Method and device for transferring a substance between closed systems

Abstract

The invention relates to a method and to a device for transferring a substance between closed systems (G 1 G/Z, Z, G+G/Z), which prior to the transfer are connected in a sterile manner and can be disconnected from each other in a sterile manner, and wherein means for transferring the substance are provided. The goal is to enable a contamination-free transfer of the substance without gas inclusions between closed systems. This is achieved with respect to the method in that the pressure differences occurring during the transfer of the substance are compensated for within the system. This is achieved with respect to the device in that a pressure compensating unit ( 1 ) is provided, which has a sterile flow connection to at least one system (G, G/Z, Z, G+G/Z).

1 .- 58 . (canceled) 
     
     
         59 . A method for transfer of a substance between closed systems, said method comprising:
 providing closed systems, namely at least one source system and at least one target system, which are simply connected in sterile fashion before transfer, in which the substance reaches the target system and in which after transfer of the substance the target system and the source system can be separated from each other in sterile fashion, wherein pressure differences occurring during transfer of the substance are compensated within the system.   
     
     
         60 . The method according to  claim 59 , wherein pressure compensation occurs where volume changes of the substance occur. 
     
     
         61 . The method according to  claim 59 , wherein the substance is transferred in metered fashion. 
     
     
         62 . The method according to  claim 59 , wherein the substance is transferred active from the source system, especially by a calibrated syringe or carpule, to the target system or wherein the substance is actively removed from the source system, especially by a calibrated syringe or that the substance reaches the target system under the influence of gravity. 
     
     
         63 . The method according to  claim 59 , wherein the source system is connected in sterile fashion to several other source systems. 
     
     
         64 . The method according to  claim 59 , wherein the target system becomes the source system when the received substance is conveyed to another target system. 
     
     
         65 . The method according to  claim 59 , wherein the substance is introduced to the source system in sterile fashion under cleanroom conditions, which is closed in sterile fashion. 
     
     
         66 . A device for transfer of a substance between closed systems, said device comprising:
 closed systems configured to be connected in sterile fashion to each other and configured to be separated in sterile fashion from each other and which have means for transfer of the substance, wherein a pressure compensation device is provided, which is in flow connection in sterile fashion to at least one system.   
     
     
         67 . The device according to  claim 66 , wherein the pressure compensation device is bonded to one system. 
     
     
         68 . The device according to  claim 66 , wherein the means for transfer includes at least one connector for sterile connection to at least one additional system. 
     
     
         69 . The device according to  claim 68 , wherein a container is provided and wherein the connector is bonded in sterile fashion to the container of system. 
     
     
         70 . The device according to  claim 69 , wherein the container includes a base plate or a cover plate or at least one holding device. 
     
     
         71 . The device according to  claim 69 , wherein at least part of the wall of the container is designed flexible so that means to transfer the substance can be operated at least partially from outside via the flexible wall, especially via a bellows. 
     
     
         72 . The device according to  claim 66 , wherein one system is a component of an overall system and a sterile connection also exists within the overall system. 
     
     
         73 . The device according to  claim 69 , wherein the substance can be transferred from one system, especially under the influence of gravity, into the other closed system, the connector facing the floor in the operating position. 
     
     
         74 . The device according to  claim 73 , wherein the connector of one system with one end opens into the container and preferably extends minimally into the substance and has a snap-in closure of sealing material with a fastening bridge which can be operated via the flexible wall of the container. 
     
     
         75 . The device according to  claim 73 , wherein the container has a preferably collapsible bed with a volume between 30 mL and 1000 mL or 10 mL to 30 mL. 
     
     
         76 . The device according to  claim 66 , wherein at least two connectors are provided, which include an inlet and an outlet facing the floor in the operating position. 
     
     
         77 . The device according to  claim 76 , wherein a calibrated drip chamber is provided as container, in which the substance is at least temporarily contained. 
     
     
         78 . The device according to  claim 77 , wherein the calibrated drip chamber forms a closed system with connectors in the sense of a gravity-operated metering device and is both source and target system. 
     
     
         79 . The device according to  claim 77 , wherein the inlet and the outlet open in sealed fashion into the drip chamber. 
     
     
         80 . The device according to  claim 76 , wherein a metering device is assigned to the connector. 
     
     
         81 . The device according to  claim 69 , wherein a receptacle is contained in the container of the system in the form of a bottle or ampule within which the substance is situated and whose closure faces the floor in the operating position. 
     
     
         82 . The device according to  claim 81 , wherein the means for transfer of the substance includes a short cannula for transfer of the substance, especially a liquid, and a long cannula for air or inert gas supply, in which the cannulas puncture the closure of the receptacle in the operating position and extend into the receptacle and in which the short cannula is in flow connection with the connection. 
     
     
         83 . The device according to  claim 82 , wherein the long cannula opens into the container. 
     
     
         84 . The device according to  claim 82 , wherein the short cannula and the long cannula in the rest position are arranged in a holding device in the form of a slotted sleeve, which is supported on one side against the base plate of the container, and against the receptacle on the other side and which encloses the receptacle in the operating position, whereas the cannulas puncture the closure of the receptacle. 
     
     
         85 . The device according to  claim 82 , wherein the volume of the receptacle is predetermined so that the amount removed can be estimated and the closure preferably includes a metering valve. 
     
     
         86 . The device according to  claim 81 , wherein the container includes a calibrated drip chamber into which at least a short cannula extends via a connection piece and on which the connection facing the floor in the operating position is provided. 
     
     
         87 . The device according to  claim 86 , wherein the long cannula opens into the pressure compensation device, which ensures pressure compensation in container and in the receptacle as well as the calibrated drip chamber of the overall system. 
     
     
         88 . The device according to  claim 66 , wherein the means to transfer substance includes at least one calibrated syringe with an ampule plunger and an ampule barrel. 
     
     
         89 . The device according to  claim 88 , wherein the syringe is arranged within a container and can be operated from the outside via an at least partially flexible wall of the container especially via a bellows. 
     
     
         90 . The device according to  claim 88 , wherein the ampule barrel simultaneously forms an at least temporary receptacle for the substance. 
     
     
         91 . The device according to  claim 88 , wherein the system has an overlapping source and target function if filling with substance and release of substance occur in the same system. 
     
     
         92 . The device according to  claim 88 , wherein a connection piece in flow connection with the connector is provided for connection to the syringe within the container. 
     
     
         93 . The device according to  claim 92 , wherein the connection piece is present in the form of an internal line. 
     
     
         94 . The device according to  claim 90 , wherein a receptacle with substance in the form of an ampule with a puncture stopper is provided in the container. 
     
     
         95 . The device according to  claim 88 , wherein the ampule barrel includes a cannula with a cannula closure, which can be manipulated from the outside via the flexible wall of the container. 
     
     
         96 . The device according to  claim 95 , wherein the container includes two chambers, both of which are in flow connection with the pressure compensation device. 
     
     
         97 . The device according to  claim 96 , wherein the first chamber contains the ampule plunger and wherein the second chamber contains the ampule barrel with the cannula. 
     
     
         98 . The device according to  claim 96 , wherein the second chamber of the container forms the connector for sterile connection to the connector of the source system or the connector of the target system on the end facing away from the first chamber. 
     
     
         99 . The device according to  claim 88 , wherein the system has a container in the form of a plastic enclosure and that an ampule containing the substance is arranged within the plastic enclosure with a puncture stopper made of elastomer. 
     
     
         100 . The device according to  claim 88 , wherein the ampule plunger is in flow connection with the ampule barrel. 
     
     
         101 . The device according to  claim 100 , wherein the ampule plunger can be connected in sterile fashion to a closed system via a connector equipped with a metering valve and wherein the connection extends into the ampule plunger and opens from there into the ampule barrel. 
     
     
         102 . The device according to  claim 101 , wherein the ampule barrel has a connector for sterile connection to a closed system equipped with a metering valve facing away from the ampule plunger. 
     
     
         103 . The device according to  claim 102 , wherein for suction of substance from the closed system the metering valve adjacent to the ampule barrel is closed and the metering valve adjacent to the ampule plunger is opened. 
     
     
         104 . The device according to  claim 103 , wherein for transfer of the substance drawn into the ampule barrel to the target system the metering valve adjacent to the ampule barrel is opened and the metering valve adjacent to the ampule plunger is closed. 
     
     
         105 . The device according to  claim 100 , wherein the container includes a bellows in the area of the ampule plunger and wherein the bellows is connected in sealed fashion to the ampule barrel. 
     
     
         106 . The device according to  claim 100 , wherein the closed system includes a short cannula for transfer of the substance, especially a liquid, and a long cannula for air or inert gas supply, in which the cannulas puncture the closure of the receptacle in the operating position and extend into the receptacle and in which the short cannula is in flow connection with the connection, and wherein the long cannula opens into the container. 
     
     
         107 . The device according to  claim 106 , wherein the source system is in sterile connection with the ampule plunger via a connection piece of the short cannula and wherein the source system and the closed system comprising the syringe form an overall system. 
     
     
         108 . The device according to  claim 88 , wherein the syringe can be tightened in a syringe pump so the transfer of substance can be accomplished automatically at pre-established times or over a determined period with precise volume. 
     
     
         109 . The device according to  claim 66 , wherein the means for transfer of substance includes a carpule with a carpule plunger and a carpule barrel containing the substance. 
     
     
         110 . The device according to  claim 109 , wherein the container includes two chambers. 
     
     
         111 . The device according to  claim 110 , wherein the first chamber includes a cannula, which faces the carpule barrel with its tip and extends into the connector with its opposite end. 
     
     
         112 . The device according to  claim 110 , wherein the second chamber comprises a cylindrical section and a bellows, in which the carpule barrel is contained within the cylindrical section as well as part of the carpule plunger and in which the rest of the carpule plunger is contained within the bellows. 
     
     
         113 . The device according to  claim 110 , wherein the second chamber and a coupling tube of the first chamber are movable relative to each other and can preferably be fastened to each other in a predetermined position. 
     
     
         114 . The device according to  claim 66 , wherein the connection is connected in sterile fashion to a closed system, which contains an internal line and wherein the system containing the internal line transfers the substance to the next closed system. 
     
     
         115 . The device according to  claim 66 , wherein the components of the device or the closed system are arranged within a sterile package before sterile connection to the other closed system. 
     
     
         116 . The device according to  claim 115 , wherein the package has a smooth surface on which a disinfectant, especially 70% ethanol, can be applied.