view and are each surrounded by a substantially annular collar 122 in the plan view. In Fig. 5, two openings 121 of the holding film 12 are shown with their collar 122 from the side, wherein the collar 122 are configured substantially in the shape of an upwardly tapering or conical relatively flat truncated cone. Fig. 6 shows one of the openings 121 together with its collar 122, wherein one of the plug 3 is intended to be arranged therein. The head portion 31 of the plug 3 abuts the collar 122 at the edge of the opening 121. The body portion 32 extends through the opening 121 and the collar 122. The opening 121 is dimensioned such that the head portion 31 of the plug 3 can not be pushed through without deforming either the collar 122 of the holding film 12 or the head portion 31 of the plug 3. FIG. 7 shows, analogously to FIG. 1, a part of a receiving film 2 of a first exemplary embodiment of a set packaging with vials. The receiving film 2 comprises a substantially circular recess 22 and a plurality of recesses 21, three of which are shown in Fig. 7. The recesses 21 are configured substantially circular in plan view and each have a bottom 212. In Fig. 8, two recesses 21 of the receiving sheet 2, which are designed substantially cylindrical, shown from the side. The depressions 21 each have an opening 211 on one side and the bottom 212 on an opposite side. FIG. 9 shows one of the recesses 21 with an injection bottle 4 arranged therein as a vial. The injection bottle 4 has a head 41 and a body 42. On the side opposite the head 41, the body 42 of the injection bottle 41 is arranged in the recess 21 in such a form-fitting manner that the injection bottle 41 is held by the frictional forces between the injection bottle 4 and the receiving film 2. In Fig. 10, a vial holder 5 of a first embodiment of a closing device according to the invention is shown. The vial holder 5 is designed as a rectangular plate and comprises five parallel rows, each with ten seats 51, wherein the receptacles 51 are configured circular in plan view and are each arranged uniformly spaced from adjacent receptacles 51. In each of the four corners of the vial holder 5, a spacer 52 in the form of a cylindrical column is arranged. FIG. 11 shows the vial holder 5 in cross section along the line A - A of FIG. 10, showing a row of ten receptacles 51. The receptacles 51 each have a bottom and are cylindrical. In the vial holder 5, a second embodiment of a set packaging with vials is arranged, which comprises a substantially rectangular receiving film 20 with corresponding to the receptacles 51 of the vial holder 5 wells 210 designed. The depressions 210 each have an opening 2110 on an upper side and a bottom 2120 on an underside. For illustration, in each of the left four recesses 210 of the receiving film 20 of the cross section of Fig. 11 each an injection bottle 40 is arranged as a vial, which obviously also in all wells 210 of the receiving film 20 injection bottles 40 may be arranged. The receiving film 20 is arranged in the vial holder 5, that in each case a recess 210 of the receiving film 20 and thus partially the associated injection bottle 40 in a receptacle 51 of the vial holder 5 is located.

Fig. 12 shows a vial closure holder 6 of the closure device of Fig. 10 and Fig. 11. The vial closure holder 6 is also designed as a rectangular plate and comprises five parallel rows of ten receptacles 61, wherein the receptacles 61 are configured in a circle and each circular evenly spaced from adjacent receptacles 61 are arranged. In each of the four corners of the vial closure holder 6, a bore 62 is arranged, in which one of the spacers 52 of the vial holder 5 can be inserted and which are designed as a blind hole with a certain depth. In Fig. 13, the vial lock holder 6 is shown in cross section along the line BB of Fig. 11, wherein a row of ten seats 61 is shown. The receptacles 61 each have a bottom and are configured cylindrically with a slightly lower height than the receptacles 51 of the vial holder 5. In the Vial closure holder 6, a second embodiment of a set packaging with vial closures 10 is arranged, which is a substantially rectangular receiving film 1 10 corresponding to the receptacles 61 of the vial closure holder 6 configured recesses 1 1 10 and a holding film 120 with corresponding to the recesses 1 1 10 openings 1210 designed and associated collar 1220. The wells 1 1 10 have at their the receptacles 61 of the vial closure holder 6 facing sides each have a hole. In the wells 1 1 10 of the receiving sheet 1 10 each have a plug 30 with a head portion 310 and a body portion 320 is arranged as a vial closures. The head portions 310 of the plug 30 are respectively on the collar 1220 of the associated opening 1210 and are held in the recesses 1 1 10 of the receiving film 1 10. The set packaging with vial closures 10 is arranged in the vial closure holder 6, that in each case a recess 1 1 10 of the receiving sheet 1 10 and thus partially the associated plug 30 in a receptacle 61 of the vial closure holder 6 is located. Above the recesses 110 of the receiving film 10, a closure cap 7 is in each case arranged as a lid in the associated receptacle 61 of the vial closure holder 6.

As shown in FIG. 14, in operation for closing the injection bottles 40, for example, after filling thereof, the vial lock holder 6 is placed above the vial holder 5. The four spacers 52 of the vial holder 5 are inserted into the four corresponding holes 62 of the vial lock holder 6 through recesses of the receiver sheet 10 and the holding sheets 120 of the bottle closure set package and the set film 20 vial through which the vial holder 5 and vial lock holder 6 are inserted intended to be positioned one above the other and their movement is guided controlled each other. The four spacers 52 are configured to carry the vial closure holder 6 when they are each disposed in one of the holes 62 formed as blind holes. In this state, the body portions 320 of the plugs 30 may already be partially in the corresponding injection bottles 40, wherein further process steps may be carried out, which are independent of the further closing of the injection bottles 40. For example, the Injection bottles 40 are acted upon in this state with an inert gas, so that they are completely filled with the medium to be filled and the inert gas.

Then, an actuation force is applied to the vial closure holder 6 and / or the vial holder 5, which acts in the direction of the vial closure holder 6 on the vial holder 5 and / or in the direction of the vial holder 5 on the vial closure holder 6. The actuation force is sufficiently large that the resistance of the spacers 52 is overcome and the vial lock holder 6 and the vial holder 5 are moved closer to each other. In this case, the plugs 30 are further inserted into the injection bottles 40 until the body portions 320 are completely arranged in the associated injection bottles 40 and the head portions 310 rest on the edges of the openings of the injection bottles 40. The vial lock holder 6 and the vial holder 5 are further moved towards each other, so that the take-up sheet 110 and the holding film 120 of the set package with vial fasteners 10 are pulled over the injection bottles 40. This is done by deforming the collars 1220 of the retainer film 120 and the holes of the recesses 11 10 of the receiving film 110, respectively, until they are sufficiently expanded to be slipped over the injection bottles 40. As a result of the further moving apart of the vial closure holder 6 and the vial holder 5, the closure caps 7 are pressed onto the respectively associated injection bottles. The closure caps 7 are designed so that they crimp by force in the direction of the injection bottles 40 with the injection bottles and thus securely close them.

After the above-described juxtaposition, the vial lock holder 6 and the vial holder 5 are separated again. The filled and securely closed injection bottles 40 are then removed, as well as the used receiving film 110 and holding film 120 of the set package with vial closures 10 and the receiving film 20 of the set packaging with vials. With the closing device described here, therefore, a plurality of injection bottles 40 can be provided in a few simple steps simultaneously with a stopper 30, crimped with a cap 7 and securely closed. The whole described closing process is also relatively easily under aseptic conditions, for example, in a lyophilizer feasible.

Fig. 15 shows a further injection bottle 49 as a vial, another stopper 39 as a vial closure or as part of a vial closure and another cap 79, said three parts in the left portion of FIG. 15 in a disassembled or opened state and in the right area of Fig. 15 are shown in a closed state. The injection bottle 49 has a head 419 and a body 429. The plug 39 comprises a body portion 329 having a plurality of legs and a head portion 319 having a larger diameter than the body portion 329, so that the head portion 319 projects beyond the body portion 329 to the outside. As shown in the right-hand illustration of FIG. 15, in the closed injection bottle 49, the body portion 329 of the plug 39 protrudes into the injection bottle 49 through an opening in the head 419 of the injection bottle 49. The head portion 319 of the plug 39 rests against an edge of the opening of the head 419 of the injection bottle 49. The plug 39 is held by means of the cap 79 on the head 419 of the injection bottle 49, whereby the injection bottle 49 is sealed. FIG. 16 shows a third exemplary embodiment of a set package with vial closures according to the invention for the closure caps 79 shown in FIG. 15. The set package comprises a receiving film 1 19 with a plurality of recesses 1 1 19, each having an opening and a push-through bottom 1 129. As shown in Fig. 17, the sealing caps 79 are disposed in the recesses 11 of the receiving sheet 19 and held therein by frictional forces between the sealing caps 79 and the receiving sheet 19. Fig. 18 shows a view of a recess 1 1 19 of the receiving film 1 19, in which one of the closure caps 79 is arranged. As can be seen therein, both the closure cap 79 and the recess 1 1 19 are substantially circular and form-fitting with each other.

In Fig. 19, a fourth embodiment of a set package according to the invention with vial closures for the plug 39 shown in Fig. 15 is shown. The set package comprises a receiving foil 129 having a plurality of depressions 1229, each having an opening and a push-through lid 1219. As shown in FIG. 20, the lids 1219 each have openings through which the body portions 329 of the plugs 39 at least partially protrude. As a result, in each case one of the plugs 39 is arranged in or on each depression 1229 of the receiving foil 129. The openings of the lid 1219 are dimensioned so that the plugs 39 are held by frictional forces between their body portions 329 and the covers 1219. Fig. 21 shows a view of one of the recesses 1229 of the receiving film 129, in which one of the plugs 39 is arranged. As can be seen therein, both the plug 39 and the recess 1229 are substantially circular in shape.

Fig. 22 shows a third embodiment of a set package with vials according to the invention for the vials 49 shown in Fig. 15. The set package comprises a receiving sheet 29 having a plurality of recesses 219, each having an opening 2119 and a bottom 2129. As shown in FIG. 23, the vials 49 are disposed in the recesses 219 of the receiving film 29 and held therein by frictional forces between the vials 49 and the receiving film 29.

Referring now to Fig. 24, there is shown a second embodiment of a closure device having a vial holder 59 and a vial closure holder 69. The vial holder 59 is configured as a rectangular plate and comprises a plurality of parallel rows, each having a plurality of evenly spaced receptacles 519. In each of the four corner regions of the vial holder 59, a spacer 529 is arranged in the form of a cylindrical column. The receptacles 519 each have an opening and a bottom and are cylindrical. In the vial holder 59, the above described in more detail third embodiment of a set packaging with vials is arranged. In the recesses 219 of the receiving film 29 each one of the injection bottles 49 is arranged. The receiving film 29 is arranged in the vial holder 59, that in each case a recess 219 of the receiving film 29 and thus partially the associated injection bottle 49 in one of the receptacle 519 of the vial holder 59 is located.

The vial closure holder 69 is configured in two parts with a cover part 619 and a closure part 629, which are analogous to the vial holder 59, respectively are also designed as rectangular plates. In the four corners of the closure part 629 of the vial closure holder 69, a through hole 6219 is respectively arranged, in which one of the spacers 529 is inserted. The closure part 629 has through holes 6219 arranged corresponding to the receptacles 519 of the vial holder 59 as receptacles. In the vial lock holder 69, the above-described third embodiment of a set package with vial stoppers comprising the above-described stoppers 79 and the above-described fourth embodiment of a set vial stoppers package including the stoppers 39 described above are disposed. In this case, the receiving foil 1 19 of the set packaging with the closure caps 79 is arranged on a side of the closure part 629 of the vial closure holder 69 facing away from the vial holder 59 such that the receptacles 1 1 19 and thus also the closure caps 79 are each located in one of the bores 6219. Analogously, the receiving foil 129 of the set packaging with the plugs 39 is arranged on a side of the closure part 629 of the vial closure holder 69 facing the vial holder 59 so that the receptacles 1229 and the plugs 39 each lie in one of the bores 6219. Thus, one of the closure caps 79, one of the plugs 39 and one of the injection bottles 49 are arranged adjacent to each other from top to bottom. At the top, the closure part 629 of the vial lock holder 69 is covered by the cover part 619 of the vial lock holder 69.

Similarly to the first embodiment of a closing device described above, in operation for closing the injection bottles 49, for example, after the filling thereof, the vial closure holder 69 is arranged above the vial holder 59 as shown in FIG. The spacers 529 are inserted through the corresponding bores 6219 of the closure portion 629 of the vial closure holder 69, whereby the vial holder 59 and the vial closure holder 69 are properly positioned one above the other and their movement is guided in a controlled manner. In this state, the body portions 329 of the plugs 39 may already be partially in the corresponding injection bottles 49, wherein further process steps can be carried out, which are independent of the further closing of the injection bottles 49. For example, the injection bottles 49 can be charged with an inert gas in this state, so that they are completely filled with the medium to be filled and the inert gas. Thereafter, an actuation force is applied to the vial closure holder 69 and / or the vial holder 59, which acts in the direction of the vial closure holder 69 on the vial holder 59 and / or in the direction of the vial holder 59 on the vial closure holder 69. The actuation force is sufficiently large that the resistance of the spacers 529 is overcome and the vial lock retainer 69 and vial retainer 59 are moved towards each other. The plugs 39 are inserted into the injection bottles 49 until the body portions 329 are arranged in the associated injection bottles 49 and the head portions 319 rest on the edges of the openings of the injection bottles 49. The vial lock holder 69 and the vial holder 59 are further moved towards each other, so that the closure caps 79 are pressed onto the respectively associated injection bottles 49. The closure caps 79 are designed so that they crimp by force in the direction of the injection bottles 49 with the injection bottles and thus securely close them. After the above-described intermingling, the vial lock holder 69 and the vial holder 59 are again separated from each other. The filled and securely closed injection bottles 49 are then removed. With the closing device described here, therefore, a plurality of injection bottles 49 can be provided in a few simple steps simultaneously with a stopper 39, crimped with a cap 79 and securely closed. The entire closure process described can also be carried out relatively easily under aseptic conditions, for example in a lyophilizer.

While the invention has been illustrated and described in detail by the figures and the accompanying description, this description and detailed description are to be considered illustrative and exemplary and not limiting as to the invention. It should be understood that those skilled in the art can make changes and modifications without departing from the scope and spirit of the following claims. In particular, the invention also includes embodiments with any combination of features mentioned or shown above or below various embodiments. The invention includes also individual features in the figures even if they are shown there in connection with other features and / or are not mentioned above or below. Hereinafter, the term "comprising" and derivatives thereof does not exclude other elements or steps. "Also, the indefinite article" a "and derivatives thereof do not exclude a multitude The terms "substantially", "approximately", "approximately" and the like in connection with a property or a value in particular also define precisely the property or exactly the value. All reference signs in the claims are not to be understood as limiting the scope of the claims.

Claims

claims

A set package (11, 12; 10; 2; 20) for sterile packaging a plurality of vials (4; 40) or a plurality of vial closures (3; 30), characterized in that the set package (11, 12; 10; 2; 20) comprises a receiving foil (11; 110; 2; 20) which has a plurality of depressions (111; 1110; 21; 210) in each of which one of the plurality of vials (4; 40) or one of the plurality of vial closures (3; 30).

A set package (11, 12; 10; 2; 20) according to claim 1, wherein the recesses (111;

1110; 21; 210) of the receiving film (11; 110; 2; 20) are designed to be push-through in the direction of an opening of the depressions (111; 1110; 21; 210).

A set package (11, 12; 10; 2; 20) according to claim 1 or 2, wherein the vials (4; 40) and the vial closures (3; 30), respectively, are surrounded by a vapor-permeable and germ-proof packaging material.

A set package (11, 12; 10; 2; 20) according to any one of the preceding claims, wherein the vials (4; 40) and vial closures (3; 30) are sterilized, respectively.

A set package (11, 12; 10; 2; 20) according to any one of the preceding claims, wherein the spacing between adjacent recesses (111; 1110; 21; 210) of the receiving sheet (11; 110; 2; 20) is the same.

A set package (11, 12; 10; 2; 20) according to any one of the preceding claims, wherein the recesses (111; 1110; 21; 210) of the receiving sheet (11; 110; 2; 20) are arranged in a plurality of rows, especially in five rows of ten wells.

A set package (11, 12; 10; 2; 20) according to any one of the preceding claims comprising vial closures (3; 30) each having a head portion (31; 310) and a body portion (32; 320) Head portion (31; 310) has a larger diameter than the body portion (32; 320) such that to close an opening of an associated vial (4; 40), the body portion (32; 320) is opened through the opening in the vial (4; ) and the head part (31, 310) can be arranged adjacent to the opening.

A set package (11, 12; 10; 2; 20) according to claim 7, comprising a holding sheet (12; 120) corresponding to the recesses (111; 1110; 21; 210) of the receiving sheet (11; 110; 2, 20), wherein the openings (121, 1210) are dimensioned and the holding foil (12, 120) is connected to the receiving foil (11, 110, 2, 20) each of the body sections (32; 320) of the vial closures (3; 30) projects through one of the openings (121; 1210) of the holding film (12; 120) and the head portions (31; 310) of the vial closures (3; 30) each at one edge one of the openings (121, 1210) abut.

A set package (11, 12; 10; 2; 20) according to any one of the preceding claims, made from a material which is dimensionally stable in an autoclaving process for sterilization, in particular polypropylene, polycarbonate, cyclo-olefin copolymer or made of polyoxymethylene.

10. Closing device for closing vials (4; 40) each having a vial closure (3; 30) which has a vial holder (5) with a plurality of receptacles (51) and a vial closure holder (6) with a plurality of corresponding receptacles (61 ), wherein the vial closure holder (6) is configured so that the recesses (111; 1110; 21; 210) of a set package (11, 12; 10; 2; 20) according to one of the preceding claims with vial closures (3; 30). in the receptacles (61) of the vial closure holder (6) can be arranged.

11. A closure device according to claim 10, wherein the vial closure holder (6) and the set package (11, 12; 10; 2; 20) are configured as a unit with vial closures (3; 30).

12. Closing device according to claim 10 or 11, wherein the vial holder

(5) is such that the recesses (111; 1110; 21; 210) of a set package (11, 12; 10; 2; 20) according to any one of claims 1 to 8 with vials (4; 40) in the receptacles of Vial holder (5) can be arranged, wherein the set packaging (11, 12; 10; 2; 20) with vials (4; 40) to the vial closures (3; 30) corresponding vials (4; 40) and corresponding to the set package (11 , 12, 10, 2, 20) with vial closures (3, 30).

13. Closing device according to one of claims 10 to 12, wherein the vial holder (5) and the vial closure holder (6) are each designed plate-shaped.

The closure device of any one of claims 10 to 13, including a spacer (52) locatable between the vial holder (5) and the vial lock holder (6), the spacer (52) carrying the vial lock holder (6) when the vial lock holder (6) vial closure holder

(6) on the vial holder (5) is arranged.

15. Closing device according to claim 14, wherein the spacer (52) is adapted to yield at a force acting on the vial closure holder (6) in the direction of the vial holder (5).

16. Closing device according to claim 14 or 15, wherein the spacer (52) with the vial holder (5) is connectable.

17. Closing device according to one of claims 10 to 16, which comprises a guide (62), by means of which the vial closure holder (6) and the vial holder (5) guided to each other are movable.

18. Closing device according to one of claims 10 to 17, wherein in the receptacles (61) of the vial closure holder (6) in each case a cover (7) can be arranged so that the vial (4; 40) facing side of one in the same receptacle (61) arranged vial closure (3; 30) facing away from the lid (7).

19. A method for the sterile closing of vials (4; 40) with vial closures (3; 30) by means of a closing device according to one of claims 10 to 18, wherein in the receptacles (51) of the vial holder (5) in each case a vial (4; 40), wherein the recesses (111; 1110; 21; 210) of the set package (11, 12; 10; 2; 20) are arranged with vial closures (3; 30) in the receptacles (61) of the vial closure holder (6) and in which the vial lock retainer (6) and vial retainer (5) are pressed together to close each of the vials (4; 40) with one of the vial closures (3; 30).

20. The method of claim 19, wherein the vials (4; 40) are filled prior to sealing.

21. The method of claim 19 or 20, which is carried out in a lyophilizer.