IRRADIATION-STERILIZABLE DISPOSABLE PROBE

Description

[0001] The invention relates to a device arrangement with a disposable probe for a disposable component that can be sterilized by irradiation and is intended for use in a biopharmaceutical process.

[0002] Recent trends in the biopharmaceutical industry have increasingly pointed towards the use of single-use components (SU components). These are now being used not only in product and process development, but also in clinical trial manufacturing (CTM) for the regulatory approval process and even in commercial "Good Manufacturing Practice" (GMP) for the production of pharmaceuticals.

[0003] In commercial manufacturing, two main approaches to the use of single-use components are emerging. Firstly, especially in new factories, sites, or companies in Asia, operators are opting for a fully single-use approach, where the entire production chain is covered almost exclusively with single-use components. Secondly, if conventional stainless steel equipment is already available, it is generally preferred to use it due to its high purchase price. In this case, so-called hybrid systems are used, combining existing stainless steel components with newly added single-use components. An example of this is the cultivation of animal cells in a bioreactor.

[0004] Particularly in the field of clinical trial sample production, or even in the context of the US-based method for verifying current manufacturing quality standards (CGM), it is essential that the integrity of the reaction vessel is ensured. This prevents both the ingress of foreign organisms and the leakage of the reaction medium from the reactor. For stainless steel reactors, this is ensured, for example, after cleaning, installation, and steam sterilization, by applying a test pressure and measuring the pressure drop over time. This pressure test is recorded and appropriately documented by the system operator. For single-use bioreactors or other systems made of plastic, this is done in a similar manner immediately before use.Immediately after the container is installed, the system is aseptically connected to a pressure testing device via a hose connection. Testing devices are available that can ensure both pressure testing and cGMP-compliant documentation, such as the "Sartocheck 4 plus Bag Tester" from Sartorius.

[0005] Since disposable systems, unlike stainless steel systems, are not stationary installations, the manufacturing and transport of the containers represent a significant source of potential leaks. To prevent this, some disposable containers undergo integrity checks during production. Manufacturers use similar systems to those employed by end users before use. A major drawback of the current method is that the integrity test information is not stored on the container itself and therefore must be laboriously traced using the lot number.

[0006] In another context, US Patent 8,963,684 B2 discloses a gamma-sterilizable RFID system that can detect non-original-manufacturer disposable bioprocess components and prevent unauthorized operation. For this purpose, a FeRAM chip (ferroelectric random access memory chip) is used to store error-correctable information on an RFID tag attached to a disposable bioprocess component. The information is typically retained in the memory chip even after gamma sterilization of the RFID tag and the disposable bioprocess component and can be corrected if necessary. A method for authenticating the disposable bioprocess component is also described, which is intended to reduce the original manufacturer's liability risk. If a component fails an authentication test, a warning is issued to the user or the bioprocess is stopped.This is intended to make it possible to identify inferior counterfeits and, in such cases, prevent users from making an unjustified complaint to the original manufacturer.

[0007] US 2015 / 0310771 A1 describes, by way of example, an RFID tag with rewritable memory in conjunction with a "smart label" attached to a product. The smart label may have a sensor to detect information about the physical or chemical environment to which the product was exposed during the shipping process.

[0008] US 2010 / 0060456 A1 describes various types of power supply for RF communication equipment, such as capacitors or batteries. Such an energy storage device can be part of the same tag or labels as the other components of the RF communication equipment. Alternatively, the energy storage device can be located in a separate tag or label from the other components of the RF communication equipment, with the energy storage device being electrically coupled to the other components.

[0009] The object of the invention is specifically to improve and make more readily available the documentation of the integrity testing of a disposable sensor unit used in a bioprocess.

[0010] This problem is solved by a device arrangement with a disposable probe having the features of claim 1. Advantageous and expedient embodiments of the disposable probe according to the invention are specified in the dependent claims.

[0011] The device arrangement according to the invention comprises a disposable probe for a disposable component, wherein the disposable probe is intended for use in a biopharmaceutical process and is contained in a package. The disposable probe is sterilizable by irradiation and comprises at least one sensor relevant to the biopharmaceutical process, an RFID tag, and a rewritable memory in which data relating to an integrity check of the disposable probe are stored. The disposable probe is equipped with a battery arranged in the RFID tag, which serves to supply power to the electronics of the disposable probe so that the sensor of the disposable probe can be used as intended and, if necessary, measurement data can be written to the memory.The device assembly comprises a battery unit attached to the packaging of the disposable probe, located outside the probe itself. This battery unit is detachably electrically connected to the electronics of the disposable probe or the RFID tag and supplies power to the probe as long as it can provide sufficient electrical power. When the packaging to which the battery unit is attached is opened, the electrical connection between the battery unit and the disposable probe is interrupted, and the RFID tag's internal battery takes over the power supply. The time of this event is then written to the memory.

[0012] The term RFID tag is not to be understood as restrictive and is intended to include all types of transponder units that can be operated and / or read wirelessly or contactlessly, and all wireless transmission types or standards, such as NFC (Near Field Communication) etc.

[0013] The invention is based on the discovery that electronic storage devices exist which can largely withstand the irradiation sterilization process of disposable probes. This opens up the possibility of dynamically designed documentation that remains attached to the product. This means that after initial data storage, the information can be modified and / or supplemented following irradiation sterilization. In this way, the history of a disposable probe can be carefully documented and more easily accessed for testing purposes.

[0014] The invention thus increases process reliability, as accurate data on the condition and relevant properties of the disposable probe are immediately available on-site. This leads, on the one hand, to fewer complaints to the disposable probe manufacturer and, on the other hand, to an improvement in the supply chain.

[0015] The memory in which the data is stored before and after irradiation sterilization of the disposable probe is preferably part of the RFID tag, so that no separate electronic component needs to be integrated into the disposable probe.

[0016] FeRAM memory is suitable for the intended purposes. This type of memory has proven to be largely resistant to the radiation doses used in the sterilization of disposable components.

[0017] The memory also advantageously stores product-relevant data, in particular a product identification code, a manufacturing date, and / or calibration information. This data can relate to the disposable probe itself and / or to the disposable component for which the disposable probe is intended.

[0018] Following the inventive concept, at least one measurement principle-specific quality parameter should be defined for each probe type (e.g., the ohmic resistance for an electronic temperature probe). Before irradiation sterilization of the disposable probe, values ​​of this measurement principle-specific quality parameter should then be determined – preferably under reproducible conditions – and stored in the memory.

[0019] To enable a meaningful verification of the integrity of the disposable probe after its irradiation sterilization, values ​​for this measurement principle-specific quality parameter are determined again after the sterilization process – preferably under the same conditions – and stored in the memory. This allows a comparison of the condition and properties of the disposable probe before and after irradiation sterilization. If the disposable probe no longer meets the specified quality requirements, it is discarded and not shipped.

[0020] If the disposable probe has not become completely unusable due to irradiation sterilization, but only exhibits a demonstrably shifted or distorted measurement characteristic that can be compensated for by appropriate calibration, delivery of the disposable probe is not necessarily prohibited. Instead, in this case, a specification for the disposable probe corrected after irradiation sterilization can be stored in the memory, which will then be taken into account when the disposable probe is used as intended.

[0021] In an advantageous embodiment of the memory of the disposable probe, it has a write protection feature which, after its activation, prevents the deletion and overwriting of the data stored in the memory.

[0022] The memory can also be advantageously divided into a free, writable area and a locked area that can no longer be written to. Manufacturer data that should not be changed can be stored in the locked area, while information about the integrity check of the disposable probe and / or measurement data acquired later during the intended use of the disposable probe can be written to the free memory.

[0023] It has been shown that certain battery types can largely withstand the sterilization process of disposable probes by irradiation without damage. Based on this surprising finding, the RFID tag according to the invention has an internal battery. This battery can, on the one hand, provide the energy required for the intended use of the disposable probe. On the other hand, the battery can also support the documentation of the disposable probe's history, which will be discussed in more detail later.

[0024] The disposable probe can, for example, be a temperature probe based on ohmic resistance, whose measurement principle-specific quality parameter is the ohmic resistance.

[0025] Another example of a disposable probe is a pH probe based on voltammetry, whose measurement principle-specific quality parameter is its electrical potential in a defined aqueous environment.

[0026] The disposable probe of the device arrangement according to the invention has one or more sensors for detecting certain events and / or environmental conditions. The device arrangement according to the invention further comprises a battery unit attached to packaging outside the disposable probe, which is detachably electrically connected to electronics of the disposable probe or the RFID tag.

[0027] The accumulator unit makes it possible to document the history of the disposable probe over a longer period, especially in the case of extended storage of the disposable probe. Since the accumulator unit is rechargeable, it can also be used to power the sensors of the disposable probe even after any discharge caused by irradiation sterilization.

[0028] A particularly preferred option is a battery unit with a wireless charging capability via an external power source. In this case, the battery unit can be charged while still packaged in the disposable probe, without the need for a cable connection or similar.

[0029] Preferably, the accumulator unit is attached to an inner side of the packaging. The interruption of the detachable electrical connection of the accumulator unit can be detected and documented as the time of unpacking and use of the disposable probe.

[0030] The device arrangement according to the invention can be supplemented by a writing device configured for wirelessly writing data to the memory of the disposable probe, and a reading device configured for wirelessly reading data stored in the memory. Naturally, the writing device and the reading device can be designed as a combined read / write device.

[0031] According to the invention, when the packaging to which the accumulator unit is attached is opened, the electrical connection between the accumulator unit and the disposable probe is interrupted, and the internal battery of the RFID tag takes over the power supply. The time of this event is written to the memory. This time is intended to document the unpacking and use, or that from this point onward, the integrity of the disposable probe is no longer guaranteed by the manufacturer.

[0032] Further features and advantages of the invention will become apparent from the following description and from the accompanying drawing, to which reference is made. In the drawing, the single figure illustrates the life cycle of a disposable probe according to the invention.

[0033] The following describes a typical life cycle of a single-use component with a single-use probe, based on the flowchart shown in the figure, starting with step 100 of the production of the single-use component, for example, a container (bag) for use in a bioreactor, and the single-use probe. The single-use probe has a sensor relevant for a biopharmaceutical process and is also equipped with an RFID tag (transponder), which in turn has a rewritable memory, in particular of the FeRAM type.

[0034] In the next step, product-relevant data is wirelessly written to the RFID tag's memory using a suitable writing device. This product-relevant data can include a product identification code, the manufacturing date, and other information about the disposable probe, such as calibration tables, etc. The product-relevant data can refer generally to the disposable probe and / or the disposable component.

[0035] The disposable component with the disposable probe, possibly together with other SU system components, is packaged in step 130 and sterilized in step 140 as a complete unit, including the packaging, by irradiation, in particular by gamma irradiation. A FeRAM memory typically survives sterilization by irradiation, meaning that the data stored in the memory can still be read after the sterilization process.

[0036] In step 150, the sterilized unit is received (inventory recording) and stored before being shipped to a customer at the appropriate time in step 160.

[0037] The single use of the disposable component with the disposable probe at the customer's site is illustrated by step 170.

[0038] The outlined resume is in no way to be understood as restrictive and can of course include further steps.

[0039] After step 140 of the irradiation process and before step 160 of shipping to the customer, the manufacturer can verify the integrity of the disposable probe at any time, as explained in more detail below. Furthermore, product-relevant data can be read from the RFID tag's memory at any time using a suitable reader and evaluated for inventory, quality control, or similar purposes. Finally, additional data can be wirelessly written to the RFID tag's memory if required.

[0040] The following section describes in detail the execution, documentation, and storage of the test and test results for a disposable probe integrity test. The basic principle of the test is a comparison of the measurement principle-specific quality parameters of the respective sensor type of disposable probe before and after irradiation sterilization. For each sensor type, specific sensor-specific quality parameters are selected in advance that are considered suitable for quality control after irradiation sterilization. Furthermore, a tolerable change in each sensor-specific quality parameter is defined according to the characteristics of the respective sensor type.

[0041] In the first part of the integrity test, the predefined, measurement-principle-specific quality parameters of the disposable probe are determined using a standard quality control procedure before irradiation sterilization. Where possible, a non-contact method is chosen for this purpose (e.g., optical, electromagnetic-inductive, or radioactive). In this case, the quality control can still be performed even after the disposable component has been packaged. The determined values ​​are written to the RFID tag of the disposable probe.

[0042] After irradiation sterilization, the same quality parameters are determined again in a second part of the integrity test, preferably again without contact, so that the disposable component does not need to be unpacked. These values ​​are then compared with the values ​​stored in the RFID chip's memory, which are read using a suitable reader, and an evaluation is performed. If the change in quality parameters caused by the irradiation sterilization is within the defined tolerance, the quality parameters determined after irradiation sterilization are stored as an additional data record in the RFID chip's memory for lifecycle monitoring. The disposable component is then released for customer delivery. However, if the change in quality parameters is outside the defined tolerance, the disposable component to which the disposable probe is attached is not released for delivery.

[0043] As already mentioned, the second part of the integrity check can be carried out immediately after irradiation sterilization and / or during storage and / or immediately before the planned delivery to a customer.

[0044] Furthermore, the date of the integrity check, the date of storage, and the storage conditions (location, temperature, etc.) can be written to the RFID tag's memory. This data allows for later conclusions to be drawn about the current condition and for statements to be made as to whether, and if so, for how long, the disposable probe is still suitable for its intended purpose.

[0045] The following are two specific examples of quality assurance for a disposable probe.

[0046] In the first example, the disposable probe is intended to be a temperature probe based on ohmic resistance. The measurement principle-specific quality parameter here is therefore the ohmic resistance, which is to be determined before and after irradiation sterilization at as similar an ambient temperature as possible. For example, before irradiation sterilization at a constant temperature of 20°C, a resistance of 107.79 ohms is measured and written to the RFID tag's memory along with the corresponding measurement conditions.

[0047] After irradiation sterilization of the disposable component with the temperature probe, the ohmic resistance of the temperature probe is measured again at the same constant temperature. If the change in resistance value is greater than a predefined tolerance value, e.g., + / - 0.3 ohms, the disposable component is discarded because the zero point and slope, as calibration parameters of the temperature probe, have changed so significantly due to the irradiation sterilization that acceptable temperature measurement for the customer can no longer be guaranteed.

[0048] Alternatively, the temperature probe can be subjected to further measurements at different temperatures to redetermine the changed zero point and slope of the disposable probe and store these values ​​in the RFID tag's memory. For example, the disposable component with the temperature probe can be subjected to constant temperatures of 5°C and 45°C, and the probe's resistance can be measured at each of these temperatures. This allows the temperature probe's specifications to be corrected, and the probe with the corrected specifications can then be delivered to the customer.

[0049] To enable non-contact measurement of ohmic resistance, a digital temperature probe can be equipped with a coil for inductive voltage transfer. The ohmic resistance of the temperature probe is then determined from the electrical power consumed by the voltage source.

[0050] In the second example, the disposable probe is a voltammetry-based pH probe. The measurement principle-specific quality parameter in this case is the electrical potential of the pH probe in a defined aqueous environment, which is to be determined before and after irradiation sterilization. For better understanding, it should be noted that the voltammetry-based pH probe must be stored in a potassium chloride (KCl) solution to prevent the electrolyte in the probe from drying out. KCl dissolved in pure water causes an electrical potential of 0 mV for a pH probe. Therefore, the electrical potential can be used as a quality parameter for the pH probe, provided it is stored in such a defined KCl solution.

[0051] For example, before irradiation sterilization, the pH probe's electrical potential is measured at 0 mV and written to the RFID tag's memory along with the corresponding measurement conditions. After irradiation sterilization of the disposable component with the pH probe, the probe's electrical potential is measured again under the same conditions. If the change in electrical potential exceeds a predefined tolerance value, e.g., + / - 0.4 mV, the disposable component is discarded because the zero point and slope, as calibration parameters of the temperature probe, have changed so significantly due to the irradiation sterilization that an acceptable pH measurement for the customer can no longer be guaranteed.

[0052] Similar to the first example, under certain conditions it is generally possible to correct the pH probe specification based on the measured value determined after irradiation sterilization and possibly other measured values, and to deliver the pH probe with the corrected specification to a customer.

[0053] To enable non-contact measurement of the electrical potential, common electromagnetic-inductive methods can be used.

[0054] Before shipping to the customer, write protection can be activated in the RFID tag's memory to protect against manipulation or accidental deletion of data stored in the memory. This ensures that the correct data is permanently available.

[0055] The customer can read out the product-relevant data and calibration information as needed and use it accordingly for their purposes.

[0056] The disposable probe is additionally equipped with a battery located in the RFID tag, which may be partially damaged by irradiation with gamma rays or other radiation used for sterilization. The battery serves primarily to power the electronics required for the intended operation of the disposable probe, enabling the sensor to be used as intended and, if necessary, allowing measurement data to be written to memory when no external power supply is available via cables or wireless systems.

[0057] Furthermore, the disposable probe is equipped with a rechargeable electrical power source (accumulator). An accumulator unit, electrically connected to the electronics of the disposable probe or its RFID tag via a cable or similar means, is attached, for example, to the inside of a cardboard outer packaging of the disposable component and features a wireless charging device, such as a suitable near-field communication (NFC) antenna. The accumulator unit can thus be wirelessly recharged from a suitable external power source as needed.

[0058] The use of such a battery unit allows relevant events and environmental conditions in the history of the disposable probe to be documented in the RFID tag's memory over time, particularly before delivery to a customer. This requires that the disposable probe has one or more suitable sensors for recording the events and / or environmental conditions, such as a temperature sensor, a humidity sensor, and / or a radiation sensor.

[0059] The accumulator unit is charged either during the completion of the sterilization process or at a later point before irradiation. From this point on, relevant events, such as the irradiation itself, the radiation dose, and the ambient temperature and humidity, can be recorded at regular or irregular intervals and written to the memory of the disposable probe. This data can be read out contactlessly at any time using a suitable reader.

[0060] However, the irradiation sterilization process can cause partial damage to the accumulator unit, leading to a complete or partial discharge. If the accumulator unit's energy is no longer sufficient for the aforementioned tasks, this point is recorded (i.e., written to memory), and the RFID tag's internal battery takes over the power supply.

[0061] Thanks to the wireless charging capability, it is generally possible to recharge the battery after irradiation sterilization, if necessary, using an external power source, as shown in step 180 of the figure. If required, the frequency of saving and reading the stored sensor data can also be reduced or adjusted to ensure coverage of a desired minimum period.

[0062] The electrically conductive connection between the RFID tag or the electronics of the disposable probe and the battery unit is designed such that the connection is interrupted when the outer packaging is opened, when the contents of the outer packaging (disposable component) are removed, or upon a defined vibration. The RFID tag's internal battery then takes over the power supply. The time of the interruption is recorded, i.e., written to the memory, and can be interpreted as an indication that the disposable probe has been unpacked and used or that the integrity of the disposable probe is no longer guaranteed.

[0063] In the second example, the disposable probe is a voltammetry-based pH probe. The measurement principle-specific quality parameter in this case is the electrical potential of the pH probe in a defined aqueous environment, which is to be determined before and after irradiation sterilization. For better understanding, it should be noted that the voltammetry-based pH probe must be stored in a potassium chloride (KCl) solution to prevent the electrolyte in the probe from drying out. KCl dissolved in pure water causes an electrical potential of 0 mV for a pH probe. Therefore, the electrical potential can be used as a quality parameter for the pH probe, provided it is stored in such a defined KCl solution.

[0064] For example, before irradiation sterilization, the pH probe's electrical potential is measured at 0 mV and written to the RFID tag's memory along with the corresponding measurement conditions. After irradiation sterilization of the disposable component with the pH probe, the probe's electrical potential is measured again under the same conditions. If the change in electrical potential exceeds a predefined tolerance value, e.g., + / - 0.4 mV, the disposable component is discarded because the zero point and slope, as calibration parameters of the temperature probe, have changed so significantly due to the irradiation sterilization that an acceptable pH measurement for the customer can no longer be guaranteed.

[0065] Similar to the first example, under certain conditions it is generally possible to correct the pH probe specification based on the measured value determined after irradiation sterilization and possibly other measured values, and to deliver the pH probe with the corrected specification to a customer.

[0066] To enable non-contact measurement of the electrical potential, common electromagnetic-inductive methods can be used.

[0067] Before shipping to the customer, write protection can be activated in the RFID tag's memory to protect against manipulation or accidental deletion of data stored in the memory. This ensures that the correct data is permanently available.

[0068] The customer can read out the product-relevant data and calibration information as needed and use it accordingly for their purposes.

[0069] The disposable probe is additionally equipped with a battery located in the RFID tag, which may be partially damaged by irradiation with gamma rays or other radiation used for sterilization. The battery serves primarily to power the electronics required for the intended operation of the disposable probe, enabling the sensor to be used as intended and, if necessary, allowing measurement data to be written to memory when no external power supply is available via cables or wireless systems.

[0070] Furthermore, the disposable probe is equipped with a rechargeable electrical power source (accumulator). An accumulator unit, electrically connected to the electronics of the disposable probe or its RFID tag via a cable or similar means, is attached, for example, to the inside of a cardboard outer packaging of the disposable component and features a wireless charging device, such as a suitable near-field communication (NFC) antenna. The accumulator unit can thus be wirelessly recharged from a suitable external power source as needed.

[0071] The use of such a battery unit allows relevant events and environmental conditions in the history of the disposable probe to be documented in the RFID tag's memory over time, particularly before delivery to a customer. This requires that the disposable probe has one or more suitable sensors for recording the events and / or environmental conditions, such as a temperature sensor, a humidity sensor, and / or a radiation sensor.

[0072] The accumulator unit is charged either during the completion of the sterilization process or at a later point before irradiation. From this point on, relevant events, such as the irradiation itself, the radiation dose, and the ambient temperature and humidity, can be recorded at regular or irregular intervals and written to the memory of the disposable probe. This data can be read out contactlessly at any time using a suitable reader.

[0073] However, the irradiation sterilization process can cause partial damage to the accumulator unit, leading to a complete or partial discharge. If the accumulator unit's energy is no longer sufficient for the aforementioned tasks, this point is recorded (i.e., written to memory), and the RFID tag's internal battery takes over the power supply.

[0074] Thanks to the wireless charging capability, it is generally possible to recharge the battery after irradiation sterilization, if necessary, using an external power source, as shown in step 180 of the figure. If required, the frequency of saving and reading the stored sensor data can also be reduced or adjusted to ensure coverage of a desired minimum period.

[0075] The electrically conductive connection between the RFID tag or the electronics of the disposable probe and the battery unit is designed such that the connection is interrupted when the outer packaging is opened, when the contents of the outer packaging (disposable component) are removed, or upon a defined vibration. The RFID tag's internal battery then takes over the power supply. The time of the interruption is recorded, i.e., written to the memory, and can be interpreted as an indication that the disposable probe has been unpacked and used or that the integrity of the disposable probe is no longer guaranteed.

Claims

1. Apparatus assembly, comprising a single-use probe for a single-use component, which single-use probe is sterilizable by irradiation, wherein the single-use probe is intended for use in a biopharmaceutical process and is located in a packaging, and wherein the single-use probe comprises at least one sensor relevant to the biopharmaceutical process, an RFID tag, and a memory which is rewritable in principle and in which data regarding an integrity check of the single-use probe are stored, characterized in that the single-use probe is equipped with a battery arranged in the RFID tag, which battery serves to supply power to the electronic unit of the single-use probe so that the sensor of the single-use probe can be used as intended and measurement data can be written to the memory when necessary, and in that the apparatus assembly comprises an accumulator unit which is mounted outside of the single-use probe on the packaging of the single-use probe and which is detachably and electrically conductively connected to an electronic unit of the single-use probe or to the RFID tag and supplies power to the single-use probe for as long as the accumulator unit can provide sufficient electrical power, wherein, upon opening the packaging on which the accumulator unit is mounted, the electrical lead between the accumulator unit and the single-use probe is broken and the internal battery of the RFID tag takes over the further power supply, and the time of this event is written to the memory.

2. Apparatus assembly according to claim 1, characterized in that the memory is part of the RFID tag, and / or in that the memory is a FeRAM memory.

3. Apparatus assembly according to any one of the preceding claims, characterized in that product-relevant data are stored in the memory, in particular a product identification code, a date of manufacture, and / or calibration information.

4. Apparatus assembly according to any one of the preceding claims, characterized in that values of a measurement-principle-specific quality parameter of the single-use probe that are determined before the single-use probe is sterilized by irradiation are stored in the memory, and / or in that values of the measurement-principle-specific quality parameter of the single-use probe that are determined after the single-use probe has been sterilized by irradiation are stored in the memory, and / or in that a specification of the single-use probe that has been corrected after the single-use probe has been sterilized by irradiation is stored in the memory.

5. Apparatus assembly according to any one of the preceding claims, characterized by a write protection which, after activation, prevents deletion and overwriting of the data stored in the memory, and / or in that the memory has a free, writable area and a locked area that is no longer writable.

6. Apparatus assembly according to any one of the preceding claims, characterized in that the single-use probe is a temperature probe based on ohmic resistance, the measurement-principle-specific quality parameter of which is the ohmic resistance, or in that the single-use probe is a pH probe based on voltammetry, the measurement-principle-specific quality parameter of which is the electric potential thereof in a defined aqueous environment.

7. Apparatus assembly according to any one of the preceding claims, characterized in that the accumulator unit comprises a device for wireless charging by an external power source, and / or in that the accumulator unit is mounted on an inner side of the packaging.

8. Apparatus assembly according to any one of the preceding claims, comprising a writing device which is designed to wirelessly write data to the memory of the single-use probe, and a reading device which is designed to wirelessly read data stored in the memory.