Temperature measuring assembly, attachment and system for determining a temperature inside a medical container, method of temperature monitoring, process validation and / or equipment qualification

Abstract

The present invention relates to a temperature measuring assembly (100) for determining a temperature inside a medical container (20), the medical container (20) having a hollow body (21) with an outer body wall (22) and a body opening (23). The temperature measuring assembly (100) comprises a temperature sensor (40) comprising at least one detector element (42) having a temperature sensing portion (41), and a sensor holder (30) holding the temperature sensor (40). The sensor holder (30) is configured to be installed on the medical container (20) such that it extends through the body opening (23) into the interior of the hollow body (21) and that the temperature sensing portion (41) of the at least one detector element (42) is positioned inside the hollow body (21) at or close to the outer body wall (22) of the hollow body (21). The present invention also relates to a temperature measuring attachment (110) and a temperature measuring system (12) for determining a temperature inside a medical container (20), as well as to a method of temperature monitoring, process validation and / or equipment qualification in connection with handling temperature-controlled medical products using such a temperature measuring assembly (100), attachment (110) or system (120).

Description

DESCRI PTIONTitleTEMPERATURE MEASURING ASSEMBLY, ATTACHMENT AND SYSTEM FOR DETERMINING A TEMPERATURE INSIDE A MEDICAL CONTAINER,METHOD OF TEMPERATURE MONITORING, PROCESS VALIDATION AND / OR EQUIPMENT QUALIFICATIONTechnical Field

[0001] The present invention relates to a temperature measuring assembly, a temperature measuring attachment and a temperature measuring system for determining a temperature inside a medical container used for storing medical products. The present invention also relates to a method of temperature monitoring, process validation and / or equipment qualification in connection with handling temperature-controlled medical products using such a temperature measuring assembly, attachment or system.

[0002] Such temperature measuring assemblies, attachments and systems as well as such methods can be used for ensuring that equipment and processes deployed in connection with the handling of temperature-controlled medical products, e.g. transportation equipment and processes, are reliable and yield consistent results in accordance with applicable regulations. Such temperature measuring assemblies, attachments and systems as well as such methods can also be used for continuously monitoring and thus ensuring correct temperature conditions throughout the handling of temperature-controlled medical products, for example, throughout a transportation chain.Background Art

[0003] In general, medical products, such as pharmaceutical products, are strictly regulated to ensure that they are fit for the intended use and that they do not have inappropriate side effects. Not only the products, but also related processes need tocomply with quality assurance programs to prevent mistakes or defects in manufactured products and avoiding issues when delivering solutions or services to customers. In particular, in the context of pharmaceutical or medical industries, it typically is of paramount importance that products, devices and processes consistently and reliably produce expected results. For ensuring this, usually processes have to be validated, and products and devices need to be qualified.

[0004] The term "validation" as used herein relates to confirming by objective evidence that requirements or conditions of a specific application or a specific use are met. It typically involves production of documented evidence that a process carried out, e.g. in testing, maintains at all stages the desired level of compliance with pre-established specifications. The outcome of a stable, validated process should then be, invariably, the production of a product which is, in real life, capable to perform the task as intended and declared. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the United States Food and Drug Administration (FDA). Good manufacturing practices guidelines issued by such agencies stipulate that a set of independent procedures be carried out to check if a final product will meet predetermined specifications and requirements of its intended purposes and will consistently perform within a given range. Validation is therefore essential to receive approval by regulating agencies. Likewise, the term "qualification" as used herein relates to the documented proof that the object to be qualified is suitable and safe for the intended use or application. The object to be qualified may be system or equipment employed for developing, testing, manufacturing and handling a final medical product.

[0005] Processes and equipment requiring validation or qualification may relate to any kind of handing medical products, for instance to the packaging and transportation of medical products. In this context, packaging and transportation of temperature-sensitive products is a major challenge, requiring special, stable, and thus well-controlled temperature conditions that must be maintained throughout the entire process of packaging and transportation. Special care is required for medical products which are packaged and transported in a frozen state, as their temperature must not exceed a critical temperature. Quality guidelines as well as handling regulations may prescribe to permanently monitor the temperature conditions throughout the entire handling process and to only use handling equipment that is appropriately qualified in order to ensure correct transport conditions. Hence, appropriate temperature monitoring systems andprocedures as well as methods for validating handling processes and qualifying handling equipment are essential.

[0006] Suitable means for process validation and equipment qualification in connection with the handling of temperature-controlled medical products stored in medical containers of larger volume are available today. However, despite that as described, e.g., in US 5,447374 A some devices for positioning probes in flasks are known, there is a lack of appropriate measuring systems and procedures for process validation and equipment qualification in connection with temperature-controlled medical products stored in smallvolume containers, especially those with small container openings. In particular, there is a lack of suitable means for verifying that the temperature inside such small-volume the container does not exceed a certain level.

[0007] Therefore, there is a need for temperature measuring means and methods allowing for validating handling processes and qualifying handling equipment involving small-volume medical containers, in particular for determining a temperature inside smallvolume medical containers, especially those with small-sized container openings.Disclosure of the Invention

[0008] According to the invention this need is settled by a temperature measuring assembly for determining a temperature inside a medical container as it is defined by the features of independent claim 1 , a temperature measuring attachment as defined by the features of independent claim 23, a temperature measuring system as defined by the features of independent claim 24, as well as a method of temperature monitoring, process validation and / or equipment qualification in connection with handling temperature- controlled medical products as defined by the features of independent claim 27. Preferred embodiments are subject of the dependent claims.

[0009] In one aspect, the present invention relates to a temperature measuring assembly for determining a temperature inside a medical container. In the context of this invention, the term medical container preferably refers to a container used for storing medical products. The medical container has a hollow body with an outer body wall and a body opening.

[0010] In particular, the medical container may be a small-volume container having a maximum storage capacity of 10 milliliters or less, or less than 5 milliliters, in particularless than 3 milliliters, more particularly less than 2.5 milliliters such as 2 milliliters. The size of the body opening may depend on the size of the hollow body. The body opening may have a cross-sectional area below 25 square millimeters, in particular below 20 square millimeters, more particularly below 18 square millimeters. Likewise, the body opening may have a diameter or an equivalent diameter below 8 millimeters, in particular below 6 millimeters, more particularly below 5 millimeters. The term "equivalent diameter" of the body opening is used herein in relation to body opening of non-circular shape cross- sectional shape and is defined as the diameter of a circular body opening which has the same surface area as the body opening of non-circular shape. The medical container can be made of a sterilizable material such as glass or plastic such as, e.g., polypropylene. It may comprise a cover or cap including a sealing such as a rubber stopper or a septum which for many applications is designed to be pierced.

[0011] The medical container may particularly be a vial or a cartridge as commonly used in pharmaceutical industry and research. The term “vial” as used herein can relate to vials in the literal sense, i.e. comparably small vessels or bottles, often used to store pharmaceutical products or pharmaceuticals or medications or drugs in liquid, powdered or capsuled form. Similarly, the term “cartridge” as herein may relate to a more cylindrical vessel, often used to store pharmaceutical products or pharmaceuticals or medications in liquid, powdered or capsuled form.

[0012] The medical container, more specifically the hollow body, may have a substantially cylindrical shape (possibly apart from a portion including the body opening). The cylindrical shape may have a circular cross-section, an oval cross-section, an elliptical cross-section, a rectangular cross-section, a quadratic cross-section, a triangular cross-section, or a polygonal cross-section.

[0013] The term “medical product” as used herein preferably refers to pharmaceutical products or pharmaceuticals or medications or drugs or drug products. The term “drug” as used herein relates to a therapeutically active agent, also commonly called active pharmaceutical ingredient (API), as well as to a combination of plural such therapeutically active substances. The term also encompasses diagnostic or imaging agents, like for example contrast agents (e.g. MRI contrast agents), tracers (e.g. PET tracers) and hormones, that need to be administered in liquid form to the patient. The term “drug product” as used herein relates to a drug as defined above formulated or reconstituted in a form that is suitable for administration to the patient. A particularly preferred drugproduct can be a drug solution, in particular a solution for body opening administration, injection or infusion.

[0014] The temperature measuring assembly according to the invention comprises a temperature sensor comprising at least one detector element having a temperature sensing portion, and a sensor holder for holding the temperature sensor. In particular, the sensor holder may be connected to the temperature sensor to hold the temperature sensor. The sensor holder is configured to be installed on the medical container, in particular at an outside of the medical container. As used herein, the term “installed on the medical container, in particular at an outside of the medical container” may include one of: placing the sensor holder, in particular loosely, on the medical container; or attaching, preferably reversibly attaching, the sensor holder to the medical container, in particular to the outside of the medical container. Likewise, installing the sensor holder on the medical container may be such that the sensor holder rests in the body opening, either directly in contact with the body opening or indirectly in a passage opening of a cap or a plug, which may be part of the medical container or part of a temperature measuring attachment as described further below.

[0015] Placing the sensor holder on the medical container may be such that at least a portion of the medical container rests on the medical container, in particular the outside of the medical container, in contact with the medical container, in particular with its outside, preferably only under the influence of gravity. For example, a portion of the sensor can be placed at a rim of the body opening, either directly on the hollow body or on a cap or a plug, which may be part of the medical container or part of a temperature measuring attachment as described further below. Thus, placing the sensor holder allows for an easy and uncomplicated installation of the temperate measuring assembly to the medical container.

[0016] Vice versa, attaching the sensor holder to the medical container, in particular to the outside of the medical container preferably is such that the sensor holder is securely coupled to the medical container. As will described in more detail further below, the sensor holder may preferably comprise a clamping mechanism, in particular one or more clamping brackets, configured to attach the sensor holder to the medical container, for example to a flange and / or cap or plug of the medical container. This advantageouslyprevents the temperature measuring arrangement from being displaced relative to the medical container or even being lost during handling.

[0017] When installed, the sensor holder of the temperature measuring arrangement according to the invention extends through the body opening into the interior of the hollow body and to position the temperature sensing portion of the at least one detector element inside the hollow body at or close to the outer body wall of the hollow body. Thus, the temperature measuring arrangement advantageous enables to measure the temperature inside the medical container in a critical area which is first affected by external influences. If, for example, during temperature-controlled transportation cooling fails or the cooling chain is interrupted, this can first affect the areas inside the container that are at or close to the outer body wall of the hollow body. Measuring the temperature in this area therefore enables to detect temperature changes as quickly as possible, which in turn allows for a reliable validation / qualification of the effectiveness and robustness of processes and equipment involved in the handling of a medical product stored in the medical container.

[0018] In particular, the sensor holder may be configured to position the temperature sensing portion of the at least one detector element inside the hollow body at or close to a side wall portion of the outer body wall of the hollow body, i.e. at or close to an outer body side wall of the hollow body. The side wall portion of the outer body wall (or the outer body side wall) may be located between the body opening and a bottom portion of the outer body wall, the bottom portion being a portion of the outer body wall opposite the body opening. Particularly compared to being arranged close to the bottom portion, this allows for a specifically efficient temperature measurement suitable for validation and similar processes.

[0019] For installing the senor holder on the medical container, the sensor holder may comprise a supporting member configured to be placed across the body opening, preferably at the outside of the medical container. Placing across the body opening may include placing directly across the body opening or across a passage opening of a cap or a plug installed on the body opening, wherein the cap or the plug may be part of the medical container or part of a temperature measuring attachment as described further below. The supporting member may be used for both just placing or attaching the sensor holder at the medical container. As will be described in more detail below, the supporting member may, for example, have a plate shape.

[0020] Furthermore, the sensor holder may comprise one (a single) or a plurality of legs to extend into the interior of the hollow body upon insertion thereinto, whereby the temperature sensing portion of the at least one detector element of the temperature sensor, when attached to the leg / one of the leg(s), may be positioned within the interior of the hollow body at or close to the outer body wall of the hollow body. For example, to be suitable for a container having a maximum storage capacity of about 10 milliliters the sensor holder may comprise four legs, or to be suitable for a container having a maximum storage capacity of about 2 milliliters, the sensor holder may comprise three legs. Each leg may be equipped with a detector element.

[0021] Advantageously, the legs have a slim design and thus allow the temperature sensor to be easily inserted into the interior of the hollow body, even with small body openings. In addition, a slim design proves beneficial with regard to a reduction of the thermal mass and the heat conduction through the senor holder, both aspects minimizing the thermal influence of the temperature sensor by the sensor holder. To this extent, the one or more legs may, for example, have a maximum lateral dimension transverse to a respective length extension of the legs in range between 1 millimeter and 3 millimeters, in particular between 1.5 millimeters and 2 millimeters or of less than 1 millimeter. Likewise, the one or more legs may have a cross-sectional area (as seen as in a respective cross-section perpendicular to a respective length extension of the legs) in a range between 0.5 square-millimeters and 2 square-millimeters, in particular between 0.75 square-millimeters and 1.5 square-millimeters.

[0022] The reduction in the thermal mass achieved by the slim design of the legs and / or of the detector elements may be further advantageous as it enables the temperature sensor to achieve shorter response times and increased sensitivity.

[0023] The sensor holder or, eventually, at least its one or more legs can be fabricated, particularly in the slim design, through precision cutting a spring steel sheet utilizing laser technology. Such cutting may be followed by shaping with a bending machine.

[0024] As described above, the sensor holder may comprise either one (a single) or a plurality of legs. A single leg may be used to place a single detector element of the temperature sensor, more specifically a temperature sensing portion of a single detector element of the temperature sensor within the interior of the hollow body. Vice versa,usage of a plurality of legs advantageously allows to position a plurality of detector elements of the temperature sensor, more specifically the temperature sensing portions of a plurality of detector elements of the temperature sensor, at different positions inside the hollow body. Thus, the temperature inside the medical container can be measured at different positions and in different spatial directions, making the temperature measuring assembly sensitive in multiple spatial directions and less critical to a particular installation configuration. Having the possibility to place a plurality of detector elements inside the medical container may further enable a differential temperature measurement. For example, the sensor holder may comprise two, three or four legs, preferably to position a corresponding number of detector elements, i.e. two, three or four detector elements within the interior of the hollow body.

[0025] Preferably, the legs branch off from the supporting member, in particular essentially along a central length axis of the sensor holder: The central length axis of the sensor holder may be given by a principal direction in which the group of legs extends. The central length axis of the sensor holder preferably defines an insertion axis of the senor holder through the body opening.

[0026] Especially, the legs may branch off from the supporting member in a symmetric arrangement with respect to the central length axis of the sensor holder. More particularly, the legs may be evenly distributed around the central length axis of the sensor holder. Especially, the legs may be arranged in a star-shaped manner as seen in a projection along the central length axis of the sensor holder Due to the symmetric arrangement, even distribution or star-shaped arrangement, respectively, the temperature measurement can advantageously be carried out uniformly in all spatial directions, e.g. with respect to the central length axis of the sensor holder.

[0027] The one or more legs may be curved or angled, in particular by an angle in a range between 1 degree and 90 degrees, more particular between 2 degrees and 45 degrees, preferably between 5 degrees and 20 degrees, for example 10 degrees. In particular, each leg may comprise a first section extending substantially parallel to the central length axis of the sensor holder, and a second portion extending away from the central length axis of the sensor holder in a direction transverse thereto so that the second portions of the legs diverge from each other. Such a curved or angled advantageously facilitates to properly position the temperature sensing portion of the at least one detectorelement of the temperature sensor inside the hollow body at or close to the outer body wall of the hollow body.

[0028] Preferably, at least a portion of each leg or each leg in its entirety is flexible, in particular elastically flexible, in at least one direction transverse to a respective length extension of the legs, in particular in a direction parallel to a plane spanned by the body opening, more particularly in a direction radially transverse to the central length axis of the sensor holder or an insertion axis of the senor holder through the body opening, respectively. Depending on the size of the body opening, the use of flexible legs can make it easier to insert the legs through the housing opening, especially where the legs are curved or angled in direction radially outward with respect to the insertion axis of the senor holder through the body opening. In addition, the use of elastically flexible legs proves beneficial to press the temperature sensing portion(s) of the detector element(s) against the outer body wall of the hollow body in order to ensure a proper contact to the outer body wall, if desired.

[0029] As already mentioned above, the one or more legs may advantageously be used to position one or more detector elements of the temperature sensor inside the medical container. Accordingly, the temperature sensor may comprise one or more (a plurality of) detector elements, wherein each of the one or more detector elements has a temperature sensing portion.

[0030] Each of the one or more (the plurality of) detector elements is preferably mounted to one of the one or more (the plurality of) legs. More preferably, each of the one or more (the plurality of) detector elements is mounted to a respective free end portion of one of the one or more (the plurality of) legs. Mounting the detector element(s) to a free end portion of the leg(s) makes it particularly easy to position the respective temperature sensing portion of the detector element(s) at or close to the outer body wall of the hollow body. Advantageously, the number of detector elements corresponds to the number of legs. Accordingly, the temperature sensor may comprise one, two, three or four detector elements.

[0031] The at least one detector element may be one of: a thermocouple, a resistance temperature detector, and a thermistor.

[0032] A thermocouple, also known as a "thermoelectrical thermometer", is an electrical device consisting of two dissimilar electrical conductors forming an electrical junction. A thermocouple produces a temperature-dependent voltage as a result of the Seebeck effect, and this voltage can be interpreted to measure temperature. Advantageously, thermocouples are self-powered and require no external form of excitation. In particular, the thermocouple may be one of one of the following types: type E, type J, type K, all of which are nickel-alloy thermocouples. Other types are also possible. Various types of material combination of the electrical conductors are available. The different types are best suited for different applications. The types may be selected on the basis of the temperature range and sensitivity needed. At hand, the thermocouple may preferably be a type K thermocouple. This type is a general-purpose thermocouple with a sensitivity of approximately 41 pV / °C, which is inexpensive, and offers a wide variety of application ranges from -200 °C to +1350 °C, making it particularly suitable for applications with cooled or deep-frozen medical products stored in the medical container.

[0033] A resistance temperature detector (RTD) typically consists of a length of fine wire wrapped around a heat-resistant ceramic or glass core. Other constructions are also used. The RTD wire is a pure material, typically platinum (Pt), nickel (Ni), or copper (Cu). These material has an accurate and repeatable resistance / temperature relationship (R vs T) which is used to provide an indication of temperature. The R vs T relationship is defined as the amount of resistance change of the sensor per degree of temperature change. The relative change in resistance (temperature coefficient of resistance) varies only slightly over the useful range of the sensor.

[0034] A thermistor is a semiconductor type of resistor whose resistance is strongly dependent on temperature, more so than in standard resistors. Depending on materials used, thermistors are classified into two types: negative-temperature-coefficient (NTC) thermistors having a resistance that decreases as temperature rises; and positive- temperature-coefficient (PTC) thermistors having a resistance that increases as temperature rises. Thermistors differ from resistance temperature detectors (RTDs) in that the material used in a thermistor is generally a ceramic or polymer, while RTDs use pure metals. The temperature response is also different; RTDs are useful over larger temperature ranges, while thermistors typically achieve a greater precision within a limited temperature range, typically -90 °C to +130 °C.

[0035] The detector elements preferably are wire-based detector elements, i.e. the detector elements comprise some kind of wiring for connecting the detector element with a read-out unit and / or control unit that is configured to generate a temperature signal indicative of the measured temperature.

[0036] In order to prevent damage to the detector element(s) or undesired detachment of the detector element(s) from the leg(s) due to a strain acting on the wiring the detector element, the leg(s) may advantageously comprise a strain-relief arrangement for a wiring of the detector element mounted to the respective leg.

[0037] As an example, each leg, more particularly a respective free end portion of each leg, may comprise a plurality of lugs through which the wiring of the detector element is threaded in an alternating manner. For instance, each leg or a respective free end portion of each leg may comprise two lugs extending through the leg from one side to an opposition side transversely to a length extension of the leg, wherein the wiring of the detector elements is passed through a first of the lugs from a first to an opposite second side of the leg and back through a second of the lugs to the first side of the leg. The same arrangement is possible with a larger number of lugs.

[0038] As another example, each leg, more particularly a respective free end portion of each leg, may comprise one or more clamps for fixing the wiring of the detector element.

[0039] Advantageously, the detector elements may be mounted to the legs by, in particular exclusively by, the coupling provided between the wiring of the detector elements and the strain-relief arrangement. Thus, no additional means are needed to mount the detector elements to the legs. This allows the temperature measuring device to be manufactured in a simple and cost-effective manner. In addition, the mass of the temperature measuring assembly, in particular the thermal mass, is reduced.

[0040] In order to securely attach the sensor holder to the medical container, the sensor holder may comprise a clamping mechanism. In particular, the clamping mechanism may comprise one or more clamping brackets configured to attach the sensor holder to the medical container, in particular to a flange of the medical container, or to both a flange and a cap of the medical container (the cap being positioned on the flange). For example, the clamping brackets may clamp around the flange or the flange and cap and extend from the top of the flange or cap around the circumferential side of the flange or aroundthe circumferential sides of the cap and flange to an undercut on an opposite side of the flange. The clamping brackets may be configured as elastically flexible clamping brackets to be attached to the medical container in a clipping manner. Alternatively, the clamping brackets may be configured as flexural clamps to be bend into a bracket shape for attaching the sensor holder to the medical container.

[0041] Preferably, the clamping mechanism may be part of the supporting member of the sensor holder. Especially, the clamping mechanism may be integral with the supporting member of the sensor holder. It is also possible that the clamping mechanism and the supporting member are different parts.

[0042] Not only the clamping mechanism and the supporting member may be integral with each other, but also the entire sensor holder may be a one-piece sensor holder. In particular, the supporting member, the legs and - if present - the clamping mechanism, may be integral with each other, preferably be made from a single piece of material. That is, the entire sensor holder may be made from a single piece of material. Advantageously, this allows the sensor holder to be manufactured in a simple and cost-effective manner.

[0043] More particularly, the entire sensor holder or at least parts of the senor holder may be made from a sheet material, in particular a sheet of spring steel. A sheet material allows the 3-dimensional sensor holder to be produced from a flat, quasi-2-dimensional material by cutting (e.g. laser cutting) or punching a 2-dimensional folding pattern (possibly including fold lines and relief cuts) which can subsequently be transformed into the final 3-dimensional shape of the sensor holder by folding, similar to the process of producing folding boxes.

[0044] In addition, the temperature measuring assembly may further comprise a readout unit and / or control unit configured to generate a temperature signal indicative of the temperature measured by the temperature sensor or the one or more detector elements, respectively. For this, the temperature sensor or the one more detector elements may be operatively coupled to the read-out unit and / or control unit.

[0045] The present invention also relates to a temperature measuring attachment for attachment to a medical container and for determining a temperature inside the medical container, wherein the medical container has a hollow body with an outer body wall and a body opening as described above with respect to the temperature measuring assembly.The temperature measuring attachment of the invention comprises a temperature measuring assembly according to the invention and as above described, as well as a cap or a plug for installation at the body opening of the medical container. The cap or the plug may have a passage opening for the sensor holder to extend therethrough into the interior of the hollow body when installed at the medical container. The plug may be made of a resilient material, such as rubber, or glass or metal. It is also possible that the cap or the plug is configured for creating a passage opening therethrough which allows the sensor holder to extend therethrough such as into the interior of the hollow body when installed at the medical container. For example, the cap or the plug may comprise a septum through which a passage opening may be created, either by piercing the sensor holder therethrough or pre-piercing with a piercing element in order create a passage opening for subsequent insertion of the sensor holder.

[0046] This aspect of the invention relates to a temperature measuring attachment that is preferably configured for use with a medial container having no plug or cap, i.e. to a temperature measuring attachment that can be fitted to a medial container without a plug or cap. Advantageously, combining a temperature measuring assembly according to invention and as above described, with a cap or a plug allows for an easy installation of the temperature assembly to a medical container.

[0047] The temperature measuring attachment may be provided in a pre-assembled form with the temperature measuring assembly being attached to the cap or plug. As such, temperature measuring attachment is ready for installation at a medical container. If present, a clamping mechanism of the sensor holder may be in a preparation configuration which may be transformed in a clamping configuration upon positioning the temperature measuring arrangement at the medical container. For instance, as described above, the clamping brackets may be configured as flexural clamps to be bend into a bracket shape for attaching the sensor holder to the medical container upon positioning the temperature measuring arrangement at the medical container.

[0048] Alternatively, the temperature measuring attachment may be provided in a dissembled configuration with the temperature measuring assembly being dismounted from the cap or plug.

[0049] The present invention also relates to a temperature measuring system comprising a medical container, wherein the medical container has a hollow body with anouter body wall and a body opening. According to the invention, the temperature measuring system further comprises a temperature measuring assembly according to the invention and as above described, or a temperature measuring attachment according to the invention and as above described.

[0050] The temperature measuring system can be understood as a ready-to-use temperature measuring system to be placed somewhere in a handling process of temperature-controlled medical products in order to enable temperature monitoring, process validation and / or equipment qualification in connection with the handling process under investigation.

[0051] Preferably, the medical container may be filled with the same medical product as processed in the handling process under investigation. Alternatively, the container may be filled with a test product. The test product may be a surrogate having similar or at least partially identical properties as the medical product of the handling process under investigation.

[0052] As described above, areas inside the medical container which are at or close to the outer body wall of the hollow body are those areas which are first affected by external influences and thus are of particular interest for temperature monitoring. Accordingly, the sensor holder may be advantageously configured to position the respective temperature sensing portions of the one or more detector elements, at a distance to the outer body wall of the hollow body of less than 15% of the inner diameter of the hollow body, of less than 10% of an inner diameter of the hollow body, or of less than 5% of the inner diameter of the hollow body. Likewise, the sensor holder may be advantageously configured to position the respective temperature sensing portions of the one or more detector elements, at a distance to the outer body wall of the hollow body of less than 1 millimeter, or less than 0.5 millimeters, or less than 0.25 millimeters, preferably of 0 millimeters, i.e. in contact with the outer body wall of the hollow body.

[0053] The present invention also relates to a method of temperature monitoring, process validation and / or equipment qualification in connection with handling temperature-controlled medical products, using at least one temperature measuring assembly, at least one temperature measuring arrangement and / or at least one temperature measuring system of the invention and as above described, wherein the method comprises:- implementing at least one temperature measuring assembly of the invention and as above described, at least one temperature measuring arrangement of the invention and as above described and / or at least one temperature measuring system of the invention and as above described at a respective pre-defined position in a handling process and / or handling equipment used for handling temperature-controlled medical products, wherein - as far as present - the at least one temperature measuring assembly and the at least one temperature measuring arrangement are installed at a respective medical container;- measuring, and preferably recording, a temperature inside the respective medical container, which the at least one temperature measuring assembly and the least one temperature measuring arrangements are installed at, and / or inside the respective medical container of the at least one temperature measuring system during handling in accordance with a pre-defined measuring protocol.

[0054] The method of the invention may be especially used for temperature monitoring during the transportation of temperature-controlled medical products, as well as for validating a process and / or qualifying equipment in connection with the transportation of temperature-controlled medical products. To this extend, the method may comprise:- placing one or more medical containers to be transported, each medical container containing a respective medical product, in a transportation system under pre-defined temperature conditions;- placing one or more of the temperature measuring systems of the invention and as above described in the transportation system, the respective medical container of the one or more temperature measuring systems being filled with a medical product contained in one of the plurality of medical containers to be transported or with a test product, wherein the one or more of the temperature measuring systems are placed at one or more pre-defined positions in the transportation system;- measuring, and preferably recording, a temperature inside the one or more medical containers of the one or more temperature measuring systems during transport in accordance with a pre-defined measuring protocol.

[0055] One of the one or more temperature measuring systems may be positioned adjacent to an outer wall or a corner of the transportation system. Similar to the reasons for positioning the temperature sensing portion of the detector element(s) inside thehollow body at or close to the outer body wall of the hollow body, areas adjacent to an outer wall or a corner of the transportation system are those areas which are first affected by external influences and thus are of particular interest for temperature monitoring.

[0056] It is also possible that one of the one or more temperature measuring systems may be positioned in or close to a center position in the transportation system.Brief Description of the Drawings

[0057] The temperature measuring assembly, attachment and system according to the invention, as well as the method of temperature monitoring, process validation and / or equipment qualification according to the invention are described in more detail hereinbelow by way of an exemplary embodiment and with reference to the attached drawings, in which:Fig. 1 shows a cross-section of an exemplary embodiment of a temperature measuring system according to the present invention;Fig. 2 shows a perspective view of the sensor holder of the temperature measuring system of Fig. 1 ;Fig. 3 shows a side view of the sensor holder of the temperature measuring system of Fig. 1 ;Fig. 4 shows a top view of a blank of the sensor holder shown in Fig. 2 and Fig. 4;Fig. 5 shows a side view of the temperature measuring system shown in Fig. 1 ; andFig. 6 shows a transportation system involving a plurality of temperature measuring system of Fig. 1 .Description of Embodiments

[0058] In the following description certain terms are used for reasons of convenience and are not intended to limit the invention. The terms “right”, “left”, “up”, “down”, “under" and “above" refer to directions in the figures. The terminology comprises the explicitly mentioned terms as well as their derivations and terms with a similar meaning. Also, spatially relative terms, such as "beneath", "below", "lower", "above", "upper", "proximal", "distal", and the like, may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the devices in use or operation in addition to the position and orientation shown in the figures. For example, ifa device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both positions and orientations of above and below. The devices may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes include various special device positions and orientations.

[0059] To avoid repetition in the figures and the descriptions of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from a description or figure does not imply that the aspect is missing from embodiments that incorporate that aspect. Instead, the aspect may have been omitted for clarity and to avoid prolix description. In this context, the following applies to the rest of this description: If, in order to clarify the drawings, a figure contains reference signs which are not explained in the directly associated part of the description, then it is referred to previous or following description sections. Further, for reason of lucidity, if in a drawing not all features of a part are provided with reference signs it is referred to other drawings showing the same part. Like numbers in two or more figures represent the same or similar elements.

[0060] With initial reference to Fig. 1 and Fig. 5, an exemplary embodiment of a temperature measuring system 120 is shown which is especially conceived for temperature monitoring during the handling of temperature-controlled medical products, as well as for validating a process and / or qualifying equipment in connection with the handling of temperature-controlled medical products. Such handling may, for example, concern the transportation of temperature-controlled medical products, an example of which will be described in more detail below with reference to Fig. 6.

[0061] The temperature measuring system 120 comprises a medical container 20 for storing a medical product and a temperature measuring attachment 110 according to the present invention. The temperature measuring attachment 110 in turn comprises a temperature measuring assembly 100 according to the invention and a plug 25 for installation at a body opening 23 of the medical container 20.

[0062] In the present embodiment, the medical container 20 is a vial as commonly used in pharmaceutical industry and research. The medical 20 comprises a hollow body 21with an outer body wall 22 and a body opening 23. The hollow body 21 has a bottle-like shape with a bottle neck 27 and a flange 24 including the body opening 23. The body opening 23 is configured to receive a plug-in portion of the plug 25, while a collar portion of the plug abuts the top side of the flange 24 of the medical container 20.

[0063] The plug 25 comprises a passage opening 26 for the temperature measuring assembly 100 to extend therethrough into the interior of the hollow body 21 when installed at the medical container 20. The plug 25 may be made of a resilient material, such as rubber, or glass or metal. Here, the plug 25 together with the temperature measuring assembly 100 forms the temperature measuring attachment 110 which can be considered as a ready-to-use measurement unit for installation to a medical container. Alternatively, the plug 25 may be part of the medical container 20.

[0064] The temperature measuring assembly 100 forms the core part of the present invention. The assembly 100 comprises a temperature sensor 40 comprising one or more detector elements 42, each having a temperature sensing portion 41 , as well as a sensor holder 30 holding the temperature sensor 40. The main purpose of the temperature measuring assembly 100 is the determination of a temperature inside the medical container 20, more particularly a temperature in one or more areas at or close to the outer body wall 22 of the hollow body 21. With regard to the handling of a temperature- controlled medical product stored in the medical container 20, these areas are of particular interest for temperature monitoring as they are the first to be thermally affected by external influences.

[0065] For this, the sensor holder 30 is configured such that it can be installed on the medical container 20, and - when installed - extends through the body opening 23 (via the opening passage 26 of the plug 25) into the interior of the hollow body 21 and positions the temperature sensing portions 41 of the detector elements 42 inside the hollow body 21 at or close to the outer body wall 22 of the hollow body 21 .

[0066] As can be seen from Fig. 1 , the temperature sensor 40 according to the present embodiment comprises three detector elements 42, each detector element 42 being a thermocouple of type Kwith a respective temperature sensing portion 41 and a respective wiring 43 passed to the outside of the medical container 20 through the body opening 23 (via the opening passage 26 of the plug 25).

[0067] The sensor holder 30 of the present embodiment comprises a supporting member 31 extending across the opening passage 26 of the plug 25, thus being placed across the body opening 23 of the medical container 20. In order to individually position each of the detector elements 42 inside the hollow body 21 , the sensor holder 30 further comprises three legs 32, one for each detector element 42, which are configured and arranged for insertion into the interior of the hollow body 21 through the body opening 23 (via the opening passage 26 of the plug 25. More precisely, each of the three detector elements 42 is mounted to a respective free end portion 35 of one of the three legs 32.

[0068] To prevent undesired detachment of the detector elements 42 from the legs 32 due to a strain acting on the wiring 43 the detector elements 42, the legs comprise a strain-relief arrangement 36. At hand, with reference to Fig. 2 and Fig. 3, the strain-relief arrangement 36 is formed by two lugs 37 at the respective free end portion 35 of each leg 32. Each of the lugs 37 extends through the leg 32 from a first side to an opposition second side transversely to a length extension of the leg 3. As shown in Fig. 1 , the wiring 43 of the detector elements 42 is passes through a first of the lugs 37 from the first to the second side of the leg 32 and back through a second of the lugs 37 to the first side of the leg 32, thus ensuring that the wiring cannot be pulled out by strain acting on the wiring 43.

[0069] In the present embodiment, the detector elements 42 are mounted to the legs 32 exclusively by the coupling provided between the wiring 43 of the detector elements 42 and the strain-relief arrangement 26. Thus, advantageously, no additional means are needed to mount the detector elements 42 to the legs 32. In addition, the end portion of the wiring 43 with the temperature sensing portion 41 at its very free end leaves the first lug 37 in a direction substantially radially outwards which proves beneficial to facilitate the positioning of the respective temperature sensing portions 41 at or close to the outer body wall 22 of the hollow body 21 .

[0070] A central length axis 38 of the sensor holder 30 - given by a principal direction in which the group of legs 32 extends - defines a general insertion direction of the sensor holder 30 into the interior of the medical container 20, which is essentially perpendicular to a plane spanned by the opening passage 26 of the plug 25 and the body opening 23 of the medical container 20, respectively.

[0071] Further details of the sensor holder 30 are illustrated in Fig. 2 and Fig. 3. To allow for temperature measurements in different spatial directions around the center axis of the medical container 20, the legs 32 branch off from the supporting member 31 in a symmetric, star-shaped arrangement with respect to the central length axis 38 of the sensor holder 30. More specifically, the three legs 32 are evenly distributed around the central length axis 38 of the sensor holder 30, separated by an angle of 120 degrees between each pair of legs as seen in a projection along the central length axis 38.

[0072] In order to position the temperature sensing portion 41 of the detector elements 42 as close as possible to or even at the inner surface of the outer body wall 22, each leg 32 comprises a first section 33 extending substantially parallel to the central length axis 38 of the sensor holder 30, and a second portion 34 extending away from the central length axis 38 in a direction transverse (radially outwards) thereto so that the second portions 34 of the legs 32 diverge from each other. In the present example, the legs are angled by an angle of 10 degrees, i.e. the second portions 34 of the legs 32 are angled by 10 degrees with respect to the first portions 33 or the central length axis 38, respectively.

[0073] As can be particularly seen from Fig. 1 , the free end portions 35 of the legs 32 radially extend beyond the cross-sectional dimensions of the opening passage 26 of the plug 25 and the body opening 23 of the medical container 20, respectively. To still enable the insertion of the legs into the interior of the medical container 20 through the opening passage 26 and the body opening 25, the legs 32 are elastically flexible in a direction transverse to the respective length extension of the legs 32, i.e. in a direction radially transverse to the central length axis 38 such that they can be compressed in order to pass through the opening passage 26 and the body opening 25. In addition, the resilience of the elastically flexible legs is advantageously used to maintain a close contact of the temperature sensing portion 41 of the detector elements 42 to the outer body wall 22 of the hollow body 21 , if desired.

[0074] Preferably, the legs 32 of the sensor holder 30 are made from spring steel to make them elastically flexible. Even more preferably, the entire sensor holder 30 is made from a single piece of material, i.e. realized as a one-piece sensor holder 30. Advantageously, this allows the sensor holder 30 to be manufactured in a simple and cost-effective manner.

[0075] Details of the manufacturing of the sensor holder 30 are illustrated in Fig. 4. According to the present embodiment the entire sensor holder 30 is made from a flat, quasi-2-dimensional material sheet of spring steel, from which a blank body (see Fig. 4) is cut out or punched in order to achieve a 2-dimensional folding pattern, which may include fold lines and relief cuts. Similar to the process of producing folding boxes, the blank body of Fig. 4 can be transformed by folding into the final 3-dimensional shape of the sensor holder 30 shown in Fig. 1 to Fig. 3. At hand, each of the legs 32 as a whole is angled relative to the support member 31 by about 90 degrees, and the second portion 34 of each leg 32 is angled relative to the respective first portion 33 by a desired angle, here 10 degrees.

[0076] As can be further seen from Fig. 4, the blank body of the sensor folder 30 further comprises three shorter arms which are designed to form clamping brackets 39 for attaching the sensor holder 30 to the medical container 20. Details of the clamping brackets 39 are illustrated in Fig. 2, Fig. 3 and Fig. 5. As can be seen from these figures, the clamping brackets 39 according to the present embodiment are configured as flexural clamps, formed by bending the three short arms of the blank body shown in Fig. 4 into a bracket shape such that each clamping bracket 39 clamps around the flange 24 and the plug 25, i.e. from the top of the plug 25 around the circumferential sides of the plug 25 and the flange 26 to an undercut on the rear side of the flange 26 formed by the body neck 27. By this, the temperature measuring assembly 100 is prevented from being displaced relative to the medical container 20 or even being lost during handling.

[0077] As described further above, the temperature measuring system 120 shown in Fig. 1 and Fig. 5 is especially conceived to monitor the temperature of a temperature- controlled medical product stored in a medical container similar or identical to the medical container of the system 120 during a handling process of the medical product. As such the system is specifically suitable for validating a process and / or qualifying equipment in connection with the handling of temperature-controlled medical products. For this, one or more of the temperature measuring systems 120 may be implemented at one or more pre-defined positions in a handling process and / or handling equipment in order to measure and record a temperature inside the one or more medical containers 20 of the one or more temperature measuring systems 120 during the handling in accordance with a pre-defined measuring protocol.

[0078] Preferably, the handling may concern the transportation of temperature- controlled medical products in medical containers similar or identical to the medical container of the system 120. Temperature-sensitive medical products stored in such containers often have to be transported in a frozen state. For this, they are packed into a suitable transportation system (transportation equipment), such as cooling boxes. As the temperature of the medical products must not exceed a critical temperature during transportation, quality guidelines as well as handling regulations may prescribe to permanently monitor the temperature conditions throughout the entire transportation and to only use transportation equipment that is appropriately qualified in order to ensure correct transport conditions. For both purposes, one or more of the temperature measuring systems 120 according to the embodiment shown in Fig. 1 and Fig. 5 may be implemented at one or more pre-defined positions in the transportation system. Fig. 6 schematically shows such a transportation system 210 in the form of a cooling boxes which offers in total fifteen (3 x 5) container slots for storing medical containers 220 similar or identical to the medical container 20 of the temperature measuring system 120.

[0079] For qualifying the transportation system 210, i.e. for confirming by objective evidence that the transportation system 210 meets the requirements or conditions of a specific application or a specific use, e.g. that the temperature of the medical products stored in the medical contains 220 does not exceed a critical temperature during the entire transportation, the present invention suggests to place one or more of the temperature measuring systems 120 in the transportation system 210 by placing them at one or more pre-defined positions (container slots) in the transportation system 210 under pre-defined temperature conditions, as well as to measure and record the temperature inside the one or more medical containers 20 of the one or more temperature measuring systems 120 during transport in accordance with a pre-defined measuring protocol. The remaining container slots may be filled with one or more medical containers 220 to be transported, each containing a respective medical product. The one or more medical containers 220 are placed in the transportation system 210 under the same pre-defined temperature conditions as the one or more of the temperature measuring systems 120.

[0080] For the qualification procedure, the respective medical containers 20 of the one or more temperature measuring systems 120 may be filled with a medical product contained in one of the plurality of medical containers 220 to be transported, oralternatively with a test product, which preferably has similar or at least partially identical properties as one of the medical products to be transported.

[0081] Those container slots which are adjacent to an outer wall or a corner of the transportation system 210 are those areas which are first affected by external influences and thus are of particular interest for temperature monitoring. Therefore, as shown in Fig. 6, four temperature measuring systems are preferably positioned adjacent to an outer wall of the transportation system 210, more specifically one at each corner of the transportation system 210. In addition, one or more of the temperature measuring systems 120 may be positioned in or close to a center position in the transportation system 210, as also shown in Fig. 6.

[0082] Instead of using fully equipped temperature measuring systems 120, it is also possible to equip one or more of the medical containers 220 to be transported with a temperature measuring assembly according to the invention or with a temperature measuring attachment according to the invention. In this case, the one or more of the medical containers 220 must not be sealed in order to allow for positioning the temperature sensing portion of the detector element(s) inside the hollow body of the medical containers 220.

[0083] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limiting-the claims defining the protected invention. In other words, while the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this description and the claims. In some instances, well-known circuits, structures and techniques have not been shown in detail in order not to obscure the invention. Thus, it will be understood that changes and modifications may be made by those of ordinary skill within the scope and spirit of the following claims. In particular, the present invention covers further embodiments with any combination of features from different embodiments described above and below.

[0084] The disclosure also covers all further features shown in the Figs, individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description andsingle alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter. The disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features. Also, the present disclosure covers intermediate generalizations of features or groups of features of the embodiments described and shown in the figures. I.e., specific features or groups of features as disclosed in the figures and the associated sections of the description may be combined with the more general embodiments of the invention disclosed in connection with the description of the invention. In particular, such specific features or groups of features may be provided in the more general embodiments of the invention in isolation from further specific features shown in the figures. For example, .... It is understood that those skilled in the art are able to incorporate specific features from the description of the figures into the embodiments of the description of the invention.

[0085] Furthermore, in the claims the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single unit or step may fulfil the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms “essentially”, “about”, “approximately” and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. The term “about” in the context of a given numerate value or range refers to a value or range that is, e.g., within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via plurality of intermediate components. Any reference signs in the claims should not be construed as limiting the scope.

Claims

CLAIMS1 . A temperature measuring assembly (100) for determining a temperature inside a medical container (20), the medical container (20) having a hollow body (21 ) with an outer body wall (22) and a body opening (23), the temperature measuring assembly (100) comprising: a temperature sensor (40) comprising at least one detector element (42) having a temperature sensing portion (41 ); and a sensor holder (30) holding the temperature sensor (40), wherein the sensor holder (30) is configured to be installed on the medical container (20) such that it extends through the body opening (23) into the interior of the hollow body (21 ) and that the temperature sensing portion (41 ) of the at least one detector element (42) is positioned inside the hollow body (21 ) at or close to the outer body wall (22) of the hollow body (21 ).

2. The temperature measuring assembly (100) of claim 1 , wherein the sensor holder (30) comprises a supporting member (31 ) configured to be placed across the body opening (23), in particular at an outside of the medical container (20), and a plurality of legs (32), in particular two, three or four legs (32), to extend into the interior of the hollow body (21 ).

3. The temperature measuring assembly (100) of claim 2, wherein the legs (32) branch off from the supporting member (31 ) essentially along a central length axis (38) of the sensor holder (30), in particular in a symmetric arrangement with respect to the central length axis (38) of the sensor holder (30).

4. The temperature measuring assembly (100) of claim 3, wherein the legs (32) are evenly distributed around the central length axis (38) of the sensor holder5. The temperature measuring assembly (100) of claim 3 or 4, wherein the legs (32) are arranged in a star-shaped manner as seen in a projection along the central length axis (38) of the sensor holder (30).

6. The temperature measuring assembly (100) of any one of claims 2 to 5, wherein the legs (32) are curved and / or angled.

7. The temperature measuring assembly (100) of claim 6, wherein the legs (32) are curved and / or angled by an angle in a range between 1 degree and 90 degrees, more particular between 2 degrees and 45 degrees, preferably between 5 degrees and 20 degrees, for example 10 degrees.

8. The temperature measuring assembly (100) of any one of claims 3 to 7, wherein each leg (32) comprises a first section (33) extending substantially parallel to the central length axis (38) of the sensor holder (30), and a second portion (34) extending away from the central length axis (38) of the sensor holder (30) in a direction transverse thereto so that the second portions (34) of the legs (32) diverge from each other.

9. The temperature measuring assembly (100) of any one of claims 3 to 8, wherein at least a portion of each leg (32) is flexible.

10. The temperature measuring assembly (100) of claim 9, wherein the flexible at least a portion of each leg (32) is elastically flexible, in at least one direction transverse to a respective length extension of the legs (32).

11. The temperature measuring assembly (100) of claim 10, wherein the at least one direction transverse to a respective length extension of the legs (32) is a direction radially transverse to the central length axis (38) of the sensor holder (30).

12. The temperature measuring assembly (100) of any one of claims 2 to 11 , wherein the temperature sensor (40) comprises a plurality of detector elements (42).

13. The temperature measuring assembly (100) of claim 12, wherein the plurality of detector elements (42) are three or four detector elements (42), whereineach of the plurality of detector elements (42) has a temperature sensing portion(41 ) and is mounted to one of the plurality of legs (32).

14. The temperature measuring assembly (100) of claim 13, wherein each of the plurality of detector elements (42) is mounted to a respective free end portion (35) of one of the plurality of legs (32).

15. The temperature measuring assembly (100) of any one of the preceding claims, wherein the at least one detector element (42) is one of: a thermocouple, a thermistor, and a resistance temperature detector.

16. The temperature measuring assembly (100) any one of claims 12 to 15, wherein the legs (32) comprise a strain-relief arrangement (36) for a wiring (43) of the detector element (42) mounted to the respective leg (32).

17. The temperature measuring assembly (100) of claim 16, wherein preferably the detector elements (42) are mounted to the legs (32) by, in particular exclusively by, a coupling provided between the wiring (43) of the detector elements(42) and the strain-relief arrangement (36).

18. The temperature measuring assembly (100) of any one of the preceding claims, wherein the sensor holder (30) comprises a clamping mechanism.

19. The temperature measuring assembly (100) of claim 18, wherein the clamping mechanism of the sensor holder (30) comprises one or more clamping brackets (39) configured to attach the sensor holder (30) to the medical container (20).

20. The temperature measuring assembly (100) of any one of the preceding claims, wherein the sensor holder (30) is a one-piece sensor holder (30).21 . The temperature measuring assembly (100) of any one of the preceding claims, wherein the sensor holder (30) is made from a sheet material.

22. The temperature measuring assembly (100) of claim 21 , wherein the sheet material is a metal sheet or a sheet of spring steel.

23. A temperature measuring attachment (110) for attachment to a medical container (20) and for determining a temperature inside the medical container (20), the medical container (20) having a hollow body (21 ) with an outer body wall (22) and a body opening (23), the temperature measuring attachment (110) comprising a temperature measuring assembly (100) of any one of the preceding claims and a cap or a plug (25) for installation at the body opening (23) of the medical container (20), the cap or the plug (25) having a passage opening (26) or being prepared for creating a passage opening for the sensor holder (30) to extend therethrough into the interior of the hollow body (21 ) when installed at the medical container (20).

24. A temperature measuring system comprising a medical container (20), the medical container (20) having a hollow body (21 ) with an outer body wall (22) and a body opening (23), and a temperature measuring assembly (100) of any one of claims 1 to 22 or a temperature measuring attachment (110) of claim 23.

25. The temperature measuring system of claim 24, wherein the sensor holder (30) is configured to position the temperature sensing portion (41 ) of the at least one detector element (42) at a distance to the outer body wall (22) of the hollow body (21 ) of less than 15% of the inner diameter of the hollow body (21 ), of less than 10% of an inner diameter of the hollow body (21 ), or of less than 5% of the inner diameter of the hollow body (21 ).

26. The temperature measuring system of claim 24 or 25, wherein the sensor holder (30) is configured to position the temperature sensing portion (41 ) of the at least one detector element (42) at a distance to the outer body wall of the hollow body of less than 1 millimeter, or less than 0.5 millimeters, or less than 0.25 millimeters, preferably of 0 millimeters.

27. A method of temperature monitoring, process validation and / or equipment qualification in connection with handling temperature-controlled medical products, using at least one temperature measuring assembly (100) of any one of claims 1 to 22, at least one temperature measuring arrangement (110) of claim 23 and / or at- implementing at least one temperature measuring assembly (100) of any one of claims 1 to 22, at least one temperature measuring arrangement (110) ofclaim 23 and / or at least one temperature measuring system (120) of any one of claims 24 to 26 at a respective pre-defined position in a handling process and / or handling equipment used for handling temperature-controlled medical products, wherein - as far as present - the at least one temperature measuring assembly (100) and the at least one temperature measuring arrangement (110) are installed at a respective medical container (20);- measuring, and preferably recording, a temperature inside the respective medical container (20), which the at least one temperature measuring assembly (100) and the least one temperature measuring arrangements (110) are installed at, and / or inside the respective medical container (20) of the at least one temperature measuring system (120) during handling in accordance with a pre-defined measuring protocol.

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