Filling device for filling containers provided in a disposable insulator

Description

[0001] The application area of ​​the present invention is in particular the metered filling of aseptic or toxic substances, for example medicines, into filling containers in a manner that protects the substances to be filled from contamination and prevents the escape of the substance to be filled into the environment.

[0002] The problem with previously known filling devices of the type considered here is that accurately recording the filling quantities was difficult or required cumbersome measures. Weighing the fill-dose containers located in a disposable isolator using a weighing device located outside the isolator during a filling process is difficult and does not yield very reliable results, since a portion of the isolator's film wall between the weighing device and the fill-dose container always interferes with the weighing. In-process control of the filling operations is difficult and inaccurate with such a procedure.

[0003] Filling devices of the type considered here have also been discussed, in which a weighing unit is designed such that a weighing pan or platform is positioned inside the disposable isolator, while the rest of the weighing unit, including controls, display, electronics, etc., is located outside the disposable isolator. This allows for a detachable, functional connection of the weighing pan or platform and the rest of the weighing unit via a sterile, sealed plug connection in the area of ​​one wall of the disposable isolator. Such an arrangement would thus allow a weighing process in which the film wall of the disposable isolator does not significantly interfere. After completion of a filling process, the weighing pan would either have to be cleaned very thoroughly or disposed of together with the disposable isolator.The weighing device can then be used for further filling processes. However, this approach has also proven to be impractical.

[0004] Furthermore, a filling device according to the preamble of claim 1 with an integrated weighing device is known from US 2016 / 0368629 A1. The use of disposable isolators in similar applications is also discussed in the article "Advantages of customer-specific foil solutions compared to stainless steel systems in containment applications" by M. Hänsel, chamanager-online.com, Hecht Technologie GmbH. A disposable isolator in a device for manually filling containers is disclosed in WO 2010 / 100234 A1.

[0005] The present invention is based on the objective of providing a filling device for the metered filling of liquid or finely powdered material from a material storage container into material dose receiving containers provided in a disposable isolator, which enables a well-controlled and precise metering of the respective filling quantities during the filling process using simple means, without contaminating components of the weighing device with the material being filled.

[0006] For this purpose, the filling device according to the invention has the features of claim 1 and, among other things, the following features: a disposable isolator with the filling material dose receiving containers provided therein, a weighing device with means for holding and weighing the filling material storage container with contents outside the disposable isolator, wherein the filling material storage container is received in or on the weighing device in readiness for weighing, A controllable dispensing device for the dose-wise removal of fill material from the fill material reservoir outside the disposable isolator, a fill material dispensing device inside the isolator for the dose-wise dispensing of fill material to the respective fill material dose receiving containers in the disposable isolator, a line arrangement connecting the fill material reservoir and the fill material dispensing device for conveying fill material removed from the fill material reservoir by means of the dispensing device to the fill material dispensing device, and a control device for controlling the fill material dispensing device depending on information from the weighing device, wherein the control device is configured to measure the respective fill material doses to be removed from the fill material reservoir depending on information about the weight loss of the unit from the fill material reservoir and its contents during the fill material dispensing.

[0007] The basic idea of ​​the present invention is therefore to determine the respective dose quantities using a weighing device located entirely outside the disposable isolator. This is achieved by monitoring the unit consisting of the supply container and its contents, which decreases in weight by the weight of the respective dispensed quantity during each filling process. The dispensing of the product from the supply container is then stopped when the weight reduction of the supply container, including its contents, equals the target weight of the respective dispensed dose. This method allows for the precise setting and documentation of dose quantities using simple means, without contaminating any components of the weighing device with the product. Therefore, it is not necessary to sterilely clean the weighing device or its components after each filling process.

[0008] A controllable peristaltic pump preferably serves as the material dispensing device. This pump applies pressure to a section of the pipe assembly designed as a pinch tube, thereby displacing the material within the tube in the desired flow direction. The components of the peristaltic pump do not come into direct contact with the material. The peristaltic pump is controllable via the control unit, allowing it to be started and stopped to initiate and terminate each filling process.

[0009] The disposable isolator can, in a manner known per se, have a preferably transparent plastic film wall that insulates the isolator's interior from the external environment, protecting it from contamination. Such disposable isolators are relatively inexpensive and can be disposed of safely and properly after use.

[0010] Preferably, the disposable isolator has glove grips, in a manner known per se, for handling objects inside the disposable isolator, in particular for handling the fill-dose containers by an operator from the outside. Using these glove grips, the operator can, for example, position the fill-dose containers into a desired filling position relative to the fill-dose dispensing device in the disposable isolator and / or close the fill-dose containers after filling with stoppers, screw caps, or the like.

[0011] According to an advantageous embodiment of the invention, the disposable isolator has means for sterilely passing the line arrangement through the isolator wall, so that the filling material can be conveyed by means of the line arrangement from the filling material storage container provided outside the disposable isolator to the dispensing device provided in the disposable isolator without risk of contamination of the outside of the disposable isolator.

[0012] The means for sterilely routing the cable assembly through the insulator wall can be push-fit connectors that, in the intended push-fit state, sterilely seal a cable section located inside the disposable insulator with a cable section leading to it from outside. When the connection is disconnected, the push-fit connectors on the disposable insulator sterilely seal the joint.

[0013] According to the present invention, the disposable insulator has connection means in its wall for connecting external lines, in particular protective gas lines, for a medium to be supplied to the interior of the disposable insulator in a contamination-protected manner, such as CO₂ or nitrogen, or clean air, such as laminar flowing air filtered by means of filters, e.g. HEPA filters. In this case as well, the connection means associated with the disposable insulator provide a sterile seal if no external line is connected.

[0014] The filling material dispensing device preferably consists of a filling needle or possibly several filling needles, through which the filling material is introduced into the filling material dose receiving containers.

[0015] The liquid reservoir can, for example, be a plastic film bag with a lower connection for the pipe arrangement.

[0016] The containers used for the dosage can be, for example, reagent vials such as medicine vials, test tubes, and the like. Preferably, the disposable isolator is equipped with closure elements for sealing the containers, so that the filled containers can be tightly sealed within the isolator before removal.

[0017] According to a particularly preferred embodiment of the invention, the control device is configured to store a value of the respective dose quantity per filled material dose container, in particular the detected dose weight, in association with the respective filled material dose containers, in order to implement in-process control and thus create the possibility of continuous monitoring of the quality of the filling processes.

[0018] An embodiment of the invention is described below with reference to the schematic representation of a filling device according to the invention. Figure 1 explained in more detail.

[0019] With 1 is in Figure 1 A disposable isolator is defined as a type of enclosed tent with walls made of transparent plastic film. The disposable isolator has two glove access holes 3 through which gloves (not shown) made of a flexible plastic material are attached, sealing them into the interior of the isolator 1 (glove box principle). An operator can access the glove access holes 3 and then, using the gloves, move and handle objects within the isolator 1. A particle counter and / or microbial sampler can be provided in the disposable isolator to monitor and ensure cleanroom quality.

[0020] The disposable isolator 1 contains vials, e.g., ampoules, serving as fill material dosing containers 5, into which, for example, a toxic liquid material is to be dosed. The filling process must be carried out in such a way that the exterior of the disposable isolator 1 is not contaminated in any way by the fill material.

[0021] The filling material is initially located in a filling material reservoir 7 outside the disposable isolator 1. The filling material reservoir 7 can, for example, be a foil bag which has a filling material outlet 9 on its underside with a line section 11a of a line assembly 11 connected to it in a sealing manner to the outside. This line assembly 11 serves to convey the filling material from the reservoir 7 to the disposable isolator 1 and further within it to a filling needle 13, which functions as a filling material dispensing device inside the disposable isolator 1. The line assembly 11 essentially consists of a flexible plastic tube which is guided through a peristaltic pump 17 at 15 and forms the pinch hose section of the peristaltic pump 17. The filling material contained therein is forced forward towards the disposable isolator 1 in the desired flow direction by a tube pinching process.This is followed by a conductor section 11b, which leads to the disposable insulator 1. The conductor assembly 11 passes through the wall of the disposable insulator 1 at 12 in a sealed manner, for which appropriate means 14 are provided for the sterile passage of the conductor assembly 11 through the insulator wall 14. These can, for example, also be push-fit connectors.

[0022] The peristaltic pump 17 can be controlled by means of a control device 19, i.e. it can be started in a targeted manner to propel the filling material and stopped to stop the propelling of the filling material, so that in this way it is possible to meter the material conveyed by the peristaltic pump 17 between pump start and pump stop.

[0023] The control unit 19 also includes a weighing device 21 or is connected to one for receiving weighing results. The material storage container 7 is suspended from a support rod 23 of the weighing device 21, so that its weight, including its contents, can be measured by the weighing device 21. Each filling process can then be carried out such that, at the beginning of the filling process, the weight of the material storage container 7, including its contents, is measured by the weighing device 21 and registered by the control unit 19, and that the weight of the material storage container 7, including its contents, is continuously monitored throughout the filling process. When the weight decrease of the material storage container 7, due to the dispensing of the material, reaches the target weight of the desired filling dose, the peristaltic pump 17 is stopped at a correspondingly precise time.An operator can then, by inserting their gloves at 3, close the filled vial 5 with a sealing plug 25 held in the disposable insulator 1 and, if necessary, bring the next vial 5 to be filled into position relative to the filling needle 13, so that in a next filling process this vial is filled with a dose of filling material.

[0024] This can be continued in the same manner until all 5 vials have been dosed, filled and sealed.

[0025] The control unit 19 is designed to store the dose quantity, in particular the dose weight, dispensed into each filled material receiving container 5, thus enabling in-process control. This also makes it easy to identify any of the filled material receiving containers 5 where the fill quantity falls outside a certain tolerance range. The fill quantity can also be adjusted depending on the dosage. Based on the results of monitoring the dispensed dose quantities within the tolerance limits, the rotations of the peristaltic pump can be optimized accordingly.

[0026] At 27, the disposable insulator 1 has connection means in its wall for connecting external lines, in this case a protective gas line 29, to which a corresponding protective gas source 31 is connected. By means of this arrangement, protective gas, such as clean air, e.g., laminar flowing air filtered by filters, e.g., HEPA filters, CO2, or nitrogen, can be introduced into the interior of the disposable insulator 1 in order to create a certain overpressure there, which prevents a residual quantity from escaping from the filling needle 13 after the peristaltic pump 17 has stopped.

[0027] Within the disposable insulator 1, further elements may also be provided, such as caps and / or appropriate tools, for example disposable pliers and the like.

Claims

1. Filling device for the metered filling of liquid or fine-powdered filling material (10) from a filling material storage container (7) into material dose receiving containers (5) which are provided in a single-use isolator (1) in a manner protected against contamination, comprising - the single-use isolator (1) with the material dose receiving containers (5) provided therein, - a weighing device (21) having means (23) for holding and weighing the filling material storage container (7), with its contents, outside of the single-use isolator (1), wherein the filling material storage container (7) is accommodated in or on the weighing device (21) in readiness for weighing, - a controllable filling material removal device (17) for the dose-by-dose removal of filling material (10) from the filling material storage container (7) outside the single-use isolator (1) - a filling material dispensing device (13) inside the single-use isolator (1)for the dose-by-dose dispensing of filling material (10) to given material dose receiving containers (5) in the single-use isolator (1), - a conduit arrangement (11) connecting the filling material storage container (7) and the filling material dispensing device (13) to each other to convey filling material (10) removed from the filling material storage container (7) by means of the filling material removal device (17) to the filling material dispensing device (13), - a control device (19) for controlling the filling material removal device (17) according to information from the weighing device (21), wherein the control device (19) is configured to measure the respective filling material doses to be removed from the filling material storage container (7) according to information about the decrease in weight of the unit consisting of the filling material storage container (7) and its contents during the filling material removal, wherein the single-use isolator (1) has connection means (27) in its wall for connecting external lines (29) for a medium to be supplied to the interior of the single-use isolator (1) in a manner protected against contamination, characterized in that the filling device further comprises a protective gas source (31), which is connected to the connection means (27) by means of a protective gas line (29)2. Filling device according to claim 1, wherein the filling material removal device (17) is designed as a controllable peristaltic pump.

3. Filling device according to claim 1 and / or 2, wherein the single-use isolator (1) has a preferably transparent film wall made of plastic film which isolates the isolator interior from the outside environment in a manner protected against contamination.

4. Filling device according to at least one of the preceding claims, wherein the single-use isolator (1) glove interaction means (3) for a person to handle objects (5, 13, 25) inside the single-use isolator (1), in particular the material dose receiving containers (5), from the outside.

5. Filling device according to at least one of the preceding claims, wherein the single-use isolator (1) has means (12, 14) for routing the conduit arrangement (11) in a sterile manner through the isolator wall.

6. Filling device according to at least one of the preceding claims, wherein the filling material dispensing device (13) has a filling needle.

7. Filling device according to at least one of the preceding claims, wherein the liquid storage container (7) is designed as a plastic film pouch with a lower connection (9) for the conduit arrangement (11).

8. Filling device according to at least one of the preceding claims, wherein the material dose receiving containers (5) are reagent vials and / or medicine vials.

9. Filling device according to at least one of the preceding claims, wherein closure elements (25) are provided in the single-use isolator (1) for closing the material dose receiving containers (5).

10. Filling device according to at least one of the preceding claims, wherein the control device (19) is configured to store a value of each dose quantity per filling material dose receiving container (5), in particular the detected dose weight, in association with the given filling material dose receiving container (5), in order to implement an in-process control.