5 FOR DIMENSIONAL MEASUREMENT OF PACKAGING MATERIAL

Technical Field 0

The invention refers to a mounting system, a kit and a tracking system, coordinate measuring machine and a method for dimensional measurement of packaging material and/or medical device. The method and devices according to the present invention may be used for quality assurance, in particular for inspection of packaging materials such as vials, sy-5 ringes, plunger and the like. Other applications are generally feasible.

Background art

For quality assurance laboratory, pharmaceutical and medical packaging materials such as 0 vials, syringes, plunger and the like need to be inspected. Therefore samples per batches of packaging materials may be selected and inspected if they are in specification. For inspection Coordinate Measuring Equipment (CME) can be used. The CME can be programmed, but the CME must know on which position it has to do which operations. Thus, the samples need to be on essentially the identical position each time, with allowed difference in 5 position of less than 1 cm. Such a precision, however, may not be realistic for a human in case of positioning a sample on an empty table. If the sample is not on the programmed position the program stops and the sample needs to be placed to its programmed position by hand, which, however, needs much time and qualification. 0 Thus, not having the samples every time on the same position is problematic due to high time and qualification demand. To solve this problem, in principle, it would be possible to use a mounting system having a fixed position of the samples. But the mount system would need to be very flexible, because of a high variety of different packaging materials and there is no possibility for high mount changing times. Known, in the technical fields of 5 machine building and automotive, are mounting systems using the machine’s screw thread and allowing building an “own” mount. This is often very flexible, but neither fast nor can be rebuild identically every time. Moreover, it is generally only possible to hold one single object to be measured with this known devices.

For example, JP 2006 170913 A describes a holding fixture which holds an optical component (the measured object) such as a lens relative to the measuring system. The holding fixture has a holding fixture body, an optical parallel (an angle reference) for indicating an inclination of the holding fixture body relative to the measuring optical system, and a position reference for indicating an origin of the holding fixture body. The optical parallel and the position reference are separately disposed in the holding fixture body.

Problem to be solved

It is therefore an objective of the present invention to provide a mounting system, a kit and a tracking system, coordinate measuring machine and a method for dimensional measurement of packaging material which at least partially avoid the shortcomings of known devices and methods of this kind and which at least partially address the abovementioned challenges. Specifically, devices and methods shall be disclosed which allow fast, precise and, for an operator, comfortable positioning of different packaging materials for dimensional measurement.

Summary

This problem is addressed by a mounting system, a kit and a tracking system, coordinate measuring machine and a method for dimensional measurement of packaging material and/or medical device with the features of the independent claims. Advantageous embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.

As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements. Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

In a first aspect of the present invention, a mounting system is disclosed configured for positioning at least one sample of packaging material and/or medical device.

The mounting system comprises a sample specific holder configured for receiving and holding the sample of packaging material and/or medical device, wherein the sample specific holder comprises at least one receptacle adapted to size and/or shape of the sample of packaging material and/or medical device; a generic holder configured for receiving and for positioning the sample specific holder.

The term “system” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an assembly of at least two elements, wherein the elements each may function and may be handled independently from each other, wherein the elements may interact to perform a common function. The term “mounting system” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limi- tation, to a system configured for performing at least one mounting function. The mounting function may comprise one or more of fixing, clamping, fastening, or attaching.

The mounting system may be used for quality control, in particular for quality control of packaging material and/or medical device. In particular, the mounting system may be used for positioning the at least one sample of packaging material and/or medical device for and/or during measurement and/or determination of dimensions of said sample. The quality control may comprise at least one dimensional measurement. The quality control may comprise comparing the determined dimensions to at least one target value. The quality control may comprise determining if the sample fulfills at least one quality limit based on the comparison. In particular it is determined whether the sample is in specification. The quality control may be performed according to at least one standard.

The term “dimensional measurement” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to determining at least one coordinate on a surface to be measured of the sample. The dimensional measurement may comprise determining a plurality of coordinates. The coordinates may comprise one or more of at least one transverse coordinate, for example an x- and/or y-coordinate, and a longitudinal coordinate, for example at least one vertical coordinate of the sample such as a distance. One or more coordinate systems can be used for the dimensional measurement. By way of example, a Cartesian coordinate system or a spherical coordinate system can be used. Other coordinate systems are also conceivable. The mounting system may be part of a coordinate measuring machine having at least one measuring system configured for the dimensional measurement. The coordinate measuring machine may have an intrinsic coordinate system. The measuring system may have an optical axis. The optical axis may constitute an axis of the coordinate system, for example the z-axis. The vertical coordinate can be a coordinate along the z-axis. Further axes, for example x-axis and y-axis and also axes of rotation, can be provided perpendicular to the z- axis.

For example, the coordinate measuring machine may be a bridge coordinate measuring machine. However, other types of coordinate measuring machine are possible.

The coordinate measuring machine may comprise at least one measuring table, wherein the mounting system is mountable onto the measuring table. The generic holder may be fixedly mounted to the measuring table, wherein the sample specific holder may be insertable and removable from the generic holder. The coordinate measuring machine may be configured for measuring distances, specifically automatically. The coordinate measuring machine may comprise at least one measuring system configured for dimensional measurement of packaging material and/or medical device. The measuring system of the coordinate measuring machine may comprise at least one optic and/or haptic probe head. The dimensional measurement may be performed in accordance to at least one pre-defined test program. The test program may be defined by setting points in a virtual coordinate system. The coordinate measuring machine may be configured for performing automated test programs such as by going to specific coordinates and perform specific operations at this position. The coordinate measuring machine may be programmed for performing the test program such that the machine knows on which position it has to do which operations. However, for a fully automatic test program, the samples must be on the identical position each time with less than 1cm difference. This is not realistic for a human by positioning a sample on an empty measuring table. The proposed mounting system allows ensuring same placement every time without high time demand or qualification needed. A user or operator may put his sample into the sample specific holder, place it in the generic holder and start the test program.

The term “packaging material” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary enclosing configured for one or more of protection, storage and use such as in one or more of the laboratory field, the pharmaceutical field or the medical field. However, generally, the proposed mounting system can be used for other applications such as in the field of food and beverages, technical parts and the like. The packaging material may comprise laboratory packaging material and/or pharmaceutical packaging material and/or medical packaging material. The packaging material may comprise primary packaging material. The packaging material and/or medical device may comprise one or more of at least one vial, at least one syringe with or without cannula, at least one plunger, at least one stopper, in particular a rubber-stopper, at least one crimp cap. For determining a reference and/or checking the measurement and mounting system a gauge block can be used. In this case a gauge block specific holder can be used as sample specific holder. For example, the packaging material may be a vial. The dimensional measurement may comprise determining one or more of a flange depth and/or diameter, body diameter, vial heights, neck diameter, wall and/or base thickness.

The packaging material and/or medical device may be provided, such as by a manufacturer, batchwise. A batch may comprise a plurality of packaging materials and/or medical devices. The term “sample” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a probe of the batch. For quality control at least one sample, preferably a plurality of samples, of the batch may be selected and tested. The sample may be selected randomly form the batch or in a defined manner. For example, 32 samples per batch may be tested.

The term "positioning" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to placing and/or orienting and/or mounting and/or holding at a pre-defined location, in particular on the measuring table of the coordinate measuring machine.

The term "sample specific holder" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one holder matched to the sample to be measured. The sample specific holder may be specially designed for a type of packaging material and/or medical device. However, sample specific holders may be cross-used with dimensional adaption.

The sample specific holder may be manufactured by 3D printing. For example, the sample specific holder may be flexible or rigid. The sample specific holder may comprise at least one plastic such as Acrylonitrile Butadiene Styrene (ABS), Polylactic Acid (PLA), Polyvinyl Alcohol (PVA), polyethylene (PE), Polyethylene terephthalate (PET). However, other embodiments are possible such as a sample specific holder comprising metal or carbon fibers. For example, the sample specific holder may be manufactured using transparent printing material such as transparent printing material available under “AR-M2” from Keyence and Rapidobject®. For example, the sample specific holder may be manufactured using transparent printing material such as transparent printing material available under “AR-M2” from Keyence and Rapidobject®, and opaque printing material, such as opaque printing material available under "Onyx" from Markforged®.

As outlined above, the sample specific holder comprises the at least one receptacle adapted to size and/or shape of the sample of packaging material and/or medical device. The term "receptacle" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element of the sample specific holder configured for receiving the sample. The receptacle of the sample specific holder and the sample of packaging material and/or medical device may be de- signed according to the key-lock principle. The sample specific holder may be designed such that there is a fix-position and the samples can be easily brought in, without need of special qualification. The sample specific holder may have, in particular, a Poka Yoke design.

The receptacle may comprise at least one positioning element configured for positioning the sample of packaging material and/or medical device within the receptacle. The positioning element may be configured for supporting correct placement of the sample within the sample specific holder. For example, the positioning element may comprises one or more of at least one magnet, at least one inner structure, at least one screw, at least one clamping, at least one spring, at least one negative form of the material, at least one bolt to plug on.

The sample specific holder may comprise an outer contour. The outer contour may be designed for each type of sample of packaging material and/or medical device identical. The outer contour of the specific holder may be generic. This may allow putting sample specific holders for different types of samples into one and the same generic holder.

The sample specific holder may comprise at least one check-hole. The sample specific holder may be assignable to the sample of packaging material and/or medical device via the check-hole. In particular, the measurement program may be linked via the check-hole, wherein the measurement program is packaging material and/or medical device specific. To ensure that the right sample specific holder is used for the test program, the sample specific holder can comprise the at least one check-hole where the machine can check whether the correct sample specific holder is used. The check hole may be a borehole through the sample specific holder. The borehole may be printed via the 3D-print. The coordinate measuring machine can check for its right position to ensure right sample specific holder is used. The coordinate measuring machine may move to the position of said borehole and can determine at the borehole an amount of light that can go through the borehole. The amount of light at the borehole is greater than an amount of light passing the sample specific holder which can absorb the light. In case the determined amount of light exceed a predefined threshold, the coordinate measurement machine may issue a warning.

The term "generic holder" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a holder configured for receiving and positioning sample specific holders of different sample types. The generic holder may comprise at least one frame, in particular a metal frame. The frame may be a stable metal frame. For example, the frame may be an aluminum frame. However, other stable materials may be possible, e.g. a plastic frame. The generic holder may be configured such that the sample specific holder can be placed within the frame. The sample specific holder may be insertable and removable from the generic holder. The frame may be adjusted to the outer contour of the sample specific holder. The frame may function as a receptacle for receiving the sample specific holder. For example, the frame may have a rectangular outer contour. An inner contour of the frame may be adapted to the outer contour of the sample specific holder.

The coordinate measuring machine may comprise at least one measuring area. The measuring area may be an area of the measuring table. The measuring area may not correspond to a complete measuring table area such that for the dimensional measurement the sample needs to be placed within the measuring area. The generic holder may comprise at least one fastening element. The fastening element may comprise at least one screw hole and/or at least one screw and/or at least one bracket. Additionally or alternatively, at least one rubber band may be used configured for pulling the sample specific holder into the generic holder. The generic holder may be fastenable via the fastening element to a further device, in particular to the measuring table. The frame may comprise rubber studs on its underside configured for supporting the frame on the measuring table. This may allow preventing that the frame lies crooked or with an angle on the measuring table. Moreover, it may be possible to reduce the risk for defects on the measuring table. For example, the frame may be tightened with screws to the measuring table’s screw threads. Brackets may ensure that the mounting system cannot move while movement of the coordinate measuring machine. The frame may be placed permanent on the measuring table, while the sample specific holders can be changed easy and quick without need of high storage place. Sample specific holders may be flexible changed due to concrete measuring challenge. This may also facilitates handling since the machine coordinate system can be adjusted to the frame, such that the position of the object to be measured at least approximately is known on the holder and can be pointed exactly to the object to measured afterwards. Thus, it may be possible to prevent manual calibrating the machine coordinate system.

The generic holder may be configured as limit stop for the sample specific holder. The frame may be a closed frame. Specifically, the frame may surround the sample specific holder in at least one plane. The frame may be open at at least one side. The generic holder may be configured such that the sample specific holder can be put into the generic holder, wherein the sample specific holder may hit the frame and cannot be moved any further. The sample specific holder may have a slant such that the sample specific holder is receivable in one direction by the generic holder. The slant may ensure correction orientation of the sample specific holder within the generic holder. The frame may be configured for ensuring the same placement of the sample specific holder every time and in the right direction due to the slant.

The generic holder, in particular the frame, may be used to set a reference coordinate system within the coordinate measuring machine. The dimensional measurement may be performed in a probe head’s coordinate system. The reference coordinate system may be used for coordinate transformation into the intrinsic coordinate system of the coordinate measuring machine.

The mounting system may allow the usage of highly accurate test and measuring programs on a complex equipment in a routine measurement context for operators. Same placement of samples with small changing times may be possible and allow an efficient use of this technology.

Known construction kit systems use the machines screw thread for building an own mount. This may be very flexible, but neither fast nor can be rebuild identically every time. The mounting system according to the invention, in contrast, proposes a combination of a sample specific holder pre-adjusted to the sample to be measured and insertable into a generic holder such that reproducibility may be guaranteed. Thus, it may be possible to conduct automated measurement of samples with small set-up-times. 3D printing techniques may allow easily printing of sample specific holders according to concrete measurement challenge. No large storage needed.

In a further aspect of the present invention a kit comprising a plurality of mounting systems according to the present invention, as described above or in more detail below, is disclosed. The mounting systems are configured for positioning different types of samples of packaging material and/or medical device. With respect to definitions and embodiments of the mounting systems reference is made to the definition and embodiments of the mounting system above or as given in more detail below.

The term "kit" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an assembly of a plurality of components, wherein the components each may function and may be handled independently from each other, wherein the components of the kit may interact to perform a common function. Thus, the kit may comprise a plurality of components, wherein each component may be handled individually, independent from the other components and may perform at least one function independently, wherein, further, all components or groups of components comprising at least two of the components may be combined, such as by physically connecting these components, in order to perform a common function implying functionality from the connected components.

The mounting system, in particular the sample specific holder may be expandable. The mounting system, in particular the sample specific holder, may be configured for receiving and holding a plurality of samples. This may allow parallel and/or simultaneous measurement of a plurality of samples, e.g. ten or more samples. The samples may be applied into the sample specific holder such that the coordinate measuring machine can measure the samples in a row with the same measuring program, in particular without that the operator is required.

The kit may comprise different types of sample specific holders such as at least one sample specific holder for a vial, at least one sample specific holder for a syringe, at least one sample specific holder for a plunger, or at least one sample specific holder for a gauge block. The sample specific holders of the kit may be exchangeable from the generic holder.

In a further aspect of the present invention a method for dimensional measurement of packaging material and/or medical device using a coordinate measuring machine and a mounting system according to the present invention is disclosed.

The method steps can be carried out in the order specified, wherein one or more of the steps can at least partly also be carried out simultaneously and wherein one or more of the steps can be multiply repeated. Furthermore, further steps can additionally be performed independently of whether or not they are mentioned in the present application. The method can be carried out automatically.

The method comprises a) Mounting the generic holder onto a measuring table of the coordinate measuring machine; b) Inserting the sample specific holder into the generic holder; c) Performing the dimensional measurement by using a measuring system of the coordinate measuring machine. Step b) may comprise placing the sample in the sample specific holder.

With respect to definitions and embodiments of the method reference is made to the definition and embodiments of the mounting system above or as given in more detail below.

Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

Embodiment 1 A mounting system configured for positioning at least one sample of packaging material and/or medical device, comprising

- a sample specific holder configured for receiving and holding the sample of packaging material and/or medical device, wherein the sample specific holder comprises at least one receptacle adapted to size and/or shape of the sample of packaging material and/or medical device;

- a generic holder configured for receiving and for positioning the sample specific holder.

Embodiment 2 The mounting system according to the preceding embodiment, wherein the packaging material comprises laboratory packaging material and/or pharmaceutical packaging material and/or medical packaging material.

Embodiment 3 The mounting system according to any one of the preceding embodiments, wherein the packaging material and/or medical device comprises one or more of at least one vial, at least one syringe, at least one plunger, at least one stopper, at least one crimp cap.

Embodiment 4 The mounting system according to any one of the preceding embodiments, wherein the receptacle of the sample specific holder and the sample of packaging material and/or medical device are designed according to the key-lock principle.

Embodiment 5 The mounting system according to any one of the preceding embodiments, wherein the sample specific holder is insertable and removable from the generic holder.

Embodiment 6 The mounting system according to any one of the preceding embodiments, wherein the receptacle comprises at least one positioning element configured for positioning the sample of packaging material and/or medical device within the receptacle, wherein the positioning element comprises one or more of at least one magnet, at least one inner structure, at least one screw, at least one clamping, at least one spring, at least one negative form of the material, at least one bolt to plug on.

Embodiment 7 The mounting system according to any one of the preceding embodiments, wherein the sample specific holder has a slant such that the sample specific holder is receivable in one direction by the generic holder.

Embodiment 8 The mounting system according to any one of the preceding embodiments, wherein the generic holder is configured as limit stop for the sample specific holder.

Embodiment 9 The mounting system according to any one of the preceding embodiments, wherein the sample specific holder is manufactured by 3D printing.

Embodiment 10 The mounting system according to any one of the preceding embodiments, wherein the sample specific holder comprises at least one check-hole, wherein the sample specific holder is assignable to the sample of packaging material and/or medical device via the check-hole.

Embodiment 11 The mounting system according to any one of the preceding embodiments, wherein the generic holder comprises at least one frame.

Embodiment 12 The mounting system according to the preceding embodiment, wherein the frame is a metal frame.

Embodiment 13 The mounting system according to any one of the preceding embodiments, wherein the generic holder comprises at least one fastening element, wherein the fastening element comprises at least one screw hole and/or at least one screw and/or at least one bracket, wherein the generic holder is fastenable via the fastening element to a further device.

Embodiment 14 A kit comprising a plurality of mounting systems according to any one of the preceding embodiments, wherein the mounting systems are configured for positioning different types of samples of packaging material. Embodiment 15 The kit according to the preceding embodiment, wherein the sample specific holders are exchangeable from the generic holder.

Embodiment 16 A method for dimensional measurement of packaging material and/or medical device using a coordinate measuring machine and a mounting system according to any one of the preceding embodiments referring to a mounting system, wherein the method comprises a) Mounting the generic holder onto a measuring table of the coordinate measuring machine; b) Inserting the sample specific holder into the generic holder; c) Performing the dimensional measurement by using a measuring system of the coordinate measuring machine.

Embodiment 17: The method according to the preceding embodiment, wherein step b) comprises placing the sample into the sample specific holder.

Short description of the Figures

Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

In the Figures:

Figure 1 shows an embodiment of a mounting system according to the present invention;

Figures 2A to 2C show embodiments of a sample specific holder according to the present invention,

Figure 3 shows an embodiment of mounting a generic holder according to the present invention a measuring table; and

Figure 4 shows an embodiment of a method according to the present invention. Detailed description of the embodiments

Figure 1 shows an embodiment of a mounting system 110 according to the present invention configured for positioning at least one sample of packaging material and/or medical device. The mounting system 110 comprises a sample specific holder 112 configured for receiving and holding the sample of packaging material and/or medical device, wherein the sample specific holder 112 comprises at least one receptacle 114 adapted to size and/or shape of the sample of packaging material and/or medical device; a generic holder 116 configured for receiving and for positioning the sample specific holder 112.

The mounting system 110 is configured for performing at least one mounting function. The mounting function may comprise one or more of fixing, clamping, fastening, or attaching. The mounting system 110 may be used for quality control of packaging material and/or medical device. In particular, the mounting system 110 may be used for positioning the at least one sample of packaging material and/or medical device for and/or during measurement and/or determination of dimensions of said sample. The quality control may comprise at least one dimensional measurement. The quality control may comprise comparing the determined dimensions to at least one target value. The quality control may comprise determining if the sample fulfills at least one quality limit based on the comparison. In particular it is determined whether the sample is in specification. The quality control may be performed according to at least one standard.

The dimensional measurement may comprise determining at least one coordinate on a surface to be measured of the sample. The dimensional measurement may comprise determining a plurality of coordinates. The mounting system 110 may be part of a coordinate measuring machine having at least one measuring system configured for the dimensional measurement. In Figure 1, a measuring table 118 of the coordinate measuring machine is partially shown. For example, the coordinate measuring machine may be a bridge coordinate measuring machine. However, other types of coordinate measuring machine are possible. The mounting system 110 may be mountable onto the measuring table 118. The generic holder 116 may be fixedly mounted to the measuring table 118, wherein the sample specific holder 112 may be insertable and removable from the generic holder 116.

The coordinate measuring machine may be configured for measuring distances, specifically automatically. The coordinate measuring machine may comprise at least one measuring system configured for dimensional measurement of packaging material and/or medical device. The measuring system of the coordinate measuring machine may comprise at least one optic and/or haptic probe head. The dimensional measurement may be performed in accordance to at least one pre-defined test program. The test program may be defined by setting points in a virtual coordinate system. The coordinate measuring machine may be configured for performing automated test programs such as by going to specific coordinates and perform specific operations at this position. The coordinate measuring machine may be programmed for performing the test program such that the machine knows on which position it has to do which operations. However, for a fully automatic test program, the samples must be on the identical position each time with less than 1cm difference. This is not realistic for a human by positioning a sample on an empty measuring table 118. The proposed mounting system allows ensuring same placement every time without high time demand or qualification needed. A user or operator may put his sample into the sample specific holder 112, place it in the generic holder 116 and start the test program.

The packaging material may comprise laboratory packaging material and/or pharmaceutical packaging material and/or medical packaging material. The packaging material may comprise primary packaging material. In particular, the packaging material and/or medical device may comprise one or more of at least one vial, at least one syringe, at least one plunger, at least one stopper, at least one crimp cap. For example, the packaging material may be a vial. The dimensional measurement may comprise determining one or more of a flange depth and/or diameter, body diameter, vial heights, neck diameter, wall and/or base thickness.

The packaging material and/or medical device may be provided, such as by a manufacturer, batchwise. A batch may comprise a plurality of packaging materials and/or medical devices. The sample may be a probe of the batch. For quality control at least one sample, preferably a plurality of samples, of the batch may be selected and tested. The sample may be selected randomly form the batch or in a defined manner. For example, 32 samples per batch may be tested.

The positioning may comprise placing and/or orienting and/or mounting and/or holding at a pre-defined location, in particular on the measuring table 118.

The sample specific holder 112 may be at least one holder matched to the sample to be measured. The sample specific holder 112 may be specially designed for a type of packaging material and/or medical device. However, sample specific holders 112 may be crossused with dimensional adaption. The sample specific holder 112 may be manufactured by 3D printing. For example, the sample specific holder 112 may be flexible or rigid. The sample specific holder 112 may comprise at least one plastic such as Acrylonitrile Butadiene Styrene (ABS), Polylactic Acid (PLA), Polyvinyl Alcohol (PVA), polyethylene (PE), Polyethylene terephthalate (PET). However, other embodiments are possible such as a sample specific holder 112 comprising metal or carbon fibers. For example, the sample specific holder 112 may be manufactured using transparent printing material such as transparent printing material available under “AR-M2” from Keyence and Rapidobject®. For example, the sample specific holder 112 may be manufactured using transparent printing material such as transparent printing material available under “AR-M2” from Keyence and Rapidobject®, and opaque printing material, such as opaque printing material available under "Onyx" from Markforged®.

As outlined above, the sample specific holder 112 comprises the at least one receptacle 114 adapted to size and/or shape of the sample of packaging material and/or medical device. The receptacle 114 and the sample of packaging material and/or medical device may be designed according to the key-lock principle. The sample specific holder 112 may be designed such that there is a fix-position and the samples can be easily brought in, without need of special qualification. The sample specific holder 112 may have, in particular, a Poka Yoke design.

The receptacle 114 may comprise at least one positioning element 120 configured for positioning the sample of packaging material and/or medical device within the receptacle 114. The positioning element 120 may be configured for supporting correct placement of the sample within the sample specific holder 112. For example, the positioning element 120 may comprises one or more of at least one magnet, at least one inner structure, at least one screw, at least one clamping, at least one spring, at least one negative form of the material, at least one bolt to plug on. For example, in Figure 1, an embodiment with a sample specific holder 112 for gauge blocks is shown. This sample specific holder 112 has as positioning element 120 additional magnets to support correct placement of the gauge blocks. Figures 2A and 2B show an embodiment with a sample specific holder 112 for vials in side view and from above. The positioning element 120 may comprise a clamp. Figure 2C shows an embodiment of a sample specific holder 112 for a safety device.

The sample specific holder 112 may comprise an outer contour 122. The outer contour 122 may be designed for each type of sample of packaging material and/or medical device identical. The outer contour 122 of the specific holder 112 may be generic. This may allow putting sample specific holders 112 for different types of samples into one and the same generic holder 116.

The sample specific holder 112 may comprise at least one check-hole, not shown here. The sample specific holder 112 may be assignable to the sample of packaging material and/or medical device via the check-hole. To ensure that the right sample specific holder 112 is used for the test program, the sample specific holder 112 can comprise the at least one check-hole where the machine can check whether the correct sample specific holder 112 is used. The check hole may be a borehole through the sample specific holder 112, which a coordinate measuring machine can check for its right position to ensure right sample specific holder 112 is used.

The generic holder 116 may be a holder configured for receiving and positioning sample specific holders 112 of different sample types. The generic holder 116 may comprise at least one frame 124, in particular a metal frame. The frame 124 may be a stable metal frame. However, other materials are possible. The generic holder 116 may be configured such that the sample specific holder 112 can be placed within the frame 124. The sample specific holder 112 may be insertable and removable from the generic holder 116. The frame 124 may be adjusted to the outer contour 122 of the sample specific holder 112. The frame 124 may function as a receptacle for receiving the sample specific holder 112. For example, the frame 124 may have a rectangular outer contour. An inner contour of the frame may be adapted to the outer contour of the sample specific holder 112.

The coordinate measuring machine may comprise at least one measuring area. The measuring area may be an area of the measuring table 118. The measuring area may not correspond to a complete measuring table 118 area such that for the dimensional measurement the sample needs to be placed within the measuring area. As shown in Figure 2, the generic holder 116 may comprise at least one fastening element 126. The fastening element 126 may comprise at least one screw hole and/or at least one screw and/or at least one bracket. The generic holder 116 may be fastenable via the fastening element 126 to a further device, in particular to the measuring table 118. For example, the frame may be tightened with screws to the measuring table’s screw threads. Brackets may ensure that the mounting system cannot move while movement of the coordinate measuring machine. The frame 124 may be placed permanent on the measuring table 118, while the sample specific holders 112 can be changed easy and quick without need of high storage place. Sample specific holders 112 may be flexible changed due to concrete measuring challenge. The screws may be used for tightening the frame on the measuring table 118. The brackets may be used for fastening the sample specific holder 112. The brackets may be moveable, in particular ro- tatable and can be rotated to a side. A front part of the knee lever then presses on the sample specific holder 112 and presses the sample specific holder 112 for stabilizing during measurement movement downwards.

The generic holder 116 may be configured as limit stop for the sample specific holder 112. The frame 124 may be a closed frame. Specifically, the frame 124 may surround the sample specific holder 112 in at least one plane. The frame 124 may be open at at least one side. The generic holder 116 may be configured such that the sample specific holder 112 can be put into the generic holder 116, wherein the sample specific holder 112 may hit the frame 124 and cannot be moved any further.

The sample specific holder 112 may have a slant 128 such that the sample specific holder 112 is receivable in one direction by the generic holder 116. The sample specific holder 112 in Fig.l has two slants 128 such that it is possible to clamp it in x- and y-orientation and to control x- and y-orientation. The slant 128 may ensure correction orientation of the sample specific holder 112 within the generic holder 118. The frame 124 may be configured for ensuring the same placement of the sample specific holder 112 every time and in the right direction due to the slant 128.

The generic holder 116, in particular the frame 124, may be used to set a reference coordinate system within the coordinate measuring machine. The dimensional measurement may be performed in a probe head’s coordinate system. The reference coordinate system may be used for coordinate transformation into the intrinsic coordinate system of the coordinate measuring machine. The generic holder may allow facilitating handling. When the object to be measured is applied to the measuring table, generally, the coordinate system of the object needs to be determined. The generic holder may allow preventing the need of manual calibration since the frame may be maintained on the measuring table and the exact calibration of the object coordinate system to be measured can be automized.

The mounting system 110 may allow the usage of highly accurate test and measuring programs on a complex equipment in a routine measurement context for operators. Same placement of samples with small changing times may be possible and allow an efficient use of this technology.

The mounting system 110 may be an element of a kit comprising a plurality of mounting systems 110 according to the present invention. The mounting systems 110 are configured for positioning different types of samples of packaging material and/or medical device. In particular, the kit may comprise a frame 124 and a plurality of sample specific holders 112. The kit may comprise different types of sample specific holders 112 such as at least one sample specific holder 112 for a vial, at least one sample specific holder 112 for a syringe, at least one sample specific holder 112 for a plunger, or at least one sample specific holder 112 for a gauge block at least one sample specific holder 112 for a (rubber-)stopper, at least one sample specific holder 112 for a medical device, at least one sample specific holder 112 for a crimp cap. The sample specific holders 112 of the kit may be exchangeable from the generic holder 116.

Figure 4 shows a flow chart of a method for dimensional measurement of packaging material and/or medical device using a coordinate measuring machine and a mounting system 110 according to the present invention.

The method comprises a) (reference number 130) mounting the generic holder 116 onto a measuring table 118 of the coordinate measuring machine; b) (reference number 132) inserting the sample specific holder 112 into the generic holder 116; c) (reference number 134) performing the dimensional measurement by using a measuring system of the coordinate measuring machine.

Step b) 130 may comprise placing the sample in the sample specific holder 112.

List of reference numbers mounting system sample specific holder receptacle generic holder measuring table positioning element outer contour frame fastening element slant mounting inserting performing