Dose calibration device and methods of use

Abstract

The disclosure relates to systems and methods for calibration of an electron beam energy delivery to a substrate. Specifically, the disclosure relates to systems and methods for calibrating radiation dose to a substrate using a calibration sheet operable to provide visual indication proportional to the absorbed radiation dose.

Description

DOSE CALIBRATION DEVICE AND METHODS OF USEBACKGROUND

[0001] The disclosure is directed to systems and methods for calibration of an electron beam (e-beam) energy delivery to a substrate. Specifically, the disclosure is directed to systems and methods for calibrating radiation dose to a substrate using a calibration sheet operable to provide visual indication proportional to the absorbed radiation dose.

[0002] Sterilization processing equipment needs to be available for manufacturing 24 hours a day, 7 days a week for 365 days. The irradiation equipment may deviate in performance due to a multiplicity of factors, including for example; contamination from by-products of the process, variation in the hardware, both mechanical and electronics stability, variation in environmental temperature, and more.

[0003] Calibrating electron beam (E-beam) sterilization systems presents several challenges. Firstly, ensuring the beam's energy and intensity are precisely controlled is vital for consistent and reliable sterilization outcomes. Deviations can lead to under-or-over-sterilization, compromising product safety. Additionally, maintaining beam uniformity across large treatment volumes is needed to guaranteeing homogenous sterilization. Calibration must also consider beam stability over time, as fluctuations could affect the efficacy of sterilization processes. Furthermore, verifying dose distribution throughout the product is essential to confirm thorough sterilization.

[0004] Furthermore, manufacturing processes require Measurement System Analysis (MSA) to control the processes as well as to maintain reproducibility and repeatability, all to guarantee the reliability of the process. This MSA must be done by user intervention with a method to test the system under a given frequency for such performance.

[0005] Overcoming these challenges through technological advancements could pave the way for broader acceptance and integration of radiation sterilization in various industries. The following disclosure and claims intend to address these deficiencies.SUMMARY

[0006] Disclosed, in various exemplary implementations, are systems and methods for calibration of an electron beam energy delivery to a substrate. Specifically, the disclosure is directedto systems and methods for calibrating radiation dose to a substrate using a calibration sheet operable to provide a visual indication proportional to the absorbed radiation dose, and more specifically to the use of radiation on individual unit products instead of multiple stacked units in packaged boxes.

[0007] In an exemplary implementation provided herein is a method of calibrating an e-beam radiation system for a single product, implemented in a system comprising: an electron beam radiation source operably coupled to a radiation chamber, a stage, operable to move in X-Y-Z direction through the radiation chamber, the method comprising: covering the stage at least partially with a single use sheet operable to provide a visual indication proportional to a radiation dose exposure; using the electron beam radiation source, exposing the covered stage to a predetermined radiation dose; moving the stage at a predetermined pattern; detecting the visual indication provided by the single use sheet; and based on the visual indication, potentially changing at least one operational parameter of the e- beam radiation system.

[0008] These and other features of systems and methods for dynamic, product- specific closed loop control of e-beam or X-ray radiation, designed to monitor and adjust the irradiation process in real-time, will become apparent from the following detailed description when read in conjunction with the figures and examples, which are exemplary, not limiting.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] For a better understanding of the systems and methods for calibrating radiation dose to a substrate using a calibration sheet operable to provide visual indication proportional to the absorbed radiation dose, with regard to the exemplary implementations thereof, reference is made to the accompanying examples and figures, in which:

[0010] FIG. 1, illustrates a front elevation schematic view of an exemplary implementation of a calibration stage in the systems disclosed; and

[0011] FIG. 2 is a flow chart showing the steps of an exemplary method.

[0012] FIG. 3 illustrates an exemplary graph showing the dose as a function of process conditions.

[0013] Fig. 4A is a graph showing the programmed dose variations at a predefined y’ scan location as a function of the x’ position, with Fig 4B showing a 3D analysis of an irradiated radio- chromatic B3 film; the y’ direction shows a uniform dose distribution These measurements are then correlated by the CPM to the reference calibration shown in Figure 3.DETAILED DESCRIPTION

[0014] Provided herein are exemplary implementations of systems and methods for calibration of an electron beam energy delivery to a substrate. Specifically, provided herein are exemplary implementations of systems and methods for calibrating radiation dose to a substrate using a calibration sheet operable to provide visual indication proportional to the absorbed radiation dose.

[0015] Whereas the traditional and prior use of colorimetry of radiation detectors has been used as user responses in the form of Go / No Go, the methods and systems disclosed enhance the use of such materials providing indications of system health, electro-mechanical performance, process control, and provide triggers for corrective system maintenance.

[0016] Furthermore, and although calibration of material dosimetry (e.g., plastic, paper, etc.), is not an exact science per se, a unit of comparison could be subject to a color change drift over a period of time. Hexadecimal color codes for digital comparison using established equipment from the print world is one aspect of aligning the color to the dosimetry image post exposure to the E-beam.

[0017] Incoming dosimetry materials (tape, reel, etc.) will require a calibration to the baseline to ensure any batch-to-batch, expired date code, temperature, humidity type of variations affecting the color post-e-beam exposure. Storage of such dosimetry materials would be subject in an exemplary implementation, to include being sealed, temperature controlled, incoming monitoring of shipment variations from source.

[0018] As noted, the use of such dosimetry material based on visual change in color is utilized as a first line of radiation exposure detection to ensure the calibration sheet has been properly exposed and compared against the desired sterility parameters. As with any sterilization, the percentage buffer dose is added and accounted for during the calibration. Thus, a color range is anticipated in the use of such methods as plus or minus range of acceptability (estimated + / - 1% to 3%). With such dosimetry, the use of color is aligned with a digital reference (fingerprint) in order to characterize the operational conditions. Some radiochromic dosimeters used in connection with the systems and methods disclosed, can be Gafchromic film, EBT3 film, and HD-V2 film. Gafchromic film, consisting of a thin layer of gelatin containing a radiation-sensitive dye, undergoes a color change upon exposure to ionizing radiation, which can be quantified using a densitometer (or any colorimeter). EBT3 film, an advancement of Gafchromic technology, offers improved sensitivity and spatial resolution. HD-V2 film, another variant, is specifically designed for high-dose applications, providing accuratemeasurements even at extremely high radiation doses. These radiochromic dosimeters are preferred for their case of use, minimal energy dependence, and tissue equivalence, making them valuable tools in radiation therapy and dosimetry applications. It is noted, that when the single use sheet is rather an array of patches (dots and the like), different radiochromic materials can be used on each patch.

[0019] In another exemplary implementation, the systems and methods disclosed methodology can be used for Statistical Process Control (SPC) with monitoring of the color as a means to detect a fault of the system eBeam dose, or trend that would indicate a failure based on Shewhart Rules used in SPC. This in turn triggers an Out-of-Control Action Plan (OCAP) for corrective action. This method is taking an analog (color) aspect, converting to a digital parameter and subsequent means for process control. For example, using the Commission Internationale de 1'Eclairage (CIE) for SPC can be done by using the CIE Lab color space, where L* represents lightness and ranges from 0 to 100, with 0 corresponding to black and 100 to white, the a* axis measures the color's position along the red-green spectrum, with negative values indicating green and positive values indicating red. This parameter's range spans from -128 to +127, while the b* axis measures the color's position along the yellow-blue spectrum, with negative values indicating blue and positive values indicating yellow. The b* parameter also ranges from -128 to +127. Together, these parameters allow for precise quantification of the color changes as a function of the various processing parameters.

[0020] Other color quantification systems can be the Munsell Color System, which organizes colors based on perceived hue, value (brightness), and chroma. Colors are specified using notation like 5YR 6 / 4, where 5YR represents hue, 6 indicates value, and 4 denotes chroma. Additionally, RGB and CMYK Color Models can be used, in digital imaging modules, quantifying colors using combinations of primary colors (Red, Green, Blue for RGB; Cyan, Magenta, Yellow, and Key for CMYK). Brightness, hue, and chroma can be analyzed through color channels (whether or not converted to grayscale), and their intensities, which can be arranged as histograms representative of a given state of the calibration sheet, providing also indication of uniformity in radiation dose coverage.

[0021] Data collected from colorimetry can be translated into Process Capability (CP), that measures the variability of the data and the distance between the process average and the specification limits, CPK accounts both the spread of the data as well as how far off-center the distribution is from the specification limits. Data determined by Cp and CpK and SPC for ongoing and real-time monitoring and feedback to the health of the system.

[0022] In yet another exemplary implementation, the systems and methods disclosed eliminate the human clement and translate the traditional dosimetry into a digitally integrated format for the integrity and quality of the system, ensure validation of materials being processed, and detectable trigger events to prevent any out of control materials being externalized.

[0023] Health of the system, preset conditions that define the material being processed can be incorporated into the calibration system and monitored. Additionally, Bracket analysis to the set conditions for a system analysis prior to processing materials. In other words, defining specific parameters or conditions that will be examined or analyzed, by establishing the specific conditions or constraints that will guide the system analysis conducted before processing (sterilizing) materials. These conditions could include factors such as temperature, pressure, time constraints, CIE L, a, and b values or other relevant variables that need to be considered in the analysis. This can be defined by the user as a correlation to the established calibration. This can include in certain exemplary implementations, pattern analysis and recognition using Artificial Intelligence (Al) for forward learning provided from the database (see e.g., FIG. 2). Such patterns generate learnings of materials, objects, and other aspects for improvement of the sterilization efficacy.

[0024] In another exemplary implementation, the electromechanical systems including the analyze X-Y scan uniformity can be monitored using the methods and systems disclosed, and also the proper scan conditions including dose and transport speed. The electro-mechanical system can be analyzed by the uniformity (calibration) sheets characterized previously as references. The energy is varied, and different dose and color variations are compared to a correlated condition. Such patterns become Al data learning sets for forward looking analysis of information for control and early fault detection.

[0025] An example for the process is illustrated in FIG.s 3-4B. As illustrated e.g., in FIG. 3, showing stage speed and stage distance to eBeam, source used as reference to monitor the dose during testing. The irradiated dose on the sample stage was measured using radio-chromic B3 films having a dimension of 30 cm x 18 cm purchased from GeX Corporation (reference: https: / / www.gexcorp.com / b3-dosime ers.html). The irradiated B3 films were scanned using an EPSON V600 scanner with parameters set by the dose calculation software Risoe Scan 1.3 software, developed at DTU’s Risoe National Laboratory, Roskilde, Denmark. A fixed electron beam provided irradiation with a 2 cm x 2 cm spot area shaped by a quadrupole from a single electron beam accelerator source, yielding a 100-pm diameter beam. The sample stage was scanned in the x and ydirections for each distance between eBeam source and the B3 films. The electron beam source energy was 4.0 MeV, and the Beam power was 147 Watts.

[0026] Additionally and as illustrated in FIG.s 4A, and 4B, where Fig. 4A showing a graph with the programmed dose variations at a predefined y’ scan location as a function of the x’ position, while Fig 4B showing a graph illustrating 3D analysis of an irradiated radio-chromatic B3 film; the y’ direction shows a uniform dose distribution at every stage motion along the X axis, as measured in kGy shown on the Z-axis. These measurements are then correlated by the CPM to the reference calibration shown in Figure 3, and used to maintain consistent irradiation across the sample in the X- Y axes.

[0027] Using the methods and systems disclosed is used in yet another exemplary implementation for preventive maintenance (PM), initiated by a periodic schedule or data sets that determine a system variability is outside the control limits of the process or given parameters. Such conditions, impact Overall Equipment Efficiency (OEE) including downtime, use of consumables, and labor. Optimization of preventive maintenance with the use of colorimetry dosimetry analysis and Al triggers rather than traditional timed based events. Such triggers from the data patterns correlated to control parameters, variations of electro-mechanical systems, and or references of baseline process parameters. Thus, periodic PMs become a dynamic event based on system information to optimize and improve the OEE performance of the overall system.

[0028] Furthermore, Pre-production materials can be utilized to validate system performance and system health as need for comparative purposes to the (color) fingerprint or acceptable, recognized standards established by and for the particular system. This includes in an exemplary implementation, running periodic sample materials with known characteristics (corresponding to a known anticipated colorimetric response) and validate system performance and use such data for process control and feed for the Al (leaming / validation dataset. This method can be based on human decision to proceed with production material processing or internal system algorithms that provides a green light system ready status.

[0029] Accordingly and in exemplary implementations as disclosed in FIGs.1-2, provided herein is method of calibrating an e-beam radiation system, implemented in a system 10 comprising: an electron beam radiation source (500, not shown) operably coupled to a radiation chamber 600 (not shown), a stage 300, operable to move in X-Y direction through the radiation chamber, the method comprising: covering 21 the stage 300 at least partially with a single use sheet 200 operable to providea visual indication proportional to a radiation dose exposure; using the electron beam radiation source, exposing 23 the covered stage to a predetermined radiation dose; moving the stage 300 at a predetermined pattern (e.g., at the X-direction); detecting the visual indication provided by the single use sheet 200; and based on the visual indication, potentially changing 28 at least one operational parameter of the e-beam radiation system. As further illustrated in FIG. 1, the system can further comprise sample tray 100, a metal cover 201, and a radiation shield 301.

[0030] Single use sheet 200, may be comprised of a monolithic sheet, or in other exemplary implementations, by an array of circular patches (or other shapes), arranged on the substrate (or metal tray), so as to give a complete indication of the radiation exposure of the substrate or metal tray. Both arranged at spacing from edge of the metal tray or substrate edge at a distance of between 1 mm to 30 mm, typically 1mm to 5 mm (creating a margin along the edges.

[0031] In an exemplary implementation, the system used to implement the methods disclosed, can further comprise a sample tray 100 having a width transverse to the X-direction movement of the stage 300, the sample tray 100 covering at least a portion (or in other examples, the whole stage) of the (X, Y) stage 300, and wherein the step of covering 21 the stage with the single use sheet 200 comprises covering the sample tray with the single use sheet. Furthermore, the step of exposing 23 the covered tray to a predetermined radiation dose, further comprises exposing the covered tray to a plurality of predetermined doses at a predetermined pattern. The predetermined doses can be predetermined by either the user, based on specific product requirements, or the equipment manufacturer based on PM requirements, or other time-related parameters. For example, a series of radiation doses along a given range can be imposed to ascertain desired colorimetric response giving data range within expected values.

[0032] In certain exemplary implementations, before the step of potentially changing the at least one operational parameter: if, and upon detecting visual indication that the width of the sample tray is not exposed evenly, covering the sample tray with another single use sheet 200’ (not shown, e.g., an imaging plate) operable to provide a visual indication proportional to the radiation dose exposure; using the electron beam radiation source, exposing 23’ the covered tray to the predetermined radiation dose; moving the stage in a Y-direction; and detecting the visual indication provided by the single use sheet 200’; and based on the visual indication, changing 28’ at least one operational parameter of the e-beam radiation system configured to cover the entire width of the sample tray evenly.

[0033] In an exemplary implementation rastering process is used in the systems disclosed, which involves systematically scanning the electron beam across the target surface in a controlled pattern to ensure uniform exposure. This can be achieved using electromagnetic deflectors or scanning coils, which steer the beam in the Y-axis, while the mechanical stage moves the substrate in the X- axis, creating a coordinated grid-like coverage. The beam is selectively blanked (turned off) during retrace movements between scan lines (or waves) to prevent unintended exposure, with the blanking intervals synchronized to stage positioning feedback from laser interferometers or other sensors. Rastering parameters such as scan rate (beam traversal speed) and scan width (deflection amplitude) are calibrated based on beam energy, substrate material, and desired dose uniformity. For example, in sterilization applications, the rastered "curtain" of electrons penetrates product packaging, with conveyor systems moving trays through the beam path to ensure multi-angle exposure. The process occurs in a vacuum environment to maintain beam focus, while real-time adjustments to deflection signals compensate for stage positioning errors.

[0034] In certain exemplary implementation, the at least one operational parameter of the e- beam radiation system is: movement velocity of the stage (in m / sec, affecting exposure uniformity and throughput, e.g., ±1 %-3%), movement direction pattern (X, Y), rastering scan pattern (referring to the systematic movement of the electron beam across the exposure area, e.g., by following a lineby-line, or waved trajectory while the beam is selectively blanked or unblanked to expose specific regions), sample tray width, eBeam energy (e.g., ±1-3%), rastering rate (referring to the speed at which the electron beam scans across the substrate surface, influencing both exposure duration and positional accuracy, e.g., ±1-3%), rastering width (referring to the lateral span of the beam's scanning path within a single field, corresponding to the deflectable range of the beam before requiring stage movement), distance between the tray and the e-beam source (affecting beam focus and current density at the target surface), or an operational parameter combination comprising one or more of the foregoing.

[0035] As further illustrated in FIG. 1, the single use sheet 200, which is operable to provide a visual indication proportional to a radiation dose exposure, is further covered with a metal sheet 201, operable to convert the e-beam radiation to x-ray radiation (e.g., via a Bremsstrahlung radiation). In certain exemplary implementation, the metals used for the metal cover, is configured to modify the characteristics of the generated X-rays, such as their energy spectrum. For example, Tungsten (W) which increases the efficiency of X-ray production through bremsstrahlung radiation is used in certain exemplary implementations, while molybdenum (Mo) and tantalum (Ta), can also be used to generateX-rays when exposed to high-energy electron beams. The choice of metal will depend on the specific requirements of the application, including the desired energy range of the X-rays and the characteristics of the target material being scanned. Accordingly, in yet another exemplary implementation, the metal of the metal sheet, the metal rod, the metal ball, or their combination is Tantalum, Tungsten or an element with atomic numbers between 20 and 84, except for 36, 43, and 61, as well as elements with atomic numbers 90 and 92 that are capable of generating X-rays.

[0036] In certain exemplary implementations, the system further comprising an imaging module 550 (not shown) operable to detect 25 the visual indication of the single use sheet 200 in the step of detecting 25 the visual indication provided by the single use sheet. It is noted that the term “imaging module” as used herein means a unit that includes a plurality of built-in image and / or optic sensors and outputs electrical signals, which have been obtained through photoelectric conversion, as an image, while the term “module” refers to software, hardware, for example, a processor, or a combination thereof that is programmed with instructions for carrying an algorithm or method. The modules described herein may communicate through a wired connection, for example, a hard-wired connections, a local area network, or the modules may communicate wirelessly. The imaging module may comprise charge coupled devices (CCDs), a complimentary metal-oxide semiconductor (CMOS), an RGB-D camera, a thermal infra-red camera, or a combination comprising one or more of the foregoing. If static images are required, the imaging module can comprise a digital frame camera, where the field of view (FOV) can be predetermined by, for example, the camera size and the distance from the target 800. The cameras used in the imaging modules of the systems and methods disclosed, can be a digital camera. The term “digital camera” refers in an exemplary implementation to a digital still camera, a digital video recorder that can capture a still image of an object and the like. The digital camera can comprise an image capturing unit or module, a capture-controlling module, a processing unit (which can be the same or separate from the central processing module); a display module; and a user interface module (not shown).

[0037] As indicated, the single use sheet can be, in certain exemplary implementations, an imaging plate, for example, a photo-stimulable phosphor screen (BaF(Br0.85,I0.15):Eu2+) deposited on a flexible metal sheet or a thermoplastic film, such that when the screen absorbs e-beam radiation, electrons in the phosphor material become excited and move to higher energy states. Upon stimulation with a laser or other light source installed for example as part of the imaging module, these trapped electrons return to their ground state, emitting light in the phosphorescence process. The intensity ofemitted light is proportional to the amount of radiation absorbed, allowing for the measurement of radiation dose. This emitted light is then detected and quantified by the imaging module, providing the dosimetric calibration information for assessing the exposure to e-beam radiation.

[0038] In certain exemplary implementations 24 (see e.g., FIG. 2), the imaging module is external to the radiation chamber, whereby the method further comprising, following the step of exposing the covered tray to the predetermined radiation dose: transferring 26 the tray to the external imaging module.

[0039] In certain exemplary implementations, the system 10 further comprises a central processing module (CPM) 850 (not shown) in communication with the e-beam radiation source, the stage 300, the imaging plate 200, and the imaging module 550, the stage further comprising at least one processor in communication with a non-transitory memory device, storing thereon a computer- readable medium with a set of executable instructions configured, when executed by the at least one processor to carry out the steps of the methods disclosed herein.

[0040] Furthermore, radiochromic film dosimeters are used in certain exemplary implementations as indicators, exhibiting a color change corresponding to the radiation dose and serving as visual markers of exposure when imaged using the imaging module 550.

[0041] In the context of the disclosure, the term "operable" means the system and / or the device and / or the program, or a certain element or step is fully functional, sized, adapted and calibrated, comprises elements for, and meets applicable operability requirements to perform a recited function when activated, coupled, implemented, actuated, effected, realized, or when an executable program is executed by at least one processor associated with the system and / or the device. In relation to systems and circuits, the term "operable" means the system and / or the circuit is fully functional and calibrated, comprises logic for, having the hardware and firmware necessary, as well as the circuitry for, and meets applicable operability requirements to perform a recited function when executed by at least one processor.

[0042] The term “coupled”, including its various forms such as “operably coupling”, "coupling" or "couplable", refers to and comprises any direct or indirect, structural coupling, connection or attachment, or adaptation or capability for such a direct or indirect structural or operational coupling, connection or attachment, including integrally formed components and components which are coupled via or through another component or by the forming process. Indirect coupling may involve coupling through an intermediary member or adhesive, or abutting andotherwise resting against, whether frictionally or by separate means without any physical connection. Likewise, “operably coupled” refers to the joining of two members directly or indirectly to one another. Such joining may be stationary in nature or moveable in nature. Such joining may be achieved with the two members (or the two members and any additional intermediate) being integrally formed as a single unitary body with one another or with the two members or the two members and any additional members being attached to one another. Such joining may be permanent in nature or may be removable or releasable in nature.

[0043] Furthermore, "communicate" (and its derivatives e.g., a first component "communicates with" or "is in communication with" a second component) and grammatical variations thereof are used to indicate a structural, functional, mechanical, electrical, optical, or fluidic relationship, or any combination thereof, between two or more components or elements. As such, the fact that one component is said to communicate with a second component is not intended to exclude the possibility that additional components can be present between, and / or operatively associated or engaged with, the first and second components

[0044] The term "comprising" and its derivatives, as used herein, are intended to be open- ended terms that specify the presence of the stated features, elements, components, groups, integers, and / or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers and / or steps. The foregoing also applies to words having similar meanings such as the terms, "including", "having" and their derivatives.

[0045] All ranges disclosed herein are inclusive of the endpoints, and the endpoints are independently combinable with each other. “Combination” is inclusive of blends, mixtures, alloys, reaction products, and the like. The terms “a”, “an” and “the” herein do not denote a limitation of quantity, and are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The suffix “(s)” as used herein is intended to include both the singular and the plural of the term that it modifies, thereby including one or more of that term (e.g., the sheet(s) includes one or more sheet). Reference throughout the specification to “one exemplary implementation”, “another exemplary implementation”, “an exemplary implementation”, and so forth, when present, means that a particular element (e.g., feature, structure, and / or characteristic) described in connection with the exemplary implementation is included in at least one exemplary implementation described herein, and may or may not be present in other exemplaryimplementations. In addition, it is to be understood that the described elements may be combined in any suitable manner in the various exemplary implementations.

[0046] All ranges disclosed herein are inclusive of the endpoints, and the endpoints are independently combinable with each other. Furthermore, the terms “first,” “second,” and the like, herein do not denote any order, quantity, or importance, but rather are used to denote one element from another.

[0047] Likewise, the term "about" means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. In general, an amount, size, formulation, parameter or other quantity or characteristic is "about" or "approximate" whether or not expressly stated to be such.

[0048] As indicated, the systems used herein can be computerized systems further comprising a central processing module (CPM); a display module; and a user interface module. The Display modules, which can include display elements, which may include any type of element acting as a display. A typical example is a Liquid Crystal Display (LCD). LCD for example, includes a transparent electrode plate arranged on each side of a liquid crystal. There are however, many other forms of displays, for example OLED displays and Bi-stable displays. New display technologies are also being developed constantly. Therefore, the term display should be interpreted widely and should not be associated with a single display technology. Also, the display module may be mounted on a printed circuit board (PCB) of an electronic device, arranged within a protective housing and the display module is protected from damage by a glass or plastic plate arranged over the display element and attached to the housing.

[0049] Additionally, “user interface module” broadly refers to any visual, graphical, tactile, audible, sensory, or other means of providing information to and / or receiving information from a user or other entity. For example, a set of instructions which enable presenting a graphical user interface (GUI) on a display module to a user for displaying and changing and or inputting data associated with a data object in data fields. In an embodiment, the user interface module is capable of displaying any data that it reads from the imaging module. In addition, the term ‘module’, as used herein, means, but is not limited to, a software or hardware component, such as a Field Programmable Gate-Array (FPGA) or Application-Specific Integrated Circuit (ASIC), which performs certain tasks. A modulemay advantageously be configured to reside on an addressable storage medium and configured to execute on one or more processors. Thus, a module may include, by way of example, components, such as software components, object-oriented software components, class components and task components, processes, functions, attributes, procedures, subroutines, segments of program code, drivers, firmware, microcode, circuitry, data, databases, data structures, tables, arrays, and variables. The functionality provided for in the components and modules may be combined into fewer components and modules or further separated into additional components and modules.

[0050] As indicated, provided herein is a computer program, comprising program code means for carrying out the steps of the methods described herein, implementable in the systems provided, as well as a computer program product (e.g., a micro-controller) comprising program code means stored on a medium that can be read by a computer, such as a hard disk, CD-ROM, DVD, USB, SSD, memory stick, or a storage medium that can be accessed via a data network, such as the Internet or Intranet, when the computer program product is loaded in the main memory of a computer [or microcontroller] and is carried out by the computer [or micro controller].

[0051] The computer readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non-exhaustive list of more specific examples of the computer readable storage medium includes the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a static random access memory (SRAM), a portable compact disc read-only memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a floppy disk, a mechanically encoded device such as punch-cards or raised structures in a groove having instructions recorded thereon, and any suitable combination of the foregoing. A computer readable storage medium, as used herein, is not to be construed as being transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission media (e.g., light pulses passing through a fiber-optic cable), or electrical signals transmitted through a wire.

[0052] Computer readable program instructions for carrying out operations of the present invention may be assembler instructions, instruction- set- architecture (ISA) instructions, machineinstructions, machine dependent instructions, microcode, firmware instructions, state-setting data, configuration data for integrated circuitry, or cither source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C++, python, Java, C#, or the like, and procedural programming languages, such as the “C” programming language or similar programming languages. The computer readable program instructions may execute entirely on the system’s computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, field-programmable gate arrays (FPGA), or programmable logic arrays (PLA) may execute the computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry, in order to perform aspects of the present invention.

[0053] In addition, the memory medium may be located in a first computer in which the programs are executed, and / or may be located in a second different computer [or micro controller] which connects to the first computer over a network, such as the Internet [or, they might be even not connected and information will be transferred using USB]. In the latter instance, the second computer may further provide program instructions to the first computer for execution.

[0054] Unless specifically stated otherwise, as apparent from the description, it is appreciated that throughout the specification discussions utilizing terms such as “using”, “processing,” “loading,” “in communication,” “detecting,” “calculating,” “determining”, “analyzing,” “presenting”, “retrieving” or the like as generally used herein, refer to the action and / or processes of a computer or computing system, or similar electronic computing device, that manipulate and / or transform data represented as physical, such as the radiation dosage adsorbed by the target material into other data similarly represented as series of numerical values, such as the transformed radiation density data.

[0055] Accordingly and in an exemplary implementation, provided herein is a method of calibrating an e-beam radiation system for a single product, implemented in a system comprising: an electron beam radiation source operably coupled to a radiation chamber, a stage, operable to move in X, Y, and Z directions through the radiation chamber, the method comprising: covering the stage atleast partially with a single use sheet operable to provide a visual indication proportional to a radiation dose exposure; using the electron beam radiation source, exposing the covered stage to a predetermined radiation dose; moving the stage at a predetermined pattern; detecting the visual indication provided by the single use sheet; and based on the visual indication, potentially changing at least one operational parameter of the e-beam radiation system, (i) the system further comprises a sample tray positioned in such a way that the width of the tray is transverse to the X-direction movement of the stage, the sample tray covering at least a portion of the stage, and wherein the step of covering the stage with the single use sheet comprises covering the sample tray with the single use sheet, wherein (ii) the step of exposing the covered tray to a predetermined radiation dose, further comprises exposing the covered tray to a plurality of predetermined doses at a predetermined pattern, (iii) the step of moving the stage at the predetermined pattern, comprises moving the covered tray at the X-direction, the method further comprising (iv), before the step of potentially changing the at least one operational parameter: upon detecting visual indication that the full width of the sample tray (or a portion thereof), is not exposed evenly, covering the sample tray with another single use sheet operable to provide a visual indication proportional to the radiation dose exposure; using the electron beam radiation source, exposing the covered tray to the predetermined radiation dose; moving the stage in a Y-direction; and detecting the visual indication provided by the single use sheet; and based on the visual indication, changing at least one operational parameter of the e-beam radiation system configured to cover the entire width of the sample tray evenly, further comprising (v) covering the sample tray covered with the single use sheet operable to provide a visual indication proportional to a radiation dose exposure, with a metal sheet, operable to convert the e-beam radiation to x-ray radiation, wherein (vi) the system further comprising an imaging module operable to detect the visual indication of the single use sheet in the step of detecting the visual indication provided by the single use sheet wherein (vii), the single use sheet operable to provide a visual indication at a measurable scale that is proportional to a radiation dose exposure (by the single product), is an imaging plate, the system further comprises (viii), a central processing module (CPM) in communication with the e- beam radiation source, the stage, the imaging plate, and the imaging module, the stage further comprising at least one processor in communication with a non-transitory memory device, storing thereon a computer-readable medium with a set of executable instructions configured, when executed by the at least one processor to carry out the steps of the methods disclosed, wherein (ix), the step of using the imaging module, detecting the visual indication provided by the single use sheet, and thestep of based on the visual indication, changing at least one operational parameter of the e-beam radiation system is configured to occur in real time using the CPM, (x), the imaging module is external to the radiation chamber, the method further comprising, following the step of exposing the covered tray to the predetermined radiation dose: transferring the tray to the external imaging module, wherein (xi) the Imaging plate is a photo-stimulable phosphor screen (BaF(Br 0.85,10.15):Eu2+) deposited on a flexible metal sheet or a thermoplastic film, wherein (xii), the at least one operational parameter of the e-beam radiation system is: movement velocity of the stage, movement direction pattern, rastering scan pattern, sample tray width, eBeam energy, rastering rate, rastering width, distance between the tray and the ebeam source, or an operational parameter combination comprising one or more of the foregoing, and wherein (xiii) the single use sheet is comprised of an array of a plurality of patches, each adapted, sized and configured to provide a dose-proportional, visual indication that can be detectable by the sensors used in the system.

[0056] The above examples and description have of course been provided only for the purpose of illustration, and are not intended to limit the disclosed technology in any way. As will be appreciated by the skilled person, the disclosed technology can be carried out in a great variety of ways, employing more than one technique from those described above, all without exceeding the scope of the invention.

Claims

What is claimed:

1. A method of calibrating an e-beam radiation system for a single product, implemented in a system comprising: an electron beam radiation source operably coupled to a radiation chamber, a stage, operable to move in X,Y, and Z directions through the radiation chamber, the method comprising: a) covering the stage at least partially with a single use sheet operable to provide a visual indication proportional to a radiation dose exposure; b) using the electron beam radiation source, exposing the covered stage to a predetermined radiation dose; c) moving the stage at a predetermined pattern; d) detecting the visual indication provided by the single use sheet; and e) based on the visual indication, potentially changing at least one operational parameter of the e-beam radiation system.2 The method of claim 1, wherein the system further comprises a sample tray having a width transverse to the X-direction movement of the stage, the sample tray covering at least a portion of the stage, and wherein the step of covering the stage with the single use sheet comprises covering the sample tray with the single use sheet.3 The method of claim 2, wherein the step of exposing the covered tray to a predetermined radiation dose, further comprises exposing the covered tray to a plurality of predetermined doses at a predetermined pattern.4 The method of 2, wherein the step of moving the stage at the predetermined pattern, comprises moving the covered tray at the X-direction.5 The method of claim 4, further comprising, before the step of potentially changing the at least one operational parameter: a) upon detecting visual indication that the width of the sample tray is not exposed evenly, covering the sample tray with another single use sheet operable to provide a visual indication b) proportional to the radiation dose exposure; c) using the electron beam radiation source, exposing the covered tray to the predetermined radiation dose; d) moving the stage in a Y-direction; and e) detecting the visual indication provided by the single use sheet; andf) based on the visual indication, changing at least one operational parameter of the e-beam radiation system configured to cover the entire width of the sample tray evenly.

6. The method of claim 2, further comprising covering the sample tray covered with the single use sheet operable to provide a visual indication proportional to a radiation dose exposure, with a metal sheet, operable to convert the e-beam radiation to x-ray radiation.7 The method of claim 1, wherein the system further comprising an imaging module operable to detect the visual indication of the single use sheet in the step of detecting the visual indication provided by the single use sheet.8 The method of claim 7, wherein the single use sheet operable to provide a visual indication proportional to a radiation dose exposure, is an imaging plate.9 The method of claim 8, wherein the system further comprises a central processing module (CPM) in communication with the e-beam radiation source, the stage, the imaging plate, and the imaging module, the stage further comprising at least one processor in communication with a non- transitory memory device, storing thereon a computer-readable medium with a set of executable instructions configured, when executed by the at least one processor to carry out the steps of claim 710 The method of claim 9, wherein the step of using the imaging module, detecting the visual indication provided by the single use sheet, and the step of based on the visual indication, changing at least one operational parameter of the e-beam radiation system is configured to occur in real time using the CPM.11 The method of claim 7, wherein the imaging module is external to the radiation chamber, the method further comprising, following the step of exposing the covered tray to the predetermined radiation dose: transferring the tray to the external imaging module.12 The method of claim 8, wherein the Imaging plate is a photo-stimulable phosphor screen (BaF(Br 0.85,10.15):Eu2+) deposited on a flexible metal sheet or a thermoplastic film.13 The method of claim 1, wherein the at least one operational parameter of the e-beam radiation system is: movement velocity of the stage, movement direction pattern, rastering scan pattern, sample tray width, eBeam energy, rastering rate, rastering width, distance between the tray and the ebeam source, or an operational parameter combination comprising one or more of the foregoing.

14. The method of claim 1 , wherein the single use sheet is comprised of an array of a plurality of patches.

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