Method for manufacturing a vibronic module

Abstract

The invention relates to a method for manufacturing a vibronic module (VM), which is in particular suitable for biopharmaceutical applications, which vibronic module (VM) comprises: a measuring tube module (MM) having at least one, in particular metal, measuring tube (31, 32) for conducting a medium; and a process connection (PA) which is in particular formed from a plastic. The vibronic module (VM), together with a base module (BM), forms a modular Coriolis flowmeter. The method comprises the method steps: - providing the measuring tube module (MM) without the process connection (PA), at least one, in particular cylindrical, exciter magnet (22) being arranged on the at least one measuring tube (31, 32), said exciter magnet being designed to cause the at least one measuring tube (31, 32) to vibrate when exposed to a time-varying magnetic field of an exciter coil (12) of the base module (BM), at least one, in particular cylindrical, sensor magnet (24, 26) being arranged on the at least one measuring tube (31, 32); - calibrating the measuring tube module (MM) without the process connection (PA), a flowable calibration medium being used during the calibration, at least one calibration value being determined during the calibration, a measurement variable that is dependent on the flow velocity of the medium being determined by means of the at least one calibration value when the vibronic module (VM) is used in a base module (BM); - attaching the process connection (PA) to the measuring tube module (MM) in order to form the vibronic module (VM), in particular using an interlocking and / or frictional connection; and - sterilising, in particular gamma sterilising, the vibronic module (VM).

Description

[0001] Method for manufacturing a vibronic module

[0002] The invention relates to a method for producing a vibronic module, particularly suitable for biopharmaceutical applications.

[0003] From WO 2019 / 017891 A1 or WO 2021 / 121867 A2 as well as the German patent applications DE 102021105397, DE 102020133614, DE 102020132685, DE 102020133851, DE 102020133566, DE 102020132986, DE 102020132686, DE 102020132685, DE 102020131452, DE 102020132223, DE 102020127356, DE 102020114519 and DE 102020112154, modular, namely (Modular) vibronic measuring systems are known which are formed by means of a base module, a vibronic module which is mechanically connected to the base module and a measuring system electronics which is electrically connected to the base module and which are used to record at least one measured variable of a fluid measuring medium flowing in a (measuring material) line, namely to determine measured values ​​for one or more measured variables, for example a mass flow, a volume flow, a density and / or a viscosity, of the measuring material.

[0004] The basic module of such a (modular) vibronic measuring system comprises a housing with at least one chamber at least partially enclosed by a housing wall, as well as one or more electrical coils, for example cylindrical and / or designed as air-core coils, which are placed (spaced apart from one another) within the chamber of the housing and are at least indirectly mechanically connected to the housing wall. Each of the coils is also electrically connected to the measuring system electronics. The measuring system electronics can be housed at least partially within the housing and / or at least partially outside the housing, for example, in a separate electronics housing.The base module is also specifically designed to accommodate the vibronic module of the measuring system and to be mechanically connected thereto (forming a vibration-type transducer) in a rigid yet detachable manner, in particular to form the vibronic measuring system itself; this is particularly also done in such a way that the vibronic module is locked in the base module and is not movable.

[0005] The vibronic module of the respective measuring system, in turn, is also designed to be replaceable, such that it can be inserted into the chamber, in particular on-site, from outside the housing of the base module or through a (sliding) opening provided in the housing wall of the housing, and that it can be removed from the base module again non-destructively, if necessary even without tools, in particular from outside the housing and / or through the (sliding) opening of the housing, or without the base module itself having to be handled or removed from the (process) system. This also makes it possible, among other things, to subsequently insert a vibronic module on-site, namely into an already installed base module, or to replace a defective or worn vibronic module on-site with a new, intact vibronic module that can be used only once or only for a specified period of time (“disposable”).In the measuring systems in question, each vibronic module further comprises a measuring tube module with at least one, in particular metallic, measuring tube and a process connection, in particular made of a plastic, which can be connected or is connected to the measuring tube module, in particular in a force-fitting and / or form-fitting manner.The vibronic module further comprises one or more, for example cylindrical, permanent magnets and is also designed to be installed in the base module in such a way that each of the permanent magnets is placed within the aforementioned chamber, yet is spaced apart from the housing wall, in particular in such a way that each of the permanent magnets is held in a static installation position predetermined with regard to an orientation and / or a smallest distance from one of the electrical coils of the base module, and that a respective imaginary longitudinal axis of each of the permanent magnets and an imaginary longitudinal axis of at least one of the electrical coils are aligned with one another or extend parallel to one another.

[0006] In the measuring systems in question, each vibronic module further comprises at least one measuring tube, for example at least partially straight and / or at least partially curved, with a tube wall forming an outer surface of the tube, in particular made of a metal or a plastic, and with a lumen enclosed by the same tube wall, in particular two essentially identical parallel measuring tubes, and each of the aforementioned permanent magnets is fixed to the outside of the tube wall, in particular to a middle segment of the tube wall extending between a first segment end and a second segment end remote therefrom, in particular is integrally connected to the tube wall. In addition, the vibronic module or its at least one measuring tube is designed so that, if necessary,to be installed into the housing without tools in such a way that the tube is positioned at least partially, in particular completely, within the chamber, yet is spaced from the housing wall, and that each of the permanent magnets, in the respective installation position, together with the respective electrical coil, forms a voice coil, particularly useful as an electrodynamic vibration exciter, and / or a plunger coil, particularly useful as an electrodynamic vibration sensor. In the case of a measuring tube that is bent at least in sections, the aforementioned segment can, for example, be substantially U-shaped or V-shaped.In such a vibronic measuring system, each of the aforementioned measuring tubes is additionally designed to guide a fluid measuring substance flowing within the lumen during operation, in particular with a predeterminable flow direction and / or pointing from the first segment end to the second segment end, and to be vibrated during this time in order to generate measuring effects correlated with one or more measured variables of the measuring substance, in particular in such a way that the middle segment executes oscillating movements about a static rest position and / or that the measuring tube is driven by means of at least one of the aforementioned (energized) moving coils and / or that a (measurement) voltage representing oscillating movements of the at least one tube and thus serving as an oscillation signal is generated by means of the aforementioned moving coils.The measuring system electronics of such a measuring system is in turn set up accordingly to feed electrical power into the at least one electrical coil forming the aforementioned moving coil by means of an electrical driver signal, in particular with an impressed alternating current and / or an impressed (alternating current) frequency substantially corresponding to a resonance frequency of the at least one tube, and / or to determine measured values ​​for the one or more measured variables to be recorded of the medium flowing through the measuring tube or tubes on the basis of the (measurement) voltage generated by the at least one electrical coil forming the aforementioned moving coil, in the case of a Coriolis mass flow measuring device ora measuring system designed as a Coriolis mass flow / density measuring device, for example, to generate (mass flow) measured values ​​representing the mass flow based on a (measurement) phase difference between two of the aforementioned vibration signals caused by Coriolis forces in the medium flowing through the vibrating pipe, as well as a phase difference to the measured value characteristic function set up in the measuring system electronics. The phase difference to the mass flow measured value characteristic function can, for example, be a (linear) parameter function with a (scale) zero point that corresponds to a (measurement) phase difference between the two vibration signals that is measurable when the medium is at rest or when the mass flow is zero, and with a gradient that corresponds to a (measurement) sensitivity of the measuring system or a change in the (measurement) phase difference related to a change in the mass flow.Since one or more resonance frequencies of the at least one pipe depend in particular on the instantaneous density of the respective measuring medium, such a measuring system can be used to directly measure not only the mass flow but also the density of the measuring medium flowing through it based on the (alternating current) frequency of the driver signal and / or on a (signal) frequency of at least one of the oscillation signals. Accordingly, the measuring system electronics of measuring systems of the type in question are typically also configured to generate (density) measured values ​​representing the density based on the aforementioned (alternating current) frequency of the driver signal and / or on a corresponding signal frequency of at least one of the oscillation signals, for example using a useful frequency to measured value characteristic function set up accordingly in the measuring system electronics.Furthermore, it is also possible to directly measure the viscosity of the medium flowing through it using vibronic measuring systems of the type in question, for example based on the excitation energy or excitation power required to maintain the useful vibrations and / or based on the damping of the excited (resonance) vibrations resulting from the dissipation of vibration energy or using a damping-to-measured value characteristic function set up accordingly in the measuring system electronics. Furthermore, further derived measured variables, such as the Reynolds number, can be easily determined from the aforementioned flow and / or material parameters using such vibronic measuring systems. To simplify the commissioning of a measuring system formed in this way, the vibronic module can furthermore have at least oneidentifying information-bearing identification element, for example a barcode, QR code or radio label (RFID TAG) attached to at least one pipe, and / or the base module can have at least one light-emitting semiconductor element positioned within the housing and connected to the measuring system electronics, for example a light-emitting diode (LED), and / or one or more radio transmitters / receivers (RF transceivers) and / or photosensors, for example one or more CCD photosensors and / or one or more CMOS photosensors, each positioned within the housing and connected to the measuring system electronics.

[0007] Especially in biopharmaceutical applications, a high degree of cleanliness is required for components that come into contact with the measured substance. At the same time, the requirements regarding measurement accuracy are increasing.

[0008] The invention is based on the object of providing a solution.

[0009] The object is achieved by the method according to claim 1 and a vibronic module according to claim 17.

[0010] The method according to the invention for producing a vibronic module, particularly suitable for biopharmaceutical applications, which vibronic module has a measuring tube module with at least one, in particular metallic, measuring tube for guiding a medium and a process connection, in particular made of a plastic, and which vibronic module together with a base module forms a modular Coriolis flowmeter, comprising the method steps:

[0011] - Providing the measuring tube module without the process connection, wherein at least one, in particular cylindrical, excitation magnet is arranged on the at least one measuring tube, which is designed to cause the at least one measuring tube to oscillate when it is exposed to a time-varying magnetic field of an excitation coil of the base module, wherein at least one, in particular cylindrical, sensor magnet is arranged on the at least one measuring tube,

[0012] - Calibration of the measuring tube module without the process connection, whereby a flowable calibration medium is used during calibration, whereby at least one calibration value is determined during calibration, whereby when using the vibronic module in a base module, a measured variable dependent on the flow velocity of the medium is determined by means of the at least one calibration value,

[0013] - Attaching the process connection to the measuring tube module to form the vibronic module, in particular using a positive and / or non-positive connection; and

[0014] - Sterilization, especially gamma sterilization, of the vibronic module.

[0015] Advantageous embodiments of the invention are the subject of the subclaims.

[0016] One embodiment provides that the calibration medium is gaseous.

[0017] One embodiment provides that during calibration a clamping condition is simulated which exists when the vibronic module is fixed in place in the base module.

[0018] One embodiment provides that the at least one calibration value is stored unencrypted or encrypted on the measuring tube module, in particular on at least one measuring tube, or on the process connection.

[0019] One embodiment provides that after calibration, the calibration medium is removed and the measuring tube module, in particular the at least one measuring tube, is blown out with a gas, in particular with ultrapure air.

[0020] One embodiment provides that after calibration, a washing process of the measuring tube module, in particular the at least one measuring tube, takes place under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

[0021] One embodiment provides that after calibration, the measuring tube module, in particular the at least one measuring tube, is autoclaved under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

[0022] One design provides for the process connection to be attached to the measuring tube module under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

[0023] One embodiment provides for an air impression test to be carried out with ultrapure air under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

[0024] One embodiment provides for a leak test between the measuring tube module and the process connection using ultrapure air under cleanroom conditions according to ISO 14644-1:2015 Class 7 or Class 6. One embodiment provides for the vibronic module to be placed in protective packaging before sterilization, in particular gamma sterilization.

[0025] One embodiment provides that the protective packaging comprises a protective blister in which the vibronic module is arranged in a stationary manner and which is designed and configured to avoid impacts against the measuring tube module, in particular the at least one measuring tube.

[0026] One embodiment provides that the protective packaging comprises at least one protective bag in which the vibronic module is arranged and which is designed and configured to prevent impacts against the measuring tube module.

[0027] One embodiment provides that the calibration is not carried out under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6, and / or wherein the calibration medium comprises water.

[0028] One embodiment provides that the calibration is carried out under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6, and / or wherein the calibration medium comprises ultrapure air according to ISO 14644-1:2015 Class 7 or Class 6.

[0029] One embodiment provides that the calibration comprises an adjustment by means of an infrared temperature sensor and the at least one calibration value comprises a calibration value of an emissivity coefficient.

[0030] The vibronic module according to the invention for a modular Coriolis flowmeter is characterized in that it is manufactured by means of the method according to the invention.

[0031] The invention is explained in more detail with reference to the following figures. They show:

[0032] Fig. 1 : a perspective view of a measuring tube module and a base module;

[0033] Fig. 2 : a perspective view of a vibronic module;

[0034] Fig. 3 : a perspective view of an embodiment of a protective packaging; and

[0035] Fig. 4 : Method steps of an embodiment of the method according to the invention.

[0036] Some embodiments of the present disclosure are described in more detail below with reference to the accompanying figures. The figures illustrate some, but not all, embodiments of the disclosure. Indeed, these disclosures may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Different embodiments, each illustrating individual details of the inventive subject matter, may be combined with one another to form new embodiments not shown in the figures. Like numbers refer to like elements throughout.

[0037] The components illustrated in the figures represent components that may or may not be present in various embodiments of the present disclosure described herein, so that the embodiments may include fewer or more components than those illustrated in the figures without departing from the scope of the present disclosure. Some components may be omitted or shown in phantom in one or more figures to reveal underlying components.

[0038] The phrases "in an exemplary embodiment," "some embodiments," "various embodiments," and the like generally mean that the particular feature, structure, or characteristic following the phrase may be included in at least one embodiment of the present disclosure and may be included in more than one embodiment of the present disclosure. Such phrases do not necessarily refer to the same embodiment.

[0039] The word "example" or "exemplary" is used herein to mean "serving as an example or illustration." Any implementation described herein as "exemplary" is not necessarily to be understood as preferred or advantageous over other implementations.

[0040] If the description of the figures states that a component, part, or feature is "preferably," "possibly," "typically," "optionally," or "for example" (or other such wording) included, or that a feature "may" be included, or that a feature "could" or "should" have a property, it is not required that a specific component or feature be included or exhibit the feature. Such components or features may be optionally included in some embodiments, but they may also be excluded. An embodiment not included in the figures may also include all features—provided they do not contradict each other—of the embodiments shown.

[0041] Fig. 1 shows a measuring tube module MM and a base module BM of a modular measuring system. No process connection is connected to the measuring tube module MM. The measuring tube module MM comprises at least one, in particular metallic, measuring tube 31, 32 for guiding the measured medium. In the embodiment of Fig. 1, the measuring tube module MM has two measuring tubes 31, 32 that run essentially parallel to one another and are bent in sections. The measuring tubes 31, 32 take on the shape of a U or a V. At least one, in particular cylindrical, excitation magnet 22 is arranged on the at least one measuring tube 31, 32. This is designed to cause the at least one measuring tube 31, 32 to oscillate when it is exposed to a time-varying magnetic field of an excitation coil 12 of the base module BM. In the embodiment of Fig.1, both measuring tubes 31, 32 each have an excitation magnet 22, which is arranged on the outer surface of the corresponding measuring tube 31, 32 and which are mounted on opposite sides of the measuring tube 31, 32. The excitation magnet of the measuring tube 32 is concealed by the measuring tube 32 itself. Furthermore, at least one, in particular cylindrical, sensor magnet 24 is arranged on at least one measuring tube 31, 32. In the case of an oscillating measuring tube 31, 32, the sensor magnet 24 generates a time-varying magnetic field that depends on the oscillation behavior of the at least one measuring tube 31, 32. In the embodiment of Fig. 1, the two measuring tubes 31, 32 each have two sensor magnets 24, 26 (partially covered by measuring tube 32), which are arranged on the outer surface 31+, 32+ of the measuring tubes 31, 32. The excitation magnets 22 and also the sensor magnets 24, 26 can be applied directly to the outer surface 31+, 32+ of the measuring tubes 31, 32, e.g.be attached in a material-to-material manner or indirectly via a connecting element which is itself materially, non-positively and / or positively connected to the corresponding measuring tube 31, 32. The connecting element can be, for example, a magnetic cup which is designed not only to hold the corresponding magnet but also to protect it. Advantageously, the sensor magnets 24, 26 and the excitation magnets 22 are arranged on the outer surface 31+ of the measuring tube 31, 32 in such a way that a collision with the housing wall 11+ can be avoided when the vibronic module VM is arranged in the chamber 11*. The sensor magnets 24, 26 are arranged offset in the flow direction of the medium in the measuring tube 31, 32. The excitation magnet 22 is always positioned between the two sensor magnets 24, 26 in the flow direction of the medium in the measuring tube 31, 32.In the solution shown, the excitation magnet 22 is arranged in a partial section of the measuring tube 31, 32 in which the measuring tube 31, 32 is bent.

[0042] The vibronic module VM shown does not have any coils, i.e., neither the excitation coil nor the sensor coil are part of the vibronic module VM. Thus, the vibronic module VM also does not have any electrical conductors (e.g., cables) that would otherwise be necessary to electrically connect the coils to the measuring system electronics ME. Furthermore, no temperature sensor is arranged on one of the measuring tubes 31, 32. Thus, the vibronic module VM also does not have any electrical conductors (e.g., cables) that would otherwise be necessary to electrically connect the temperature sensor to the measuring system electronics ME.

[0043] Furthermore, the measuring tube module MM comprises a connecting body 50, which is mechanically connected to the at least one measuring tube 31, 32 (e.g. via a material-to-material connection) and via which the at least one measuring tube 31, 32 can be mechanically connected to the base module BM. The connecting body 50 connects the two ends of the at least one measuring tube 31, 32 to one another. In the embodiment of Fig. 1, the connecting body 50 is planar. Furthermore, the connecting body 50 connects the ends of the measuring tube 31 and the ends of the measuring tube 32 to one another and to one another. The two measuring tubes 31, 32 extend through openings in the connecting body 50. The fixing of the connecting body 50 to the measuring tubes 31, 32 is realized via a material-to-material connection (welded or soldered connection).The vibronic module VM shown also has four couplers 110i, which are designed to mechanically couple the two measuring tubes 31, 32 to each other in the coupling areas. The two couplers 110a, 110b couple the two measuring tubes 31, 32 in the inlet area, and the remaining two couplers couple the two measuring tubes 31, 32 in the outlet area.

[0044] The base module BM has a measuring system electronics ME and a housing 11 with at least one chamber 11* at least partially enclosed by a housing wall 11+. The measuring system electronics ME is arranged separately in a measuring system electronics housing. Alternatively, the housing can have a measuring system electronics chamber in which the measuring system electronics ME is arranged, separate from the chamber 11*. The measuring system electronics ME comprises electrical components (e.g., active components, passive components, discrete components, and integrated components) that are arranged on at least one printed circuit board and interact with one another in such a way that they are suitable for operating the base module BM. Furthermore, the measuring system electronics ME can comprise at least one microprocessor or microcontroller.

[0045] Within the chamber 11* is at least one cylindrical and / or air-core coil excitation coil 12, which is at least indirectly mechanically connected to the housing wall 11+ and electrically connected to the measuring system electronics ME. The excitation coil 12 can be arranged in an opening in the housing wall 11+, as shown, or can be positioned separated from the chamber 11* by the housing wall 11+. Alternatively, the excitation coil 12 can also be placed on the front surface of the housing wall 11+ facing the chamber 11*. In the embodiment of Fig. 1, the base module BM has one excitation coil 12 for each measuring tube 31, 32 (i.e., a total of two excitation coils), which are arranged opposite one another on an excitation coil axis, which itself runs perpendicular to the longitudinal axis of the chamber 11*.The measuring system electronics ME is configured to operate the at least one excitation coil 12 with an operating signal which is designed such that the at least one excitation coil 12 generates a time-varying magnetic field.

[0046] Furthermore, at least one sensor coil 14, 16, in particular a cylindrical one and / or designed as an air-core coil and / or structurally identical to the excitation coil 12, is arranged within the chamber 11* of the housing 11. This sensor coil is positioned, in particular, remote from the excitation coil 12 and is at least indirectly mechanically connected to the housing wall 11+, which is electrically connected to the measuring system electronics ME. The at least one sensor coil 14, 16 can be arranged, as shown, in an opening in the housing wall 11+, or can be positioned separated from the chamber 11* by the housing wall 11+. Alternatively, the at least one sensor coil 14, 16 can also be placed on the front surface of the housing wall 11+ facing the chamber 11*. In the embodiment of Fig. 1, the base module BM has two sensor coils 14, 16 for each measuring tube 31, 32 (i.e., a total of four sensor coils).Two of the four sensor coils 14, 16 are arranged on one side of the chamber 11, opposite each other. The measuring system electronics ME is configured to read the voltages induced at the sensor coils 14, 16 and to determine a phase shift between the measurement signals provided at the individual sensor coils 14, 16.

[0047] The base module M1 is designed to accommodate the vibronic module VM or the measuring tube module, in particular in the chamber 11*, and to be mechanically connected thereto in a secure yet releasable manner, in particular to form a vibration-type measuring sensor or a vibronic measuring system and / or such that the vibronic module VM is locked in the base module BM or is immobile. For this purpose, the base module BM can have fastening means or a fastening device (not shown) - as disclosed, for example, in DE 10 2020 114 519 A1.The vibronic module VM is designed to be installed in the base module BM such that its excitation magnet 22 is placed within the chamber, yet is spaced apart from the housing wall 11+, in particular in a predetermined orientation and / or minimum distance from the excitation coil 12 and / or is held in the static installation position and / or such that an imaginary longitudinal axis of the excitation magnet 22 and an imaginary longitudinal axis of the excitation coil 12 are aligned with one another or extend parallel to one another.Furthermore, the vibronic module VM is configured to be installed in the base module BM such that its sensor magnet 24, 26 is placed within the chamber, yet is spaced from the housing wall 11+, in particular, namely in a predetermined orientation and / or minimum distance from the sensor coil 14, 16 and / or is held in the static installation position, and / or such that an imaginary longitudinal axis of the sensor magnet 24, 26 and an imaginary longitudinal axis of the sensor coil 14, 16 are aligned with one another or extend parallel to one another. Furthermore, an optical unit 181 is part of the base module BM. The optical unit 181 can have a camera for detecting a code and / or an infrared camera for determining a temperature of the vibronic module, in particular of the at least one measuring tube 31, 32. In this case, the code is arranged on the at least one measuring tube 31, 32.

[0048] The embodiment of Fig. 1 discloses a modular measuring system in which the vibronic module VM is inserted into and removed from the chamber 11* in a direction perpendicular to its own longitudinal axis. Alternatively, the housing 11 can also be designed such that the vibronic module VM is inserted into the chamber 11* in the direction of its own longitudinal axis. Such a solution is taught, for example, in DE 10 2020 133 851 A1. Fig. 2 shows a perspective view of a vibronic module VM with a measuring tube module MM and a process connection PA. The process connection PA can be made of a plastic, while the measuring tube module MM is made of metal. The process connection PA is connected to a measuring tube module MM via a positive and / or non-positive connection. Furthermore, the process connection PA comprises two connections 33, 34, to which, for example, a hose system can be attached.Part of the respective connections 33, 34 is an inlet channel 35 and an outlet channel 36. The process connection PA has a distribution channel 37 which, starting from the connection 33, distributes the medium into the two measuring tubes or from the two measuring tubes into the connection 34. The process connection PA and the connecting body 50 are formed in at least two parts and are connected to one another via a positive, non-positive and / or material-locking connection. Seals can be provided which seal the measuring tubes towards the inlet and / or outlet channels 35, 36. The calibration of the vibronic module VM is carried out exclusively without the process connection PA. After calibration and cleaning of the measuring tube module MM, the process connection PA is connected to the measuring tube module MM. This can be done under clean room conditions.

[0049] Fig. 3 shows a perspective view of an embodiment of a protective packaging SV with a vibronic module VM. The vibronic module VM is arranged in the said protective packaging SV before sterilization, in particular gamma sterilization. The vibronic module VM is arranged in a form-fitting and / or force-fitting and stationary manner in a protective blister SBL. In particular, the measuring tube module is in contact with the protective blister SBL. The process connection PA can also be in mechanical contact with the protective blister SBL. A blister is generally used whenever the customer is to be allowed to see the packaged goods. The protective blister SBL shown is designed and configured to prevent impacts against the measuring tube module MM, in particular the at least one measuring tube. The vibronic module VM and the protective blister SBL are arranged in at least one protective bag SBE1, SBE2, in particular with two protective bags SB1, SB2.The at least one protective bag SBE1, SBE2 may be sealed. This serves as an indicator of whether the protective packaging SV has been opened improperly, thus potentially contaminating the vibronic module VM. The at least one protective bag SB1, SB2 may be vacuum-sealed, meaning that the air in the at least one protective bag SB1, SB2 was sucked out during production and the at least one protective bag SB1, SB2 was sealed hermetically.

[0050] The at least one protective bag SBE1, SBE2 can alternatively be designed and configured to prevent impacts against the measuring tube module MM. For this purpose, the at least one protective bag SBE1, SBE2 can be designed as an air cushion.

[0051] Fig. 4 schematically shows a process flow of a method for manufacturing a vibronic module, particularly suitable for biopharmaceutical applications. This vibronic module comprises a measuring tube module with at least one, in particular metallic, measuring tube for conveying a medium and a process connection, in particular made of a plastic. This vibronic module, together with a base module, forms a modular Coriolis flowmeter. The method comprises the following process steps:

[0052] I. Providing the measuring tube module without the process connection.

[0053] The measuring tube module comprises at least one, in particular metallic, measuring tube and a, in particular metallic, connecting body on at least one measuring tube, via which the measuring tube module can be connected to the base module. Alternatively, the measuring tube module does not have a connecting body, and instead the process connection has a connecting body, or the process connection is designed such that the connection between the vibronic module and the base module can be established via the process connection.

[0054] According to the invention, the measuring tube module is calibrated separately and without a process connection.

[0055] II. Calibrating the measuring tube module without the process connection.

[0056] For this purpose, the measuring tube module is installed in a calibration system, and at least one measuring tube is connected to a calibration line. The calibration system can be designed in such a way that during calibration, a clamping condition can be recreated that would exist if the vibronic module were permanently mounted in a base module. The calibration system can be designed according to a base module for customer use. However, this is not absolutely necessary. It has been found that it is sufficient to simulate the mounting of the measuring tube module in a base module. This means that the forces expected when attaching the vibronic module in the base module holder are simulated.

[0057] To calibrate the measuring tube module, a flowable calibration medium is used, which is introduced into at least one measuring tube via the calibration line. The flowable calibration medium can be gaseous. The calibration medium can be ultrapure air (e.g., according to ISO 8573-1:2010 or ISO 14644-1:2015 Class 7 or Class 6) or water.

[0058] During calibration, at least one calibration value is determined, which is taken into account when using the vibronic module in a base module for a measured variable dependent on the flow velocity of the medium. The calibration value results from the known, set flow velocity-dependent measured variable of the calibration medium and the measured value actually determined during calibration. Furthermore, during calibration, an adjustment can be carried out using an infrared temperature sensor - which is part of the calibration device - and in the process, a further calibration value can be determined, which represents a value for an emissivity coefficient of an infrared temperature sensor. The at least one calibration value can be stored unencrypted or encrypted on the measuring tube module, in particular on at least one measuring tube, or on the process connection.For this purpose, a QR code or a barcode can be lasered into at least one measuring tube or into the process connection. The calibration value can be a zero point, a natural frequency of at least one measuring tube, a correction coefficient, a calibration factor, and / or one or more correction values.

[0059] The measuring tube module can be calibrated under cleanroom conditions according to ISO 14644-1:2015 Class 7 or Class 6. Alternatively, calibration can be performed under non-cleanroom conditions according to ISO 14644-1:2015 Class 7 or Class 6.

[0060] III. Attaching the process connection, in particular made of a plastic, to the measuring tube module to form the vibronic module, in particular using a positive and / or non-positive connection.

[0061] The process connection can be attached to the measuring tube module under cleanroom conditions according to ISO 14644-1:2015 Class 7 or Class 6. The process connection itself can also be manufactured under cleanroom conditions according to ISO 14644-1:2015 Class 7 or Class 6. The process connection can be manufactured using an injection molding process.

[0062] IV. Sterilization, especially gamma sterilization, of the vibronic module.

[0063] Fig. 5 schematically shows a process flow of a method for manufacturing a vibronic module, particularly suitable for biopharmaceutical applications. This vibronic module comprises a measuring tube module with at least one, in particular metallic, measuring tube for conveying a medium and a process connection, in particular made of a plastic. This vibronic module, together with a base module, forms a modular Coriolis flowmeter. The method comprises the following process steps:

[0064] I. Providing the measuring tube module without the process connection.

[0065] II. Calibrating the measuring tube module without the process connection.

[0066] III. Removing the calibration medium, in particular by blowing out the measuring tube module, in particular the at least one measuring tube, with a gas, in particular with ultrapure air.

[0067] The calibration medium can be removed by blowing it out with a gaseous medium using a calibration system or manually. A further heating step can be provided to ensure that no calibration medium remains in at least one measuring tube.

[0068] IV. Washing the measuring tube module, in particular the at least one measuring tube, under cleanroom conditions according to ISO 14644-1:2015 Class 7 or Class 6. Cleaning agents that are also used in biopharmaceutical applications can be used for the washing process. After the washing process, the measuring tube module can be finally cleaned with ultrapure water. After the final cleaning step, the measuring tube module can be baked to remove traces of ultrapure water. Alternatively, an additional heating process can be omitted.

[0069] After the washing process, autoclaving of the measuring tube module, in particular of at least one measuring tube, may be provided under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

[0070] V. Attaching the process connection, in particular made of a plastic, to the measuring tube module to form the vibronic module, in particular using a positive and / or non-positive connection.

[0071] VI. Conduct an air imprint test and / or a leak test with ultrapure air under cleanroom conditions according to ISO 14644-1:2015 Class 7 or Class 6. The air imprint test can be conducted with ultrapure air at a pressure of approximately 6 bar.

[0072] VII. Pack the vibronic module in protective packaging.

[0073] The protective packaging may comprise a protective blister in which the vibronic module is arranged in a stationary manner and which is designed and configured to prevent impacts against the measuring tube module, in particular the at least one measuring tube. A protective blister is a

[0074] Additionally, the protective packaging can include at least one protective bag in which the vibronic module is arranged and which is designed and configured to prevent impacts against the measuring tube module. The protective bag can, for example, be a pressurized plastic cushion. Furthermore, more than one protective bag can be provided. For example, the vibronic module can be packaged in a first plastic cushion, which in turn can be packaged in a second plastic cushion. Packaging can take place under cleanroom conditions according to ISO 14644-1:2015 Class 7 or Class 6.

[0075] VIII. Sterilization, especially gamma sterilization, of the vibronic module.

Claims

PATENT CLAIMS 1. A method for producing a vibronic module (VM), particularly suitable for biopharmaceutical applications, which vibronic module (VM) comprises a measuring tube module (MM) with at least one, particularly metallic, measuring tube (31, 32) for guiding a medium and a process connection (PA), particularly made of a plastic, and which vibronic module (VM) together with a base module (BM) forms a modular Coriolis flowmeter, comprising the method steps: - Providing the measuring tube module (MM) without the process connection (PA), wherein at least one, in particular cylindrical, excitation magnet (22) is arranged on the at least one measuring tube (31, 32), which is designed to cause the at least one measuring tube (31, 32) to oscillate when it is exposed to a time-varying magnetic field of an excitation coil (12) of the base module (BM), wherein at least one, in particular cylindrical, sensor magnet (24, 26) is arranged on the at least one measuring tube (31, 32), - Calibration of the measuring tube module (MM) without the process connection (PA), whereby a flowable calibration medium is used during calibration, whereby at least one calibration value is determined during calibration, whereby when using the vibronic module (VM) in a base module (BM), a measured variable dependent on the flow velocity of the medium is determined by means of the at least one calibration value, - Attaching the process connection (PA) to the measuring tube module (MM) to form the vibronic module (VM), in particular using a positive and / or non-positive connection; and - Sterilization, especially gamma sterilization, of the vibronic module (VM).

2. The method according to claim 1, wherein the calibration medium is gaseous.

3. Method according to claim 1 or 2, wherein during calibration a clamping condition is simulated which exists when the vibronic module (VM) is fixed in the base module (BM).

4. Method according to one of the preceding claims, wherein the at least one calibration value is stored unencrypted or encrypted on the measuring tube module (MM), in particular on the at least one measuring tube (31, 32), or on the process connection (PA).

5. Method according to one of the preceding claims, wherein after the calibration the calibration medium is removed and the measuring tube module (MM), in particular the at least one measuring tube (31, 32) is blown out with a gas, in particular with ultrapure air.

6. Method according to one of the preceding claims, wherein after the calibration a washing process of the measuring tube module (MM), in particular the at least one measuring tube (31, 32), takes place under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

7. Method according to one of the preceding claims, wherein after calibration, the measuring tube module (MM), in particular the at least one measuring tube (31, 32), is autoclaved under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

8. Method according to one of the preceding claims, wherein the attachment of the process connection (PA) to the measuring tube module (MM) takes place under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

9. Method according to one of the preceding claims, wherein an air impression test is carried out with ultrapure air under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

10. Method according to one of the preceding claims, wherein a leak test between the measuring tube module (MM) and the process connection (PA) is carried out with ultrapure air under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6.

11. Method according to one of the preceding claims, wherein before sterilizing, in particular gamma sterilizing, the vibronic module (VM), the vibronic module (VM) is placed in a protective packaging (SV).

12. The method according to claim 11, wherein the protective packaging (SV) comprises a protective blister (SBL) in which the vibronic module (VM) is arranged in a stationary manner and which is designed and configured to avoid impacts against the measuring tube module (MM), in particular the at least one measuring tube (31, 32).

13. The method according to claim 11 or 12, wherein the protective packaging (SV) comprises at least one protective bag (SBE1, SBE2) in which the vibronic module (VM) is arranged and which is designed and configured to avoid impacts against the measuring tube module (MM).

14. Method according to one of the preceding claims, wherein the calibration is not carried out under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6, and / or wherein the calibration medium comprises water.

15. Method according to one of the preceding claims, wherein the calibration is carried out under clean room conditions according to ISO 14644-1:2015 Class 7 or Class 6, and / or wherein the calibration medium comprises ultrapure air according to ISO 14644-1:2015 Class 7 or Class 6.

16. A method according to any one of the preceding claims, wherein the calibration comprises an adjustment using an infrared temperature sensor, and the at least one calibration value comprises a calibration value of an emissivity coefficient.

17. A vibronic module (VM) for a modular Coriolis flowmeter, characterized in that it is manufactured using a method according to any one of the preceding claims.

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