Method for producing a medical preparation

Patent metadata

Field	Value
Publication number	US-10966906-B2
Application number	US-201716084396-A
Country	US
Kind code	B2
Filing date	Mar 15, 2017
Priority date	Mar 15, 2016
Publication date	Apr 6, 2021
Grant date	Apr 6, 2021

Abstract

The invention relates to a method and a system for synthesizing a medical preparation, a peristaltic pump being used for pumping liquid from a plurality of source containers. According to the invention, the individual metering steps are verified by a weighing process, even the metering of micro-amounts being verifiable.

First claim

The invention claimed is:

1. A method for producing a medical preparation, for parenteral nutrition, comprising: transferring liquid by a peristaltic pump from a plurality of source containers into a target container, and weighing the target container at individual metering steps, wherein quantity of the liquid transferred into the target container is thus checked at the individual metering steps, in which an impeller of the peristaltic pump is at a rotation angle within a rotation region with a linear characteristic curve, liquid is removed from another source container, different than the target container, the other source container filled with universal liquid or water.

2. The method for producing a medical preparation as claimed in claim 1 , wherein the quantity of the liquid transferred into the target container is checked at all the metering steps.

3. The method for producing a medical preparation as claimed in claim 1 , wherein the quantity of the liquid transferred into the target container in one metering step is calculated taking into account a pressure-side characteristic curve of the pump output of the peristaltic pump, wherein the calculated quantity is compared to the quantity determined by the weighing of the target container.

4. The method for producing a medical preparation as claimed in claim 1 , wherein the quantity of liquid removed from a source container is calculated taking into account a suction-side characteristic curve of the pump output of the peristaltic pump, wherein the calculated quantity is compared to the quantity determined by the weighing of the target container.

5. The method for producing a medical preparation as claimed in claim 1 , wherein the sequence of different liquids in an inflow of the target container is taken into consideration in order to allow for the specific mass of the liquid in the check during weighing.

6. The method for producing a medical preparation as claimed in claim 1 , wherein a very small quantity of below 10 ml is transferred in at least one metering step.

7. The method for producing a medical preparation as claimed in claim 6 , wherein the quantity transferred in the at least one metering step is below 5 ml.

8. The method for producing a medical preparation as claimed in claim 1 , wherein the peristaltic pump has at least one region with a linear characteristic curve and one region with a non-linear characteristic curve of the pump output, wherein metering from at least one source container is effected by bringing the peristaltic pump to a position such that the metering from the source container takes place entirely in the region with the linear characteristic curve.

9. The method for producing a medical preparation as claimed in claim 1 , wherein the peristaltic pump is brought to a position in which the suction-side characteristic curve of the peristaltic pump is linear.

10. The method for producing a medical preparation as claimed in claim 1 , wherein a very small quantity with a volume of under 10 ml is delivered in the region of the linear characteristic curve.

11. The method for producing a medical preparation as claimed in claim 10 , wherein the very small quantity delivered in the region of the linear characteristic curve is with a volume of under 3 ml.

12. The method for producing a medical preparation as claimed in claim 1 , wherein the delivery rate of the peristaltic pump is checked with a flow sensor.

13. The method for producing a medical preparation as claimed in claim 1 , wherein a metering factor of the peristaltic pump is determined in a preceding calibration step by means of weighing the target container.

14. The method for producing a medical preparation as claimed in claim 1 , wherein in order to transfer the liquids from the source containers into the target container, a transfer set is used which comprises a valve unit, a hose, which is insertable into the peristaltic pump, and a plurality of hoses for attachment of the source containers.

15. The method for producing a medical preparation, in as claimed in claim 1 , wherein liquids are transferred by means of a peristaltic pump from the plurality of source containers into the target container, wherein a metering factor of the pump is calibrated in a metering step from a source container in which the impeller of the peristaltic pump rotates through at least one full revolution.

16. An installation for producing a medical preparation, in particular an installation for producing parenteral nutrition, comprising a peristaltic pump and a system for carrying out a method as claimed in claim 1 .

17. The method for producing a medical preparation as claimed in claim 1 , wherein a bubble sensor is used to check that there are no bubbles in an inflow to the target container.

18. A method for producing a medical preparation, in particular parenteral nutrition, comprising: transferring liquid by a peristaltic pump from a plurality of source containers into a target container, and weighing the target container at individual metering steps, wherein quantity of the liquid transferred into the target container is thus checked at the individual metering steps, and wherein a sequence of different liquids in an inflow of the target container is taken into consideration in order to allow for calculation of the specific mass of the liquid to be checked during weighing.

19. The method for producing a medical preparation as claimed in claim 18 , wherein the quantity of the liquid transferred into the target container in one metering step is calculated taking into account a pressure-side characteristic curve of the pump output of the peristaltic pump, wherein the calculated quantity is compared to the quantity determined by the weighing of the target container.

20. The method for producing a medical preparation as claimed in claim 18 , wherein the quantity of liquid removed from a source container is calculated taking into account a suction-side characteristic curve of the pump output of the peristaltic pump, wherein the calculated quantity is compared to the quantity determined by the weighing of the target container.

21. The method for producing a medical preparation as claimed in claim 18 , wherein the peristaltic pump has at least one region with a linear characteristic curve and one region with a non-linear characteristic curve of the pump output, wherein metering from at least one source container is effected by bringing the peristaltic pump to a position such that the metering from the source container takes place entirely in the region with the linear characteristic curve.

22. The method for producing a medical preparation as claimed in claim 18 , wherein the peristaltic pump is brought to a position in which the suction-side characteristic curve of the peristaltic pump is linear.

23. The method for producing a medical preparation as claimed in claim 18 , wherein a metering factor of the peristaltic pump is determined in a preceding calibration step by means of weighing the target container.

24. The method for producing a medical preparation as claimed in claim 18 , wherein in order to transfer the liquids from the source containers into the target container, a transfer set is used which comprises a valve unit, a hose, which is insertable into the peristaltic pump, and a plurality of hoses for attachment of the source containers.

25. The method for producing a medical preparation as claimed in claim 18 , wherein liquids

Assignees

• Fresenius Kabi Deutschland Gmbh

Inventors

• Biehl Martin
• Hock Michael
• Schaake Henrik
• Schöbel Ulla
• Bohm Martin

Classifications

• A61J3/002 Primary

  Compounding apparatus specially for enteral or parenteral nutritive solutions (bottling liquids B67C) · CPC title

• A61J2200/74

  for weight · CPC title

• F04B43/12

  having peristaltic action · CPC title