Method and arrangement for making up preparations

[0001] The invention relates to a method of filling a container with a formulation containing a plurality of liquid components. For example, this method is used to prepare injection preparations. Usually, the preparation must be done aseptically, which, according to the principles of this art, takes place inside a room with controlled environmental parameters by people who are dressed in sterile clothes that are admitted to this room with controlled environmental parameters by a security system. Preparation prepared in this way is expensive and cleaning is difficult. In addition, controlling the composition of the injection preparation is virtually impossible.

[0002] According to the method of the invention, the ingredients are stored in rows of base containers. Based on the recipe provided, the robot selects containers containing the ingredients listed in the prescription and using the controller causes a specific amount of ingredient to flow out of the selected base container, as determined by the prescription on the container. The method according to the invention can be carried out inside a small aseptic room, without the intervention of human hands. In addition, the likelihood of doing the wrong preparation by a robot is much less than the likelihood of it being done by a human. To make many preparations, many base containers and many containers can be brought inside the aseptic room through the aseptic closing airlock and from where then this preparation is taken. Usually, the aseptic room is again sterilized, for example after performing these activities. By using the sluice it is possible to install the device virtually anywhere.

[0003] The method according to preamble 1 of claim and the device according to preamble 7 of claim are known from US-A-2004/0017728.

The method according to the invention aims to reduce subsequent cases of the likelihood of making preparations having the wrong composition.

According to the invention, this object is achieved by means of a procedure

EP 1 753 526 B1 described in claim 1 in such a way that an identification label is placed on each base container and that the robot reads the identification label by means of a reading device behind it the controller is started. In a small number of cases, the wrong base container is placed above the container, which is detected by the robot and production is stopped and, for example, an alarm is triggered. This method is beneficial, especially for the preparation of individual preparations or preparations for special patients for whom the probability of making a mistake is relatively high when prepared by a traditional method.

[0004] A further advantageous implementation is characterized in that after the controller is started, the robot writes the data on the appropriate identification label by the writing device, so it is always obvious how much of the ingredient in question is present in the base container. If there is not enough of the right ingredient, the production process may be interrupted and, for example, an alarm may occur.

[0005] A further preferred embodiment is characterized in that each container is provided with an identification label and after the preparation of the preparation, the robot writes the identification on the identification label by means of a writing device, for example the composition of the preparation. It is possible to clearly identify the type of preparation afterwards.

[0006] A further preferred embodiment is characterized in that each container is weighed during filling and / or after filling. If inexplicable differences are found, then all preparations will, for example, be destroyed and thus the possibility of providing the wrong preparations will be prevented.

[0007] A further advantageous embodiment is characterized in that after the preparation of many preparations, the contents of the base containers are read by means of a reading device and compared with the contents of the base containers as required by the robot. If inexplicable differences are found, then all preparations will, for example, be destroyed and thus the possibility of providing the wrong preparations will be prevented.

[0008] A further preferred embodiment is characterized in that it is base

The container is a hypodermic syringe, and that the controller is a pressing device and that prior to actuation of the controller the actuating mechanism present within the subcutaneous injection syringe is activated, so you can be sure that the applied liquid components have a homogeneous composition.

[0009] The invention also relates to an apparatus for preparing preparations according to claim 7, comprising a plurality of base containers filled with liquid ingredients for the preparations and at least one container for preparing the ingredients. According to this invention, the device is housed in a closed housing and is equipped with at least one controller so that the components flow from the base containers into at least one container, which means that proper mixing can take place inside a small aseptic room, while the device control can be located outside the aseptic room. Human errors can be excluded when preparing preparations, because the device is made of a robot to drive at least one controller and to place the container under the controller outlet or to place the controller outlet above the container. Preparation of preparations and control of finished preparations can be accurately carried out, as the base containers and at least one container, each of which is provided with an identification label and the robot is equipped with a reading device for reading the identification label.

[0010] A further advantageous implementation in which the erroneous substitution of containers with final formulations can be excluded is characterized in that the robot comprises a writing device for writing on identification labels.

[0011] A further preferred embodiment of the device according to the invention is characterized in that the robot comprises a weighing device for determining the weight of the container that can be used to control the controller and / or to carry out an additional check during filling.

[0012] A further advantageous embodiment of the device according to the invention is characterized in that the robot comprises an input device into which a list of ingredients of a given container can be introduced. At a time when the list of ingredients remained

Once introduced, the device can fill these containers completely automatically. [0013] A further preferred embodiment of the device according to the invention is characterized in that the base container is a hypodermic syringe and the controller comprises a pressing device.

[0014] A further advantageous embodiment of the device according to the invention is characterized in that the device comprises drive means for the mixing device and that at least several hypodermic syringes contain the mixing device, so it can be ensured that the liquid components applied have a homogeneous composition.

[0015] The invention will be further elucidated with references in the following drawings in which:

Fig. 1 schematically shows a subcutaneous injection syringe fitted with a mixer in side view,

Fig. 1B schematically shows the agitator from above,

Fig. 2 schematically shows a possible example of the device according to the invention in side view,

Fig. 3A schematically shows a device with a circular magazine in a top view,

Fig. 3B schematically shows a device with a linear warehouse in a top view,

Fig. 4 schematically shows an alternative example of the device according to the invention in side view,

Fig. 5A schematically shows an alternative base container in a front view,

Fig. 5B schematically shows a base container in side view,

Fig. 6 schematically shows a device according to the invention in which the additional dispenser is in a side view,

Fig. 7 schematically shows a device comprising a robot arm, a magazine and an input device.

[0016] Fig. 1A schematically shows a hypodermic syringe 1 equipped with a side view agitator with which the formulation ingredients are to be prepared and can be delivered. Syringe for

The subcutaneous injection 1 is formed of a base container 2, a piston 3 connected to a pressing part 4 and an outlet 5, which can be provided with a valve not shown here. The base container 2 contains component 6, usually a liquid in which the substances are dissolved or present in the form of an emulsion. To ensure that component 6 is sufficiently homogeneous during preparation of the formulation, the base container 2 is equipped with a stirrer 7, here having the shape of a cross made of plastic, in which a magnet is permanently placed, which can start to rotate when the magnetic field is delivered. On the base container 2 is placed an RF device 8, well known in the art, inside which data can be stored, which data can be read by an RF medium and changed if necessary. Data on component 6 is stored, for example, in an RF device connected to the base container 2. Fig. 1B schematically shows a mixer 7 in plan view, provided with a magnetic rod 9.

[0017] Fig. 2 schematically shows in view a preferred embodiment of the device according to the invention, formed of an arm 10 to which a linear motor 11 is attached together with a pressing finger 12 which can be actuated which can push the pressing part 4 of the syringe for subcutaneous injection 1 until a predetermined amount of the component present in the subcutaneous injection syringe is excreted 1. The arm 10 is connected to a drive 13 to which the pressing finger 12 can be located above the pressing part 4 of the selected syringe for subcutaneous injection. An auxiliary arm 14 is attached to the arm 10, at the end of which the container 15 is clamped by means of a clamp 16, in such a way that the container 15 always accumulates the component excreted by the subcutaneous syringe. A hypodermic syringe containing various components can be placed in a circular warehouse in which the encapsulated drive 13 is a rotary motor. The hypodermic syringe may also be placed in a linear container in which the drive 13 is a linear motor. When preparing the formulation, the pressing finger 12 and container 15 are positioned above and below the selectable syringe for subcutaneous injection, respectively. In this example, each subcutaneous injection syringe is provided with an RF device 8, in

Which data on the current component is stored in the hypodermic needle, such as the composition and its remaining quantity. Before the linear motor 11 is started, the reading device 17 checks that the correct hypodermic syringe is placed above the container 15 and that the amount of component in the hypodermic syringe is sufficient. In this case, the desired amount is spent. The container 15 is also provided with an RF device 18 into which, for example, a formulation component can be entered by means of the writing device 19 during infusion. Furthermore, the coil assembly 20 is connected to the linear motor 11 by means of which the stirrer 7 can be rotated in a manner well known as such before the linear motor 11 is switched on. The actual dosing takes place by actuating the pressing finger 12 by means of the linear motor 11, from a given distance, but this also makes it possible to provide the clamp 16 with, for example, a load cell 21, well known in the art, by means of which the amount of ingredient prepared can be weighed.

[0018] Fig. 3A schematically shows a device with a circular magazine 22 in a top view, filled with subcutaneous syringes 1. The rotary motor 13 sets the arm 10 and the linear motor 11 in such a position that the pressing finger 12 is positioned above the syringe for subcutaneous injection and the container 15 (not shown in this figure) is placed below it, after which the linear motor 11 squeezes the desired amount of the component present from the hypodermic syringe. Fig. 3B schematically shows the device together with the linear magazine 23 in a top view, filled with hypodermic syringes 1. The linear motor 13 aligns the arm 10 and the linear motor 11 in such a way that the pressing finger 12 is located above the hypodermic syringe and container 15 (not shown in this figure) is located below it, after which the linear motor 11 from the subcutaneous injection syringe squeezes the desired amount of the component present.

[0019] Fig. 4 schematically shows another example of the device according to the invention in side view, with a rigidly mounted linear motor 11 where the pressing finger 12 can move and can press the pressing part 4 of the hypodermic syringe 1 until a predetermined amount of

In the subcutaneous injection syringe 1, the component is excreted. Below the hypodermic syringe, the container 15 is connected via clamp 16 and the sub-arm 14 to the linear motor 11, in such a way that the container 15 is positioned exactly below the subcutaneous injection syringe. In this example, a plurality of subcutaneous injection syringes 1 are placed in a circular magazine 22 so that it can be rotated by means of a rotary motor 13 until the selected subcutaneous injection syringe is placed above the container 15. Behind it, the linear motor 11 is turned on, the reading device 17 it checks if the correct subcutaneous injection syringe is selected and a series of coils 20 are activated, where the mixer 7 can be centrifuged in a known manner. The actual dosing takes place by moving the pressing finger 12 by means of the linear motor 11 from a certain distance, but it is also possible to provide, for example, a clamp 16 with a load cell 21, well known in the art by which the prepared quantity of the ingredient can be determined by weighing . It is obvious that the examples shown here can also be implemented with a linear magazine, in such cases the linear motor must be selected for drive 13. [0020] Fig. 5A schematically shows another variation of the base container in a front view, formed of a storage tank, e.g. an infusion tank 23, to which is connected an actuator 24, known in the art, comprising a coil 25, whose core 26 in the rest position by blocking the conduit 27 connected to the infusion reservoir 23, such that when a short current pulse is delivered to the coil 25, a small amount of the component present in the infusion reservoir 23 is excreted. Fig 5B schematically shows the base container in view, together with the infusion container 23, actuator 24 and conduit 27.

[0021] Fig. 6 schematically shows the device according to the invention together with a variant of the dispenser in a side view, comprising a frame 10 to which a supporting plate 28 is attached, to which is attached a series of storage containers 23, connected together with controllers 24. Practically, the container 15 is located strictly below the controller 24 to be started, in which case the earlier amount is expelled by this

The controller, of the present component in the storage container 23 connected to the controller, so that it can flow into the container 15. The arm 10 is connected to the drive 13, with which the supporting plate 28 can be moved in a direction perpendicular to the plane of the figure, until until the selected controller 24 is located above the container 15. To the arm 10, connected to the auxiliary arm 14, at the end of which the container 15 together with the clamp 16 is clamped, in such a way that the container 15 always accumulates the component prepared by the controller 24. It is advantageous, for example, when the clamp 16 is provided with a load link 21 , well known in the art, so that the amount of ingredient taken from the storage container 23 can be precisely determined. Of course, it is also possible to move the sub-arm 14 together with the drive 13, in which case the support plate 28 can be rigidly mounted. In the example shown here, the drive 13 is a linear motor, but the supplying tanks 23 filled with various components can also be placed in a circular warehouse, in which case the support plate 28 is round and the drive 13 is a rotary motor. In addition, each storage tank 23 is equipped with an RF device 8 in which data regarding the components present in the respective storage tank 23 is recorded, as is the composition and the remaining quantity. Before the controller 24 is activated, a reading device 17 is used, connected to the sub-arm 14 to check that the correct storage tank 23 is located above the tank 15 and is present in sufficient quantity. In this case, the desired component is released until the correct amount is dispensed by means of the load cell 21. The container 15 is also provided with an RF device 18, in which the formulation composition can be recorded after filling, by means of the writing device 19.

[0022] Fig. 7 schematically shows a device placed in a housing 29, together with a robot arm 30, which can take empty containers from magazine 31 and place them in clamp 16 and which delivers them with the closure and then places them in magazine 32 after filling these tanks. In addition, the input device 33 is shown, in this example the computer in which

The composition of the preparations can be introduced and which can make different variants of checking.

[0023] Before subsequent production steps begin, the filled hypodermic syringes or storage tanks with aseptic content are taken from the aseptic sluice, placed in the housing and put into storage 31, as well as aseptic containers and closures, after which further production steps. At the end of the production sequence, the containers are removed from storage 32 and put into the lock located in the housing. It is also possible to use the lock as a combined storage, in which case the lock will take over the function of storage 31.32.

[0024] The housing 29 is preferably provided with a cross flow system, known in the art, through which filtration is possible, aseptic air is guided through the system in such a direction that multiple contamination is practically excluded.

EP 1 753 526 B1