WO2015089569A1

WO2015089569A1 - An assured integrity container

Info

Publication number: WO2015089569A1
Application number: PCT/AU2014/001153
Authority: WO
Inventors: Roderick Alexander DRAPER
Original assignee: Amtac Professional Services Pty Ltd
Priority date: 2013-12-21
Filing date: 2014-12-19
Publication date: 2015-06-25
Also published as: AU2014366899A1; AU2014366899B2

Abstract

An assured integrity container comprises a vessel portion bearing permanent vessel markings and a lid assembly for closing the vessel portion that also bears permanent lid markings. The combination of the vessel markings and the lid markings indicate whether or not the vessel portion and the lid portion have remained fastened together since such time as the lid assembly was applied to the vessel portion. The permanent vessel markings and the permanent lid markings are preferably the result of a laser carbonization process.

Description

AN ASSURED INTEGRITY CONTAINER

TECHNICAL FIELD The present invention relates to a tamper-evident container. BACKGROUND

Any references to methods, apparatus or documents of the prior art are not to be taken as constituting any evidence or admission that they formed, or form part of the common general knowledge.

Tamper-evident packaging has been available in various forms for several decades. Notwithstanding the wide range of contexts in which if may be applied, the objective of tamper-evident packaging is somewhat self- evidently to provide an indication that the contents of the container is unlikely to have been compromised after sealing.

One of the most commonly experienced forms of tamper-evident packaging is the detachable ring (using frangible connections) on a plastic milk bottle. This invention dates back to the late 1960s and can now also be found in scientific applications. For example, tamper-evident vials, tubes and containers with very similar features to the original milk bottle seal are used, to protect specimens for drug testing and many other forensic applications.

One of the vulnerabilities associated with the tamper-evident ring is that a lid from an unused container can be applied to a compromised container. I.e. the original lid is removed along with the detached locking ring. The unused lid is then applied after the contents have been compromised. As a result of the lid substitution, there is no outward sign that the contents of the container have been accessed. This lid-substitution vulnerability may be addressed by applying a separate numbered seal ("Seal ID") that intersects both the lid and the container. However, the security derived from the seal relies on it remaining intact in al! the conditions under which it must be handled, stored and transported, and the ability to validate the Seal ID against contents of the container to which it was applied.

It is an object of the invention to provide a container which addresses one or more problems of the prior art wherein it is possible for an inspector to verify that the iid on a container bearing a payload is the lid that was attached when the lid was originally applied.

SUMMARY OF THE INVENTION According to a first aspect of the present invention there is provided an assured integrity container comprising:

a vessel portion bearing permanent vessel markings; and

a lid assembl for closing the vessel portion bearing permanent lid markings;

wherein the combination of the vessel markings and the lid markings confirm the containers integrity, that is, that the vessel portion and the lid portion have remained in combination since such time as the lid assembly was fastened to the vessel portion. in a preferred embodiment of the invention the permanent vessel markings and the permanent lid markings are formed by a laser carbonization process.

The vessel markings and the lid markings may be identical. Alternatively, the vessel markings and the lid markings may be different but uniquely associated with each other in an information source available to a person inspecting the container for assurance as to its integrity. Preferably the container bears a machine readable code identifying the container wherein the machine readable code is related to the vessel markings and the !id markings. For example, the machine readable code will preferably comprise a barcode such as a quick response (Q ) code.

Preferably the container includes an RFID member. For example, the lid assembly may include the RFID member, in a preferred embodiment of the invention the lid assembly ineludes a lid, which has a iower portion for engagement with the vessel portion and a cap that attaches to an upper portion of the lid wherein the RFID member is held by cooperation of the lid and the cap. In a preferred embodiment of the invention the lid is formed with a recess for receiving the RFID member. Preferably the cap and lid are formed with complementary engagement formations for fastening the cap to the lid to thereby capture the RFID member in the recess. It is preferred that the lid assembiy includes detachable inspection ring arranged to remain with the vessel upon detachment of the lid assembly therefrom.

The container may include a spacing member for insertion between the vessel and the lid assembly to thereby prevent the detachable inspection ring from inadvertently assuming an engaged position relative to the vessel during shipping of the container.

In a preferred embodiment of the invention the spacing member comprises a disk formed with a protrusion on one side for location within an opening of the vessel. Preferably the vessel is marked with a quality assuranc mark that is only visible under a specific frequency of light, for example ultra violet light.

Preferably the lid assembly is marked with a quality assurance mark that is only visible under a specific frequency of light, for example ultra violet light.

A method of authenticating the integrity of a plurality of containers of the previously described type, the method including:

maintaining a secure electronic database associating vessel markings with lid markings of the containers;

entering vessel markings and lid markings of each container into said database wherein the vessel markings and lid markings of the container provide information for the unique identification of the container; providing for the remote querying of said database by inspectors receiving the containers in order that the inspectors may authenticate the integrity of the received containers.

According to another aspect of the present invention there is provided a method of authenticating the integrity of assured integrity containers comprising the steps of:

producing a plurality of assured integrit containers, each said container including a vessel and a lid assembly, each vessel including an indelible vessel marking and each lid assembly including an indelible lid marking;

uniquely associating corresponding vessel markings and lid markings for each of said containers in a data source for further reference; providing said containers to end users with the vessel and lid assembly of each container in an unlocked state;

upon receiving locked containers back from the end users verifying that the lid markings and vessel markings for each said locked container remain uniquely associated as indicated in the data source to thereby determine whether or not the iid assembly and vessel of a container have been dissociated.

In a preferred embodiment of the method said containers bear a machine readable code, the method including associating the machine readable code of each container with its uniquely associated corresponding vessel markings and lid markings in the data source for further reference.

Where said containers include tamper evident rings to indicate removal of lid assemblies from locked vessels, the method may include providing said containers to the end users with a shipping member to prevent inadvertent locking of lid assemblies to vessels prior to use of containers by the end users. The containers may include radio frequency identification (RFID) tags and the method may include associating the RFID tags with corresponding lid and vessel markings of a container in the data source.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred features, embodiments and variations of the invention may be discerned from the following Detailed Description which provides sufficient information for those skilled in the art to perform the invention. The Detailed Description is not to be regarded as limiting the scope of the preceding Summary of the invention in any way. The Detailed Description will make reference to a number of drawings as follows:

Figure 1 is an exploded view of a container according to a preferred embodiment of the present invention. Figure 2 is a block diagram of a secure database system for remote authentication of the integrity of a containers according to preferred embodiment of the present invention.

Figures 3 and 4 are various side views of the container of Figure 1 in a shipping configuration.

Figure 5 is a cross section through the container of Figure 4.

Figure 6 is a detail view of a portion of the cross section of Figure 5.

Figures 7 and 8 are various side views of the container of Figure 1 in a sealed configuration.

Figure 9 is a cross section through the container of Figure 7.

Figure 10 is a detail view of a portion of the cross section of Figure 9.

Figure 1 1 is an exploded view of a container according to a further embodiment of the present invention.

Figure 12 is an exploded view of a bucket type container according to another embodiment of the present invention.

Figure 13 illustrates a method according to a further embodiment of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to Figure 1 , there is depicted an assured integrity container . Broadly speaking, the container 1 is comprised of a vessel 3 and a corresponding lid assembly 5. The lid assembiy 5 is in turn comprised of a lid 7, cap 9, RFID member 11 , detachable tamper-evident ring 13 and sealing ring 15.

The tamper-evident ring 13 is connected to the lid 7 by means of frangible interconnectors 14 (visible in Figures 6 and 10) as is known in the prior art.

The exterior of the vessel 7 bears indelible vessel markings 17. Similarly the iid assembiy bears indelible lid markings 19. The markings may be, for example, alphanumeric, alpha or numeric codes, including (or without) separators or supporting elements such as spaces, punctuation, or other characters e.g. ABCD-1234, ABCD1234, (ABCD) 1234, ABCD 1234. The markings could also be pictograms or standard bar codes. The combination of the vessel markings and the lid markings can be used to confirm the container's integrity. That is, that the vessel 17 and the lid assembly 5 have remained in combination since such time as the lid assembly 5 was fastened to the vessel 3. The permanent vessel markings and the permanent lid markings can be formed using any permanent and indelible marking system. A preferred marking process is that of laser carbonization. The preferred materia! for the vessel and lid are polypropylene with a suitable additive and/or polycarbonate. Suitable material may be obtained from PolyOne Corporation of 33587, Walker Road, Avon Lake, Ohio 44012, USA and/or LATI Industria Termoplastici S.p.A of Via F. Baracca, 7 1-21040 Vedano Olona (VA) Italy.

The vessel markings 17 and the lid markings 19 are preferably unique and identical so that it is immediately apparent to a human inspector if there is a mismatch between the lid markings and the vessel markings, in that case the inspector would be alerted to the fact that a lid and a vessel have been impermissibly swapped with the intent of substituting or contaminating the contents of the vessel.

However, in a less preferred embodiment of the invention the vessel markings and the lid markings may be different but their combination is unique. For example, with reference to Figure 2, they may be associated in an information source, such as a table 21 of a database 23 that is maintained by a secure server 25, The database 23 can be accessed by inspector 29 using a computational device such as laptop computer 31 to access the server 25 across a data network such as internet 27. The inspector can then log in to the secure server 25 and then submit the iid markings and the vessei markings. The secure sever 25 then checks the database 23 and table 21 thereof to verify that the markings are associated. A verification is then returned from the secure server 25 back to the inspector 29.

Referring again to Figure 1 , container 1 may aiso bear a machine readable code 33 comprising a barcode such as a quick response (QR) code as depicted in Figure 1 . The QR code 33 identifies the container. The machine readab!e code 33 is preferably also related to the vessel markings 17 and the lid markings 19. For example, the machine readable code may be a machine representation incorporating the markings in a manner that enables access to the data from the table 21 for comparison with both markings. Alternatively, if it is the combination of the vessei markings 17 and fid markings 19 that is unique to the container then the QR code may incorporate either the vessei markings 17 or the lid markings 19 and enab!e access to the data from the table 21 to verify the markings that form a valid combination for assured integrity.

As previousi mentioned, the fid assembly 5 includes the RFID member 1 1. More particularly, the lid 7 is formed with a recess 35 (best seen in Figures 6 and 10) for receiving the RFID member 11. The cap 9 attaches to an upper portion of the lid 7 wherein the RFID member 1 1 is held in place by cooperation of the fid 7 and the cap 9. The cap and lid are formed with complementary engagement formations, namely lateral protrusions 37 which extend from cap 9 and engage with corresponding indents 39 formed on an inside rim of the iid 7. The cap 9 is thereby fastened to the iid so that the RFID member 1 1 is captured in the recess 35. As previously mentioned, it is preferred that the lid assembfy 5 includes a detachable tamper evident ring 13, which is arranged to remain with the vessel 3 upon detachment of the lid assembly 5 therefrom. The container 1 also includes a spacing member 41 for insertion between the vessel 3 and the lid assembly 5 to thereby prevent the detachable inspection ring 13 from inadvertently assuming an engaged position relative to the vessel during shipping of the container. The spacing member 41 comprises a ring 43 formed with a tubular extension 45 on one side for location within an opening 47 of the vessel 3. The ring 43 seats above the rim of the opening 47 and thereby prevents the lid from being sufficiently threaded onto the vessel 7 to bring the inspection ring 13 into engagement with the vessels ring retainer formations 49. The vessel 3 may be marked with a quality assurance mark 51 that is only visible under a specific frequency of light, for example ultra violet light.

Similarly, the lid assembly may also be marked with a quality assurance mark 53 that is also only visible under a specific frequency of light, for example ultra violet iight. Consequently the inspector can ascertain that both the vessel and the lid assembly bear the same quality assurance mark.

USE FOR THE INVENTION

Referring now to Figures 3 to 6 of the invention, the container of Figure 1 is shown in an assembled state with the lid attached to the vessel. The indelible markings 17 and 19 on the vessel and the lid assembly respectively are either identical or form a unique combination which has been recorded in a data source, as previously explained with reference to Figure 2. The QR code and RFID member have been correspondingly coded. In this state the shipping disk 41 has been inserted into the neck 47 of the vessel 3 as shown in Figure 6. Accordingly, the lid assembly has been screwed down onto the vessel but cannot be screwed down to such a degre that the tamper-evident ring 13 is engaged by the detachment formations 49 of the vessel.

The shipping disk serves two purposes; 1. It allows the lid assembly to be applied without the tamper- evident ring engaging; and

2. It allows the QR code 33 to be laser marked on the lid in a location that will become the back of the vessel when the shipping disk is removed and the tamper-evident ring is engaged. This allows conventional laboratory labels to be applied to the front of the container for ease of reference in storage without obscuring the QR code.

The container is now ready to be shipped to destination wherein the vessel will be filled with a payload and dispatched. For example, the container may be shipped to a dispatcher who is an animal breeder. The dispatcher will unscrew the lid, remove the shipping disk and then insert a pay!oad into the vessel. For example, where the dispatcher is an animal breeder the payload may take the form of animai semen for breeding purposes.

Referring now to Figures 7 to 10, once the payload has been inserted into the vessel the lid is then tightened with shipping disk removed. The lid is tightened sufficiently for the tamper-evident ring 13 to become engaged by the detachment formations 49 of the vessel 3. Consequently, if the lid is unscrewed from the vessel before the container meets its intended destination the detachment of the tamper evident ring 13 from the lid assembly will be visible.

The dispatcher also labels the container with information that may include its origin, destination, date dispatched and contents by means of a conventional adhesive label, for example. The dispatcher also makes a record of the identity of the container and the purpose for which it has been used. More particularly, the breeder writes down the markings 17 and 19 of the vessel and the lid assembly and the nature of the payload. For later reference if needs be. Alternatively, and more preferably The QR serial code 33 can be read and or scanned by the dispatcher and details recorded in the database system of Figure 2 confirmed before being placed in the_ Once the container is sealed the QR coding continues to provide a final layer of protection from tampering.

At its final destination a person inspecting the container can tell if the tamper-evident ring 13 has become detached. The inspector can also discern if the indelible markings on the vessel and lid assembly match or are paired in the remote database, thereby indicating that the lid has not been substituted for another during transit. The inspector can also check the QR code and the RFID to confirm that they also correspond to the indelible markings by accessing the database system previously discussed with reference to Figure 2. The inspector may also inspect the quality assurance marks 51 with the aid of an ultraviolet light, for example.

All of these tests assist in providing a high level of assurance that the integrity of the container has been maintained since it was sealed with its payload therein. Embodiments of the invention provide a container for which it is possible to verify that the lid of the container that was originally applied has remained with the vessel. An inspector can also tell if the container lid has been removed at some time b checking the tamper evident ring. The inspector is also able to identify the contents of the container by cross-referencing a unique identifier associated with the container against other labels and identifiers associated with the contents. For example, the unique combination of the indelible vessel and lid markings are associated with the QR code and the RF!D code and also the contents as recorded in the secure database shown in Figure 2.

It will be realised that the above description identifies at least one specific, substantia! and credible use for the invention. The present invention has been described with reference to an embodiment which comprises a container in the form of a 1 .5ml capacity vial. However, the invention is also applicable to containers of larger capacities. Referring now to Figure 1 1 , there is shown a further embodiment of the invention comprising a container 50. In this Figure like item numbers from the earlier figures have been used to indicate like components. The container 50 includes an RFID chip 1 1 that is held into a recess on the underside of lid 7 by means of a RFiD cover disc 12 that secures the RFID chip in a recess formed on the underside of the lid. The lid 16 also has a recess 16 formed on its topside which receives a color coded disc 14 to assist in color coding the container 50 as desired.

Referring now to Figure 12, there is depicted a further embodiment of the invention comprising a container in the form of a bucket-like vessel 52, in this figure like item numbers from the earlier figures have been used to indicate like components. The container includes a tamper-evident tear off tab 13 that allows access to the iip 8 of the lid 7 upon application of removal force. The lid 7 is formed with a peripheral !ip 8 that secures under a locking iip 10 of the cover as shown in the encircled detail cross sectional view.

A further example of the use of a method according to a preferred embodiment of the invention will now be described with reference to Figure 13. With reference to Figure 13, a method of authenticating the integrity of a plurality of assured integrity containers 1a, n comprises the steps of firstly producing the plurality of assured integrity containers 1 a,..,, n with each container including a vessel (e.g. item 3 of Figure 1 ) and a lid assembly (e.g. item 7 of Figure 1 ). Each of the vessels includes an indelible vessel marking (e.g. item 17 of Figure 1 ) and each lid assembly includes an indelible lid marking (e.g. item 19 of Figure 1 ). The method includes operator 59 operating a computer 31 to uniquely associate the corresponding vessel markings and lid markings for each of the containers in a data source, e.g. a table 21 of database 23, for further reference.

The operator 59 then provides the containers 1 a,..,1 n to end users 55 a,.., 55n with the vessel and lid assembly of each container in an unlocked state, indicated as 1 a',.., 1 b' and preferably with a shipping ring (item 15 of Figure 1 ) in place to prevent inadvertent Socking.

The end users (or "dispatchers") 55a,,., 55n, remove lid assemblies from the vessels and fill the vessels with content, e.g. animal semen. The end users then, with the shipping ring removed, lock the corresponding lid assemblies to the vessels in order to lock the containers. The end users then send the locked containers (indicated as 1 a",..,1 n") to a desired destination where an inspector 57 verifies that they have not been tampered with. Upon receiving the locked containers back from the end users the inspector verifies that the lid markings and vessel markings for each said locked container remain uniquely associated as indicated in the data source (i.e. table 21 of database 23) to thereby determine whether or not the lid assembly and vessel of a container have been dissociated, (i.e. separated and mismatched) since they were provided to the end users.

As previously discussed, the containers 1 a,..,1 n may bear a machine readable code (e.g. QR code 33 of Figure 1 ) in which case the method includes the administrator 59 associating the machine readable code of each container with its uniquely associated corresponding vessel markings and lid markings in the table of the data source (items 21 , 23) at the time of initial shipping to the end users 55a,..,55n.

The containers preferably include tamper evident rings to indicate removal of lid assemblies from locked vessels 1 a'V.,1 rr" during transit from the end users 55a,..,55n to the inspecto 57. in that case the method includes providing containers 1 a", ...,1n" to the end users 55a, ..55n with a shipping member (e.g. item 15 of Figure 1 ) to prevent inadvertent locking of lid assemblies 7 to vessels 3 prior to use of containers 1a',..,1 ' by the end users.

Where the containers 1a,..1 n include radio frequency identification (RFID) tags (e.g. item 1 1 of Figure 1 ) the method may include the operator 59 associating the RFiD tags with corresponding lid and vessel markings of a container in the data source 23 prior to shipping the containers to end users 55a,..55n.

In compliance with the statute, the invention has been described in language more or less specific to structural or methodicai features.

The term "comprises" and its variations, such as "comprising" and "comprised of is used throughout in an inclusive sense and not to the exclusion of any additional features. It is to be understood that the invention is not !imited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted by those skilled in the art.

Throughout the specification and claims (if present},, unless the context requires otherwise, the term "substantially" or "about" will be understood to not be limited to the value for the range qualified by the terms.

Any embodiment of the invention is meant to be illustrative only and is not meant to be limiting to the invention. Therefore, it should be appreciated that various other changes and modifications can be made to any embodiment described without departing from the spirit and scope of the invention.

Claims

1. An assured integrity container comprising:

a vessel portion bearing permanent vessel markings; and

a lid assembly for closing the vessel portion bearing permanent lid markings;

the vessel markings and the lid markings being either identical or, if non-identical, uniquely associated with each other in an information source; and

a machine readable code identifying the container formed thereon wherein the machine readable code corresponds at least in part to the vessel markings and the lid markings;

wherein the combination of the vessel markings and the lid markings in conjunction with the machine readable code indicate whether or not the vessel portion and the Sid portion have remained fastened together since such time as the lid assembly was applied to the vessel portion.

2. A container according to claim 1 , wherein the permanent vessel markings and the permanent lid markings are the result of a laser carbonization process.

3. A container according to claim 1 or claim 2, wherein the machine readable code comprises a quick response (Q ) code.

4. A container according to any one of the preceding claims, wherein the lid assembly includes a lid, which has a lower portion fo engagement with the vessel portion and a cap that attaches to an upper portion of the lid wherein a the lid and the cap cooperate for holding an RFID member therebetween.

5. A container according to any one of claims 1 to 4 including an RFID member.

6. A container according to claim 5 wherein the RFID member is located between the cap and the iid.

7. A container according to claim 6, wherein the cap and lid are formed with complementary engagement formations for fastening the cap to the lid to thereby capture the RFiD member in the recess.

8. A container according to any one of the preceding claims, including a detachable inspection ring arranged to remain with the vessel upon detachment of the lid assembly therefrom.

9. A container according to any one of the preceding claims, including a spacing member for insertion between the vessel and the lid assembly to thereby prevent the detachabie inspection ring from inadvertently assuming an engaged position relative to the vessel during shipping of the container.

10. A container according to claim 9, wherein the spacing member comprises a disk formed with a protrusion on one side for location within an opening of the vessel.

11. A container according to any one of the preceding claims, wherein the vessel is marked with a quality assurance mark that is only visible under a specific frequency of light.

12. A container according to claim 14, wherein the lid assembly is marked with a quality assurance mark that is only visible under a specific frequency of light.

13. A container according to claim 1 , wherein the vessel comprises a bucket.

14. A container according to claim 1 , wherein the vessel comprises a vial.

15. An assured integrity container comprising;

a vessel portion bearing permanent vessel markings; and

a lid assembly for dosing the vessel portion bearing permanent !id markings;

wherein the combination of the vessel markings and the lid markings indicate whethe or not the vessel portion and the lid portion have remained fastened together since such time as the lid assembly was applied to the vessel portion.

16. A method of authenticating the integrity of a plurality of containers of a type according to any one of claims 1 to 14, the method including:

entering vessel markings and lid markings of each container into said database wherein the vessel markings and lid markings of the container provide information for the unique identification of the container;

providing for the remote querying of said database by inspectors receiving the containers in order that the inspectors may authenticate the integrity of the received containers.

17. A method of authenticating the integrity of assured integrity containers comprising the steps of:

producing a plurality of assured integrity containers, each said container including a vessel and a lid assembly, each vessel including an indelible vessel marking and each lid assembly including an indelible lid marking;

uniquely associating corresponding vessel markings and lid markings for each of said containers in a data source for further reference;

providing said containers to end users with the vessel and lid assembly of each container in an unlocked state;

upon receiving locked containers back from the end users verifying that the lid markings and vessel markings for each said locked container remain uniquely associated as indicated in the data source to thereby determine whether or not the lid assembly and vessel of a container have been dissociated since they were provided to the end users.

18. A method according to claim 17 wherein said containers bear a machine readable code, the method including associating the machine readable code of each container with its uniquely associated corresponding vessel markings and lid markings in the data source for further reference.

19. A method according to claim 17 or claim 18, wherein said containers include tamper evident rings to indicate removal of lid assemblies from locked vessels, the method including providing said containers to the end users with a shipping member to prevent inadvertent locking of lid assemblies to vessels prior to use of containers by the end users.

20. A method according to any one of claims 17 to 20 wherein said containers include radio frequency identification (RFID) tags and wherein the method includes associating the RFID fags with corresponding lid and vessel markings of a container in the data source.