JP5091313B2 - Device for supplying fluid to the receptacle - Google Patents

Description

  The invention relates to an apparatus for supplying a cleaning fluid, ie gas and / or liquid, to a receptacle according to the premise of claim 1 and to an apparatus for supplying a cleaning fluid to a receptacle according to the premise of claim 10.

  The present invention can be implemented in a sterile formulation that supplies sterilized / clean air to a medical receptacle such as a bottle or vial for the purpose of extracting a solution or other liquid used in medical applications from the medical receptacle, for example.

  In the field of injection or infusion preparation, two basic issues generally need to be considered. First, there is a certain demand for sterility to avoid contamination of the drug, and secondly, the drug needs to be handled to prevent or minimize leakage of the drug to the surroundings. By handling the drug in a sterile or aseptic condition, the risk of transferring bacteria or other undesirable substances to the patient is reduced. By preventing drug leakage to the surroundings, medical and pharmacological personnel are less exposed to harmful drugs.

  To achieve aseptic conditions, special safety boxes, cabinets, or isolators in which air is filtered through HEPA filters are used to prevent contamination during dispensing. Ventilation cabinets are also used to reduce uncontrolled leakage to the environment and prevent occupational exposure to potentially harmful drugs.

  However, such equipment requires a lot of space and leads to a relatively high cost. Furthermore, the protection provided may be inadequate, and work environment issues have been reported due to inadvertent exposure to drugs, eg, cytotoxins.

  Another solution to the problem described above is to create a so-called “closed” or “non-vented” system for handling the drug during preparation. Such systems exist and allow preparation to be accomplished without the use of special safety boxes, cabinets, or isolators. In such a closed system, the drug is handled isolated from the surroundings throughout all steps to avoid drug contamination and unwanted drug leakage to the environment.

  A known problem associated with dispensing solutions is usually the fact that medical bottles or vials are made of incompressible materials such as glass or plastic. Emptying the vial requires air to flow into the vial to avoid negative pressure in the vial; otherwise, the negative pressure causes the vial to move to another receptacle, such as a syringe. , Further transport of liquid is inhibited or prevented.

  A system for supplying sterilizing gas is disclosed in WO 00/35517. A soft bag containing a sterile gas is provided. The bag has an opening covered by a gas or liquid impervious membrane that can be pierced by a needle to draw sterile gas from the bag and further transport the gas to the bottle. A bottle connector is arranged in the current bottle, and the bottle connector has a pressure correction means for receiving gas. Using a syringe or infuser with a needle, the sterilized gas is transferred from the soft bag to the bottle and also to the pressure compensation means located at the bottle connector. Thereafter, the substance in the bottle can be aspirated from the bottle using an injector, while the sterilizing gas flows from the pressure correction means into the bottle.

  However, the prior art system disclosed in WO 00/35517 has drawbacks. The system comprises several components to be handled, and it is necessary to aspirate sterile gas from the soft bag using a syringe equipped with a needle and then transfer it to the bottle and pressure compensation means. Thus, several operations must be performed before the medical substance can be aspirated from the bottle.

  WO 02/11794 describes a system for supplying clean gas. This system works with an injecting syringe and an air filter attached to the connecting nozzle of the syringe. The container portion of the syringe is filled with air that has been forced through the filter for cleaning. Thereafter, the air filter is removed, the syringe is connected to the coupling means (injector), and the coupling means (injector) is further connected to the capping means (bottle connector) arranged on the bottle. The capping means has a pressure equalizing chamber whose volume is variable. The clean gas in the syringe is transferred from the syringe to the bottle and is transferred to a pressure equalizing chamber disposed in the capping means. The substance in the bottle can then be aspirated from the bottle using a syringe and coupling means, while the clean gas flows from the pressure equalization chamber into the bottle.

  The prior art system described in WO 02/11794 also has drawbacks. The system requires an adapter with an air filter connected to and removed from the syringe to fill the pressure equalization chamber before the medical substance can be aspirated from the bottle. In another embodiment, the air filter is fixedly attached to the syringe. However, in such a case, the conventional syringe cannot be used. In either case, the clean gas must be aspirated from the surrounding environment and transferred to the bottle and pressure equalization chamber before the medical substance can be aspirated from the bottle.

  It is an object of the present invention to provide an apparatus for supplying a cleaning and / or sterilizing fluid of the type mentioned in the introduction, which reduces at least one of the problems of the prior art apparatus described above to a substantial extent. In particular, the present invention aims to show a method of supplying sterilization / clean gas in a rational and safe manner during dispensing.

  The present invention is based on the insight that it is advantageous to supply sterilizing / cleaning gas through the connector system itself, rather than utilizing additional equipment to fill the expansion container included in the connector system during dispensing. However, the container needs to be filled during manufacture of the device or by the user, and these two options result in two aspects of the invention.

According to a first aspect of the invention, the object is achieved by an apparatus according to claim 1.
By providing a connector and a container forming an integral unit, the connector is provided with a first means for connecting to the receptacle, the container being transferred from the container to the connector during transport of the material from the receptacle. An additional flexible bag filled with sterilization / cleaning fluid is necessary because it is or will be prefilled with sterilization or cleaning fluid to be transferred to the interconnected receptacle Disappear.

  For example, handling is simplified because it eliminates the use of a syringe with a needle to transfer sterilization / cleaning fluid to the vial and transport material from the vial. The prefill container replaces both the additional soft bag and pressure correction means required in prior art devices. Transport of material from the receptacle can be accomplished immediately after the connector is placed in the receptacle.

According to a second aspect of the invention, the object is achieved by an apparatus according to claim 10.
By providing a connector and a container forming an integral unit, the connector is provided with a first means for connecting to the receptacle, the integral unit, for example, prior to connecting the connector to the receptacle, Because a filter is provided to clean the fluid that passes when the container is filled with fluid, for example, an air filter adapter is provided to transport the sterilization / cleaning fluid to the vial and transport the material from the vial. There is no need for a syringe or a syringe with a fixedly attached air filter. Alternatively, conventional syringes can be used to transport material from the receptacle immediately after the connector is placed in the receptacle.

  Comparing the two aspects of the present invention, it can be seen that the device according to the first aspect does not include any filter and that the costs associated with the manufacture of the device are saved. Furthermore, the cleanliness obtained during the manufacture of the device, for example by sterilization, is very high and in most cases is very important. On the other hand, the device according to the second aspect can be reduced in volume, can be made into a smaller package, and transportation costs can be reduced. In many applications, the fluid is filtered to provide a clean fluid suitable for sterile dispensing.

It is a perspective view which shows the apparatus by the 1st aspect of this invention. FIG. 2 is a view corresponding to FIG. 1, showing the device in another state. 2 shows a perspective view of the device according to FIG. 1 connected to a vial. FIG. FIG. 4 is an exploded view corresponding to FIG. 3. It is a perspective view which shows the apparatus by the 2nd aspect of this invention. FIG. 6 shows another embodiment of the apparatus shown in FIG. FIG. 6 is a diagram corresponding to FIG. 5 showing the device in another state. FIG. 6 is a perspective view showing the device according to FIG. 5 connected to a vial. FIG. 4 is an exploded view corresponding to FIG. 3.

Hereinafter, embodiments of the present invention cited as examples will be described in more detail with reference to the accompanying drawings.
1 and 2 show a device 1 according to a first aspect of the present invention. The apparatus 1 can be used to supply a clean and / or sterilized gas, such as air, to the receptacle, thereby facilitating the transport of material from the receptacle. Such materials may be various solutions and liquids that make up drugs used in the medical field, such as cytotoxic drugs and antibiotics. The apparatus comprises a connector 2 and a container 3 that form an integral unit 4. The connector 2 is provided with a first means 5 for connecting to the receptacle, in other words, a first connector portion 5 for connecting to the receptacle.

  The container 3 is pre-filled or becomes pre-filled with a clean and / or sterilized gas to be transferred from the container 3 to the receptacle connectable to the connector 2 during the transport of the substance from the receptacle. ing. See also the exploded view of FIGS. 3 and 4 showing the device 1 connected to a medical receptacle such as a bottle or vial 6. The expression “pre-fill” means that the container is already filled with gas before it is used to supply gas to the receptacle. The device is already properly filled when delivered to the user, preferably the container is filled during or after manufacture of the device, for example just before or at the moment of packing or packaging the device.

  The expression “clean” gas means that the gas has been filtered and the particulates and / or viable microorganisms have been removed to the extent that the gas is classified as sterile and allowed by the relevant authorities and / or any standards. Means. Cleanliness can be expressed as the largest particle that can pass through the filter for a constant gas flow rate. In some cases, particles having a size greater than 5 μm are tolerated in the clean gas with little or no presence. However, the acceptable particle size is determined by the requirements of the intended application. In the handling of some drugs, particles having a size greater than 0.15 μm need to be substantially all removed from the gas by a particulate air filter. As an example, a filter having a mesh size of 0.2 μm can be used to remove substantially all particles and microorganisms larger than that size.

The expression “sterile” gas means that the gas has been subjected to a sterilization method approved by the relevant authorities for the target product in order to remove viable microorganisms. The current European regulations for “sterilized” designated medical devices can be found in the European standard EN 556-1. There may be other rules in other countries. Sterilization can be by ethylene oxide sterilization, irradiation sterilization, or (wet) heat sterilization or other recognized methods. The requirements of European standards mean that the theoretical probability that viable microorganisms exist on / in a sterilizer should be 1 × 10 ⁻⁶ or less.

  When sterilizing a gas, it is not always necessary to clean the gas by the above-described cleaning process, but such cleaning and sterilization can be combined. However, if necessary, other methods can be used to remove particulates, etc. from the gas, or the sterilization process itself will be sufficient to make the gas clean and sterilized. There is a case.

  The first connecting means 5 can be designed to connect to a receptacle, such as the neck of a vial. In the embodiment shown in FIGS. 1 to 4, the first connecting means 5 is constituted by a ring-shaped part 7 surrounding the neck part 8 of the vial 6. The ring-shaped portion 7 has a slit 9 so that a flange 10 protruding downward is formed. The flange 10 can be provided with a hook 11 or barb for gripping the periphery of the neck 8 of the vial 6. The connector 2 is suitably provided with a second means 12 for connection with a transfer member 13 (see FIGS. 3 and 4) such as an injection device to be interconnected to the connector for transporting substances from the receptacle 6 Provide. In other words, the connector 2 is appropriately provided with the second connector portion 12.

  In another embodiment (not shown) of the present invention, the second connecting means 12 may comprise a luer lock coupling or bayonet coupling so that the syringe can be connected to the connector. Both the syringe and the connector are provided with a membrane to form a double membrane bond between the syringe and the target device.

The amount of gas, preferably air, supplied by the prefilled container should be suitable for the volume of the receptacle to be emptied. The volume of gas when present in the receptacle should preferably correspond to the volume of the receptacle so that the receptacle can be completely emptied. This is because if the gas pressure is substantially the same in the receptacle and in the container, the volume of clean or sterilized gas in the pre-filled container is preferably approximately equal to or greater than the volume of the receptacle. Means that. For most medical receptacles, the gas volume should be between 1 and 100 cm ^{3 at} atmospheric pressure.

  The connector 2 is preferably provided with a puncture member such as a hollow needle 14 (not shown) that penetrates a rubber closing part (not shown), for example, and the closing part opens an opening of the receptacle 6 such as a vial. cover. In addition to the injection needle or cannula, the expression “needle” refers to spikes and similar components that penetrate these closures to form a flow path between the container 3 and the receptacle 6 connecting the connector 2. Is included. Through the flow path or passage 15 inside the needle 14, the gas stored in the container 3 can move from the container to the receptacle 6, that is, the gas can flow from the container 3 to the receptacle 6.

  The connector 2 and the container 3 form an integrated unit 4. This means that the connector and container can be made as one piece, or that the connector 2 and container 3 can be coupled together to form an integral unit 4. Various types of coupling means known from the prior art can be used as long as an airtight or at least substantially airtight connection is obtained between the components 2, 3.

  The volume of the container 3 can be made variable so that gas can flow from the container 3 to the receptacle 6. The container 3 is appropriately made of a compressible material in order to make the volume of the container variable. In order to obtain a container 3 having a variable volume, the container is made of a relatively hard material and is made of a relatively soft material and is attached to the first part 17 and connected to the connector 2. Second portion 18 can be provided. For example, the container 3 can be designed to have a flexible part such as a bellows that can be compressed and expanded.

  According to one embodiment of the present invention, the container or the flexible portion of the container is a removable spring, such as an axial spring load element, arranged to allow fluid to flow into the flexible portion of the container / container. With load elements. The removable spring load element is constrained between the two flange ends of the flexible part, for example. When the flexible part is empty, the spring (s) of the spring load element are highly compressed. When the flexible part is filled with fluid, the spring (group) of the spring load element is less compressed. The spring may be disposed inside or outside the flexible portion, or may be formed integrally with the flexible portion. The removable spring-loaded element can be arranged to be separated from the container / container flexible part after the container / container flexible part has been filled to a desired amount.

  According to one embodiment, the flexible portion of the container may be removably disposed from the rest of the container, so that the flexible portion allows fluid to flow before and / or after attachment to the remaining portion of the container. Can be filled. Thereby, the volume of the container 3 can be increased or decreased. Although the apparatus shown in FIG. 1 comprises a compressible container, in another embodiment, the container can have a cylinder and a piston disposed therein so that the volume of the container can be changed. .

  According to one embodiment of the invention, the container comprises locking means to prevent fluid from entering the container, for example during transport of the apparatus or during any period when the apparatus is not in use.

  Instead of a collapsible container or in combination with a collapsible container, the container 3 can be pressurized with a clean or sterilizing gas to generate an overpressure in the container. The overpressure allows gas to flow from the container 3 to the connector 6 and the receptacle 6 connected to the container. In such a case, the container 3 does not necessarily need to be foldable. The overpressure is appropriately matched to the size of the receptacle connected to the connector, ensuring that the receptacle can be completely emptied in subsequent steps. The pressure in the filling container can be, for example, between 1 atm and 2 atm. Preferably, the device comprises any means such as a valve that allows gas to flow out of the container after the device is connected to the receptacle and during transport of the material from the receptacle.

  5, 5b and 6 show a device 1 'according to a second aspect of the invention. The apparatus can be used to supply clean gas to the receptacle, thereby facilitating transport of material from the receptacle. Such materials may be various solutions and liquids that make up drugs used in the medical field, such as cytotoxic drugs and antibiotics. The device comprises a connector 2 'and a container 3' forming an integral unit 4 '. The connector 2 'is provided with a first means 5' for connecting to the receptacle 6 ', in other words, a first connector portion 5'. See also the exploded view of FIGS. 7 and 8 showing the device connected to the medical bottle or vial 6 '.

  The first connecting means 5 'can be designed to connect to a bottle, such as the neck of a vial. In the embodiment shown in FIGS. 5 to 8, the first connecting means 5 'is constituted by a ring-shaped part 7' surrounding the neck 8 'of the vial 6'. The ring-shaped portion 7 'has a slit 9' so that a flange 10 'protruding downward is formed. The flange 10 'can be provided with a hook 11' or barb for gripping around the neck 8 'of the vial 6'. The connector 2 'is suitably provided with a second means 12' for connection with a transfer member 13 'such as a syringe to be interconnected with the connector for the transport of substances from the receptacle 6', in other words, The connector 2 ′ is appropriately provided with a second connector portion 12 ′.

  In another embodiment of the invention (not shown), the second connection means 12 'can comprise a luer lock coupling or bayonet coupling so that a syringe can be connected. As already described for the device according to the first aspect of the invention, both the syringe and the connector are suitably provided with a membrane to form a double membrane bond between the syringe and the target device.

  The connector 2 ′ is preferably provided with a puncture member such as a hollow needle 14 ′ (not shown) that penetrates a rubber closure (not shown), for example, and the closure is a receptacle 6 ′ such as a vial. Cover the opening. In addition to infusion needles or cannulas, the expression “needle” refers to spikes and the like that penetrate these closures to form a flow path between the container 3 ′ and the receptacle 6 ′ connecting the connector 2 ′. The component is included. By the flow path or passage 15 'inside the needle 14', the gas contained in the container 3 'can move from the container to the receptacle 6', that is, the gas can flow from the container 3 'to the receptacle 6'. .

  Connector 2 'and container 3' form an integral unit 4 '. This means that the connector and container can be made as one piece, or the connector 2 'and container 3' can be coupled together to form an integral unit. As long as an airtight or at least substantially airtight connection is obtained between the components 2 ', 3', various types of coupling means 16 'known from the prior art can be used.

  The container 3 'needs to be filled with gas before connecting the connector 2' to the receptacle 6 '. The volume of the container 3 'is preferably variable. In order to obtain a container 3 ′ having a variable volume, the container is made of a relatively hard material and is made of a first part 17 ′ coupled to the connector 2 ′ and a relatively soft material, the first part And a second portion 18 'attached to 17'. The second portion 18 'can be made inflatable, for example, by manipulating the handle 20' disposed at the end of the container 3 '. Thereby, the volume of the container 3 ′ can be increased or decreased. For example, the container 3 'can be designed to have a flexible portion such as a bellows that can be manually compressed and expanded. The container 3 'is preferably provided with a handle 20' for adjusting the volume of the container 3 '.

  The volume of the container is preferably variable as shown, but there are other ways to fill the container and at the same time ensure that gas passes through the filter 21 '. For example, the gas container can be constituted by a soft bag of a sealed vacuum pack, and the gas can flow into the bag by opening the seal. Alternatively, the gas container is rigid or semi-rigid and uses pressurized gas to fill the container.

The amount of gas, preferably air, supplied by the prefilled container should be suitable for the volume of the receptacle to be emptied. The volume of gas when present in the receptacle should preferably correspond to the volume of the receptacle so that the receptacle can be completely emptied. This is because if the gas pressure is substantially the same in the receptacle and in the container, the volume of clean or sterilized gas in the pre-filled container is preferably approximately equal to or greater than the volume of the receptacle. Means that. For most medical bottles or vials, the gas volume should be between 1 and 100 cm ^{3 at} atmospheric pressure.

  Therefore, the integral unit 4 ′ passes through the filter 21 ′ while filling the container 3 ′ with gas by increasing the volume of the container 3 ′ as much as possible before connecting the connector 2 ′ to the receptacle 6 ′. A filter 21 ′ such as a particulate air filter that cleans the gas is provided. Hereinafter, the filter called the particulate air filter 21 ′ can be arranged in various forms, but according to the embodiment shown in FIGS. 5 and 6, the particulate air filter 21 ′ is arranged on the connector 2 ′. . By covering the opening 32 ′ of the needle 14 ′ with the particulate air filter 21 ′, it is ensured that the gas introduced into the container 3 ′ must pass through the particulate air filter 21 ′. The particulate air filter 21 ′ is disposed so as to be removed from the integrated unit 4 ′ after the container 3 ′ is filled with a clean gas. Following filling of the container 3 ', the particulate air filter 21' is removed and then the connector 2 'is connected to the receptacle 6'.

  The expression “clean” gas means that the gas has been filtered and the particulates and / or viable microorganisms have been removed to the extent that the gas is classified as sterile and allowed by the relevant authorities and / or any standards. Means. Cleanliness can be expressed as the largest particle that can pass through the filter for a constant gas flow rate. In some cases, particles having a size greater than 5 μm are tolerated in the clean gas with little or no presence. However, the acceptable particle size is determined by the requirements of the intended application. In the handling of some drugs, particles having a size greater than 0.15 μm need to be substantially all removed from the gas by a particulate air filter. As an example, a filter having a mesh size of 0.2 μm can be used to remove substantially all particles and microorganisms larger than that size.

  The particulate air filter 21 'is preferably designed as a needle shield 22' for the tip of the needle 14 '. The filter can be arranged to at least partially cover or surround the tip of the needle 14 '. This means that the particulate air filter 21 'cleans the gas and at the same time the particulate air filter 21' functions as a protector during handling of the device 1 '. Further, such needle tip shield 22 'protects the sterile package enclosing the device during transport and storage of the device.

  After the container 3 ′ is filled with gas, it is removed from the gas and collected in the particulate air filter 21 ′ by removing the particulate air filter 21 ′ before the connector 2 ′ and the receptacle 6 ′ are interconnected with each other. Any contaminating particles are removed from the integrated unit 4 '. Thus, one and the same flow path can be used both for filling the container 3 'with clean gas and for transferring clean gas from the container 3' to the receptacle 6 '.

  In the embodiment shown in FIG. 5b, where the particulate air filter 21 ′ is not removed prior to interconnection with the connector 2 ′ and the receptacle 6 ′, the particulate air filter 21 ′ is capable of gas flow from the container 3 ′ to the receptacle 6 ′. It needs to be arranged to avoid contamination during transport. The integrated unit 4 ′ can be provided with a first flow path 23 ′ for filling the container 3 ′ with a clean gas and a second flow path 15 ′ for transferring the clean gas to the receptacle. . Otherwise, that is, when the same flow path is used to transport gas in both directions, leaving the particulate air filter, the particles collected in the particulate air filter will be dissociated from the particulate air filter and There is a possibility that it will be unintentionally brought into the receptacle 6 '. Such contamination can be prevented by providing a removable air filter, or by providing different openings / flow paths for the transport of gas into and out of the container 3 '.

  After filling the container 3 ′, a lid 26 ′ is disposed on the integrated unit 4 ′ to prevent further communication between the interior of the integrated unit 4 ′ and the surrounding environment via the particulate air filter 21 ′. Thus, the particulate air filter 21 'can be covered. First, the container 3 ′ is filled with clean gas, and then the lid 26 ′ is attached to the integrated unit 4 ′ to cover the particulate air filter 21 ′ and prevent further gas transportation through the particulate air filter 21 ′. To do. Thereafter, the integral unit 4 'and the receptacle 6' can be interconnected to perform subsequent operations safely.

  The lid 26 'functions to prevent the movement of liquid, gas, or any vapor in the direction from the integrated unit 4' to the surroundings in order to prevent any undesirable material in the receptacle 6 'from escaping to the surroundings. Have.

  It will be appreciated that the invention is not limited to the embodiments described above and shown in the drawings, but rather, those skilled in the art will recognize that numerous modifications and variations may be made within the scope of the appended claims. For example, the present invention is applicable to other medical applications, and there may be an additional purpose of supplying clean or sterile gas to the receptacle.

Claims (25)

Connector (1) for supplying cleaning fluid, ie gas and / or liquid, to the receptacle (6), thereby facilitating the transport of substances from the receptacle, forming a unitary unit (4) (2) and a container (3), wherein the connector (2) is provided with a first means (5) for connection with the receptacle (6), and the container (3) is connected to the receptacle (6). ) During the transport of the substance from, or pre-filled with, or pre-filled with a clean fluid to be transferred from the container to the receptacle connectable to the connector (2) , transport of material from the receptacle (6), when material is transported from the receptacle (6), since the cleaning fluid is transported to the receptacle (6) from the container (3), the connector And wherein after placing (2) to the receptacle (6), that immediately becomes achievable.   The apparatus of claim 1, wherein the fluid is sterilized.   Device according to claim 1 or 2, characterized in that the volume of the container (3) is variable.   Device according to claim 3, characterized in that the container (3) is made of a compressible material that makes the volume of the container variable.   Device according to claim 3 or 4, characterized in that the container (3) is designed to have a flexible part such as a foldable bellows.   6. A device according to claim 5, characterized in that the container or the flexible part comprises a removable spring-loaded element arranged to allow the flow of fluid into the container / flexible part. It said container (3) is characterized in that it comprises a locking means for preventing the flow of fluid into the container (3) A device according to any one of claims 1 to 6. It said container (3) is pressurized by the cleaning or sterilizing fluid to generate excess pressure in the range of 1-2 atmospheres in the container, the overpressure, the size of the receptacle to the container is connected The device according to claim 1, wherein the device is suitable. 9. The connector (2) according to any one of the preceding claims , characterized in that the connector (2) is provided with second means (12) for connecting to a transfer member (13) for transporting a substance from the receptacle (6). the apparatus according to.   A device (1 ′) for supplying a cleaning fluid to the receptacle (6 ′) and thereby facilitating transport of a substance from the receptacle, comprising a connector (2 ′) forming an integral unit (4 ′); A container (3 ′), wherein the connector (2 ′) is provided with a first means (5 ′) for connection with a receptacle (6 ′), and the integrated unit (4 ′) includes: An apparatus comprising a filter (21 ') for purifying fluid that passes while the container (3') is filled with fluid by increasing the volume of the container.   The integral unit (4 ′) includes a volume of fluid in the container (3 ′) by increasing the volume of the container before connecting the connector (2 ′) to the receptacle (6 ′). 11. A device according to claim 10, characterized in that it is provided with a filter (21 ') for cleaning the fluid passing through it.   The integral unit (4 ′) has a first flow path (23 ′) for filling the container (3 ′) with a clean fluid and a transport for transferring the clean fluid to the receptacle (6 ′). Device according to claim 11, characterized in that a second flow path (15 ') is provided.   The filter (21 ′) may be removed from the integral unit (4 ′) after filling the container (3 ′) and before connecting the connector (2 ′) to the receptacle (6 ′). Device according to claim 11, characterized in that it is arranged in   The integrated unit (4 ′) is for both filling the container (3 ′) with clean fluid and transferring the clean fluid from the container (3 ′) to the receptacle (6 ′). 14. The device according to claim 13, characterized in that it is provided with one and the same flow path (15 ').   15. A device according to any of claims 10 to 14, characterized in that the integral unit (4 ') has a needle (14') that passes through a closure located in the receptacle (6 ').   Device according to claim 15, characterized in that the filter (21 ') is arranged as a needle shield for the needle (14').   In order to prevent further communication between the interior of the integrated unit (4 ′) and the surrounding environment via the filter (21 ′) after the container (3 ′) is filled. Device according to claim 10, characterized in that it comprises a lid (26 ') covering the filter (21').   18. The volume of the container (3 ′) can be varied such that the volume of the container increases while the container (3 ′) is filled with fluid. The device described.   19. Device according to claim 18, characterized in that the container (3 ') is made of a compressible material in order to make the volume of the container variable.   20. Device according to claim 18 or 19, characterized in that the container (3 ') is designed to have a flexible part such as a bellows that can be compressed and expanded.   21. The apparatus of claim 20, wherein the flexible portion is compressible and expandable by manually affecting the container.   Device according to claim 21, characterized in that the container (3 ') is provided with a handle (20') for adjusting the volume of the container.   11. The connector (2 ′) is provided with second means (12 ′) for connecting to a transfer member (13 ′) for transporting a substance from the receptacle (6 ′). The apparatus according to 22. Said first means (5 ') is a receptacle (6', characterized in that it is designed for connection to a), according to any one of claims 10 to 23.   25. Device according to claim 24, characterized in that the first means (5 ') are designed for connection with a neck (8') of a receptacle, such as a vial (6 ').