MICROCAPILLARY HOLDER, TEST SYSTEM AND PROCESS

Abstract

The present invention is directed to a microcapillary holder (1) for holding a microcapillary (5) during positive control physical container closure integrity (pCCI) testing of a packaging (10). The microcapillary holder (1) comprises a body (2) with an elongated portion (2a) having a longitudinal axis (X). The body (2) has a lateral circumference, a duct (3) and a pass-through channel (4). The duct (3) of the body (2) extends along the longitudinal axis (X) through the elongated portion (2a). The duct (3) of the body (2) is dimensioned to receive the microcapillary (5). The pass-through channel (4) of the body (2) extends between the lateral circumference and the duct (3). The present invention is further directed to a respective pCCI testing system (30) and to a process of positive control of a pCCI of a packaging (10).

Claims

1. A microcapillary holder for holding a microcapillary during positive control physical container closure integrity testing of a packaging, comprising: a body with an elongated portion having a longitudinal axis, wherein the body has a lateral circumference, a duct and a pass-through channel, wherein the duct of the body extends along the longitudinal axis through the elongated portion, wherein the duct of the body is dimensioned to receive the microcapillary, and wherein the pass-through channel of the body extends between the lateral circumference and the duct.

2. The microcapillary holder of claim 1, wherein the duct of the elongated portion of the body is dimensioned to hold the microcapillary when the microcapillary is received by the duct.

3. The microcapillary holder of claim 1 or 2, wherein the pass-through channel of the body opens at the lateral circumference and at the duct.

4. The microcapillary holder of claim 1, wherein the body comprises a head portion from which the elongated portion extends.

5. The microcapillary holder of claim 4, wherein the head portion has a cavity to which the duct opens.

6. The microcapillary holder of claim 5, wherein the cavity transitions into the duct via a tapering section.

7. The microcapillary holder of claim 5, comprising a nut with a first mounting structure, wherein the head portion of the body has a second mounting structure corresponding to the first mounting structure of the nut such that the nut is mountable to the head of the body by the first mounting structure and the second mounting structure interacting.

8. The microcapillary holder of claim 7, comprising a filter unit, wherein the filter unit is arranged in the cavity of the head portion of the body such that the duct is covered.

9. A physical container closure integrity testing system to positive control physical container closure integrity of a packaging, comprising: a microcapillary; and a microcapillary holder according to claim 1.

10. The pCCI testing system of claim 9, comprising: an adapter with a first coupling structure configured to be connected to the microcapillary holder; a second coupling structure configured to be connected to a packaging member; and a through-hole connecting the first coupling structure to the second coupling structure.

11. The pCCI testing system of claim 10, wherein the adapter has a sealing arrangement configured to seal the connection between the first coupling structure and the microcapillary holder.

12. The pCCI testing system of claim 9, comprising an adhesive configured to be delivered into the pass-through channel of the body of the microcapillary holder when the microcapillary is received in the duct of the body of the microcapillary holder such that the microcapillary is fixed in the microcapillary holder.

13. The pCCI testing system of claim 9, comprising a packaging dummy having a receiving structure configured to receive the microcapillary holder.

14. A process of positive control of a physical container closure integrity of a packaging, the process, comprising: obtaining a microcapillary and a microcapillary holder according to claim 1; arranging the microcapillary into the duct of the body of the microcapillary holder; and delivering an adhesive into the pass-through channel of the body of the microcapillary holder.

15. The process of claim 14, comprising: obtaining a packaging member; and connecting the microcapillary holder to the packaging member.

16. The microcapillary holder of claim 1, wherein the pass-through channel of the body is essentially orthogonal to the longitudinal axis of the elongated portion of the body.

17. The microcapillary holder of claim 8, wherein the filter unit is locked in the cavity of the head portion of the body by the nut.

18. The pCCI testing system of claim 10, wherein the adapter has a sealing arrangement configured to seal the connection between the second coupling structure and the packaging member.

19. The pCCI testing system of claim 10, wherein the adapter has a sealing arrangement configured to seal the connection between the first coupling structure and the microcapillary holder and the connection between the second coupling structure and the packaging member.

20. The pCCI testing system of claim 13, wherein the receiving structure of the packaging dummy has a gasket to seal a connection between the packaging dummy and the microcapillary holder.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The microcapillary holder 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:

[0050] FIG. 1a shows a cross-sectional view of a microcapillary holder according to the present invention;

[0051] FIG. 1b shows a front view of the microcapillary holder of FIG. 1a;

[0052] FIG. 2 shows an inventive microcapillary holder receiving a microcapillary and with a nut put on a head portion of the microcapillary holder;

[0053] FIG. 3a shows a side view of a negative control plug;

[0054] FIG. 3b shows a front view of the negative control plug according to FIG. 3b;

[0055] FIG. 4 shows a cross-sectional view of an adapter connecting a microcapillary holder according to the present invention with a positive dummy syringe;

[0056] FIG. 5a shows a cross-sectional view of an alternative adapter according to the present invention;

[0057] FIG. 5b shows a front view of the alternative adapter according to FIG. 5a;

[0058] FIG. 5c shows a side view of the alternative adapter according to FIG. 5a;

[0059] FIG. 6a cross-sectional view of a positive control dummy in form of a vial,

[0060] FIG. 6b a front view of the vial dummy according to FIG. 6a;

[0061] FIG. 6c a side view of the vial according to FIG. 6a;

[0062] FIG. 6d shows a cross-sectional view of the alternative adapter according to FIG. 5a connecting a microcapillary holder according to the present invention with a positive dummy syringe;

[0063] FIG. 7a shows a cross-sectional view of a positive control dummy in the form of a syringe; and

[0064] FIG. 7b shows a rear view of the syringe dummy according to FIG. 7a.

DESCRIPTION OF EMBODIMENTS

[0065] 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, if a 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.

[0066] 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.

[0067] FIG. 1a shows a microcapillary holder 1 in accordance with the present invention. The microcapillary holder 1 comprises a body 2 with an elongated portion 2a and a head portion 2b. The elongated portion 2a has a diameter D.sub.3 which is usually smaller than the diameter of the head portion 2b. The head portion 2b comprises a cavity 6 with a protrusion 6c and a tapering section 6a which joins into a straight duct 3. The duct 3 has a length L.sub.1 and extends through the elongated portion 2a along a longitudinal axis X of the microcapillary holder 1. The duct 3 has a diameter D.sub.1 which is smaller than the diameter D.sub.3 of the elongated portion 2a and smaller than the diameter of the cavity 6. At the free end of the elongated portion 2a there is provided a taper 8. Further, in the head portion 2b there is arranged a pass-through channel 4 which is arranged perpendicularly to the longitudinal axis X and which joins into the duct 3. The pass-through channel 4 has a diameter D.sub.2 which may be approximately of the same size as the diameter D.sub.3 of the duct 3. However, it may also be somewhat smaller or somewhat larger. Through the pass-through channel 4 an adhesive may be applied in order to fix and/or seal a microcapillary which is received within the duct 3. At the head region 2b of the microcapillary holder 1 there is also arranged a second mounting structure 17 including a thread 17a for receiving a nut 15 (see FIG. 2). The head portion 2b also includes an edge portion 6b which encloses the cavity 6.

[0068] FIG. 1b depicts a front view of the elongated portion 2a of the microcapillary holder 1. From outside to inside one can see the second mounting structure 17 respectively the thread 17a, a front face 14 of the elongated portion 2a and the duct 3.

[0069] In FIG. 2 the microcapillary holder 1 is shown with the screwed-on nut 15. Thereby, a first mounting structure respectively a thread 16 of the nut 15 interacts with the second mounting structure 17 of the head portion 2b of the microcapillary holder 1. The nut 15 comprises an outlet opening 15a for gas outlet which is centrally arranged in a top or end side of the nut 15. Within the duct 3 of the microcapillary holder 1 there is arranged a microcapillary 5. The microcapillary 5 is partially surrounded by adhesive 12 provided through the pass-through channel 4 such that the microcapillary 5 has a firm seat and is sealed to the duct 3. The right end of the microcapillary 5 slightly extends into the tapering section 6a of the cavity 6. Here, the duct 3 of the microcapillary holder 1 is about twice as long as the microcapillary 5 received within the duct 3. In any case, the microcapillary 5 shall not protrude through the opening 3a of the elongated portion 2a at its free end. Within the cavity 6 of the head portion 2a of the microcapillary holder 1 there is arranged a filter unit 7, preferably in the form of a sinter metal filter, which is clamped by two O-rings 9a and 9b as first and second gaskets in order to achieve a press-fit connection. The filter unit 7 shall provide for a sterile atmosphere. Yet, instead of a filter unit 7 there may also be provided some other material within the cavity 6, e.g., for measuring the gas permeability of said material. For such permeability measurements, the dimensions of the microcapillary holder 1 and of the nut 15 may be different from the dimensions used when carrying out CCI tests. In particular, the duct 3 may be somewhat bigger or smaller. Also, in such a case, no pass-through channel 4 would be required.

[0070] FIG. 3a illustrates a negative control plug 20, i.e., not having a duct. The negative control plug 20 comprises a head 21 and a shaft 22 with a tapered end 22a. FIG. 3b depicts a top view on the head 21 of the negative plug 20 which comprises a trapezoidal shape.

[0071] In FIG. 4 there is shown a pCCI testing system 30 to positive control physical container closure integrity (pCCI) of a packaging 10, here in the form of a positive control syringe dummy. The testing system 30 comprises a microcapillary holder 1 with a nut 15 and a microcapillary 5 received within the microcapillary holder 1, an adapter 11 and the positive syringe dummy 10. The adapter 11 comprises a first coupling structure 11a for coupling the microcapillary holder 1 and a second coupling structure 11b for coupling the positive control syringe dummy 10. Seal coupling of the microcapillary holder 1 is achieved by means of two O-rings 9c, 9d as third and fourth gaskets and seal coupling of the syringe dummy 10 likewise is achieved by two O-rings 9e, 9f as fifth and sixth gaskets. The adapter 11 also comprises a central through hole 11c for connecting the ducts of the microcapillary holder 1 and of the positive control syringe dummy 10 such that gas may flow from the positive control syringe dummy 10 to and through the microcapillary holder 1, the filter unit 7 and the outlet opening 15a.

[0072] An identical adapter 111 is illustrated in FIG. 5a. It comprises a cylindrical outer wall 113. On each side of the adapter 111 there is provided an opening 115 for receiving a positive control dummy and the microcapillary holder 1. There is also provided a through hole 111c connecting the two openings 115. Within each of the openings 115 there are provided two recesses 112 for receiving the O-rings 9c, 9d, 9e, 9f as sealing means. Hereby, the first and second coupling structures 111a and 111b are formed in a tight and firm manner. The adapter 111 provides for an optimal clamping and sealing function. In addition to tightness, the adapter 111 prevents slipping of the dummy 10 and/or the microcapillary holder 1 by friction.

[0073] FIG. 5b shows a front view of the adapter 111. From outside to inside one can see the edge 114, a protrusion 116, a protrusion 117 and the through hole 111c. FIG. 5c shows the adapter 111 with the cylindrical outer wall in a side view.

[0074] A positive control vial dummy 40 is depicted in FIG. 6a. The vial dummy 40 comprises at its bottom section an opening 44 surrounded by an edge 45, which opening 44 is formed as coupling structure in correspondence to the openings 115 of the adapter 111 shown in FIG. 5a. In other words, the opening 44 comprises two recesses 42 for receiving sealing means or gaskets in the form of O-rings. In this manner, an optimal clamping and sealing function may be provided. The vial dummy 40 further comprises a through opening or channel 43 and a top or end opening 49. A neck portion 47 connects a head 41 with a body 48 of the vial dummy 40. FIG. 6b shows a rear view of the vial dummy 40. From outside to inside one can see the bottom edge 45, a protrusion 46 and the through opening 43. FIG. 6c shows the vial dummy 40 in a side view, with the bottom side, the cylindrical body portion 48 and the neck portion 47 connecting the body portion 48 and the head 41.

[0075] In FIG. 6d, the positive control vial dummy 40 is shown coupled to the microcapillary holder 1. More specifically, the elongated portion 2a of the microcapillary holder 1 extends into the opening 44 and is clamped or held by the two O-rings 9g, 9h arranged in the two recesses 42. Like this, the microcapillary holder 1 is firmly held or coupled in the positive control vial dummy 40 by friction and the outer circumference of the elongated body 2b is tightly connected to the interior wall of the channel 43.

[0076] A positive control syringe dummy 50 is depicted in FIG. 7a. The syringe dummy 50 comprises a cylindrical body 51 from which a neck portion 53 with a smaller diameter protrudes and which comprises at its rear end, i.e. the end opposite from the neck portion 53, a holding edge 58. The cylindrical body 51 of the syringe dummy 50 encloses a chamber 52. The chamber 52 is followed by the smaller diameter through opening of the neck portion 53. FIG. 7b shows a front view of the syringe dummy 50. From outside to inside one can see the through opening of the head 54, the front face 55 of the neck portion 53, the protrusion 56, the chamfer 57 and the holding edge 58.

[0077] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limitingthe 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.

[0078] 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 and single 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.

[0079] 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.

[0080] Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. Any reference signs in the claims should not be construed as limiting the scope.

LIST OF REFERENCE SIGNS

[0081]

TABLE-US-00001 1 microcapillary holder 21 head 2 body 22 shaft 2a elongated portion 22a tapered end 2b head portion 30 pCCI system 3 duct 40 positive control dummy vial 3a opening 41 head 4 pass-through channel 42 recesses (for sealing members) 5 microcapillary 43 through opening 6 cavity 44 opening (bottom) 6a tapering section 45 edge (bottom) 6b edge portion 47 neck 6c protrusion 48 body portion 7 filter unit 49 top opening 8 taper 50 positive control dummy syringe 9a first gasket 51 body 9b second gasket 52 chamber 9c third gasket 53 neck 9d fourth gasket 54 through opening (neck) 9e fifth gasket 55 front face 9f sixth gasket 56 edge (body) 9g seventh gasket 57 chamfer 9h eighth gasket 58 holding edge 10 packaging (syringe) 111 adapter 11 adapter 111a first coupling structure 11a first coupling structure 111b second coupling structure 11b second coupling structure 111c through hole 11c through hole 112 recesses (for sealing members) 11d indentation 113 cylindrical outer surface 12 adhesive 114 edge 13 seat 115 opening 14 front face 116 protrusion 15 nut 117 protrusion 15a outlet opening D.sub.1 inner diameter duct 16 first mounting structure D.sub.2 inner diameter pass through nut channel 17 protrusion D.sub.3 outer diameter elongated portion 17a second mounting L.sub.1 length duct structure X longitudinal axis 18 packaging dummy 18a receiving structure 20 negative plug 46 protrusion