Method for manufacturing a vibronic module

Abstract

The invention relates to a method for producing a vibronic module (VM), particularly suitable for biopharmaceutical applications, which vibronic module (VM) has 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).

Description

The invention relates to a method for producing a vibronic module, which is particularly suitable for biopharmaceutical applications.WO 2019 / 017891 A1 or WO 2021 / 121867 A2 and also 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 are each modular, namely formed by means of a base module, a vibronic module mechanically connected to the base module and measuring system electronics electrically connected to the base module and detecting at least one measured variable of a fluid measured material flowing in a (measured material) line, namely known from the ascertainment of measured values for one or more measured variables, for example a mass flow, a volume flow, a density and / or a viscosity, of the measurement material are similar (modular) vibronic measurement systems.The base module of such a (modular) vibronic measuring system has a housing with at least one chamber at least partially enclosed by a housing wall as well as one or more, for example cylindrical and / or designed as an air coil, electric coils which are placed (spaced apart from each other) 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 electronics measuring system. The measuring system electronics can be accommodated at least partially within the housing and / or at least partially outside the housing, for example, namely in a separate electronics housing. The base module is in particular also configured to receive the vibronic module of the measuring system and thus be connected mechanically firmly, nevertheless releasably (forming a transducer of vibration type), in particular namely forming the vibronic measuring system itself; this in particular also in such a way that the vibronic module is locked in the base module or is not movable.The vibronic module of the respective measuring system is in turn designed to be replaceable in such a way that it can be introduced into the chamber from outside the housing of the base module, in particular also on site, or through an (insertion) opening of the housing provided in its housing wall, and that it can be removed again from the base module in a non-destructive manner, optionally also without tools, in particular namely from outside the housing and / or through the (insertion) opening of the housing, or without the base module itself having to be handled or removed from the (process) installation for this purpose. 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 an intact new vibronic module, which may also be used only once or only for a predetermined period of time (disposable), on site. 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 formed from a plastic, which is connectable or connected to the measuring tube module, in particular in a force-fit and / or form-fit manner. The vibronic module furthermore has in each case one or more, for example cylindrical, permanent magnets and is also configured to be installed in the base module in such a way that each of the permanent magnets is placed within the aforementioned chamber, but nevertheless is in each case spaced apart from the housing wall, this in particular in such a way that each of the permanent magnets is held in a respective static installation position predetermined with respect 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 run parallel to one another in extension.In the measuring systems in question, each vibronic module further comprises at least one measuring tube, for example at least sectionally straight and / or at least sectionally curved measuring tube, having a tube wall forming an outer lateral surface of the tube, in particular made of a metal or a plastic, and having a lumen enveloped by said tube wall, in particular namely two substantially identically constructed parallel measuring tubes, and each of the above-mentioned permanent magnets is fixed on the outside of the tube wall, in particular namely at a means segment of the tube wall extending between a first segment end and a second segment end remote therefrom, in particular specifically connected to the tube wall in a materially integral manner. In addition, the vibronic module or its at least one measuring tube is designed to be installed into the housing, optionally also without tools, in such a way that the tube is placed at least partially, in particular completely, inside the chamber, nevertheless is spaced apart from the housing wall, and that each of the permanent magnets in the respective installation position together with the respective electrical coil form a voice coil, in particular serving as an electrodynamic vibration exciter, and / or a voice coil, in particular serving as an electrodynamic vibration sensor. In the case of a measuring tube bent at least in sections, the aforementioned means segment can be embodied, for example, substantially U-shaped or V-shaped. In such a vibronic measuring system, each of the aforementioned measuring tubes is additionally configured to guide a fluid measuring substance during operation within the lumen, in particular with a flow direction that can be predetermined and / or points from the first segment end to the second segment end, and during this, to be caused to vibrate 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 segment means performs oscillatory movements about a static rest position and / or that the measuring tube is driven by means of at least one of the aforementioned (energized) oscillatory coils and / or that by means of the aforementioned inductive coils, in each case one oscillatory movement of the at least one tube, and thus the (measuring) voltage that is useful as an oscillatory signal, is generated. The measuring system electronics of such a measuring system is accordingly configured to feed electrical power into the at least one electrical coil forming the aforementioned voice coil by means of an electrical driver signal, in particular with an impressed alternating current and / or an impressed (alternating current) frequency corresponding substantially to a resonant frequency of the at least one tube, and / or to determine measured values for the one or more measured variables to be detected of the measured material flowing through the measuring tube or the tubes on the basis of the (measurement) voltage generated by the at least one electrical coil forming the aforementioned voice coil, In the case of a measuring system designed as a Coriolis mass flow measuring device or as a Coriolis mass flow / density measuring device, for example, specifically based on a (measurement) measurement value between two of the aforementioned oscillation signals, which is caused by Coriolis forces in the measurement substance flowing through the oscillating tube, as well as a phase difference between measured values representing the mass flow and a (mass flow) measured values established in the measuring system electronics. The phase difference to the mass flow measurement value characteristic curve function can be, for example, a (linear) parameter function with a (scale) measurement curve which corresponds to a (measurement) measurement curve of the two oscillation signals that can be measured when the measurement substance is stationary or a mass flow of zero, and with a slope which corresponds to a (measurement) sensitivity of the measurement system or a change in the (measurement) measurement curve related to a change in the mass flow. Since one or more resonance frequencies of the at least one tube are also dependent in particular on the instantaneous density of the respective test substance, by means of such a measuring system, in addition to the mass current, the density of the test substance flowing through in each case can additionally also be measured directly on the basis of the (alternating current) frequency of the drive signal and / or on the basis of a (signal) frequency of at least one of the oscillation signals. Accordingly, the measuring system electronics of measuring systems of the type in question is typically also configured to generate (density) measurement values representing the density on the basis of the aforementioned (alternating current) frequency of the driver signal and / or on the basis of a corresponding signal frequency of at least one of the oscillation signals, for example using a useful frequency to measurement value characteristic function configured accordingly in the measuring system electronics. In addition, it is also possible to measure the viscosity of the material to be measured flowing through directly by means of vibronic measuring systems of the type in question, for example based on an excitation energy or excitation power required for maintaining the wanted oscillations and / or based on a damping of the excited (resonance) oscillations resulting from dissipation of oscillation energy or using a damping to measured value characteristic function correspondingly set up in the measuring system electronics. In addition, further derived measured variables, such as the Reynolds number, can be easily determined from the aforementioned flow and / or substance parameters by means of such vibronic measurement systems.To simplify the startup of a measuring system formed in this way, the vibronic module can furthermore have at least one identification element, for example a barcode, QR code or radio tag (RFID TAG), which is positioned within the housing and connected to the measuring system electronics, and / or the base module can have at least one light-emitting semiconductor element, for example a light-emitting diode (LED), which is positioned within the housing and connected to the measuring system electronics, and / or one or more radio transmitters / receivers (RF transceivers) and / or photosensors, for example, namely one or more CCD photosensors and / or one or more CMOS photosensors, which are respectively positioned within the housing and connected to the measuring system electronics.Particularly in the case of biopharmaceutical applications, a high degree of cleanliness is required for the components which come into contact with the test substance to be guided. At the same time, the requirements with regard to the measurement accuracy increase.The object of the invention is to provide a solution.The object is achieved by the method according to claim 1 and a vibronic module according to claim 17.The method according to the invention for producing a vibronic module, which is suitable in particular 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, which is formed in particular from a plastic, and which vibronic module together with a base module forms a modular Coriolis flowmeter, comprising the method steps: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 excitation magnet is configured to cause the at least one measuring tube to oscillate when it is exposed to a temporally variable magnetic field of an excitation coil of the basic modulewherein at least one, especially cylindrical, sensor magnet is arranged on the at least one measuring tube,calibrating the measuring tube module without the process connection,wherein a flowable calibration medium is used during calibration,wherein at least one calibration value is determined during calibration,wherein, when using the vibronic module in a basic module, a measurement variable dependent on the flow speed of the medium is determined by means of the at least one calibration value,attaching the process connection to the measuring tube module for forming the vibronic module, in particular using a form-fit and / or force-fit connection; andsterilizing, in particular gamma sterilizing, the Vibronic module.Advantageous embodiments of the invention are the subject matter of the dependent claims.One embodiment provides that the calibration medium is gaseous.One embodiment provides that during calibration a clamping condition is adjusted which is present when the vibronic module is fixed in place in the base module.One embodiment provides that the at least one calibration value is stored unencrypted or encrypted on the measuring tube module, in particular on the at least one measuring tube, or on the process connection.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 ultra clean air.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.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.One embodiment provides that the process connection to the measuring tube module is attached under clean room conditions according to ISO 14644-1:2015 class 7 or class 6.One embodiment provides that an air impression test is carried out with ultra clean air under clean room conditions according to ISO 14644-1:2015 class 7 or class 6.One embodiment provides that a tightness test between the measuring tube module and the process connection is carried out with ultra clean air under clean room conditions according to ISO 14644-1:2015 class 7 or class 6.One embodiment provides that before sterilizing, in particular gamma sterilizing, the vibronic module is arranged in a protective packaging.One embodiment provides that the protective packaging comprises a protective blister pack in which the vibronic module is arranged in a fixed position and which is designed and configured in such a way as to avoid impacts against the measuring tube module, in particular the at least one measuring tube.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 in such a way as to avoid impacts against the measuring tube module.One embodiment provides that calibration does not take place under clean room conditions according to ISO 14644-1:2015 class 7 or class 6, and / or wherein the calibration medium comprises water.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 ultra clean air according to ISO 14644-1:2015 class 7 or class 6.In one embodiment, the calibration comprises a calibration by means of an infrared temperature sensor and the at least one calibration value comprises a calibration value of an emissivity coefficient.The vibronic module according to the invention for a modular Coriolis flowmeter is characterized in that it is produced by means of the method according to the invention.The invention is explained in more detail with reference to the following figures. It shows: FIG. 1 : a perspective view of a measuring tube module and a base module; FIG. 2 : a perspective view of a vibronic module; FIG. 3 : a perspective view of an embodiment of a protective packaging; and FIG. 4 : method steps of an embodiment of the method according to the invention.Some aspects of the present disclosure will be described in more detail below with reference to the accompanying drawings. The figures show some, but not all, embodiments of the disclosure. Indeed, these disclosures may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Different embodiments, each of which shows individual details of the subject matter according to the invention, can be combined with one another to form new embodiments not shown in the figures. Like numbers refer to like elements throughout.The components depicted in the figures represent components that may or may not be present in various embodiments of the present disclosure described herein, such that the embodiments may include fewer or more components than those depicted in the figures without departing from the scope of the present disclosure. Some components may be omitted from one or more figures or shown in phantom to visualize the underlying components.The terms "in an exemplary embodiment," "some embodiments," "various embodiments," and the like generally mean that the particular feature, structure, or characteristic following the term 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 terms need not necessarily refer to the same configuration.The word "example" or "exemplary" is used herein in the sense of "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.When the description of the figures indicates that a component, component, or feature is included or "may be included (or some other such formulation), "preferably", "possibly", "typically", "optionally", or "for example" (or some other such formulation), a feature may have a property "could" or "should", it is not necessary that a particular component or feature be included or have the feature. Such components or features may be optionally included in some embodiments, but may also be excluded. A configuration not included in the figures can also include all features-insofar as they do not conflict-of the shown configurations.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 material to be measured. In the embodiment of FIG. 1, the measuring tube module MM has two measuring tubes 31, 32 running essentially parallel to one another and bent in sections. The measuring tubes 31, 32 take the form of a U or a V.At least one, in particular cylindrical, exciter magnet 22 is arranged on the at least one measuring tube 31, 32. This is configured to oscillate the at least one measuring tube 31, 32 when it is exposed to a time-variable magnetic field of an excitation coil 12 of the basic module BM. In the embodiment of FIG. 1, both measuring tubes 31, 32 each have an exciter magnet 22, which is arranged on the outer lateral surface of the corresponding measuring tube 31, 32 and which are attached on opposite sides of the measuring tubes 31, 32. The exciter 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 the at least one measuring tube 31, 32. In the case of an oscillating measuring tube 31, 32, the sensor magnet 24 generates a magnetic field which varies over time and which 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 lateral surface 31+, 32+ of the measuring tubes 31, 32. The exciter magnets 22 and likewise the sensor magnets 24, 26 can be attached directly to the outer lateral surface 31+, 32+ of the measuring tubes 31, 32, for example in a materially bonded manner, or indirectly via a connecting element which is itself connected to the corresponding measuring tube 31, 32 in a materially bonded, force-fit and / or form-fit manner. The connecting element can be, for example, a magnet cup which is not only configured to hold the corresponding magnet but also to protect it. Advantageously, the sensor magnets 24, 26 and the exciter magnets 22 are arranged on the outer lateral surface 31+ of the measuring tube 31, 32 in such a way that, when the vibronic module VM is arranged in the chamber 11*, a collision with the housing wall 11+ can be avoided. The sensor magnets 24, 26 are arranged offset in the direction of flow of the medium in the measuring tube 31, 32. The exciter magnet 22 is always positioned in the direction of flow of the medium in the measuring tube 31, 32 between the two sensor magnets 24, 26. In the depicted solution, the exciter magnet 22 is arranged in a subsection of the measuring tube 31, 32 in which the measuring tube 31, 32 is bent.The illustrated vibronic module VM has no coils, i.e. neither excitation coil nor sensor coil are part of the vibronic module VM. Thus, the vibronic module VM also does not have any electrical conductors (e.g. cables) which would otherwise be necessary to electrically connect the coils to the measurement 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) which would otherwise be necessary to electrically connect the temperature sensor to the measurement system electronics ME.Furthermore, the measuring tube module MM comprises a connecting body 50, which is mechanically connected (for example via a cohesive connection) to the at least one measuring tube 31, 32 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 illustrated vibronic module VM also has four couplers 110 iwhich are configured to mechanically couple the two measuring tubes 31, 32 to one another in the coupling regions. The two couplers 110 a, 110 bconnect the two measuring tubes 31, 32 in the inlet region and the remaining two couplers connect the two measuring tubes 31, 32 in the outlet region.The base module BM has a measurement system electronics ME and a housing 11 with at least one chamber 11* at least partially surrounded by a housing wall 11+. The measurement system electronics ME are arranged separately in a measurement system electronics housing. Alternatively, the housing can have a measurement system electronics chamber in which the measurement system electronics ME is arranged separately from the chamber 11*. The measurement system electronics ME comprises electrical components (e.g. active components, passive components, discrete components and integrated components) which are arranged on at least one printed circuit board and are in effect with one another in such a way that they are suitable for operating the basic module BM. Furthermore, the measuring system electronics ME can comprise at least one microprocessor or microcontroller.Within the chamber 11*, at least one cylindrical excitation coil 12 is provided, which is designed as an air coil and is at least indirectly mechanically connected to the housing wall 11+ and is electrically connected to the measuring system electronics ME. The excitation coil 12 can be arranged in an opening in the housing wall 11+ as depicted, 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+ directed toward the chamber 11*. In the embodiment of FIG. 1, the basic module BM has an excitation coil 12 (i.e. a total of two excitation coils) for each measuring tube 31, 32, 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 magnetic field which varies over time.Furthermore, at least one sensor coil 14, 16, in particular cylindrical and / or constructed as an air coil and / or identical in construction to the excitation coil 12, is arranged within the chamber 11* of the housing 11, which 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 sensor coil is electrically connected to the measurement system electronics ME. The at least one sensor coil 14, 16 may be disposed in an opening in the housing wall 11+ as depicted, or may 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+ directed toward the chamber 11*. In the embodiment of FIG. 1, the basic module BM has two sensor coils 14, 16 (i.e. a total of four sensor coils) for each measuring tube 31, 32. Two of the four sensor coils 14, 16 are arranged on one side of the chamber 11 opposite the other two sensor coils. The measuring system electronics ME is configured to read out the voltages induced at the sensor coils 14, 16 and to determine a phase offset between the measuring signals provided at the individual sensor coils 14, 16.The base module M 1 is configured to receive the vibronic module VM or the measuring tube module, in particular in the chamber 11*, and thus to be connected mechanically firmly, nevertheless in a detachable manner, in particular, forming a measurement pickup of the vibration type or a vibronic measurement system and / or such that the vibronic module VM is locked in the base module BM or is not movable. 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 configured to be installed in the base module BM in such a way that its excitation magnet 22 is placed inside the chamber, but is nevertheless spaced apart from the housing wall 11+, in particular namely held in a predetermined and / or static installation position with respect to an alignment and / or a smallest distance from the excitation coil 12 and / or in such a way 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 run parallel to one another in an extension. Furthermore, the vibronic module VM is configured to be installed in the base module BM such that its sensor magnet 24, 26 is placed inside the chamber, nevertheless is spaced apart from the housing wall 11+, in particular namely held in a predetermined and / or static installation position with respect to an alignment and / or a smallest distance from the sensor coil 14, 16 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 run parallel to one another in extension. Furthermore, an optical unit 181 is part of the base module BM. The optical unit 181 can have a camera for detecting a coding and / or an infrared camera for determining a temperature of the vibronic module, in particular of the at least one measuring tube 31, 32. The coding is arranged in this case on the at least one measuring tube 31, 32.In the embodiment of FIG. 1, a modular measurement system is disclosed in which the vibronic module VM is introduced or removed into 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 to be 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 formed from a plastic, while the measuring tube module MM is made from metal. The process connection PA is connected to a measuring tube module MM via a form-fit and / or force-fit 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 accordingly an inlet channel 35 and an outlet channel 36. The process connection PA has a distributor channel 37, which, starting from the connection 33, distributes the medium accordingly 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 at least in two parts and are connected to one another via a form-fit, force-fit and / or material-fit connection. Seals may be provided which seal the measuring tubes from the inlet and / or outlet duct 35, 36. The calibration of the vibronic module VM takes place exclusively without a process connection PA. After the calibration and the 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.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 said protective packaging SV before sterilization, in particular gamma sterilization. The vibronic module VM is arranged in a protective blister SBL in a form-fit and / or force-fit and stationary manner. In this case, the measuring tube module is in particular in contact with the protective blister pack SBL. The process terminal PA may also be in mechanical contact with the protection blister SBL. A blister is usually used whenever the customer is to be allowed to see the packaged goods. The protective blister SBL depicted is designed in such a way 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 protection blister SBL are arranged in at least one protection bag SBE 1, SBE 2, in particular with two protection bags SB 1, SB 2. The at least one protective bag SBE 1, SBE 2 may be sealed. This serves as an indicator of whether the protective packaging SV has been incorrectly opened and the vibronic module VM has thus potentially been contaminated. The at least one protective bag SB 1, SB 2 can be vacuumed, i.e. the air in the at least one protective flexor SB 1, SB 2 has been sucked out during production and the at least one protective bag SB 1, SB 2 has been sealed in an airtight manner.The at least one protective bag SBE 1, SBE 2 can alternatively be designed in such a way and configured to avoid impacts against the measuring tube module MM. For this purpose, the at least one protective bag SBE 1, SBE 2 can be designed as an air cushion.FIG. 4 schematically shows a method sequence of a method for producing a vibronic module, which is suitable in particular 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, which is formed in particular from a plastic, and which vibronic module together with a base module forms a modular Coriolis flowmeter. The method comprises the method steps:I. Providing the Measuring Tube Module Without the Process Connection.The measuring tube module comprises at least one, in particular metallic, measuring tube and an, in particular metallic, connecting body on the 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 configured such that the connection between the vibronic module and the base module can take place via the process connection.According to the invention, the measuring tube module is calibrated separately and without process connection.Calibration of the Measuring Tube Module Without the Process Connection.For this purpose, the measuring tube module is installed in a calibration system and the at least one measuring tube is connected to a calibration line. The calibration system can be constructed such that during calibration a clamping condition can be adjusted which would be present if the vibronic module were fixed in a base module. The calibration system can be designed to correspond to a basic module for customer use. However, this is not absolutely necessary. It has been found that it is sufficient if the bearing of the measuring tube module is simulated in a basic module. This means that the expected forces are simulated when fastening the vibronic module in the receptacle of a base module.For calibrating the measuring tube module, a flowable calibration medium is used, which is introduced into the at least one measuring tube via the calibration line. The flowable calibration medium can be gaseous. The calibration medium can be ultra-pure air (for example according to ISO 8573-1:2010 or according to ISO 14644-1:2015 class 7 or class 6) or water.During calibration, at least one calibration value is determined, which is taken into account when using the vibronic module in a basic module for a measurement variable dependent on the flow speed of the medium. The calibration value is obtained from the known set flow-speed-dependent measured variable of the calibration medium and the measured value actually determined during calibration. Furthermore, during calibration, a calibration can be carried out by means of an infrared temperature sensor-which is part of the calibration device-and a further calibration value can be determined in the process, 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 the at least one measuring tube, or on the process connection. For this purpose, a QR code or a bar code can be lasered into the at least one measuring tube or into the process connection, for example. The calibration value can be a zero point, a natural frequency of the at least one measuring tube, a correction coefficient, a calibration factor and / or one or more correction values.The measuring tube module can be calibrated under clean room conditions according to ISO 14644-1:2015 class 7 or class 6. Alternatively, the calibration cannot be carried out under clean room conditions according to ISO 14644-1:2015 class 7 or class 6.Attachment of the process connection, in particular formed from a plastic, to the measuring tube module for forming the vibronic module, in particular using a form-fit and / or force-fit connection.The process connection to the measuring tube module can be attached under clean room conditions according to ISO 14644-1:2015 class 7 or class 6. The process connection itself can also be produced under clean room conditions according to ISO 14644-1:2015 class 7 or class 6. Thus, the process connection can be produced by means of an injection molding method.IV. Sterilizing, in particular gamma sterilizing, the Vibronic module.FIG. 5 schematically shows a method sequence of a method for producing a vibronic module, which is suitable in particular 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, which is formed in particular from a plastic, and which vibronic module together with a base module forms a modular Coriolis flowmeter. The method comprises the method steps: I. providing the measuring tube module without the process connection. Calibration of the Measuring Tube Module Without the Process Connection. Removal of 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 ultra clean air.The removal of the calibration medium by blowing out with a gaseous medium can be carried out by calibration installation or manually. A further heating step can be provided which ensures that no calibration medium remains in the at least one measuring tube.Washing of the measuring tube module, in particular the at least one measuring tube, under clean room conditions according to ISO 14644-1:2015 class 7 or class 6.Cleaning agents can be used for the washing process, which are also used for use in biopharmaceutical applications. After the washing process, the measuring tube module can be finally cleaned with ultra-pure water. After the final cleaning step, the measuring tube module can be baked so that the traces of ultra-pure water are removed. Alternatively, an additional heating process can be dispensed with.After the washing process, an autoclaving of the measuring tube module, in particular of the at least one measuring tube, under clean room conditions according to ISO 14644-1:2015 class 7 or class 6 can be provided. V. Attaching the process connection, in particular formed from a plastic, to the measuring tube module for forming the vibronic module, in particular using a form-fit and / or force-fit connection. VI. Carrying out an air impression test and / or a tightness test with ultra clean air under clean room conditions according to ISO 14644-1:2015 class 7 or class 6. VII. Packaging of the Vibronic Module in a Protective Packaging.The protective packaging can comprise a protective blister pack in which the vibronic module is arranged in a fixed position and which is designed and configured in such a way as to avoid impacts against the measuring tube module, in particular the at least one measuring tube. A protection blister is a protection blisterIn addition, the protective packaging can comprise at least one protective bag, in which the vibronic module is arranged and which is designed and configured in such a way as to avoid impacts against the measuring tube module. The protective bag can be, for example, a plastic bag under overpressure. Furthermore, more than one protective bag can also be provided. Thus, the vibronic module can be packaged in a first plastic cushion and which in turn can be packaged in a second plastic cushion. Packaging can be carried out under clean room conditions according to ISO 14644-1:2015 class 7 or class 6.VIII. Sterilizing, in particular gamma sterilizing, the Vibronic Module.References included in the specificationThis list of documents cited by the applicant has been produced in an automated manner and is only included for the better information of the reader. The list is not part of the German patent application or utility model application. The DPMA does not take any adhesion for any faults or omissions.Patent Literature citedWO 2019 / 017891 A1

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[0041] Cited Non-Patent LiteratureISO 14644-1:2015 [0023, 0024, 0049]ISO 8573-1:2010

[0049]

Claims

Method for producing a vibronic module (VM), which is suitable in particular for biopharmaceutical applications, which vibronic module (VM) has a measuring tube module (MM) with at least one in particular metallic measuring tube (31, 32) for guiding a medium and a process connection (PA), which is formed in particular from 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, exciter magnet (22) is arranged on the at least one measuring tube (31, 32), which is configured to actuate the at least one measuring tube (31, 31, 31, 32) to oscillate when it is exposed to a time-variable magnetic field of an excitation 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 calibration, at least one calibration value being determined during calibration, a measurement variable dependent on the flow speed 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) for forming the vibronic module (VM), in particular using a form-fit and / or force-fit connection; and sterilizing, in particular gamma-sterilizing, the vibronic module (VM).The method of claim 1, wherein the calibration medium is gaseous.Method according to Claim 1 or 2, wherein a clamping condition is adjusted during calibration, which clamping condition is present when the vibronic module (VM) is fixed in place in the base module (BM).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).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 ultra-clean air.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.Method according to one of the preceding claims, wherein, after the 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.Method according to one of the preceding claims, wherein the process connection (PA) is attached to the measuring tube module (MM) under clean room conditions according to ISO 14644-1:2015 class 7 or class 6.Method according to one of the preceding claims, wherein an air impression test is carried out with ultra clean air under clean room conditions according to ISO 14644-1:2015 class 7 or class 6.Method according to one of the preceding claims, wherein a tightness test between the measuring tube module (MM) and the process connection (PA) is carried out with ultra clean air under clean room conditions according to ISO 14644-1:2015 class 7 or class 6.Method according to one of the preceding claims, wherein before the sterilization, in particular gamma-sterilization, of the vibronic module (VM), the vibronic module (VM) is arranged in a protective packaging (SV).Method according to claim 11, wherein the protective packaging (SV) comprises a protective blister pack (SBL), in which the vibronic module (VM) is arranged in a fixed position and which is designed and configured in such a way as to avoid impacts against the measuring tube module (MM), in particular the at least one measuring tube (31, 32).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 in such a way and configured to avoid impacts against the measuring tube module (MM).Method according to one of the preceding claims, wherein the calibration does not take place under clean room conditions according to ISO 14644-1:2015 class 7 or class 6, and / or wherein the calibration medium comprises water.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 ultra clean air according to ISO 14644-1:2015 class 7 or class 6.Method according to any one of the preceding claims, wherein the calibration comprises a calibration by means of an infrared temperature sensor and the at least one calibration value comprises a calibration value of an emissivity coefficient.Vibronic module (VM) for a modular Coriolis flowmeter, characterized in that it is produced by means of a method according to one of the preceding claims.

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