Method for venting a system for producing a parenteral nutritional composition, and system designed therefor

Abstract

The invention relates to a method for venting a system for producing a parenteral nutritional composition, wherein the system comprises a valve unit, having a plurality of valves, and a peristaltic pump. The valves are connected on the inlet side to a plurality of source containers and on the outlet side, via a central tube, to a target container. The central tube is guided through the peristaltic pump, wherein liquids are transferred from the source containers into the target container by means of the peristaltic pump via the valve unit, and wherein a negative pressure is generated in the central tube between the peristaltic pump and the outlet of the valve unit by means of the peristaltic pump before a valve of the valve unit is opened to one source container of the plurality of source containers.

Description

[0001] Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0002] Method for venting a system for the production of a parenteral nutrition composition and system designed for this purpose

[0003] Description

[0004] Field of invention

[0005] The invention relates to a method for venting a system for the production of a medical fluid, in particular a system for the production of a parenteral nutrition composition. The invention further relates to a system configured for carrying out the venting method.

[0006] Background of the invention

[0007] Systems for the production of a parenteral nutrition composition, also known as PN or TPN compounders, are known.

[0008] Using such a system, an individually prepared parenteral nutrition composition can be provided based on a patient-specific prescription. The individual components of the parenteral nutrition composition are taken from source containers and transferred to a target container, which can then be used for the patient.

[0009] In addition to components of a parenteral nutrition composition, the product can also include pharmaceuticals that can likewise be dosed via the system. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0010] Disclosure document WO 2017 / 158011 Al shows such a plant for the production of a parenteral nutrition composition.

[0011] The system includes, among other things, one or more valve units, which are connected to the source container(s) on the inlet side via connecting hoses. The valve unit is then connected to the destination container on the outlet side via a central hose. The central hose is inserted into a pump or peristaltic pump.

[0012] The pump, in this case a peristaltic pump, transfers the liquids from the source containers to the target container. The system includes a control unit that operates the valves of the valve assembly. By opening the valve connected to each source container, the individual components of the food composition can be dispensed.

[0013] The valve unit, including connecting hoses, is specifically designed as a disposable component, which is replaced with a new one after a defined period of use.

[0014] To ensure sufficiently precise liquid delivery, the supply system to the pump must be as free as possible from gas bubbles, e.g., air bubbles. Therefore, in order to use the system for product manufacturing after installing the valve unit and connecting the hoses, the valve unit and hoses must first be vented.

[0015] This is achieved, according to the aforementioned state of the art, firstly by means of the conveying device, here the peristaltic pump, by means of a universal liquid (water or a Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0016] similar universal component) is pumped into the valve unit and the central hose until at least the valve unit and the central hose between the valve unit and the hose pump are filled with liquid.

[0017] The connecting hoses to the source containers are then filled with liquid by opening the respective valve and drawing liquid into the hose via the peristaltic pump until it is completely filled. To complete the venting process, the valve unit and central hose are flushed again with universal liquid to ensure that no relevant residual components from the other source containers remain in the valve unit or central hose when the system is subsequently used to manufacture the product. The flushing process may need to be repeated several times to achieve a state as free of gas bubbles as possible within the hose system.

[0018] The target container used for venting (“waste-bag”) is removed and a new target container is connected, which is then filled with the product.

[0019] Object of the invention

[0020] It is an object of the invention to provide a simple and efficient method for venting a plant for the production of a medical nutritional composition.

[0021] Summary of the invention

[0022] The object of the invention is already achieved by a method according to the following general Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0023] The inventive concept is solved by a method for venting a system for producing a parenteral nutrition composition according to claim 1, and by a system designed for carrying out the method.

[0024] Preferred embodiments and further developments of the invention can be found in the dependent claims, the description and the drawings.

[0025] According to the general concept of the invention, the invention relates to a method for venting a system for the production of a medical liquid, in particular a parenteral nutrition composition.

[0026] This system uses a device comprising at least one valve unit, which is connected via channels, in particular hoses, on the inlet side to at least one source container, in particular a plurality of source containers, and on the outlet side to the target container. The valve unit, including hoses for connection, can in particular be designed as a disposable component. The target container is in particular designed as a foil bag with at least one connection.

[0027] A pump, in particular a peristaltic pump, is used to pump at least one liquid from at least one source container by opening the valve associated with the (respective) source container and switching on the pump.

[0028] According to the general concept of the invention, the invention relates to a method in which the system is vented by first switching on the pump and then, after a time delay, opening a valve associated with the (respective) source tank. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0029] In contrast to the state of the art described at the beginning, the pump is switched on before the valve is opened during the venting of the system.

[0030] It has been found that the ventilation can be significantly improved by the procedure according to the invention.

[0031] Without being bound to the theory, this effect is due to the fact that the delayed opening of the respective valve creates a pressure accumulator in the connecting channel between the pump and the valve, which serves as a vacuum reservoir.

[0032] A negative pressure below atmospheric pressure, i.e., a vacuum, forms in the channel and possibly also in the valve unit, especially in the central hose, which leads to the respective channel between the source tank and the valve unit being flushed with an increased flow velocity after the valve is opened.

[0033] In a first embodiment of the invention, the pressure accumulator can be provided by the volume present in the connecting channel, in particular the central channel, between the valve unit and the pump. The connecting channel between the valve unit and the pump is first evacuated. Due to the resulting negative pressure in the channel, the fluid flows from the respective source reservoir towards the pump at a higher flow velocity when the valve is opened.

[0034] Furthermore, according to one embodiment of the invention, a pressure equalization vessel, in particular a diaphragm expansion vessel, can be connected. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0035] In a preferred embodiment of the invention, the pressure accumulator is provided by an elastic component that contracts against a preload under negative pressure. A central hose connecting the valve unit to the pump can be used for this purpose. When the pump is switched on, the hose contracts due to the volume extracted by the pump. The resulting restoring forces of the hose then provide a simple pressure accumulator without the need for an additional component.

[0036] This creates a pressure reservoir, especially when the hose is completely filled with liquid. After the pump has filled the pressure reservoir, if the valve is opened, the hose's expansion and contraction results in an increased negative pressure in addition to the pressure generated by the pump.

[0037] The system, particularly with regard to the pressure accumulator and pump, is preferably configured such that the pressure accumulator is charged in such a way that its capacity is sufficient to store at least the volume which is present in the respective channel between the source tank and the valve unit.

[0038] The capacity and maximum vacuum of the pressure accumulator can be adjusted, in particular, by its material, volume, diameter, and the level of vacuum applied to the accumulator. Possible hose materials include polypropylene, PVC, and / or silicone.

[0039] For example, in the case of a source tank whose channel to the valve unit has a smaller internal volume than another source tank, the Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0040] The initial pressure in the pressure accumulator can be reduced by drawing less volume from the other source vessel. This can be achieved, for example, by adjusting the time delay between switching on the pump and opening the valve, and / or by adjusting the pump's flow rate. The flow rate of a peristaltic pump, for instance, can be adjusted by changing the rotor speed.

[0041] Preferably, the system includes a control unit with a non-volatile memory in which, for example, values ​​or value ranges for the time offset and / or the volume flow of the pump during the venting step are stored, assigned to the respective channels and / or source tanks.

[0042] After venting, the system can be used to manufacture medical containers.

[0043] For this purpose, the first target container (“waste-bag”) is removed and a second target container is connected, which is filled with the medical fluid (“product”).

[0044] During the product manufacturing process, when transferring the liquids from the source containers, the respective valve is preferably opened first, and only then is the pump switched on. The delayed opening of the valve after switching on the pump is therefore preferably only carried out during the venting step.

[0045] This allows for more precise verification of the quantities extracted from the source containers, taking into account the pumping time and, if necessary, with additional calibration using a scale that weighs the target container. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0046] The general inventive concept can also be combined with the features described below, wherein, in each case, instead of connecting hoses and a central hose via which the valve unit is connected, other channels are used and / or instead of a peristaltic pump, a different pump is used and / or a system for the production of any medical fluid is vented.

[0047] According to independent claim 1, the invention is described by a method for venting a system for producing a parenteral nutrition composition, wherein the system comprises at least one valve unit with at least one valve and a pump, preferably a peristaltic pump, wherein the at least one valve is connected on the inlet side to at least one source container and on the outlet side via a central hose to a target container, and the central hose is guided through the pump, preferably a peristaltic pump, wherein liquid is transferred from the at least one source container to the target container via the valve unit by means of the pump, preferably a peristaltic pump, characterized in that a vacuum is generated in the central hose between the pump, preferably the peristaltic pump, and the outlet of the valve unit by means of the pump, preferably a peristaltic pump.before at least one valve of the valve unit is opened to the source container.

[0048] In the case of a valve unit with a plurality of valves, with several valve units and / or with a plurality of source vessels, the invention can also be described as follows: Method for venting a system for the production of a parenteral nutrition composition, wherein the system comprises a valve unit with a plurality of valves and a peristaltic pump, wherein the valves are connected on the inlet side to a plurality of source vessels and on the outlet side via Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0049] a central hose is connected to a target container and the central hose is guided through the peristaltic pump, wherein liquids from the source containers are transferred to the target container via the valve unit by means of the peristaltic pump, and wherein a vacuum is created in the central hose between the peristaltic pump and the outlet of the valve unit by means of the peristaltic pump before a valve of the valve unit is opened to a source container of the plurality of source containers.

[0050] As described above, a pressure accumulator can be provided via the central hose, which, through the delayed opening of the valve, at least assists in the venting of the connecting channels between the valve unit and the source containers. Due to the negative pressure present in the central hose, the connecting channels are vented at a higher flow rate than with regular pumping.

[0051] In particular, the central hose is compressed by the volume pumped by the peristaltic pump. When the valve opens, the hose relaxes, thus acting as a pressure reservoir and creating a vacuum that is present in the channel between the respective source container and the respective valve, leading to a higher flow velocity until, except for the pressure gradient generated by the pump, the pressure is equalized again through the relaxed hose.

[0052] The valve unit is preferably connected to the source vessels via connecting hoses. For this purpose, the source vessels can, for example, include a connection with a puncture-resistant sealing element. In particular, a spike or a Luer-lock connection can be used. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0053] The valve unit, along with the central hose and connecting hoses, can be provided in particular as a hose set, in which the valve unit is permanently connected to the hoses and the hoses each include a connection for a source container or the destination container.

[0054] In a further development of the invention, before the step of switching on the peristaltic pump, a channel which connects a source container of the plurality of source containers to the valves of the valve unit on the inlet side is pre-vented by passing the medical fluid through it.

[0055] In particular, the connecting hoses between the valve unit and the source containers are pre-vented.

[0056] Pre-venting is carried out in particular by opening the respective valve assigned to the source container and then switching on the peristaltic pump to direct the medical fluid through the channel, in particular through the connecting hose, towards the central hose.

[0057] Pre-venting therefore takes place without charging the pressure accumulator. It has been shown that pre-venting further improves the efficiency of the venting process.

[0058] Preferably, the peristaltic pump is switched off after pre-venting, and only then is the inventive step of venting carried out by switching on the peristaltic pump before opening the respective valve.

[0059] The time interval between switching on the peristaltic pump and opening the valve and / or a volume flow generated by the peristaltic pump is determined according to a design of Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0060] The invention is adjusted depending on the respective connecting hose.

[0061] In particular, the charging of the pressure accumulator can be adjusted via the speed of the peristaltic pump and / or the time interval between switching on the peristaltic pump and opening the valve.

[0062] Depending on the volume of the respective connecting hose, the pressure accumulator will be loaded to a greater or lesser extent.

[0063] Preferably, a volume is taken from the pressure accumulator during loading which corresponds at least to the volume of the respective connecting hose, preferably at least 1.5 times the volume of the respective connecting hose, in particular 1.5 to 5 times the volume of the respective connecting hose.

[0064] This ensures that the entire volume of the respective connecting hose is drawn through the valve unit with the support of the pressure accumulator.

[0065] In particular, the peristaltic pump can be switched on for a period of 100-1000 ms until the respective valve opens.

[0066] In one embodiment of the invention, at least two source containers with different volumes of medical fluid are connected.

[0067] Smaller source containers can be used particularly for so-called micro-quantities. For example, in the case of a

[0068] According to the embodiment of the invention, a very small quantity with a volume of less than 10 ml, in particular less than 5 ml, is transferred from at least one source container into the target container. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0069] transferred. Such micro-quantities are used in particular for the dosing of pharmaceuticals.

[0070] According to one implementation method, fluid with a volume exceeding 15 ml is transferred from at least one additional source container to the target container, in particular with a volume of 15–5000 ml. These so-called macro quantities can be, in particular, the main components of the parenteral nutrition composition as well as the universal fluid. Besides water, a parenteral nutrition composition contains as its main components a glucose solution, an amino acid solution, and a fat emulsion.

[0071] Furthermore, connecting tubes with at least one small and at least one larger diameter can be provided. In particular, the connecting tubes through which micro-quantities are dosed are thinner than the connecting tubes through which the main components of the parenteral nutrition composition are dosed.

[0072] During the step of venting a small diameter connecting hose, in particular 3-15 ml, especially 4-10 ml, volume can be transferred towards the target container.

[0073] To vent a connecting hose with a larger diameter, 20-100 ml, especially 25-60 ml, of volume can be transferred towards the target container.

[0074] The peristaltic pump can be operated with a flow rate of 1-25 ml / s. The flow rate can be adjusted via the speed of the peristaltic pump.

[0075] Preferably, a system is used which has a

[0076] includes non-volatile memory in which the Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0077] Time intervals between switching on the peristaltic pump and opening the valve and / or flow rates are stored for connecting hoses and / or source containers.

[0078] In particular, minimum and / or maximum values ​​assigned to the respective connecting hose and / or source tank can be stored in the memory. This ensures that the user cannot configure the system in such a way that only a minimum volume is drawn from the pressure tank, which is insufficient to vent the respective connecting hose.

[0079] At the same time, maximum values ​​can be used to ensure that, especially in the case of source containers, micro-quantities are dispensed and that unnecessary amounts of liquid are not removed, which are then discarded with the waste bag.

[0080] In a further development of the invention, the medical fluid can be checked using a bubble sensor. The bubble sensor can be arranged, in particular, downstream or upstream of an outlet of the peristaltic pump. The bubble sensor can be used, in particular, during the venting and / or pre-venting steps to check whether bubbles are still present in the central tubing. Furthermore, the bubble sensor can be used as an additional safety feature during the manufacturing of the product.

[0081] In a further development of the invention, the target container is weighed to verify the amount of liquid transferred into it. Particularly during the production of the usable product, the dosage can be determined by weighing the target container, taking into account the inlet and / or outlet characteristic curve of the peristaltic pump as well as the sequence and distribution of the liquid flow through the central hose. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0082] The guided components of the parenteral nutrition composition are verified.

[0083] According to one implementation form, at least three source tanks or, in particular, 1-36 source tanks are vented.

[0084] At least one source container can be hung with the connection facing downwards. Particularly with source containers that hang upside down, there is an increased likelihood of bubbles forming in the connecting hose.

[0085] The source containers can be designed to be collapsible. Examples of such collapsible containers include bags and plastic bottles. However, the source containers can also be non-collapsible. These must then be vented when dispensing liquid. Possible examples of non-collapsible containers include glass bottles or vials.

[0086] In one embodiment of the invention, the venting step is repeated for at least one source tank by switching on the peristaltic pump before the respective valve is opened. In this way, at least one source tank can be vented at least twice using the pressure accumulator.

[0087] The invention further relates to a method for producing a parenteral nutrition composition, in which the system used for this purpose is vented by the method described above.

[0088] The invention further relates to a system for venting a medical preparation, wherein the system comprises a control unit with a non-volatile memory in which a Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0089] A program for executing a procedure described above is stored.

[0090] The system may include, in particular, an input device, such as a touch display, through which a ventilation program can be selected and started.

[0091] In particular, the input device allows the user to select the time interval between switching on the peristaltic pump and opening the valve, the volume for venting and / or the flow rate during venting.

[0092] The non-volatile memory may contain minimum and / or maximum values, in particular those assigned to the respective connecting hose and / or source container, for the time period between switching on the peristaltic pump and opening the valve, the volume for venting and / or the flow rate during venting.

[0093] This allows the user to easily increase the load of the pressure reservoir if isolated bubbles form in certain source containers, leading to product rejection.

[0094] Brief description of the drawings

[0095] The subject matter of the invention will be explained in more detail below with reference to the drawings Fig. 1 - Fig. 6.

[0096] Fig. 1 is a schematic representation of a system used for the method according to the invention.

[0097] Fig. 2 shows the switching of the valve and pump during

[0098] Before venting.

[0099] Fig. 3 shows the switching of the valve and pump during venting. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0100] Fig. 4 shows the switching of the valve and pump during venting with pre-venting.

[0101] Fig. 5 is an embodiment in which the venting is carried out repeatedly.

[0102] Fig. 6 is a flowchart of an embodiment of the method according to the invention.

[0103] Detailed description of the drawings

[0104] Fig. 1 shows a schematic representation of a system as it can be used for the method according to the invention.

[0105] The system includes the valve unit 10, which includes inlets 14a-14f to which connecting hoses 3a-3d are attached to connect the source tanks la-ld to the valve unit 10.

[0106] The connecting hoses 3a-3d are preferably permanently connected to the valve unit 10 and are coupled to a connection 7 of the respective source container 1a-1d, for example with a Luer-Lock connection or with a piercing pin. Additional valve units can be connected via the central channel 12.

[0107] The outlet 13 of the valve unit 10 is coupled to a central hose 4, which is connected to the port 7 of the target container 2 by the peristaltic pump 5, which is only shown schematically.

[0108] The peristaltic pump 5 is designed such that in every position of the rotor at least one roller is engaged with the Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0109] The central hose 4 is engaged. The number of rollers must be greater than or equal to 2 so that no fluid can flow back and fluid can be continuously transferred towards the target container 2 by the peristaltic pump 5. This creates a negative pressure in the central hose 4 on the inlet side of the peristaltic pump 5, which depends on the volume of fluid extracted and the restoring force of the central hose 4. If gas, especially air, is still present in the central hose 4 and / or the valve unit 10, this gas, which is compressible (unlike a liquid), also acts as a pressure accumulator, effectively creating a negative pressure.

[0110] provided.

[0111] The valve unit 10 includes the valves lla-llf, which may, for example, include a rotatable valve plug in order to open the valve lla-llf, and thus a fluid connection to the respective source container la-ld, by turning the plug.

[0112] In the embodiment shown here, the valves lla-llf are located in a single housing. The outlet of each valve lla-llf leads into a central channel 12, which opens into the central hose 4.

[0113] The opening and closing of valves 11a-11f is effected by actuators of the system (not shown), which are controlled by the system's controller 20. Opening a valve 11a-11f establishes a fluid connection between the respective connecting hose 3a-3d and the central channel 12 of the valve unit 10. The medical fluid can now be transferred from the respective source container 1a-11f to the target container 2 via the peristaltic pump 5.

[0114] Furthermore, in this embodiment, the system includes a scale 6, which serves in particular to validate the quantities transferred into the target container 2. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0115] The system further includes the schematically depicted control unit 20, which may include an optional display 21 for configuring the system. The control unit may, in particular, include a PC, e.g., a laptop. The PC may, in particular, provide a user interface for the control unit.

[0116] According to the inventive method, a target container 2, which serves as a waste bag, is first connected to the central hose 4. To improve the venting of the connecting hoses 3a-3d, the peristaltic pump 5 is started. This creates a vacuum in the central hose 4. Even if the central hose 4 is already filled with medical fluid, it contracts due to the extracted volume and forms a pressure reservoir due to the restoring forces of the hose wall. Then, the valves 11a-11f are opened sequentially, and the respective connecting hose 3a-3d can each be vented, at least with the assistance of the pressure reservoir formed by the central hose 4.

[0117] Preferably, at least during the venting step, only a single valve lla-llf is open at any given time.

[0118] The venting step with the support of the pressure accumulator can also be performed for only a single source tank la-ld or a part of the source tanks la-ld.

[0119] The source containers la-ld and the connecting hoses 3a-3d can be of different sizes.

[0120] For example, the source container Id can be used to dispense a micro-quantity, particularly of a pharmaceutical. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0121] Larger source containers la-lc which are connected to the valve unit 10 via connecting hoses 3a-3c which have a larger diameter than another hose 3d, can, for example, contain the universal liquid, i.e. water, as well as the main components of a parenteral nutrition composition.

[0122] In Fig. 2, the switching of valve lla-llf and pump 5 is dimensionless with respect to time during pre-venting.

[0123] worn on.

[0124] During pre-venting, a valve lla-llf is first opened, then the pump 5 is switched on with a time delay.

[0125] Depending on a pre-set or stored time interval, pump 5 is switched off again and valve lla-llf is then closed. During pre-venting, connecting hoses 3a-3d are filled with fluid.

[0126] Pre-venting corresponds to the venting step according to the aforementioned state of the art and the procedure used in the manufacture of the usable product.

[0127] Therefore, the pressure accumulator is not charged during the production of the usable product, as this could impair the accuracy of the dosing.

[0128] Fig. 3 shows in a corresponding representation the switching of valve lla-llf and pump 5 during the venting step according to the invention.

[0129] First, pump 5 is switched on, creating a vacuum which charges the pressure accumulator, in the form of the central hose 4, with a vacuum. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0130] The respective valves 11a-11lf are then opened after a time delay, so that the respective connecting hose 3a-3d is vented with the assistance of the pressure accumulator. To end the venting process for a connecting hose 3a-3d, the pump is first switched off and then the respective valve 11a-11lf is closed.

[0131] Fig. 4 shows a corresponding embodiment in which pre-venting is carried out as shown in Fig. 2. After pre-venting, the pump 5 is switched off, then switched on again and the respective valves 11-15 are opened after a time delay.

[0132] As shown in Fig. 5, venting and / or pre-venting can also be performed repeatedly. In the method shown in Fig. 5, pre-venting is carried out, then vented with the assistance of the pressure accumulator, then pre-vented again, and finally vented once more with the assistance of the pressure accumulator. Such repetition of the venting steps can significantly reduce the likelihood of bubbles, particularly in the case of connecting hoses 3a-3d that are difficult to vent, such as a connecting hose 3a-3d for a grease emulsion.

[0133] Fig. 5 is a flowchart of an embodiment of the method according to the invention.

[0134] First, a transfer or hose set, comprising the valve unit 10, the central hose 4, and the connecting hoses 3a-3d, is attached to a destination container 2 and the source containers 1a-1ld and connected. The valve unit 10 is then attached, e.g., snapped onto a carrier with the actuators for the valves 11a-11f. Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO

[0135] The user can select and start a venting program on display 21.

[0136] First, universal fluid is transferred from a first source container 1a to the target container 2 via the peristaltic pump 5. Specifically, valve 1e can be opened first, and then the peristaltic pump 5 can be started. The source container 1a is filled with universal fluid, which is now pumped towards the target container 2.

[0137] The valve unit 10, in particular the central channel 12 of the valve unit 10 and the central hose 4 are now filled with medical fluid.

[0138] The connecting hoses to the other source containers Ib-lc are then pre-vented. Connecting hoses 3b-3c are now also filled with liquid.

[0139] The next step involves venting the connecting hoses 3a-3d to the source containers la-ld according to the invention, supported by the negative pressure created by switching on the peristaltic pump 5 and opening the respective valve lla-llf with a time delay.

[0140] This step can optionally be repeated.

[0141] To complete the venting process, the valve unit 10 and the central hose 4 are flushed with universal fluid. This ensures that no relevant quantities of the medical fluids from the source containers Ib-lc are present in the central hose 4.

[0142] The first target container 2, which serves as a waste bag, is discarded and a second target container (Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO) is attached to the now vented system.

[0143] 2 connected and filled for the production of a parenteral nutrition composition.

[0144] The invention made it possible to improve the venting of a system for the production of a medical liquid, in particular a parenteral nutrition composition, in a simple way.

[0145] Reference symbol list

[0146] la-ld source container

[0147] 2 target containers

[0148] 3a-3d connecting hose

[0149] 4 Central hose

[0150] 5 Hose pump / Pump

[0151] 6 Scales

[0152] 7 connection

[0153] 10 valve unit

[0154] lla-llf valve

[0155] 12 Central Channel

[0156] 13 Exit

[0157] 14a-14f Entrance

[0158] 20 Control

[0159] 21 Display

Claims

Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO Patent claims 1. Method for venting a system for the production of a parenteral nutrition composition, wherein the system comprises at least one valve unit ( 10) with at least one valve ( lla-llf ) and a peristaltic pump (5), wherein at least one valve (lla-llf) is connected on the inlet side to at least one source container (la-ld) and on the outlet side via a central hose (4) to a target container (2) and the central hose (4) is guided through the peristaltic pump (5), wherein liquid is transferred from the source container (1a-1ld) via the peristaltic pump (5) through the valve unit (10) into the target container (2), characterized in that a vacuum is generated in the central hose (4) between the hose pump (5) and the outlet (13) of the valve unit (10) by means of the peristaltic pump (5) before the valve (10a-10f) of the valve unit (10) is opened to the source container (1a-10ld).

2. Method according to the preceding claim, characterized in that a plurality of source vessels ( laid) are connected and / or that the valve unit ( 10) is provided with a plurality of valves ( lla-llf ).

3. Method according to one of the preceding claims, characterized in that the valve unit ( 10 ) is connected to the source containers ( laid ) via connecting hoses (3a-3d ). 23 Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO 4. Method according to one of the preceding claims, characterized in that, prior to the step of switching on the peristaltic pump (5), a channel, in particular the respective connecting hose (3a-3d) which connects a source container (laid) of the plurality of source containers (la-ld) on the inlet side to the valves of the (lla-llf) of the valve unit (10), is pre-vented by passing the medical fluid through it, in particular wherein the peristaltic pump (5) is switched off after the pre-venting step.

5. Method according to one of the preceding claims, characterized in that a time interval between switching on the peristaltic pump (5) and opening the valve (10a-1Of) and / or a volume flow generated by the peristaltic pump (5) is set depending on the respective connecting hose (3a-3d).

6. Method according to one of the preceding claims, characterized in that, that the peristaltic pump (2 ) is operated with a flow rate of 1 to 25 ml / s, and / or that the peristaltic pump (5) is switched on 100 to 1000 ms before the respective valve is opened.

7. Method according to one of the preceding claims, characterized in that, that a minute quantity with a volume of less than 10 ml, in particular less than 5 ml, is transferred from at least one source container (a-ld) into the target container (2), and / or that liquid with a volume greater than 20 ml is transferred from at least one source container (1a-1ld) into the target container (2). Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO 8. Method according to one of the preceding claims, characterized in that the connecting hoses (3a-3d) are provided with at least one small and one large diameter.

9. Method according to one of the preceding claims, characterized in that, that a volume of 3 to 15 ml, in particular 4 to 10 ml, is transferred towards the target container (2) to vent the connecting hose (3a-3d) with the small diameter, and / or that to vent the connecting hose with the larger diameter (3a-3d) a volume of 10 to 100 ml, in particular 25 to 60 ml, is transferred towards the target container (2 ).

10. Method according to one of the preceding claims, characterized in that a system is used which includes a storage unit in which time intervals between switching on the peristaltic pump (5) and opening the valve (10a-11of) and / or volume flows assigned to the connecting hoses (3a-3d) and / or the source containers (1a-11d) are stored.

11. Method according to one of the preceding claims, characterized in that the medical fluid is checked on the outlet side of the valve unit ( 10) by means of a bubble sensor, in particular wherein the bubble sensor is arranged behind or in front of an outlet of the peristaltic pump (5 ).

12. Method according to one of the preceding claims, characterized in that that the target container (2) is weighed in order to determine the amount of liquid transferred into the target container (2) Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO check, and / or that at least three source tanks (la-ld) or 1 to 36 source tanks (la-ld) are vented.

13. Method according to one of the preceding claims, characterized in that that the source containers (la-ld) are designed to be collapsible or are ventilated, and / or that at least one source vessel (la-ld) is suspended with the connection (7) facing downwards.

14. Method according to one of the preceding claims, characterized in that source containers (1a-1ld) containing water, a glucose solution, a lipid-containing emulsion and / or an amino acid solution are connected to the valve unit.

15. Method according to one of the preceding claims, characterized in that a first target container (2 ) is used as a “waste bag” for venting, which is discarded after venting, in particular wherein after discarding the first target container (2 ) a second target container is connected which is filled with the parenteral nutrition composition.

16. Method according to one of the preceding claims, characterized in that the step of venting by switching on the peristaltic pump (5) before the respective valve is opened is repeated for at least one source vessel (1a-1ld).

17. Method for the production of a parenteral nutrition composition comprising a method 26 Fresenius Kabi Deutschland GmbH FK25038-05-PAT-WO for venting according to one of the preceding claims.

18. Plant for the production of a medical preparation, wherein the plant comprises a control unit with a non-volatile memory in which a program for the execution of a method according to one of the preceding claims is stored.

19. System according to the preceding claim, characterized in that minimum and / or maximum values ​​for the time interval between switching on the peristaltic pump (5) and opening the valve (11a-11f), for the volume for venting and / or for the volume flow during venting are stored on the non-volatile storage medium and are assigned to the respective connecting hose (3a-3d) and / or the source container (11a-11f).

20. System according to one of the preceding claims, characterized in that the system comprises an input device (21) by which a time interval between switching on the peristaltic pump (5) and opening the valve (1a-1lf) can be selected, the volume for venting and / or the volume flow rate during venting. TI

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