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WO1995022954A1 - Dispositif et procede de melange aseptique de produits liquides - Google Patents

Dispositif et procede de melange aseptique de produits liquides Download PDF

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Publication number
WO1995022954A1
WO1995022954A1 PCT/SE1995/000178 SE9500178W WO9522954A1 WO 1995022954 A1 WO1995022954 A1 WO 1995022954A1 SE 9500178 W SE9500178 W SE 9500178W WO 9522954 A1 WO9522954 A1 WO 9522954A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
connection device
product
pointed part
pointed
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.)
Ceased
Application number
PCT/SE1995/000178
Other languages
English (en)
Inventor
Lajos Pethö
Ivan HÅKANSSON
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.)
IMIA DEVELOPMENT AB
IMIA Development AB
Original Assignee
IMIA DEVELOPMENT AB
IMIA Development AB
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 IMIA DEVELOPMENT AB, IMIA Development AB filed Critical IMIA DEVELOPMENT AB
Priority to EP95911514A priority Critical patent/EP0750488B1/fr
Priority to DE69509508T priority patent/DE69509508T2/de
Priority to PL95316025A priority patent/PL178101B1/pl
Priority to AU19052/95A priority patent/AU1905295A/en
Publication of WO1995022954A1 publication Critical patent/WO1995022954A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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 adminis ⁇ tering 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 com ⁇ prised 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 for mixing three liquid products aseptically, said apparatus including a) a first pointed connection device for insertion through a penetrable closure means of a first product container, wherein the connection device includes two separate, general ⁇ ly parallel through-penetrating passageways of which the first opens at one end into the pointed part of the connec ⁇ tion device and at the other end communicates with the surrounding atmosphere through a sterilizing filter, and wherein the second passageway also opens at one end into the pointed part of the connection device and is connected to a connection line at its other end; and b) a second, double-pointed connection device, wherein a first pointed part of said device is arranged for insertion through a penetrable closure member of a second product container and includes two separate, generally parallel through-penetrating passageways of which a first passageway opens at one end into the first pointed part and the other end of said passageway is connected to the connection line extending from the first connection device, and wherein the second passageway also opens at one end into
  • the connec ⁇ tion line between the first and the second connection devices has coupled therein one or more additional, intermediate, pointed connection devices each having a pointed part for insertion through a respective penetrable closure.-..means of a liquid product container, said pointed part including two separate, generally parallel passageways, both of which open at one end into the pointed end of the connection device and the other ends of which are each connected to a respective connection line extending from a preceding or to a subsequent connection device.
  • a connec ⁇ tion device for mixing together three or more' liquid prod ⁇ ucts, this device including a first, hollow pointed part which is arranged to pierce a penetrable closure means of a liquid product container, wherein the pointed part includes two separate, generally parallel through-penetrating passage ⁇ ways, both of which open at one end into the pointed part, wherein the first passageway is connected to a connection line for supplying a liquid product or product mixture to be mixed with the liquid product in the container, and wherein the second passageway opens at one end into another pointed part which is arranged to pierce a penetrable closure means of a container which contains another product with which the other liquid products are to be mixed to provide a final mixture.
  • the invention also relates to a method of mixing three or more liquid products aseptically, each of said products being contained in separate product containers which are connected to each other series, wherein a product or a product mixture is caused to flow initially from the first container in the series under aseptic conditions to the next following container and there be mixed with a product in said container, until a final mixture of all products has been collected in the last container in the series.
  • 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 for producing an aseptic mixture of three liquid products, ' this system including
  • a container which contains a first liquid product which is enclosed in the container with the aid of a penetrable closure means;
  • a first, pointed connection device which includes a first through-passing passageway which opens at one end into the pointed part of the connection device and is connected with the ambient atmosphere at its other end through the medium of a sterilizing filter, and which also includes a second, through-passing passageway which is generally parallel with the first passageway spaced therefrom, wherein one end of the second passageway opens into the pointed part of the connec ⁇ tion device and the other end is connected to a connection line, wherein the pointed part of the first connection device is inserted through the penetrable closure means of the first container to achieve fluid connection therewith;
  • a second, double-pointed connection device which includes a first through-passing passageway which opens at one end into the first pointed part of the connection device and is connected at its other end to the connection line extending from the first connection device, and also includes a second through-passing passageway which is generally parallel with the first passageway and opens at one end into the first pointed part of the connection device and opens at its other end into the second pointed part of said connection device, wherein the first pointed part is inserted through the penetrable closure means of the second product container to achieve fluid connection therewith; and e) a third product container in which the product is con ⁇ tained at a pressure beneath atmospheric pressure and which includes a penetrable closure means through which the second pointed part of the second connection device is inserted to achieve fluid connection with said product container, wherein the volumetric capacity of the container is sufficient to accommodate the mixture of liquid products.
  • one or more additional, intermediate pointed connection devices is/are coupled in the connection line between the first and the second connection devices, each of these additional connec ⁇ tion devices including two through-passing, generally parallel passageways which open at one end into the pointed part of the connection device, with the other end connected to the connection line, wherein the pointed part of each intermediate connection device is inserted through a penetra ⁇ ble closure means of an additional liquid product container.
  • 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 steril ⁇ izing 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 steriliz ⁇ ing 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 i.s 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 penetra ⁇ ble product container closure means.
  • the protective hoods have not been shown in the drawings, for the sake of clarity.
  • FIG. 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 contain ⁇ ers 52 and 54 respectively.
  • the three containers 52, 54 and 56 are closed by means of penetrable closure means 58, 59 and 60 respectively.
  • These 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 transporta ⁇ tion 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
  • 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 passage ⁇ ways 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 atmo ⁇ spheric 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 subpres ⁇ sure in the container 52 has been equalized. This is impor ⁇ tant 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 steril- ized filter 7 and from there into the product container 52, while displacing part of its content 51 into the 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 acknowledgedl ⁇ ne.
  • 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 connec ⁇ tion 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 contamina ⁇ tion. 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)

Abstract

L'invention concerne un appareil pour le mélange aseptique de trois produits liquides (51, 53, 55) ou plus qui comporte au moins deux dispositifs de raccordement pointus (1, 21, 41) dotés de deux passages d'écoulement traversants (3, 4, 24, 25, 43, 44) et raccordés en série au moyen d'une ligne de raccordement (61). Ces dispositifs de raccordement (1, 21, 41) sont destinés à être insérés dans des moyens de fermeture pénétrables (58, 59, 60) de récipients (52, 54, 56) à produit. Un premier dispositif de raccordement (1) permet de mettre le premier récipient (52) en communication avec le milieu ambiant par l'intermédiaire d'un filtre de stérilisation (7) et de le raccorder au second récipient (54) au moyen de la ligne de raccordement (61). Les récipients à produit sont raccordés successivement entre eux, en ligne, au moyen de dispositifs de raccordement respectifs, jusqu'au dernier récipient (56) dans lequel le mélange final de produits, y compris le produit (55), est recueilli. Le dernier récipient en ligne est sous pression négative, laquelle constitue la force au moyen de laquelle les produits sont acheminés dans le système. L'invention porte également sur un dispositif de raccordement (21) et un système pour le mélange aseptique de trois produits liquides ou plus, ainsi que sur un procédé de mélange de ces derniers. Le procédé et l'appareil selon l'invention sont principalement destinés au mélange de composants liquides d'une préparation destinée à être administrée de manière parentérale.
PCT/SE1995/000178 1994-02-28 1995-02-21 Dispositif et procede de melange aseptique de produits liquides Ceased WO1995022954A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP95911514A EP0750488B1 (fr) 1994-02-28 1995-02-21 Dispositif et procede de melange aseptique de produits liquides
DE69509508T DE69509508T2 (de) 1994-02-28 1995-02-21 Vorrichtung und verfahren zum aseptischen vermischen von flüssigkeiten
PL95316025A PL178101B1 (pl) 1994-02-28 1995-02-21 Zestaw do aseptycznego mieszania cieczy
AU19052/95A AU1905295A (en) 1994-02-28 1995-02-21 A device and a process for aseptic mixing of liquid products

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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
SE9400681-4 1994-02-28

Publications (1)

Publication Number Publication Date
WO1995022954A1 true WO1995022954A1 (fr) 1995-08-31

Family

ID=20393107

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE1995/000178 Ceased WO1995022954A1 (fr) 1994-02-28 1995-02-21 Dispositif et procede de melange aseptique de produits liquides

Country Status (10)

Country Link
EP (1) EP0750488B1 (fr)
CN (1) CN1054279C (fr)
AT (1) ATE179589T1 (fr)
AU (1) AU1905295A (fr)
CA (1) CA2184249A1 (fr)
DE (1) DE69509508T2 (fr)
HU (1) HUT76713A (fr)
PL (1) PL178101B1 (fr)
SE (1) SE9400681L (fr)
WO (1) WO1995022954A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012092564A3 (fr) * 2010-12-30 2012-10-26 Ge Healthcare Limited Distribution à plusieurs flacons

Families Citing this family (4)

* 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
CN101426465B (zh) * 2006-04-24 2013-05-22 诺沃-诺迪斯克保健股份有限公司 由冻干药物生成药物溶液的转移系统
CN101081192B (zh) * 2007-07-03 2011-10-05 王建友 一种输液瓶口装置
AU2018319625B2 (en) * 2017-08-24 2023-02-16 Innatoss Laboratories B.V. Liquid handling system and method

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EP0484751A1 (fr) * 1990-11-06 1992-05-13 Pall Corporation Système de séparation au fond du sac à sang
EP0542221A1 (fr) * 1991-11-11 1993-05-19 Terumo Kabushiki Kaisha Récipient médical et procédé de fabrication

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WO1991015182A1 (fr) * 1990-04-06 1991-10-17 Omega Teknik Hb Sac a sang servant a separer les composants du sang
EP0484751A1 (fr) * 1990-11-06 1992-05-13 Pall Corporation Système de séparation au fond du sac à sang
EP0542221A1 (fr) * 1991-11-11 1993-05-19 Terumo Kabushiki Kaisha Récipient médical et procédé de fabrication

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WO2012092564A3 (fr) * 2010-12-30 2012-10-26 Ge Healthcare Limited Distribution à plusieurs flacons
US9433556B2 (en) 2010-12-30 2016-09-06 Ge Healthcare Limited Multi-vial dispensing

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CN1054279C (zh) 2000-07-12
CA2184249A1 (fr) 1995-08-31
EP0750488B1 (fr) 1999-05-06
DE69509508T2 (de) 1999-09-02
ATE179589T1 (de) 1999-05-15
DE69509508D1 (de) 1999-06-10
AU1905295A (en) 1995-09-11
PL316025A1 (en) 1996-12-23
SE501835C2 (sv) 1995-05-22
HU9602344D0 (en) 1996-10-28
PL178101B1 (pl) 2000-02-29
SE9400681D0 (sv) 1994-02-28
HUT76713A (en) 1997-10-28
CN1123521A (zh) 1996-05-29
SE9400681L (sv) 1995-05-22
EP0750488A1 (fr) 1997-01-02

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