Tamper evident labels

Abstract

The present disclosure relates to a packaged needle assembly product (100) including a hard shell packaging product including a case (2) and a cap (3) arranged in an assembled configuration forming a housing for a needle assembly, and an adhesive label (13) affixed to an exterior surface of the housing, the label extending across at least a portion of a circumferential gap (g) between the cap and the case, thereby sealing the hard shell packaging product (1). The label includes a perforation portion including a plurality of perforation lines 51 that traverse the gap at a predetermined angle from a first end terminating at or beyond an edge of the cap, across the gap to a second end terminating at or beyond an edge of the case.

Description

[Technical field]

[0001] The present invention relates generally to medical devices, and more specifically to a tamper evident label for a hard case packaging product for the sterile packaging of a needle assembly for use in a medical injection device. Safety needle assemblies are widely known and used. Typically, a safety needle assembly includes a hub having a proximal end for connecting to a syringe. Prior to use, the assembly is stored in a package under sterile conditions. [Background technology]

[0002] Blister packaging solutions are well known. In use, a user, e.g., a medical professional, partially opens the blister to release the hub, and then retains the assembly in the packaging to connect the hub to a syringe to avoid possible contamination of the needle assembly or breach of sterility. The user then further removes the packaging to release the safety needle assembly. This process is fairly complicated and subject to user error.

[0003] As an alternative packaging solution that is generally more compatible with high speed automated packaging processes than blister packaging, hard case packaging products, including caps and cases, can be used.

[0004] However, this relatively rigid housing can be more problematic in providing a reliable indicator to assure the end user that the package has not been tampered with or opened prior to end use. For example, in the absence of specific countermeasures, an opened package can be attempted to be reclosed by replacing the cap onto the case.

[0005] Therefore, there remains a need to provide a tamper-evident packaging solution that assures the end user of the sterility of the product. In particular, there remains a need for a solution that irreversibly provides a highly visible indication of an opening event while maintaining compatibility with automated mechanical packaging processes. Patent Document 1 shows a container that is separated into a body and a cap, and a label is attached to the boundary where the body and the cap connect. The label has a lower seal that covers the boundary and an upper seal that can be peeled off.

[0006] US Patent No. 5,399,663 describes an intradermal needle including a needle cannula assembly with a limiter portion and a protective cap having front and rear caps for protecting the needle cannula before and after use. US Patent No. 5,399,663 shows a method and system for an injection system including a pharmaceutical container sealed with a plunger having a pressing surface and a plunger rod with a cover extending from a proximal end of the container. US Patent No. 5,399,663 discloses a polymer film with specially structured and positioned perforations that allow controlled break propagation along a desired break path. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] JP 2013-189241 A [Patent Document 2] European Patent Application Publication No. 1631388 [Patent Document 3] U.S. Patent Application Publication No. 2016030677 [Patent Document 4] U.S. Patent Application Publication No. 20040175527 [Patent Document 5] PCT / EP2021 / 063205 Summary of the Invention [Problem to be solved by the invention]

[0008] The present disclosure aims to alleviate one or more of the above disadvantages. [Means for solving the problem]

[0009] Aspects of the present disclosure relate to a packaged needle assembly product. In particular, the packaged needle assembly product includes a hard shell packaging product including a case and a cap that are arranged relative to one another in an assembled configuration to form a housing for the needle assembly. To seal and close the housing, the packaged needle assembly product further includes an adhesive label. The adhesive label is affixed to an exterior surface of the housing, the label extending across at least a portion of the gap between the cap and the case, typically circumferentially between an edge of the cap and an edge of the case.

[0010] The label includes a perforation portion including a plurality of perforation lines disposed at an angle relative to the gap, the perforations extending across the gap from a first boundary of the gap, e.g., a first end terminating at or beyond an edge of the cap, across the gap to a second boundary of the gap, e.g., a second end terminating at or beyond an edge of the case.

[0011] As described in more detail herein below, the label provides a tamper evident feature that assures the end user of the quality of the packaged product. It has been found that the multiple perforation lines provide an effective visual indication that the package has previously been opened or an attempt has been made to reclose it, through the presence of tear marks, e.g., creases.

[0012] The perforation line is preferably disposed at an angle θ of 20° to 40° relative to the circumferential gap, more preferably between 25° and 35°, most preferably about 30°, e.g., 28° to 32°. It has been found that angles of 20° to 40° constitute a good range for opening, tear propagation, and thus formation of highly visible creases. Thus, the inclination of the perforation line (180°-θ), defined by a positive angle less than 180° measured counterclockwise from the gap to the perforation line, is preferably 140° to 160°, more preferably between 145° and 155°, most preferably about 150°, e.g., 148° to 152°. As will be described in more detail herein below, the applicant has discovered that the specified perforations are optimal in terms of optimizing the visibility of the tear mark, the stability of the label before and during assembly into the packaging product, as well as in terms of providing an optimized user experience in terms of the range of forces required to access the packaged product.

[0013] The label and perforation portion is preferably at least 50%, preferably at least 80%, of the circumference of the housing at the gap. The larger the label, the more securely the cap will be secured to the case and the more potential space available on the label for product information and / or user instructions. The label may be made longer than the circumference of the housing so that it wraps around itself.

[0014] The perforation lines are preferably spaced from adjacent ones by a distance of 1 mm or less, preferably in the range of 0.7 mm to 0.9 mm. It has been found that larger spacings require greater tear forces and result in less predictable quality of tear patterns. It has been found that smaller spacings increase the overall weakness of the label as a whole before and during (mechanical) application to the cap and case.

[0015] The length of the perforations and therefore the width of the perforated portions in a direction perpendicular to the parting lines between the cap and the case are preferably such that these lines cover manufacturing tolerances.

[0016] Preferably, the perforations extend beyond the gap a distance of at least 0.1 mm on both ends. Most preferably, the perforations extend beyond the gap at least 0.5 mm on at least one end. The longer the overlap, the more visible the tear. To reduce weakening of the label, the perforated portion preferably does not extend beyond 50% of the overall height of the label. Machine processing of labels with unperforated borders (top, bottom and sides) of approximately 1 mm has been confirmed.

[0017] Preferably, all of the perforation lines are arranged in a row and essentially parallel. Other arrangements including more than one row of perforations, arrangements with intersecting perforations, and / or arrangements with perforations extending at different inclinations are less preferred. Additional perforations and / or other configurations have been found to reduce the visibility of the tear pattern and / or reduce the structural integrity of the label, increasing the likelihood of premature tearing or rupture, in response to application of forces perpendicular to the label, for example during roll-on application.

[0018] In a preferred embodiment, the case and cap are configured for sliding engagement into an assembled configuration, the case and cap including circumferentially overlapping sidewall portions. Advantageously, the hard shell packaging product can include one or more radial channels extending from a gap along a longitudinal direction between the overlapping sidewall portions to provide a gas passageway P into the interior of the enclosure.

[0019] The channel may be at least partially defined by one or more protrusions extending outward from at least one of an inner surface of the circumferentially overlapping wall portion of the cap toward the corresponding overlapping wall portion of the case and an outer surface of the circumferentially overlapping wall portion of the case toward the corresponding overlapping wall portion of the cap.

[0020] Further or additional embodiments relate to an adhesive label for sealing a hard shell packaging product, and to a roll including a backing that supports a plurality of adhesive labels. In particular, further or additional embodiments relate to an adhesive label for sealing a hard shell packaging product, such as disclosed herein, including a case and a cap configured to form a housing for a needle assembly in an assembled configuration, the label configured to adhere to an exterior surface of the housing and dimensioned to extend across at least a portion of a circumferential gap between an edge of the cap and an edge of the case, thereby securing the case to the cap, the label including a perforation portion including a plurality of perforation lines that are angled across the gap when adhered, from a first end that terminates at or beyond the edge of the cap, across the gap, to a second end that terminates at or beyond the edge of the case.

[0021] These and other features, aspects, and advantages of the presently disclosed apparatus, systems, and methods will become better understood from the following description, appended claims, and accompanying drawings. [Brief description of the drawings]

[0022] [Figure 1A] FIG. 1 illustrates a packaged needle assembly. [Figure 1B] FIG. 1 illustrates a hard shell packaging product in an open position. [Figure 1C] FIG. 14 provides a perspective view of the case and needle assembly. [Figure 2A] FIG. [Figure 2B] FIG. 1 illustrates a packaged needle assembly. [Figure 2C] FIG. [Figure 3A] FIG. 1 illustrates an opened packaged needle assembly product. [Figure 3B] FIG. 1 shows a comparative packaged needle assembly product in a closed state (left) and after opening (right). [Figure 3C] FIG. 2 illustrates a partial cross-sectional side view of a hard shell packaging product. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] The terms used to describe certain embodiments are not intended to limit the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural, unless the context clearly indicates otherwise. The term "and / or" includes any and all combinations of one or more of the associated listed items. It will be understood that terms such as "comprises" and / or "comprising" specify the presence of a stated feature, but do not preclude the presence or addition of one or more other features. When a particular step of a method is referred to as following another step, it will be further understood that this may directly follow said other step, unless otherwise specified, or that one or more intermediate steps may be performed before performing that particular step. Similarly, when a connection between structures or components is described, it will be understood that this connection may be established directly or through an intermediate structure or component, unless otherwise specified.

[0024] The term needle assembly as used herein may be understood to refer to a needle assembly including a hub having a proximal end for connecting with a syringe, the syringe extending at a proximal region of the hub, and a needle extending longitudinally from the distal end of the hub at a distal region of the hub.

[0025] The needle assembly usually includes at least a cannula (also called a needle) extending from the needle hub for receiving a corresponding portion of a syringe. Preferably, the needle assembly is a safety needle assembly including a protector, usually embodied as a longitudinally extending sleeve that can be engaged over the needle and removably connected at one end to the hub, and a sheath pivotally connected to the hub. The sheath usually has two side walls connected by a back wall that defines a receiving space therebetween for receiving the needle. The sheath is pivotable between a start position in which the sheath is free from the needle, a use position in which the sheath is pivoted away from the needle and the needle is exposed, and a locked position in which the sheath is locked and secures the needle in the receiving space. In the locked position, the sheath protects the needle against unintentional contact, contamination, needlestick injury, etc. after its use. In the locked position, the needle is received in the receiving space of the sheath and surrounded by the sheath, thus covering the needle.

[0026] Although not exclusively, this packaging product is particularly useful for safety needle assemblies such as the safety needle assembly described in full detail in US Pat. No. 6,399,323, which is incorporated herein by reference.

[0027] The safety needle assembly preferably includes a hub having a proximal end for connection with a syringe, the syringe extending at a proximal region of the hub; a needle extending longitudinally from the distal end of the hub at a distal region of the hub; and a sheath pivotally connected to the hub, the sheath having two side walls connected by a back wall defining a receiving space therebetween for receiving the needle, the sheath having a start position in which the sheath is substantially disposed at the distal region of the hub, a use position in which the sheath is substantially disposed at the proximal region of the hub, and a use position in which the sheath ( and a locked position in which the needle (protector) is locked to secure the needle in the receiving space, wherein in the start position the sheath extends longitudinally from the hub, the hub is provided with at least one first cooperating element and the sheath is provided with at least one second cooperating element, wherein in the locked position of the sheath the first cooperating element and the second cooperating element engage each other to lock the sheath, and wherein in the start position the first cooperating element and the second cooperating element contact each other to define the start position of the sheath.

[0028] By providing a sheath extending longitudinally from the hub in the starting position, the footprint of the safety needle assembly in the starting position, and therefore for packaging purposes, is much smaller, allowing for different types of packaging and / or more efficient packaging and / or transport and / or storage. For example, such a reduced footprint allows for hard case packaging, allowing for automated processing of the packaged safety needle assembly. On the other hand, automated processing of blister packaged assemblies is practically not possible, so the blister packaged assemblies have to be manually collected in boxes for transport and storage, which limits the speed of the assembly line. By providing a sheath extending longitudinally from the hub in the starting position, a more compact arrangement of the safety needle assembly is obtained, allowing for hard case packaging. Such hard case packaging can be automated, allowing for increased assembly line speeds, allowing for more efficient manufacturing, packaging, transport and / or storage of the safety needle assembly. Also, by using a hard cap, the method of operation for preparing the needle assembly for use remains unchanged. This is advantageous for the user, as they can follow the procedures they are familiar with. Upon removal of the cap of the hard case, the hub of the needle assembly is exposed and can be connected to a syringe without compromising sterility and avoiding the possibility of contamination. Once connected to a syringe, the hard case can be removed from the needle assembly and the sheath can be pivoted to a use position to prepare the needle with the syringe for use.

[0029] The hard case preferably comprises or consists essentially of a medical grade composition, preferably an injection moldable plastic composition, such as polypropylene.

[0030] The labels described herein typically include a substrate and an adhesive known in the art. The adhesive is typically a pressure sensitive adhesive composition. Other adhesives, such as temperature sensitive or radiation curable adhesives, can also be used. The pressure sensitive adhesive advantageously allows for mechanical application, positioning and application of adhesive pressure (e.g., by a roller).

[0031] The present invention will be described more fully hereinafter with reference to the accompanying drawings, which show embodiments of the invention. In the drawings, absolute and relative sizes of systems, components, layers, and regions may be exaggerated for clarity. The embodiments may be described with reference to schematic and / or cross-sectional illustrations of possibly ideal embodiments and intermediate structures of the invention. In the description and drawings, like numbers refer to like elements throughout. Relative terms and derivatives thereof should be construed to refer to the orientation shown in the drawings being described or discussed at the time. These relative terms are for convenience of description and do not require that the system be constructed or operated in a particular orientation, unless otherwise specified.

[0032] 1A illustrates an exemplary embodiment of a packaged needle assembly product 100. The packaged needle assembly product includes a hard shell packaging product that forms a housing for a needle assembly. The hard shell packaging product 1 includes a case 2 and a cap 3 arranged in an assembled configuration that form a housing for the needle assembly. A parting line or gap "g" is formed between the cap and the case.

[0033] The packaged needle assembly product includes an adhesive label 13 (see, e.g., FIG. 2B) affixed along the exterior surface of the housing, the label extending across at least a portion of the circumferential gap g between edge 3e of the cap and edge 2e of the case, thereby securing the cap to the case and providing a seal onto the hard shell packaging product 1. Details regarding the label are described with reference to FIGS. 2A, 2B, and 2C.

[0034] In one preferred embodiment, the case 2 and cap 3 are configured to slidingly engage into an assembled configuration, as shown, for example, in Figures 1B, 1C and 3C. The case and cap include circumferentially overlapping sidewall portions 20, 30.

[0035] Advantageously, the hard shell packaging product 1 may include one or more radial channels 5 extending longitudinally between overlapping sidewall portions to provide a gas passageway P to the interior of the enclosure.

[0036] Providing a gas passageway into the sealed space advantageously allows for sterilization of the packaged product, e.g., the needle assembly. The packaged product advantageously allows gas access to the needle assembly for sterilization with a gas agent while sealed by the cap and case, as described in more detail herein below. Preferably, the channel forms the only passageway between the interior space and the surroundings. By having the channel extend over a distance between the inner surface of the cap and the outer surface of the case (or vice versa), e.g., a pre-designed engagement distance, recontamination of the needle assembly with airborne infectious agents is mitigated.

[0037] In some embodiments, for example as shown, the channel 5 is at least partially defined by one or more protrusions 7 (e.g., ribs) extending outwardly from at least one of the inner surface of the circumferentially overlapping wall portion of the cap toward the corresponding overlapping wall portion of the case, and the outer surface of the circumferentially overlapping wall portion of the case toward the corresponding overlapping wall portion of the cap.

[0038] These spacers can advantageously define the cross-sectional dimensions of the channel, as can be seen in more detail in FIG. 1B. It can be seen that the channel length is mainly defined by the overlap distance between the cap and the case. The overlap length L1 is usually 2 mm or more. The longer the overlap, the more complex the ingress path for contaminants to enter. In principle the overlap can be larger. The longer the overlap, the more stable the cap can be placed on the case. For example, the overlap L1 can be up to about 20 mm, for example in the range of 2 mm to 20 mm, or in the range of 3 mm to 10 mm. It is believed that the prevention of recontamination concerns the channel providing stagnant air. It has been found that an overlap of 2 mm prevents recontamination. In practice the overlap length L1 is between 5 mm and 10 mm, for example about 8 mm. It has been found that a range between 5 mm and 10 mm is an optimum between compactness and stability of the cap on the case. The width of the channel (distance between the opposing sides) is preferably as thin as possible while still allowing the passage of gas. Typically, the distance "d" between the opposing sides is less than 1 mm. In principle the spacing can be larger, for example up to 2 mm or even 3 mm or more. The narrower the channel, the more compact the packaged product can be. Preferably, the spacing "d" is less than or equal to 0.5. More preferably, d≦0.3 mm, for example about 0.2 mm. The wider the channel, the greater the access for possible recontamination and the less compact the packaged product. A spacing of about 0.05 mm has been found to be sufficient.

[0039] In a preferred embodiment, for example as shown, the projections form exclusive contact between opposing sidewall surfaces of the case and the cap, thereby limiting the area of ​​surface contact between the cap and the case to a substantially point or line contact defined by the projections.

[0040] In some embodiments, one or more additional spacers 7a are provided between opposing surfaces of the cap 3f and the case 2f, e.g., as shown in Figures 1C and 3C, to ensure axial clearance between the cap and the case in a closed condition, e.g., as shown in Figures 1A and 3C.

[0041] To prevent internal rotation of needle assembly 100 within case 2, one or more inwardly extending ribs 71 or slots may be provided that engage needle assembly 100 (e.g., with hub 102 as shown) (see, e.g., Figures 1C and 3C).

[0042] The case and / or cap parts may include a flat portion (e.g., as shown) that prevents rolling movement of the product, for example along a table top.

[0043] To facilitate removal of the cap, the cap and / or case may be provided with one or more exterior features for manual gripping, such as rib 9 shown in FIG. 1B.

[0044] The cases and caps disclosed herein may be particularly useful for packaging products in a sterile package that is ready for direct use by an end user, advantageously allowing the product to be sterilized in the package while providing effective tamper-evident functionality through one or more elements that provide a visual indication of an opening event.

[0045] 2A shows a portion of a backing 201 that includes multiple labels 13, 13-n. The labels include perforated portions 50 to facilitate opening and the formation of a highly visible tear mark 13r. The perforated portions are dimensioned to overlap the location of the parting line or gap g between the cap and the case. The width of the perforated portions 50 is dimensioned to cover the overlap with the manufacturing tolerance Tg that includes the parting line.

[0046] 2B provides a partial view of a packaged needle assembly product 100 further including a label as disclosed herein, for example the same product as shown in FIG 1A. As shown the perforations overlap the parting line or gap g within manufacturing tolerances.

[0047] The label is secured to the case spanning a circumferential gap (g) (indicated by a line) between the cap and the case. The label secures the cap to the case. To gain access to the packaged product, the user removes the cap from the case (e.g., by pulling and / or twisting), which causes irreversible damage (tear) to the label.

[0048] 2C, perforated portion 50 includes a plurality of perforation lines 51. These lines traverse the gap at an angle (θ) from a first end 51-1 that terminates at or beyond the edge of the cap to a second end 51-2 that spans the gap and terminates at or beyond the edge of the case.

[0049] The perforation lines are disposed at an angle (θ) relative to the circumferential gap (g) ranging from 20 degrees to 40 degrees. In one preferred embodiment, for example as shown, the angle θ is approximately 30°.

[0050] The length L13 of the label is typically in the range of 80% to 120% of the circumference of the hard shell packaging product at the parting line.

[0051] The perforations 51 are spaced apart from adjacent ones by a distance of 1 mm or less, preferably in the range of 0.7 mm to 0.9 mm. The perforations may be suitably made as known in the art, for example with a rotating drum equipped with a blade.

[0052] The perforations preferably extend across the gap a distance s50 of at least 0.1 mm on each end. Portions 53, 54 above and below the perforated portion of the label may contain one or more data display areas for product information and / or user instructions.

[0053] The length L13 and height h13 of the label, the width L2 of the perforation portion, and the length L51 of each individual perforation depend on the dimensions of the cap, the case, the width of the gap g, and the manufacturing tolerances Tg. In some embodiments, for example as shown, the length L51 can be, for example, 3 mm to 5 mm. The width L2 of the perforation portion can be, for example, 1 mm to 3 mm.

[0054] User testing studies have shown that placing the perforations at an angle between 20 degrees and 40 degrees, preferably in the range of 25°-35°, and most preferably at about 30°, consistently produces a highly visible tear mark regardless of left- or right-handed user operation, and regardless of whether the user moves only the cap, only the case, or both. The preferred right-handed orientation of the perforation line 51 relative to the parting line is consistent with user expectations of applying an opening force along a counterclockwise direction.

[0055] User studies further confirmed that the labels disclosed herein advantageously allow control over the force or torque experienced by the user to open the product.

[0056] FIG 3A shows an exemplary embodiment of a hard shell packaging product sealed with a label disclosed herein after opening of the housing, removal of the packaged needle assembly, and replacement of the cap. FIG 3B shows a comparative example of the same hard shell packaging product before (left) and after (right) opening and reclosure, whereby the label was provided with a perforation line 51' running parallel to the parting line between the cap and the case. As can be seen, opening of the product sealed with a label disclosed herein is clearly visible by the presence of multiple tear marks 13t (wavy edges), whereas the comparative example has no clear tear marks, resulting in a clean tear that allows the package to be visually reclosed after the initial opening.

[0057] It will be understood that, although features are described herein as part of the same or separate embodiments for purposes of clarity and concise description, the scope of the invention can include embodiments having all or some combination of the described features. Of course, it should be understood that any one of the above embodiments can even be combined with one or more other embodiments to further improve the discovery and coordination of designs and advantages.

[0058] In interpreting the appended claims, it should be understood that the word "comprises" does not exclude the presence of elements or acts other than those recited in a given claim, that the word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements, that any reference sign in a claim does not limit its scope, that several "means" can be represented by the same or different items or implemented structures or functions, and that any of the disclosed devices or parts thereof can be combined together or separated into further parts, unless specifically stated otherwise. When one claim refers to another claim, this can indicate synergistic effects achieved by the combination of their respective features. However, the mere fact that some measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to advantage. The present embodiment can thus include all practical combinations of the claims, and each claim can in principle refer to any preceding claim, unless clearly excluded by the context. [Explanation of symbols]

[0059] 100 Packaged Needle Assembly Products 1. Hard Shell Packaging Products 2 Cases 2e Edge 3 Cap 3e Edge 5 Radial Channels 7 protrusions 7a Spacer 9. Ribs 13. Label 13t Torn mark 20, 30 side wall part 71 Ribs 102 Hub 200 rolls 201 Backing 50 Perforated section 51 Perforation 51-1 First end 51-2 Second end 51' Perforation 53 Upper part of the label perforation 54 Lower part of the label perforation

Claims

1. A packaged needle assembly product (100), comprising: a hard shell packaging product (1) including a case (2) and a cap (3) arranged in an assembled configuration forming a housing for said needle assembly; an adhesive label (13) affixed to an exterior surface of the housing, the adhesive label (13) extending across at least a portion of a circumferential gap (g) between the edge of the cap (3e) and the edge of the case (2e), thereby sealing the hard shell packaging product (1); Including, the adhesive label includes a perforated portion (50) including a plurality of perforation lines (51) that cross the circumferential gap at a predetermined angle (θ) from a first end (51-1) that terminates at or beyond the edge of the cap to a second end (51-2) that spans the circumferential gap and terminates at or beyond the edge of the case; A packaged needle assembly product (100).

2. 2. The packaged needle assembly product of claim 1, wherein said perforation line is disposed at an angle (θ) in the range of 20 degrees to 40 degrees relative to said circumferential gap (g).

3. 3. The packaged needle assembly product of claim 2, wherein said angle (θ) is between 25 and 35 degrees, preferably about 30 degrees.

4. 4. The packaged needle assembly product of claim 1, wherein said adhesive label (13) and said perforated portion (50) together extend over at least 80% of the circumference of said housing at said circumferential gap.

5. 5. A packaged needle assembly product according to any one of claims 1 to 4, wherein said perforation lines are spaced apart from adjacent ones by a distance of 1 mm or less, preferably in the range of 0.7 mm to 0.9 mm.

6. 6. The packaged needle assembly product of claim 1, wherein said perforations extend beyond said circumferential gap by at least 0.1 mm on each end.

7. 7. The packaged needle assembly product of claim 6, wherein said perforations extend beyond said circumferential gap by at least 0.5 mm on at least one end.

8. 8. The packaged needle assembly product of claim 1, wherein the adhesive label includes a data display area adjacent the perforated portion.

9. 9. The packaged needle assembly product of claim 1, wherein all of the perforation lines (51) are arranged in a row and parallel to one another.

10. 10. The packaged needle assembly product of any one of claims 1 to 9, wherein the case (2) and the cap (3) are configured for sliding engagement into the assembled configuration, the case and the cap including circumferentially overlapping sidewall portions (20, 30).

11. 11. The packaged needle assembly product of claim 10, wherein said hard shell packaging product (1) includes one or more radial channels (5) extending longitudinally between said overlapping sidewall portions to provide a gas passageway (P) into the interior of said housing.

12. 12. The packaged needle assembly product of claim 11, wherein the radial channel (5) is at least partially defined by one or more protrusions (7) extending outwardly from at least one of an inner surface of the circumferentially overlapping wall portion of the cap toward a corresponding overlapping wall portion of the case and an outer surface of the circumferentially overlapping wall portion of the case toward a corresponding overlapping wall portion of the cap.

13. A hard-shell packaging product (1) comprising, in an assembled configuration, a case (2) and a cap (3) configured to form a housing for a needle assembly, preferably an adhesive label (13) for sealing the hard-shell packaging according to any one of claims 1 to 12, the adhesive label is configured to adhere to an exterior surface of the housing and is dimensioned to extend across at least a portion of a circumferential gap (g) between an edge of the cap and an edge of the case, thereby securing the case to the cap; said adhesive label, when adhered, comprises a perforated portion (50) including a plurality of perforation lines (51) arranged to cross said circumferential gap at a predetermined angle (θ) from a first end (51-1) terminating at or beyond said edge (3e) of said cap to a second end (51-2) spanning said circumferential gap to a second end (51-2) terminating at or beyond said edge (2e) of said case; Adhesive label (13).

14. A roll (200) comprising a backing (201) supporting a plurality of adhesive labels (13) according to claim 13 or adhesive labels (13) according to any one of claims 1 to 12.

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