FILLING DEVICE FOR THE DOSED FILLING OF A LIQUID OR FINE POWDERY PRODUCT FROM A PRODUCT STORAGE CONTAINER INTO PRODUCT DOSE RECEIVING CONTAINERS PROVIDED IN A DISPOSABLE ISOLATOR SO AS TO BE PROTECTED AGAINST CONTAMINATION

Abstract

A filling device for dosed filling of a product from a product storage container into product dose receiving containers provided in a disposable isolator so to be protected against contamination. The device includes means for holding the product storage container together with the contents outside of the disposable isolator. The device includes a controllable product removal device for a dosed removal of the product from the product storage container. The device includes a product dispensing device for the dosed dispensing of the product to the product dose receiving containers. The device includes a line assembly interconnecting the product storage container and the product dispensing device to conduct the product to the product dispensing device. The device includes at least one ultrasonic flowmeter outside of the disposable isolator fixed to the outside of the line assembly to detect the flow rate. The device includes a controller for measuring the product dose.

Claims

1. A filling device for a dosed filling of a liquid or fine powdery product from a product storage container into product dose receiving containers provided in a disposable isolator so as to be protected against contamination, the filling device comprising: the disposable isolator together with the product dose receiving containers provided therein; means for holding the product storage container together with the contents of the product storage container outside of the disposable isolator; a controllable product removal device for a dosed removal of the product from the product storage container outside of the disposable isolator; a product dispensing device within the disposable isolator for the dosed dispensing of the product to the product dose receiving containers in the disposable isolator; (1), a line assembly interconnecting the product storage container and the product dispensing device to conduct the product removed from the product storage container by means of the product removal device to the product dispensing device; at least one clamp-on-type ultrasonic flowmeter outside of the disposable isolator, on the line assembly, the flowmeter being fixed to the outside of the line assembly to surround at least some regions of the line assembly to detect the relevant flow rate; and a controller for measuring the relevant product dose to be removed from the product storage container on the basis of information from the flowmeter regarding the flow rate and for controlling the product removal device.

2. The filling device of claim 1, wherein the product removal device comprises a controllable peristaltic pump.

3. The filling device of claim 1, wherein the disposable isolator has a film wall made of a plastics film, wherein the film wall isolates the isolator interior from the external environment so as to be protected against contamination.

4. The filling device of claim 1, wherein the disposable isolator comprises glove intervention means for handling of objects inside the disposable isolator from the outside.

5. The filling device of claim 1, wherein the disposable isolator has means for routing the line assembly through the isolator wall in a sterile manner.

6. The filling device of claim 1, wherein the disposable isolator comprises connection means in a wall of the disposable isolator for connecting external lines for a medium to be supplied to the interior of the disposable isolator in a manner so as to be protected against contamination.

7. The filling device of claim 1, wherein the product dispensing device comprises a filling needle.

8. The filling device of claim 1, wherein the liquid storage container comprises a plastics film bag with a lower connection for the line assembly.

9. The filling device of claim 1, wherein the product dose receiving containers are one or more of reagent bottles or medicine bottles.

10. The filling device of claim 1, wherein the disposable isolator comprises closing elements for closing the product dose receiving containers.

11. The filling device of claim 1, wherein the controller is configured to store a value of the relevant dose quantity per filled product dose receiving container in association with the respective filled product dose receiving containers to implement in-process control.

12. The filling device of claim 3, wherein the film wall is transparent.

13. The filling device of claim 4, wherein the objects comprise the product dose receiving containers.

14. The filling device of claim 6, wherein the connecting external lines comprise protective gas lines.

15. The filling device of claim 11, wherein the value comprises the detected dose weight.

Description

[0025] An embodiment of the invention is explained in more detail below with reference to the schematic representation of a filling device according to the invention according to FIG. 1.

[0026] In FIG. 1, a disposable isolator is designated with the reference sign 1, which disposable isolator is a type of closed tent with walls made of a transparent plastics film. The disposable isolator has two glove intervention holes 3 to which gloves (not shown) made of a flexible plastics material that extend into the space of the disposable isolator 1 are attached in a sealed manner (glove box principle). An operator can reach into the glove intervention holes 3 in order to then move and handle objects in the disposable isolator 1 using the gloves. A particle counter and/or a germ collector can be provided in the disposable isolator in order to monitor or ensure the cleanroom quality therein.

[0027] In the disposable isolator 1 there are small bottles, for example vials, as product dose receiving containers 5, into which a liquid, for example a toxic liquid, is to be filled in doses as the product. Filling processes should be carried out in such a way that the outside of the disposable isolator 1 is not contaminated in any way with the product.

[0028] The product is initially located in a product storage container 7 outside of the disposable isolator 1. The product storage container 7 can be, for example, a film bag which has a product outlet 9 on its underside with a line portion 11a of a line assembly 11 connected in a sealing manner to the outside of said product storage container, which line assembly is used to conduct the product from the storage container 7 to the disposable isolator 1 and further therein to a filling needle 13 which serves the function of a product dispensing device within the disposable isolator 1. The line assembly 11 substantially consists of a flexible plastics tube, which is guided at 15 through a peristaltic pump 17 and there forms the squeeze tube portion of the peristaltic pump 17, at which the product material contained therein is driven forward by a squeeze tube process in the target flow direction to the disposable isolator 1. This is followed by a line portion 11b which leads to the disposable isolator 1. The line assembly 11 passes through the wall of the disposable isolator 1 in a sealed manner at 12, for which purpose corresponding means 14 for routing the line assembly 11 through the isolator wall 14 in a sterile manner are provided. Said means can also be plug-in connection means, for example.

[0029] The peristaltic pump 17 can be controlled by means of a controller 19, i.e. the peristaltic pump can be started in a targeted manner to advance the product material and stopped to stop the advance movement of the product material, so that in this way dosing of the material conveyed by the peristaltic pump 17 between the pump start and pump stop is possible.

[0030] The product storage container 7 is suspended from a support rod 23.

[0031] A clamp-on-type ultrasonic flowmeter 21, known per se, is arranged on the line assembly 11 to detect the respective dose quantities. In the example, the ultrasonic flowmeter is attached to the outside of the line portion 11a so as to surround it and is electrically connected to the controller 19 in order to transmit its measurement information. The ultrasonic flowmeter 21 detects the relevant flow rate of the product flowing in the line portion 11a when the product is being dosed and the controller determines the dose quantity of the relevant dose to be filled by integrating the measurement information over time.

[0032] A particular filling process can then take place in such a way that the controller 19 starts the filling process by appropriately activating the peristaltic pump and, beginning with the start time, integrates the flow rate measurement information from the ultrasonic flowmeter 21 over time until the controller determines that the desired dose quantity has been reached, in order to then stop the current filling process by activating the peristaltic pump accordingly. In one variant, the ultrasonic flowmeter can optionally already have means for integrating the measurement information over time and thus determine dose quantities.

[0033] An operator can then, by reaching into the gloves at 3, close the filled bottle 5 with a stopper 25 held ready in the disposable isolator 1 and, if necessary, bring a next bottle 5 to be filled into position for the filling needle 13, so that this bottle is filled with a product dose during the next filling process.

[0034] This can be continued in a corresponding manner until all the bottles 5 have been dosed, filled and sealed.

[0035] The controller 19 is configured to store the dose quantity filled in each filled product dose receiving container 5, in particular the dose weight, in association with the each filled product dose receiving container, in order to implement in-process control. In this way it is also possible to easily recognise whether there are any filled product dose receiving containers 5 in which the filling quantity is outside a certain tolerance range. The filling quantity of the product can also be readjusted depending on the dosage. Depending on the result of the monitoring of the filled dose quantities within the tolerance limits, the revolutions of the peristaltic pump can be optimised accordingly.

[0036] At 27, the disposable isolator 1 has connection means in its wall for connecting external lines, here a protective gas line 29 to which a relevant protective gas source 31 is connected.

[0037] By means of this arrangement, protective gas such as clean air, for example laminar air filtered by filters, e.g. HEPA filters, CO2 or nitrogen can be introduced into the interior of the disposable isolator 1 in order to also generate a certain overpressure therein, which prevents an overflow quantity from escaping from the filling needle 13 after each stop of the peristaltic pump 17.

[0038] Further elements can also be provided inside the disposable isolator 1, such as caps and/or appropriate tools, for example disposable pliers and the like.