EP3684320B1 - Verfahren zum befüllen einer medizinischen verpackung, befüllvorrichtung, sowie als beutel ausgebildete medizinische verpackung - Google Patents

Verfahren zum befüllen einer medizinischen verpackung, befüllvorrichtung, sowie als beutel ausgebildete medizinische verpackung Download PDF

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Publication number
EP3684320B1
EP3684320B1 EP18773762.2A EP18773762A EP3684320B1 EP 3684320 B1 EP3684320 B1 EP 3684320B1 EP 18773762 A EP18773762 A EP 18773762A EP 3684320 B1 EP3684320 B1 EP 3684320B1
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EP
European Patent Office
Prior art keywords
liquid
packaging
nozzle
gas
filling
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
EP18773762.2A
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German (de)
English (en)
French (fr)
Other versions
EP3684320A1 (de
EP3684320C0 (de
Inventor
Joern WITTORF
Gerald Wegner
Witali KLAN
Marius RUFFER
Stefan Faber
Denis KOSATSCH
Behnam ZANDNIA
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.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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Publication of EP3684320A1 publication Critical patent/EP3684320A1/de
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Publication of EP3684320B1 publication Critical patent/EP3684320B1/de
Publication of EP3684320C0 publication Critical patent/EP3684320C0/de
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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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1431—Permanent type, e.g. welded or glued
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1462—Containers with provisions for hanging, e.g. integral adaptations of the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • 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
    • B65B31/02—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
    • B65B31/024—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas specially adapted for wrappers or bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • B65D1/09—Ampoules
    • B65D1/095—Ampoules made of flexible material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit

Definitions

  • the invention relates to a method for filling medical packaging designed as a bag.
  • the invention relates to a method for filling bags with an infusion liquid, for example a liquid containing an active substance or a liquid for parenteral nutrition.
  • the invention also relates to a device for filling a medical packaging designed as a bag, and a medical packaging designed as a bag, which is filled with an infusion liquid.
  • Prefilled medical packaging designed as bags are known from practice. These are in particular bags which are filled, for example, with a liquid containing an active substance or a liquid for parenteral nutrition. Such a bag has at least one port.
  • the port generally includes a septum which is pierceable with a spike or needle to withdraw liquid from the bag.
  • a residual volume of gas generally remains in the inner volume of the bag. This residual volume should contain as little oxygen as possible, depending on what kind of liquid is in the bag otherwise a drug may decompose or a parenteral nutrition fluid may spoil.
  • An example of a method and a device for filling a medical-pharmaceutical packaging shows WO 2014/147159 . 1
  • the object of the invention is to provide a method and a device for filling medical packaging, preferably designed as a bag, in which a low residual oxygen content in the remaining gas volume of the bag or the packaging can be achieved.
  • the invention further relates to the provision of medical packaging designed as a bag, in which the introduction of an oxygen absorber into the secondary packaging can be dispensed with even in the case of oxygen-sensitive contents.
  • the object of the invention is achieved by a method for filling a medical packaging designed as a bag, by a device for filling a medical packaging designed as a bag, and by a medical packaging designed as a bag as part of a pharmaceutical product according to one of the independent claims.
  • the invention generally relates to a method for filling a medical packaging designed as a bag.
  • the invention relates to a method with which bags are filled with a liquid containing an active ingredient or a liquid for parenteral nutrition.
  • the present invention is described by a method for filling a medical packaging, preferably designed as a bag, the packaging being filled with a liquid via access and access being provided during filling in a protective gas atmosphere, characterized in that the packaging is Filling with the liquid is filled with an inert gas.
  • the protective gas atmosphere In order to provide the protective gas atmosphere, at least one opening preferably extends at least in sections around the gas nozzle. As a result, a locally limited inert gas atmosphere can be provided.
  • Filling is part of the manufacturing process of a pharmaceutical product.
  • the packaging is designed in particular as a film bag. According to one embodiment, it is a bag made from two polyolefin films welded together, in particular polypropylene films.
  • the films can have a single-layer or multi-layer structure.
  • the polyolefin-containing layers provide the inner layers that are in contact with the liquid.
  • the bag comprises at least one port, via which the bag can be or is filled with liquid.
  • the port preferably also serves to remove liquid.
  • the port can have a septum for sealing, which can be pierced by inserting a spike or a needle.
  • the port is preferably an injection molded component. However, the port can also be provided by a simple hose section.
  • the port is sealed between the foils.
  • it is a port with a tapered sealing boat, which is welded into a welded seam of the bag.
  • the bag is filled with a liquid via an access, the access during filling being provided in a preferably locally limited inert gas atmosphere.
  • the protective gas is a gas that displaces oxygen and/or does not react with the liquid to be filled.
  • the protective gas is or includes an inert gas.
  • the protective gas preferably comprises or is nitrogen.
  • the bag is preferably filled by means of a liquid nozzle.
  • access in or to the bag may be provided via an opening in the weld.
  • access is provided through the port.
  • the bag is filled with liquid via a liquid nozzle, with the port, in particular a filling opening of the port, being gassed with the inert gas, preferably nitrogen, during filling.
  • a laminar flow of the protective gas is generated in the area of the access, preferably the filling opening of the port, so that filling takes place in the protective gas atmosphere which extends around the liquid nozzle and the filling opening of the port.
  • the locally limited protective gas atmosphere can be provided as a displacement flow.
  • the protective gas flow preferably runs at least partially vertically from top to bottom.
  • the packaging in particular the bag, is filled with an inert gas before it is filled with liquid.
  • an inert gas is also actively introduced into the medical packaging designed as a bag before filling.
  • the filling of the Inert gas by means of a gas nozzle, to which in particular the filling opening of the access, eg the port, of the bag is docked.
  • at least one opening is preferably provided, which extends at least in sections around the liquid nozzle and/or the gas nozzle.
  • the packaging is filled with a volume of inert gas which corresponds at least to the volume of a gas volume remaining after the packaging has been filled.
  • a volume of inert gas which corresponds at least to the volume of a gas volume remaining after the packaging has been filled.
  • at least or substantially the amount of inert gas is introduced whose volume is at least as large as the gas volume or residual volume remaining in the packaging after the end of the filling process.
  • a volume of inert gas preferably nitrogen, of 10 to 50 ml, preferably 15 to 30 ml, is introduced.
  • the inert gas is at least one gas selected from a group consisting of nitrogen, argon, helium, neon and carbon dioxide.
  • Nitrogen is preferably used as the inert gas. Among other things, it serves to displace the oxygen and thereby prevent oxidation of the contents as far as possible.
  • the bag is preferably evacuated before being filled with the inert gas.
  • the evacuation preferably takes place via the gas nozzle to which the bag, in particular the filling opening of the access or the port of the bag, is docked.
  • the packaging is preferably evacuated to a pressure of less than 300 mbar, preferably less than 100 mbar, particularly preferably less than 50 mbar.
  • no gas is released from or introduced into the interior volume of the bag while the liquid is being filled.
  • the filling opening of the bag access or of the port can be docked onto the liquid nozzle in a sealing manner. No turbulence is generated by the gas entering or exiting, which in turn could lead to air or oxygen entering the area of the filling opening.
  • the medical packaging designed as a bag is first checked for leaks by first evacuating it and then, after closing the negative pressure, checking whether there is a pressure increase due to a leak in the packaging.
  • the packaging is evacuated and then filled with the inert gas.
  • the package is filled with the liquid using a filling head.
  • the filling head has a gas nozzle and a liquid nozzle open.
  • the packaging is first docked to the gas nozzle and, after being filled with inert gas, preferably nitrogen, converted to the liquid nozzle.
  • inert gas preferably nitrogen
  • the liquid nozzle and/or the gas nozzle are in each case in sealing contact with the filling opening of the access, for example the port, of the bag.
  • Both the gas nozzle and the liquid nozzle are preferably continuously gassed with the inert gas to provide the inert gas atmosphere.
  • the access, in particular the port, of the bag is blocked off, preferably pressed shut, when the packaging is transferred from the gas nozzle to the liquid nozzle. This prevents gas from flowing in or being pushed out during the transfer, for example due to deformations of the bag that occur during transfer due to the forces that occur.
  • squeezing tongs are used to shut off the bag, preferably to press it closed.
  • the bag is pressed shut with the squeezing tongs in that the contact surface of a jaw of the closed squeezing tongs surrounds the welded-in section of a port and reaches at least up to a welded seam of the bag.
  • the squeezing tongs in particular a jaw of the squeezing tongs, is essentially U-shaped and presses the film shut around the weld-in area of the port.
  • the port itself does not have to be pressed shut. Pressing together the superimposed films adjacent to the port has the advantage that there are no changes in the volume of the inner volume of the bag, if at all. Such changes in volume could lead to pumping effects, which in turn can cause oxygen to be introduced.
  • the port itself can also have an area that is squeezed off in order to shut off the port before and/or after the filling process, i.e. to temporarily close it.
  • the packaging After being filled with the liquid, the packaging is preferably moved to a closing device, in which the access is then closed.
  • the access can be closed by welding, in particular an opening in the weld.
  • the bag is moved to a closure and closed by placing the closure on the port.
  • the closure can in particular be a snap closure.
  • it can be a closure designed as a cap, which is already provided with a pierceable septum and, in particular, is closed with a snap-off part.
  • the closure is preferably applied fully automatically by the closure device, which has a closure receptacle.
  • the closure is preferably gassed with an inert gas, for example nitrogen, before and/or during the fitting process.
  • an inert gas for example nitrogen
  • the interior of the closure is flushed with the inert gas. Any oxygen that may be present can be displaced as a result.
  • the access or port is gassed with an inert gas, for example nitrogen, while the closure is being fitted.
  • an inert gas for example nitrogen
  • the access or port will be docked to the gas nozzle first.
  • the bag is then evacuated and filled with the inert gas.
  • the bag is then transferred to the liquid nozzle and filled.
  • the bag is transferred to a closure device or closure receptacle where the access is closed, in particular the closure is applied. It should be noted that preferably less than one second elapses between filling and sealing the bag. As a result, filling can take place outside of a sterile room.
  • the access in particular the port, is continuously with a protective gas, preferably nitrogen gassed.
  • the gassing takes place in particular by generating a laminar protective gas flow around the access or around the port, in particular the filling opening of the access or port.
  • the bag is also blocked, preferably pressed shut, during the process of the closing device, in particular the closure receptacle.
  • the bag prior to undocking, the bag is blocked from the fluid nozzle and then moved to the capping device where the access is capped.
  • the bag is pressed closed by the liquid nozzle and then moved to the closure receptacle, where the closure is placed, in particular snapped open. Then the filling process is finished.
  • the squeeze tongs can be opened and the bag ejected.
  • the packaging is filled while hanging.
  • the bag is preferably aligned in such a way that the filling opening, in particular of the port, is directed upwards when being filled with the inert gas and when being filled with the liquid.
  • liquid present at the liquid nozzle for example a drop present
  • withdrawn e.g. by applying a negative pressure in the liquid line.
  • the liquid for example the droplet, is preferably withdrawn in such a way that after the withdrawal an edge of the liquid nozzle is still in contact with the liquid. Not enough fluid is withdrawn to empty a portion of the fluid nozzle or the fluid line leading to the fluid nozzle. The liquid is only withdrawn so far that no drop is hanging down, but the edge of the liquid nozzle is still in contact with the liquid. In particular, it is provided that the liquid is drawn back to such an extent that a meniscus of liquid with a concave cross-section is formed in the liquid nozzle.
  • the liquid nozzle is blown from below with an inert gas, in particular nitrogen. Provision is made in particular for nitrogen to be introduced diagonally below the opening of the liquid nozzle via at least one channel from which the protective gas emerges, so that the protective gas flow is directed counter to the direction of movement of the emerging liquid. This supports the withdrawal of the liquid and further reduces the risk of dripping.
  • an inert gas in particular nitrogen. Provision is made in particular for nitrogen to be introduced diagonally below the opening of the liquid nozzle via at least one channel from which the protective gas emerges, so that the protective gas flow is directed counter to the direction of movement of the emerging liquid. This supports the withdrawal of the liquid and further reduces the risk of dripping.
  • the scope of the invention also includes a method for filling a medical packaging, the packaging being filled with a liquid via an access and the access being provided during filling in a protective gas atmosphere.
  • the method is characterized in that the packaging is filled with an inert gas before being filled with the liquid.
  • the inert gas then provides the gas space of the filled and sealed packaging. Possible embodiments of the method can be found in the configurations of the method described above.
  • the invention also relates to a device for filling a medical packaging designed as a bag.
  • the device is designed in particular to use the method described above.
  • the device comprises a filling head with a gas nozzle for filling an inert gas into the packaging and with a liquid nozzle for filling the packaging.
  • An opening for providing a protective gas atmosphere extends at least in sections around the liquid nozzle and/or the gas nozzle.
  • the filling head is preferably designed in one piece.
  • the gas nozzle and the liquid nozzle are preferably spaced apart from one another.
  • a plurality of openings extends around the liquid nozzle and/or the nitrogen nozzle, from which a protective gas, preferably nitrogen, emerges to provide the protective gas atmosphere.
  • the openings extend at least in sections on a circle around the gas nozzle and/or the liquid nozzle.
  • a preferably essentially laminar protective gas flow is achieved via the openings in the area of the gas nozzle and/or the liquid nozzle, so that the outlet opening of the gas nozzle and/or the liquid nozzle is completely in a protective gas atmosphere.
  • the gas nozzle and/or the liquid nozzle is/are located in a depression, the gas nozzle and/or the liquid nozzle having an opening spaced from an edge of the depression.
  • a bell is formed by the depression, within which the liquid nozzle and/or the gas nozzle are arranged.
  • the bell formed by the depression is preferably flushed with the protective gas, preferably nitrogen, during the entire filling process by continuously generating a laminar flow of protective gas, preferably nitrogen flow, via the openings.
  • the filling head also includes a channel from which an inert gas, preferably nitrogen, emerges, through which an outlet opening of the liquid nozzle is blown with the inert gas.
  • an inert gas preferably nitrogen
  • the invention relates to the use of the device described above for filling a medical packaging designed as a bag.
  • the invention further relates to a pharmaceutical product comprising medical packaging designed as a bag, which can be manufactured or manufactured in particular with the method described above and/or in particular using the device described above.
  • the medical packaging designed as a bag is filled with a liquid, in particular with a liquid containing an active ingredient or a solution for parenteral nutrition.
  • the liquid is a medicinal liquid to be administered intravenously.
  • the liquid is an oxygen sensitive, preferably to a high degree, intravenous medicinal liquid.
  • the active ingredient is at least one active ingredient selected from a group consisting of paracetamol, cyanocobalamin, dexamethasone, etoposide, gentamicin, tobramycin and granisetron.
  • the active ingredient can be dissolved and/or dispersed in the liquid.
  • the internal volume of the medical packaging or bag has a volume of gas.
  • the oxygen content in the gas volume of the packaging, at least immediately after filling is less than 1% by volume, preferably less than 0.5% by volume.
  • the gas volume present in the bag is 10 to 50 ml, preferably from 15 to 30 ml.
  • the volume can be determined simply by taking gas from the filled and sealed bag with a needle syringe.
  • the invention has therefore made it possible to provide medical packaging with a gas volume that already has an oxygen content of less than 1% by volume immediately after filling.
  • the invention is also characterized by relatively low nitrogen consumption.
  • For the filling process with a nitrogen atmosphere less than 20 liters per minute, preferably less than 10 liters per minute, for example about 8 Liters per minute, per filling point of nitrogen consumed.
  • no further protective measures against lack of oxygen are necessary for the operating personnel of the filling plant.
  • the packaging is arranged in a secondary packaging comprising an oxygen barrier, preferably a metal foil.
  • the secondary packaging has at least one metal layer that acts as an oxygen barrier. This can be an aluminum foil, for example.
  • the secondary packaging is provided by a deep-drawn foil, preferably an aluminum foil, into which the packaging is placed and which is closed by a preferably transparent foil that has an oxygen barrier.
  • the oxygen barrier in the cover film can be provided by a silicon oxide and/or aluminum oxide layer, for example.
  • the secondary packaging can also be evacuated and/or filled with an inert gas, e.g. nitrogen.
  • an inert gas e.g. nitrogen.
  • the secondary packaging preferably contains only the medical packaging designed as a bag, ie the primary bag.
  • the packaging preferably does not contain an oxygen absorber, such as inserted iron filings.
  • FIG. 1 shows a schematic diagram of the components of a device 1 for filling a medical packaging 20 designed as a bag.
  • the device 1 comprises a filling head 2 embodied as a block in this exemplary embodiment, which comprises a gas nozzle 3 and a liquid nozzle 4 .
  • the gas nozzle 3 provides the inert gas for pre-filling the bag.
  • nitrogen is used as the inert gas.
  • the gas nozzle 3 is briefly referred to as the nitrogen nozzle 3 in the following description.
  • the liquid nozzle 4 and the nitrogen nozzle 3 are arranged side by side and spaced from each other.
  • access 20 to the bag is provided through the fill opening 51 of port 22 .
  • the nitrogen nozzle 3 to which the medical packaging 20 is docked with a filling opening 51 of the port 22, serves both to fill the medical packaging 20 designed as a bag with nitrogen and to evacuate the packaging 20.
  • the nitrogen nozzle 3 is connected to a vacuum line 17 for evacuation.
  • a docked bag 20 is evacuated via the valve 19 and the valve 16 designed as a switching valve.
  • the nitrogen nozzle 3 can be made of an elastic material, for example. Alternatively or additionally, the nitrogen nozzle 3 can include a seal.
  • the vacuum used for evacuation (before filling) is also referred to below as "deep vacuum”. This is a vacuum in which a pressure of less than 100 mbar is preferably applied to the filling opening 51 .
  • the vacuum line 17 there is a container 18 which serves as a buffer volume.
  • the pressure drop occurring at the nitrogen nozzle 3 when the valves 16 and 19 open is reduced by the buffer volume.
  • the nitrogen nozzle 3 is connected to a further vacuum line 12 .
  • a vacuum can also be applied to the nitrogen nozzle 3 via the vacuum line 12 via the switching valve 16 and the valves 14 and 15 .
  • a container 13 is arranged in the vacuum line 12 and is provided with a pressure sensor (not shown) which measures the pressure inside the container 13 .
  • the container 13 is evacuated in a first step via the valve 14 with the valve 15 still closed. Then the valve 14 is closed. Then the valves 15 and 16 are opened. The valve 19 is or remains closed, however. In the event of a leak, an increase in pressure greater than a predetermined reference value can be determined in the container 13 and the filling process is not started. The pressure in this integrity test need not be as low as when the bag 20 is evacuated before it is filled in a subsequent step.
  • valve 15 is closed and valve 19 is opened. A higher negative pressure is then applied to the nitrogen nozzle via the vacuum line 17 . The bag 20 docked to the nitrogen nozzle 3 is now evacuated.
  • the bag 20 is filled with nitrogen as an inert gas.
  • the valve 16 is closed.
  • a defined volume of nitrogen is introduced into the bag 20 via the nitrogen nozzle 3 .
  • the nitrogen nozzle 3 is connected to a supply line 8 for the inert gas, here nitrogen.
  • the supply line 8 leads via a container 10.
  • a valve 11, 49 designed as a switching valve is located in front of and behind the container 10.
  • valve 49 is first opened, with valve 11 still being closed.
  • the container 10 is now filled with nitrogen, the pressure that is set in the container 10 corresponding to the pressure applied via the feed line 8 .
  • valve 49 is closed and then the valve 11 is opened.
  • the nitrogen enclosed in the container 10 can now expand and nitrogen escapes through the nozzle 3 into a docked bag 20 until the pressure has equalized.
  • the volume of the container 10 and the pressure in the container 10 as well as the pressure in the supply line 8 determine the volume of nitrogen that flows into the bag 20 .
  • a pressure of 0.5 bar to 4.0 bar for the nitrogen supply of the gassing is provided in the container 10 .
  • the container 10 is so dimensioned and/or the pressure in the container 10 is so chosen so that the volume of nitrogen flowing into the bag 20, including the volume of the port 22, corresponds to the desired volume of gas remaining in the bag 20 after it has been filled with liquid.
  • the bag 20 After the bag 20 has been filled with nitrogen, it is temporarily closed and transferred to the liquid nozzle 4, where it is filled with liquid. During the temporary closure, the access 22 to the bag 20, here the filling opening 51 of the port 22, is blocked, preferably pressed closed (see the following Figures 5 to 5b and 9 ).
  • the liquid nozzle 4 is connected via the feed line 7 to a reservoir (not shown), via which a medical packaging 20 docked to the liquid nozzle 4 is filled with liquid.
  • the medical packaging 20 is docked to the liquid nozzle 4 with a filling opening 51 .
  • the liquid nozzle 4 is pressed against the filling opening in a sealing manner.
  • the liquid nozzle can have a seal or consist of a sealing elastic material.
  • the device 1 for filling comprises at least one valve 5, 6.
  • two valves 5, 6 designed as switching valves are arranged one behind the other.
  • a valve 6 is used for fine dosing and is designed in such a way that it can change the volume in the inlet, as a result of which a small amount of liquid can be withdrawn. This prevents the formation of drops and dripping after the medical packaging 20 has been undocked from the liquid nozzle 4 .
  • the bag 20 is temporarily closed again (see also the Figures 5 to 5b and 9 ) and to a closure device, not shown here, here in the form of a closure receptacle 29.
  • the port 22 is closed on the closure receptacle 29 with a closure 23 designed in particular as a cap.
  • the 2 shows a medical packaging 20 designed as a bag 20.
  • the bag 20 consists of a foil welded together, in particular a polyolefin foil.
  • the bag 20 comprises an internal volume 21 which is preferably between 50 and 1000 ml, particularly preferably between 80 and 150 ml.
  • the bag 20 comprises a hanger 25 and a port 22 welded into the transverse weld seam 54, which is closed with a snapped-on closure 23, which has a tear-off cap 24 in this embodiment.
  • the bag 20 is placed in a secondary bag 48 which serves as secondary packaging.
  • the bag in its secondary bag is then sterilized, preferably thermally.
  • the secondary bag 48 can be torn open to remove the bag 20, for example.
  • the secondary bag 48 preferably consists of a foil with an oxygen barrier layer, in particular a metal foil.
  • the secondary bag 48 can have an internal volume filled with nitrogen.
  • FIG 3 shows parts of the device 1 for filling a bag 20 in a side view.
  • this can accommodate a closure 23 via pneumatic suction, which is pressed onto the port 22 of a bag 20 .
  • a nitrogen connection 26 for gassing the closure 23 with nitrogen and a pneumatic connection 27 via which compressed air for operating the moving parts of the device 1 is provided are shown.
  • the device comprises a movable support 28 in which there is a channel 30 through which the closure 23 and the port 22 of the bag 20 are gassed with nitrogen.
  • the channel 30 is directed obliquely upwards, so that the exiting flow of nitrogen flushes the closure 23 held by the closure receptacle 29 with nitrogen.
  • the carrier 28 for the channel 30 can be moved upwards in order to be able to dodge when feeding a bag 20 to be filled, in particular to be able to dodge a carrier 44 that holds the bag 20 (see 4 and figure 5 ) .
  • a filling head 2 which cannot be seen in this illustration, is located in the image plane behind the closure receptacle 29 for filling the bag 20 with liquid and for filling with nitrogen.
  • FIG. 4 is another view of the system 1 for filling medical packaging 20 designed as a bag 20.
  • This view shows the carrier 44, which serves as a gripping element for the bag 20 and feeds it to the nitrogen nozzle 3, the liquid nozzle 4 and the closure receptacle 29.
  • the bag 20 is grasped at the port 22 and moved from the carrier 44 to the nitrogen nozzle 3 and to the liquid nozzle 4 and to the closure receptacle 29 .
  • the closure 23 is gassed via the channel 30 in the area of the filling opening 51 of the port 22 .
  • a carrier 31 on which a jaw 32b of the pinching tongs 32 (see figure 5 , as well as Figures 5a and 5b ) is movably arranged.
  • the squeezing tongs 32 can be opened and closed via the carrier 31 in order to press the bag 20 shut around the port 22 . Otherwise the carrier 31 is moved together with the carrier 44 .
  • figure 5 is a perspective view of the system 1.
  • the carrier 44 is shown in particular, over which the bag 20 is gripped and moved.
  • one half 32a of the squeezing pincer 32 can be seen in this illustration.
  • the squeezing tongs 32 are designed in such a way that the foil material of the bag 20 is pressed together around the welded-in port 22 and the bag 20 can thus be pressed closed.
  • the bag 20 is so blocked or temporarily closed around the port 22 by closing the crimping tongs 32 .
  • the bag 20 is shut off or pressed shut with the pinching tongs 32 when it is moved to carry out the various process steps during filling.
  • the carrier 28 for the channel 30 for gassing the closure 23 with nitrogen can be moved in height in order to avoid the carrier 44 .
  • nitrogen can be blown into the closure 23 via the channel 30 .
  • FIGS 5a and 5b show perspective cut-away detailed views of the device 1 for filling, in which the area of the squeeze tongs 32 is shown.
  • Figure 5a shows how the closed crimping tongs 32 squeeze a bag 20 shut.
  • the crimper 32 includes opposed jaws 32a and 32b.
  • the jaw 32b is arranged on the carrier 44 with which the bag 20 is grasped and moved.
  • the jaw 32a which can be moved relative to the jaw 32b, allows the squeezing tongs to be closed and the bag 20 to be shut off, pressed closed here.
  • Figure 5b 12 is a perspective cut-away view of crimping tongs 32 opened (without pouch 20).
  • the jaw 32b comprises a recess 52 which is open at the top and in which a welded-in section of a port 22, in particular a welded-in boat 34, is located when the squeezing tongs are closed.
  • the recess 52 is essentially U-shaped.
  • the opposite jaw 32a is a type of open hollow body or case.
  • the jaw 32a is formed by the base plate 32a-1, the two side walls 32a-2 and 32a-3 and the lower side wall 32a-4 (the two side walls 32a-3 and 32a-4 are not visible in the perspective shown.)
  • the sealing jaw 32a is designed to be open upwards in the direction of the port 22 and laterally in the direction of the sealing jaw 32b.
  • the welding jaw 32a is essentially U-shaped.
  • the U-shape or U-shaped portion of the sealing jaw 32a is formed by the side walls 32a-2, 32a-3, 32a-4 of the jaw 32a.
  • the U-shaped section formed by the jaw 32a comes to rest around the recess 52 of the opposite jaw 32b.
  • the faces of the side walls 32a-2, 32a-3, 32a-4 of jaw 32a abut around the recess 52 of the opposite jaw 32b.
  • the foils of the bag 20 are pressed together around the sealing area of the port 22 so that the bag 20 is closed and no fluid can escape or enter.
  • the position 53 of the contact surface of the jaw 32a on the bag is in 2 shown.
  • the faces of side walls 32a-2, 32a-3, 32a-4 of jaw 32a abut at position 53.
  • the contact surface 53 is also U-shaped, with the base being arranged below the welding boat 34 of the port 22 .
  • the legs of the contact surface 53 extend laterally along the welding boat 34 and reach at least up to the level of a transverse welding seam 54 of the bag 20.
  • the bag 22 can thus be pressed shut with the squeezing tongs 32 around the welded section of the port 22.
  • the port 22 itself is not pressed shut, since the welded region of the port 22 is located partly in the recess 52 and partly between the legs of the U-shaped section of the jaw 32a when the squeeze pincer is closed.
  • FIG. 12 is a detail view of port 22 in one possible embodiment.
  • the port 22 comprises a tapered welding boat 34, which serves as a welding section, and a filling opening 51, below which a collar 33 is located.
  • the closure 23 can be pressed onto the collar 33 .
  • the bag 20 is filled with liquid via the filling opening 51 .
  • the fill opening 51 also serves to form a septum port 22 when the closure is in place.
  • the filling opening 51 of the port 22 can be docked to both the nitrogen nozzle 3 and the liquid nozzle 4 in a sealing manner.
  • the filling head 2 When assembled, the filling head 2 sits behind the in 3 closure receptacle 29 shown.
  • the filling head 2 comprises a connecting piece for attachment to the system 1.
  • the filling head 2 also comprises a product connection and a gas connection.
  • Liquid for filling the bag 20 is supplied via the product connection, which is connected to the liquid nozzle 4 .
  • the bag 20 can be both evacuated and filled with nitrogen via the gas connection, which is connected to the nitrogen nozzle 3 .
  • valve 6 designed as a switching valve is integrated into the filling head 2 . Fine dosing can be carried out via the switching valve 6. At the same time, via the valve 6 a Change in volume are effected in the liquid inlet, whereby a drop of liquid can be withdrawn.
  • the fill head 2 includes a nitrogen nozzle 3 and a liquid nozzle 4.
  • the liquid nozzle 4 has a larger diameter than the nitrogen nozzle 3.
  • the diameter of the liquid nozzle 4 is between 4.5 and 6.5 mm .
  • the diameter of the nitrogen nozzle 3 is preferably between 2.5 and 3.5 mm.
  • the nitrogen nozzle 3 When installed, the nitrogen nozzle 3 is located behind the in 3 shown closure receptacle 29. This is followed by the liquid nozzle 4. The nitrogen nozzle 3 is arranged between the liquid nozzle 4 and the closure receptacle 29.
  • Both the nitrogen nozzle 3 and the liquid nozzle 4 have annular openings 38 from which nitrogen emerges and with which a laminar flow in the direction of flow of the product, ie the liquid flow during filling, is generated.
  • the openings 38 are located in a depression 39 whose edge 40 extends along the underside of the filling head 2 .
  • the sink 39 is open to the side and is directly adjacent to the closure receptacle 29 in the assembled state.
  • the depression 39 thus forms a channel 42 that reaches up to the closure receptacle 29 and is continuously flushed with nitrogen during operation of the device 1 for filling in order to provide a protective gas atmosphere.
  • the lower end of the filling head 2 is designed as an insert part 41 made of stainless steel, which connected to the rest of the filling head 2, in particular glued and / or screwed, and optionally sealed with sealing rings.
  • This insert part 41 includes the liquid nozzle 4 and the nitrogen nozzle 3, to which the filling opening 51 of the port 22 can be docked.
  • the edge 45 of the liquid nozzle 4 and also the edge 47 of the nitrogen nozzle 3 are at a distance from the edge 40 of the depression 39 .
  • the outlet openings of the liquid nozzle 4 and nitrogen nozzle 3 are thus located within a channel 42 which is open at the bottom and which is flushed with nitrogen in the operating state by a preferably laminar flow of nitrogen.
  • a meniscus 50 is shown in this detailed illustration, which forms the liquid when the bag 20 is undocked from the liquid nozzle 4 .
  • the liquid and the filling opening of the liquid nozzle 4 are blown on at an angle from below via the channel 46, in particular at an angle of 10-60° to the horizontal plane. This counteracts the formation of drops and supports the formation of the concave meniscus 50. At the same time, the liquid is not drawn back in such a way that gas is sucked in and thus oxygen is possibly also drawn into the area of the liquid nozzle 4 due to the flow.
  • FIG. 9 shows the method steps according to an embodiment in a flow chart.
  • the bag 20 is picked up by the device 1 for filling by means of the carrier 44 and docked with the filling opening 51 of the port 22 on the nitrogen nozzle 3 .
  • a vacuum is then applied in the container 13 via the line 12 . Then the valve 14 is closed. By opening the valves 15 and 16, the vacuum is also applied in the bag 20.
  • a pressure sensor in the container 13 is used to check whether the bag 20 is tight by comparing the pressure drop that occurs with a predetermined reference range.
  • a deep vacuum is then applied via the vacuum line 17 and the valve 19 is opened. After applying the deep vacuum, the valve 19 is closed.
  • the bag 20 is filled with the inert gas, here nitrogen, in that a defined volume of nitrogen is filled into the bag 20 via the container 10 by actuating the valves 11 and 49 .
  • the volume filled essentially corresponds to the desired gas volume of the bag 20.
  • the bag 20 is blocked, in this case pressed shut by the squeezing tongs 32 being closed.
  • the bag 20 now filled with inert gas is then transferred from the nitrogen nozzle 3 to the filling nozzle, ie to the liquid nozzle 4 .
  • Closing with the crimping tongs 32 prevents gas from entering or exiting the bag 20 during the transfer.
  • the liquid in the liquid nozzle 4 is reset via the valve 6 so that nothing drips out of the liquid nozzle 4 when the bag 20 is then moved to the closure 23, where the port 22 is closed with the closure 23.
  • the bag 20 When moving from the liquid nozzle 4 to the closure receptacle 29 , the bag 20 , which is now filled with liquid and inert gas, is also blocked, here it is pressed closed with the squeezing tongs 32 .
  • the squeezing tongs 32 are opened and the bag 20, now completely filled and closed by the closure 23, can be ejected and transported away.
  • the head volume ie the area of the liquid nozzle 4, the nitrogen nozzle 3 and the filling opening 51 of the port 22, is continuously flushed with nitrogen.
  • the components are continuously in a protective gas atmosphere.
  • the closure 23 is also flushed with nitrogen, with a carrier 28, which includes the channel 30 provided for this purpose, being moved upwards when the bag 20 is fed in, in order to be able to move out of the way.
  • the invention has made it possible to reduce the residual oxygen content in the remaining gas volume of a bag 20 to below 1% by volume.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Ceramic Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Vacuum Packaging (AREA)
  • Basic Packing Technique (AREA)
EP18773762.2A 2017-09-22 2018-09-21 Verfahren zum befüllen einer medizinischen verpackung, befüllvorrichtung, sowie als beutel ausgebildete medizinische verpackung Active EP3684320B1 (de)

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PCT/EP2018/075647 WO2019057918A1 (de) 2017-09-22 2018-09-21 Verfahren zum befüllen einer medizinischen verpackung, befüllvorrichtung, sowie als beutel ausgebildete medizinische verpackung

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IT201600079175A1 (it) * 2016-07-28 2018-01-28 Fillshape Srl Dispositivo e procedimento di verifica buste per linee di riempimento.
EP3684320B1 (de) * 2017-09-22 2023-06-07 Fresenius Kabi Deutschland GmbH Verfahren zum befüllen einer medizinischen verpackung, befüllvorrichtung, sowie als beutel ausgebildete medizinische verpackung
CN111824494A (zh) * 2020-06-18 2020-10-27 苏州微敏检测技术服务有限公司 一种防吸附药物包装惰性气体保护生产***
EP4339111A1 (de) * 2022-09-13 2024-03-20 Harro Höfliger Verpackungsmaschinen GmbH Vorrichtung und verfahren zum befüllen von beuteln

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US11548665B2 (en) 2023-01-10
BR112020000069A2 (pt) 2020-07-07
US20200270003A1 (en) 2020-08-27
CN111107822B (zh) 2023-10-24
KR20200050942A (ko) 2020-05-12
EP3684320A1 (de) 2020-07-29
EP3684320C0 (de) 2023-06-07
WO2019057918A1 (de) 2019-03-28

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