EP3973044A1 - Connecteur stérile destiné au transfert stérile d'un milieu liquide - Google Patents

Connecteur stérile destiné au transfert stérile d'un milieu liquide

Info

Publication number
EP3973044A1
EP3973044A1 EP20732521.8A EP20732521A EP3973044A1 EP 3973044 A1 EP3973044 A1 EP 3973044A1 EP 20732521 A EP20732521 A EP 20732521A EP 3973044 A1 EP3973044 A1 EP 3973044A1
Authority
EP
European Patent Office
Prior art keywords
coupling device
cannula
coupling
sterile
sterile connector
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.)
Pending
Application number
EP20732521.8A
Other languages
German (de)
English (en)
Inventor
Mario Deuse
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.)
Sartorius Stedim Biotech GmbH
Original Assignee
Sartorius Stedim Biotech GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sartorius Stedim Biotech GmbH filed Critical Sartorius Stedim Biotech GmbH
Publication of EP3973044A1 publication Critical patent/EP3973044A1/fr
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M33/00—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus
    • C12M33/04—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus by injection or suction, e.g. using pipettes, syringes, needles
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L29/00—Joints with fluid cut-off means
    • F16L29/005—Joints with fluid cut-off means joints with cut-off devices which can be perforated
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/56—Labware specially adapted for transferring fluids
    • B01L3/563—Joints or fittings ; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/40—Manifolds; Distribution pieces
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/46—Means for fastening
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M33/00—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus
    • C12M33/14—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus with filters, sieves or membranes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M37/00—Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
    • C12M37/04—Seals
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L33/00—Arrangements for connecting hoses to rigid members; Rigid hose connectors, i.e. single members engaging both hoses
    • F16L33/02—Hose-clips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L2201/00—Special arrangements for pipe couplings
    • F16L2201/40—Special arrangements for pipe couplings for special environments
    • F16L2201/44—Special arrangements for pipe couplings for special environments sterile

Definitions

  • the invention relates to a sterile connector for the sterile transfer of a liquid, in particular biological, medium according to the preamble of claim 1, a packaging arrangement with a packaging and at least one first or second coupling device of such a sterile connector or a sterile packaged therein
  • a bioprocess engineering system is understood here quite generally to mean a device with which biotechnological processes can be carried out or supported.
  • Bioreactors in which microorganisms or tissue cells are cultivated under specified conditions are mentioned here merely as examples.
  • Such a device usually has a container in which a biological reaction medium is made up of the substances intended for a biotechnological process, e.g. Microorganisms or tissue cells on the one hand and a corresponding nutrient medium on the other hand, is absorbed in order to be able to carry out the respective biotechnological process step, for example fermentation or cultivation.
  • a bioreactor is on the one hand a production bioreactor, ie a relatively large bioreactor in the production maize stick with a working volume of, for example, several 100 or several 1000 liters, for the industrial production of microbial or cellular products, in particular biopharmaceuticals.
  • a bioreactor forms a fermentation broth as a product, which is usually further treated in a so-called downstream process in order to obtain a product from the cells or the culture supernatant.
  • a laboratory bioreactor that is to say a relatively small bioreactor on a laboratory scale with a working volume of, for example, less than 10 liters.
  • Such a laboratory bioreactor is used, for example, to produce Provision of ATMPs (Advanced Therapy Medical Products) and / or the implementation of a cell expansion through which a sufficient number of cells, in particular tissue cells or microbial cells, can be generated for the respective application.
  • ATMPs Advanced Therapy Medical Products
  • a cell expansion through which a sufficient number of cells, in particular tissue cells or microbial cells, can be generated for the respective application.
  • One application for this is the multiplication of human cells, for example T cells (T lymphocytes), which are taken from the patient, then expanded ex vivo and then reinfused into the patient
  • the sterile addition of the individual liquid, for example biological, media to the respective bioreactor is particularly important. Since many ATMPs cannot be filtered sterile or finally sterilized, such drugs are produced in a sterile manner in clean rooms of the corresponding clean room classes. For example, the addition of a liquid medium to a bioreactor or the transfer of a liquid medium between two culture vessels and / or bioreactors generally involve the risk of contamination, which is why such handling steps are usually carried out in a clean room of clean room class A (GMP guidelines Annex 1) or ISO 5 (ISO 14644-1). The manufacture of pharmaceuticals in such clean rooms is very cost-intensive due to the high monitoring requirements, complex clothing procedures, etc.
  • the invention is based on the problem of designing and developing a sterile connector for the sterile transfer of a liquid medium from a liquid container into a fluid chamber, for example of a bioprocess engineering system, in such a way that sterile conditions can be easily established during the transfer of the medium .
  • the fundamental consideration is to create a sterile connector with two coupling devices to be connected to one another for the transfer of liquid from a liquid container, which is, for example, a minimum-quantity liquid container, into a fluid chamber, in which the coupling devices are initially provided in a state in which contamination by the user of the parts which are decisive for the transfer of liquid is not easily possible, since in this state they are covered in the coupling device and thus protected from contact.
  • the fluid chamber into which the liquid medium is filled from the liquid container via the sterile connector, can be formed by a bioprocess engineering system, in particular by a bioreactor. In principle, however, it is also conceivable that the fluid chamber forms part of the second coupling device, that is to say the coupling device facing away from the liquid container.
  • the fluid chamber is preferably closed with the exception of a fluid passage through which the liquid medium is introduced into the fluid chamber.
  • the fluid chamber can, however, also open into a further fluid outlet which is fluidly connected or can be connected to a bioprocess engineering system, in particular a bioreactor.
  • a first septum is arranged which axially covers and / or closes the fluid passage in this coupling device and thus also protects it from contamination.
  • the first septum is pierced by the first cannula in an activation process which creates a fluid connection through the entire sterile connector, whereby the liquid medium can then pass through the fluid passage via the first cannula.
  • a second septum In order to be able to come into contact with the first septum, access must first be established through a second septum, which is done automatically by a coupling process in which the two coupling devices are connected to one another as intended.
  • a second, preferably sterile, cannula in and / or into which the first cannula can be moved, penetrates said second septum.
  • the second cannula can still be arranged in a sealing sleeve, which is also pierced by the second septum when it is pierced.
  • the first cannula can now be guided through the second cannula to the first septum and then pierce it.
  • the first cannula can still be arranged in a sealing sleeve which is also pierced by the first septum when it is pierced.
  • the cannulas provided are preferably made of metal for optimal penetration of the respective septum, but can in principle also be made of a plastic material. Particularly preferably, the cannulas are pointed at their end facing the respective septum, but can in principle also be blunt.
  • the first septum cannot be contaminated up to this point in time, since in the initial state of the sterile connector, that is, before the coupling process is carried out, it is arranged in a preferably sterile area protected from contamination.
  • the fluid passage in the second coupling device is also sterile and protected from contamination up to the point in time when the first cannula pierces the first septum. This ensures that no Germs or other media can get into the liquid medium during transfer.
  • the liquid container from which the medium is to be dispensed and / or a bioprocessing system into which the medium is to be added are sterile connected to the respectively assigned coupling device.
  • bioprocess engineering system in which it is also conceivable that the manufacturer of the system already provides this with the assigned second coupling device of the sterile connector, possibly with several such coupling devices, whereby the bioprocessing system and the second coupling device can be made available to the user in the intended interconnected state, in particular as single-use components.
  • the two coupling devices of the sterile connector cannot be contaminated at any point relevant for the liquid transfer before the connection is established, as in the area in which the medium passes from the liquid container into the first coupling device connected to it a sterile connection already exists in the area in which the medium reaches the bioprocess engineering system from the further, second coupling device.
  • the sections or elements of the coupling devices via which the liquid medium reaches the respective other coupling device as intended from the coupling device assigned to the liquid container are also protected from contamination until the time of the liquid transfer.
  • the fluid chamber does not necessarily have to be part of a bioprocess engineering system, but can also be part of the second coupling device and in particular be closed with the exception of the fluid passage through which the liquid medium enters the fluid chamber can.
  • the first coupling device has a fluid inlet and a fluid outlet which is in fluid connection therewith, the first coupling device having a first, preferably sterile, cannula which has an end facing away from the fluid inlet, which the flow idauslass that the second coupling device has a fluid passage which is axially covered by a first septum in an initial state of the sterile connector, that in the initial state of the sterile connector the fluid outlet formed by the first cannula is hermetically hermetic to the surroundings of the first coupling device sealed, in particular sterile, area of the first coupling device is arranged and the surface of the first septum facing away axially from the fluid passage is arranged in a hermetically sealed, in particular sterile
  • hermetically sealed or “hermetically sealed” means that a tightness is provided that prevents the ingress of impurities, in particular germs.
  • hermetically tight or “hermetically sealed” refers to a sterile and / or contamination-protected area of the sterile connector.
  • the terms “hermetically” include tight ”or“ hermetically sealed ”also use the term“ sterile ”and are thus interchangeable.
  • Claims 2 and 3 define the fluid technology connection process in which a fluid connection is established between the fluid inlet of the first coupling device and the fluid passage of the second coupling device becomes.
  • the fluid-technical connection process comprises on the one hand a coupling process in which the first coupling device is mechanically connected to the second coupling device (claim 2), and on the other hand an activation process in which the first coupling device moves from an initial position to an operating position relative to the second coupling device is stiffened (claim 3).
  • the adjustment preferably comprises a linear relative movement and possibly also a rotary relative movement of the two coupling devices to one another.
  • the coupling process serves, in particular, exclusively to establish a mechanical connection, whereas the activation process, in particular, serves exclusively to establish a fluid-technical connection.
  • Claims 4 to 10 relate to the coupling process and describe preferred configurations and mechanisms of action of the elements of the sterile connector that interact in the context of the coupling process.
  • the area of the second coupling device, which is hermetically sealed in the initial state is delimited by the first septum and a second septum ( Claim 4), a second, preferably sterile, cannula of the first coupling device (claim 5) can then provide access for the first cannula into the hermetically sealed area of the second coupling device through the coupling process.
  • the second cannula is particularly preferably surrounded by a first sealing sleeve, in particular in the form of a bellows, which pierces the second cannula during the coupling process (claim 8), in particular immediately before the piercing second septum.
  • the movement that causes the second cannula to pierce the second septum and in particular the first sealing sleeve can be transmitted to the second cannula by a cannula holder that is axially movably mounted in the first coupling device (claim 9).
  • Claims 11 to 14 relate to the activation process and describe preferred configurations and mechanisms of action of the elements of the sterile connector that cooperate in the context of the activation process.
  • the first coupling device preferably has a second sealing sleeve which in any case surrounds the section of the first cannula that is used during the activation process first septum pierces (claim 11)
  • the second sealing sleeve is preferably arranged together with the first cannula inside the second cannula, the second cannula being able to be axially displaced relative to the first cannula and the second sealing sleeve during the coupling process, see above that the front end of the first cannula and the second sealing sleeve protrude axially from the second cannula, but this is preferably only after the second cannula has pierced the second septum.
  • an axial cannula section of the first cannula which in particular comprises the front cannula end or the fluid outlet, can pierce the second sealing sleeve (claim 12), the first cannula then preferably immediately afterwards piercing the first septum
  • at least one actuating element can be provided on the cannula holder (claim 13), via which the cannula holder and correspondingly the second cannula together with the mechanically connected second coupling device can be displaced linearly and in particular rotationally.
  • Claim 15 relates to a fluid chamber of the second coupling device into which the fluid passage of the second coupling device opens.
  • This fluid chamber can be in fluid connection with a fluid outlet of the second coupling device or else be closed. “Otherwise closed” means that the fluid chamber, with the exception of the fluid passage, has no further opening and to that extent forms a further liquid container. Storage and / or mixing of liquid media can then also take place in such a liquid container, as in a bioprocess engineering system.
  • the fluid chamber of the second coupling device is preferably only one component through which the liquid medium that flows via the first coupling device from the fluid container connected to it through the fluid passage of the second coupling device is passed, in particular to a bioprocess engineering system, for example a bio - reactor.
  • Claims 16 to 25 relate to the fluid-technical connection process of a further embodiment of a sterile connector and describe preferred configurations and mechanisms of action of the elements of the sterile connector that interact in the context of the coupling process and the activation process.
  • the adjustment during the activation process here also includes a linear relative movement, In contrast to the previously described embodiment, however, there is preferably no rotational relative movement between the two coupling devices (claim 16).
  • the area of the second coupling device which is hermetically sealed in the initial state, is particularly preferably delimited by the first septum and a first sealing sleeve, in particular in the form of a bellows (claim 17).
  • the cannula of the second coupling device (claim 18) can then provide access for the first cannula to the first septum through the coupling process (claim 20).
  • an axial cannula section of the second cannula which pierces the second septum during the coupling process, surrounded by the first sealing sleeve in the initial state (claim 21), in particular immediately before the second septum is pierced.
  • a mechanism for displaying, in particular haptic display, at least one defined axial position of the first coupling device relative to the second coupling device is provided in the further embodiment.
  • a defined axial position corresponds in particular to the initial position in the coupled state and / or a defined axial position corresponds to the operating position in the coupled state, that is to say the state after the activation process has been completed.
  • a packaging arrangement with a packaging and with at least one, preferably exactly one, first or second coupling device of a proposed sterile connector or a In view of the fact that the proposed packaging arrangement has a proposed sterile connector or a coupling device of a proposed sterile connector, reference may be made to all relevant statements on the first-mentioned teaching.
  • either a liquid container or a bioprocessing system can be packaged sterile in the packaging, the liquid container or the bioprocessing system already being fluidically coupled to the respective coupling device in the packaging.
  • a sterile packed, proposed sterile connector a sterile packed coupling device of a proposed sterile connector and / or a proposed packaging arrangement for the sterile transfer of a liquid, in particular biological medium from a liquid container into a fluid chamber, preferably a bioprocess engineering system, in particular a bioreactor, or into a fluid chamber of the second coupling device.
  • a liquid, in particular biological medium from a liquid container into a fluid chamber, preferably a bioprocess engineering system, in particular a bioreactor, or into a fluid chamber of the second coupling device.
  • a liquid medium is particularly easy without any significant risk Contamination can be fed to a closed system, in particular a bioreactor, in that the coupling devices keep the parts relevant for the liquid transfer, in particular the said first cannula and the fluid passage, in a sterile state for a long time, namely in the coupling state in said initial position, until the fluid transfer, namely in the The operating position set by the activation process actually took place.
  • some of the named components are preferably designed as single-use components, the components preferably being made from a plastic material.
  • FIG. 1 shows a perspective view of a proposed sterile connector according to a first embodiment when connecting its two coupling devices
  • FIG. 2 is a perspective view of the proposed sterile connector according to FIG. 1 with its two coupling devices in an exploded view
  • FIG. 3 shows a perspective view of the two coupling devices of the sterile connector according to FIG. 1 a) in the initial state before a coupling process, b) in the coupling state after the coupling process before an activation process and c) in the coupling state after the activation process,
  • FIG. 4 shows a sectional view of the two coupling devices of the sterile connector according to FIG. 1 a) in the initial state before a coupling process, b) in the coupling state after the coupling process before an activation process and c) in the coupling state after the activation process,
  • Plant » 6 shows a perspective view of a proposed sterile connector according to a second embodiment when connecting its two coupling devices
  • FIG. 7 is a perspective view of the proposed sterile connector according to FIG. 6 with its two coupling devices in an exploded view
  • FIG. 8 shows a perspective view of the two coupling devices of the sterile connector according to FIG. 6 a) in the initial state before a coupling process, b) in the coupling state after the coupling process before an activation process and c) in the coupling state after the activation process,
  • FIG. 9 shows a sectional view of the two coupling devices of the sterile connector according to FIG. 6 a) in the initial state before a coupling process, b) in the coupling state after the coupling process before an activation process and c) in the coupling state after the activation process,
  • FIG. 10 shows a perspective view of a proposed packaging arrangement with the first coupling device of the proposed sterile connector according to FIG. 6 and a liquid container connected to it, and a proposed packaging arrangement with the second coupling device of the proposed sterile connector according to FIG. 6 and a bioprocess technology connected to it Investment.
  • the proposed sterile connector 1 shown in FIGS. 1 to 5 according to the first embodiment and the proposed sterile connector 1 shown in FIGS. 6 to 10 according to the second embodiment. each serves for the sterile transfer of a liquid, in particular biological, medium from a liquid container 2, here a low-volume liquid container, that is to say a liquid container with a small holding volume of, for example, a maximum of 30 ml, into a fluid chamber 3, which here and preferably is formed by a bioprocess engineering system 4, here a bioreactor.
  • the proposed sterile connector 1 has a first and a second coupling device 5, 6, which can be connected to one another mechanically and fluidically, and of which the first coupling device 5 the liquid container 2 and the second coupling device 6 is assigned to the bioprocess engineering system 4.
  • “Assigned” means that the first coupling device 5 is connectable or connected to the liquid container 2 and the second coupling device 6 is connectable or connected to the bioprocess engineering system 4 is. It is particularly preferred that the manufacturer, namely in the sterile state, connect the liquid container 2 to the first coupling device 5 assigned to it and the bioprocessing system 4 to the second coupling device 6 assigned to it.
  • the bioprocess engineering system 4 in particular the bioreactor, here forms a closed system or is integrated into a closed system.
  • the bioreactor is designed, for example, as a laboratory bioreactor, that is to say as a bioreactor which, in contrast to a production bioreactor, has a relatively small working volume (maximum available filling volume) of a maximum of 10 liters.
  • a bioreactor is used to carry out a biotechnological process which, here and preferably, is used to manufacture a drug for novel therapies (ATMP).
  • the biotechnological process can also be a cell expansion process for T cells.
  • a biological reaction medium is provided in the bioreactor, which in particular has tissue cells or microbial cells and a nutrient medium.
  • the first coupling device 5 has a fluid inlet 7 and a fluid outlet 8 that is fluidly connected to it, the first coupling device 5 having a first, preferably sterile, cannula 9, which has an end facing away from the fluid inlet 7, that the fluid outlet 8 forms that the second coupling device 6 is a, preferably sterile, fluid passage 10 autoeist, which is covered in an initial state of the sterile connector 1 by a first septum 11 axially forwards, i.e.
  • the fluid outlet 8 formed by the first cannula 9 is arranged in an area of the first coupling device 5 that is hermetically sealed against the surroundings of the first coupling device 5, in particular sterile, and the surface 11a of the first septum 11 facing away from the fluid passage 10 is nem area of the second coupling device 8 that is hermetically sealed off from the surroundings of the second coupling device 6, in particular sterile, and that, starting from the initial state of the sterile connector 1, a fluid connection between the fluid inlet 7 of the first coupling device 5 and the The fluid passage 10 of the second coupling device 8 can be produced in that the end of the first cannula 9 forming the fluid outlet 8 penetrates the first septum 11 of the second coupling device 6.
  • a “septum”, also referred to as a puncture membrane, generally means a membrane separating two space sections from one another. This generally has the effect that any adhesions on the outside of a cannula are stripped off when the septum is pierced.
  • This is preferably made from a plastic material, more preferably from an elastomer, in particular silicone material.
  • Such a septum can have any shape.
  • a septum such as the first septum 11 here, can be disk-shaped or, as the second septum 12 described below, pot-shaped.
  • first septum 11 and a second septum 12 can each have a different or the same design (disk-shaped, pot-shaped), with preferably only one septum 11, 12, in particular the The second septum 12, or alternatively (not shown here) both the first and the second septum 11, 12 is cup-shaped.
  • “Cup-shaped” means that a space section is delimited by radial winds and an axial wall.
  • axial and radial as well as the term “in the circumferential direction” are here always related to a sterile connector longitudinal axis X, along which the two coupling devices 5, 6 extend as intended during the transfer of the liquid medium.
  • the first cannula 9 of the first coupling device 5 is arranged such that the liquid medium can flow from the fluid inlet 7 via the first, preferably sterile, cannula 9 to the fluid outlet 8.
  • the first cannula 9, which is preferably made of metal, in particular stainless steel, is directly connected to this the fluid inlet 7 in fluid connection.
  • the fluid inlet 7 is formed by a housing part 13a, here a cap-shaped housing part 13a, of the first coupling device 5, which is preferably made of a thermoplastic, in particular PE (polyethylene).
  • PE polyethylene
  • the housing part 13a is here firmly and / or non-positively fixed to a housing part 13b of the first coupling device 5, in particular plugged onto the housing part 13b, which is preferably made of a thermoplastic, in particular PC (polycarbonate).
  • the housing part 13b is designed here and preferably essentially cylindrical with a cylinder axis coaxial with the sterile connector longitudinal axis X.
  • the second coupling device 6 also has two housing parts 14a, 14b, which are preferably made of a thermoplastic, in particular PC (polycarbonate), of which the housing part 14a is here and preferably also essentially cylindrical with a sterile connector.
  • Longitudinal axis X is designed coaxial cylinder axis.
  • the first septum 11 and the second septum 12 described below are arranged in the first housing part 14a, the first septum 11 covering the, preferably sterile, fluid passage 10 and thus also the, preferably sterile, outlet channel 16 axially forward and thereby the fluid passage 10 here and preferably hermetically closes.
  • “Axially forward” means in the direction from which the first coupling device 5 is fed during the connection process, that is, the direction towards the first coupling device 5.
  • the first septum 11 ensures the sterility of the fluid passage 10 until it is pierced, as will be described below, by protecting the fluid passage 10 from contact by the user or other parts.
  • the other housing part 14b forms a fluid chamber 3 'which, in particular along the sterile connector longitudinal axis X, extends from the fluid passage 10 of the second coupling device 6 to a fluid outlet 15 of the second coupling device. l device 6 extends.
  • the fluid passage 10 thus opens into a fluid chamber 3 'of the second coupling device 6, which has a fluid outlet 15 that is in fluid connection with the fluid passage 10 and, in this respect, an outlet channel! 16 forms.
  • the fluid chamber 3 ' can also, with the exception of the fluid passage 10, otherwise be closed, that is to say form a further liquid container.
  • the second housing part 14b of the second coupling device 6 is connected to the first housing part 14a of the second coupling device 6, in particular in an axially and rotationally fixed manner, and is preferably designed in one piece.
  • the front end of the first cannula 9, which was previously arranged in the hermetically sealed, in particular sterile, area of the first coupling device 5 and which forms the fluid outlet 8 is also included brought into contact with the first septum 11 previously arranged in the hermetically sealed, in particular sterile, region of the second coupling device 6, the front end of the first cannula 9 then penetrating the first septum 11 and thus the fluid outlet 8 to create a fluid connection the first septum 1 1 penetrates.
  • the fluid-technical connection process comprises on the one hand a coupling process and on the other hand an activation process, which are described in more detail below.
  • the coupling process is shown in Figures 3a) and 4a).
  • the first coupling device 5 is mechanically connected to the second coupling device 6, which is shown in FIGS. 3 a) by an arrow.
  • the second coupling device 6 is here and preferably plugged into the first coupling device 5.
  • the housing part 14a of the second coupling device 6 has a smaller cross section than the housing part 13b of the first coupling device 5 into which the housing part 14a is inserted.
  • the coupling process comprises in particular a linear movement, here and preferably exclusively a linear movement, of the first coupling device 5 relative to the second coupling device 6, specifically along the sterile connector longitudinal axis X.
  • a linear movement here and preferably exclusively a linear movement
  • another movement or a combination of movements for example a combined linear and rotary movement, in particular a screwing movement, of the first coupling device 5 relative to the second coupling device 6 is conceivable in order to carry out the coupling process.
  • the coupling process is followed by an activation process, which is shown in FIGS. 3b) and c) on the one hand and 4b) and c) on the other hand.
  • the first coupling device 5 is moved from an initial position relative to the second coupling device 6 (FIG. 3b). and 4b)) into an operating position (Fig. 3c) and 4c)), which is shown in Fig. 3b) and c) by arrows.
  • This takes place in the coupling state, here when the second coupling device 6 is plugged into the first coupling device 5.
  • the activation process here and preferably initially comprises a rotary movement of the first coupling device 5 relative to the second coupling device 6, namely in the circumferential direction around the longitudinal axis X of the sterile connector.
  • the rotary movement serves to adjust the coupling devices 5, 6 relative to one another from the initial position into which the coupling devices 5, 6 have been brought by the coupling process, in particular the linear movement of the coupling process, into an intermediate position, which is shown in FIG. 3b).
  • c) is shown in dashed lines.
  • the activation process here also includes a linear movement of the first coupling device 5 relative to the second coupling device 6, specifically also along the sterile connector longitudinal axis X.
  • the linear movement which Here the rotary movement is in particular downstream, is used to adjust the coupling devices 5, 6 relative to one another from the intermediate position into the operating position.
  • the latter movement i.e. the linear movement movement, causes the first septum 11 to pierce through the first cannula 9.
  • the hermetically sealed, preferably sterile, area of the second coupling device 8 is in particular at least partially, here and preferably completely, delimited by the first septum 11 and the second septum 12.
  • the hermetically sealed area of the second coupling device 6 is not only limited by the first septum 11 and the second septum 12, but also by a wall section of the second coupling device 8 and in particular a wall section of the housing part 14a becomes. It is only essential that the first septum 11 and the second septum 12 hermetically seal the space section formed between them.
  • the second septum 12 protects the first septum 11 from contact by the user or other parts, it ensures the sterility of the first septum 11 until the coupling process and in particular until the second septum 12, as will be described below, penetrates becomes.
  • the coupling process in particular the linear movement of the coupling process, provides access for the first cannula 9 through the second septum 12 into the preferably sterile area of the second, which is hermetically sealed in the initial state
  • Coupling device 8 is formed and / or the end of the first, preferably sterile, canute 9 forming the fluid outlet 8 protrudes axially into the area of the second coupling device 6, which is hermetically sealed in the initial state.
  • the first coupling device 5 has here and preferably one second, preferably sterile cannula 17 which is arranged coaxially to the first cannula 9 and through which the first cannula 9 can be moved.
  • the second cannula 17, which is preferably made of metal, in particular brass, has a larger cross section for this purpose than the first cannula 9.
  • the first cannula 9 can be moved so far through the second cannula 17 during the activation process that the cannula end of the first cannula 9 which forms the fluid outlet 8 protrudes from the second cannula 17 and the first septum 11 can touch and pierce.
  • first cannula 9 is axially displaced relative to the second cannula 17, but this is not, at least not necessarily, a movement of the first cannula 9 within the housing parts 13a, 13b, but rather is effected by a linear movement of the second cannula 17 within the housing part 13b along the sterile connector longitudinal axis X.
  • second cannula 17 is actively movable within the first coupling device 6, but not the first cable. nule 9.
  • an axial cannula section of the second cannula 17 now penetrates the second septum 12 and thereby provides access for the first cannula 9 to the preferably sterile area of the second coupling device 6, which is hermetically sealed in the initial state and / or provides access for the first cannula 9 to the first septum 11. It is provided here that the first cannula 9 and the second septum 12 do not touch each other before, during and / or after the coupling process. A contamination of the first cannula 9 by the second septum 12 can thus be ruled out.
  • the first coupling device 5 has at least one sealing sleeve.
  • a first sealing sleeve 18, here and preferably in the form of a bellows is provided, which surrounds the axial cannula section of the second cannula 17, which penetrates the second septum 12 during the coupling process, radially and at the front end in the initial state.
  • the first sealing sleeve 18 or here the bellows is, as Fig.
  • the first sealing sleeve 18 is preferably made of a silicone material
  • the first sealing sleeve 18 is here and preferably fixed to a cannula holder 19 for the second cannula 17, which will be described in more detail below.
  • the first sealing sleeve 18 is hermetically sealed to the cannula holder 19.
  • the first sealing sleeve 18 is attached to an axial cannula section of the second cannula 17 and / or to a Wall section of the first coupling device, in particular of the housing part 13b, lies hermetically tight and / or is fixed.
  • the first sealing sleeve 18 ensures the sterility of the axial cannula section of the second cannula 17 until it penetrates the second septum 12 by protecting the second cannula 17 from contact by the user or other parts.
  • the second cannula 17 penetrates the first sealing sleeve 18 preferably only during the coupling process when the first sealing sleeve 18 comes to rest axially on the second septum 12.
  • the second cannula 17 preferably penetrates the second septum 12 immediately after the first sealing sleeve 18 has been pierced and then pierces it completely.
  • the axial cannula section of the second cannula 17 penetrates the first sealing sleeve 18, it is preferably the case that the first Cannula 9 and the first sealing sleeve 18 do not touch each other before, during and / or after the coupling process. In this way, contamination of the first cannula 9 by the first sealing sleeve 18 is also excluded.
  • the second cannula 17 is, as stated, in the exemplary embodiment shown here and in this respect preferred, fixed to a cannula holder 19 which is preferably made of a thermoplastic, in particular PC (polycarbonate).
  • the cannula holder 19 is mounted in the first coupling device 5 in an axially movable manner.
  • the second coupling device now comes device 6, in particular the housing part 14a, on the cannula holder 19 axially to the contact. It is particularly preferred here that the second coupling device 6 or the housing part 14a is axially and / or radially positively or non-positively connected to the cannula holder 19 through the coupling process.
  • the second coupling device 6 or the housing part 14a is latched onto the cannula holder 19.
  • an axial and / or radial displacement of the cannula holder 19 in the first coupling device 5 or relative to the housing part 13b causes the relative movement of the first cannula 9 within the second cannula 17 and ultimately the piercing of the first septum 11 by the first cannula 9 in the activation process
  • a guide device 20 is also provided here and preferably. During the coupling process, this causes the first coupling device 5 to be axially guided relative to the second coupling device 6.
  • a projection or axially extending web 21 and / or an axially extending groove and a corresponding counterpart 22 can be provided on a wall section of the second coupling device 6, in particular on the housing part 14a, preferably on the outside.
  • the counterpart 22 is for example an axially extending groove corresponding to the projection or axially extending web 21 of the first coupling device 5 or a projection or axially extending web corresponding to the axially extending groove of the first coupling device 5.
  • the projection or web 21 or the groove of the first coupling device 5 and the corresponding counterpart 22 of the second coupling device 6 then together form the guide device 20.
  • two such guide devices 20 are opposite on the radial sides of the sterile connector 1 intended.
  • the respective guide device 20 here also specifies the angular position or the angular positions in the circumferential direction in which the first coupling device 5 is to be connected to the second coupling device 6 for the coupling process, in particular is to be plugged together .
  • two guide devices 20 opposite to the radial Sides of the sterile connector 1 are provided which are arranged here at an angular distance of 180 degrees from one another in relation to the circumferential direction, the first coupling device 5 can be connected to the second coupling device 6 in two different angular positions.
  • the first coupling device 5 here also has a second sealing sleeve 23, in particular in the form of a tube closed at one end, which has an axial cannula section of the first cannula 9 that encompasses the fluid outlet 8, which penetrates the first septum 11 during the activation process, surrounds it radially in the initial state and at the front end which forms the fluid outlet 8.
  • the second sealing sleeve 23 is preferably made from a silicone material.
  • the second sealing sleeve 23 surrounds the first cannula 9 here and preferably even over the major part of its length or essentially its entire length.
  • the second sealing sleeve 23 is axially closed on the side facing the second coupling device 8 during the coupling process, but is open on the side facing the fluid inlet 7. With the closed side, the first cannula 9 then penetrates the second sealing sleeve 23 in the activation process, before the first cannula 9 penetrates the first septum 11.
  • the second sealing sleeve 23 rests here and preferably also on the inside of the second cannula 17, whereby the hermetically sealed area, which is enclosed by the first sealing sleeve 18, is also hermetically sealed through the second cannula 17.
  • the second sealing sleeve 23 is fixed here and preferably on the housing part 13a.
  • the second sealing sleeve 23 is hermetically sealed to the housing part 13a.
  • the second sealing sleeve 23 rests hermetically and / or is fixed on an axial cannula section of the first cannula 9 and / or on the housing part 13b.
  • This second sealing sleeve 23 ensures the sterility of the axial cannula section of the first cannula 9 encompassing the fluid outlet 8 until the first cannula 9 penetrates the first septum 11 by protecting the first cannula 9 from contact by the user or other parts.
  • the first cannula 9 preferably only penetrates the second sealing sleeve 23 when it is axially in contact with the first septum 11.
  • the first cannula 9 then penetrates the septum 11, preferably immediately after the second sealing sleeve 23 has been pierced.
  • an actuating element 24 for manual actuation of the cannula holder 19 is provided here and preferably on the cannula holder 19.
  • the cannula holder 19, together with the second cannula 17 and the second coupling device 6, can be displaced linearly and here also rotationally relative to the first coupling device 5 during the activation process.
  • two such actuating elements 24 are provided opposite one another on the radial sides of the sterile connector 1 or the first coupling device 5 or the cannula holder 19.
  • the actuating element 24 extends radially outward from the cannula holder 19 through a guide opening 25 which is provided in a wall section of the first coupling device 5, in particular in the housing part 13b.
  • the actuating element 24 is here and preferably in the guide opening 25 in the activation process axially and here also rotationally displaceable.
  • the actuating element 24 can be displaced here in the guide opening 25 during the activation process, first in the circumferential direction (FIGS. 3b) and 4b)) and then axially (FIGS. 3c) and 4c)).
  • the displacement movement of the actuating element 24 in the guide opening 25, shown by an arrow in FIGS. 3b) and c), is here and preferably limited by the edge of the guide opening 25 so that the user always receives feedback that tells him the current position of the coupling devices 5, 6 indicates relative to one another
  • the dashed illustration of the actuating element 24 shows an intermediate position into which the actuating element 24 is shifted in reverse. is brought catch direction and out of which the actuator 24 is then linearly displaced.
  • the respective end positions of the actuating element 24 in the guide opening 25 are shown with a solid line, a first end position being shown in FIG. 3b) which correlates to the starting position of the two coupling devices 5, 8, and FIG ) a second end position is shown, which correlates to the operating position of the two coupling devices 5, 8.
  • the coupling devices 5, 6 are shown in the disconnected state for reasons of clarity.
  • the fluid inlet 7 of the first coupling device 5 and the fluid outlet 15 of the second coupling device 8 can be or are connected to a hose 26 or tube, in particular via a plug connection, such as this is shown in FIG.
  • the fluid inlet 7 of the first coupling device 5 is coupled to the fluid container 2 via a hose 26 or a tube.
  • the fluid outlet 15 of the second coupling device 6 can be connected to the fluid chamber 3 of the bioprocess engineering via a hose 26 or a small tube Plant 4, in particular the bioreactor, be fluidically coupled.
  • the first cannula 9 of the first coupling device 5 is arranged such that the liquid medium can flow from the fluid inlet 7 via the first cannula 9 to the fluid outlet 8.
  • the first cannula 9 is directly in fluid connection with the fluid inlet 7 for this purpose.
  • the fluid inlet 7 is in this case from a housing part 13a, here a cap-shaped housing part 13a, of the first coupling device 5 formed.
  • the fluid inlet 7 is arranged here centrally in the housing part 13a and / or coaxially to the longitudinal axis X of the sterile connector.
  • the housing part 13a is here fixed to a housing part 13b of the first coupling device 5 in a materially and / or non-positively locking manner, in particular being plugged onto the housing part 13b.
  • the housing part 13b is designed here and preferably essentially cylindrical with a cylindrical axis coaxial with the sterile connector longitudinal axis X.
  • the second coupling device 6 also has two housing parts 14a, 14b, of which the housing part 14a is designed here and preferably likewise essentially cylindrical with a cylinder axis coaxial with the sterile connector longitudinal axis X.
  • the first septum 11 and a first die cover 18, which will be described below, are arranged, the first septum 11 covering the fluid passage 10 and thus also the outlet channel 16 axially towards the front and thereby preferably hermetically sealing the fluid passage 10 here .
  • “Axially forward” means in the direction from which the first coupling device 5 is fed during the connection process, that is to say the direction towards the first coupling device 5.
  • the first septum 11 ensures the sterility of the fluid passage 10 until it is pierced, as will be described below, by protecting the fluid passage 10 from contact by the user or other parts.
  • the other housing part 14b forms a fluid chamber 3 ′, which extends, in particular along the sterile connector longitudinal axis X, from the fluid passage 10 of the second coupling device 6 to a fluid outlet 15 of the second coupling device 6.
  • the fluid passage 10 thus opens into a fluid chamber 3 ′ of the second coupling device 6, which has a fluid outlet 15 in fluid connection with the fluid passage 10 and to that extent forms an outlet channel 16.
  • the fluid chamber 3 ' can also, with the exception of the fluid passage 10, otherwise be closed, that is to say form a further liquid container. the.
  • the second housing part 14b of the second coupling device 6 is connected to the first housing part 14a of the second coupling device 6, in particular in an axially and rotationally fixed manner, and is preferably designed in one piece.
  • the front end of the first cannula 9, which was previously arranged in the hermetically sealed, in particular sterile, area of the first coupling device 5 and which forms the fluid outlet 8 is also included brought into contact with the first septum 11 previously arranged in the hermetically sealed, in particular sterile, area of the second coupling device 6, the front end of the first cannula 9 then penetrating the first septum 11 and thus the fluid outlet to create a fluid connection 8 penetrates the first septum 11.
  • the fluid-technical connection process comprises on the one hand a coupling process and on the other hand an activation process, which are described in more detail below.
  • the coupling process is shown in Figures 8a) and 9a).
  • the first coupling device 5 is mechanically connected to the second coupling device 6, which is shown in FIG. 8a) by an arrow.
  • the second coupling device 6 is here and preferably plugged into the first coupling device 5.
  • the housing part 14a of the second coupling device 6 has a smaller cross-section than the housing part 13b of the first coupling device 5 into which the housing part 14a is inserted.
  • the second coupling device 6 can also be plugged onto the first coupling device 5, in which case the housing part 14a of the second coupling device 6 in particular has a larger cross section than the housing part 13b of the first coupling device 5 , onto which the housing part 14a is pushed.
  • the coupling process includes, in particular, a linear movement, here and preferably exclusively a linear movement, of the first coupling device 5 relative to the second coupling device 6, specifically along the sterile connector longitudinal axis X.
  • a linear movement here and preferably exclusively a linear movement
  • a Another movement or a combination of movements for example a combined linear and rotary movement, in particular a screwing movement, of the first coupling device 5 relative to the second coupling device 6 is conceivable in order to carry out the coupling process.
  • the coupling process is followed by an activation process, which is shown in FIGS. 8b) and c) on the one hand and 9b) and c) on the other hand.
  • the first coupling device 5 is moved relative to the second coupling device 6 from an initial position ⁇ Fig. 8b) and 9b)) into an operating position (FIGS. 8c) and 9c)), which is shown in FIG. 8b) by an arrow.
  • This takes place in the coupling state, in this case when the second coupling device 6 is plugged into the first coupling device 5.
  • the front end of the first cannula 9 of the first coupling device 5, which forms the fluid outlet 8 penetrates the first septum 11 of the second coupling device 6.
  • the activation process comprises in particular a linear movement, here exclusively a linear movement, of the first coupling device 5 relative to the second coupling device 6, namely parallel to the sterile connector longitudinal axis X and in particular coaxial to the linear movement
  • the linear movement is used here to adjust the coupling devices 5, 6 relative to each other from the initial position into which the coupling devices 5, 6 have been brought by the coupling process, in particular the linear movement of the coupling process, into the operating position.
  • This movement causes the first septum 11 to penetrate through the first cannula 9.
  • the hermetically sealed, preferably sterile, area of the second coupling device 6 is in particular at least partially, here and preferably completely, of the first septum 11 and the first sealing sleeve 18, which here has the shape of a bellows.
  • the first sealing sleeve 18 protects the first septum 11 and a second cannula 17, which will be explained below, in which the first septum 11 is arranged, in particular axially fixed, from contact by the user or other parts, the first ensures Sealing sleeve 18 the sterility of the first septum 11 and the second cannula 17 until the coupling process.
  • FIG. 9b shows, an access for the first, preferably sterile, cannula 9 into the area of the second coupling device 6, which is hermetically sealed in the initial state, is formed and / or the end of the first cannula 9 forming the fluid outlet 8 protrudes axially into the area of the second coupling device 6, which is hermetically sealed in the initial state.
  • the second coupling device 6 has here and preferably the already mentioned second, preferably sterile, cannula 17, into which the first cannula 9 can be moved during the coupling process and which is then arranged coaxially to the first cannula 9 in the coupled state.
  • the second cannula 17 has a larger cross-section than the first cannula 9.
  • FIG. 9c shows, the first cannula 9 can be moved so far into the second cannula 17 during the activation process that the fluid outlet 8 forming the fluid outlet 8
  • the cannula end of the first cannula 9 can touch the first septum 11 and pierce it.
  • the second cannula 17 is connected to the housing part 14a of the second coupling device 6 in an axially fixed and in particular rotationally fixed manner.
  • first cannula 9 of the first coupling device 5 can come into contact with the first septum 11 of the second coupling device 6, an access through a second septum 12 in the first coupling device 5 must first be established.
  • This is achieved by the coupling Process in particular through the linear movement of the coupling process, an axial cannula section of the second cannula 17 of the second coupling device 6 penetrates the second septum 12 of the first coupling device 5 and thereby provides access for the first cannula 9 into the area of the hermetically sealed in the initial state second coupling device 6 and / or an access for the first cannula 9 to the first septum 11.
  • the first cannula 9 and the second septum 12 do not touch each other before, during and / or after the coupling process. A contamination of the first cannula 9 by the second septum 12 can thus be ruled out.
  • the first coupling device 5 has a second sealing sleeve 23 in addition to the second septum 12, in particular in the form of an nem end of closed tube, which surrounds the first cannula 9 radially and at the front end, which forms the fluid outlet 8.
  • the first sealing sleeve 18 is fixed here and preferably on the housing part 14a.
  • the first sealing sleeve 18 is connected to the housing part 14a in a hermetically sealed manner. According to an alternative embodiment, not shown here, it is also conceivable that the first sealing sleeve 18 rests hermetically and / or is fixed on an axial cannula section of the second cannula 17.
  • the first sealing sleeve 18 ensures the sterility of the axial cannula section of the second cannula 17 until it penetrates the second septum 12 by protecting the second cannula 17 from contact by the user or other parts.
  • the second cannula 17 penetrates the first sealing sleeve 18 preferably only during the coupling process when the first sealing sleeve 18 comes to rest axially on the second septum 12.
  • the second cannula 17 preferably penetrates into the second septum 12 immediately after the first sealing sleeve 18 has been pierced and then pierces it completely.
  • the axial cannula section of the second cannula 17 penetrates the first sealing sleeve 18, it is preferably such that the first cannula 9 and the first sealing sleeve 18 do not touch each other before, during and / or after the coupling process. In this way, contamination of the first cannula 9 by the first sealing sleeve 18 is also excluded.
  • the first coupling device 5 also has the already mentioned second sealing sleeve 23, which encompasses an axial cannula section of the first cannula 9 that encompasses the fluid outlet 8 and penetrates the first septum 11 during the activation process , surrounds radially in the initial state.
  • the second sealing sleeve 23 surrounds the first cannula 9 here and preferably even over the greater part of its length or essentially its entire length.
  • the second sealing sleeve 23 is axially closed on the side facing the second coupling device 6 during the coupling process, but is open on the side facing the fluid inlet 7. With the closed side, the first cannula 9 then pierces the second sealing sleeve 23 in the activation process, before the first cannula 9 penetrates the first septum 11.
  • the second sealing sleeve 23 is fixed on the housing part 13a.
  • the second sealing sleeve 23 is hermetically sealed to the housing part 13a.
  • the second sealing sleeve 23 rests hermetically and / or is fixed on an axial cannula section of the first cannula 9 and / or on the housing part 13b.
  • This second sealing sleeve 23 ensures the sterility of the axial cannula section of the first cannula 9 encompassing the fluid outlet 8 until the first cannula 9 penetrates the first septum 11 by protecting the first cannula 9 from contact by the user or other parts.
  • the first cannula 9 preferably only pierces the second sealing sleeve 23 when it is axially in contact with the first septum 11.
  • the first cannula 9 then penetrates the septum 11, preferably immediately after the second sealing sleeve 23 has been pierced.
  • 9 a) to c) shows, a mechanism 31 for displaying, in particular haptic displays, at least one defined axial position of the first coupling device 5 relative to the second coupling device 6 is provided.
  • An axial form fit between the first coupling device 5 and the second coupling device 6 is preferably generated here in the respective defined axial position, in particular via a snap connection. The snap connection can be released again when a defined axial force that is applied between the two coupling devices 5, 6 is exceeded.
  • a defined axial position corresponds in particular to the initial position in the coupled state (FIGS. 8b) and 9b)).
  • a defined axial position here corresponds to the operating position in the coupling state (FIGS. 8c) and 9c)), i.e.
  • the first coupling device 5 is relative to the second coupling device 6 from the initial state to the respective defined one axial position can be brought. In this way, the user recognizes, in particular haptically, that the starting position and / or the operating position have been reached.
  • the coupling devices 5, 6 are shown in the disconnected state for reasons of clarity.
  • the fluid inlet 7 of the first coupling device 5 and the fluid outlet 15 of the second coupling device 6 can be or are connected to a hose 26 or tube, in particular via a plug connection, such as this is shown in FIG.
  • the fluid inlet 7 of the first coupling device 5 is preferably coupled to the liquid container 2 via a hose 26 or a tube.
  • the fluid outlet 15 of the second coupling device 6 can be fluidically coupled to the fluid chamber 3 of the bioprocess engineering system 4, in particular the bioreactor, via a hose 26 or a tube.
  • a packaging arrangement 27 as shown in FIG. 5 at the top and in FIG. 10 at the top, is provided with a packaging 29 and with a first coupling device 5 of the proposed sterile connector 1 that is sterile-packed therein and with one that is sterile-packed therein , in particular filled, here already filled by the manufacturer, liquid container 2 is provided.
  • the liquid container 2 is here with the coupling device
  • the coupling device 5 of the sterile connector 1 that is, already in the packaged state, preferably via a hose 26 or a tube, coupled fluidically, but the coupling device 5 is not yet coupled to the further coupling device 6 of the sterile connector 1.
  • a packaging arrangement 28 as shown in each case in FIG. 5 at the bottom and in FIG. 10 at the bottom, is provided with a packaging 30 and with a second coupling device packaged in a sterile manner therein
  • a bioprocess engineering system 4 or the bioreactor is fluidly coupled to the second coupling device 6 of the sterile connector 1, ie already in the packaged state, preferably via a hose 26 or a tube, but the coupling device 6 is not yet connected to the further coupling device 5 of the sterile connector 1 is coupled.
  • a packaging arrangement with a packaging is also conceivable in which only a proposed sterile connector 1, comprising the two coupling devices 5, 6, is packaged in a sterile manner.
  • a sterile packaged, proposed sterile connector 1 a sterile packaged first or second coupling device is device 5, 6 of a proposed sterile connector 1 and / or a proposed packaging arrangement 27, 28 for the sterile transfer of a liquid, in particular biological medium, from a liquid container 2 into a fluid chamber 3, in particular a bioprocess engineering system 4, for example a bioreactor, claimed as such.
  • a bioprocess engineering system 4 for example a bioreactor
  • the packaging arrangements 27, 28 respectively shown in FIGS. 5 and 10 after the unpacking of the unit comprising the first coupling device 5 and the liquid container 2 on the one hand and after the final packaging of the unit consisting of the second coupling device 6 and the bioprocess engineering system 4, on the other hand, in each case with the hoses 26 or small tubes making the connection, the first coupling device 5 with the second coupling device 6, as described, are mechanically connected to one another in a coupling process.
  • the first coupling device 5 or the second coupling device 6 of the proposed sterile connector 1 in particular both coupling devices 5, 6, preferably also the liquid container 2 and / or the bioprocessing system 4 and / or in the case of the hose or tubes 26 or small tubes, each around a single-use component.
  • the respective component i.e. the respective coupling device 5, 6, the liquid container 2, the bioprocess engineering system 4 and / or the respective hose 26 or the respective tube is at least partly, preferably at least predominantly, made of a plastic material.
  • the plastics used for the individual components are in particular a silicone material and / or a poly mermaterial, in particular an elastomer and / or thermoplastic, in question.
  • PE polyethylene
  • PP polypropylene
  • PTFE polytetrafluoroethylene
  • PBT polybutylene terephthalate
  • PSU polysulfone
  • PESU polyether sulfone
  • PC polycarbonate

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Abstract

L'invention concerne un connecteur stérile destiné au transfert stérile d'un milieu liquide, en particulier biologique, à partir d'un récipient de liquide (2) dans un compartiment de fluide (3, 3'), le connecteur stérile (1) présentant un premier et un deuxième dispositif d'accouplement (5, 8). Il est proposé que le premier dispositif d'accouplement (5) présente une entrée de fluide (7) et une sortie de fluide (8) ainsi qu'une premier canule (9), qui présente une extrémité opposée à l'entrée de fluide (7), qui forme la sortie de fluide (8), que le deuxième dispositif d'accouplement (6) présente un passage de fluide (10) qui est recouvert de manière axiale par un premier septum (11) dans un état de sortie du connecteur stérile (1), que la sortie de fluide (8), dans un état de sortie du connecteur stérile (1), est disposée dans un domaine étanchéifié hermétiquement du premier dispositif d'accouplement (5) et la surface (11a) du premier septum (11) opposée de manière axiale au passage de fluide (10) est disposée dans un domaine étanchéifié hermétiquement du deuxième dispositif d'accouplement (6), et que, en partant de l'état de sortie du connecteur stérile (1), dans une opération de liaison fluidique, une liaison fluidique entre l'entrée de fluide (7) et le passage de fluide (10) peut être obtenue par le fait que l'extrémité formant la sortie de fluide (8) de la première canule (9) traverse le premier septum (11) du deuxième dispositif d'accouplement (6).
EP20732521.8A 2019-06-24 2020-06-05 Connecteur stérile destiné au transfert stérile d'un milieu liquide Pending EP3973044A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102019116970.4A DE102019116970B4 (de) 2019-06-24 2019-06-24 Sterilverbinder für den sterilen Transfer eines flüssigen Mediums
PCT/EP2020/065686 WO2020259985A1 (fr) 2019-06-24 2020-06-05 Connecteur stérile destiné au transfert stérile d'un milieu liquide

Publications (1)

Publication Number Publication Date
EP3973044A1 true EP3973044A1 (fr) 2022-03-30

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EP20732521.8A Pending EP3973044A1 (fr) 2019-06-24 2020-06-05 Connecteur stérile destiné au transfert stérile d'un milieu liquide

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US (1) US20220260189A1 (fr)
EP (1) EP3973044A1 (fr)
CN (1) CN113993984A (fr)
DE (1) DE102019116970B4 (fr)
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DE102019116970A1 (de) 2020-12-24
WO2020259985A1 (fr) 2020-12-30
CN113993984A (zh) 2022-01-28
US20220260189A1 (en) 2022-08-18

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