GB2289040A - Tamper evident packages - Google Patents

Abstract

A tamper-evident package comprises a cardboard box having one side wall formed by bonding of two superimposed panels 5, 6 of which an outer panel includes an opening 9 to expose a bar code 10 on the exterior surface of the inner panel, and including an adhesive bond between the inner and outer panels at the opening 9 whereby any attempt to open the carton by peeling the outer panel 5 from the inner panel 6 will result in at least partial disruption of the bar code 9 either visible to the naked eye or detectable by a bar code reader. A water-soluble security label bearing a bar-code may also be provided. <IMAGE>

Description

NEW PACKAGES This invention relates to a tamper-evident packaging system, in particular a tamper-evident system for pharmaceutical packages.

It is common for companies and in particular pharmaceutical companies to use various tamper evident devices on their packaging. A tamper-resistant package is defined by the United States Food and Drug Administration (FDA) as a package having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that the package has been tampered with. There are numerous types of systems designed to provide a visual indication when a seal on for example the opening flap of a package has been tampered with. Many of these systems are reasonably effective but may not be considered 100% secure.

Typically a pharmaceutical package is prepared from a cardboard blank which is folded to provide a rectangular shaped carton with two end flaps and a side wall formed by an inner panel bonded to an opposing outer panel. In such a construction, the most obvious points of entry are at the two end flaps and for this reason tamper evident seals are typically provided at one or both of these ends. However, such a system can be by-passed by separating the bonded side panels of the package which would leave the end seals untouched.

The present invention thus seeks to provide a tamperevident system which prevents access to the package being gained through this side wall.

Accordingly one aspect of the present invention provides a tamper evident package comprising a pair of opposing side walls and a pair of end openings adjacent to the side walls wherein at least one of the side walls is formed by bonding an outer panel to an inner panel, the outer panel having an aperture thus exposing a region of the inner panel to visual inspection, the bond between the outer panel and the inner panel being such that a break in the bond surrounding the said exposed region (for example by tampering) causes a visual disruption in the exposed part of the inner panel.

The bond is generally formed in the region surrounding the aperture with an adhesive which is absorbed into the surfaces of the bonded side wall panels, and forms a strong seal. Any attempt to break the seal thus results in disruption of the inner panel, which will be visible in the exposed inner panel, thus providing tamper evidence.

Preferably only one of the side walls is formed with an aperture. This offers the advantage of a simple construction.

Advantageously the exposed part of the inner surface bears a bar code. This allows not only visual inspection of the disruption thereof when the package is tampered with but also allows a bar code reader to be employed to determine whether tampering has occurred. This may be particularly useful where the package is sold in a store using bar code readers, or where the packages are being checked at the point of manufacture (e.g. as part of a quality control system).

Preferably the package is provided from a cardboard blank which is folded to provide the opposing side walls and two ends. This simplifies manufacture and allows easy printing of the details of the product and the bar code. In addition the fibres of a cardboard material are particularly suited to disruption where a strong bond produced between two cardboard surfaces is broken.

The package is preferably provided with further tamper evident means on one or both of the end openings. This ensures that the package is provided with tamper evident means on the likely areas of access for a tamperer.

A second aspect of the present invention provides a tamper-evident package comprising a box-like carton with an opening at least partially covered by a security label bearing a bar code and formed of water-soluble sheet material.

The invention may be illustrated with reference to the accompanying drawings in which: FIGURE 1 shows the outline of an unassembled package according to the invention; FIGURE 2 shows the assembled package of Figure 1.

Referring to the drawings Figure 1 shows a cardboard blank 1 which is to be folded to form the box or carton of Figure 3.

The blank 1 comprises a succession of five panels separated by preferably pre-scored fold lines. These panels comprise major second and fourth panels 2 and 3, respectively, and minor first, third and fifth panels 6, 4 and 5, respectively.

In the finished carton the major panels 2 and 3 define the upper and lower main walls of the carton of Figure 3, whereas the minor third panel 4 defines the side wall at the left hand side of Figure 3 and the minor first and fifth panels 5 and 6 become adhered to one another to define together the side wall at the right hand side of Figure 3.

Figure 1 shows the blank as viewed from the side which will be the exterior of the finished pack.

The major fourth panel 3 has end flaps 7 and 8 which will in the conventional manner close the ends of the carton in the Figure 2 configuration.

The minor first panel 6 has an opening 9 which in the present case is rectangular and the minor fifth panel 5 has a corresponding region 10 which will be visible through the opening 9 when, in the formation of the finished carton, the minor first panel 6 has been folded over and adhered on to the minor fifth panel 5.

In the preferred embodiment the region 10 has a bar code printed thereon, to be visible through the opening 9 of minor first panel 6 and readable by a bar code reader in the validation (tamper detection) process to be described later.

The region of the minor fifth panel 5 immediately surrounding the region 10 to be visible in the exposed pack is coated with a first adhesive, preferably a cyanoacrylate adhesive such as that known by the Trade Mark SUPERGLUE.

This adhesive bonds to the region of the minor first panel 6 around the opening 9, to provide a strong bond surrounding the exposed region 10 of the minor fifth panel 5.

The area of the minor fifth panel 5 which is coated with this first adhesive is bounded by a line 11 visible in Figure 1, whereas the remainder of the area of the minor fifth panel 5 is coated with a second adhesive, preferably in the form of a line of dots of adhesive as illustrated at 12 in Figure 1.

As seen in Fig. 2, the assembled package 1 has an exposed region 10 which will be clearly seen to have been tampered with, by visual inspection.

In this embodiment the package of Fig. 2 is also provided with further tamper evident means consisting of a label 13 with a bar code printed thereon. This second bar code may be used in conjunction with the first bar code provided in the region 10; for example the bar code reader may first read the data provided on the second bar code.

This second bar code may instruct the reader to check the first bar code (at 10) and if any discontinuities are found at the first bar code, for example due to tampering, the reader may indicate an error. This system is designed to be self-policing at a retail check out, or to be used before the packed product leaves the packing line.

The invention also as a preferred embodiment replaces conventional security tabs at the end of a carton by a security tab 13 preferably made from a water soluble material such as poly vinyl alcohol. For the purpose of preferred material the device could be made from water-soluble paper i.e. "Dissolvo" (Trademark) paper. The paper would be printed using a non-soluble ink, typically a black pigmented ink suitable for litho or flexographic printing. The security tab would be self-adhesive and printed with a bar code designed to be read with an industrial infra-red laser e.g. the European Article Numbering (E.A.N.) system.

The water soluble label 13 printed complete with bar code is then fixed in the same way (Fig. 2), and to serve the same purpose, as a conventional tamper evident seal, but with a big difference. The bar code on the security tab 13 will contain product identification information, but more importantly it will contain instructions to seek and read a pharmacode contained on the flap 8 of the carton. If at this stage the carton has not been opened or tampered with, the first bar code 10 will be complete and readable. The scanning device will therefore complete the loop of the validation process and validate the carton. If, for any reason, any of the points of entry have been broken, or if the continuous bar codes have become broken or distorted due to fibre tear, it will either be visible to the naked eye, or will be visible by the infra-red scanning device.

The material used as the security tab 13 need not be made out of water-soluble paper or tissue, but this material is preferred since the introduction of liquid chemicals in tampering would cause all or part of the substrate to dissolve, rendering the bar code printing unsupported and thus unreadable. Part of the invention consists of printing either or both bar codes in different inks, some of which will be resistant to solvents, and some of which will be soluble in solvents. This is desirable in order to prevent the use of solvents and other preparations to remove the security bar code altogether for replacement with a counterfeit version.

In normal use the security bar coded label is designed to be removed as follows: The label 13 has a preferably integral pull tab 14 over a varnished area of the carton end flap 8, the substrate on the pull tab having a low tack peelable adhesive. This has the effect of not only facilitating release, but accelerating the process of aggressive fibre tear when the rest of the label is treated with permanent adhesive. The combination of permanent adhesive and weak fibrous water soluble material causes considerable visual distortion to the bar code lines, which is plainly visible to the naked eye. Trying to lift the label with liquid water or solvent will have a similar effect.

In the normal scanning of bar codes, whilst it is a rare occurrence, it is nevertheless possible to obtain a nonreadable bar code. This can be caused by a number of reasons, such as poor print, damage to the code, or simply faulty scanning equipment. In these circumstances the operator at the check out will be obliged to key the bar code in manually using a digital identification number (shown as 16 in Figure 2) corresponding to the E.A.N. number encoded in the bar code. Since the invention depends on accurate bar code reading, such a situation raises the question whether there is a genuine fault or whether the bar code reader is picking up a label that has been tampered with. In such an event the invention incorporates a visual system to reject the carton or to enable the code to be simply keyed in to authenticate the package. This is achieved by a specially designed panel 15 (Fig. 2), directly alongside the bar code 10 and digital number 16, that shows a small rectangle printed on the label and containing the letters "VN" (Validate Manually) in red. The rear surface of this panel of the label 13 will have been spot glued to the carton end flap 8 with a "3M" (Trademark) molecular adhesive. If the carton has been violated beyond this point by attempts to peel off the label 13 the letters "VM" will have been destroyed by aggressive fibre tear. The centre part of the bar code will also be very badly damaged and this will be VISUALLY very evident to the person who has purchased the item, but more importantly to the trained operator at the check out.

It is not essential for the label 13 to be formed of water-soluble "Dissolvo" (Trade Mark) paper. It could for example be formed of poly vinyl alcohol (PVOH) fibres or of thicker paper, or indeed of any other material.

Claims (11)

CLAIMIS

1. A tamper-evident package comprising a pair of opposing side walls and a pair of end openings adjacent to the side walls, wherein at least one of the side walls is formed by bonding an outer panel to an inner panel, the outer panel having an aperture thus exposing a region of the inner panel to visual inspection, and the bond between the inner and outer panels being such that a break in the bond surrounding the said exposed region will cause visual disruption in the exposed part of the inner panel.

2. A package according to claim 1, when formed from a folded cardboard blank having at one end a panel to define said outer panel with its aperture, and having at the other end a panel to define said inner panel with its bar code, and including pre-scored fold lines between various panels defining the blank.

3. A package according to either one of the preceding claims, wherein said inner and outer panels are bonded by means of a cyano-acrylate adhesive.

4. A package according to claim 3, wherein said cyano-acrylate adhesive is confined to parts of the panels adjacent to said opening in the outer panel, and including further adhesive joining said inner and outer panels together, but of a tack strength less than that of said cyano-acrylate adhesive.

5. A package according to any one of the preceding claims, in the form of a rectangular box-shaped carton having at at least one end a security label requiring destruction before said one end can be opened, said security label including a bar code related to the first-mentioned bar code on said inner panel such that any disruption to any said first-mentioned bar code will be evident by comparison of the first-mentioned bar code and that on said security label.

6. A package according to claim 5, wherein said security label is formed of a water-soluble sheet.

7. A tamper-evident package comprising a box-like carton with an opening at least partially covered by a security label bearing a bar code and formed of water-soluble sheet material.

8. A package according to claim 6 or 7, wherein said water-soluble sheet material is formed of poly vinyl alcohol.

9. A package according to any one of claims 5 to 8, wherein said security label includes an integral pull tab facilitating removal of the security label for authorised opening of the carton, and further including between the bar code and the pull tab of said security label indicia instructing an operator of the bar code reader to key in (by means other than the bar code reader) the number encoded in the bar code when said security label is intact.

10. A package according to claim 9, wherein said indicia are defined on a panel of the label behind which is a molecular adhesive providing a bond of said panel to the underlining carton much stronger than the bond of the rest of the label to said underlining carton whereby any attempt to peel off said security label must result in destruction of the said indicia to indicate that the package has been violated or that an attempt to violate it has been made.

11. A tamper evident package constructed and arranged substantially as hereinbefore described with reference to, and as illustrated in, the accompanying drawing.