EP0750488B1 - Vorrichtung und verfahren zum aseptischen vermischen von flüssigkeiten - Google Patents

Vorrichtung und verfahren zum aseptischen vermischen von flüssigkeiten Download PDF

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Publication number
EP0750488B1
EP0750488B1 EP95911514A EP95911514A EP0750488B1 EP 0750488 B1 EP0750488 B1 EP 0750488B1 EP 95911514 A EP95911514 A EP 95911514A EP 95911514 A EP95911514 A EP 95911514A EP 0750488 B1 EP0750488 B1 EP 0750488B1
Authority
EP
European Patent Office
Prior art keywords
container
product
connection device
pointed
pointed part
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.)
Expired - Lifetime
Application number
EP95911514A
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English (en)
French (fr)
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EP0750488A1 (de
Inventor
Lajos Pethö
Ivan Hakansson
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IMIA DEVELOPMENT AB
Original Assignee
IMIA Development AB
IMIA Development AB
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Publication of EP0750488A1 publication Critical patent/EP0750488A1/de
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Publication of EP0750488B1 publication Critical patent/EP0750488B1/de
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Classifications

    • 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
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration

Definitions

  • the present invention relates to an apparatus and a method for aseptically mixing liquid products.
  • the invention particularly relates to an apparatus and a method for mixing aseptically three or more liquid products for pharmaceutical or nutritive use. Even more particularly, the invention relates to an apparatus and to method for mixing aseptically liquid products for inclusion in a preparation for administering nutrient parenterally, particularly intravenously.
  • the invention also relates to a connection device and to a system for mixing aseptically three or more liquid products.
  • Nutrients are very often administered parenterally to patients who are unable to ingest nutrients in the normal way, for some reason or another.
  • the nutrient supply is comprised primarily of three main types of nutrient, namely carbohydrates, amino acids and fat.
  • carbohydrates and amino acids are supplied in the form of solutions, and the fat in the form of an emulsion.
  • These preparations also contain other necessary nutrients, such as electrolytes, trace elements and water-soluble and fat-soluble vitamins.
  • the present invention provides an apparatus in accordance with claim 1 for mixing three liquid products aseptically.
  • connection device in accordance with claim 2 for mixing together three or more liquid products.
  • the invention also relates to a method in accordance with claim 4, using said device for mixing three or more liquid products aseptically.
  • At least the product in the last container is pre-packed at a pressure beneath atmospheric pressure and the first product container is caused to communicate with the surrounding atmosphere through the medium of a sterilizing filter, so that the products will be driven or drawn successively through the series of product containers under the influence of the outer atmospheric pressure and mixed mutually together and are finally collected in the last product container as a final mixture.
  • all products are packed in their respective containers at a pressure beneath atmospheric pressure.
  • the invention also relates to a system in accordance with claim 3 for producing an aseptic mixture of three or more liquid products.
  • Figure 1 is a sectioned view of the first pointed connection device according to the invention
  • Figure 2 is a side view of the connection device shown in Figure 1
  • Figure 3 is a sectioned view of the second pointed connection device according to the invention
  • Figure 4 is a side view of the second connection device
  • Figure 5 illustrates an additional, intermediate connection device used in accordance with one embodiment of the invention
  • Figure 6 illustrates schematically the construction of the inventive system.
  • Figs. 1 and 2 illustrate the first connection device, generally referenced 1, which includes a pointed part 2 and two mutually separate and generally parallel through-passing passageways 3 and 4.
  • One end of the first passageway 3 opens at 5 into the pointed end 2, while the other end of the first passageway communicates at 6 with the surrounding atmosphere through a sterilizing filter 7.
  • the Figure shows the sterilizing filter 7 mounted in a chamber 8 and held in position by a cover member 9 provided with openings 10 in communication with the surrounding atmosphere.
  • the sterilizing filter may, of course, be arranged in other ways.
  • the second passageway 4 also opens at one end into the pointed part 2, at 11, while the other end of the second passageway 4 is connected at 12 to a connection line (not shown) by means of a connection 13.
  • Figs. 3 and 4 illustrate the second connection device, generally referenced 21, which includes a first pointed part 22 and a second pointed part 23, said pointed parts normally extending in mutually opposite directions, although this is not strictly necessary.
  • the second connection device 21 includes two mutually separate and generally parallel passageways 24 and 25. One end of the first passageway 24 opens at 26 into the first pointed part 22, while the other end of said passageway is connected at 27 to a connection line (not shown) from the first connection device 1, by means of a connection 28.
  • a first end of the second passageway 25 also opens into the first pointed part 22, at 29, and the other end of the passageway opens out adjacent the second pointed part 23, at 30.
  • FIG. 5 is a sectional view of an intermediate, pointed connection device, generally referenced 41, which is used in the embodiment of the invention in which four or more liquids are to be mixed together.
  • This intermediate connection device includes a pointed part 42 and two mutually separate and generally parallel through-passing passageways 43 and 44.
  • One end 45 and 46 of respective passageways 43 and 44 opens into the pointed end-part 42, while the other ends 47 and 48 of respective passageways connect with connections 49 and 50 for coupling the intermediate connection device in the connection line (not shown) between the first and the second connection devices 1 and 21.
  • connection devices 41 may be coupled sequentially in the connection line, one such intermediate connection device being required for each additional liquid product to be mixed in accordance with the invention, over and above the first-mentioned three products.
  • connection devices illustrated in Figures 1-5 and the passageways contained therein shall be protected against mechanical damage and primarily against microbial contamination, by means of protective hoods or caps placed over respective points.
  • protective hoods will preferably be airtight and may also include a means which is destroyed when the hood is removed, so that the hood cannot subsequently be replaced without it being evident that the hood has been removed (tamper-proof).
  • the design of such protective hoods and such safety devices lies within the competence of one of normal skill in this art.
  • the protective hood shall not be removed from its respective point until immediately prior to inserting the point through the penetrable product container closure means.
  • the protective hoods have not been shown in the drawings, for the sake of clarity.
  • Figure 6 is a schematic illustration of an inventive system for mixing three liquid products aseptically.
  • the first product 51 is contained in the first product container 52
  • the second product 53 is contained in the second product container 54
  • the third product 55 is contained in a product container 56 whose empty volume 57 is sufficiently large to accommodate the products 51 and 53 arriving from the containers 52 and 54 respectively.
  • the three containers 52, 54 and 56 are closed by means of penetrable closure means 58, 59 and 60 respectively.
  • closure means may be of a conventional kind, consisting in a rubber membrane which closes the container opening and which is held in place by a metal capsule.
  • This capsule contains in the central region of the closure an opening which exposes the rubber membrane so as to enable said membrane to be pierced by a pointed connection device.
  • the opening in the metal capsule can be protected from damage and from bacterial contamination during storage and transportation with the aid of a metal or plastic protective covering. It will be obvious to those skilled in this art that other penetrable closure means are conceivable.
  • Figure 6 shows schematically a first pointed connection device 1 according to Figures 1 and 2 inserted through the penetrable closure means 58 of the container 52.
  • the passageways 3 and 4 of the connection device 1 connect at one end with the interior of the container 52 at the pointed end 2 of the device.
  • the other end of the passageway 3 communicates with the surrounding atmosphere through a sterilizing filter at 6, while the other end of the passageway 4 connects at 12 to a connection line 61 extending to a second connection device 21 of the kind illustrated in Figures 3 and 4.
  • connection device 21 The pointed end 22 of the connection device 21 is inserted into the container 54 through the penetrable closure means 59, while the pointed end 23 of said connection device 21 is inserted into the container 56 through the penetrable closure means 60.
  • the orifice 27 of the first passageway 24 of said connection device connects with the connection line 61 extending from the first container 52.
  • the second passageway 25 connects the interior of the second container 54 with the interior of the third container 56.
  • liquid product 51 when subjected to the influence of a suitable driving force, liquid product 51 is able to flow from the container 52 and through the container 54 while mixing with the liquid product 53 contained therein, and finally into the conductor 56 in which all three products are mixed together to form a final mixture.
  • connection line 61 When four or more liquid products are to be mixed together, one or more intermediate connection devices of the kind shown in Figure 5 are coupled in the connection line 61 with the aid of their two connectors 49 and 50.
  • the pointed part 42 of this connection device which includes the passageways 43 and 44, is then inserted through a penetrable closure means of a product container of similar type to the containers 52 and 54.
  • the last container 56 in line which accommodates the final mixture of said liquid products, including the product 55, shall have a volumetric capacity sufficient to accommodate the final mixture.
  • the final container 56 will thus have a significant empty volume 57 prior to the mixture components having been transferred to this final container.
  • This empty volume shall be under a vacuum or a pressure beneath atmospheric pressure. It is this subpressure that generates the driving force in the mixing process, as will be described in more detail below.
  • the products contained in the containers 52 and 54, and also in any other additional container arranged upstream of the final container 56 will also preferably be contained under a vacuum or a subpressure.
  • subpressure conditions are not necessary in the case of these containers, and the containers may be under atmospheric pressure or a moderate overpressure.
  • an overpressure or subpressure prevails in one or more containers, with the exception of the last container, this overpressure must be equalized through the sterilizing filter.
  • the pointed ends of the connection devices In order to achieve this, it is necessary for the pointed ends of the connection devices to lie above the surfaces of the liquid in respective containers.
  • the products are often packed under some suitable protective gas, such as nitrogen, and not under air, in order to prevent the oxidation of sensitive components.
  • connection line 61 extending between the two connection devices 1 and 21 may have the form of a hose connection between the connectors 13 and 28 of respective connection devices, optionally with additional, intermediate connection devices 41 coupled in the connection line.
  • connection line 61 and the two connection devices 1 and 21 are permanently connected together in the manufacture of the mixing apparatus, such as to form a unit.
  • This combination of connection devices and connection line can then be combined with a suitable container holding device which functions to hold the three product containers 52, 54 and 56 and their respective connections and connecting line in the form of a unit.
  • a suitable container holding device which functions to hold the three product containers 52, 54 and 56 and their respective connections and connecting line in the form of a unit.
  • Such a unit can be handled more easily in the mixing process than separate product containers.
  • the inventive method of aseptically mixing three liquid products is carried out in the following manner:
  • connection devices 1 and 21 will have been connected together by means of the connecting line 61 and all pointed parts 2, 22 and 23 of respective connection devices will have been covered with protective hoods (not shown) which are impervious to air and bacteria and therewith prevent air and bacteria from entering the passageways 3, 4 and 24, 25 of respective devices 1 and 21, as before described.
  • the protective hood is now removed from the pointed part 2 of the connection device 1 and the point is inserted through the penetrable closure means 58 of the product container 52. If the product 51 in the container 52 is under subpressure, the interior of the container will now assume atmospheric pressure by virtue of ambient air being able to flow into the device 1, through the sterilizing filter 7 and the passageway 3.
  • the protective hood covering the pointed part 22 of the connection device 21 must not be removed before the subpressure in the container 52 has been equalized. This is important in ensuring aseptic conditions in the container 52. If the hood covering the point 22 is removed prematurely while a subpressure still prevails in the container 52, unfiltered air will be sucked in through the passageway 24 and the connection line 61 and enter the container 52 and therewith contaminate the container contents 51.
  • the hood covering the point 22 of the connection device 21 is removed and the point is inserted through the penetrable closure means 59 of the container 54.
  • the subpressure prevailing in this container is thereafter equalized by air that flows into the connection device 1 through the sterilized filter 7 and from there into the product container 52, while displacing part of its content 51 into the container 54.
  • the hood covering the point 23 of the connection device 21 may not be removed before the pressure has been equalized. This is important in preventing unfiltered air from flowing into the product container 54 through the passageway 25 and contaminating the content 53 of said container.
  • the hood is removed from the point 23 of the connection device 21 and said point is inserted through the penetrable closure means 60 of the last container 56 in line.
  • the subpressure prevailing in the mixing chamber 57 in the container 56 will now draw in product 53 from the container 54 by suction, at the same time as the product 51 from the container 52 will pass through the container 54 and enter the final container 56, in which the three products are mixed.
  • the subpressure prevailing in the final container 56 will also be equalized by air drawn by suction through the sterilizing filter 7 and passing through the containers 52 and 54 and the connection line 61.
  • the mixing process is analogous with that described above.
  • the containers are connected successively by means of the pointed connection devices, it being ensured that the subpressure in a connected container has been equalized before removing the protective hood from the point of the next following connection device and a liquid connection is established with the next following container.
  • the container can be removed from the connection device 21 and the finished mixture administered in a conventional manner, for instance by infusion or by injection.
  • the mixture is administered as quickly as possible after being produced, in order to reduce the risk of reactions taking place between the component products, these reactions possibly giving rise to undesirable reaction products.
  • the finished mixture will preferably be stored in a dark and cool environment, until it can be administered.
  • the penetrable closure means will preferably be washed with a disinfectant, e.g. alcohol, prior to inserting the point of a connection device therethrough.
  • a disinfectant e.g. alcohol
  • the actual connection devices and associated connecting line will preferably be disposable, i.e. intended for one-time use only and stored in a sterilized package prior to use, for instance a package that has been sterilized by ionizing radiation.
  • the simple method and apparatus provided by the invention enable the products to be mixed by hospital personnel who have no particular training in this regard without any appreciable risk of bacterial contamination.
  • the components of the inventive apparatus may be made of a material that is normally used within known techniques for the aseptic handling of liquids.
  • the product containers are conveniently conventional glass or plastic bottles intended for injection or infusion preparations.
  • the pointed connection devices are conveniently made of a metal and/or plastic material conventionally used in this field. It is important that the materials can be sterilized, for instance by autoclaving or with the aid of gas or radiation. Since the components will preferably be intended for one-time use only, the cost of the components is also important. A skilled person who has knowledge of the invention will find no difficulty in choosing suitable materials and determining the construction of the components in detail.
  • the present invention thus provides a simple technical solution to the problem of mixing three or more liquid products under aseptic conditions without risk of contamination. This is of particular value when, e.g., mixing all of the nutrients required for a complete intravenous nutrient supply.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
  • Accessories For Mixers (AREA)

Claims (7)

  1. Vorrichtung zum aseptischen Zusammenmischen von drei oder mehr flüssigen Produkten,
    gekennzeichnet durch
    a) eine erste spitze Verbindungsvorrichtung (1) zum Einführen durch eine durchstoßbare Verschlußeinrichtung (58) eines ersten Produktbehälters (52), wobei die Verbindungsvorrichtung zwei getrennte, allgemein parallele, durchgehende Durchführungen (3, 4) aufweist, von denen sich die erste (3) an ihrem einen Ende in den spitzen Teil (2) der Verbindungsvorrichtung (1) öffnet und an dem anderen Ende durch ein Sterilisierfilter (7) mit der umgebenden Atmosphäre kommuniziert, und wobei die zweite Durchführung (4) sich ebenfalls an dem einen Ende in den spitzen Teil (2) der Verbindungsvorrichtung (1) öffnet und an ihrem anderen Ende mit einer Verbindungsleitung verbunden ist; und
    b) eine zweite, mit Doppelspitze versehene Verbindungsvorrichtung (21), wobei ein erster spitzer Teil (22) der Vorrichtung zum Einführen durch ein durchstoßbares Verschlußelement (59) eines zweiten Produktbehälters (54) ausgebildet ist und zwei getrennte, allgemein parallele, durchgehende Durchführungen (24, 25) aufweist, von denen sich eine erste Durchführung (24) an dem einen Ende in den ersten spitzen Teil (22) öffnet und das andere Ende der Durchführung (24) mit der Verbindungsleitung (28) verbunden ist, die sich von der ersten Verbindungsvorrichtung (1) wegerstreckt, und wobei sich die zweite Durchführung (25) ebenfalls an einem Ende in den ersten spitzen Teil (22) öffnet und sich an dem anderen Ende in den zweiten spitzen Teil der Verbindungsvorrichtung (21) öffnet, wobei dieser zweite spitze Teil (23) zum Einführen durch eine durchstoßbare Verschlußeinrichtung (60) eines abschließenden Produktbehälters (56) ausgebildet ist, in dem eine Mischung aus allen Produkten gesammelt wird; und
    c) ferner, wenn vier oder mehr flüssige Produkte gemischt werden sollen, durch eine oder mehrere zusätzliche, zwischengeordnete, spitze Verbindungsvorrichtungen (41), die jeweils eine hohle Spitze (42) zum Einführen durch eine durchstoßbare Verschlußeinrichtung eines zwischengeordneten Behälters für flüssiges Produkt aufweisen, wobei jede Spitze (42) zwei getrennte, allgemein parallele Durchführungen (43, 49) aufweist, die sich beide in das spitze Ende (42) der Verbindungsvorrichtung öffnen und die an ihren anderen offenen Enden mit einer jeweiligen Verbindungsleitung verbunden sind, die sich von einer vorausgehenden bzw. zu einer nachfolgenden Verbindungsvorrichtung erstreckt.
  2. Verbindungsvorrichtung (21) zum Mischen von drei oder mehr flüssigen Produkten,
    gekennzeichnet durch
    einen ersten hohlen spitzen Teil (22), der zum Durchstoßen einer durchstoßbaren Verschlußeinrichtung eines Behälters für flüssiges Produkt ausgebildet ist, wobei der spitze Teil (22) zwei getrennte, allgemein parallele, durchgehende Durchführungen (24, 25) aufweist, die sich beide in das Ende des spitzen Teils (22) öffnen, wobei die erste Durchführung (24) mit einer Verbindungsleitung (28) verbunden ist für die Zufuhr von flüssigem Produkt oder produktmischung zur Mischung mit dem flüssigen Produkt in dem Behälter, und wobei die zweite Durchführung (25) sich in das Ende eines zweiten spitzen Teils (23) öffnet, der zum Durchstoßen einer durchstoßbaren Verschlußeinrichtung eines abschließenden Behälters für ein zusätzliches flüssiges Produkt ausgebildet ist, mit dem die anderen flüssigen Produkte letztendlich zur Bildung einer abschließenden Mischung gemischt werden sollen.
  3. System zum aseptischen Zusammenmischen von drei oder mehr flüssigen Produkten,
    dadurch gekennzeichnet,
    daß das System folgendes aufweist:
    a) einen Behälter (52), der ein erstes flüssiges Produkt (51) enthält, das in den Behälter mit Hilfe einer durchstoßbaren Verschlußeinrichtung (58) eingeschlossen ist;
    b) eine erste spitze Verbindungsvorrichtung (1), die eine erste durchgehende Durchführung (3) aufweist, die sich an ihrem einen Ende (5) in den spitzen Teil (2) der Verbindungsvorrichtung öffnet und an ihrem anderen Ende unter Zwischenschaltung eines Sterilisierfilters (7) mit der umgebenden Atmosphäre verbunden ist, und die ferner eine zweite durchgehende Durchführung (4) aufweist, die allgemein parallel zu der ersten Durchführung (3) sowie von dieser getrennt ausgebildet ist, wobei sich das eine Ende der zweiten Durchführung in den spitzen Teil (2) der Verbindungsvorrichtung öffnet und das andere Ende (12) mit einer Verbindungsleitung (13) verbunden ist, wobei der spitze Teil (2) der ersten Verbindungsvorrichtung (1) durch die durchstoßbare Verschlußeinrichtung (58) des ersten Behälters (52) hindurch eingeführt wird, um eine Fluidverbindung mit diesem herzustellen;
    (c) einen Behälter (54), der ein zweites flüssiges Produkt (53) enthält, das mittels einer durchstoßbaren Verschlußeinrichtung (59) in dem Behälter eingeschlossen ist;
    (d) eine zweite, mit Doppelspitze versehene Verbindungseinrichtung (21), die eine erste durchgehende Durchführung (24) aufweist, die sich an ihrem einen Ende (26) in den ersten spitzen Teil (22) der Verbindungsvorrichtung öffnet und an ihrem anderen Ende (27) mit der sich von der ersten Verbindungsvorrichtung (1) wegerstreckenden Verbindungsleitung (28) verbunden ist, und die ferner eine zweite durchgehende Durchführung (25) aufweist, die allgemein parallel zu der ersten Durchführung (24) ist und sich an ihrem einen Ende (29) in den ersten spitzen Teil (22) der Verbindungsvorrichtung (21) öffnet und sich an ihrem anderen Ende (30) in den zweiten spitzen Teil (23) der Verbindungsvorrichtung (21) öffnet, wobei der erste spitze Teil (22) durch die durchstoßbare Verschlußeinrichtung (59) des zweiten Produktbehälters (54) hindurch einführbar ist, um eine Fludiverbindung mit diesem herzustellen; und
    (e) einen abschließenden Produktbehälter (56), in dem das Produkt mit einem unter dem Atmosphärendruck liegenden Druck enthalten ist und der eine durchstoßbare Verschlußeinrichtung (60) aufweist, durch die der zweite spitze Teil (23) der zweiten Verbindungseinrichtung (21) hindurch eingeführt wird, um eine Fluidverbindung mit dem Produktbehälter (56) herzustellen, wobei die Volumenkapazität des Behälters zum Aufnehmen der Mischung der flüssigen Produkte ausreichend ist; und
    (f) ferner, wenn vier oder mehr flüssige Produkte gemischt werden sollen, eine oder mehrere zusätzliche, zwischengeordnete spitze Verbindungsvorrichtungen (41), deren jede einen hohlen spitzen Teil (42) zum Einführen durch eine durchstoßbare Verschlußeinrichtung eines zwischengeordneten Behälters für flüssiges Produkt aufweist, wobei jeder spitze Teil (42) zwei getrennte, allgemein parallele Durchführungen (43, 44) aufweist, die sich beide in den spitzen Teil (42) der Verbindungsvorrichtung (41) öffnen und deren am anderen Ende befindlichen Öffnungen (47, 48) mit einer jeweiligen Verbindungsleitung (49, 50) verbunden sind, die sich von einer vorausgehenden bzw. zu einer nachfolgenden Verbindungsvorrichtung erstrecken, und wobei der spitze Teil (42) jeder der zwischengeordneten Verbindungsvorrichtungen (41) durch eine durchstoßbare Verschlußeinrichtung eines weiteren, zwischengeordneten Behälters für flüssiges Produkt hindurch eingeführt wird, um eine Flüssigkeitsverbindung mit dem Produktbehälter herzustellen.
  4. Verfahren zum aseptischen Mischen von drei oder mehr flüssigen Produkten,
    dadurch gekennzeichnet,
    daß jedes der Produkte in einem einzelnen Produktbehälter (52, 54, 56) enthalten ist, wobei die Behälter in Reihe miteinander verbunden werden und Produkt oder Produktmischung von jedem der Behälter beginnend mit dem ersten Behälter (52) in der Reihe dazu veranlaßt wird, nacheinander unter aseptischen Bedingungen zu dem nächsten Behälter in der Reihe zu fließen und sich dort mit dem Produkt in dem Behälter zu mischen, bis eine abschließende Mischung von allen Produkten in dem letzten Behälter (56) in der Reihe angesammelt ist, wobei der letzte sowie der vorletzte Behälter durch die Verbindungsvorrichtung gemäß Anspruch 2 verbunden sind.
  5. Verfahren nach Anspruch 4,
    dadurch gekennzeichnet,
    daß wenigstens das Produkt (55) in dem letzten Produktbehälter (56) in der Reihe vorab unter einem unter dem Atmosphärendruck liegenden Druck in den Behälter eingebracht wird; und daß der erste Produktbehälter (52) über ein Sterilisierfilter (7) mit der umgebenden Atmosphäre in Verbindung gebracht wird, so daß die Produkte unter dem Einfluß des umgebenden Atmosphärendrucks unter gleichzeitiger gegenseitiger Mischung des Inhalts der Behälter durch die Reihe von Produktbehältern getrieben werden, wobei die Produkte schließlich als abschließende Mischung in dem letzten Produktbehälter (56) in der Reihe gesammelt werden.
  6. Verfahren nach Anspruch 4 oder 5,
    dadurch gekennzeichnet,
    daß der erste Produktbehälter (52) zuerst mit der Verbindungsleitung (61), die sich zu dem zweiten Behälter (54) erstreckt, und der umgebenden Atmosphäre verbunden wird, und der erste Behälter (52) auf Atmosphärendruck gebracht wird, während die Verbindungsleitung (61) zu dem zweiten Behälter (54) geschlossen ist, wonach die Verbindungsleitung (61) zu dem zweiten Behälter (54) geöffnet wird, nachdem der Druck in dem ersten Behälter (52) Atmosphärendruck angenommen hat, und daß der zweite Behälter (54) auf Atmosphärendruck gebracht wird, während die Verbindungsleitung zu dem dritten Behälter geschlossen gehalten wird, wonach die Verbindungsleitung zu dem nachfolgenden Behälter geöffnet wird, wenn der zweite Behälter Atmosphärendruck angenommen hat, und der nachfolgende Behälter auf Atmosphärendruck gebracht wird, wobei der Prozeß nacheinander für jeden der Produktbehälter in der Reihe bis zu dem letzten Produktbehälter (56) in der Reihe wiederholt wird, wobei der in den vorausgehenden Produktbehältern bis zu dem abschließenden Produktbehälter in der Reihe vorherrschende Atmosphärendruck derart ist, daß eine abschließende Produktmischung in dem Behälter erzielt wird.
  7. Verfahren nach einem der Ansprüche 4 bis 6,
    dadurch gekennzeichnet,
    daß drei flüssige Produkte zusammengemischt werden.
EP95911514A 1994-02-28 1995-02-21 Vorrichtung und verfahren zum aseptischen vermischen von flüssigkeiten Expired - Lifetime EP0750488B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9400681 1994-02-28
SE9400681A SE9400681L (sv) 1994-02-28 1994-02-28 Anordning och förfarande för aseptisk blandning av tre eller flera vätskeformiga produkter samt anslutningsdon och system för åstadkommande av nämnda blandning
PCT/SE1995/000178 WO1995022954A1 (en) 1994-02-28 1995-02-21 A device and a process for aseptic mixing of liquid products

Publications (2)

Publication Number Publication Date
EP0750488A1 EP0750488A1 (de) 1997-01-02
EP0750488B1 true EP0750488B1 (de) 1999-05-06

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AT (1) ATE179589T1 (de)
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DE (1) DE69509508T2 (de)
HU (1) HUT76713A (de)
PL (1) PL178101B1 (de)
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI319984B (en) * 2003-06-06 2010-02-01 Sterile combined preparation
WO2007122209A1 (en) * 2006-04-24 2007-11-01 Novo Nordisk A/S Transfer system for forming a drug solution from a lyophilized drug
CN101081192B (zh) * 2007-07-03 2011-10-05 王建友 一种输液瓶口装置
WO2012092564A2 (en) * 2010-12-30 2012-07-05 Ge Healthcare Limited Multi-vial dispensing
AU2018319625B2 (en) * 2017-08-24 2023-02-16 Innatoss Laboratories B.V. Liquid handling system and method

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* Cited by examiner, † Cited by third party
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SE9001271D0 (sv) * 1990-04-06 1990-04-06 Eric Westberg Blodpaase foer anvaendning vid separation av blod i komponenter
US5154716A (en) * 1990-11-06 1992-10-13 Miles Inc. Bottom blood bag separation system
JPH05131018A (ja) * 1991-11-11 1993-05-28 Terumo Corp バツグ連結体およびその製造方法

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Publication number Publication date
WO1995022954A1 (en) 1995-08-31
SE501835C2 (sv) 1995-05-22
CN1123521A (zh) 1996-05-29
PL316025A1 (en) 1996-12-23
CA2184249A1 (en) 1995-08-31
PL178101B1 (pl) 2000-02-29
HUT76713A (en) 1997-10-28
DE69509508D1 (de) 1999-06-10
SE9400681D0 (sv) 1994-02-28
SE9400681L (sv) 1995-05-22
EP0750488A1 (de) 1997-01-02
ATE179589T1 (de) 1999-05-15
CN1054279C (zh) 2000-07-12
AU1905295A (en) 1995-09-11
DE69509508T2 (de) 1999-09-02
HU9602344D0 (en) 1996-10-28

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