A radiation dosage indicator with a colored laminate layer

Abstract

This present disclosure provides a radiation dosage indicator comprising: a first ply comprising at least one radiochromic film having a substrate covering with an active layer; optionally, a second ply having at least one visible indicium is configured to underlay the first ply; optionally, a third ply overlying the first ply comprising at least a one viewing zone and the visible indicium; and a fourth ply having a colored lamination layer overlying the active layer of the radiochromic film, optionally a fifth ply having a complementary colored lamination layer overlying the forth colored ply, wherein the active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film; and wherein the visible indicium of the second ply is configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold. The present disclosure also provides a semi quantitative radiation dosage indicator. The present disclosure also provides a radiation dosage indicator used in the field of insect sterilization, phytosanitary, food sterilization, medical device sterilization, and cannabis irradiation.

Description

Version 2 4370-NONPROV 8thNovember 2024 A RADIATION DOSAGE INDICATOR WITH A COLORED LAMINATE LAYER FIELD OF THE INVENTION

[0001] The presently disclosed process(es), procedure(s), method(s), product(s), result(s), and / or concept(s) (collectively referred to hereinafter as the “present disclosure or invention”) relates generally to a radiation dosage indicator comprising: at least one radiochromic film having a substrate covering with an active layer; and a colored lamination layer overlying the active layer of the radiochromic film. BACKGROUND OF THE INVENTION

[0002] The use of dosimeters to determine the absorbed dose of ionizing radiation received by a person or a substrate to which it is attached is well known. There are many types of dosimeters, the most common being the air-capacitor dosimeter, film badge and thermoluminescent dosimeter.

[0003] The air-capacitor dosimeter includes an inside chamber which serves as an ion chamber, and a central collecting electrode. An electric charge is placed on the central electrode. Such dosimeters, when charged, are essentially air-capacitors, and the amount of discharge during use is proportional to the absorbed dose of X-ray or gamma ray radiation received. Inherent in the use of such dosimeters is the need of a power source for applying a voltage between the electrode and the chamber wall.

[0004] A film badge dosimeter usually is loaded with one or more film packets. The simplest type of film badge consists of a small paper envelope containing a dental film, one-half of which is surrounded by a thin lead foil. The badge must contain one or more filters so that a comparison can be made of the relative blackening of the developed film from behind the various filters. This comparison reveals the extent of exposure to various types of radiation. Inherent in the use of such badge is the need of a developing process to develop the exposed film.

[0005] A thermoluminescent dosimeter is one that functions on the principle of thermoluminescence; that is, the property of certain substances that release light upon heating after they have been exposed to ionizing radiation. Inherent in this type of dosimeter is the need for measuring either the peak intensity or the integrated quantity of the light emitted.Version 2 4370-NONPROV 8thNovember 2024

[0006] It is known to make dosimeters having a substance which changes color when exposed to ionizing radiation. For example, in U.S. Pat. No. 4,001,587 to Georgy Mitrofanovich Panchenkov et al dated Jan. 4, 1977, dosimeters are disclosed which incorporate various dyes, some acid-sensitive and some not acid-sensitive, which change their color on exposure to radiation.

[0007] U.S. Pat. No. 5,051,597 and 5,084,623 disclose a radiation dosage indicator having a radiation sensitive zone capable of changing opacity in response to exposure to radiation to change the visibility of indicia on said indicator, and to the method of manufacturing such indicator.

[0008] U.S. Publication No.2016 / 0290859 discloses a film that is specifically manufactured for measuring long wavelength Ultraviolet (UVA) light. More specifically, it relates to a film manufactured for use in indicating an exposure and / or measuring dose of the exposure of long wavelength UV that is commonly used for UV curing of coating, pathogen inactivation and other industrial and medical applications.

[0009] U.S. Design Pat. No. 458,642 discloses an ornamental design for a radiation indicator tag.

[0010] U.S. Pat. No. 4,536,450 discloses a novel nonlinear optical, piezoelectric, pyroelectric, waveguide, and other materials are presented together with processes for their employment and articles formed thereby.

[0011] U.S. Pat. No.7,445,880 discloses photochromic filaments composed of the lithium salt of a conjugated, polymerizable polyacetylene having a carboxylic acid or carboxylate terminal group.

[0012] Radiochromic dosimetry film, sold by a brand name of Gafchromic™ RADIOCHROMIC by Ashland Inc, is designed for the quantitative measurement of absorbed dose of high-energy photons. As a self-developing film, radiochromic, can be used for the measurement of radiation. Since radiochromic film requires no post-exposure processing, there are no chemicals to dispose of and the film can be handled and used without need of a darkroom.Version 2 4370-NONPROV 8thNovember 2024

[0013] A Journal article, Nuclear Instruments & Methods in Physics Research, Section B: Beam Interactions with Materials and Atoms (2017), 406 (Part_A), 221-224 by Yuri, Y et. al. discloses use of a Gafchromic film radiochromic for the profile measurement of energetic ion beam.

[0014] A Journal article, Review of Scientific Instruments (2021), 92(6), 063301 by Abe Y et.al, discloses dosimetric calibration of Gafchromic radiochromic, MD-V3, and EBT3 films for dose ranges up to 100 kGy.

[0015] A Journal article, Nuclear Instruments and Methods in Physics Research B (2017), 406, 221-224 by Yosuke Yuri et.al, discloses use of a gafchromic film HD-V2 for the profile measurement of energetic ion beams.

[0016] It is surprisingly found that the ability to control the dose response of Gafchromic™ radiochromic film solely by varying color of the top laminate material. The optical density and dose at which each sample can obscure the current Rad-Sure “NOT” was observed. These kinds of films have a variety of applications utilize irradiation doses which fall within the range of radiochromic film. Such applications include insect sterilization, phytosanitary, and cannabis irradiation.

[0017] Hence, radiosensitive film solely by varying color of the top laminate material is very useful for various applications include insect sterilization, phytosanitary, food industry and cannabis irradiation.Version 2 4370-NONPROV 8thNovember 2024 SUMMARY OF THE INVENTION

[0018] One of the aspect of the present disclosure relates to a radiation dosage indicator comprising: a first ply comprising at least one radiochromic film having a substrate covering with an active layer; optionally, a second ply having at least one visible indicium is configured to underlay the first ply; optionally, a third ply overlying the first ply comprising at least a one viewing zone and the visible indicium; and a fourth ply having a colored lamination layer overlying the active layer of the radiochromic film, optionally a fifth ply having a complementary colored lamination layer overlying the forth colored ply wherein the active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film; and wherein the visible indicium of the second ply is configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

[0019] One of the aspect of the present disclosure relates to a radiation dosage indicator comprising: a first ply comprising at least one radiochromic film having a substrate covering with an active layer; optionally, a second ply having at least one visible indicium is configured to underlay the first ply; optionally, a third ply overlying the first ply comprising at least a one viewing zone and the visible indicium; a fourth ply having a colored lamination layer overlying the active layer of the radiochromic film; optionally a fifth ply having a complementary colored lamination layer overlying the forth colored ply, wherein the active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film; and wherein the visible indicium of the second ply is configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

[0020] Another aspect of the present disclosure relates to an active layer comprises: a) an active component; and optionally b) an amelioration agent.

[0021] Another aspect of the present disclosure relates to a radiation dosage indicator, comprising: a first ply comprising at least one radiochromic film having a substrate covering withVersion 2 4370-NONPROV 8thNovember 2024 an active layer; optionally, (a) a second ply overlying the first ply having indicator base comprising at least one color indicium overlying the substrate and underlying the active layer, or (b) a second ply having at least one indicator base comprising a color indicia underlying the substrate; optionally, a third ply overlying the first ply comprising at least a one viewing zone and the visible indicium; and a fourth ply having a colored lamination layer overlying on the active layer of the radiochromic film, optionally a fifth ply having a complementary colored lamination layer overlying the forth colored ply, wherein an active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film, and wherein the visible indicium of the second ply is configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

[0022] According to one of the aspect of the present application, the color indicia right below a color ply that is complementary will make the color indicia become dark. Green and purple colors lowers the threshold using a purple marker and a green ply, and the letters become dark.

[0023] One more aspect of the present application relates to a radiation dosage indicator, comprising: a first ply comprising first radiochromic film and second radiochromic film, wherein each radiochromic film is provided with a substrate covering with an active layer; optionally, a second ply having first visible indicium and a second visible indicium are configured to underly the first ply; optionally, a third ply overlying the first ply comprising a first viewing zone, and a second viewing zone; and a fourth ply having a colored lamination layer overlay the active layer of first radiochromic film and second radiochromic film, optionally a fifth ply having a complementary colored lamination layer overlying the forth colored ply, wherein the first radiochromic film is configured to overlay the first visible indicia and the second radiochromic film is configured to overlay the second visible indicium, wherein each radiochromic film is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film, wherein an active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film, and wherein the visible indicia of the second ply are configured to be exposed to view through the viewing zone and providing aVersion 2 4370-NONPROV 8thNovember 2024 visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

[0024] Another aspect of the present disclosure relates to the application of the radiation dosage indicator in the fields of insect sterilization, phytosanitary, food industry, medical products, and cannabis irradiation.Version 2 4370-NONPROV 8thNovember 2024 BRIEF DESCRIPTION OF THE FIGURES

[0025] The invention will be better understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawing are not to scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. The following figures are included in the drawing:

[0026] FIG. 1: Illustrates a Radiation dosage indicator X-Ray Dose Response Curves

[0027] FIG.2: Illustrates a structure of radiation dosage indicator.

[0028] FIG.3: Illustrates a structure of radiation dosage indicator with indicia.

[0029] FIG.4: Illustrates a structure of radiation dosage indicator with indicia.

[0030] FIG.5: Illustrates a structure of radiation dosage indicator with one indicia.

[0031] FIG.6: Illustrates a structure of radiation dosage indicator with two indicia.

[0032] FIG. 7: Complementary colors effect of wavelength on %Transmission Fifth ply and colored indicia.

[0033] FIG. 8: Complementary colors effect of wavelength on %Transmission Fifth ply and colored indicia with No Threshold and Threshold range

[0034] FIG.9. Proportional relation between % visible light transmission (color laminate).Version 2 4370-NONPROV 8thNovember 2024 DETAILED DESCRIPTION OF THE INVENTION

[0035] Before explaining at least one embodiment of the present disclosure in detail, it is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of the components or steps or methodologies set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0036] Unless otherwise defined herein, technical terms used in connection with the present disclosure shall have the meanings that are commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0037] All patents, published patent applications, and non-patent publications mentioned in the specification are indicative of the level of skill of those skilled in the art to which the present disclosure pertains. All patents, published patent applications, and non-patent publications referenced in any portion of this application are herein expressly incorporated by reference in their entirety to the same extent as if each individual patent or publication was specifically and individually indicated to be incorporated by reference.

[0038] All the articles and / or methods disclosed herein can be made and executed without undue experimentation in light of the present disclosure. While the articles and methods of the present disclosure have been described in terms of preferred embodiments, it will be apparent to those of ordinary skill in the art that variations can be applied to the articles and / or methods and in the steps or in the sequence of steps of the method(s) described herein without departing from the concept, spirit, and scope of the present disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the present disclosure.

[0039] As utilized in accordance with the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings.Version 2 4370-NONPROV 8thNovember 2024

[0040] The use of the word “a” or “an” when used in conjunction with the term “comprising” can mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.” The use of the term “or” is used to mean “and / or” unless explicitly indicated to refer to alternatives only if the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and / or.” Throughout this disclosure, the term “about” is used to indicate that a value includes the inherent variation of error for the quantifying device, the method(s) being employed to determine the value, or the variation that exists among the study subjects. For example, but not by way of limitation, when the term “about” is utilized, the designated value can vary by plus or minus twelve percent, or eleven percent, or ten percent, or nine percent, or eight percent, or seven percent, or six percent, or five percent, or four percent, or three percent, or two percent, or one percent. The use of the term “at least one” will be understood to include one as well as any quantity more than one, including but not limited to, 1, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 100, etc. The term “at least one” can extend up to 100 or 1000 or more depending on the term to which it is attached. In addition, the quantities of 100 / 1000 are not to be considered limiting as lower or higher limits can also produce satisfactory results.

[0041] References herein to "one embodiment," or "one aspect" or "one version" or “one objective” or "another embodiment," or " another aspect" or " another version" or “another objective” of the present disclosure can include one or more of such embodiment, aspect, version, or objectives, unless the context clearly dictates otherwise.

[0042] All percentages, parts, proportions, and ratios as used herein are by weight of the total composition, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and therefore do not include solvents or by-products that can be included in commercially available materials, unless otherwise specified.

[0043] All references to singular characteristics or limitations of the present disclosure shall include the corresponding plural characteristics or limitations, and vice-versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made.

[0044] Numerical ranges as used herein are intended to include every number and subset of numbers contained within that range, whether specifically disclosed or not. Further, theseVersion 2 4370-NONPROV 8thNovember 2024 numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range.

[0045] As used herein, the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps. The terms “or combinations thereof” and “and / or combinations thereof” as used herein refer to all permutations and combinations of the listed items preceding the term. For example, “A, B, C, or combinations thereof” is intended to include at least one of: A, B, C, AB, AC, BC, or ABC and, if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more items or terms, such as BB, AAA, AAB, BBC, AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context.

[0046] For purposes of the following detailed description, other than in any operating examples, or where otherwise indicated, numbers that express, 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”. The numerical parameters set forth in the specification and attached claims are approximations that can vary depending upon the desired properties to be obtained in carrying out the invention.

[0047] The term “or combinations thereof”, “and combinations thereof”, and “combinations thereof” as used herein refers to all permutations and combinations of the listed items preceding the term.

[0048] The term “laminate” refers to a layer adhered to active layer.

[0049] The term “amelioration agent” refers to an ingredient in a composition or formulation that provides a beneficial physical and / or chemical effect.

[0050] The term “substrate” refers to a material that serves as a base for an active layer.Version 2 4370-NONPROV 8thNovember 2024

[0051] The term “covering” refers to applying a layer on a substrate by using a composition selected from the group consisting of a coating composition, a printing composition, a extrusion composition, a lamination composition and combinations thereof.

[0052] The term “coating composition” refers to a composition in the form of, for example, a solution, an emulsion, a suspension, or a dispersion, that is suitable for applying onto a surface of a substrate.

[0053] The term “lamination composition” refers to a composition including at least two layers disposed adjacent to each other along a substrate (e.g., stacked layers).

[0054] The term "printing" is used to describe the operation of delivering radiosensitive ink composition from the inked member to the sheet or web being printed, whether this is effected solely by mechanical impression pressure, solely by electric forces, or a combination of the two. That is, the word "printing" is used in the broad sense merely to mean transfer from one element to another. It will be also understood that when one of the rolls or printing members is spoken of as having designs formed on the surface thereof, such designs may comprise text, pictures, or anything else desired to be printed. Moreover, the designs may be formed on the surface of the printing member in relief, by intaglio or gravure, or by planographic or lithographic methods. All such methods of forming or preparing a printing surface are well known in the conventional printing art and need not be described here, as Is also the case in connection with methods and apparatus for delivering Ink to the inked surface in desired quantities. In reading and interpreting this specification and the claims accompanying it, all terminology borrowed from the conventional printing art must be given broad meaning appropriate to this rather special field. As used herein, “extrusion composition” refers to the mixture of components that is extruded to form at least one extruded layer having a radio sensitive composition. The term extrusion composition may be used interchangeably with ‘extrusion mixture’. “Extruded composition” refers that has been extruded. All disclosures relating to (e.g. content of) the extrusion composition are equally applicable to the extruded composition, and vice versa.

[0055] In the present disclosure the term “radiation” refers to ionizing or non-ionizing radiation that carries enough energy to liberate electrons from atoms or molecules, thereby ionizing them. Radiation may include, but is not limited to, X-rays, gamma rays, electrons, protons, neutrons,Version 2 4370-NONPROV 8thNovember 2024 ions, or any combination thereof. Non-ionizing radiation refers to any type of electromagnetic radiation that does not carry enough energy per quantum (photon energy) to ionize atoms or molecules, that is, to completely remove an electron from an atom or molecule. Non-ionizing radiation may include, but is not limited to, ultraviolet (UV), visible, or infrared (IR) light, or any combination thereof.

[0056] The term “ionizing radiation” as used herein generally refers to radiation with a level of energy that is high enough to cause atoms to lose electrons and become charged or ionized. Ionizing radiation may be in the form of high energy particles, like alpha and beta particles, protons and neutrons, or in the form of electromagnetic waves, like gamma rays or X-rays. High energy particles and electromagnetic waves are released from the nuclei of radioactive atoms that are decaying or may be created by causing accelerated electrons to strike a metal target. Food irradiation is the physical treatment of food with high-energy ionizing radiation for the purpose of prolonging shelf life and prevent food-borne diseases in meat, poultry and seafood. Irradiation achieves this by destroying micro-organisms, viruses, bacteria or insects; preventing germination and sprouting of potatoes, onions and garlic and slowing down the ripening and ageing of fruit and vegetables. Irradiation can reduce the risk of food poisoning, control food spoilage and extend the shelf-life of foods without detriment to health and with minimal effect on nutritional or sensory quality. This view has been endorsed by international bodies such as the World Health Organisation (WHO), the Food and Agricultural Organisation (FAO) and Codex Alimentarius.

[0057] As used herein, the term "insect sterilization” is a biological control process. In this process, for example, a large number of male insects are sterilized by a radiation process. These insects are then released in the wild and compete to fertilize wild female insects. Because these sterile insects are competing with fertile insects, the total insect population is more controlled and potentially reduced.

[0058] As used here, the term "phytosanitary application" refers to a process that is intended to protect humans against harmful pests and diseases that can be found on plants.

[0059] As used herein, the term " medical device sterilization" refers to medical device or component to withstand sterilization and functional characteristics and mechanical properties without significant loss of capacity. sterilizing comprises sterilizing process during exposure toVersion 2 4370-NONPROV 8thNovember 2024 radiation such as gamma ray and / or X-ray. can withstand radiation sterilization and functional characteristics without substantial loss of medical device or parts thereof can be referred to as "radiation". Examples of high-energy photon sterilizing process comprises exposing the medical device to self-isotope source such as cobalt 60 emitted by the isotope source throughout the medical device generating ionized or electronic damage (those fracturing). sterilization may also comprise ethylene oxide sterilization, electronic beam sterilization, autoclaving (steam sterilization), plasma sterilization, dry heat sterilization, chemical sterilization and X-ray beam sterilization.

[0060] The term cannabis irradiation refers to exposing harvested cannabis to radiation— commonly including but not limited to gamma, electron-beam (e-beam), or x-ray—to render contaminants such as mould spores and other microbes inert and harmless to the consumer. At the outset of legalization, gamma irradiation was the most common method of decontamination, but since then, some producers have moved to e-beam irradiation, a shorter and cheaper process than gamma that produces comparable results.

[0061] The term “radiation sensitive film or radiochromic film” refers to a radiochromic dosimetry film comprises a substrate covering with an active layer, the film is designed for the quantitative measurement of absorbed dose of high-energy photons. Key technical features include: (i) dynamic dose range: 5 Gy to 50,000 Gy, (ii) develops in real time without post- exposure treatment; (iii) energy-dependence: minimal response difference from 100 keV into the MV range; (iv) near tissue equivalent; (v) high spatial resolution - can resolve features to 5 ppm, or less; (vi) active coating exposed for detection of low energy photon and electron; (vii) proprietary new technology incorporating a marker dye in the active coating: enables nonuniformity correction by using triple-channel dosimetry and decreases UV light sensitivity; and (viii) stable at temperatures up to 60 °C.

[0062] Gafchromic™ RADIOCHROMIC is useful as an active layer for the radiation dosage indicator of the present disclosure. Gafchromic™ RADIOCHROMIC has an asymmetrical cross section. Measurements indicate that the response of scanner or densitometer may be dependent on which side of the film is facing the light source. It is advised that active layer be consistentlyVersion 2 4370-NONPROV 8thNovember 2024 measured with the same side of the film facing the light source regardless of whether landscape or portrait orientation is used.

[0063] The term "about" refers to a range of values + 10% of a specified value. For example, the phrase "about 200" includes ± 10% of 200, or from 180 to 220.

[0064] All percentages, ratio, and proportions used herein are based on a weight basis unless other specified.

[0065] The active component is filamentary particles of lithium salt of a conjugated polymerizable polyacetylene having at least one terminal carboxylic acid or carboxylate group and a mixture of said polyacetylenes; said filamentary particles having a length to width ratio of at least 5:1; said filamentary particles having no platelet particles mixed therewith. The active component is further described in U.S. Pat. No.7,445,880.

[0066] The active component / coating is a radiation sensitive coating composition comprising a component (a) and a component (b) wherein said component (a) is a metal compound or a metalloid compound and said component (b) is at least one different metal compound or metalloid compound and further described in PCT Pub. No. WO 2023 / 064136.

[0067] The radiation sensitive material of a radiation dosimeter may be comprised of microcrystalline pentacosadiynoic acid (PCDA), or other diacetylenic compounds and other compounds that exhibit dose responsive chemical changes, dispersed in a polymer matrix. Subjecting monomeric PCDA crystals, or related compounds such at the metal salts of PCDA, to ionizing radiation results in progressive polymerization, the degree of polymerization increasing with radiation dose. The amount of polymerization (and hence, the radiation dose) can be determined by measuring either the optical density or the spectral absorption of the exposed dosimeter. However, it has been found that these parameters also vary with both the temperature of the device when measured as well as the thickness of PCDA dispersion and the moisture content of the polymer matrix. Maximum accuracy of dose measurement must account for the temperature and thickness and moisture effects.

[0068] Current film analysis technology centers around color change. A film badge dosimeter usually is loaded with one or more film packets. The simplest type of film badge consists of aVersion 2 4370-NONPROV 8thNovember 2024 small paper envelope containing a dental film, one-half of which is surrounded by a thin lead foil. The badge must contain one or more filters so that a comparison can be made of the relative blackening of the developed film from behind the various filters. This comparison reveals the extent of exposure to various types of radiation. Inherent in the use of such badge is the need of a developing process to develop the exposed film. A thermoluminescent dosimeter is one that functions on the principle of thermoluminescence; that is, the property of certain substances that release light upon heating after they have been exposed to ionizing radiation. Inherent in this type of dosimeter is the need for measuring either the peak intensity or the integrated quantity of light emitted. While such dosimeters perform satisfactorily, they require outside equipment or processes in order to function and / or be readable. That is, one cannot detect the level of absorbed radiation merely by visually observing the exposed material.

[0069] The present disclosure is directed to a radiation dosage indicator comprising: a first ply comprising at least one radiochromic film having a substrate covering with an active layer; optionally, a second ply having at least one visible indicium is configured to underlay the first ply; optionally, a third ply overlying the first ply comprising at least a one viewing zone and the visible indicium; and a fourth ply having a colored lamination layer overlying the active layer of the radiochromic film, optionally a fifth ply having a complementary colored lamination layer overlying the forth colored ply, wherein the active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film; and wherein the visible indicium of the second ply is configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

[0070] According to one more embodiment, mathematically f((Dose gray scale - indicia gray scale) + %T film color) = 0, where 0 defined not being able to see the NOT.

[0071] According to one of the embodiments, active layer comprises: a) an active component; and optionally, b) an amelioration agent.

[0072] According to one of the embodiments, the present disclosure relates to a radiation dosage indicator comprising: a radiosensitive film is comprised of an active component on a substrate;Version 2 4370-NONPROV 8thNovember 2024 and a colored-lamination layer is attached to the active layer of the radiosensitive film, and wherein the radiosensitive film visually represents the amount of radiation emitted as color change.

[0073] According to one more embodiment, the active component is present in amount from about 1 w / w% to 99 w / w% of the active layer.

[0074] According to one more embodiment, the active component is present in amount from about 1 w / w% to 10 w / w%, from about 11 w / w% to 20 w / w%, from about 21 w / w% to 30 w / w%, from about 31 w / w% to 40 w / w%, from about 41 w / w% to 50 w / w%, from about 51 w / w% to 60 w / w%, from about 61 w / w% to 70 w / w%, from about 71 w / w% to 80 w / w%, from about 81 w / w% to 90 w / w%, from about 91 w / w% to 99 w / w% of the active layer.

[0075] According to a non-limiting embodiment, the present disclosure relates to an active component selected from the group consisting of a functionalized or unfunctionalized acetylenic compound, metal compound, metalloid compound, and combinations thereof.

[0076] According to one more embodiment, the present disclosure relates to functionalized or unfunctionalized acetylenic compound is a the functionalized or unfunctionalized diacetylene compound.

[0077] According to another non-limiting embodiment of the present disclosure, the diacetylene compound is a lithium-based diacetylene compound.

[0078] In another non-limiting embodiment of the present disclosure, the metal and metalloid compound is selected from the group consisting of bismuth compound, cesium compound, barium compound, tungsten compound, aluminum compound, lead compound, silicon compound, lithium compound, potassium compound, zinc compound, sodium compound and combinations thereof.

[0079] In another non-limiting embodiment of the present disclosure, the metalloid compound is a silicon compound.

[0080] In another non-limiting embodiment of the present disclosure, the amelioration agent is selected from the group consisting of adsorption agents, binders, dyes, stabilizers, polymers, shelf life extenders, solvents, surfactants, and combinations thereof.Version 2 4370-NONPROV 8thNovember 2024

[0081] According to one more embodiment, the amelioration agent is present in amount from about 1w / w% to 99 w / w% of the of the active layer.

[0082] According to one more embodiment, the amelioration agent is present in amount from about 1 w / w% to 10 w / w%, from about 11w / w% to 20 w / w%, from about 21w / w% to 30 w / w%, from about 31w / w% to 40 w / w%, from about 41w / w% to 50 w / w%, from about 51w / w% to 60 w / w%, from about 61 w / w% to 70 w / w%, from about 71 w / w% to 80 w / w%, from about 81w / w% to 90 w / w%, from about 91 w / w% to 99 w / w% of the

[0083] In another non-limiting embodiment of the present disclosure, the dye is selected from the group consisting of new sunset yellow, fuschin cyanide, hexahydroxy ethyl violet cyanide, pararose aniline cyanide, leuco crystal violet, leuco malachite green, malachite green base, p- roseaniline base and combination thereof.

[0084] In one non-limiting embodiment of the present application, the suitable substrate of the present application is a paper, a plastic, a textile, a metal, a canvas, a cloth, a wood, a leather, a ceramic utensil, a ceramic cup, a ceramic tile, a composite and a glass.

[0085] The paper substrate is plain, coated or treated papers, particularly photographic quality paper.

[0086] The plastic substrate of the present application is made of polymers selected from the group consisting of transparent or non-transparent polyurethane, polycarbonate, polyethers, polyesters, polyvinyl chloride, polystyrene, polyethylene, polyolefin, vinyl, polyvinyl acetate, silicone rubbers, rubber latex, polyester-polyether copolymers, ethylene methacrylates, silicone, natural and synthetic rubbers, nylon, polyamide or combinations thereof.

[0087] According to one more embodiment of the present application, the substrate is a polyester.

[0088] In another embodiment of the present application, the colored lamination layer is selected from the group consisting of a polymer, a composite, an elastomer, plastic, a coating, and a glass.Version 2 4370-NONPROV 8thNovember 2024

[0089] In one non-limiting embodiment of the present application, the polymer of lamination layer is selected from the group consisting of polyvinyl chloride (PVC), polypropylene, polyethylene, polycarbonate, acrylic polymer, polyethylene terephthalate (PET), polyester, and olefin copolymers.

[0090] In another non-limiting embodiments of the present application, the composite lamination layer is selected from the group consisting of an inorganic-polymer composite, and fiber reinforced composites.

[0091] In one more embodiment of the present application, the glass lamination layer is selected from the group consisting of lower-iron glass, band pass selective glass, borosilicate glass and combinations thereof..

[0092] In a different embodiment of the present application, a suitable adhesive that could be optional for adhering this colored polymer to the active substrate.

[0093] In one more embodiment of the present application, a suitable adhesive is selected from the group consisting of cellulosic resins, polysulfone, agriculturally base glue, phosphate cement, ethylene vinyl acetate, epoxy, phenolics, cyanoacrylates, styrene butadiene rubber, silicone, epoxy hybrid, modified phenolics, modified acrylics, polychloroprene, Polyvinyl acetal, melamine formaldehyde, polyurethanes, reclaimed rubber, polyvinyl methyl ether, Thermoplastic elastomers, phenol resorcinol formaldehyde, polyesters, asphalt, polyisobutylene, Polyvinyl alcohol, polyamide, phenoxy, animal based glue, litharge cement, polysulfide, polyolefin, acrylic, sodium silicate, sulfur cement, butyl rubber. resorcinol formaldehyde, polyaromatic high temperature resins, natural rubber, acrylonitrile butadiene, polyvinyl acetate, urea formaldehyde, anaerobic resins, bituminous, polyvinyl chloride plastisol, hydrocarbon rubber based, chlorosulfonated polyethylene, hot-melt, fluorosilicone, fluoropolymer, polysulfide, polyether, chloroprene, maleimides and combinations thereof.

[0094] Examples of cellulosic resins include ethyl cellulose (EC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), ethylhydroxyethyl cellulose (EHEC), carboxymethyl cellulose (CMC), carboxymethylhydroxyethyl cellulose (CMHEC), hydroxypropylhydroxyethyl cellulose (HMHEC), methylcellulose (MC), methylhydroxypropyl cellulose (MHPC), methylhydroxyethylVersion 2 4370-NONPROV 8thNovember 2024 cellulose (MHEC), carboxymethylmethylcellulose (CMMC), hydrophobically modified carboxymethylcellulose (HMCMC), hydrophobically modified hydroxyethyl cellulose (HMHEC), hydrophobically modified hydroxylpropyl cellulose (HMHPC), hydrophobically modified ethylhydroxyethyl cellulose (HMEHEC), hydrophobically modified carboxymethylhydroxyethyl cellulose (HMCMHEC), hydrophobically modified hydroxypropylhydroxyethyl cellulose (HMHPHEC), hydrophobically modified methyl cellulose (HMMC), hydrophobically modified methylhydroxypropyl cellulose (HMMHPC), hydrophobically modified methylhydroxyethyl cellulose (HMMHEC), hydrophobically modified carboxymethylmothyl cellulose (HMCMMC), cationic hydroxyethyl cellulose (cationic HEC), cationic hydrophobically modified hydroxyethyl cellulose (cationic HMHEC), nano fibrillated cellulosics (NFC), microfibrillated cellulosics (MFC), cellulose acetate, cellulose triacetate, cellulose acetate phthalate, cellulose acetate butyrate, cellulose butyrate, cellulose tributyrate, cellulose propionate, cellulose tripropionate, cellulose acetate propionate, carboxymethylcellulose acetate, carboxymethylcellulose acetate propionate, carboxymethylcellulose acetate butyrate, cellulose acetate butyrate succinate, cellulose propionate butyrate, and the like.

[0095] Examples of epoxy compounds useful include epoxy compounds based on epichlorohydrin reaction products with polyfunctional alcohols, phenols, cycloaliphatic carboxylic acids, aromatic amines, or aminophenols. For example, bisphenol A diglycidyl ether, bisphenol F diglycidyl ether, resorcinol diglycidyl ether, and triglycidyl ethers of para-aminophenols. Other examples include epichlorohydrin reaction products with o-cresol novolacs, hydrocarbon novolacs and phenol novolacs. Diluents may also be used and include polymeric glycidyl ethers. The polymeric glycidyl ether can be formed from the reaction of epichlorohydrin with polyalkylene oxide to form glycidyl ethers. The glycidyl ether can be selected from groups consisting of allyl glycidyl ethers, diglycidyl ethers, phenyl glycidyl ethers and alkyl glycidyl ethers. In another approach, polymeric glycidyl ethers can be formed from mono- to poly-hydroxyl compounds with alkylene oxides and epichlorohydrin followed by treatment with aqueous sodium hydroxide. Cycloaliphatic epoxy resins, 1,6-hexanediol diglycidylether, and 1,4-butanediol diglycidylether are also useful as diluents.

[0096] Examples of compounds useful in the construction of polyurethanes include cyclobutane- 1,3-diisocyanate, cyclohexane-1,3- and 1,4-diisocyanate and mixtures of these isomers, diphenylVersion 2 4370-NONPROV 8thNovember 2024 methane-2,4'- and / or 4,4'-diisocyanate, 1,12-dodecane diisocyanate, ethylene diisocyanate, 1,6- hexamethylene diisocyanate, 2,4- and 2,6-hexahydrotolylene diisocyanate and mixtures of these isomers, hexahydro-1,3- and / or 1,4-phenylene diisocyanate, 1-isocyanato-3,3,5-trimethyl-5- isocyanato methyl cyclohexane, naphthylene-1,5-diisocyanate, perhydro-2,5'-and / or 4,4'-diphenyl methane diisocyanate, 1,3- and / or 1,4-phenylene diisocyanate, polyphenyl polymethylene polyisocyanates, perchlorinated aryl polyisocyanates, polyisocyanates containing carbodiimide groups, polyisocyanates containing allophanate groups, polyisocyanates containing isocyanurate groups, polyisocyanates containing urethane groups, polyisocyanates containing acrylated urea groups, polyisocyanates containing biuret groups, polyisocyanates obtained by telomerization reactions, polyisocyanates containing ester groups, 2,4- and 2,6-tolylene diisocyanate and mixtures of these isomers, 1,4-tetramethylene diisocyanate and triphenyl methane-4,4',4"- triisocyanatediisocyanates.

[0097] Suitable polyols useful in the preparation polyurethanes include polyether polyols, polyoxyethylene, polyoxypropylene, polyoxy butylene, polytetramethylene ether diols and triols, polyester polyols, poly(alkylene carbonate) polyols, hydroxyl-containing polythioethers and polymer polyols.

[0098] Suitable alkylene oxides useful in the preparation of polyurethanes include butylene oxides, epibromohydrin, epichlorohydrin, ethylene oxide, propylene oxide and styrene oxide which can be initiated by compounds such as amines, bisphenols, butanediol, catechol, ethylene glycol, glycerin, hexanediol, hexanetriol, hydroquinone, novolac resins, pentaerythritol, phosphoric acid, propylene glycol, resorcinol, sorbitol, sucrose, trimethylol propane and water.

[0099] Polyester polyols suitable in the preparation of polyurethanes include polycarboxylic acids such as adipic acid, azelaic acid, endomethylene tetrahydrophthalic acid anhydride, fumaric acid, glutaric acid anhydride, hexahydrophthalic acid anhydride, isophthalic acid, maleic acid, maleic acid anhydride, phthalic acid, phthalic acid anhydride, sebacic acid, suberic acid, succinic acid, trimellitic acid, tetrahydrophthalic acid anhydride and tetrachlorophthalic acid anhydride. Examples of polyhydric alcohols include butane diols, diethylene glycol, ethylene glycols, glycerol, 1,6-hexanediol, mannitol, methyl glycoside, neopentylglycol, 1,8-octanediol,Version 2 4370-NONPROV 8thNovember 2024 polyethylene glycols, polypropylene glycols, propane diols, pentaerythritol, quinitol, sorbitol, trimethylol propane, triethylene glycol and tetraethylene glycol.

[0100] Useful polyurethanes can be in the form of solid and liquids. For liquids, the polyurethane can be water-based (e.g., dispersion) or solvent based (e.g., solvent or curable monomer).

[0101] Useful hydroxyl-containing polymers include poly(vinyl alcohol), partially hydrolyzed poly(vinyl acetate / vinyl alcohol) or copolymers containing hydroxyethyl(meth)acrylate, copolymers containing hydroxypropyl(meth)acrylate, including modified and unmodified poly(vinyl alcohol), such as, acetoacetylated, anionic PVA, carboxylated PVA, non-cationic modified PVA and sulfonated. Copolymers of PVA, for example with ethylene oxide or propylene oxide, are also envisioned.

[0102] Useful phenoxy or poly(hydroxy ethers) materials include compositions derived from dihydric mononuclear phenols such as alkenylcatechols and halogenated catechols, alkenylhydroquinones and halogenated hydroquinones, alkenylresorcinols and halogenated resorcinols, catechol, hydroquinone, substituted hydroquinones such as alkylhydroquinones, substituted resorcinols (e.g., 5-methylresorcinol, 2,5-dimethylresorcinol, 5-ethylresorcinol, 4,5- dimethylresorcinol), resorcinol and substituted catechols. Examples of bis(4-hydroxyphenyl) alkanes such as bis(4-hydroxyphenyl)methane, dihydric polynuclear phenol include bisphenol A, 1,1-bis(4-hydroxyphenyl)ethane and 2,2-bis(4-hydroxyphenyl)butane, bis(4-hydroxyphenyl) cycloalkanes such as 1,1-bis(4-hydroxyphenyl)cyclohexane and compounds such as 4,4'- dihydroxybiphenyl.

[0103] Components to emulsion and / or solvent acrylic adhesives can include numerous acrylate and methacrylate monomers such as acrylic acid, n-butyl (meth)acrylate, 2-ethylhexyl (meth)acrylate, ethyl (meth)acrylate, 2-hydroxyethyl (meth)acrylate, isooctyl (meth)acrylate, isononyl (meth)acrylate, lauryl (meth)acrylate, methacrylic acid and methyl (meth)acrylate. Other monomeric components can include styrene, vinyl acetate, N-vinyl caprolactam and N-vinyl pyrrolidone.Version 2 4370-NONPROV 8thNovember 2024

[0104] Components to a polyvinyl chloride plastisol adhesive general include polyvinyl chloride (PVC) resins, PVC resin coated with a polyalkyl acrylate and PVC plasticizer. Examples of suitable acrylate monomers for coating the PVC resin include acid anhydrides, acrylic acid, acrylonitrile, 2-aminoethyl (meth)acrylate, 2-aminopropyl (meth)acrylate, 3-aminopropyl (meth)acrylate, 2-aminobutyl (meth)acrylate, 3-aminobutyl (meth)acrylate, 4-aminobutyl (meth)acrylate, (meth)acrylamide, N-2-aminoethyl (meth)acrylamide, N-2-aminpropyl (meth)acrylamide, and N-3-aminopropyl (meth)acrylamide, butene-1, n-butyl (meth)acrylate, cyclohexyl (meth)acrylate, cyclohexene monoxide, dipentaerythritol hexa(meth)acrylate, 3,4- epoxycyclohexylmethyl (meth)acrylate, ethylene, 2-ethylhexyl (meth)acrylate, ethacrylic acid, ethyl (meth)acrylate, fumaric acid, glycidyl (meth)acrylate, 2-hydroxyethyl (meth)acrylate, 2- hydroxypropyl (meth)acrylate, 3-hydroxyethyl (meth)acrylate, 2-hydroxybutyl (meth)acrylate, 3- hydroxybutyl (meth)acrylate, 4-hydroxybutyl (meth)acrylate, isobutyl (meth)acrylate, sec-butyl (meth)acrylate, t-butyl (meth)acrylate, isopropyl (meth)acrylate, itaconic acid, lauryl (meth)acrylate, maleic acid, methacrylic acid, α-methylstyrene, methyl methacrylate, pentene-1, propylene, n-propyl (meth)acrylate, stearyl (meth)acrylate, styrene and p-vinyl toluene.

[0105] Vinyl chloride monomer can be copolymerized with acrylic acid, acrylonitrile, 2- aminoethyl (meth)acrylate, 2-aminopropyl (meth)acrylate, 3-aminopropyl (meth)acrylate, 2- aminobutyl (meth)acrylate, 3-aminobutyl (meth)acrylate, 4-aminobutyl (meth)acrylate, (meth)acrylamide, N-2-aminoethyl (meth)acrylamide, N-2-aminopropyl (meth)acrylamide, N-3- aminopropyl (meth)acrylamide, benzyl (meth)acrylate, butene-1, butyl (meth)acrylate, cinnamic acid, cyclohexene monoxide, cyclohexyl (meth)acrylate, dibutyl maleate or fumarate, dibenzyl maleate or fumarate, dicyclohexyl maleate or fumarate, diethyl maleate or fumarate, dimethyl maleate or fumarate, dioctyl maleate or fumarate, dipentaerythritol hexa(meth)acrylate, dipropyl maleate or fumarate, 3,4-epoxycyclohexyl (meth)acrylate, ethacrylic acid, ethyl (meth)acrylate, ethylene, ethyl vinyl ether, fumaric acid, glycidyl (meth)acrylate, 2-hydroxyethyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxybutyl (meth)acrylate, 3-hydroxybutyl (meth)acrylate, 4-hydroxybutyl (meth)acrylate, itaconic acid, and itaconic anhydride, maleic acid, maleic anhydride, methacrylic acid, methacrylonitrile, methyl (meth)acrylate, α-methylstyrene, methyl vinyl ether, monoalkyl maleate, monoalkyl fumarate,Version 2 4370-NONPROV 8thNovember 2024 monoalkyl itaconate, octyl (meth)acrylate, pentene-1, propyl (meth)acrylate, propyl vinyl ether, propylene, styrene, vinylidene chloride.

[0106] Examples of suitable plasticizers include acetyl triethyl citrate, acetyl tri-(2-ethylhexyl) citrate, benzyl phthalate, butyl acetyl ricinolate, n-butyl stearate, cresyl dipenyl phosphate, di-n- butyl adipate, butyl benzyl phthalate, dibutylmethylenebisthio-glycolate, dibutyl itaconate, di-n- butyl fumarate, di-n-butyl maleate, butyl oleate, dibutyl phthalate, di-n-butyl sebacate, di-(2- ethylhexoate, 2-ethylhexyl epoxyhexahydrophthalate, diisodecyl epoxyhexahydrophthalate, diethyl itaconate, diethylene glycol dibenzoate, diethylene glycol monooleate, diethylene glycol monolaurate, diethylene glycol dipelargonate, glyceryl monooleate, glyceryl monoricinolate, glycerol monoacetate, glycerol triacetate, glycerol tributyrate, glycerin monostearate, diethylene glycol ricinolate, diethylene glycol distearate, diethyl maleate, diisodecyl adipate, diisononyl adipate, dicyclohexyl phthalate, di-(2-ethylhexyl) adipate, di-(2-ethylhexyl) azelate, di-(2- ethylhexyl) fumarate, di(2-ethylhexyl) itaconate, di-(2-ethylhexyl) phthalate, di-(2-ethylhexyl) isophthalate, di-(2-ethylhexyl) maleate, di-(2-ethylhexyl) sebacate, di-(2-ethylhexyl) tetrahydrophthalate, diethyl phthalate, di-n-hexyl azelate, diheptyl phthalate, diisodecyl phthalate, diisobutyl phthalate, diisodecyl tetrahydrophthalate, diisooctyl azelate, diisooctyl disophthalate, dimethyl itaconate, dimethyl isophthalate, dimethyl maleate, dimethyl phthalate, di-n-octyl phthalate, di-n-octyl tetrahydrophthalate, dinonyl phthalate, diphenyl phthalate, dipropylene glycol dibenzoate, ditridecyl phthalate, diundecyl phthalate, di(heptyl, nonyl, undecyl) phthalate), epoxytriglyceride, epoxylated octyl oleate, epoxylated decyl oleate, epoxylated soy bean oil, epoxybutyl stearate, methyl acetyl ricinolate, monomethyl itacontate, monobutyl itacontate, n- octyl-2-pyrrolidone, n-alkyl-2-pyrroldione, n-alkyl-2-lactam, pentaerythritol fatty acid ester, phthalate type polyester; partially hydrogenated terphenyl, sebacate type polyester, tetra-(2- ethylhexyl) pyromellitate, tetra-n-octyl pyromellitate, tri-n-butyl citrate, tributyl phosphate, tributoxyethyl phosphate, triethyl citrate, triethyl phosphate, tri(2-ethylhexyl) trimellitate, tri-n- octyl trimellitate, triisodecyl trimellitate, triisooctyl trimellitate, tri-n-hexyl trimellitate, triisononyl trimellitate, tri-(2-ethylhexyl) phosphatetriphenyl phosphate, tricresyl phosphate, trixylenyl phosphate, and tris(chloroethyl) phosphate, triethylene glycol di-(2-ethylbutyrate) and triethylene glycol.Version 2 4370-NONPROV 8thNovember 2024

[0107] Components of polyisobutylene adhesives can comprise functionalized and un- functionalized polyisobutylene (PIB) polymer. PIB is the product of the polymerization of isobutylene. In cases where functionalization is desirable, the functionalized PIB polymer can be a homopolymer of isobutylene or a copolymer of isobutylene and another monomer such as butadiene, butene, isoprene and / or styrene.

[0108] The functionalization of polyisobutylene can be achieved by modification with functional group that is capable of hydrogen bonding (e.g., a carboxylic acid or amine moiety). Common hydrogen-bond donors include alcohols, carboxylic acids, phenols, phosphonic acids, phosphoric acid esters, sulfonic acids and sulfinic acids. Common hydrogen-bond acceptors include nitrogen containing groups such as amides, amines, carbamates, carboxylic acid, carboxylic ester, imidazole, imides, imines, nitriles, phosphonates, pyridines, sulfoxides, sulfones and ureas. For example, the functionalized PIB can possess a functional moiety having a terminal nitrogen containing group such as an amine or imide.

[0109] Components of polyvinyl acetate adhesives comprise vinyl acetate and may optionally include one or more additional ethylenically unsaturated copolymerizable monomers. Examples of comonomers include alpha, beta-unsaturated C4-C10 alkenedioic acids such as maleic acid, fumaric acid and itaconic acid and their monoesters and diesters with the C1-C18alkanols, such as dibutyl maleate and dioctyl maleate, ethylene, C3-C10alkenoic acids (e.g., acrylic acid, methacrylic acid, crotonic acid and isocrotonic acid and their esters with C1-C18 alkanols, such as butanol, ethanol, 2-ethylhexanol, methanol and propanol), vinyl halides such as vinyl chlorides, nitriles, amides, N-methylol amides, lower alkanoic acid esters of N-methylol amides, lower alkyl ethers of N-methylol amides and allylic carbamates, such as acrylonitrile, acrylamide, methacrylamide, N-methylol acrylamide, N-methylol methacrylamide, N-methylol allylcarbamate, and lower alkyl ethers or lower alkanoic acid esters of N-methylol acrylamide, N-methylol methacrylamide and N-methylol allylcarbamate.

[0110] Components of cyanoacrylate adhesives include 2-cyanoacrylates (2-cyanoacrylic acid esters) and additives such as anionic polymerization inhibitors, dyes, perfumes, pigments, plasticizers, radical polymerization inhibitors and thickening agents. Additional examples of 2- cyanoacrylates include esters of methyl, ethyl, chloroethyl, n-propyl, i-propyl, allyl, propargyl, n-Version 2 4370-NONPROV 8thNovember 2024 butyl, i-butyl, t-butyl, n-pentyl, n-hexyl, cyclohexyl, phenyl, tetrahydrofurfuryl, heptyl, 2- ethylhexyl, n-octyl, nonyl, oxononyl, decyl, n-dodecyl, ethoxyethyl, 3-methoxybutyl, ethoxyethoxyethyl, trifluoroethyl and hexafluoroisopropyl moieties on 2-cyanoacrylic acid.

[0111] In a different embodiment of the present application, the colored lamination layer of the radiation dosage indicator is subjected to a radiation dosage to measure dose response characteristics.

[0112] Another objective of the present disclosure relates to colored lamination of a RGB color shade of R is ranging from 0 to 255; G is ranging from 0 to 255; and B is ranging from 0 to 255, and wherein R=G=B≠0.

[0113] The radiation dosage indicator, wherein the colored lamination layer is intrinsic with percentage transmission and spectra; wherein the colored lamination layer is intrinsic with percentage transmission and wavelength; wherein the colored lamination layer causes changes in the threshold in the addition of colors; or wherein the colored lamination layer at any two wavelength specific percentage transmission can be added or cancelled.

[0114] In one more embodiment of the present application, R is in the range of from about 0 to about 20, from about 21 to about 40, from about 41 to about 60, from about 61 to about 80, from about 81 to about 100, from about 101 to about 120, from about 121 to about 140, from about 141 to about 160, from about 161 to about 180, from about 181 to about 200, from about 201 to about 220, from about 221 to about 240. from about 241 to about 255.

[0115] In one more embodiment of the present application, G is in the range of from about 0 to about 20, from about 21 to about 40, from about 41 to about 60, from about 61 to about 80, from about 81 to about 100, from about 101 to about 120, from about 121 to about 140, from about 141 to about 160, from about 161 to about 180, from about 181 to about 200, from about 201 to about 220, from about 221 to about 240. from about 241 to about 255.

[0116] In one more embodiment of the present application, B is in the range of from about 0 to about 20, from about 21 to about 40, from about 41 to about 60, from about 61 to about 80, from about 81 to about 100, from about 101 to about 120, from about 121 to about 140, from about 141Version 2 4370-NONPROV 8thNovember 2024 to about 160, from about 161 to about 180, from about 181 to about 200, from about 201 to about 220, from about 221 to about 240. from about 241 to about 255.

[0117] In a different embodiment of the present application, R=G=B≠0.

[0118] In one more embodiment of the present application, the radiation dosage indicator is capable of measuring dose response characteristics that are from about 5Gy to about 50,000 Gy .

[0119] In one more embodiment of the present application, the radiation dosage indicator is capable of measuring dose response characteristics that are from about 10Gy to about 10,000 kGy.

[0120] In one more embodiment of the present application, the radiation dosage indicator is capable of measuring dose response characteristics that are from about 100Gy to about 2,500 kGy.

[0121] In one more embodiment of the present application, the radiation is based on X-rays, alpha rays, beta rays, neutron rays, gamma rays, ultraviolet light rays, visible light, electron beam, or combinations thereof.

[0122] In another embodiment of the present application, the radiation dosage indicator further comprises a layer of visible indicia between the radiosensitive film and the substrate.

[0123] In another embodiment of the present application, the visible indicia are obscured by the layer of radiosensitive film in response to exposure to a radiation dosage exceeding a predetermined threshold.

[0124] In another embodiment of the present application, the requisite amount of radiation in a process of measuring dose response characteristics is machine readable.

[0125] In one more embodiment of the present application, the radiation dosage indicator is used in the field of insect sterilization, phytosanitary, food sterilization, medical device sterilization, and cannabis irradiation.

[0126] In another embodiment of the present application the radiochromic film is produced by covering with an active layer composition selected from the group consisting of a coating composition, a printing composition, a extrusion composition, a lamination composition and combinations thereof.Version 2 4370-NONPROV 8thNovember 2024

[0127] According to a non-limiting embodiment of the present application, the structure of radiation dosage indicator is shown in FIG. 2. The structure comprises a radiosensitive film attached to a colored lamination layer. The radiosensitive film is comprised of active film on a polyester substrate. The film comprised of an active layer, nominally 8μm thick, containing the active component, and optionally amelioration agent, giving the film its energy-independent response. The thickness of the active layer may vary slightly from batch-to-batch. The active layer is coated on a clear, 97μm polyester substrate.

[0128] In one non-limiting embodiment of the present application, the visible indicia is a Rad- Sure – “NOT” base. FIG.3 and FIG.4 represents radiation dosage indicator with visible indicia.

[0129] Another objective of the present disclosure relates to a radiation dosage indicator, comprising: a first ply comprising at least one radiochromic film having a substrate covering with an active layer; optionally, (a) a second ply overlying the first ply having indicator base comprising at least one color indicium overlying the substrate and underlying the active layer, or (b) a second ply having at least one indicator base comprising a color indicia underlying the substrate; optionally, a third ply overlying the first ply comprising at least a one viewing zone and the visible indicium; and a fourth ply having a colored lamination layer overlying on the active layer of the radiochromic film, optionally a fifth ply having a complementary colored lamination layer overlying the forth colored ply, wherein an active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film, and wherein the visible indicium of the second ply is configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

[0130] In one non-limiting embodiment of the present application, a radiation dosage indicator, comprising: a first ply comprising first radiochromic film and second radiochromic film, wherein each radiochromic film is provided with a substrate covering with an active layer; optionally, a second ply having first visible indicium and a second visible indicium are configured to underly the first ply; optionally, a third ply overlying the first ply comprising a first viewing zone, and a second viewing zone; and a fourth ply having a colored lamination layer overlay the active layer of first radiochromic film and second radiochromic film, optionally a fifth ply having aVersion 2 4370-NONPROV 8thNovember 2024 complementary colored lamination layer overlying the forth colored ply, wherein the first radiochromic film is configured to overlay the first visible indicia and the second radiochromic film is configured to overlay the second visible indicium, wherein each radiochromic film is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film, wherein an active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film, and wherein the visible indicia of the second ply are configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

[0131] In one non-limiting embodiment of the present application, a radiation dosage indicator, is a semi quantitative radiation dosage indicator comprises a first radiochromic film and second radiochromic film and both radiochromic films exhibits a different radiation response corresponding to a different radiation dosage.

[0132] In one non-limiting embodiment of the present application, the radiation dosage indicator is produced by a composition selected from the group consisting of coating composition, printing composition, extrusion composition, lamination composition and a combination thereof.

[0133] In one more embodiment of the present application, the radiation dosage indicator is used in the field of insect sterilization, phytosanitary, and cannabis irradiation.

[0134] In one more embodiment of the present application, the radiation dosage indicator is used in the field of sterilization of surfaces and solutions, medical imaging, medical or industrial equipment quality assurance testing, UV light measurement, food processing and storage, transportation of radiation sensitive materials, phytosanitary applications, insect sterilization processes, industrial curing processes, pathogen reduction processes, blood processing, or other applications where the knowledge of radiation exposure dose is important. In another embodiment, the dosimetry device of the present application finds various uses in blood bags, their method of processing and use. Blood products are typically irradiated using photons to diminish the risk of transfusion- associated graft vs. host disease (TA-GVHD). The desired effect of irradiating theVersion 2 4370-NONPROV 8thNovember 2024 blood is to inhibit lymphocyte function and therefore to prevent GVHD while not causing damage to platelets and other blood fractions.

[0135] Further, certain aspects of the present application are illustrated in detail by way of the following examples. The examples are given herein for illustration of the application and are not intended to be limiting thereof. EXAMPLES

[0136] The application discloses the ability to control the dose response of a radiosensitive film solely by varying the top laminate material. The optical density and dose at which each sample can obscure the current Rad-Sure “NOT” is reported. The equipment for the manufacturing of radiation dosage indicator is as described below:

[0137] Equipment & Materials 1. X-Ray Cabinet - PANTAK X-Rad 160, 2. RADIOCHROMIC - Radiochromic film 3. Densitometer - X-rite 310T, Transmission Mode, 4. Rad-Sure – “NOT” base, and 5. Laminates: a. Red, b. Dark Violet, c. Dark Blue, d. Medium Blue, e. Medium Grey, f. Orange, g. Light Green, h. Medium Green and i. Medium Pink.

[0138] Four samples of films were prepared: 1. Unlaminated (control),2. Laminated with red,3. Laminated with orange, andVersion 2 4370-NONPROV 8thNovember 2024 4. Laminated with green.

[0139] The above four films were exposed to X-Ray doses ranging from 50 Gy – 2000 Gy at 160 kv and 20mAs with a 2mm aluminum filter. The laminated side of the film was facing up towards the X-ray source during the exposures. The absolute visible density was measured and graphed.

[0140] “before exposure” laminated samples allowed for clear visibility of the “NOT”. The red and green laminated samples obscured the “NOT” at a density of ~1.7 du. This occurred at 1100 Gy for the red, and 1300 Gy for the green.

[0141] The dose response curves with absolute visual density for the radiochromic film samples are displayed below in FIG.1 and the densities are reported in Table 1.

[0142] The structure of radiation dosage indicator is shown in FIG.2. The structure comprises a radiosensitive film attached to a colored lamination layer. The radiosensitive film is comprised of active film on a polyester substrate. The film comprised of an active layer, nominally 8μm thick, containing the active component, and optionally amelioration agent, giving the film its energy- independent response. The thickness of the active layer may vary slightly from batch-to-batch. The active layer is coated on a clear, 97μm polyester substrate.

[0143] The visible indicia is a Rad-Sure – “NOT” base. FIG.3 and FIG.4 represents radiation dosage indicator with visible indicia.

[0144] FIG.5 and FIG.6 represents radiation dosage indicator with a single visible indicia and double visible indicia respectively.

[0145] FIG. 7 describes complementary colors effect of wavelength on %Transmission Fifth ply and colored indicia. It’s a description of % visible light transmission as a function of color laminate spectra. In this case, indicia to background threshold can change by adding color laminates that will proportionally cancel out high % transmission peaks in the spectra signature of the other laminate.

[0146] The word proportionally here defines the difference of the highest % transmission peak at a wavelength (λ range) in one laminate and the lowest % transmission value at or around the same wavelength range of another laminate. For example, light, medium, and dark green all have the same % transmission spectra signature with variable % transmission magnitude. In the sameVersion 2 4370-NONPROV 8thNovember 2024 manner another laminate with variable % transmission magnitude will subtract proportionally to get different background thresholds.

[0147] FIG. 8 describes Complementary colors effect of wavelength on %Transmission Fifthply and colored indicia with No Threshold and Threshold range. It’s a description of % visible light transmission as a function of indicia color spectra. In this case, colored indicia to background threshold can change by adding color laminates that will proportionally cancel out high % transmission peaks in the spectra signature of colored indicia. Note: the word proportionally here defines the difference of the highest % transmission peak at a wavelength (λ range) in one laminate and the lowest %transmission value at or around the same wavelength range of another laminate. For example, light, medium, and dark green all have the same % transmission spectra signature with variable % transmission magnitude. In the same manner a laminate with variable % transmission magnitude will subtract proportionally to get different background thresholds. Fig 9. Proportional relation between % visible light transmission (color laminate)describes and end dose (Gy) for thresholds greater than 1.5 density unit threshold, which defines enough change of exposed active to reach similar indicia gray scale value. The slope or the proportionality value depends on active sensitivity, and range of % visible light transmission leading to a final threshold value.

[0148] Table 1. Dose and optical visual density when “NOT” is obscured Dose at which C l "NOT" i Optical visible4202rebmevokNniP 8 ktraelDoiV y arG m ui edeulB M keseraulitD B VisOnRetPDhnNlagi eLerO u GN-si07V34etm uluineosdeerb M G A-emlign4 47 79 33 45 71 88 52 2A / 7 78 1A / A / 8 76 9336 56 76782716 -2 far 1.d03.0 5.07.0 8.09.0 0.1 1.1N1.1 2.1N N2.1 2.1.1 3.1 3. 913. 114. 314. 514. 614. 814. 914.13 -eO tani13463835A / 45A / A / 836745395712 made84.798015253 4.N559546669617 7 777 708183848l R0.0.0.1.1.1.1 1.1.1N N.1.1.1.1.1.1.1.1.1.1.1.1cim ordhe )ctaloo87876671 76 4389 inirtdaman 40lo. 003. 504. 506. 807. 808. 609. 200. A / 71 N0. 111. A / A / 71 N N1. 911. 212. 47 12. 74 12. 98 12. 19 13. 31 13. 54 13. 73 13. 89 13. 913.1Rnc(.2 U elbe)aso y0050 0000000000000000000000 00 00 0T DG( 10203040506560708580959011121301401501601701801901022n]ois94re10V0[Version 2 4370-NONPROV 8thNovember 2024

[0150] The visible density at which the “NOT” is obscured varies for each colored laminate.

[0151] The pink laminate obscured the “NOT” at 2000 Gy.

[0152] According to one of the embodiments, the radiation dosage indicator measures a dose response characteristic(s) that are from 5Gy to about 50,000 Gy.

[0153] According to another embodiment, the radiation dosage indicator measures a dose response characteristic(s) that are from 10Gy to about 10,000 kGy. Table 3. Expansion of end dose (>1.5du) as a function of Coat weight and % Transmission Coat wight Range % Transmission End Dose End Dose End Dose End 4

[0154] While preferred embodiments of the present disclosure have been shown and described in detail, it will be readily understood and appreciated that numerous omissions, changes, and additions can be made without departing from the spirit and scope of the present disclosure.

[0155] The designs of radiation dosage indicator according to the present disclosure can be prepared and used according to the description above. These designs are presented herein for purposes of illustration of the present disclosure and are not intended to be limiting, for example, the making and using of the radiation dosage indicator.

[0156] While the compositions and methods of the disclosed and / or claimed inventive concept(s) have been described in terms of particular aspects, it will be apparent to those of ordinary skill in the art that variations may be applied to the compositions and / or methods and in the steps or in the sequence of steps of the method described herein without departing from theVersion 2 4370-NONPROV 8thNovember 2024 concept, spirit and scope of the disclosed and / or claimed inventive concept(s). All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosed! and / or claimed inventive concept(s).

Claims

Version 2 4370-NONPROV 8thNovember 2024 We Claim:

1. A radiation dosage indicator comprising: a first ply comprising at least one radiochromic film having a substrate covering with an active layer; optionally, a second ply having at least one visible indicium is configured to underlay the first ply; optionally, a third ply overlying the first ply comprising at least a one viewing zone and the visible indicium; and a fourth ply having a colored lamination layer overlying the active layer of the radiochromic film, optionally, a fifth ply having a complementary colored lamination layer overlying the forth colored ply, wherein the active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film; and wherein the visible indicium of the second ply is configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

2. The radiation dosage indicator according to claim 1, wherein the active layer comprises: a) an active component; and optionally b) an amelioration agent.

3. The radiation dosage indicator according to claim 1, wherein the active layer compound is selected from the group consisting of a functionalized or unfunctionalized acetylenic compound, metal or metalloid compound, and combinations thereof.Version 2 4370-NONPROV 8thNovember 2024 4. The radiation dosage indicator according to claim 3, wherein the functionalized or unfunctionalized acetylenic compound is a the functionalized or unfunctionalized diacetylene compound.

5. The radiation dosage indicator according to claim 4, wherein the diacetylene compound is a lithium-based diacetylene compound.

6. The radiation dosage indicator according to claim 3, wherein the metal or metalloid compound is selected from the group consisting of bismuth compound, cesium compound, barium compound, tungsten compound, aluminum compound, lead compound, silicon compound, lithium compound, potassium compound, zinc compound, sodium compound and combinations thereof.

7. The radiation dosage indicator according to claim 2, wherein the amelioration agent is selected from the group consisting of an adsorption agent, a binder, a dye, a stabilizer, a polymer, a shelf-life extender, a solvent, a surfactant, an adhesive, and combinations thereof.

8. The radiation dosage indicator according to claim 7, wherein the dye is selected from the group consisting of new sunset yellow, fuschin cyanide, hexahydroxy ethyl violet cyanide, pararose aniline cyanide, leuco crystal violet, leuco malachite green, malachite green base, p-roseaniline base and combination thereof.

9. The radiation dosage indicator according to claim 1, wherein the substrate is selected from the group consisting of a paper, a plastic, a textile, a metal, a canvas, a cloth, a wood, a leather, a ceramic utensil, a ceramic cup, a ceramic tile, a composite and a glass.

10. The radiation dosage indicator according to claim 1, wherein the colored lamination layer is selected from the group consisting of a polymer, a composite, an elastomer, plastic, a coating, and a glass.

11. The radiation dosage indicator according to claim 10, wherein the polymer of lamination is selected from the group consisting of polyvinyl chloride (PVC), polypropylene, polyethylene, polycarbonate, acrylic polymer, polyethylene terephthalate (PET), polyester, olefin copolymers, cellulosic or cellulose acetate, and combinations thereof.Version 2 4370-NONPROV 8thNovember 2024 12. The radiation dosage indicator according to claim 10, wherein the glass layer is selected from the group consisting of lower-iron glass, band pass selective glass, borosilicate glass and combinations thereof.

13. The radiation dosage indicator according to claim 1, wherein the colored lamination has a Red Green Blue (RGB) ratio having R in the range of from 0 to 255; G in the range of from 0 to 255; and B in the range of from 0 to 255, and wherein R=G=B≠0.

14. The radiation dosage indicator according to claim 1, wherein the colored lamination layer is intrinsic with percentage transmission and spectra; wherein the colored lamination layer is intrinsic with percentage transmission and wavelength; wherein the colored lamination layer causes changes in the threshold in the addition of colors; or wherein the colored lamination layer at any two wavelength specific percentage transmission can be added or cancelled.

15. The radiation dosage indicator according to claim 1, wherein the radiation dosage indicator measures a dose response characteristic(s) that are from about 5Gy to about 50,000 Gy.

16. The radiation dosage indicator according to claim 1, wherein the radiation dosage indicator measures a dose response characteristic(s) that are from about 10Gy to about 10,000 kGy.

17. The radiation dosage indicator according to claim 1, wherein the radiation dosage indicator measures a dose response characteristic(s) that are from about 100Gy to about 2,500 kGy.

18. The radiation dosage indicator according to claim 1, wherein the radiation is based on X-rays, alpha rays, beta rays, neutron rays, gamma rays, ultraviolet light rays, visible light, electron beam, or combinations thereof.

19. The radiation dosage indicator according to claim 1, wherein the radiation dosage indicator further comprises a layer of visible indicia between the radiosensitive film and the substrate.

20. The radiation dosage indicator according to claim 19, wherein the visible indicia are obscured by the layer of radiosensitive film in response to exposure to a radiation dosage exceeding a predetermined threshold.Version 2 4370-NONPROV 8thNovember 2024 21. The radiation dosage indicator according to claim 1, wherein the requisite amount of radiation in a process of measuring dose response characteristics is machine readable.

22. The radiation dosage indicator according to claim 1, wherein the radiation dosage indicator is used in the field of insect sterilization, phytosanitary, food sterilization, medical device sterilization, and cannabis irradiation.

23. A radiation dosage indicator, comprising: a first ply comprising at least one radiochromic film having a substrate covering with an active layer; optionally, (a) a second ply overlying the first ply having indicator base comprising at least one color indicium overlying the substrate and underlying the active layer, or (b) a second ply having at least one indicator base comprising a color indicia underlying the substrate; optionally, a third ply overlying the first ply comprising at least a one viewing zone and the visible indicium; and a fourth ply having a colored lamination layer overlying on the active layer of the radiochromic film, optionally a fifth ply having a complementary colored lamination layer overlying the fourth colored ply, wherein an active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film, and wherein the visible indicium of the second ply is configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

24. A radiation dosage indicator, comprising: a first ply comprising first radiochromic film and second radiochromic film, wherein each radiochromic film is provided with a substrate covering with an active layer;Version 2 4370-NONPROV 8thNovember 2024 optionally, a second ply having first visible indicium and a second visible indicium are configured to underly the first ply; optionally, a third ply overlying the first ply comprising a first viewing zone, and a second viewing zone; and a fourth ply having a colored lamination layer overlay the active layer of first radiochromic film and second radiochromic film, optionally a fifth ply having a complementary colored lamination layer overlying the forth colored ply, wherein the first radiochromic film is configured to overlay the first visible indicia and the second radiochromic film is configured to overlay the second visible indicium, wherein each radiochromic film is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film, wherein an active layer is configured to change opacity in response to exposure to a certain radiation dosage exceeding an independently predetermined threshold of each radiochromic film, and wherein the visible indicia of the second ply are configured to be exposed to view through the viewing zone and providing a visual indication as to whether the indicator has been exposed to a radiation dosage exceeding the predetermined threshold.

25. The radiation dosage indicator of claim 24, wherein the radiation dosage indicator is a semi quantitative radiation dosage indicator comprises a first radiochromic film and second radiochromic film and both radiochromic films exhibits a different radiation response corresponding to a different radiation dosage.

26. The radiation dosage indicator of claim 1, wherein the radiochromic film is produced by covering with an active layer composition selected from the group consisting of a coating composition, a printing composition, a extrusion composition, a lamination composition and combinations thereof.

Images