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EP-4069408-B1 - METHOD AND ARRANGEMENT FOR MIXING A LIQUID

EP4069408B1EP 4069408 B1EP4069408 B1EP 4069408B1EP-4069408-B1

Inventors

  • KIRCHMAIR, Johannes

Dates

Publication Date
20260513
Application Date
20201117

Claims (8)

  1. Method for mixing a liquid which is present in several closed containers (2) each having at least one axis of symmetry (A), wherein - the containers (2) are arranged such that the axes of symmetry each lie substantially in a horizontal plane (3), - the containers (2) are moved in an oscillating manner along a movement path (B) that appears linear when the horizontal plane (3) is viewed from above, - in order to generate at least one vortex in the liquid (1) the containers (2) are oriented such that the movement path (B) and the axes of symmetry (A) each are different when the respective horizontal plane (3) is viewed from above - when viewed from above the containers (2) are moved exclusively linearly in an oscillating manner, - the containers (2) are moved exclusively in the respective horizontal plane, and - several shelves disposed above each other are used and the containers (2) are placed on the shelves.
  2. Method according to claim 1, characterized in that the containers (2) are oriented such that the axes of symmetry (A) and the movement path (B) form an angle (α) of between 5° and 85°, preferably between 10° and 60° and particularly preferably between 20° and 40°, when the horizontal plane (3) is viewed from above.
  3. Method according to claim 1 or 2, characterized in that , when viewed from above the containers (2) have a basic shape of a rectangle, an isosceles trapezium or a combination of a rectangle and an isosceles trapezium.
  4. Method according to one of claims 1 to 3, characterized in that the containers (2) are used only partly filled, with the result that a gas cushion (6) - in particular an air cushion - is present in the containers (2) in addition to the liquid (1).
  5. Method according to one of claims 1 to 4, characterized in that flexible bags - preferably made of plastic - are used as containers (2).
  6. Method according to one of claims 1 to 5, characterized in that a medicinal product or a precursor and/or intermediate occurring in a pharmaceutical or biotechnology production process is used as liquid (1).
  7. Arrangement consisting of a device (10) for mixing a liquid (1) present in several closed containers (2) and of the containers (2) with the liquid (1), in particular for carrying out a method according to one of claims 1 to 6, wherein the containers (2) each have at least one axis of symmetry (A) and are each arranged on the device (10) such that the axes of symmetry (A) each lie substantially in a horizontal plane (3), and wherein the device is designed to move the containers (2) in an oscillating manner along a movement path (B) that appears linear when the respective horizontal plane (3) is viewed from above, characterized in that the containers (2) are oriented such that the movement path (B) and the axes of symmetry (A) are different when the respective horizontal plane (3) is viewed from above, wherein the apparatus is configured to - move the containers (2) exclusively linearly in an oscillating manner when viewed from above and - move the containers (2) exclusively in the respective horizontal plane and wherein the containers (2) are placed on several shelves disposed above each other.
  8. Arrangement according to claim 7, characterized in that a transport shell (5) is located between the containers and the shelf.

Description

Changed description The present invention relates to a method for mixing a liquid which is present in several closed containers and to an arrangement comprising a device for mixing a liquid present in several closed containers and the containers with the liquid. Methods and devices for mixing liquids are disclosed in the following publications: GB 816960 A , WO 98/37955 A1 , DE 102013107935 A1 , US 6299344 B1 , EP 0569214 A2 and US 7195394 B2 . The EP 0569214A2 disclosed a method and an arrangement for mixing a liquid which is present in several closed containers, each having at least one axis of symmetry, wherein several stacking surfaces arranged one above the other are used and the containers are placed on the stacking surfaces. Flexible, single-use containers for liquids are increasingly used in pharmaceutical and biotechnology production processes. These flexible, single-use containers are also known as single-use bags. Compared to rigid containers, such as those made of stainless steel, these flexible, single-use containers offer many advantages: Firstly, they are delivered clean and sterile, meaning they do not need to be cleaned and sterilized. Secondly, they can be disposed of after use and therefore do not require cleaning. Furthermore, the complex validation steps for sterility and cleaning that are necessary for rigid containers are eliminated. One challenge with flexible single-use containers is preventing the mixing of liquids within the sealed container. Opening the container to mix the contents is obviously undesirable, as this would negate the sterility benefits of flexible single-use containers. Rotating shafts, which drive high-performance mixers, can therefore only be inserted into flexible containers with considerable effort. Sealing the shaft presents a major problem here. Magnetically driven stirrers can be inserted into the flexible container during the manufacturing process before sterilization. However, the mixing power they can impart to the liquid remains limited. The methods described above are mechanically very complex, technically demanding, and require a large amount of space. Especially in applications such as fractionation, where many fractions need to be mixed, the mixing systems described above do not offer an acceptable solution due to their large space requirements and complex technical effort. Other devices known for mixing liquids in closed containers use the principle of inertia to induce movement of the liquid within the container by moving the container itself. In principle, these devices can be divided into those that, when viewed from above on a horizontal plane, produce linear trajectories of the container, and those that produce more complex trajectories. The former are naturally preferred in practice, since the simpler, linear trajectory can be achieved with simpler designs, which are therefore lower maintenance-intensive and more durable. Examples of such designs include those with seesaws and similar devices, which are intended to generate waves that promote mixing (see, for example, US 7195394 B2 or WO 2009/114442 A1 ). However, mixing would be more beneficial if a vortex (also called a eddy) could be induced in the liquid instead of waves. This was demonstrated in the US 2010/0172203 A1 A proposed method, however, relied on asymmetrically designed containers to generate the vortices. Manufacturing these asymmetrical containers is naturally more difficult than manufacturing symmetrical ones, which is why this system ultimately failed to gain widespread acceptance due to its uneconomical nature. Against this background, the object of the present invention is to provide a method and an arrangement for mixing liquids contained in closed containers, wherein, on the one hand, symmetrical containers can be used, and on the other hand, vortices in the liquid can be utilized for mixing. With regard to the method, this problem is solved by the features of claim 1. With regard to the arrangement, the problem is solved by the features of claim 7. To induce a vortex in the liquid, an asymmetrical situation must ultimately be created in the containers. A key insight of the invention is that the symmetry of the containers and the symmetry of the device for moving the containers along the path of motion do not have to be broken by making the containers or the device themselves asymmetrical. Rather, the clever The alignment or arrangement of the containers in relation to the device can be used to induce a vortex in the liquid. The invention thus combines particularly good mixing of the liquid within the closed containers with a particularly simple method. In other words, the invention combines particularly good mixing of the liquid within the closed containers with a particularly simple design of the device for moving the containers. The method according to the invention is carried out with several containers simultaneously. According to the invention, the containers are