EP4288193A1 - Dispositif et procédé de surveillance d'un processus de mélange - Google Patents

Dispositif et procédé de surveillance d'un processus de mélange

Info

Publication number
EP4288193A1
EP4288193A1 EP22709216.0A EP22709216A EP4288193A1 EP 4288193 A1 EP4288193 A1 EP 4288193A1 EP 22709216 A EP22709216 A EP 22709216A EP 4288193 A1 EP4288193 A1 EP 4288193A1
Authority
EP
European Patent Office
Prior art keywords
mixing process
measuring
mixing
density
mixture
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22709216.0A
Other languages
German (de)
English (en)
Inventor
Patrick BEßLER
Andreas HEMM
Stefan EBERLEIN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vivonic GmbH
Original Assignee
Vivonic GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vivonic GmbH filed Critical Vivonic GmbH
Publication of EP4288193A1 publication Critical patent/EP4288193A1/fr
Pending legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/40—Mixing liquids with liquids; Emulsifying
    • B01F23/49—Mixing systems, i.e. flow charts or diagrams
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/40—Mixing liquids with liquids; Emulsifying
    • B01F23/48—Mixing liquids with liquids; Emulsifying characterised by the nature of the liquids
    • B01F23/483—Mixing liquids with liquids; Emulsifying characterised by the nature of the liquids using water for diluting a liquid ingredient, obtaining a predetermined concentration or making an aqueous solution of a concentrate
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/21—Measuring
    • B01F35/213—Measuring of the properties of the mixtures, e.g. temperature, density or colour
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/22—Control or regulation
    • B01F35/2201—Control or regulation characterised by the type of control technique used
    • B01F35/2202—Controlling the mixing process by feed-back, i.e. a measured parameter of the mixture is measured, compared with the set-value and the feed values are corrected
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions

Definitions

  • the mixing process of a concentrate raw material with a liquid takes place according to a fixed, predetermined scheme, for example by always carrying out the mixing process for a predetermined period of time, e.g. 70 minutes.
  • a mixture is initially formed in which the concentrate raw material is partially dissolved and partially undissolved in the liquid.
  • Such a mixture thus preferably forms an intermediate product of the mixing process between an initial state in which the concentrate raw material and the liquid are present separately or the concentrate raw material is present undissolved in the liquid and a final state in which the concentrate raw material is dissolved in the liquid and a desired medicinal solution present.
  • the designation of the product of the mixing process thus changes from mixture (intermediate, not yet meeting target) to medicinal solution (final product, meeting target).
  • the quality of the mixture produced is usually checked manually, for example by measuring the density or by means of a laboratory analysis.
  • the mixture does not meet the target specifications or a desired medicinal solution, the mixture usually has to be discarded, thereby wasting resources. It is often not possible to continue the mixing process until the optimum mixing result or a desired medical solution has been achieved. In addition, in many cases a shorter mixing process would be sufficient to obtain the desired mixture.
  • the presetting of fixed specifications for the duration of the mixing process results in unnecessary expenditure of time and energy in these cases. Particularly in cases in which it is not possible to continue a mixing process after the predetermined period of time has elapsed, a particularly long period of time with a large safety buffer is set—for example in order to avoid wasting resources. This routinely wastes a lot of time and energy.
  • the present invention is based on the object of alleviating the problems of the prior art or even eliminating them entirely.
  • the object of the present invention is to optimize the production of a medical solution by a mixing process and to avoid unnecessary waste of resources.
  • the medical solution generated by the device can be a medical solution that is used directly (for example - in the case of renal replacement therapy by means of dialysis - dialysis liquid, also called dialysate) or form an intermediate stage in the generation of such a solution (for example a liquid concentrate, which - in the case of renal replacement therapy using dialysis - is also called dialysis concentrate or dialysate concentrate).
  • the measuring device is preferably designed to carry out measurements continuously and/or online during a mixing process carried out by means of the device.
  • a measuring device that measures online is preferably to be understood here as meaning that the measuring device is coupled into the ongoing operation of a device, eg a mixing device or dosing unit, and, for example, records measurement data during operation, in particular during a mixing process.
  • a measuring device that measures online is "online" in that the measuring device is connected to other data-processing devices, so that the measuring device can, for example, always be controlled or exchange data.
  • the control device is designed to control or regulate the operation of the device, in particular a mixing process carried out by it, on the basis of the parameter values determined by means of the measuring device, for example the measured density of the mixture.
  • this is done by comparing measured values with previously specified target values and/or limit values or error limits.
  • parameter values for any section of the past e.g. from the last week, the last month or the last year
  • control and/or regulation and/or forecasts changing needs, different concentrations used raw materials or solutions for the future, foreseeable completion of the mixing process
  • control device can be designed to analyze the dynamics of the mixing process, for example by determining rates ei, on the basis of the parameter values determined by means of the measuring device, preferably during an ongoing mixing process or retrospectively on the basis of historical data of a mixing process or several mixing processes nes dissolving process and/or mixing process, for example by determining a slope of a dissolving curve, detecting the change in certain parameters and/or determining the progress of the dissolving process by forming an integral of a dissolving curve.
  • the adjustment or control or regulation of the mixing process preferably takes place during an ongoing mixing process, so that the mixing process can be flexibly adjusted in such a way that the solution produced corresponds to the target specifications. In this way, unnecessary waste of resources can be prevented. because it does not wait until the end of a preset mixing process before checking whether this mixing process leads to a desired solution.
  • control device is designed to compare the parameter values measured by the measuring device with a target value and to end the ongoing mixing process when the target value or a tolerance range surrounding it is reached and/or make an issue to a user.
  • the output can be optical and/or acoustic, for example through a signal lamp or a loudspeaker.
  • a message can also be displayed on a display unit, or a message can be sent to an external terminal such as a smartphone or tablet.
  • the output to a user can take place via a hospital IT system or a hospital control room implemented in hardware and/or software, with the message also being able to be sent to a local computer or server or a remote server.
  • a solution with the desired parameters can be produced after just 20 minutes of mixing (e.g. due to different ambient or input conditions), although this usually takes 50 minutes.
  • a device according to the invention can be used to detect that the desired solution has already been produced after 20 minutes and the mixing process has ended. This saves 30 minutes of unnecessary mixing.
  • a user can be informed that the mixture produced has reached the desired value or a tolerance range surrounding it.
  • the user can then start the mixing process by means of an input break up. Provision can also be made to inform the user about a predicted end of the mixing process.
  • control device is designed to operate the device for a first predetermined period of time to carry out a mixing process and after the end and/or during the predetermined first period of time the parameter values measured by the measuring device to be compared with a target value and, if the target value or a tolerance range surrounding it is not reached, to extend the mixing process once or several times by a second predetermined time span and/or to make an output to a user, with which the user preferably asked to authorize or instruct the extension of the mixing process.
  • the user can also enter that the mixture does not reach the predefined target value or the tolerance range, but can still be used.
  • the second period of time for extending the mixing process can be set to any value, for example between 10 minutes and 4 hours, and the mixing process can be extended once or several times by the same or different periods of time.
  • a maximum period of time can be provided for the mixing process, which the mixing process must not exceed despite a single or multiple extension.
  • control device it would also be conceivable for the control device to be designed for an adaptive mixing time extension and, preferably based on a time profile of the parameter values determined by the measuring device, to propose a specific length of the second time period by which the mixing process must be extended in order to achieve a specific target specification.
  • a running Mixing process automatically optimized by means of a device according to the invention and / or with a user interaction on the basis of parameters of the mixture.
  • the adaptation to the prediction is suggested to the user, who can confirm or reject it.
  • the device autonomously adapts the mixing time according to the prediction without a release or input.
  • the adjustment can optionally be displayed.
  • the adaptive adjustment to the prediction takes place continuously throughout the mixing process, which enables tailor-made optimization using current values.
  • the measured values and the predicted values can also be documented in a local or cloud-based storage location, in an electronic log book and/or in a control room.
  • historical knowledge from historical time courses can be used, for example that shorter or longer periods of time typically occur at certain times of the year. Additionally or alternatively, this also applies to daily courses, weekly courses, monthly courses.
  • parameters of the mixing process can also be optimized on the basis of the measured values, for example storage, preheating (e.g. of the permeate) or predosing of the starting materials or the like.
  • a further embodiment of the invention relates to a device in which the control device is designed to discard a mixture generated by the device and/or to issue an output to a user that the mixture generated is to be discarded if the values measured by the measuring device After a period of time for executing a mixing process, these parameter values do not reach a target value or a tolerance range surrounding it reach and/or a time course of the measured parameter values during a predetermined time interval during the mixing process does not or not sufficiently approach the target value or the tolerance range or moves away from it.
  • a measuring device based on the oscillating vibrator principle is preferably used, through which the mixture or solution produced by the device preferably flows continuously.
  • the oscillating U-tube system can include a U-shaped or a W-shaped measuring tube.
  • the measuring device can be a device for measuring density based on selective ion concentration, a device for measuring density using a volumetric measuring chamber and/or mass measurement, a device for measuring density using ultrasound or gamma rays, a device for measuring Density using the Coriolis principle and/or a device for optical density measurement or for density measurement by means of refraction or include such.
  • a (mass) density can be detected on the basis of one or more selective ion concentrations or ion densities.
  • the measured density values of a dialysate concentrate typically range between 1.14-1.22 g/cm 3 at 25°C.
  • the liquid used for mixing eg pure water, dialysis water, or pure water obtained by means of reverse osmosis, also known as reverse osmosis permeate, has a lower density than 1.
  • the measured density values at the start of the mixing process are between 0.99 and 1 g/cm 3 , for example.
  • the minimum permissible density for a finished solution is, for example, ie at At the end of the mixing process - at 1.197 g/cm 3
  • the target value for a finished dialysis concentrate is 1.200 g/cm 3
  • the maximum permissible density of a finished dialysis concentrate is 1.203 g/cm 3 .
  • a dialysate concentrate for example, the minimum permissible density for a finished solution is 1.195 g/cm 3 , the target value is 1.198 g/cm 3 and the maximum permissible density is 1.198 g/cm 3 at 1.201 g/cm 3 .- in each case an example of a ready-mixed solution at the end of a successful mixing process.
  • control device can be designed to electronically document the parameter values determined by means of the measuring device and preferably their time profiles, preferably to store them in an electronic log book and/or to transmit them to another device, preferably to a control room.
  • the execution of a mixing process (time, duration, solutions to be produced, starting materials used, e.g. dialysis water and concentrate raw materials(s) etc.) and preferably also the measured values determined as part of the process are automatically documented / recorded in a logbook, whereby the recording may involve remote data transmission.
  • the digital logbook can be recorded locally in a mixing device, in the nearby data environment (e.g. in the control center of a clinic) or remotely (e.g. on a server or in a data cloud).
  • the recording can include the time at which the method was carried out, the duration and the determined density values of the mixture, as well as other data.
  • a device preferably also has a container for receiving and/or storing the mixture produced and/or the medicinal solution produced, and/or a container for storing at least one other raw material for producing the medicinal solution.
  • a device according to the invention preferably has two redundant containers per type for storing the finished solution, so that it is ensured that sufficient solution of this type is always available. In practice, between one and three types are used.
  • a device according to the invention preferably also has at least one pump for conveying raw materials for producing the medicinal solution and valves for controlling or regulating the flow of raw materials.
  • a device according to the invention to have a marking device for marking a container with medical solution produced by the device, for which the measuring device has detected that it meets the target specifications and/or which a user releases has, exhibits.
  • the marking device can be, for example, a printer which prints a label with data relating to the medical solution, which can then be applied to a container of the medical solution.
  • the data can also be printed directly onto the container.
  • Another aspect of the invention relates to a method for monitoring a mixing process for producing a medicinal solution by mixing at least one liquid and at least one concentrate raw material, the mixing process preferably being carried out using a device according to the invention, with the step: measuring a parameter, preferably one Density of a mixture produced by means of the device during the mixing process, preferably by means of a measuring device belonging to the device performing the mixing process.
  • the parameter is preferably measured continuously and/or online.
  • a method according to the invention preferably comprises the step: controlling or regulating the operation of the device, in particular a mixing process carried out by it, on the basis of the parameter values determined by means of the measuring device.
  • a method according to the invention can have the features and steps described above in the context of a device according to the invention in any combination, which are not reproduced here in order to avoid redundancies.
  • FIG. 1 shows a flow chart of a method according to the invention
  • FIG. 3 shows a flow chart of a further method according to the invention.
  • a mixing process of at least one concentrate raw material and at least one liquid or one solvent is started in step S1.
  • the function of the measuring device here a density sensor, is checked, for example using a reference liquid or permeate.
  • step S3 a predetermined period of time, for example 10 minutes, can be waited before the preferably continuous measurement of the density of the mixture produced during the mixing process is started in step S4.
  • the waiting period in step S3 can be used, for example, to avoid measurements being taken at a point in time when the mixing most likely not meeting the targets. In addition, measurement inaccuracies at the beginning of the mixing process are avoided.
  • step S4 takes place continuously during the mixing process, as a result of which the mixing process can be monitored particularly precisely and without gaps.
  • step S5 it is checked whether the measured values from step S4 correspond to a target value, ie whether a target density has been reached. If this is the case, a user is notified in step S6 and the mixture produced is transferred to a storage system, for example a barrel or a tank, in step S7.
  • a storage system for example a barrel or a tank
  • An optional additional waiting time of, for example, 10 minutes can be provided between steps S5 and S6 so that the absolute minimum target density is not operated on. If such an additional waiting time is provided, it is likely that the density of the mixture will continue to increase beyond the minimum target density achieved if the mixing process is carried out properly.
  • step S8 it is awaited whether the notified user releases the mixture or the medical solution. If this is the case, the medical solution is released and used in step S9 for its final use.
  • step S5 If it is detected in step S5 that the measured values from step S4 do not correspond to the target value, then the mixing process is continued in step S10 until a predetermined period of time, for example 70 minutes, has elapsed.
  • a predetermined period of time for example 70 minutes
  • steps S4 and S5 can be carried out regularly at predetermined intervals in order to check whether the entire 70 minute mixing process is actually required to achieve a desired ten medical solution or its parameter target values or target value ranges.
  • the period of time in step 10 can be different for the first run through of the loop with steps S4, S5 and S10 than for the second, third, and each subsequent run, e.g. 70 minutes for the first run and 30 minutes for each subsequent run.
  • the values mentioned are examples, any other values are conceivable.
  • step S10 After the predetermined period of time from step S10 is optional in step S10
  • the 511 waits for user input for a specified amount of time, e.g. 10 minutes.
  • the length of this period of time can be set arbitrarily.
  • step S12 a decision is made in step S12 as to whether the mixing process will be continued for a second predetermined period of time.
  • the mixing process can be automatically extended if there is no user input.
  • the predetermined period of time is 30 minutes, for example.
  • step S12 If it is decided in step S12 that the mixing process should be continued, the density is then measured again according to step S4. If it is decided in step S12 that the mixing process should not be continued, then the mixture is either transferred to the storage system for manual sampling in accordance with step S13 or discarded in accordance with step S15.
  • An optional request for a release by a user can be interposed between steps S12 and S13. For example, if a user in step
  • a Query are issued to the user, whether the mixture or the medical cal solution, ie the contents of the storage tank (also called mixing tank) should be transferred to a storage device or not.
  • step S14 If the manual sampling in step S14 shows that the mixture corresponds to the target specifications, the procedure continues according to step S8. If the mixture does not meet the target specifications, it is discarded in step S15.
  • the mixing device is rinsed with permeate or another suitable rinsing liquid in step S16 and is thus ready for the next mixing process.
  • step S16 may occur prior to or partially concurrently with step S15.
  • FIG. 2 shows a flow chart of a method according to the invention, which has a reduced number of method steps compared to the method from FIG. 1 .
  • FIG. 3 shows a flowchart of a method according to the invention, which is based on the method according to FIG. 2, but also includes step S2.
  • step S8 the release of a user can first be awaited before the mixture or the medical solution is released into the in step S7 if the release has taken place Storage device is transferred.
  • the release can take place automatically, for example by a device according to the invention, if it has been detected in step S5 that the mixture corresponds to the target specification of the medicinal solution. In other words, for example, if the mixture meets the target specifications, ie is the desired medicinal solution, the mixture is released.
  • a method according to the invention can be carried out automatically without the need for user input.
  • step S5 if it is detected in step S5 that the target density has not been reached and it is detected in step S10 that the first time period of the mixing operation, in this example 70 minutes, has elapsed, the mixing operation in step S10 S12 can be automatically extended once or several times by a predetermined second period of time until either the target density is reached or the mixture is discarded in step S15, for example due to the expiry of a specific maximum time span.
  • the mixture is discarded.
  • step S18 is provided between step S7, in which the mixture is supplied to the storage device because the mixture corresponds to the desired medicinal solution, and step S8, in which a release of the mixture by the user is awaited , in which it is detected whether the mixture or the medicinal solution has been completely supplied to the storage device and the transfer to the storage device is thus ended.
  • step S8 After positive user approval in step S8, the mixture or the medicinal solution is used, e.g. as a dialysate concentrate.
  • step S16 the device is flushed with permeate or another liquid.
  • step S17 after it is decided in step S12 not to extend the mixing process, it is decided in step S17 whether the mixture should be transferred to the storage system. If an affirmative decision is made in step S17, the mixture is transferred to the storage system in step S7 and it is checked in step S18 whether the transfer has ended. If a negative decision is made in step S17, it is decided in step S24 whether the mixture should be discarded. If it is decided that the mixture should not be discarded, the process advances to step S12. If it is decided in step S24 that the mixture should be discarded, it is discarded in step S15.
  • step S19 a sample of the mixture is taken and tested in step S20 (for example with an alternative measuring device), for example by a manual density measurement.
  • step S21 it is determined whether the measured values determined in step S20 correspond to a target specification.
  • step S21 If it is found in step S21 that the measured values determined in step S20 do not correspond to the target specification, then the mixture is discarded from the storage system in step S22.
  • FIG. 7 shows a device 1 according to the invention for producing a medicinal solution by mixing at least one liquid and at least one concentrate raw material by means of any mixing method with or in a Mixing container 2, into which the at least one liquid and the at least one concentrate raw material can be fed, a control device 3 and a measuring device 4 for measuring at least one parameter, preferably the density, of a mixture produced by the device 1 during the mixing process.
  • the device 1 preferably has two containers 5 which contain the same medicinal solution produced and store it redundantly and are connected to the mixing container 2 via a line 6 .
  • the containers 5 are used to store the dialysate concentrate produced.
  • Liquid, for example permeate is fed to the mixing tank 2 via a line 7 .
  • the concentrate raw material can be fed to the mixing tank via line 8 . Any raw material container with concentrate raw material can be connected to line 8.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • External Artificial Organs (AREA)
  • Accessories For Mixers (AREA)

Abstract

L'invention concerne un dispositif (1) de fabrication d'une solution médicale par mélange d'au moins un liquide et d'au moins une matière première concentrée, comprenant : - un récipient de mélange (2) dans lequel ledit liquide et ladite matière première concentrée peuvent être introduits ; - un dispositif de commande (3) ; et - un dispositif de mesure (4) pour mesurer, pendant le processus de mélange, au moins un paramètre, de préférence une densité, d'un mélange produit au moyen du dispositif. L'invention se rapporte également à un procédé correspondant.
EP22709216.0A 2021-02-10 2022-02-07 Dispositif et procédé de surveillance d'un processus de mélange Pending EP4288193A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021103141.9A DE102021103141A1 (de) 2021-02-10 2021-02-10 Vorrichtung und Verfahren zur Überwachung eines Mischvorgangs
PCT/EP2022/052876 WO2022171568A1 (fr) 2021-02-10 2022-02-07 Dispositif et procédé de surveillance d'un processus de mélange

Publications (1)

Publication Number Publication Date
EP4288193A1 true EP4288193A1 (fr) 2023-12-13

Family

ID=80685344

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22709216.0A Pending EP4288193A1 (fr) 2021-02-10 2022-02-07 Dispositif et procédé de surveillance d'un processus de mélange

Country Status (6)

Country Link
US (1) US20240109046A1 (fr)
EP (1) EP4288193A1 (fr)
JP (1) JP2024507285A (fr)
CN (1) CN116829250A (fr)
DE (1) DE102021103141A1 (fr)
WO (1) WO2022171568A1 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19809945C2 (de) 1998-03-07 2002-02-21 Fresenius Medical Care De Gmbh Vorrichtung zur Bereitstellung von Dialysierflüssigkeit mit einer Einrichtung zur Überwachung ausgewählter Parameter der Dialysierflüssigkeit und Verfahren zur Überwachung ausgewählter Parameter der Dialysierflüssigkeit bei einer Dialysebehandlung
DE102006001623B4 (de) * 2006-01-11 2009-05-07 Sartorius Stedim Biotech Gmbh Behälter und Verfahren zum Mischen von Medien
DE102010055781B4 (de) 2010-12-23 2014-07-24 Manfred Völker Mischanlage
CN104379189B (zh) * 2013-04-25 2016-10-12 甘布罗伦迪亚股份公司 医疗流体制备系统和方法
DE102019126086A1 (de) 2019-09-27 2021-04-01 Fresenius Medical Care AG & Co. KGaA Verfahren und System zur nicht-elektrischen Kommunikation bei Wasseraufbereitungsanlagen oder Medizingeräten

Also Published As

Publication number Publication date
JP2024507285A (ja) 2024-02-16
CN116829250A (zh) 2023-09-29
US20240109046A1 (en) 2024-04-04
DE102021103141A1 (de) 2022-08-11
WO2022171568A1 (fr) 2022-08-18

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