DEVICE AND METHOD FOR WEIGHING IN A CARRIER OF NESTED PHARMACEUTICAL CONTAINERS

Description

State of the art

[0001] The present invention relates to a device and a method for weighing nested pharmaceutical containers in a carrier according to the preamble of the independent claims.

[0002] In the mass production of pharmaceutical products, the problem often arises that appropriate pharmaceutical containers or vessels, e.g. syringes, ampoules, cartridges, vials or the like, must be provided and filled in a sterile manner and their fill quantity must be checked.

[0003] A device for weighing nested pharmaceutical containers in a carrier is also known from EP 2207019 A1. The features of the preamble of the present independent claims are disclosed here.

[0004] Another generic device for weighing nested pharmaceutical containers in a carrier is known, for example, from DE 102016207600 A1. In this device, a plurality of nested containers are weighed essentially simultaneously, either individually or in groups, using a plurality of independent load cells of a weighing device. Further generic devices are known, for example, from EP 2949353 B1, DE 102005014116 B4, WO 2020 / 240601 A2, or WO 2018 / 019985. For weighing, the containers are moved relative to the nest to be released onto the load cell. In this process, the containers are no longer, or only partially, within the protective nest. Disclosure of the invention

[0005] The device and method according to the invention for weighing nested pharmaceutical containers in a carrier, with the features of the independent claims, have the advantage that pharmaceutical containers can be weighed and their weight individually and easily recorded in a simple and reliable manner without increasing the complexity of the equipment and without having to remove them from the nest. According to the invention, this is achieved with the features of the independent claims by providing a device and method for weighing nested pharmaceutical containers in a carrier, wherein a plurality of the nested containers can remain in the carrier or nest by connecting a receptacle for the carrier to a weighing station, in particular with at least one load cell, for weight measurement.The removal of containers and their handling with automated grippers is a process that can occasionally require manual intervention. The solution according to the invention further reduces such manual intervention. According to the invention, the containers no longer need to be removed from the carrier, nest, or tray for weighing, but can remain in their protective outer packaging, the carrier, throughout the entire processing. Thanks to the solution according to the invention, the processes are simplified. Furthermore, an associated filling machine with fill weight control can be set up much more easily, since no container lifters or grippers are required. Trouble-prone processes such as the handling of individual containers are no longer necessary.Furthermore, the device according to the invention is characterized by its small footprint, which represents a significant cost advantage, particularly in the cleanrooms of the pharmaceutical industry. Another advantage of the described system is that the risk of packaging damage is avoided because the containers do not need to be removed from their protective outer packaging, the carrier. The risk of glass breakage when removing the containers is considered critical by both pharmaceutical manufacturers and the respective regulatory authorities, a risk that can be avoided according to the invention.

[0006] The weighing station of the present invention comprises at least two load cells connected to the receptacle at least via a plunger, preferably on opposite sides of the receptacle. This allows the use of load cells with improved weighing accuracy, even though the weighing area would otherwise be too small for the entire mass to be weighed. The accuracy of the weight measurement can thus be improved.

[0007] In proper training, the container remains in the carrier during weighing. This prevents damage that can occur during removal.

[0008] In a suitable further development, at least one filling station is provided that fills at least one container, and in particular only a single container, when the container is in the carrier and the carrier is positioned in the holder. This allows for in-process control of the fill weight, whereby all filled containers can be checked for correct weight sequentially. Only one weighing station is necessary to determine the fill weight of a filled container from the tare weight and the gross weight.

[0009] For this purpose, it is particularly advantageous that the weighing station determines a weight before the container is filled and a weight after the container is filled, and / or a weight after another container has been filled. In this way, the recorded gross weight after filling one container becomes the tare weight of the next container to be filled, without the need for an additional measuring step. This simplifies and speeds up the weight determination process.

[0010] In a suitable further development, the filling station comprises at least one arm, in particular a robotic arm, which moves at least one filling needle to fill a container. This increases the flexibility in choosing the filling points. Furthermore, an arm, especially a robotic arm, can be programmed particularly advantageously to generate low laminar airflows when moving from one filling point to the next. This reduces particle movement and is therefore particularly desirable from a pharmaceutical perspective.

[0011] Further appropriate training courses result from other dependent requirements and from the description. Brief description of the characters

[0012] With reference to the attached figures, embodiments of the invention are described in detail. Figure 1 shows a perspective side view of an embodiment of the device according to the invention for weighing nested pharmaceutical containers in a carrier. Figure 2 shows a section through the device. Figure 1 . Preferred embodiments of the invention

[0013] The following are, with reference to the Figure 1 and 2 Exemplary embodiments of the invention are described in detail.

[0014] Figure 1 Figure 1 shows a perspective side view of an embodiment of the device 10 for filling pharmaceutical containers 19 nested in a carrier 18, using an embodiment of the weighing device 22 according to the invention. Hereinafter, the filling device 10 is also referred to as the filling station 10. Similarly, the weighing device 22 is also referred to as the weighing station 22.

[0015] The filling station 10 according to the present invention has, in addition to the weighing station 22, a filling unit 15 which includes at least a filling needle 16 and a hose 14 for supplying the medium to be filled, such as pharmaceuticals.

[0016] By means of a robot arm 12, the filling unit 15 or filling needle 16 can be raised and lowered in relation to the carrier 18 and the pharmaceutical containers 19 contained therein.

[0017] The in Figure 1 The illustrated carrier 18 for receiving the pharmaceutical containers 19 consists of a carrier body. Recesses extending completely through the carrier body are formed in which the pharmaceutical containers 19 can be received completely through the recesses, the pharmaceutical containers 19 being supported by their shape against a respective seat on the upper side of the carrier body, so that they do not fall downwards through the carrier 18.

[0018] The carrier 18 with the containers 19 is arranged in a receptacle 20. The receptacle 20 is designed, for example, as a retaining frame and surrounds the carrier 18, particularly for positive locking and retention. The receptacle 20 has a corresponding recess so that the carrier 18 can be placed into the receptacle 20 from above and set down. The carrier 18 is slightly widened at least on one, preferably two, sides. The receptacle 20 is connected to a weighing station 22. This is done, for example, via at least one plunger 28, which interacts with at least one load cell 24, 26 of the weighing station 22 for the purpose of weight detection. In the exemplary embodiment, the weighing station 22 comprises two load cells 24. Here, the two outer sides of the receptacle 20, which enclose the carrier 18, are each connected to the two load cells 24, 26 via corresponding plungers 28.Several load cells 24, 26 are used to enable the use of load cells 24, 26 with improved weighing accuracy, even though the weighing range would be too small for the entire mass to be weighed. At least one plunger 28 is provided for connecting one side of the receptacle 20 to each load cell 24, 26. Preferably, several plungers 28 are provided for connecting one side of the receptacle 20 to each load cell 24, 26; in the exemplary embodiment, three plungers 28 are used.

[0019] These and other features and properties of the present invention are further explained below: The complete carrier 18 with containers 19 placed therein is placed on the receptacle 20 by means of a suitable transport device. The transport device detaches from the carrier 18, so that the carrier 18, with its weight and that of the containers 19 arranged therein, acts on the receptacle 20 and thus on the weighing station 22.

[0020] The next processing step then takes place there. As already described, the recording device 20 for weight detection is connected to the weighing station 22 and the associated load cells 24 and 26. First, the weighing station 22 records the tare weight. The tare weight thus includes the weight of the carrier 18 as well as the weight of all containers 19 located in the carrier 18, all of which are empty before the first filling process.

[0021] Subsequently, a single container 19 is filled, for example, with a medication. The weighing station 22 then determines the gross weight. The gross weight thus includes the weight of the carrier 18 as well as the weight of all containers 19 within the carrier 18, one of which is filled after the initial filling process.

[0022] The difference between the gross weight and the tare weight yields the fill weight. The determined gross weight (from the previous filling) can be used as the tare weight for the subsequent filling. This is followed by the filling of another container 19. The gross weight is again determined after the subsequent filling of the next container 19. The difference between the current gross weight and the previous gross weight yields the fill weight of the next container 19.

[0023] The described procedure is repeated for each additional container 19 to be filled until all containers 19 of the carrier 18 are filled and weighed. Normally, all containers 19 are filled; however, it is also possible that not all containers 19 are filled.

[0024] It should be emphasized that the containers 19 always remain in the carrier 18 during weighing; they are not released, lifted, etc. The measured fill weight is checked to ensure it matches the target fill weight. In case of unacceptable deviations, countermeasures are initiated, such as removing incorrectly filled containers 19 and / or issuing appropriate warnings, for example, to check the filling station 10. If the fill level is too low, the missing amount can be added instead of removing the cutlery container 19. It is also possible to implement a weighing and dosing function. In this function, the fill quantity is determined by the weighing result. Filling stops when the target weight is reached.

[0025] The filling of the containers 19 in the carrier 18 can, for example, be carried out using a suitably programmed arm, such as the robot arm 12. This arm is designed, or its movement path is programmed, in such a way that the laminar airflow is disturbed as little as possible. This increases the safety of the arrangement by reducing the movement of particles.

[0026] The sealing of the filled containers 19 takes place in a subsequent step, as the weight of the seals could distort the weighing result at the weighing station 22. Therefore, the carrier 18 with the filled containers 19 is removed from the receiving station 20 and taken to a sealing station. The containers 19 are sealed at the sealing station. Alternatively, it is also possible to seal each container 19 directly after filling. In this case, a new tare value simply needs to be determined before the next filling process begins.

[0027] With the described system, a filling machine with in-process weight control (IPC) can be set up much more simply, since no ejectors or container grippers are required. Trouble-prone processes, such as the handling of individual containers 19, can be eliminated. This is achieved by including the carrier 18 and the other containers 19 in the tare and gross weight of the container 19 to be filled.

[0028] The described system is particularly suitable for single-digit filling machines with low output, since individual fillings are necessary one after the other and parallel filling of several containers 19 is not possible.

[0029] The present invention relates in particular to the determination of the fill weight of pre-filled syringes, vials, or cartridges as containers 19, e.g., according to DIN-ISO 11040-4, which are already cleaned and sterilized, e.g., in packaging according to DIN-ISO 11040-7, and fed to a filling machine 10. Several containers 19 are nested in a plastic carrier plate 18, also called a nest or tray, and arranged therein in several rows. Other pre-configured container shapes in carrier plates or magazines are also suitable for this purpose.

[0030] For the IPK of such containers 19, the present invention is based on systems in which the containers do not have to be removed from the nest or released for weighing.

[0031] Weighing can be performed before inserting a container closure, piston stopper, or similar item, as these components would distort the result due to their additional weight. Alternatively, it is also possible to close the respective container 19 immediately after filling. In this case, a new tare value simply needs to be determined before the next filling takes place. This takes the additional weight of the closure into account.

[0032] Because the weighing process takes place directly below the filling point, the known methods for avoiding loss of filling material during filling in carrier 18 or nest can also be applied.

[0033] A filling machine 10 according to the invention therefore also has a smaller space requirement, which is a significant cost issue in the cleanrooms of the pharmaceutical industry.

[0034] Furthermore, the described system makes it easy to weigh all containers or syringes, not just a sample. This is achieved with the previously described short weighing time. This is referred to as 100% intermittent quality control (IPC).

[0035] Another advantage of the described system is that the risk of packaging damage is avoided because the containers 10 do not need to be lifted out of the protective nest 40. The risk of glass breakage when removing the containers 10 is considered critical by both pharmaceutical manufacturers and the FDA.

[0036] Although syringes were mentioned in connection with the present invention, the inventive method and system are also able to handle and weigh any nested pharmaceutical containers, e.g. vials, ampoules or cartridges, in the same way, if necessary by using suitable format parts.

Claims

1. Device for weighing a plurality of pharmaceutical containers (19) nested in a carrier (18), comprising at least one weighing station (22), at least one receptacle (20) being provided for the carrier (18) of the containers (19), the receptacle (20) being connected to the weighing station (22) for weight measurement and characterized in that the weighing station (22) comprises at least two or more weighing cells (24, 26), each of which is connected to the receptacle (20) via at least one stem (28), preferably on opposite sides of the receptacle (20).

2. Device according to claim 1, characterized in that during weighing the container (19) remains in the carrier (18).

3. Device according to either of the preceding claims, characterized in that at least one filling station (10) is provided which fills at least one container (19) when the container (19) is located in the carrier (18) and the carrier (18) is arranged in the receptacle (20).

4. Device according to any of the preceding claims, characterized in that the weighing station (22) determines a weight before the container (19) is filled and / or determines a weight after the container (19) has been filled and / or determines a weight after another container (19) has been filled.

5. Device according to any of the preceding claims, characterized in that the filling station (10) comprises at least one arm, in particular a robot arm (12), which moves at least one filling needle (16) for filling a container (19).

6. Method for weighing a plurality of pharmaceutical containers (19) nested in a carrier (18), characterized by the following steps: - the carrier (18) with the containers (19) to be filled therein is brought into a receptacle (20), the receptacle being connected to a weighing station (22) for weight measurement, characterized in that - the weighing station (22) comprises at least two or more weighing cells (24, 26), each of which is connected to the receptacle (20) via at least one stem (28), preferably on opposite sides of the receptacle (20), - when the carrier (18) is in the receptacle (20), the weighing station (22) measures the weight.

7. Method according to the preceding method claim, characterized in that a container (19) is filled and in that the weighing station (22) then measures the weight.

8. Method according to any of the preceding method claims, characterized in that another container (19) is filled and the weighing station (22) measures the weight after it has been filled.

9. Method according to any of the preceding method claims, characterized in that the filling weight is determined from the weight determined after the container (19) has been filled and from the weight determined before the container (19) is filled.

10. Method according to any of the preceding method claims, characterized in that the filling weight of a further container (19) is determined on the basis of a weight which is determined in a previously filled container (19).

11. Method according to any of the preceding method claims, characterized in that after the last container (19) arranged in the carrier (18) has been filled, at least one container (19) is closed.

12. Method according to any of the preceding method claims, characterized in that before and / or after the container (19) has been closed, the weight is determined and / or a further container (19) is filled and / or closed and the weight of the further container (19) is determined.

13. Method according to any of the preceding method claims, characterized in that the weighing station (22) measures the weight when the carrier (18) is in the receptacle (20) and all containers (19) are in the carrier (18).