Patent Publication Number: US-2021186809-A1

Title: Ready-to-sell packaging unit containing at least one pharmaceutical product, set including a plurality of such packaging units and method for producing such packaging unit

Description:
FIELD OF THE INVENTION 
     The invention relates to ready-to-sell packaging units containing at least one pharmaceutical product. 
     BACKGROUND ART 
     Already known packaging units of this kind include:
         an inner enclosure within which is (are) contained the product(s);   a patient or health care professional information leaflet, sometimes termed a paper insert; and   an outer enclosure such as a cardboard box within which are contained the inner enclosure and the information leaflet.       

     The inner enclosure is for instance a primary container such as a vial or a syringe body or a cartridge in direct contact with a liquid pharmaceutical product such as a dose of vaccine; or a primary container such as a blister containing solid pharmaceutical products; or the combination of one or more primary container(s) in direct contact with the pharmaceutical product with a further member such as a blister or a carton tray for holding and/or grouping the primary container(s). 
     The outer enclosure is provided with labelling features which are for instance the name of the product, mentions in relation with the nature and use of the product, registration code and special logo. 
     Many of such labelling features are dependent on the market on which the product is to be sold, for instance as regards the language in which the mentions in relation with the nature and use of the product are to be drafted. 
     The same applies to the information leaflet. 
     The outer enclosure and the information leaflet must thus be customized to the market on which the ready-to-sell packaging unit is to be sold. 
     One known method for producing a ready-to-sell packaging unit for a relatively small market is to provide a ready-to-sell packaging unit produced for a relatively large market, to provide an information leaflet and an outer enclosure customized to the relatively small market, to open the outer enclosure of the ready-to-sell packaging unit produced for a relatively large market, to take the inner enclosure therein and to place this inner enclosure together with the customized information leaflet within the customized outer enclosure. 
     This method is becoming difficult to implement with the more and more stringent security and regulatory requirements applying to ready-to-sell pharmaceutical packaging units, which are met thanks to the provision to the outer enclosure of traceability and anti-counterfeiting features as well as anti-tampering features. 
     The traceability and anti-counterfeiting features are for instance batch number, manufacturing date, expiry date, 2D or 3D codes such as QR codes or Data Matrix codes, proprietary safety Label, Global Trade Item Number (GTIN) and/or serial numbers, which are affixed to the external surface of the outer enclosure, enabling to keep track and trace and/or check the authenticity of the packaging unit. 
     The anti-tampering features are for instance provided with glued end flaps so that the body and/or end flaps of the outer enclosure must be teared or broken for opening the outer enclosure, revealing that someone accessed to the inner enclosure. In other instances, the anti-tampering features are provided with adhesive security labels or tapes or seals which must be teared or broken for opening the outer enclosure, or with void (self-destructing) labels that leave behind semi-permanent text when removed. 
     The above-mentioned method for producing a ready-to-sell packaging unit for a relatively small market is becoming difficult to implement in particular because relatively complex industrial equipment is needed for providing the traceability and anti-counterfeiting features and providing the anti-tampering features. 
     SUMMARY OF THE INVENTION 
     The invention is directed to enabling to produce such a packaging unit with a customized information leaflet and a customized outer enclosure in a simple, convenient and economical way while complying with the more and more stringent security and regulatory requirements. 
     The invention accordingly provides in a first aspect a ready-to-sell packaging unit containing at least one pharmaceutical product, including:
         an inner enclosure within which is contained each said pharmaceutical product;   a patient or health care professional information leaflet; and   an outer enclosure within which are contained said inner enclosure and said information leaflet, said outer enclosure being provided with labelling features, with traceability and anti-counterfeiting features, and with anti-tampering features;       

     characterized in that said outer enclosure includes:
         a first outer enclosure within which is contained said inner enclosure; said first outer enclosure being provided with said traceability and anti-counterfeiting features and with said anti-tampering features; said information leaflet being outside of said first outer enclosure; and   a second outer enclosure within which is contained said first outer enclosure and said information leaflet; said second outer enclosure being provided with said labelling features; said second outer enclosure having an opening, said opening and said traceability and anti-counterfeiting features being arranged so that said traceability and anti-counterfeiting features are visible through said opening.       

     The invention is based on the observation that the information leaflet does not need to be within the enclosure bearing the features enabling to meet the product security requirements (the traceability and anti-counterfeiting features together with the anti-tampering features), provided that an outermost enclosure (herein termed the second outer enclosure) encloses the enclosure bearing the features enabling to meet the product security requirements (herein termed the first outer enclosure), provided that the information leaflet is placed between the two enclosures, and provided that the two enclosures are mutually arranged so that an opening in the second outer enclosure enables to see the traceability and anti-counterfeiting features on the first outer enclosure. 
     Since the second outer enclosure is provided with the labelling features enabling to meet the outer enclosure customization requirements (such as local language, registration code and special logo in accordance with the market/country requirements), and since the information leaflet is outside of the first outer enclosure, no feature needing market specific customization has to be present on or within the first outer enclosure. 
     The first outer enclosure can thus be used in different markets and can accordingly be manufactured in very large series. 
     This is very convenient and economical because it enables efficient use of the industrial equipment for producing the first outer enclosure, including the relatively complex portion of this equipment providing the traceability and anti-counterfeiting features and providing the anti-tampering features. 
     The production of the ready-to-sell packaging unit is relatively simple since it involves only placing the first outer enclosure and the information leaflet within the second outer enclosure, so that once the first outer enclosure is produced, the ready-to-sell packaging unit according to the invention can be produced simply, conveniently and economically, including for small series which can even be made manually. 
     According to advantageous features of the ready-to-sell packaging unit according to the invention:
         said traceability and anti-counterfeiting features include individual alphanumeric features and the second outer enclosure has along said opening a set of headers for identifying said individual alphanumeric features;   said first outer enclosure includes for said individual alphanumeric features a set of headers for identifying said individual alphanumeric features, said set of headers of said first outer enclosure being masked by said second outer enclosure;   said first outer enclosure includes labelling features at least partially masked by said second outer enclosure;   said opening is a window made in one panel of said second outer enclosure;   said information leaflet is isolated from said window by said first outer enclosure;   said second outer enclosure includes a body having said one panel and a further panel parallel to said one panel, said information leaflet being located between said further panel and said first outer enclosure;   said second outer enclosure includes a body having a rectangular profile, said one panel belonging to said body and corresponding to a long side of said rectangular profile;   said second outer enclosure has a body and end flaps;   said second outer enclosure is a sleeve with open ends;   said second outer enclosure is a sleeve with open ends, said opening being one of said open ends;   said outer enclosure further includes at one end a sticker securing together the first outer enclosure and the second outer enclosure;   said first outer enclosure includes a body having ends closed by end flaps with a glued outermost end flap so that said end flaps and said body form said anti-tampering features;   said first outer enclosure includes an easy opening feature; and/or   said easy opening feature is a curved line of precuts.       

     In a second aspect, the invention provides a set including a first ready-to-sell packaging unit and a second ready-to-sell packaging unit each as disclosed above, wherein said first outer enclosure is identical for the first ready-to-sell packaging unit and the second ready-to-sell packaging unit whereas said information leaflet and said outer enclosure are different for the first ready-to-sell packaging unit and the second ready-to-sell packaging. 
     In a third aspect, the invention provides a method for producing a ready-to-sell packaging unit as disclosed above, including the step of manufacturing said first outer enclosure in a first factory, the step of shipping the first outer enclosure to a second factory, the step of providing the second factory with said second outer enclosure and said information leaflet and the step of placing said first outer enclosure and said information leaflet inside said second outer enclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The description of the invention continues now with a detailed description of preferred embodiments given hereinafter by way of non-limiting illustration and with reference to the appended drawings. In the drawings: 
         FIG. 1  is a perspective view of a ready-to-sell packaging unit according to the invention; 
         FIGS. 2 and 3  are schematic cross-section views taken as shown by II-II and III-Ill on  FIG. 1 ; 
         FIGS. 4 and 5  are perspective views of respectively the first outer enclosure and the second outer enclosure of the packaging unit illustrated on  FIG. 1 ; 
         FIG. 6  is a perspective view showing the insertion of the first outer enclosure and the patient or health care professional information leaflet into the second outer enclosure; 
         FIG. 7  is a diagrammatic view showing a central factory in which the first outer enclosure is manufactured and three different local factories in which ready-to-sell packaging units according to the invention are produced with the first outer enclosure manufactured at the central factory; 
         FIG. 8  is a schematic view of a set of three different packaging units according to the invention each produced at a respective local factory, the different packaging units being illustrated as on  FIG. 2 ; 
         FIGS. 9 and 10  are views similar to  FIGS. 5 and 6  but for a variant of the packaging unit according to the invention in which the second outer enclosure is a sleeve instead of a box; 
         FIG. 11  is a schematic view of a sticker included in this variant of the packaging unit for mutually securing the first outer enclosure and the second outer enclosure; and 
         FIG. 12  is a view similar to  FIG. 10  for a further variant of the packaging unit according to the invention in which the traceability and anti-counterfeiting features are visible through one open end of the sleeve forming the second outer enclosure. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     The ready-to-sell packaging unit  10  illustrated on  FIGS. 1 to 3  includes an inner enclosure  11  in which is contained one or more pharmaceutical product(s)  12 , a patient or health care professional information leaflet  13  and an outer enclosure  14  within which are contained the inner enclosure  11  and the information leaflet  13 . 
     The inner enclosure  11  is for instance formed by a syringe and by a blister or carton tray holding the syringe whereas the pharmaceutical product  12  is for instance a dose of liquid vaccine to be injected, the body of the syringe containing in direct contact the dose of liquid vaccine. 
     In other instances, the pharmaceutical product  12  is different from a dose of vaccine and/or is solid rather than liquid, for instance tablets; the primary container in direct contact with the product  12  is different from a syringe, for instance a vial if the product is liquid or freeze-dried or a blister or a tube if the product is solid; more than one pharmaceutical product  12  is contained in the inner enclosure  11 , for instance a set of a plurality of doses of vaccine each contained in a vial while a blister holds and groups the vials; and/or the inner enclosure  11  is formed only by the primary container with which the body is in direct contact, for instance a blister containing in direct contact a plurality of tablets. Other instances of products contained in a syringe or a vial are lyophilized products that are to be reconstituted extemporaneously by mixing with a liquid. 
     The information leaflet  13  contains medical information, recommendations of uses and the like and/or regulatory information according to the market on which the packaging unit  10  is to be sold. Such information is thus customized to this market, in particular as regards the contained information and the language used. 
     Here, the information leaflet  13  is a folded sheet of paper. 
     In the ready-to-sell packaging unit  10 , the outer enclosure  14  includes a first outer enclosure  15  and a second outer enclosure  16 . 
     Within the first outer enclosure  15  is contained the inner enclosure  11 . Here, the first outer enclosure  15  is in direct contact with the inner enclosure  11 . 
     Within the second outer enclosure  16  are contained the first outer enclosure  15  and the information leaflet  13 . 
     Here, the second outer enclosure  16  is in direct contact with the first outer enclosure  15  and with the information leaflet  13 . 
     The first outer enclosure  15  is here a fully closed box having a body  17  and end flaps  18 . 
     The body  17  has a rectangular profile. 
     As visible on  FIGS. 2, 3 and 6  the information leaflet  13  has a width similar to the dimension of the long side of the rectangular profile of the body  17 . The length of the information leaflet  13  is similar to the length of the body  17 . 
     The end flaps  18  close the ends of the first outer enclosure  15 . At each end, the outermost end flap  18  is maintained with glue to the other end flaps so that the end flaps  18  form with the body  17  an anti-tampering feature: for opening the first outer enclosure  15 , the end flaps  18  and/or the body  17  must be teared or broken, revealing that someone accessed to the inner enclosure  11 . 
     For helping the user to open the first outer enclosure  15 , an easy opening feature is provided, here a curved line  19  of precuts arranged in the body  17  in the vicinity of one of its ends. 
     The first outer enclosure  15  is provided with traceability and anti-counterfeiting features  20 , enabling to keep track and trace the authenticity of the packaging unit  10 . 
     The traceability and anti-counterfeiting features  20  are here a Data Matrix code  21 , a serial number  22 , an expiry date  23 , a batch number  24 , a manufacturing date  25  and a Global Trade Item Number (GTIN)  26 . 
     The serial number  22 , expiry date  23 , batch number  24 , manufacturing date  25  and Global Trade Item Number (GTIN)  26  are individual alphanumeric features. 
     The traceability and anti-counterfeiting features  20  are affixed to the external surface of the first outer enclosure  15 . 
     In addition to the traceability and anti-counterfeiting features  20 , the first outer enclosure  15  includes a set  27  of headers for identifying each of the individual alphanumeric features in the traceability and anti-counterfeiting features  20 . 
     In the set  27 , each header is in line with the feature it identifies, respectively the serial number  22  (header is SN), the expiry date  23  (header is EXP), the batch number  24  (header is LOT), the manufacturing date  25  (header is MANUF) and the Global Trade Item Number  26  (header is GTIN). 
     The first outer enclosure  15  also has labelling features  28 , here the International Non-proprietary Name (INN) and/or brand name  29  of the product(s)  12  and mentions  30  in relation with the nature and use of the product(s)  12 . 
     The second outer enclosure  16  is here a box having a body  31  and end flaps  32 . 
     The body  31  has a rectangular profile. 
     For enabling the second outer enclosure  16  to accommodate the first outer enclosure  15  and the information leaflet  13 , as visible on  FIGS. 2 and 3  the dimension of the long side of the rectangular profile of the body  31  is greater than the dimension of the long side of the rectangular profile of the body  17  and greater than the width of the information leaflet  13 ; the dimension of the short side of the rectangular profile of the body  31  is greater than the sum of the dimension of the short side of the rectangular profile of the body  17  and the thickness of the information leaflet  13 ; and the length of the body  31  is greater than the length of the first outer enclosure  15  and greater than the length of the information leaflet  13 . 
     Due to its rectangular profile, the body  31  has two main panels  33  and  34  each corresponding to a respective long side of the rectangular profile, and two lateral panels  35  and  36  each corresponding to a respective short side of the rectangular profile. 
     A window  37  is made in the main panel  33 , here by a rectangular cut-out. 
     Except the window  37 , the main faces  33  and  34  and the lateral faces  35  and  36  of the body  31  are solid and opaque. 
     In the ready-to-sell packaging unit  10 , the window  37  and the traceability and anti-counterfeiting features  20  are arranged so that the traceability and anti-counterfeiting features  20  are visible through the window  37 . 
     Here, the long sides of the window  37  are parallel to the long sides of the main panel  33  and the short sides of the window  37  are parallel to the short sides of the main panel  33 . 
     Here, the window  37  is near a corner of the main panel  33  while being away from the sides of the main panel  33 . 
     The traceability and anti-counterfeiting features  20  are also located on a main panel of the body  17  of the first outer enclosure  15 , away from the sides of this main panel. 
     Here, the set  27  of headers is masked by the main panel  33  along one side of the window  37  and the body  31  includes along that side of the window  37  a set  40  of headers for identifying each of the features  20 , except the Data Matrix  21  for which there is no header. 
     Here, the set  40  is similar to the set  27 : each header of the set  40  is in line with the feature it identifies, respectively the serial number  22  (header is SN), the expiry date  23  (header is EXP), the batch number  24  (header is LOT), the manufacturing date  25  (header is MANUF) and the Global Trade Item Number  26  (header is GTIN). 
     The second outer enclosure  16  is provided with labelling features  41 , here the International Non-proprietary Name (INN) and/or brand name  42  of the product(s)  12  and mentions  43  in relation with the nature of the product(s)  12 . 
     The ready-to-sell packaging unit  10  is prepared simply by placing the first outer enclosure  15  and the information leaflet  13  within the second outer enclosure  16  as shown by the arrow  45  on  FIG. 6  and then folding the flaps  32  at each end of the body  31 . 
     In the ready-to-sell packaging unit  10  the information leaflet  13  is placed between the first outer enclosure  15  and the second outer enclosure  16 . 
     Here, the information leaflet  13  is placed on the side of the first outer enclosure  15  which is away from the window  37 , so that the information leaflet  13  is isolated from the window  37  by the first outer enclosure  15  which is interposed between the information leaflet  13  and the window  37 . 
     For further helping the retention of the information leaflet  13  within the second outer enclosure  16 , there is a slight compression of the information leaflet  13  between the first outer enclosure  15  and the second outer enclosure  16 . 
     The end flaps  32  provide a further retention of the information leaflet  13  within the second outer enclosure  16 . 
     For opening the ready-to-sell packaging unit  10 , the end flaps  32  of one end of the second outer enclosure  16  are unfolded, the first outer enclosure  15  and the information leaflet  13  are taken out, the first outer enclosure  15  is opened thanks to the easy opening feature  19  and the inner enclosure  11  is taken out. 
     The labelling features  41  of the second outer enclosure  16  enables the ready-to-sell packaging unit  10  to meet the customization requirements such as local language, registration code and special logo. 
     Since the information leaflet  13  is outside of the first outer enclosure  15 , no feature needing market specific customization has to be present on or within the first outer enclosure  15 . 
     The first outer enclosure  15  can thus be used in different markets and can accordingly be manufactured in very large series. 
     This is very convenient and economical because it enables efficient use of the industrial equipment for producing the first outer enclosure  15 , including the relatively complex portion of this equipment providing the traceability and anti-counterfeiting features  20  and providing the glued outermost end flaps  18  forming with the body  17  the anti-tampering features of the first outer enclosure  15 . 
     Once the first outer enclosure  15  is produced, the production of the ready-to-sell packaging unit  10  involves only placing the first outer enclosure  15  and the information leaflet  13  within the second outer enclosure  16 . 
     The ready-to-sell packaging unit  10  can thus be produced simply, conveniently and economically, including for small series which can even be made manually. 
       FIG. 7  illustrates a method for producing a ready-to-sell packaging unit  10  in which the step of manufacturing the first outer enclosure  15  is carried out in a first factory  51 , then the first outer enclosure  15  is shipped as shown by the arrow  52  to a second factory  53 , the second outer enclosure  16  and the information leaflet  13  are provided to the second factory  53 , and the step of placing the first outer enclosure  15  and the information leaflet  13  inside the second outer enclosure  16  is carried out at the second factory  53 . 
     More precisely, in the method illustrated on  FIG. 7 , the first factory  51  is a central factory manufacturing the first outer enclosure  15  in very large series. 
     The first outer enclosures  15  manufactured at the central factory  51  are shipped as shown by the arrows  52 ,  52 A and  52 B to different local factories, here the second factory  53  and two other local factories  53 A and  53 B. 
     The second outer enclosure  16  and the information leaflet  13  provided to the local factory  53  are customized to the requirements of the market on which the packaging units  10  produced by the local factory  53  are to be sold. 
     The second outer enclosure  16 A and the information leaflet  13 A provided to the local factory  53 A are customized to the requirements of the market on which the packaging units  10 A ( FIG. 8 ) produced by the local factory  53 A are to be sold. 
     The second outer enclosure  16 B and the information leaflet  13 B provided to the local factory  53 B are customized to the requirements of the market on which the packaging units  10 B ( FIG. 8 ) produced by the local factory  53 B are to be sold. 
     In the set of different ready-to-sell packaging units  10 ,  10 A and  10 B shown in  FIG. 8 , the first outer enclosure  15  is identical for the three packaging units  10 ,  10 A and  10 B whereas the information leaflet  13 ,  13 A or  13 B and the second outer enclosure  16 ,  16 A or  16 B are different for the three ready-to-sell packaging units  10 ,  10 A and  10 B. 
     In non-illustrated variants, the central factory  51  ships the first outer enclosures  15  to only two different local factories or to more than three different local factories, for instance eighteen different local factories each providing a respective market. 
     In non-illustrated variants, the first outer enclosure  15  has no labelling features  28 . 
     It should be noted in this respect that the labelling features  28  are masked by the second outer enclosure  16 ,  16 A or  16 B in the ready-to-sell packaging units  10 ,  10 A and  10 B so that they are not useful in these packaging units but that the labelling features  28  may be useful for meeting regulatory requirements for shipping the first outer enclosures  15  to the local factories, in particular regulations of certain countries regarding importation of pharmaceutical products. The labelling features  28  may thus be drafted in a language (or a couple of languages) easily read in a number of countries, for instance English and/or Spanish and/or French. 
     The labelling features  28  may also be used for drawing attention to the fact that the first outer enclosure is a semi-finished product not ready to be put on the market. It is noted in this respect that a packaging unit containing pharmaceutical products but no information leaflet is not ready to be put on the market because it is not compliant with typical regulatory requirements. 
     For simplifying the drawings, the labelling features  28  and  41  are shown on a main panel of the first outer enclosure  15  or the second outer enclosure  16 , but it is understood that such labelling features can be affixed anywhere on the first outer enclosure  15  or the second outer enclosure  16 . 
     In non-illustrated variants, the set of different ready-to-sell packaging units is produced in a same factory. 
       FIGS. 9 and 10  illustrate a variant of the ready-to-sell packaging unit  10  in which the second outer enclosure  16  is a sleeve  31 A similar to the body  31  but opened at each end (there is no end flaps  32 ). 
     As mentioned above, for further helping the retention of the information leaflet  13  within the second outer enclosure  16 , there is a slight compression of the information leaflet  13  between the first outer enclosure  15  and the second outer enclosure  16 . This is very useful in this variant in which the second outer enclosure  16  is opened at each end. 
     For helping the user to access or grip the first outer enclosure  15 , a recess or a cut-out can be provided at one end of the second outer enclosure  16 , for instance in the main panels  33  and  34  of the body  31 A. 
     For preventing the information leaflet  13  from leaving the ready-to-sell packaging unit  10 , a sticker  55  ( FIG. 11 ) is used at one end of the packaging unit  10  for securing together the first outer enclosure  15  and the second outer enclosure  16 . 
     The sticker  55  is here a simple transparent sticker. Other examples for the sticker  55  is a simple non-transparent sticker or a tamper evident sticker (also named void label or tamper evident label) configured for leaving behind a word message, for instance the word “open”, on both the sticker and the enclosure to which it was applied, if an attempt is made to remove the sticker. 
     The opening of this variant of the ready-to-sell packaging unit  10  with the body  31 A is similar except that the sticker  55  is taken out instead of unfolding the end flaps  32 . 
     Since the end flaps  18  of the first outer enclosure  15  are visible through the open ends of the sleeve  31 A, it is possible to have on the end flaps  18  a portion of the labelling features  28  intended not be masked by the second outer enclosure, for instance a manufacturer logo. 
       FIG. 12  illustrates a variant of the ready-to-sell packaging unit  10  similar to the variant shown on  FIGS. 9 to 11  but in which there is a sleeve  31 B instead of the sleeve  31 A. 
     The sleeve  31 B is similar to the sleeve  31 A but without window  37 , the opening through which the traceability and anti-counterfeiting features  20  are visible being the open end  56  of the sleeve  31 B seen at the left on  FIG. 12 . 
     In this variant, the traceability and anti-counterfeiting features  20  are affixed on the end flaps  18  of the corresponding end of the first outer enclosure  15  and the set  40  of headers of the second outer enclosure  16  are affixed along the open end  56 . 
     In non-illustrated variants, the information leaflet  13  is different from a folded sheet of paper, for instance a paper book; and/or the length and/or width of the information leaflet  13  is smaller than the length and/or width of the body  17 . 
     In non-illustrated variants, the anti-tampering feature of the first outer enclosure is provided differently than with glued end flaps such as  18 , for instance with adhesive security labels or tapes or seals or tamper evident stickers which must be teared or broken for opening the first outer enclosure; and/or the end flaps  32  of the body  31  of the second outer enclosure  16  can also be glued or sealed with any other suitable anti-tampering feature. 
     In non-illustrated variants, the Data Matrix code such as  21  is replaced by a different 2D or 3D code such as QR code or replaced by a proprietary safety Label and/or the traceability and anti-counterfeiting features include a hologram, a microprinting, a Guilloche-pattern and/or a heat and UV-sensitive label. 
     In non-illustrated variants, the set  40  of headers is different from the set  27  of headers, for instance in another language such as a translation into the language of the country/market; the location of the headers of the set  40  and/or  27  is different from in line with the identified features, for instance the headers are grouped; there is no set of headers  27 ; and/or the window  37  is located and/or arranged differently, for instance remote from any corner of the main panel  33  (instead of near a corner) and/or with an outline partially curved (instead of a rectangular outline). 
     In non-illustrated variants, the general form of the ready-to-sell packaging unit is different from parallelepiped, for instance another polyhedral form. 
     In non-illustrated variants, the second outer enclosure  16  is not in an opaque material but in a transparent material and includes no labelling features such as  41  since the labelling features  28  of the first outer enclosure  15  are visible through the transparent material and includes no window such as  37  since the traceability and anti-counterfeiting features such as  20  can be seen through the transparent material and/or through an open end such as  56 . 
     Numerous other variants are possible according to the circumstances and it is reminded in this respect that the invention is not limited to the described and drawn embodiments.