WO2012055459A1

WO2012055459A1 - Method and system for filling and sealing packaging containers in a sterile or aseptic manner

Info

Publication number: WO2012055459A1
Application number: PCT/EP2011/004596
Authority: WO
Inventors: Thomas Niehr
Original assignee: Khs Gmbh
Priority date: 2010-10-25
Filing date: 2011-09-13
Publication date: 2012-05-03
Also published as: DE102010049263A1

Abstract

The invention relates to a method and system for filling and sealing packaging containers, in particular bag packages, in a sterile manner, wherein the packaging containers are each hermetically sealed by means of a temporary seal and subsequently sterilized at least in the packaging container interior thereof before being filled and then are fed to an aseptic filler, in which the filling opening is produced or opened again and subsequently the packaging containers are filled in at least one sterile, aseptic chamber through a filling opening and are hermetically sealed in the at least one sterile, aseptic chamber after being filled.

Description

Method and equipment for sterile or aseptic filling and sealing of packaging

The invention relates to a method according to the preamble of claim 1 and to a system according to the preamble of claim 9.

Packing means are in the context of the invention, in particular pouches (Pourches), especially those made of a single or multilayer material, e.g. Plastic and / or metal foil. Packing means are in the sense of the invention but in principle also other packaging or containers, e.g. in the pharmaceutical sector, in the cosmetics sector and / or in the food sector and are also used in the beverage sector, and u.a. Soft packaging, such as those made of cardboard and / or plastic film and / or metal foil and containers such. As bottles, cans, especially plastic.

Methods and systems for the sterile filling and closing of packaging materials in the form of pouches are known (EP 1 598 274 B1, US Pat. No. 4,742,667). In this case, it is also known in particular to sterilize or sterilize the bag packages outside and inside before filling.

Furthermore, it is also known to pack pouches and their contents after filling and sealing by external exposure to a germicidal energy radiation, i. to sterilize by exposure to a germicidal energy radiation (eg beta or gamma radiation) of an external radiation source, which is often not accepted by consumers and / or inevitably leads to a deterioration in product quality and / or product properties in a variety of products, and therefore is not possible with a variety of products.

The object of the invention is to provide a method by which a sterile filling and closing of packaging materials with a high quality of sterilization or with a high rate of sterilization is possible, without the risk of impairment of product quality and / or product properties and in the possibility of a flexible design of the processes, in particular during sterilization, filling and sealing. To solve this problem, a method according to claim 1 is formed. A plant is the subject of claim 9. The peculiarity of the method according to the invention is generally that the packaging, which are preferably pouches are hermetically sealed during sterilization of the packaging interior and an opening of the respective filling opening, through which the product or product is introduced into the packaging interior, only in a sterile interior before or immediately before filling takes place. In this way, in particular, there is the possibility that the sterilization of the packaging interior ggs. together with the production of the packaging, for example, by joining different packaging components, can be done in an area or room, which is spatially separated from another room or area, in which then ultimately the filling and closing of the packaging takes place.

This is particularly advantageous in medical applications, since the sterilization of the outer packaging material, the opening of the filling opening, the filling and sealing of the packaging can be carried out in a protected, for example designed as a clean room area of production, would be at least the sterilization of the packaging interior in one Area outside this specially protected area. By sterile filling, sterilizing, etc., in the context of this application, in particular, a hygiene standard and germ-reducing performance should be understood, as for perishable foods, for example low-pH milk products and medicinal-pharmaceutical products, for example infusions, parenteral foods, etc., required are. Furthermore, there is the possibility of the packaging interior sterilized packaging between storage and / or (eg by a packaging manufacturer) to a spatially and / or geographically remote location (eg user) to transport the packaging then filled and closed again by the inventive design become.

Further developments, advantages and applications of the invention will become apparent from the following description of exemplary embodiments and from the figures. In this case, all described and / or illustrated features alone or in any combination are fundamentally the subject of the invention, regardless of their summary in the claims or their dependency. Also, the content of the claims is made an integral part of the description.

The invention will be explained in more detail below with reference to the figures of an embodiment. Show it: _

Fig. 1 in a simplified schematic representation of a plant for the sterile filling and closing of packaging in the form of pouches (pouches);

Fig. 2 in an enlarged partial view of the bag packaging consisting of a bag and from the inserted into a bag opening and there by welding or sealing tightly connected to the bag spout.

The plant, generally designated 1 in the figures, is used for the manufacture, sterilization, sterile filling and sterile sealing of the bag packages, generally designated 2 in the figures, wherein, inter alia, the filler and the capper constitute a unit and are therefore not separately identified. The aforementioned pouches consist in the illustrated embodiment in each case of the thin-walled from a single or multilayer flat material, for example, made of a plastic film bag 3 with bag interior 3.1, Furthermore, the bag 3 shown comprises a bag opening 3.2, in which a spout 4 used in a known manner is and there is tightly connected to the bag 3 by welding or other suitable manner. The plant 1 has for this purpose several sections, which are designated in the figure 1 with I - VIII, of which the sections I and II are provided in a system part 1.1 with machine housing 5 and the sections IV - VIII in a system part 1.2 with machine housing 6 , The section III is, for example, a transport path for the bag packaging 2 between the plant part 1.1 and the plant part 1.2.

In section I, the production of the bag packages 2 by connecting each of a spout 4, each with a bag 3, the this section or the plant part 1.1 via a bag feed 7 according to the arrow A preferably hanging, i. be supplied with the bag opening 3.2 above. The system components 1.1 and 1.2 are each formed in the interior of a machine housing 5 and 6 respectively.

As FIG. 2 shows, the spouts 4, which are preferably made of plastic, each essentially consist of a sleeve-like spout body 8 with a sleeve or spout opening 9, which is open at one, ie at the lower end 8.1 in FIG. 2 and at the upper end 8.2 is hermetically sealed by a molded sleeve body portion or closure 10. In the illustrated embodiment, the spout 4 at the transition between the closure 10 and the remaining spout body 8 with an axis of the Spout 4 concentrically enclosing ring-shaped predetermined breaking line 11 is provided, which facilitates facilitating removal of the closure 10 and thus a facilitated opening the spout opening 9 at the upper end 8.2 of the spout 8. Furthermore, the spout body 8 in the illustrated embodiment is made in one piece with a projecting beyond the other circumference of the spout 8 annular flange 12, in the area between the predetermined breaking line 1 1 and the lower end 8.1 of the sleeve opening 9. The joining of the bag 3 and the Spout 4 in the section I is made by inserting the respective spout 4 with the lower open end 8.1 of the spout 8 in the bag opening 3.2 and sealing or welding the material of the bag 3 in the region of the bag opening 3.2 with the portion of the Spout 8 between the Flange 12 and the lower end 8.1. For fixing the spouts 4 in the respective bag opening 3.2, the section I has a working or treatment position with corresponding welding or sealing jaws 14.

The flange 12 forms in the bag packages 2 thus produced in each case a "neck ring" on which the bag packages 2 suspended, for example, at least one in Figure 1 schematically designated 13 transporter hanging through the sections II - VIII of Appendix 1 in a transport direction ( In the illustrated embodiment, at least in the region of sections II-VIII, the bag packages 2 are clocked with the conveyor 13 designed as a linear conveyor or moved stepwise in the transport direction A.

In section II by external energy input sterilization of the bag packaging 2 in particular also the interior 2.1 of the bag packaging 2, the (interior) the bag interior 3.1 and 9 Ausgießeröffnung, and on all surfaces of this interior, which is hermetically sealed by the closed spout 4 , For this sterilization, the respective pouch packaging 2, for example, with microwave energy or radiation and / or electron beam or beta radiation, and / or gamma radiation is applied, the intensity of this radiation is chosen so that it penetrates the walls of the bag and the spout 4 and Sterilization or sterilization with the required rate of germination or germ killing rate causes, for example, a germ killing rate of about log 3.55. For applying the pouches 2 with the outer microwave radiation and / or electron radiation or beta radiation and / or gamma radiation, the section II has a corresponding, in the figure 1 with 15 schematically indicated high-power radiator. The so sterilized and still temporarily hermetically sealed by the respective closure 10 pouches 2 are supplied via the section III of Appendix 1 to the plant part 1.2 and the local section IV, and in accordance with the arrow A. In Section IV is a (again) External sterilization of the still tightly closed pouches 2, at least in the area of their spouts 4, for example, by loading the pouches 2 and the sealed spout 4 with a gaseous and / or vapor sterilant, such as vaporized hydrogen peroxide (for example, 20% tiges to 30% tiges H202) and by subsequently activating a precipitate or condensate, which has formed on the outer surfaces of the pouches 2, in particular in the region of the respective spout 4 from the sterilization medium. The exposure to the vaporized hydrogen peroxide takes place for example with a treatment time of about 4 seconds at a temperature of about 130 ° C. The activation takes place in particular when using H 2 O 2 as a sterilization medium by heating, for example by exposure to a hot gaseous and / or vaporous activation medium, for example by exposure to hot, sterile air, for example at a temperature of about 90 ° C. and with a treatment time of about 14 seconds. In this case, oxygen radicals are released from H 2 O 2, which ensure sterilization or sterilization of the bag packages 2, in particular also in the area of the outer surfaces of the respective spout 4 with the high rate of sterilization. At the same time, a drying of the bag package 2 takes place on its outer surface. Section IV is designed for the aforementioned sterilization with at least one treatment head 16 for applying the sterilization medium to the bag packages 2 and with at least one treatment head 17 for activating the sterilization medium following the treatment head 16 in the transport direction A.

In section V takes place with suitable measures or means an opening of the respective spout 4 by separating the spout 9 closing temporary closure 10. This separation can be done in different ways or with different means, for example by at least one heated cutting wire, by laser cutting, by at least one motor-driven knife, etc. As an example, a rotating blade 18 is indicated in FIG. The separated from the spouts 4 temporary closures 10 are removed from the section V in a suitable manner and collected, as indicated by the arrow B. In the section VI, the now opened bag packages 2 are internally subjected to a sterile gas and / or vapor medium in order to form the respective bag interior 3.1 at least partially for a trouble-free implementation of the subsequent filling process.

In the section VII then takes place the filling of the open bag packages 2 with the contents, in the dargstellten embodiment in each case in two steps at two filling positions on filling tubes 19, which are inserted for filling in the spout 4 of the respective bag package 2 and on the Filling is introduced into the respective bag packaging 2. Finally, in the section VIII, the filled bag packages 2 are closed at their spouts 4, specifically in the illustrated embodiment by sealing caps 20, which are screwed onto the upper section of the respective spout 4 provided with an external thread and protruding from the bag 3. The caps 20 are suitably sterilized or sterilized prior to application to the spouts 4, for example by exposure to microwave radiation, beta radiation, electron radiation and / or gamma radiation and / or using a suitable gas and / or vapor sterilization medium, for example using of the above-mentioned vaporized H 2 O 2, and then activating and drying with the aforementioned hot gas and / or vapor activation medium.

The filled and closed bag packages 2 are fed from the system part 1.2 in the transport direction A for further use.

Sections IV - VIII of Appendix 1 are located in a sterile interior 21 of the plant part 1.2, the (interior) u.a. is separated from the environment by the machine housing 6 and the (interior) is acted upon in accordance with the arrows C of Figure 1 with a sterile gas and / or vapor medium, for example with sterile air, in such a way that the pressure in the interior 21 something greater than the ambient pressure.

Furthermore, at least also the section II is preferably provided in a sterile interior 22, which is separated from the environment by the machine housing 5. It will be understood that at transitions between non-sterile areas or rooms and the sterile internal spaces 21 and 22, respectively, suitable, germ-preventing sluices are provided. Furthermore, there is also the possibility, in particular the plant part 1.2 to be designed so that the bag packaging 2 included in the individual sections IV - VIII only with its upper, the spout 4 and the spout opening 9 and particularly critical in terms of germination area in the sterile interior 21 while the remainder of each bag package 2 is underneath it in a non-sterile room. As a result, the volume of the sterile interior space 21 is substantially reduced, with the advantage, inter alia, of a lower consumption of the sterile interior space supplied sterile vapor and / or gaseous medium. In this case, entry of germ-preventing sluices is only required between the reduced-volume sterile interior 21 and the surroundings.

A peculiarity of Appendix 1 or the method carried out with this Appendix is that the bag packages 2 are sterilized internally in a hermetically sealed condition, i. in the interior 2.1 of each bag closed packaging 2 existing germs are killed, and that only after introducing at least the most critical in terms of germination of bag packaging 2 in the sterile interior 21 there the temporary closure 10 and the bag 2 opened and then (after a Outside sterilization in the region of the spout 4) the filling of the bag packages 2 via the spout openings 9 serving as filling openings and sealing with the sterile closures 20 takes place, specifically in the sterile interior 21.

By dividing the system 1 into two parts of the system 1.1 and 1.2, it is possible to accommodate these parts of a manufacturing plant in different areas, for example when using the system 1 in the medical field, the system part 1.2 in a highly sensitive and specially protected and / or as a clean room trained part or building section of a production and the plant part 1.1 outside of this part or building section.

Furthermore, it is possible to provide instead of a section III forming transporter devices with which the hermetically sealed from the system part 1.1 and sterilized in the interior 2.1 bag packages 2 are packed for transport and / or an intermediate storage, for example, a buffer memory. The sealed and sterilized bag packages 2 are then fed to the system part 2.1 via a suitable unpacker or via a corresponding sorting and insertion path. In this case, in particular, it is also possible to provide the two plant parts 1.1 and 1.2 at geographically separate locations.

Furthermore, there is the possibility of additionally providing UV emitters in the sterile inner space 21, in particular above the movement path of the bag packages 2, with which the bag packages 2 are exposed to UV radiation externally, at least also in the area of their spouts 4 for further sterilization.

Above, it was assumed that the bag packages 2 are closed after filling in section VIII by caps 20, in particular by screw-on caps 20. In principle, it is also possible for the bag packages 2 after filling in the section VIII first at the top of their spouts 4 only with a membrane, for example in the form of a thin plastic and / or metal foil, e.g. to close by welding and then apply only outside the sterile room 21, the caps 20 on the spout 4, with the advantage of reducing the design effort for the corresponding Verschließstation.

It was also assumed above that the bag packages 2 are each provided with the spout 4. In principle, the invention can also be applied to pouches which consist exclusively of the pouch 3, that is to say without a spout 4, also called "spout" or "mouthpiece". The so sealed or glued on the reverse side This pouch packaging is then sealed in an analogous manner on all sides to hermetically seal them, and is then sterilized inside in section II, in section IV in an opening to form the filling opening area, for example on the Top of the hanging bag 3 transported sterilized outside and then opened in section IV there to form the filling opening. About the filling opening is then in section VII filling the relevant bag packaging. In section VIII, the respective bag 3 or its filling opening are closed by welding. This final closure can be achieved via a sealing unit, a suitable gluing or otherwise.

It was also assumed above that the packaging in station IV as a whole is aseptically treated from the outside. It is part of the invention and economically very advantageous if in such a system at least in the area of sections IV to VII a first sterile room 21 and a second sterile room 22 is provided, wherein the first sterile room has a higher standard of hygiene than the second sterile room 23. Between the two sterile rooms an opening or a gap must be provided, so that the Packaging can be held or guided such that the head or mouth portion in which or adjacent to which the filling opening (9) is arranged, in the first sterile room 21 projects and the remaining portions of the packaging (9) in the second sterile room 23. Um To prevent contamination, a forced ventilation is provided, so that always at least a partial volume flow of sterile air from the first sterile room 21 into the second sterile room 22 is passed.

It is part of the plant or process that prefabricated, sterile packaging with a temporary closure made in a location that is spatially separated from the filling and sealing plant. In such a case, for example, these are delivered in an outer packaging, from which the packaging must be removed prior to feeding to the filling and sealing system and introduced or introduced into the appropriate means of transport to follow open as described above and aseptically filled or finally closed , These steps can be done manually or automatically.

The invention has been described above by means of an embodiment. It is understood that further changes and modifications are possible without thereby departing from the inventive concept underlying the invention.

The invention has been described above in connection with the bag packages 2. It is understood that the system 1 or the procedure carried out with this system, with appropriate modification for a sterile filling and closing of other packaging, especially other containers and thereby especially for the sterile filling and closing of plastic containers or bottles is suitable.

LIST OF REFERENCE NUMBERS

1 plant

1.1, 1.2 System Part

2 pouches

2.1 Interior of the bag packaging 2

3 bags

3.1 Bag interior

3.2 bag opening

4 spouts

5, 6 machine or device housing

7 bag feed

8 sleeve body

8.1 lower or bag-side end of the sleeve body 8 and the spout 4th

8.2 upper or outer end of the sleeve body 8 of the

Pourer 4

9 sleeve opening or spout opening

10 sleeve body section or temporary closure of the

Pourer 4

11 predetermined breaking line

12 flange

13 transporter

14 welding or sealing jaws

15 spotlights

16, 17 treatment head

18 cutting or separating device

19 filling tube

20 cap

21, 22, 23 sterile interior

A transport direction

B Transport direction for the separated temporary

Closures 10

C Stream of sterile vapor and / or gaseous medium

I - VIII Sections of Appendix 1

Claims

claims

1. A method for sterile or aseptic filling and sealing of packaging (2), in particular of bag packaging, wherein the packaging (2) respectively before filling and closing in a filler or filling step and a capper or closure step sterilized at least in their packaging material interior (2.1) , are filled in at least one sterile germ-free space (21) via a filling opening (9) and hermetically sealed after filling in the at least one sterile germ-free space (21), comprising one of the following steps in the following order be made: a. Production of a packaging material (2)

b. sterilizing the interior of the packaging (2.1) of the empty packaging (2), c. hermetically closing the empty packaging (2) with a first temporary closure (10),

d. Transferring the hermetically sealed and empty packaging material (2) to a filling and sealing plant, comprising at least one station for sterilizing at least partial surfaces of the outer surfaces of the packaging (2), a tool (18) for opening the filling opening (9) and / or a tool for removing a temporary closure (10),

e. Sterilizing at least part surfaces of the outer surfaces of the packaging (2), in particular only the head and mouth region near the filling opening (9),

f. opening the filling opening (9), in particular by completely or partially removing the temporary closure (10) and subsequent g. aseptic filling and closing of the packaging (2).

2. The method according to claim 1, characterized in that the sterilization of the respective packaging material interior (2.1) in hermetically sealed packaging means (2) by the application of at least one outer, germicidal energy radiation, for example by exposure to electron radiation and / or beta radiation and / or gamma radiation and / or microwave radiation and / or thermal radiation.

3. The method according to claim 1 or 2, characterized in that the respective packaging means (2) after sterilizing the packaging interior (2.1) to form the filling opening (9) in at least one sterile, germ-free space (21) is opened.

4. The method according to any one of the preceding claims, characterized in that prior to the opening of the respective packaging means for forming the filling opening (9) the packaging material is sterilized at least in the filling opening having or for the introduction of the filling opening portion of the packaging material outer surface, for example by applying with at least one germicidal energy radiation, eg with an electron radiation and / or beta radiation and / or gamma radiation and / or microwave radiation and / or heat radiation and / or by sterilization with a liquid and / or gas and / or vaporous sterilization medium, for example with a sterilization medium in the form of hydrogen peroxide (H 2 O 2).

5. The method according to any one of the preceding claims, characterized in that at least the opening of the filling opening (9), the filling and closing takes place in a common sterile, germ-free space (21) or each in independent sterile, germ-free rooms.

6. The method according to any one of the preceding claims, characterized in that the packaging means (2) are hermetically sealed in a sterilization of the packaging interior (2.1) preceding or immediately preceding step.

7. The method according to claim 6, characterized in that the bag packages (2) are produced or produced in a preceding the interior sterilization step from bags and connected to the bags spouts, each with a temporarily closed filling opening (9) are provided is opened only before filling in the sterile room (21).

8. The method according to any one of the preceding claims, characterized in that the respective filling opening (9) is closed after filling by welding and / or by Aüfbringen a sterile closure and / or by applying a sealing membrane.

9. The method according to any one of the preceding claims, characterized in that the packaging means (2) during sterilization of the packaging interior (2.1) and / or during the sterilization of the packaging material outer surface at least in the area of the still closed filling opening (9) and / or during opening the filling opening (9) and / or are kept suspended during filling and / or during closing on at least one transport element (13).

10.Verfahren according to any one of the preceding claims, characterized in that the packaging means are such for medical products.

11.Anlage for sterile or aseptic filling and closing of packaging (2), in particular of bag packaging, with a transport system formed by at least one feed dog (13), with which the packaging means (2) in a transport direction (A) at least at sections (IV , VII, VIII) of the plant (1) for sterilization of the packaging interior (2.1) and on the packaging material outer surface and for filling and closing are moved, characterized in that a portion (V) for opening the filling opening (9), in particular to the whole or partial removal of a temporary closure (10) of the respective packaging means (2) is provided.

12. Plant according to claim, characterized in that a section (II) for the sterilization of the packaging interior (2.1) and the hermetic seal of the empty packaging (2) is provided.

13. Plant according to claim 12, characterized in that the section (II) for the sterilization of the packaging interior (2.1) of a hermetically sealed empty packaging (2) is formed and at least one device comprises by exposure to an external, germicidal radiation.

14. Plant according to one of claims 11 to 13, characterized in that the portion (V) for opening the respective packaging means (2) with at least one tool (18) for opening the filling opening (9) is formed, preferably with a tool for Removing a temporary closure (10) at the filling opening (9) of the respective packaging (2).

15. Plant according to one of claims 11 to 14, characterized in that relative to the transport direction (A) on the section (V) for opening the filling opening (9) following the sections (VII, VIII) for filling and closing the packaging (2 ) are provided.

16. Plant according to claims 11 to 15, characterized in that relative to the transport direction (A) in front of the section (V) for opening the filling opening (9) of the section (IV) for sterilizing the packaging material outer surface is provided at least in the region of the filling opening (9) to be introduced or opened.

17. Plant according to claims 11 to 16, characterized by at least one sterile space (21, 22) in which the packaging means at least during the sterilization of the packaging material outer surface, during the opening of the filling opening (9), during filling and closing at least with their the filling opening (9) having the packaging means area are arranged.

18. Plant according to one of claims 11 to 17, characterized in that the transport system forming, at least one transporter (13) for a suspended arrangement of the packaging (2) and / or for timed transport of the packaging (2) by the plant ( 1) or their sections (I - VIII) is formed.

19. Plant according to one of claims 11 to 18, characterized in that it is divided into at least two parts of the plant (1.1, 1.2), in a first part of the plant (1.1), which u.a. has the section (II) for the sterilization of the packaging material interior (2.1), and in a second section (1.2), which u.a. the section (IV) for sterilizing the packaging material outer surface, the section (V) for opening the filling opening (9), the section (VII) for filling the packaging means (2) and the section (VIII) for closing the packaging means (2).

20. Plant according to any one of claims 11 to 19, characterized in that it comprises at least in the region of sections IV to VII a first sterile room 21 and a second sterile room 22, wherein the first sterile room has a higher standard of hygiene than the second sterile room 23 and the packaging can be held or guided so that the head or mouth portion in which or adjacent to which the filling opening (9) is arranged, projects into the first sterile room 21 and the remaining portions of the packaging (9) can be arranged in the second sterile room 23.

21. Plant according to one of claims 11 to 20, characterized in that at least a partial volume flow of sterile air from the first sterile room (21) in the second sterile room (22) can be passed.