CN112654563A

CN112654563A - Tracking and tracing packages and systems

Info

Publication number: CN112654563A
Application number: CN201980056491.2A
Authority: CN
Inventors: L·K·盖恩斯; V·M·雅克; A·雅克; D·A·盖恩斯; C·G·莫里森; T·迈尔斯
Original assignee: Baby Blue Brand Corp
Current assignee: Baby Blue Brand Corp
Priority date: 2018-07-23
Filing date: 2019-07-22
Publication date: 2021-04-13
Also published as: EP3826938A4; CA3107428A1; EP3826938A1; WO2020023402A1; MX2021000940A

Abstract

Tracking and tracing packages are disclosed, which may also be tamper evident. Tracking and traceability functions can be incorporated on, in or near the packaging at various stages of the supply chain. The tamper evident material may be incorporated into a variety of packaging substrates that change color when exposed to oxygen, excessive heat and/or pressure. The security marking agent material may be used to provide tracking and traceability functions. Exemplary products that may be used with the tracking and tracing package of the present invention include packaged condoms, food and beverages, pharmaceutical products, hemp products, and the like.

Description

Tracking and tracing packages and systems

Technical Field

The present invention relates to tracking and retroactive packaging for articles of manufacture such as condoms, food and beverages, pharmaceutical products, cannabis and the like. The tracking and retroactive packaging may also contain tamper (damage indicating) material.

Background

Conventional condom packaging provides an expiration date, but no evidence of significant tampering. Air bubbles have been used in condom packaging as an indication of whether the packaging is damaged. However, there is a need for an easy and reliable indication that the condom packaging has been compromised. In addition, other types of tamper evident packaging for food products, pharmaceutical products, and the like are needed. Further, it would be desirable to provide tracking and traceability functionality for tamper-evident packages and other types of packages.

Disclosure of Invention

The present invention provides tracking and tracing packages, which may also be tamper evident. Tracking and traceability functions can be incorporated on, in or near the packaging at various stages of the supply chain. The tamper evident material may be incorporated into a variety of packaging substrates that change color when exposed to oxygen, excessive heat, and/or excessive pressure. The security marking agent material may be used to provide tracking and traceability functions. Exemplary products that may be used with the present tracking and tracing package include packaged condoms, food and beverages, pharmaceuticals, cannabinoids, etc.

One aspect of the present invention is to provide a tracking and tracing package comprising: an interior volume constructed and arranged to contain a product; and a first packaging layer between the interior volume and the exterior of the package, wherein the first packaging layer comprises: an inner wrap adjacent the interior volume; an outer layer comprising a film at least partially covering the inner wrapper and the interior volume; a pocket between the outer surface of the inner wrap and the inner surface of the outer layer; and at least one tracking and tracing element attached to at least one of the inner wrap layer or the outer layer, or located within the bag.

Another aspect of the present invention is to provide a tracking and tracing packaging material comprising: an inner wrap layer comprising a film; an outer wrap layer comprising a film; a pouch between the inner and outer wraps; at least one tracking and tracing element attached to the inner or outer wrap layer or located in a pocket between the inner and outer wrap layers.

Another aspect of the invention is to provide a method of manufacturing a tracking and tracing packaging material, the method comprising: providing an inner wrap layer comprising a film, an outer wrap layer comprising a film, and a pouch between the inner and outer wrap layers; at least one tracking and tracing element is applied in the inner or outer wrapping layer or in the pocket between the inner and outer wrapping layers.

These and other aspects of the invention will be apparent from the following description.

Brief description of the drawings

Fig. 1 is a partial schematic elevational view of a sealed condom package having a substantially transparent company logo and generally recognized symbols, according to an embodiment of the invention.

Fig. 2 is a partially schematic rear view of the sealed condom package of fig. 1, showing a generally transparent disposable symbol according to an embodiment of the invention.

Fig. 3 is a partial schematic elevational view of a condom package, once exposed to oxygen, showing a generally recognized symbol in a tamper-resistant color due to bloom of the color of the insult material, in accordance with an embodiment of the present invention.

Fig. 4 is a partial schematic elevational view of the condom package of fig. 3 once exposed to oxygen, showing a universally recognized or custom symbol in a tamper-resistant color due to the bursting of the tamper-evident material color.

Fig. 5 is a flow chart illustrating a method of manufacturing a tamper-evident condom package, according to an embodiment of the invention.

Fig. 6 is a partially schematic side cross-sectional view showing a portion of a layered packaging material according to an embodiment of the present invention.

Fig. 7 is a partly schematic side sectional view showing a part of a layered packaging material according to another embodiment of the present invention.

Fig. 8 is a partially schematic elevational view of a tracking and tracing condom package with tamper evident seals according to an embodiment of the invention.

Fig. 9 is a partially schematic side sectional view illustrating a portion of a layered package having a tracking and tracing element and an impairment indicating material in accordance with an embodiment of the present invention.

Fig. 10 is a partial side cross-sectional view showing a portion of a layered packaging material having a tracking and tracing element and a tamper indicating material in accordance with another embodiment of the present invention.

Fig. 11 is a partial schematic view of a multi-pack container for tamper evident packaged products including tracking and traceability features associated with the container, according to an embodiment of the present invention.

Fig. 12 is a partially schematic side cross-sectional view of a portion of a package including a package wrap including a tracking and tracing element and a tamper-indicating material, according to an embodiment of the invention.

Fig. 13 is a partially schematic side cross-sectional view of a portion of a package including a package seal including a tracking and tracing element and a tamper-indicating material according to another embodiment of the invention.

Fig. 14 is a schematic diagram illustrating features of a tracking and tracing system according to an embodiment of the present invention.

Fig. 15 and 16 show an impaired ink print pattern according to an embodiment of the present invention.

Figures 17-21 show the loss results from the following examples.

Detailed Description

The following is a detailed description of exemplary embodiments to illustrate the principles of the invention. The embodiments are provided to illustrate aspects of the invention, but the invention is not limited to any embodiment. The scope of the present invention encompasses numerous alternatives, modifications and equivalents. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention may be practiced according to the claims without some or all of these specific details. For the purpose of clarity, technical material that is known in the technical fields related to the invention has not been described in detail so that the invention is not unnecessarily obscured.

Embodiments of the present invention provide packaging for active and smart products, including information printed thereon that lets anyone who sees it know that the packaging has been compromised, and if so, discards the product. A tamper evident material may be used that causes the package to discolor when exposed to oxygen, extreme heat, and/or overpressure (e.g., pressure or tension). The tamper evident packaging provides a clear indication to the user: the products contained therein are damaged and can be immediately discarded.

Although the packaging for condoms is primarily described herein, the invention may be used with other products to be packaged, and for other applications. Non-limiting examples include food and beverages, pharmaceutical products and packaging (packaging, including modified atmosphere packaging, additives, coatings), cannabis, opioids, life sciences (laboratory products, including bioreactors and cell culture bottles, medical devices, diagnostics and equipment, surgical supplies and equipment, fertility supplies and equipment, imaging oxygen distribution in biomedicine, microbiology, and imaging oxygen distribution in and out of cells in biological systems), military and defense supplies and equipment, weapons, security and authentication (ciphertext, forgery prevention, anti-piracy, microprint, document stamping or stamping, currency, stamps, security tags and stamps), documents, evidence, commercial products (electronic devices, such as cell phones, tablets, computer chips and computers), vessels, tattoos and shipping containers, high-end (luxury goods, medical products, medical devices, and equipment, medical devices, and equipment, Artwork, archival protection), detectors/sensors (variable oxygen content detector, enzyme sensor, oxygen distribution sensor), advanced packaging (biodegradable packaging, braille-based packaging), and other advanced materials (reactive and responsive materials).

In certain embodiments, the tamper evident packaging may be provided as an overwrap for a previously packaged product, such as for a prepackaged food or pharmaceutical product. For example, pills, tablets, capsules, liquids, etc. packaged in bottles, blister packs, etc. may be overwrapped with tamper-evident packaging. In other embodiments, the food, pharmaceutical product, or other product may be directly wrapped with the tamper evident packaging.

Other features of the invention provide for information to be printed on the front and/or back layers of the package. The information may include any one or more of manufacturing information, artwork, text, logos, slogans, insignia, instructions, or the like.

Embodiments of the present invention also provide a method for making a tamper-evident package having a film layer of plastic, foil, paper or the like having a tamper-evident material applied thereto. The packaging film layer and the tamper-indicating material may be exposed to electromagnetic radiation, which renders the tamper-indicating material substantially colorless. In certain embodiments, the tamper evident material may be added to the packaging layer prior to insertion of the product and sealing of the package. The sealing unit may seal the packaging layers together around each product and dispense the packaged products separately or in strips. The sealing unit may also print manufacturing information on the sealed package.

Referring now in more detail to the embodiment of the invention in fig. 1 and 2, the combination of a condom and its packaging is schematically shown at 100. The combination includes a package, shown generally at 110, and a rolled condom, shown generally at 120. The package includes a front wrapper panel or layer 130 and a back wrapper panel or layer 140. The front 130 and back 140 wraps are sealed to each other around their respective edges. The label is shown generally at 150. The package description is shown generally at 199. In the illustrated embodiment, description 199 describes "techniques including tamper resistance. If the indication on the package turns dark blue please discard the product ". As shown in fig. 1, the front outer layer 210 covers the front wrapping layer 130. A wear indicating material is applied to the front outer layer 210. As shown in fig. 2, a rear outer layer 220 covers rear wrapping 140 and a wear indicating material is applied to rear outer layer 220.

Still referring to fig. 1 and 2, the universal symbols 190, 200 and company logo 180 are printed on a package having an indicating material comprising a reactive dye, such as methylene blue, an alternative oxygen sensitive reactive dye, or an alternative indicating material on the interior of the package, and processed to convert them to a colorless or different color form. When the reactive damage indicating material is subsequently activated by exposure to oxygen, extreme heat, or overpressure (e.g., pressure or tension), its appearance changes. For example, reactive lossy materials change color when exposed to oxygen. The color change should be stable enough to make the color visible for a long enough time. In certain embodiments, long-term stability may last for days, weeks, months, or years.

Fig. 3 and 4 schematically illustrate the condom package 100 in a compromised state, in which the condom package has been torn open. The

generic symbols

390, 400 and the company logo 380 are re-oxidized and change color (in the case of methylene blue) due to exposure to oxygen, or bloom in color due to extreme heat, overpressure, pressure or tension. Reoxidation is indicated by the color bloom of the company logo 380 and the

generic symbols

390, 400.

It will be appreciated that the rolled condom 120 as shown in Figs. 1-4 has an open end 160 and a closed end 170. However, the precise details of condom 120 are not relevant to the present invention, e.g., the condom may or may not be pre-lubricated, may have a tip for collecting ejaculation, etc.

Fig. 5 is a flow diagram illustrating a method of manufacturing a tamper-evident condom package, according to an embodiment of the invention. In step 510, the inner wall of the condom packaging layer is coated with an insult material, such as methylene blue, any suitable alternative oxygen sensitive reactive dye, or a combination of responsive color change materials. The material may be applied by any suitable means, such as spraying, brushing, screen printing, ink jet printing, and the like. Methylene blue dye can be used in the printing process. Other responsive materials may be thiazines, thionins, oxazines, azines, triphenylmethanes, indophenols, indigoids, thioindigoids, pyridinium viologenides (pyridines), and quinone-based substances. The additional responsive material may be a non-toxic phosphorus pigment, or any other oxygen sensitive reactive dye, or any dye that changes color when exposed to oxygen, extreme heat, overpressure, pressure or tension. The responsive wear material may include more than one reactive dye. There are processes involved to prepare oxygen sensitive reactive dyes to reduce them to a colorless form. The printer may be of conventional construction and operation and sprays the dye onto the package. The manufacturing information is provided by a processor (not shown) whose operation is not relevant to the present invention and which also controls the printing by the sealing unit.

In step 520, another layer (which may also have a tamper material applied thereto) may also be sealed or otherwise attached to the layer formed in step 510, e.g., to form a bag.

In step 530, the condom is inserted into a condom package or pouch. The condom may be pre-wrapped in any suitable type of wrapping prior to insertion into the pouch. Company logos and/or universal symbols may be printed on one or more of the packaging layers.

In step 540, the sealing unit seals the packaging layers together around each condom 120 and dispenses the condoms individually or in strips.

In step 550, the sealed condom package is exposed to electromagnetic radiation, such as ultraviolet radiation or any other radiation of appropriate wavelength, for example, to render the tamper-evident material substantially colorless.

In step 560, the compound is exposed to oxygen to change the color of the tamper-evident material by oxidation or another chemical reaction that changes the reactive dye from colorless to colored or from one color to another color when tampered with, extremely hot, over-pressurized, tensioned, or any other breach of the condom package, such as tearing, needle punching, or intentional opening of the condom package. Printing between the packaging layers prevents the dye from contacting the condom. Therefore, the user is unlikely to experience any reaction due to contact with the dye.

Fig. 6 and 7 are partial schematic side cross-sectional views illustrating various condom packaging layers according to embodiments of the invention. In fig. 6, the outer layer 610 is provided with a layer of lossy material 615 applied thereto. Inner condom wrap layer 630 is positioned adjacent outer layer 610 and insult material 615. In certain embodiments, the inner wrapper 630 may not adhere to the wear material layer 615, as shown by the gap 640 in fig. 6. Although gap 640 is shown in fig. 6 as a physical separation between

layers

630 and 615, it should be appreciated that the gap may be closed such that

layers

630 and 615 contact each other. For example, when the space between the outer layer 610 and the inner wrapper 630 is evacuated, the tamper material layer 615 will typically contact the underlying inner wrapper 630. Alternatively, when the space 630 between the outer layer 610 and the inner wrapper is filled with an inert or non-reactive gas, the pressure of the gas may cause a physical gap 640 to form, as shown in fig. 6.

The embodiment shown in fig. 7 is similar to the embodiment of fig. 6, except that the layer of abuse material 615 is applied to the outer surface of the inner casing 630 instead of the inner surface of the outer layer 610.

The various inner condom wrap layers and outer layers may be made from any suitable material, such as polymeric films, foils, papers, and the like, according to embodiments of the invention. Some examples of polymer layers include cellulosic materials, vinyl polymers such as polyvinyl alcohol and polyacrylates, polyolefins such as polyethylene, polyethylene terephthalate (PET), ethylene vinyl acetate copolymers, polyethylene, nylon (polyamide), and the like. The inner and outer layers may be made of the same or different materials. In certain embodiments, the inner wrapping layer may comprise a foil coated with any of the aforementioned polymers or just such polymers. In certain embodiments, the outer layer may comprise polyethylene or the like, which may optionally be coextruded with nylon or the like.

In an embodiment of the invention, the condom or other product is disposed in an inner wrap, an outer wrap surrounds the inner wrap, and a layer of the tamper-indicating material is applied to an inner surface of the outer wrap. Alternatively, as described above, the outer surface of the inner wrap may have an lossy material applied thereto. In both embodiments, the space between the inner and outer wraps may be evacuated by a vacuum source of any suitable type to remove gases including oxygen from the space between the wraps. In this embodiment, when the outer wrap is punctured, torn or otherwise breached, air will fill the previously evacuated space between the inner and outer wraps, making contact with the relatively large surface area of the wrap, i.e., the outer surface of the inner wrap will be exposed to the air and the inner surface of the outer wrap will be exposed to the air. The presence of the tamper-indicating material on the inner surface of the outer wrapper and/or on the outer surface of the inner wrapper will thereby provide an indication: the outer wrap has been punctured, torn or otherwise damaged and air has entered the space between the wraps. As an alternative to evacuating the space between the inner and outer wrappers, the inner space may be at least partially filled with an inert or non-reactive gas, such as nitrogen or the like, which does not cause the spoiled material to react and discolor.

According to embodiments of the present invention, a double wrap arrangement as described above may be performed by providing a pre-packaged condom or other product in an inner wrap, and then applying an outer wrap around the inner wrap. For example, the outer wrapper may be provided as a pre-formed bag into which the inner wrapper containing the product is inserted, followed by sealing the open end of the outer wrapper. As described above, the space between the inner and outer wraps may be evacuated and/or filled with a non-reactive gas before, during or after the sealing operation. As another example, the inner wrap and product may be sealed within the outer wrap by placing separate sheets of outer wrap material on opposite sides of the inner wrap containing the product and then sealing the peripheral edges of the outer wrap layers together. Also, during the sealing operation, the space between the inner wrap and the outer wrap may be evacuated and/or filled with a non-reactive gas. Such an operation, in which the product is first sealed in an inner wrapper and then an outer wrapper is sealed around the inner wrapper, may be performed simultaneously with each other, for example the inner and outer wrappers may be applied in the same manufacturing operation. Alternatively, the prepackaged product can be altered by applying the overwrap at a different time or location, for example, at a different facility than the original product manufacturing location.

According to another embodiment of the invention, a single product package is provided with a plurality of laminate layers, wherein at least one layer comprises a tamper-indicating material. For example, a layer of tamper indicating material may be sandwiched between inner and outer polymer layers to provide a composite wrap structure with tamper indicating capabilities. As another example, a layer of mar material may be applied on the inner surface of the individual product packages. In this embodiment, the tamper indicating material layer will be exposed to the product and the tamper indicating material must be non-reactive with the material of the product or any other liquid or gas contained in the package and the tamper indicating layer must not damage the product and vice versa.

The lossy material may comprise an absorption-based substance that produces a visible color change caused by chromogenic chemistry involving oxidation of molecular oxygen. Examples include methylene blue, resorufin, resazurin, thiazine, thionine, oxazine, azine, triphenylmethane, indophenol, indigo, thioindigo, viologen pyridinium, and quinone-based materials. The lossy material can also comprise luminescent-based substances such as polycyclic aromatic hydrocarbons, polypyridyl complexes, metalloporphyrins, complexes including platinum and palladium, cyclometallated complexes, and other luminescent metal complexes such as lead, aluminum, copper, gold, europium, terbium, molybdenum, and the like. Other lossy material substances include fullerenes, fluorescent polymers, and modified polymer materials containing absorbing-based or luminescence-based substances as described above. The additional responsive material may be a non-toxic phosphorus pigment, or any alternative oxygen sensitive reactive dye, or any dye that changes color when exposed to oxygen, extreme heat, overpressure, pressure or tension.

The reactive/responsive materials can be incorporated into a variety of formulations, including: inks, gels, plastics, composites, and the like. Ink formulations include resin/binder variants such as gelatin, celluloses such as hydroxyethyl cellulose (HEC), ethyl cellulose, cellulose acetate, polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), polyamides, polyurethanes, polyethylene oxide (PEO), polyacrylates, for example polymethyl methacrylate (PMMA), polymethacrylates and polystyrene or modified polystyrenes. The ink formulation may include inks commonly used on plastic films and vacuum packaging films, or inks used for pad printing, flexography, gravure, dot matrix pattern printing, steganography printing, and the like. Semiconductor variants include oxides of titanium, tin, tungsten, zinc, and/or mixtures thereof. Semiconductor size variations include sub-micron diameters, sub-50 nm diameters and sub-10 nm diameters. Variants of the sacrificial electron donor may be mild reducing agents, amines such as sodium ethylenediaminetetraacetate (NaEDTA) or Triethanolamine (TEOA), sugars such as glucose or fructose, antioxidants such as ascorbic acid or citric acid, or other easily oxidizable substances such as glycerol or oxidizable polymers such as polyvinyl alcohol (PVA). Variations of the additives include solubility modifiers (e.g., surfactants), permeability modifiers (e.g., silicones), and modifiers of Oxygen Transmission Rate (OTR) or Water Vapor Transmission Rate (WVTR). Examples of additives include moisture absorbers, oxygen scavengers, microwave susceptors, and antimicrobial agents.

In certain embodiments, a security marker material may be added to the formulation to authenticate the product to prevent counterfeiting. A known type of marking agent may be added to the lesion material. For example, the marking agent particles or compositions may be added to coatings, inks, and adhesives, or embedded in packaging layers and/or labels. Types of security marking agent materials include Infrared (IR) responsive particles and inks, Ultraviolet (UV) responsive particles and inks, fixed pigments, color changing materials, color shifting materials, thermochromic materials, and the like. A non-limiting example of a commercially available taggant that may be added to or used in conjunction with the lossy materials of the present invention is a granular taggant material sold under the name Microtaggant by Microtrace, LLC. Other types of commercially available taggant materials include the SunGuard ink sold by Sun Chemical Corporation. When the marking agent particles or compositions are added to the present mar coating, they may typically be present in minimal detectable trace amounts (up to 5 or 10% or more by weight of the coating). For example, the marking agent may comprise 0.001 to 5 wt%, or 0.01 to 2 wt%, or 0.1 to 1 wt% of the material.

In certain embodiments, tracking and traceability elements may be added to the formulation, to the outer layer of the package, to the inner layer of the package, to the design of the package (bag), to the vicinity of the tamper evident material, to the vicinity of the layer or bag of the package created by forming a unique pattern or layer or created by methods such as a blockchain that can capture, link and protect all information about the product. Tracking and tracing elements can be used to identify, authenticate, retain information/data, record location, report location, or provide real-time location tracking over a range of distances (short-range contact to long-range global positioning). Types of tracking and tracing elements include the above-described marker materials, and may also include machine-readable codes, such as Quick Response (QR) codes, bar codes, active Radio Frequency Identification (RFID), passive RFID, Bluetooth Low Energy (BLE), WiFi, GPS, and the like. Types of trace and trace elements also include real time tracking systems (RTLS) for real time. RTLS can be based on a variety of systems including active RFID, passive RFID, Infrared (IR), optical, ultrasonic, WiFi, bluetooth, etc., and combinations thereof. Non-limiting examples of commercially available tracking and tracing elements are embeddable RFID transponders (low (LF), High (HF), and Ultra High (UHF) frequencies) from HID, as well as various form factors and sizes. Other types of commercially available tracking and tracing elements include the RFID inlay design commercially available from Avery Dennison for operation in UHF, HF bands, and Near Field Communication (NFC). For the GPS tracking and traceability elements, commercially available GPS transceivers with miniature batteries or other suitable power sources may be used. Different types of tracking and tracing elements can be used in various combinations to meet product requirements. The blockchain technique may also generate tracking and tracing functionality for the product and/or significantly enhance the capture, security, transparency, and visibility of data from other tracking and tracing techniques.

Fig. 8 illustrates a tracking and tracing and tampering condom package 700 according to an embodiment of the invention. The package 700 has similar tamper-indicating features as the embodiment shown in fig. 1. In addition, the package 700 includes tracking and tracing

elements

710 and 730, as described more fully below. For example, at least one of the tracking and tracing

elements

710 and 730 may include a scannable code, such as a QR code, a barcode, or cross-hatching.

Fig. 9 and 10 are partial schematic side cross-sectional views of layered

packaging materials

701 and 702 according to embodiments of the present invention.

In the embodiment shown in fig. 9, a layered packaging material 701 includes tamper-indicating

elements

610, 615, 630, and 640, similar to the embodiment shown in fig. 6. In addition, the package 701 of fig. 9 includes tracking and tracing

elements

710, 720 and 730 located on or in the inner wrap 630 or outer layer 610. Although a plurality of tracking and tracing

elements

710, 720 and 730 are shown in fig. 9 at different locations relative to the inner 630 and outer 610 layers, it should be understood that only one such element may be used, or two such elements may be used.

In the embodiment shown in fig. 10, the layered packaging material 702 includes tamper-indicating

elements

610, 615, 630 and 640 similar to the embodiment shown in fig. 7. In addition, the package 702 of fig. 10 includes tracking and

traceability elements

712, 722 and 732 located on or in the inner wrap 630 or outer wrap 610. Although a plurality of tracking and tracing

elements

712, 722, and 732 are shown in fig. 10 at different locations relative to the inner 630 and outer 610 layers, it should be understood that only one such element may be used, or two such elements may be used.

Fig. 11 shows a multi-pack container 800 for a plurality of packaged products 700, which may correspond to the packaged products shown in fig. 1 and 8, or other types of packaged products. As shown in fig. 11, a multi-pack container 800 includes tracking and tracing

elements

810 and 830 attached to the container 800. Although each packaged product 700 shown in fig. 11 may have its own tracking and tracing

elements

710 and 730, the use of tracking and tracing

elements

810 and 830 on a multi-pack container 800 may eliminate the need for tracking and tracing elements on a single package 700. Further, the individual packages 700 may include tamper-indicating materials and features as described above.

Fig. 12 shows a package 900 comprising a container 910 and a layered tracking and tracing and tamper evident packaging material 701, which forms a product bag 920. The package 701 includes

impairment components

610, 615, 630, and 640, as described above, and also includes tracking and tracing

components

710, 720, and 730, as described above. The tracking and traceability and tamper evident package 900 shown in fig. 12 may be used with any desired type of product, such as food, pharmaceuticals, cannabis products, and the like.

Fig. 13 shows a package 950 comprising a container 960 having a threaded upper neck and opening 962, and a layered tracking and tracing and tamper evident seal 701 forming a product pouch 970. A threaded cap (not shown) may be removably secured to the threaded neck 962 of the container 960. Seal 701 includes

lossy elements

610, 615, 630, and 640 as described above, and also includes tracking and

traceback elements

710, 720, and 730 as described above. The tracking and tracing and damaging package 950 shown in fig. 13 may be used with any desired type of product, such as water or other beverages, liquids, flowable powders and granules, flowable tablets and capsules, and the like.

Fig. 14 illustrates various features of a tracking and tracing system according to an embodiment of the present invention. As shown in fig. 14, in certain embodiments, the lesion material 615 and tracking and tracing

elements

710, 730 may be applied to

packaging substrates

610, 630, such as plastic films and the like. Thus, a tracking and traceability package 701 is provided which can be applied to a product at various stages of the supply chain. For example, the loss-indicating tracking and tracing package 701 may be applied by the manufacturer, supplier, and/or breeder 1010 at an early stage in the supply chain. Alternatively, the loss-indicating tracking and traceability package 701 may be applied by a distributor, vendor and/or pharmacy 1020 further downstream in the supply chain. When the tamper evident tracking and traceability package 701 is applied at the manufacturing, supply or incubation stage 1010, the product with the tracking and traceability package applied thereto may thereafter be delivered 1015 to a distributor, vendor, pharmacy 1020, or the like. As further shown in fig. 14, with the tracking and traceability package 701 applied, the tamper package applied by a distributor, vendor, pharmacy, etc. may be delivered 1025 to the customer 1200. Alternatively, after the tamper-indicating tracked and traceable package 701 has been applied by the manufacturer, supplier, breeder 1010, etc., the tracked and traceable product may then be delivered directly to the customer 1200.

After delivering the tracking and tracing product to the customer 1200, the customer may verify the tracking and tracing information, for example, by using a scanner 1220 and an application 1210. The application 1210 may communicate with a display system 1230 that may be viewed or otherwise accessed by a customer. For example, the application 1210 may be loaded onto a customer's smart phone or other computing device, which may also include a display 1230. When scanner 1220 is used, it may be a stand-alone scanner or may be integrated with a user's smart phone or other personal device. The scanner 1220 may be used to detect the tracking and tracing information provided by the tracking and tracing

elements

710, 730. Further, the scanner 1220 may be used to detect color changes, etc. of the lossy material 615, such as by using visible, IR, and/or UV detectors capable of emitting color changes, etc. Additionally, the customer 1200 may visually inspect the package 701 to determine if the tamper material has been exposed to air.

As further shown in fig. 14, the tracking and trace back and impairment reporting system may include a tracking system 1100 that receives inputs from various sources, including: from the point or location where the tracking and tracing

elements

710, 730 and the tamper material 615 are applied to the

packaging substrates

610, 630; the point at which the loss-indicating tracking and traceability package 710 is applied to the product at the manufacturer, supplier or breeder 1010; during the shipping and/or delivery 1015 of the tracked and traceable product from the manufacturer, supplier, or breeder 1010; at a distributor, vendor or pharmacy location 1020; upon shipping and/or delivery 1025 of the tracked and traced product from the distributor, vendor or pharmacy 1020; when customer 1200 receives the tracking and tracing product; when the customer 1200 or another scans 1220 the tracking and tracing product; and/or when the customer 1200 or others retrieve the tracking and tracing information using the application 1210.

As further shown in FIG. 14, the tracking system 1110 includes outputs for various locations or stages of the supply chain, including outputs for: a manufacturer, supplier, or breeder 1010; the tracking and traceback product shipment and/or delivery 1015 from the manufacturer, supplier, or breeder 1010; a distributor, seller, or pharmacy 1020; the shipping and delivery 1025 of the tracked and traced product; a customer 1200; a data storage system 1110; and/or a blockchain system 1120. Data systems may receive, store, and transmit data using various types of hardware and software systems known to those skilled in the art and described more fully below. The blockchain system may include cryptography, point-to-point communication networks, and program protocols known to those skilled in the art. Blockchains allow digital information to be securely tracked and stored across multiple computers or blocks in a network. The data contained in each block can be verified by the previous block, thereby preventing the user from altering the information. The interconnected nature of the blockchain ensures the accuracy and validity of the collected data.

As mentioned above, the packaging substrate for the tracking and tracing elements and for the tamper evident material may be made of plastic film or the like. Suitable substrate types include plastics, glass, metals, organic composites (binders such as cellulose, polymers, etc.), inorganic composites (binders such as zeolites, silica gels, etc.), nanocomposites, and the like. Other embodiments of the formulation include multilayer plastic films, filled reinforced plastic composites, and filled non-reinforced plastic composites.

The tracking and traceability elements and/or the tamper evident material may be printed or applied to the packaging substrate by any suitable means, such as spraying, screen printing, brushing, dipping, ink jet printing, adhesives, and the like. Various printing variants can be used to track and trace elements and/or damage inks, such as variable coating thicknesses and variable coating line widths. In fig. 15, a microdot or dot matrix pattern is shown to increase the surface area of the ink throughout the mark. A cross-hatched pattern is shown in fig. 16 to increase the surface area of the ink throughout the mark.

In one embodiment, the finished form of the package may have a clearly displayed company logo on one side, and a clear icon of tampering on the opposite side, such as a trash can. If opened for intended use or punctured unintentionally or intentionally, exposing the interior of the product, exposing to extreme heat, excessive pressure or tension, the color of the package will change and highlight a generic "NO" symbol decorated thereon on the company logo, including but not limited to "don't go", "Prohibited", "X", circles, squares, triangles with a back-slash or straight line passing horizontally, vertically or diagonally therethrough, a stop sign, a hand, trash can symbol or custom symbol. On the opposite side, the trash can icon or alternative custom symbol may also change color, indicating that the package and product contained therein may be damaged and should be discarded.

The disclosed embodiments are illustrative and not restrictive. Although a particular configuration of condom and other types of containers including packages has been described, it should be understood that the invention may be applied to a variety of other packages for other types of products including paper, foil or plastic, and any combination thereof, such as foil-lined paper, plastic-lined paper or wax-lined paper. The packaging may take various forms, such as rectangular, oval, etc., or may be male or female condom packaging, or packaging for other types of products. The package may be provided with a separating structure, such as an edge tear region, a zip-lock edge region or an openable adhesively sealed edge region. There are many alternative ways of implementing the invention. Alternative embodiments include a transparent or translucent plastic lid, a transparent or translucent plastic container. The plastic may be LDPE, HDPE, PP or a combination of plastics including, but not limited to, polycarbonate or acrylic.

Embodiments of the packaging format include a wrap, a seal, a vacuum sealed outer wrap with an interior printed surface, a vacuum sealed outer wrap with a printed coupon between the article and the interior outer wrap surface, a vacuum sealed outer wrap comprising a multilayer plastic and an oxygen indicating ink added as an inner layer, and a vacuum sealed outer wrap comprising a multilayer plastic and compounding the oxygen indicating ink into a plastic material comprising at least one layer of the multilayer film.

The following embodiments are intended to illustrate various aspects of the present invention, and are not intended to limit the scope of the present invention.

Example 1

The damage indicating material was produced as follows. Ten grams of a 5% aqueous solution of hydroxyethyl cellulose (HEC) and 2.5 grams of a 5% aqueous dispersion of titanium dioxide (TiO)₂) Add to a 20mL amber glass scintillation vial. The mixture was sonicated in a warm sonication bath for about 30 minutes. In dispersing TiO₂Thereafter, 0.5 g of a 5% aqueous solution of Methylene Blue (MB) was added to the mixture. The mixture was sonicated or magnetically stirred for 10-15 minutes to disperse the MB in the aqueous mixture. After dispersing the MB into the mixture, 0.15g Triethanolamine (TEOA) was added using a plastic or glass pipette. The final formulation was sonicated in a warm sonication bath for about 30 minutes prior to substrate application.

The formulation is applied as a thin layer on a glass or plastic film substrate and allowed to dry. A standard laboratory glass microscope slide and a 3mil thick coextruded polyethylene-nylon vacuum packaging film were used as substrates for the coating. The plastic film may also be used as an overwrap to seal the coated glass sheet or plastic film prior to activation and deactivation. The formulations are typically applied by painting a film on the substrate with a paintbrush. Uniform film casting can also be accomplished using a spin coater or kbar technique. The coated substrate was dried in a dark oven set at 50 ℃ for 16 hours. The resulting blue layer has a dry film thickness of about 2 mils or less, with the thickness varying depending on the exact formulation. The dried blue tamper-indicating film was vacuum sealed within the plastic film overwrap. After evacuation and heat sealing, the material was "activated" under an ultraviolet lamp to convert the blue MB form to the white MB form. Upon such uv exposure, the layer changes from substantially blue to off-white or light gray. After activation, the layer was exposed to air by puncturing or cutting the vacuum overwrap, thereby turning blue. After color conversion, the layer retained its striking blue color for several weeks.

The formulations in examples 2 to 8 used commercial Ink formulations (Ink4 and Ink 6) for flexographic and gravure printing by Siegwerks. Ink6 was also modified for this work to give Ink 6A free of water, Ink 6B free of water or titanium dioxide, Ink 6C free of water and nano-titania and Ink 6D free of water and additives to increase oxygen permeability. Thus, the six different starting Ink formulations are Ink4, 6A, 6B, 6C, and 6D. Modification of the starting ink formulation produces a reactive/responsive loss indicating material. The reactive/responsive lossy material is labeled Ink X-Y, where X ═ 4, 6A, 6B, 6C, 6D, Y ═ a to J.

The reactive/responsive ink formulation was prepared as follows. Two grams of well mixed Ink formulation (Ink4, 6A, 6B, 6C, or 6D) was added to a 20mL amber glass scintillation vial. Then, 0.01 to 0.02 g of a reactive/responsive substance (methylene blue ═ MB) was weighed into a bottle. Finally, 0.10-0.80 grams of the sacrificial electron donor (TEOA) was weighed into a bottle. A magnetic stir bar was added to the bottle and the mixture was stirred and/or sonicated until the dye was well dissolved or dispersed (half an hour to 24 hours).

Prior to printing, the substrate is dried to remove any residual moisture. The substrate was a 75 micron thick 2-layer coextruded film of nylon and polyethylene. A small amount of the reactive/responsive ink formulation is applied to the dried substrate. A uniform film thickness was obtained using K-Bar (#0, #2, or # 6). The ink was drawn with K-Bar at a steady, constant pressure and speed. The printed substrate was dried in an oven at 50 degrees celsius until the ink cured (1 hour to 24 hours). The dried printed substrate was evacuated and heat sealed using a commercially available vacuum sealer. In one packaging version of this embodiment, the dried printed substrate is used as a vacuum-sealed outer wrap around a packaged product (e.g., a packaging condom).

The reactive/responsive ink formulation on the dried, printed and vacuum sealed substrate is activated with UV light. The uv lamp was preheated for at least 1 hour to stabilize and equalize the uv intensity. By heating at a set distance (3 inches) and intensity (about 10mW/cm for 1 hour of preheating)²) The printed and sealed substrate is exposed and the ink is uv activated to achieve a stable color change. MB changes from blue to colorless form. After activation, the layer is exposed to air by puncturing or cutting through the vacuum sealed overwrap. The color change was monitored over the course of about 20 minutes. The color begins to change the first minute after exposure.

Example 2

Using Ink6 listed in table 1 with Methylene Blue (MB) as the reactive/responsive species and Triethanolamine (TEOA) as the sacrificial electron donor, reactive/responsive lossy materials were prepared. Amounts are in grams. The damage indicating material was produced as follows. Two grams of well mixed Ink6 were added to a 20mL amber glass scintillation vial. Then, 0.01 to 0.02 g of a reactive/responsive substance (methylene blue ═ MB) was weighed into a bottle. Finally, 0.10-0.80 grams of the sacrificial electron donor (TEOA) was weighed into a bottle. A magnetic stir bar was added to the bottle and the mixture was stirred and/or sonicated until the dye was well dissolved or dispersed (half an hour to 24 hours).

Prior to printing, the substrate is dried to remove any residual moisture. The substrate was a 75 micron thick 2-layer coextruded film of nylon and polyethylene. A small amount of the reactive/responsive ink formulation is applied to the dried substrate. A uniform film thickness was obtained using K-Bar (#0, #2, or # 6). The ink was drawn with K-Bar at a steady, constant pressure and speed. The printed substrate was dried in an oven at 50 degrees celsius until the ink cured (1 to 24 hours). The dried printed substrate was evacuated and heat sealed using a commercial vacuum sealer. In one packaging version of this embodiment, the dried printed substrate is used as a vacuum-sealed outer wrap around a packaged product (e.g., a packaging condom).

The damage indicating ink formulation on the dried, printed and vacuum sealed substrate was activated with UV light. The uv lamp was preheated for at least 1 hour to stabilize and equalize the uv intensity. By heating at a set distance (3 inches) and intensity (about 10mW/cm for 1 hour of preheating)²) The printed and sealed substrate is exposed and the ink is uv activated to achieve a stable color change. MB changes from blue to colorless form. After activation, the layer is exposed to air by puncturing or cutting through the vacuum sealed overwrap. The color change was monitored over the course of about 20 minutes. The color begins to change the first minute after exposure.

TABLE 1

Example 3

Reactive/responsive lossy materials were prepared using Ink6 with Methylene Blue (MB) as the reactive/responsive species and glycerol as the sacrificial electron donor, as listed in table 2. Amounts are in grams. A lossy material was prepared as described in example 2.

TABLE 2

Example 4

Reactive/responsive lossy materials were prepared using Ink6 with resorufin (RR) as the reactive/responsive species and Triethanolamine (TEOA) as the sacrificial electron donor, listed in table 3. Amounts are in grams. The sacrificial material was prepared as described in embodiment 2.

TABLE 3

Example 5

Reactive/responsive lossy materials were prepared using Ink4 listed in table 4 with resorufin (RR) as the reactive/responsive species and Triethanolamine (TEOA) as the sacrificial electron donor. Amounts are in grams. A lossy material was prepared as described in example 2.

TABLE 4

Example 6

Reactive/responsive lossy materials were prepared using Ink 6A, 6C, and 6D listed in table 5 with Methylene Blue (MB) as the reactive/responsive species and Triethanolamine (TEOA) as the sacrificial electron donor. Amounts are in grams. A lossy material was prepared as described in example 2.

TABLE 5

Example 7

Reactive/responsive lossy materials were prepared using Ink 6A and 6D listed in table 6 with resorufin (RR) as the reactive/responsive species and Triethanolamine (TEOA) as the sacrificial electron donor. Amounts are in grams. A lossy material was prepared as described in example 2.

TABLE 6

Example 8

Reactive/responsive lossy materials were prepared using Ink 6C with resorufin (RR) as the reactive/responsive species and Triethanolamine (TEOA) as the sacrificial electron donor, listed in table 7. The response was adjusted with dilute acetic acid and dilute ammonium hydroxide. Amounts are in grams. The sacrificial material was prepared as described in embodiment 2.

TABLE 7

Fig. 17-20 show the results from the above example.

FIG. 17: UV activation of Ink 6C with MB and H/I modification.

FIG. 18: air exposure with MB and H/I modified UV activated Ink 6C.

FIG. 19: UV activation and air exposure (after 2 minutes) of Ink4 with RR and H/I modification.

FIG. 20: UV activation and air exposure (after 15 min) of Ink4 with RR and H/I modification.

Example 9

Reactive/responsive lossy materials were prepared using Ink4 and Ink6 listed in table X with Methylene Blue (MB) as the reactive/responsive species and Triethanolamine (TEOA) as the sacrificial electron donor. Amounts are in grams. The damage indicating material was produced as follows. Two grams of well mixed Ink4 or Ink6 were added to a 20mL amber glass scintillation vial. Then, 0.1 g of the reactive/responsive substance (methylene blue ═ MB) was weighed into a bottle. Finally, 0.10 grams of the sacrificial electron donor (TEOA) was weighed into a bottle. A magnetic stir bar was added to the bottle and the mixture was stirred and/or sonicated until the dye was well dissolved or dispersed (half an hour to 24 hours).

Prior to printing, the substrate is dried to remove any residual moisture. The substrate was a 75 micron thick 2-layer coextruded film of nylon and polyethylene. A small amount of the reactive/responsive ink formulation is applied to the dried substrate. K-Bar (#6) was used to obtain a uniform film thickness. The ink was drawn with K-Bar at a steady, constant pressure and speed. The printed substrate was dried in an oven at 50 degrees celsius until the ink cured (1 to 24 hours). The dried printed substrate was evacuated and heat sealed using a commercially available vacuum sealer. In one packaging version of this embodiment, the dried printed substrate is used as a vacuum-sealed outer wrap around a packaged product (e.g., a packaging condom).

The damage indicating material was activated with UV light on a dried, printed and vacuum sealed substrate. The UV lamp was preheated for at least 1 hour to stabilize and uniform the UV intensity. By heating at a set distance (3 inches) and intensity (about 10mW/cm for 1 hour of preheating)²) The printed and sealed substrate is exposed and the ink is uv activated to achieve a stable color change. MB changes from blue to bluish or colorless form. After activation, the layer is exposed to air by puncturing or cutting through the vacuum sealed overwrap. The color change was monitored over the course of one week as shown in fig. 21.

TABLE 8

For any element expressed herein as a means for performing a specified function, such element is intended to encompass any way of performing that function including, for example, a combination of elements that performs that function. Furthermore, the invention as may be defined by such means-plus-function claims resides in the fact that: the functions provided by the various described means are combined and brought together in the manner defined by the appended claims. Thus, any means that can provide such a function is deemed equivalent to that shown herein.

In various embodiments, certain aspects of the invention may be practiced using various models or platforms. For example, a software as a service (SaaS) model or an Application Service Provider (ASP) model may be used as a software application delivery model to convey software applications to users. Such software applications may be downloaded, for example, over an internet connection, and may run independently (e.g., to a laptop or desktop computer system), or through a third party service provider (e.g., accessed through a third party website). Additionally, cloud computing technology may be employed in connection with various embodiments of the invention.

Further, the processes related to the present embodiment may be executed by a programmable device such as a computer. Software or other sets of instructions that may be used to cause a programmable device to perform processes may be stored in any storage device, such as a computer system (non-volatile) memory. Further, some processes may be programmed at the time of manufacture of the computer system or via a computer-readable memory storage medium.

It will also be appreciated that certain process aspects described herein may be performed using instructions stored on a computer-readable storage medium or media that direct a computer or computer system to perform process steps. The computer readable medium may include, for example, storage devices such as magnetic disks, optical disks of the read-only and read/write variety, optical disk drives, and hard disk drives. The computer-readable medium may also include memory, which may be physical, virtual, permanent, temporary, semi-permanent, and/or semi-temporary. The memory and/or storage components may be implemented using any computer-readable media capable of storing data, such as volatile or non-volatile memory, removable or non-removable memory, erasable or non-erasable memory, writeable or re-writeable memory, and so forth.

A "computer," "computer system," "computing device," "component," or "computer processor" may be, for example, but not limited to, a processor, a minicomputer, a server, a mainframe, a laptop, a Personal Data Assistant (PDA), a wireless email device, a smartphone, a mobile phone, an electronic tablet, a portable phone, a pager, a facsimile machine, a scanner, or any other programmable device or computer device configured to transmit, process, and/or receive data. The computer systems and computer-based devices disclosed herein may include memory and/or storage components for storing certain software applications used in acquiring, processing, and communicating information. It is to be understood that such memory may be internal or external with respect to the operation of the disclosed embodiments. In one of the various embodiments, the first and second electrodes are,

a "host," "engine," "loader," "filter," "platform," or "component" may comprise various computers or computer systems, or may comprise a reasonable combination of software, firmware, and/or hardware. In certain embodiments, a "module" may comprise software, firmware, hardware, or any reasonable combination thereof.

In general, it will be apparent to one of ordinary skill in the art that the various embodiments described herein, or components or portions thereof, may be implemented in many different embodiments of software, firmware, and/or hardware or modules thereof. The software code or dedicated control hardware used to implement some of the present embodiments does not limit the invention. Programming languages for computer software and other computer implemented instructions may be translated into machine language by a compiler or assembler prior to execution and/or may be translated directly by an interpreter at runtime. Such software may be stored on any type of suitable computer readable medium or media, such as magnetic or optical storage media. Thus, the operation and behavior of the embodiments were described without specific reference to the actual software code or specialized hardware components. The absence of such specific references is feasible because it is clearly understood that one of ordinary skill in the art would be able to design software and control hardware to implement embodiments of the present invention based on the description herein with reasonable effort and without undue experimentation.

Various embodiments of the systems and methods described herein may employ one or more electronic computer networks to facilitate communication, transfer data, or share resources and information between different components. Such computer networks may be classified according to the hardware and software technology (e.g., fiber optic, ethernet, wireless LAN, HomePNA, power line communication, or g.hn) used to interconnect devices in the network.

Computer networks may be characterized based on the functional relationships between elements or components of the network (e.g., active networks, customer-side servers, or peer-to-peer functional architectures). For example, computer networks may be classified according to a network topology, such as a bus network, star network, ring network, mesh network, star bus network, or a layer topology network. Computer networks may also be classified based on the methods used for data communication, such as digital and analog networks.

As employed herein, an application server may be a server that hosts APIs to expose business logic and business processes for use by other applications. The application server may serve primarily network-based applications, while other servers may, for example, act as session initiation protocol servers, or work with the telephone network.

Although some embodiments may be illustrated and described as comprising functional components, software, engines, and/or modules performing various operations, it should be appreciated that such components or modules may be implemented by one or more hardware components, software components, and/or combinations thereof.

The flowcharts and methods described herein illustrate the functionality and operation of various implementations. If embodied in software, each block, step, or action may represent a module, segment, or portion of code, which comprises program instructions for implementing the specified logical function(s). The program instructions may be embodied in the form of source code that includes human-readable statements written in a programming language or machine code that includes digital instructions recognizable by a suitable execution system, such as a processing component in a computer system. If embodied in hardware, each block may represent a circuit or a plurality of interconnected circuits to implement the specified logical function.

As used herein, in the context of this application, the terms "comprising," "including," and the like are to be understood as being synonymous with "comprising," and thus open-ended, and do not exclude the presence of additional unrecited or unrecited elements, materials, stages, or method steps. As used herein, in the context of the present application, "consisting of" is understood to exclude the presence of any unspecified element, material, stage or method step. As used herein, in the context of the present application,

"consisting essentially of" is to be understood to include the specified elements, materials, stages or method steps (as applicable), as well as any unspecified elements, materials, stages or method steps that do not materially affect the basic or novel characteristics of the invention.

For the purposes of the foregoing description, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. Moreover, all numbers expressing, for example, quantities of ingredients used in the specification and claims are to be understood as being modified in all instances by the term "about" except in any operating examples or where otherwise indicated. Accordingly, the numerical parameters set forth are approximations that may vary depending upon the desired properties sought to be obtained by the present invention, unless otherwise indicated. At the very least, and not as an attempt to limit the application of the doctrine of equivalents, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

It should be understood that any numerical range recited herein is intended to include all sub-ranges subsumed therein. For example, a range of "1 to 10" is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, i.e., sub-ranges having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.

In this application, the use of the singular includes the plural, and plural encompasses singular, unless specifically stated otherwise. In addition, in this application, the use of "or" means "and/or," even though "and/or" may be explicitly used in some cases, unless explicitly stated otherwise. In this application, the articles "a," "an," and "the" include plural referents unless expressly and unequivocally limited to one referent.

While specific embodiments of the invention have been described above for purposes of illustration, it will be apparent to those skilled in the art that numerous variations of the details of the present invention may be made without departing from the invention as defined in the appended claims.

Claims

1. Tracking and tracing packaging comprising:

an interior volume constructed and arranged to contain a product; and

a first packaging layer located between the interior volume and the exterior of the package, wherein the first packaging layer comprises:

an inner wrap adjacent the interior volume;

an outer layer comprising a film at least partially covering the inner wrapper and the interior volume;

a pocket between the outer surface of the inner wrap and the inner surface of the outer layer; and

at least one tracking and tracing element attached to at least one of the inner or outer wrap layers or located inside the bag.

2. The tracking and tracing package of claim 1 further comprising a tamper indicating material in said bag between an outer surface of said inner wrapper and an inner surface of said outer layer.

3. The tracking and tracing package of claim 2 wherein said at least one tracking and tracing element comprises a taggant material.

4. The tracking and tracing package of claim 3 wherein said marking agent material is located inside said bag with tamper evident material.

5. The tracking and tracing package of claim 3, wherein said tamper or taggant material is applied to an inner surface of said outer layer.

6. The tracking and tracing package of claim 3 wherein said tamper or taggant material is applied to an outer surface of said inner wrapping.

7. The tracking and tracing package of claim 1, wherein said at least one tracking and tracing element comprises a scannable code, an RFID device, a BLE device, a WiFi device, a GPS device, or a combination thereof.

8. The tracking and tracing package of claim 1, wherein said at least one tracking and tracing element comprises a QR code and/or a GPS transceiver.

9. The tracking and tracing package of claim 1 wherein said at least one tracking and tracing element is attached to an inner surface of said outer layer or an outer surface of said inner wrapping layer.

10. The tracking and tracing package of claim 1 wherein said outer layer is coextensive with said inner wrapping layer.

11. The tracking and tracing package of claim 1, wherein a tamper evident material is located in said pouch and changes color when exposed to oxygen.

12. The tracking and tracing package of claim 1, wherein said bag is evacuated or at least partially filled with an inert gas.

13. The tracking and tracing package of claim 1, further comprising a second package layer comprising:

an inner wrap layer comprising a film having an inner surface contiguous with the interior volume;

an outer layer comprising a film at least partially covering the inner wrap and the interior volume and forming a damage indicating material pouch between an outer surface of the inner wrap and an inner surface of the outer layer, wherein the damage indicating material pouch is evacuated or at least partially filled with an inert gas; and

the tamper-indicating material in the tamper-indicating material pocket between the outer surface of the inner casing and the inner surface of the outer skin.

14. The tracking and tracing package of claim 1, wherein the product to be contained in the package is a condom, a food product, a beverage, a pharmaceutical product, or a cannabis product.

15. A tracking and tracing packaging material comprising:

an inner wrap layer comprising a film;

an outer wrap layer comprising a film;

a pouch between the inner and outer wraps; and

at least one tracking and tracing element attached to the inner or outer wrap layer or located in a pocket between the inner and outer wrap layers.

16. The tracking and tracing packaging material of claim 15, further comprising a tamper indicating material in said bag between said inner and outer wrappers.

17. The tracking and tracing packaging material of claim 15, wherein said tracking and tracing element comprises a scannable code, an RFID device, a BLE device, a WiFi device, a GPS device, or a combination thereof.

18. The tracking and tracing packaging material of claim 15, wherein said bag is evacuated or at least partially filled with an inert gas.

19. A method of manufacturing a tracking and tracing packaging material, comprising:

providing an inner wrap layer comprising a film, an outer wrap layer comprising a film, and a pouch between the inner and outer wrap layers; and

at least one tracking and tracing element is applied in the inner wrap layer or the outer wrap layer, or in the pocket between the inner wrap layer and the outer wrap layer.

20. The method of claim 19, further comprising applying a tamper evident material to the inner or outer wrapping layer within the bag.