EP3909868B1 - Method and arrangement for filling a sterile container - Google Patents

Method and arrangement for filling a sterile container Download PDF

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Publication number
EP3909868B1
EP3909868B1 EP20173894.5A EP20173894A EP3909868B1 EP 3909868 B1 EP3909868 B1 EP 3909868B1 EP 20173894 A EP20173894 A EP 20173894A EP 3909868 B1 EP3909868 B1 EP 3909868B1
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EP
European Patent Office
Prior art keywords
container
sterile
opening
flexible bag
liquid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP20173894.5A
Other languages
German (de)
French (fr)
Other versions
EP3909868A1 (en
Inventor
Thomas Wurm
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Single Use Support GmbH
Original Assignee
Single Use Support GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Single Use Support GmbH filed Critical Single Use Support GmbH
Priority to EP20173894.5A priority Critical patent/EP3909868B1/en
Priority to DK20173894.5T priority patent/DK3909868T3/en
Priority to ES20173894T priority patent/ES2916053T3/en
Priority to PCT/EP2021/060495 priority patent/WO2021228527A1/en
Publication of EP3909868A1 publication Critical patent/EP3909868A1/en
Application granted granted Critical
Publication of EP3909868B1 publication Critical patent/EP3909868B1/en
Priority to US17/976,293 priority patent/US20230052250A1/en
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Anticipated expiration legal-status Critical

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/18—Controlling escape of air from containers or receptacles during filling
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging

Definitions

  • the present invention concerns a method and an arrangement for filling a sterile container, such as a bottle, with a liquid.
  • air filters are used. Unlike usual filters, these are used to avoid outside substances, in particular micro-organisms and other contaminants to enter the bottle while the gas is discharged through the filter. Naturally, these filters need to have some sort of openings in order to allow the displaced gas to leave the container. Even though these openings are made extremely small (e.g. less than 0.2 micrometres) there exists a risk of contamination such that a post-integrity test of the air filter is needed and a confirmation of sterility can only be granted after this post-use test, with the risk of a failed test upon which the liquid in the bottle has to be discharged. Furthermore, this test obviously constitutes additional effort and costs.
  • the object of the invention is to provide a method and an arrangement for filling a container, such as a bottle, in such a way that no integrity test of an air filter or the like after the filling process is necessary.
  • the arrangement according to the invention comprises the sterile container and a sterile flexible bag, wherein
  • the basic idea of the invention is to use a flexible bag - which can attain different filling volumes - as an intermediate "storage" for the displaced gas volume. This solves the object of the invention because disconnecting the flexible bag after filling it with gas such that the original container is not contaminated is very easy - at least compared to directly discharging the displaced gas into the environment.
  • the invention makes it possible to fill a bottle without any external opening, and hence in a fully closed manner.
  • the invention can be used on any container with so much rigidity such that the removal of displaced gas during the filling process is a concern (e.g. because the container would be damaged or the filling process would not be possible due to the increase in pressure, if the displaced gas would not be removed).
  • a main example of containers which can be filled according to the invention would be sterile bottles e.g. made from glass or various sorts of plastics.
  • the flexible bag can also be made of plastic or the like. Particularly preferable may be embodiments, where the flexible bag is made of plastic foils which are welded together on boundaries to form the bag.
  • An arrangement according to the invention has the advantage that it could be provided as one sterile set or kit (where the flexible bag is already connected to the container). For filling the container it is only necessary to connect the source for liquid, fill the container and disconnect the flexible bag as well as the source. The container is virtually guaranteed to be sterile and no integrity checks of the container are necessary, which was previously believed to be simply impossible.
  • the flexible bag can be discarded, or recycled, or kept on the bottle for a draining process in the next process steps, e.g. if closed draining of the bottle is required. For that the excess air/gas is in the connected flexible bag can be used to displace the liquid from the bottle.
  • first opening and the second opening of the container may particularly preferably be separate openings, i.e. they would be geometrically distant from each other.
  • first opening and the second opening are the same opening of the container are however in principle conceivable.
  • connection between the first opening of the container and the flexible bag can be established before, after and/or at the same time as the connection between the second opening and the source is established.
  • Severing these connections in a sterile way means that the possibility of fluid communication is stopped without introducing the possibility of a contamination of the container (e.g. using sterile connectors or fusing tubing shut).
  • the flexible bag and/or the source for the liquid can also be detached after the connection is severed.
  • the invention can be used for filling any container with liquid being used in or resulting from a pharmaceutical, in particular biopharmaceutical, production process.
  • connection between the flexible bag and the first opening of the container can be severed in a sterile way.
  • the flexible bag can in principle also be kept (i.e. stored or transported) together with the container.
  • Severing the connection between the first opening of the container and the flexible bag can be performed before, after and/or at the same time as the connection between the second opening and the source is severed.
  • a sterile connector For the connection between the flexible bag and the first opening of the container tubing and/or a sterile connector is used, which are both readily available.
  • Sterile connectors are devices which allow for a (usually one time) sterile connection between two (or more) tubes. Both such tubing and sterile connectors can be made mainly of different sorts of plastics.
  • Analogous measures can be taken for the connection between the second opening and the source of liquid.
  • connection between the first opening of the container and the flexible bag or the connection between the second opening of the container and the source of liquid may for example be severed by fusing and/or welding shut tubing or by decoupling a sterile connector.
  • Fusing tubing shut or welding tubing shut is a simple and reliable process.
  • the severing of the connections between first or second opening and flexible bag or source for liquid can be achieved by closing clamps around connecting tubing and optionally cutting the tubing on the distal side (from the first or second opening) of the clamp.
  • the sealed connecting device comprised in the arrangement according to the invention can for example be a sterile connector (or part thereof).
  • the sealed connecting device avoids contamination of the container before the filling process begins.
  • the sealed connecting device can just be a sealed length of tubing or the like.
  • a so-called “single use bag” (usually used for storing and/or transporting (bio-) pharmaceutical liquids) or a similar bag can be used a flexible bag.
  • Fig. 1 shows an arrangement comprising a container 1 in the form of a bottle, e.g. made from glass or plastic.
  • a first opening 4 of the bottle is connected to the flexible bag 3 via tubing 8 (e.g. made also from plastic).
  • a second opening 5 of the bottle is connected to a source 6 of liquid 2 to be filled into the bottle. Also for this connection tubing 8 is used.
  • a sterile connector 9 is used to facilitate a very easy connecting and/or disconnecting of the source 6 with/from the bottle in a sterile manner.
  • the arrangement shown in Fig. 1 can particularly easily be achieved if the arrangement shown in Fig. 2 is provided as a set or kit, such that only the source 6 for the liquid 2 needs to be connected to the second opening 5 of the bottle (e.g. via the sterile connector 9), in order to start the filling process.
  • Figs. 3a and 3b The situation after the filling of the bottle is depicted in Figs. 3a and 3b .
  • the bottle i.e. container 1 is now filled with the liquid 2 and the gas 8 (e.g. air) displaced from the bottle has made its way into the flexible bag 3.
  • the gas 8 e.g. air
  • the source 6 and the flexible bag 3 can now easily be disconnected (i.e. the connections can be severed) and the container 1 is sterile without the need for any integrity testing.

Description

  • The present invention concerns a method and an arrangement for filling a sterile container, such as a bottle, with a liquid.
  • In the pharmaceutical industry obviously strict requirements regarding sterility of any container holding substances which are used in or result from the production process have to be fulfilled. This includes for example bottles, which can be sterilized easily enough.
  • Methods and arrangements for filling a sterile container are for instance described in US 2013/220484 A1 , US 2017/312543 A1 and US 2014/238542 A1 .
  • However, when such containers are filled with a liquid, a problem occurs because the liquid displaces a gas, such as air, which is present in the container before the filling process and this displaced gas has to be removed from the container without compromising the sterility of the container.
  • In the prior art air filters are used. Unlike usual filters, these are used to avoid outside substances, in particular micro-organisms and other contaminants to enter the bottle while the gas is discharged through the filter. Naturally, these filters need to have some sort of openings in order to allow the displaced gas to leave the container. Even though these openings are made extremely small (e.g. less than 0.2 micrometres) there exists a risk of contamination such that a post-integrity test of the air filter is needed and a confirmation of sterility can only be granted after this post-use test, with the risk of a failed test upon which the liquid in the bottle has to be discharged. Furthermore, this test obviously constitutes additional effort and costs..
  • The object of the invention is to provide a method and an arrangement for filling a container, such as a bottle, in such a way that no integrity test of an air filter or the like after the filling process is necessary.
  • Regarding the method this object is achieved with the features of claim 1, wherein
    • a sterile connection is established between a flexible bag and a first opening of the container,
    • a sterile connection is established between a second opening of the container and a source of the liquid to be filled into the container,
    • the liquid is filled into the container,
    • a gas, in particular air, which is present in the container is displaced by the liquid and forced into the flexible bag while increasing the volume of the flexible bag and
    • the connection between the source of liquid and the second opening of the container is severed in a sterile way.
  • Regarding the arrangement the object is achieved with the features of claim 6. The arrangement according to the invention comprises the sterile container and a sterile flexible bag, wherein
    • the flexible bag is in fluid communication with the container via a first opening of the container,
    • the container comprises a second opening and a sealed connecting device for connecting in a sterile way the container to a source of liquid to be filled into the container.
  • The basic idea of the invention is to use a flexible bag - which can attain different filling volumes - as an intermediate "storage" for the displaced gas volume. This solves the object of the invention because disconnecting the flexible bag after filling it with gas such that the original container is not contaminated is very easy - at least compared to directly discharging the displaced gas into the environment.
  • In other words, the invention makes it possible to fill a bottle without any external opening, and hence in a fully closed manner.
  • The invention can be used on any container with so much rigidity such that the removal of displaced gas during the filling process is a concern (e.g. because the container would be damaged or the filling process would not be possible due to the increase in pressure, if the displaced gas would not be removed).
  • A main example of containers which can be filled according to the invention would be sterile bottles e.g. made from glass or various sorts of plastics.
  • The flexible bag can also be made of plastic or the like. Particularly preferable may be embodiments, where the flexible bag is made of plastic foils which are welded together on boundaries to form the bag.
  • An arrangement according to the invention has the advantage that it could be provided as one sterile set or kit (where the flexible bag is already connected to the container). For filling the container it is only necessary to connect the source for liquid, fill the container and disconnect the flexible bag as well as the source. The container is virtually guaranteed to be sterile and no integrity checks of the container are necessary, which was previously believed to be simply impossible.
  • The flexible bag can be discarded, or recycled, or kept on the bottle for a draining process in the next process steps, e.g. if closed draining of the bottle is required. For that the excess air/gas is in the connected flexible bag can be used to displace the liquid from the bottle.
  • In particular, the first opening and the second opening of the container may particularly preferably be separate openings, i.e. they would be geometrically distant from each other. Embodiments where the first opening and the second opening are the same opening of the container are however in principle conceivable.
  • Under connections between the first or second opening on the one hand and the flexible bag or the source for the liquid on the other hand it can be understood that fluid communication is established.
  • The connection between the first opening of the container and the flexible bag can be established before, after and/or at the same time as the connection between the second opening and the source is established.
  • Severing these connections in a sterile way means that the possibility of fluid communication is stopped without introducing the possibility of a contamination of the container (e.g. using sterile connectors or fusing tubing shut).
  • In particularly preferred embodiments the flexible bag and/or the source for the liquid can also be detached after the connection is severed.
  • The invention can be used for filling any container with liquid being used in or resulting from a pharmaceutical, in particular biopharmaceutical, production process.
  • Further advantageous embodiments are defined in the dependent claims.
  • In particularly preferred embodiments the connection between the flexible bag and the first opening of the container can be severed in a sterile way. Otherwise, the flexible bag can in principle also be kept (i.e. stored or transported) together with the container.
  • Severing the connection between the first opening of the container and the flexible bag can be performed before, after and/or at the same time as the connection between the second opening and the source is severed.
  • For the connection between the flexible bag and the first opening of the container tubing and/or a sterile connector is used, which are both readily available. Sterile connectors are devices which allow for a (usually one time) sterile connection between two (or more) tubes. Both such tubing and sterile connectors can be made mainly of different sorts of plastics.
  • Analogous measures can be taken for the connection between the second opening and the source of liquid.
  • The connection between the first opening of the container and the flexible bag or the connection between the second opening of the container and the source of liquid may for example be severed by fusing and/or welding shut tubing or by decoupling a sterile connector. Fusing tubing shut or welding tubing shut is a simple and reliable process.
  • In very simple embodiments the severing of the connections between first or second opening and flexible bag or source for liquid can be achieved by closing clamps around connecting tubing and optionally cutting the tubing on the distal side (from the first or second opening) of the clamp.
  • The sealed connecting device comprised in the arrangement according to the invention can for example be a sterile connector (or part thereof).
  • The sealed connecting device avoids contamination of the container before the filling process begins. In the simplest embodiments the sealed connecting device can just be a sealed length of tubing or the like.
  • A so-called "single use bag" (usually used for storing and/or transporting (bio-) pharmaceutical liquids) or a similar bag can be used a flexible bag.
  • Further details and advantages of the invention are apparent from the figures and the accompanying figure description. The figures show schematically:
    • Fig. 1
    an arrangement according to the invention with the container connected to a source of liquid,
    Fig. 2
    an arrangement according to the invention,
    Fig. 3a
    the arrangement of Fig. 1 after filling the container and
    Fig. 3b
    the flexible bag in a side view.
  • Fig. 1 shows an arrangement comprising a container 1 in the form of a bottle, e.g. made from glass or plastic. A first opening 4 of the bottle is connected to the flexible bag 3 via tubing 8 (e.g. made also from plastic).
  • A second opening 5 of the bottle is connected to a source 6 of liquid 2 to be filled into the bottle. Also for this connection tubing 8 is used.
  • Additionally, in this embodiment a sterile connector 9 is used to facilitate a very easy connecting and/or disconnecting of the source 6 with/from the bottle in a sterile manner.
  • The arrangement shown in Fig. 1 can particularly easily be achieved if the arrangement shown in Fig. 2 is provided as a set or kit, such that only the source 6 for the liquid 2 needs to be connected to the second opening 5 of the bottle (e.g. via the sterile connector 9), in order to start the filling process.
  • The situation after the filling of the bottle is depicted in Figs. 3a and 3b. The bottle (i.e. container 1) is now filled with the liquid 2 and the gas 8 (e.g. air) displaced from the bottle has made its way into the flexible bag 3.
  • As shown schematically in Fig. 3b by a dashed line, viewed from the side the flexible bag 3 has been "blown up", i.e. increased in volume, in order to accommodate the displaced gas 8.
  • The source 6 and the flexible bag 3 can now easily be disconnected (i.e. the connections can be severed) and the container 1 is sterile without the need for any integrity testing.

Claims (7)

  1. Method for filling a sterile container (1), in particular a bottle, with a liquid (2), wherein
    - a sterile connection is established between a flexible bag (3) and a first opening (4) of the container (1),
    - a sterile connection is established between a second opening (5) of the container (1) and a source (6) of the liquid (2) to be filled into the container (1),
    - the liquid (7) is filled into the container (1),
    - a gas (8), in particular air, which is present in the container (1) is displaced by the liquid (2) and forced into the flexible bag (3) while increasing the volume of the flexible bag (3) and
    - the connection between the source (6) of liquid (2) and the second opening (5) of the container (1) is severed in a sterile way.
  2. Method according to claim 1, wherein the connection between the flexible bag (3) and the first opening (4) of the container (1) is severed in a sterile way.
  3. Method according to one of the preceding claims, wherein for the connection between the flexible bag (3) and the first opening (4) of the container (1) tubing (8) and/or a sterile connector (9) is used.
  4. Method according to one of the preceding claims, wherein for the connection between the second opening (5) and the source (6) of liquid (2) tubing (8) and/or a sterile connector (9) is used.
  5. Method according to one of the preceding claims, wherein the connection between the first opening (4) of the container (1) and the flexible bag (3) or the connection between the second opening (5) of the container (1) and the source (6) of liquid (2) is severed by fusing and/or welding shut tubing (8) and/or decoupling a sterile connector (9).
  6. Arrangement for filling a sterile container (1), in particular a bottle, comprising the sterile container (1) and a sterile flexible bag (3), wherein
    - the flexible bag (3) is in fluid communication with the container (1) via a first opening (4) of the container (1),
    - the container (1) comprises a second opening (5) and a sealed connecting device for connecting in a sterile way the container (1) to a source (6) of liquid (2) to be filled into the container (1).
  7. Arrangement according to claim 6, wherein the sealed connecting device is a sterile connector (9).
EP20173894.5A 2020-05-11 2020-05-11 Method and arrangement for filling a sterile container Active EP3909868B1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP20173894.5A EP3909868B1 (en) 2020-05-11 2020-05-11 Method and arrangement for filling a sterile container
DK20173894.5T DK3909868T3 (en) 2020-05-11 2020-05-11 PROCEDURE AND DEVICE FOR FILLING A STERILE CONTAINER
ES20173894T ES2916053T3 (en) 2020-05-11 2020-05-11 Method and arrangement for filling a sterile container
PCT/EP2021/060495 WO2021228527A1 (en) 2020-05-11 2021-04-22 Method and arrangement for filling a sterile container
US17/976,293 US20230052250A1 (en) 2020-05-11 2022-10-28 Method and arrangement for filling a sterile container

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20173894.5A EP3909868B1 (en) 2020-05-11 2020-05-11 Method and arrangement for filling a sterile container

Publications (2)

Publication Number Publication Date
EP3909868A1 EP3909868A1 (en) 2021-11-17
EP3909868B1 true EP3909868B1 (en) 2022-03-02

Family

ID=70681658

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20173894.5A Active EP3909868B1 (en) 2020-05-11 2020-05-11 Method and arrangement for filling a sterile container

Country Status (5)

Country Link
US (1) US20230052250A1 (en)
EP (1) EP3909868B1 (en)
DK (1) DK3909868T3 (en)
ES (1) ES2916053T3 (en)
WO (1) WO2021228527A1 (en)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2635335B1 (en) * 2010-11-01 2021-01-13 GE Healthcare Limited Pierce and fill device
EP2635228B1 (en) * 2010-11-01 2016-08-17 GE Healthcare Limited Asceptic dispenser
ES2577858T3 (en) * 2011-10-31 2016-07-19 Ge Healthcare Limited Drilling and filling device

Also Published As

Publication number Publication date
ES2916053T3 (en) 2022-06-28
WO2021228527A1 (en) 2021-11-18
DK3909868T3 (en) 2022-05-23
US20230052250A1 (en) 2023-02-16
EP3909868A1 (en) 2021-11-17

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