System and uses for closed-loop control of e-beam and x-ray sterilization

Abstract

The disclosure relates to systems and methods for closed-loop control of electronbeam (EB)-based sterilization, and more particularly, to an improved solution for sterilizing a product using closed loop control of EB radiation, designed to monitor and adjust the irradiation process in real-time to ensure that the desired level of sterilization is achieved efficiently and consistently.

Description

SYSTEM AND USES FOR CLOSED-LOOP CONTROL OF E-BEAM AND X-RAY STERILIZATIONBACKGROUND

[0001] The disclosure is directed to systems and methods for closed- loop control of electronbeam (EB) and / or X-ray radiation based sterilization, and more particularly, to an improved solution for sterilizing a product using closed loop control of the radiation, designed to monitor and adjust the irradiation process in real-time to ensure that the desired level of sterilization is achieved efficiently and consistently.

[0002] Electron beam (EB) and X-ray sterilization are a versatile method employed to ensure the microbial safety of various products in the medical devices, pharmaceutical, surgical equipment, food, and cosmetic industries. In medical devices, radiation sterilization is utilized for such devices as catheters, syringes, and empty vials for sample collection. Pharmaceuticals require radiation sterilization for drug products and packaging materials such as filled vials, liquid medicines, and blister packs, preserving their sterility throughout shelflife. Surgical equipment, including instruments and implants, undergo radiation treatment to aseptic conditions in medical settings. In the food industry, e-beam technology is applied to spices, herbs, packaged foods, fresh food, and ingredients, extending shelf life and enhancing safety. Medical supplies like single-use items and dressings, as well as certain cosmetic products, benefit from the ability of radiation sterilization to penetrate materials effectively without leaving chemical residues. The method's versatility and effectiveness make it a valuable tool in maintaining the integrity and safety of a diverse array of products across these critical industries.

[0003] Currently, controls of e-beam and X-ray sterilization are constant in terms of energy density, and the variable component seems to be solely the exposure time, by controlling the conveyor belt if used, or the residence time in batch operations based on predefined conditions using dosimeters distributed along the package containing a multiplicity of units. Likewise, dosimeters are used, mainly for monitoring human radiation exposure or as a go / no go to determine whether the process is complete, by using change in color of radiachromic dosimeters after the product exits the sterilization system.

[0004] 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

[0005] Disclosed, in various exemplary implementations, are systems, assemblies and methods for sterilizing a product using closed loop control of e-beam or X-ray radiation, designed to monitor and adjust the irradiation process in either real-time or inmediately following irradiation, to ensure that the desired level of sterilization is achieved efficiently and consistently.

[0006] In an exemplary implementation provided herein is a closed-loop system for monitoring and inspection of e-beam and / or x-ray radiation comprising: an e-beam source, operable to generate an electron-beam, and / or x-ray having an energy density (D) configured to irradiate a target at a predetermined dose (E) configured to effectively sterilize the target; an e-beam raster coupled to the e-beam source, the e-beam raster configured to scan the target at a given longitudinal direction; a holding stage, having an upper surface defining: a first portion sized and configured to be at least partially shielded from direct irradiation by the target; a second portion, upstream from the first portion relative to the scan direction configured to be completely exposed to irradiation, the second portion defining a longitudinal axis transverse to the longitudinal scan direction; and a third portion, downstream from the first portion relative to the scan direction configured to be completely exposed to irradiation, the third portion defining a longitudinal axis transverse to the longitudinal scan direction wherein the first, second, and third portion are each in communication with at least one sensor operable to detect a measurable parametric change, such as, for example resistance, inductance, current, capacitance, or photons, and are each plated with a composition configured to interact with the e-beam , which is proportional to an absorbed radiation; and a central processing module (CPM), in communication with the e-beam source, the e-beam raster, and each sensor in communication with the first, the second and the third portions of the holding stage, the CPM 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 to cause the at least one processor to perform the steps of: receive an input indicating a presence of the target on the first portion of the holding stage; receive a plurality of target parameters configured to affect the predetermined dose configured to effectively sterilize the target; based on the plurality of parameters,determine the radiation dose configured to effectively sterilize the target; using the e-beam source and e-beam raster, initiate scanning of the target at the energy density configured to irradiate the target at the predetermined dose configured to effectively sterilize the target; using the at least one sensor, detect the resistance, current, capacitance or photon density at each portion of the holding stage; using the differential in the detected resistance, current, capacitance, photon density or their combination, between the first, the second, and the third portions of the holding stage, calculate the dose adsorbed by the target; and if the dose adsorbed by the target is between about 80% and about 120% of the predetermined dose configured to sterilize the target, release the target for further processing; else adjust a parameter that is: an energy density of the e-beam, a scanning rate of the e-beam rastering, an electromagnetic deflection of the e-beam rastering, a raster fan width, the number of passes under the rastering beam, beam pulse frequency, speed of the conveyor, or their combination; and using the e- beam source and e-beam raster, initiate scanning of the target at the adjusted energy density configured to irradiate the target at the predetermined dose configured to effectively sterilize the target. For clarification, rastering can also be accomplished by a fixed beam having a predefined spot size and using the conveyor to move the stage in x and y according to the desired results. Additionally, or alternatively, rastering can be accomplished by moving both the beam and the stage in a predetermined pattern, configured to provide the required cover.

[0007] 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

[0008] For a better understanding of the systems and methods for closed loop control of EB or X-ray radiation, designed to monitor and adjust the irradiation process in real-time, with regard to the exemplary implementations thereof, reference is made to the accompanying examples and figures, in which:

[0009] FIG. 1, illustrates a front elevation schematic view of an exemplary implementation of a holding stage in the systems disclosed;

[0010] FIG. 2A, illustrates a top plan schematic view of an optional exemplary implementation of a holding stage in the systems disclosed, with FIG. 2B, illustrating a correspondingexemplar}' implementation of the control loop used to monitor and control the irradiation process using the holding stage implementation illustrated schematically in FIG. 2A;

[0011] FIG. 3 A, illustrates a top plan schematic view of another optional exemplary implementation of a holding stage in the systems disclosed, with FIG. 3B, illustrating a corresponding exemplar)' implementation of the control loop used to monitor and control the irradiation process using the holding stage implementation illustrated schematically in FIG. 3A;

[0012] FIG. 4A, illustrates a top plan schematic view of yet another optional exemplary implementation of a holding stage in the systems disclosed, with FIG. 4B, illustrating a corresponding exemplar)' implementation of the control loop used to monitor and control the irradiation process using the holding stage implementation illustrated schematically in FIG. 4A; and

[0013] FIG. 5 illustrates a schematic of additional exemplary implementation of the holding stage.

[0014] FIG. 6 Illustrates an exemplary flow chart of a closed loop control sequence used to optimize the uniformity of the irradiation.

[0015] FIG. 7 Shows exemplary results of a 3-step uniformity optimization based on the closed-loop control sequence illustrated schematically in Fig. 6.

[0016] FIG. 8 Illustrates another exemplary use of the closed loop control for adjusting a varied irradiated dose in different sections of the product under irradiation.DETAILED DESCRIPTION

[0017] Provided herein are exemplary implementations of systems and methods for sterilizing a product using closed loop control of EB or X-ray radiation, designed to monitor and adjust the irradiation process in real-time or quasi real-time to ensure that the desired level of sterilization is achieved efficiently and consistently.

[0018] Accordingly and in exemplary implementations as disclosed in FIG.s 1-5, provided herein is system 10 for closed-loop monitoring and inspection of e-beam and / or x-ray radiation comprising: e-beam source 700, operable to generate electron-beam having energy density (D) configured to irradiate a target at predetermined dose (E) configured to effectively sterilize target 800; e-beam raster 701 coupled to e-beam source 700, e-beam raster configured to scan target 800 across given longitudinal direction XL105', holding stage 100, having upper surface defining: first portion 505 (see e.g., FIG. 5) sized and configured to be at least partially shielded from irradiation by target 800; second portion 501, upstream from first portion 505 relative to scan direction XL505,configured to be completely exposed to irradiation (e.g., by e-beam source 700 rastering), second portion 501 defining longitudinal axis XL01, transverse to longitudinal scan direction XL05, and third portion 502, downstream from first portion 505 relative to scan direction XL505, configured to be completely exposed to irradiation, third portion 502 defining longitudinal axis XL502, transverse to longitudinal scan direction XL505, wherein first 505, second 501, and third portion 502 are each in communication with at least one sensor 1010, 1020, 1050 (see e.g., FIG. 1) operable to detect resistance, current, or capacitance, photons, or color change (or their combination) and are each (first 505, second 501, and third portion 502 ) plated (or coating) with composition configured to interact with e-beam and generate change in resistance, current, capacitance, photons, or color change that is proportional to absorbed radiation by that portion; and central processing module (CPM) 11, in communication with e-beam source 700, e-beam raster 701, and each sensor 1010, 1020, 1050 as well as in further communication with first 505, second 501, and third portion 502 of holding stage 100, CPM 11 further comprising at least one processor in communication with non-transitory memory device storing thereon computer-readable medium with set of executable instructions, configured when executed to cause at least one processor to perform steps of: receive input indicating presence of target 800 material (e.g., a consumable, medical device, etc.) on first portion 505 of holding stage 100; receive plurality of parameters associated with target material 800, the plurality of parameters configured to affect predetermined dose (E), or energy density (D) configured to effectively sterilize target. Based on the plurality of parameters, determine radiation dose (E) configured to effectively sterilize target; using e-beam source 700 and e-beam raster 701, initiate scanning of target 800 material at energy density (D) configured to irradiate target at the predetermined dose (E) configured to effectively sterilize target. Further, using at least one sensor (coupled to each portion, or sector) 1010, 1020, 1050, detect resistance, current, capacitance or photons at each first 505, second 501, and third portion 502 of holding stage 100, then, using differential in detected resistance, cunent, capacitance or photons (proportional to the radiation dose absorbed in each first 505, second 501, and third 502 portion (interchangeable with sector) between first 505, second 501, and third 502 sectors of holding stage 100, calculate dose (E) adsorbed by the target 800 material. If dose (E) adsorbed by target 800 material is between about 80% and about 120% of the predetermined dose (E) configured to sterilize target, release target for further processing (e.g., cooling, QA / QC inspection, packaging, etc.). As noted a safety margin of dose will be considered and integrated for any variation in the pathogens and added to the total dose for as a risk factor compensation of sterilization.

[0019] Otherwise adjust at least one parameter that is:• energy density (D, in electron volts) of e-beam 700; e.g., by increasing or decreasing the beam current, varying acceleration voltage, altering spot size, beam modulation using magnetic fields or modulating devices and the like.• scanning rate of e-beam rastering 701 ; e.g., varying the speed at which the e-beam raster scans across the target material, as well as the scanning pattern and the like.• electromagnetic deflection of e-beam rastering; e.g., changing the amplitude and frequency of the electromagnetic fields, changing (temporo-) spatial resolution, changing the shape and size of the irradiated area, and the like• raster fan width; e.g., by changing focal lengths, having a variable aperture system (e.g., irises), and the like• number of passes under rastering beam;• speed of conveyor in both the x and y axes• beam pulse frequency e.g., in pulsed e-beam, varying pulse duration, pulse frequency, pulse energy (see above), duty cycle, pulse shape and the like. or their combination; and using e-beam source 700 and e-beam raster 701, initiate scanning of target 800 material using the energy density adjusted based on these parameters, such that the adjusted energy will be configured to irradiate target at predetermined dose configured to effectively sterilize the target.

[0020] Adjustment of these parameters can be done using deep machine learning (DML) algorithms that will be configured to optimize the delivery of the energy density based on various parameters defined by the user. Accordingly, various parameters are configured and used to ensure both the efficacy of the process and the preservation of product integrity. These can be, for example, the energy density of the electron beam, measured in kilo-electron volts (keV) or mega-electron volts (MeV), influencing the penetration depth essential for comprehensive sterilization. The dose rate, expressed in grays per second (Gy / s), dictating the speed at which energy is deposited during thesterilization process. Beam current, measured in amperes and measured using various AMP- meters (e.g., one of sensors 1010, 1020, or 1050) disposed along the process flow, which affects the overall intensity of the electron beam, influencing sterilization efficiency. Another parameter can be beam uniformity, ensuring consistent exposure across the product surface. The scanning pattern parameters, encompassing speed and density, are calibrated initially in certain exemplary implementations, to facilitate complete coverage of the target material.

[0021] In an exemplary implementation, the composition that each of first 505, second 501, and third 502 sectors of the holding stage 100 used in the methods and systems for closed-loop control of electron-beam (EB)-based sterilization disclosed herein, can each be plated with a copper (Cu) plate coated with a metal alloy configured to reflect or adsorb high-energy electrons such as those irradiated by the-beam source. For example, and in another exemplary implementation, the metal alloy configured to reflect or adsorb high-energy electrons is nickel / gold (Ni / Au) film.

[0022] While copper provides the desired conductivity and dynamic response in certain exemplar)' implementations to the adsorbed radiation, oxidative stability may require coating with other metal alloys suitable to absorb the irradiation by the e-beam or X-ray. These other alloys can be, for example, tungsten-copper alloy (W / Cu), Molybdenum-copper alloys (Mo / Cu), Tantalum- copper alloys (Ta / Cu), Nikel-chromium (Ni / Cr, Nichrome), Titanium-nitride (Ti / N). Likewise, the alloy used depends in certain implementations on, for example, specific requirements of the application (e.g., consumables vs. surgical equipment), including the energy level of the e-beam, the desired balance between absorption and reflection, and the thermal properties required. Furthermore, the plating method, for example, sputtering, chemical vapor deposition, atomic layer deposition, electroplating and the like can influence the performance of the coating.

[0023] In an exemplary implementation, holding stage 100 is further temperature controlled (see e.g., 1001) by the CPM 11 to a temperature between -18 °C (e.g., using an array of Peltier devices) and 300 °C (using e.g., the holding stage 100 as a resistor). As illustrated in FIG. 1, and in addition, the system can be configured to impose positive bias voltage (1001) opposite the e-beam source, in communication with CPM 11, thereby regulating the kinetic energy of electrons in the e-beam, influencing penetration depth, dose rate, and energy density, all which are salient factors for effective sterilization. In an exemplary implementation, CPM 11 continuously monitors and dynamically adjust the voltage bias in real time based on feedback from dosimeters and sensors, thereby allowing for compensation resulting from variations in the irradiation environment and product geometry, ensuringconsistent sterilization efficacy. Additionally, the voltage bias is continuously monitored and controlled to maintain safety by preventing overexposure or underexposure of products to the e-beam, thus contributing to the precision and reliability of the sterilization process, for example, in those products where over-exposure can result in target 800 material degradation. In an exemplary implementation, the voltage bias (referring to a specific electrical condition where a constant direct current (DC) voltage is applied to the holding stage to establish its operating point) is maintained between about 0.1V and about 25 KV.

[0024] As indicated and in another exemplary implementation, each of sectors 505, 501, 502 is operably coupled to at least one sensor, the at least one sensor in each sector operable to measure resistance, current, or capacitance that is proportional to an absorbed radiation. For example, Faraday cups are used in certain exemplary implementations for collecting and measuring the charge carried by the e-beam, providing a quantifiable measure of the delivered dose to a given sector. Likewise, semiconductor diodes, e.g., those made from silicon can serve as solid-state detectors sensitive to ionizing radiation, with changes in electrical conductivity proportional to the radiation dose. Examples of capacitance sensors used in the systems and methods disclosed can be, for example, Electret ion chambers, which utilize alterations in dielectric properties to measure radiation dose exposure. Likewise, Metal-Insulator-Semiconductor (MIS) capacitors and Field-Effect Transistor (FET) sensors, with radiation- sensitive components, and voltage-variable capacitors (Varactors), configured as sensors, can also respond to radiation-induced charge alterations.

[0025] Additionally, or alternatively, resistance sensors are employed to monitor e-beam dose exposure by exploiting changes in material resistivity induced by the e-beam and / or x-ray radiation. These can be, for example, metal-oxide- semiconductor field-effect transistor (MOSFET) dosimeters, which incorporates a radiation-sensitive insulator between the gate and substrate, altering the transistor's electrical characteristics upon exposure to e-beam and / or x-ray radiation. As the e-beam interacts with the insulator, charge trapping or release affects the conductivity, leading to a measurable change in resistance. Likewise, thermoluminescent dosimeters (TLDs) can be used, where radiation exposure causes defects in the crystal lattice (e.g., lithium fluoride (LIF), Calcium Sulfate (CaSCL), Lithium borate (LizILO?), Lithium magnesium silicate (LisMgSiCL)) influencing the TLD's resistance to thermoluminescent emission when subsequently heated.

[0026] Furthermore, current sensors such as amp meters, can be employed to monitor e-beam dose exposure and provide real-time feedback. These can also be, for example, semiconductor devicessuch as p-i-n diodes and photodiodes. P-i-n diodes, comprising a p-type, intrinsic, and n-type semiconductor layers, allow for the detection of ionization events induced by e-beams, generating a measurable current. Similarly, photodiodes, particularly those sensitive to ionizing radiation, produce a photocurrent proportional to the incident radiation. These sensors, in conjunction with appropriate electronics and readout systems, provide in another exemplary implementation, a quantification of e- beam dose exposure indirectly and are calibrated separately in another exemplary implementation at the radiation range expected for the specific target 800 material. Selection of the specific sensor type is predicate on factors like radiation energy, sensitivity requirements, and the dosimetry system's overall design.

[0027] In certain exemplary implementations, X-ray intensity is measured using various detectors, including ionization chambers, solid-state detectors, scintillation detectors, and filmless digital detectors. For example, Ionization chambers quantify X-ray intensity by measuring the ionization of air caused by X-ray exposure, correlating the resulting electrical current to intensity. Also, solid-state detectors, which use semiconductors to directly convert X-rays into electrical signals can be used, while scintillation counters utilize materials emitting light upon X-ray exposure (e.g., Sodium Iodine Nal crystal), with the intensity of the emitted light corresponding to X-ray intensity. Moreover, filmless digital detectors directly (in the case of direct digital radiography, using e.g., amorphous Selenium (a-Se) in combination with an electric field) convert X-rays into digital signals, facilitating real-time imaging. The choice of detector depends on factors like sensitivity, resolution, and application requirements. Advances in technology have led to sophisticated detectors, enhancing medical imaging and industrial non-destructive testing processes. Traditional X-ray films, though less common today, can also measure X-ray intensity by capturing the darkness of the film, indicative of X-ray exposure levels

[0028] Additionally, target 800 material characteristics, such as, for example; density, composition, and packaging materials, radiation sensitivity, degree of degradation following exposure, are used in determining the requisite energy levels and penetration depth. Likewise, dose mapping, is used to ensure that the radiation dose is distributed uniformly across the product, avoiding overexposure or underexposure. In addition product parameters such as, for example target size, target density, target composition, target biological, organic contaminant, type, target contaminant composition, target contaminant concentration, target intended use target location in the target transfer stage, or a parameter comprising one or more of the foregoing are also used.

[0029] Turning now to FIG.s 2A, and 3A. As illustrated schematically in FIG. 3A, in an exemplar)' implementation, first portion (or sector) AW, is comprised of an array of sub-regions 105p, each pthsub-region 105p associated with at least one sensor 1050p configured to measure the change in resistance, current, capacitance or their combination in response to irradiation of each pthsub-region 105p, and wherein the at least one sensor that is coupled to each ithsub-region lOli is in further communication with CPM 11. Similarly, in another exemplary implementation, second portion AB (downstream from portion 105 holding target 800 material), is further divided to sub-regions lOli along the longitudinal axis of the second portion ( LAB), each ithsub-region lOli, associated with at least one sensor lOlOi configured to measure the change in resistance, current, or capacitance in response to irradiation at each ithsub-region lOli, and wherein each sensor 1020j associated with the sub-region is in further communication with the CPM 11.

[0030] In yet another exemplary implementation, system 10 used for closed-loop control of electron-beam (EB)-based sterilization described herein, can further comprising imaging module 750 in communication with CPM 11, wherein the set of executable instructions are further configured when executed by the at least one processor to: detect the presence of target 800 on the first portion 105 of the holding stage 100; and calculate the fractional area of the first portion 105 shielded by the target. In this context, the term “shielded” refers to the target footprint or shadow, covering the upper surface of the first sector configured to hold the target during irradiation. Accordingly, and in an exemplar)' implementation, dose / cm2is calculated by subtracting the dose / cm2from the average of the first lOli (501) and second 102j (502) form the dose / cm2measured in the first sector 105p (505).

[0031] 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 imagingmodules 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).

[0032] As further illustrated in FIG. 2A, holding stage 100 further comprises: fourth portion 103 (OB), disposed between first portion 105 and second 101 portion relative to scan direction XL105, configured to be completely exposed to e-beam irradiation, fourth portion 103 defining longitudinal axis Az / 05transverse to longitudinal scan direction XL105', and fifth portion 104, disposed between first portion 105 and third portion 102 relative to scan direction XL105, configured to be completely exposed to e-beam irradiation, fifth portion 104 defining longitudinal axis XL104transverse to longitudinal scan direction XL105, wherein surface of fourth 103 and fifth 104 portions are each covered with tape, film or coating, configured to provide optical response proportional to adsorbed radiation. In an exemplary implementation the set of executable instructions are further configured when executed by the at least one processor to: using imaging module 750, detect the energy density (D) adsorbed in each of the fourth and fifth portions, wherein the tape, film or coating, covering the fourth and fifth (elongated sectors) are adapted to provide optical response proportional to the adsorbed radiation from the e- beam.

[0033] Similar to the second and third sectors, the fourth and fifth sectors can likewise be partitioned to sub-regions along each longitudinal axis, covered with the same or different optic indicator (sensor) thereby providing higher spatial resolution of the adsorbed radiation.

[0034] Furthermore, photodiodes, converting photons into an electric current, can be used in combination with scintillation counters that transform the e-beam's energy into photons for detection in these sectors. Additionally, radiochromic film dosimeters are used in certain exemplary implementations as dynamic indicators, exhibiting a color change corresponding to the radiation dose and serving as visual markers of exposure when imaged using the imaging module 750. Moreover, thermoluminescent dosimeters (TLD) are used in yet additional implementations, to trap energy when exposed to radiation, releasing it as light during heating of, for example holding stage 100, with the emitted light intensity being proportional to the radiation dose. Also, the scintillation detectors utilize materials that emit light upon exposure to ionizing radiation, their measured light intensity configured to provide a direct correlation to the radiation dose delivered. Accordingly and in an exemplaryimplementation, the optical radiation dose sensor is at least one of: a photodiode, a scintillation counter, a radiochromic film dosimeter, and a thermoluminescent dosimeter (TLD).

[0035] In certain exemplary implementations, the composition that the first 505, the second 501, and the third 502 sectors of the holding stage 100 are each plated with a metal sheet configured to generate x-rays when irradiated (or exposed) with (to) the e-beam. For example, Tungsten (W) that increases the efficiency of X-ray production through bremsstrahlung radiation is used in certain exemplar)' implementations, while molybdenum (Mo) and tantalum (Ta), can also be used to generate X-rays when exposed to high-energy e-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 alloy 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] The X-ray intensity increases with the e-beam current, the kinetic energy of the electrons (e.g., adjustable using the voltage bias), and the atomic number of the target material. In healthcare sterilization, radiation energies in the range of 0.5-12 MeV needed to provide an alternative to gamma irradiation.

[0037] Accordingly, and in an exemplary implementation, the holding stage 100 further comprises a plated material, or a plated metal alloy, configured to absorb x-rays not adsorbed by the target 800 acting substantially as shielding. For example, the plated material, or the plated metal alloy, configured to absorb x-rays not adsorbed by the target can be: anodized aluminum, lead, platinum, titanium, chromium, manganese, iron, copper, cobalt, nickel, zinc, brass, argon, potassium, tellurium, iodine, uranium, neptunium, lanthanide series, molybdenum, lead-tin alloy, lead-copper-tin alloy, lead-bismuth alloy, lead-cadmium alloy, lead-antimony alloy, tungsten-nickel-copper alloy, tungstennickel-iron alloy, tungsten-nickel-cobalt alloy, or tungsten-nickel-iron-cobalt alloy.

[0038] In certain exemplary implementations, the closed loop control can be used to apply an exemplar)' deep machine learning (DML) algorithms (see e.g., FIG. 6.), to optimize the desired irradiation uniformity.

[0039] FIG.s 7A-8B illustrate the results of an irradiated dose on the sample stage using radio- chromic B3 films having a dimension of 30 cm x 18 cm purchased from GeX Corporation (reference: https: / / www.gexcorp.com / b3-dosimeters.html). The irradiated B3 films were scanned using anEPSON 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 y directions. The electron beam source energy was 4.0 MeV, and the Beam power was 147 Watts.

[0040] FIG. 7A-7C Shows the actual data generated on the radiochormatic B3 dosimetry films obtained using the closed loop control sequence provided in FIG. 6 to optimize the irradiated does and corresponding uniformity in x and y directions, and more specifically in the y direction. FIG 7a shows the dose uniformity resulting from the first pass according to the system-estimated x, y conveyor speed for the desired nominal dose of 30 kGy. Both the actual does and uniformity are not at the desired values. FIG. 7b, shows the effect of the DML closed loop control on dialing the dose and improving the uniformity, while FIG. 7c shows the results after a third pass of the close loop control, thus setting the optimum parameters for subsequent processing of the products.

[0041] FIG. 8 A shows the dose variation capabilities as the DML closed loop control adjusts the sample stage speed based on user-defined dose requirements per (x, y,) location. Fig 8A shows the programmed dose variations at a predefined y’ scan location as a function of the x’ position. Similarly, Fig 8B shows a 3D analysis of the same irradiated radio-chromatic B3 film; the y’ direction shows a uniform dose distribution as optimized using the procedure illustrated in FIG 6.

[0042] In the context of the disclosure, the term “closed loop control” is understood to generally refer to operation that involves constant feedback and modification of a control signal. For clarification pruposes, the term “closed loop control” is used here to refer to either feedback in real time during the process, or feedback post irradiation.

[0043] 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.

[0044] 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 and otherwise 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.

[0045] 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

[0046] 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.

[0047] 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 protrusion(s) includes one or more protrusion). 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 exemplar}' implementation is included in at least one exemplary implementation described herein, and may or may not be present in other exemplar}' implementations. In addition, it is to be understood that the described elements may be combined in any suitable manner in the various exemplary implementations.

[0048] 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.

[0049] 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.

[0050] As indicated, the systems used herein can be computerized systems further comprising a central processing module; 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.

[0051] 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 module may 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.

[0052] 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].

[0053] 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 wavesor 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.

[0054] Computer readable program instructions for carrying out operations of the present invention may be assembler instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state-setting data, configuration data for integrated circuitry, or either 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.

[0055] 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.

[0056] 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 datarepresented 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.

[0057] Accordingly and in an exemplary implementation, provided herein is a system for closed-loop monitoring and inspection of e-beam and / or x-ray radiation comprising: an e-beam source, operable to generate an electron-beam and / or x-ray having an energy density (D) configured to irradiate a target at a predetermined dose (E) configured to effectively sterilize the target; an e- beam raster coupled to the e-beam source, the e-beam raster configured to scan the target across a given longitudinal direction; a holding stage, having an upper surface defining: a first portion sized and configured to be at least partially shielded from irradiation by the target; a second portion, upstream from the first portion relative to the scan direction configured to be completely exposed to irradiation, the second portion defining a longitudinal axis transverse to the longitudinal scan direction; and a third portion, downstream from the first portion relative to the scan direction configured to be completely exposed to irradiation, the third portion defining a longitudinal axis transverse to the longitudinal scan direction wherein the first, second, and third portion are each in communication with at least one sensor operable to detect resistance, current, or capacitance, and are each plated with a composition configured to interact with the e-beam and generate a change in the resistance, current, or capacitance that is proportional to an absorbed radiation; and a central processing module (CPM), in communication with the e-beam source, the e-beam raster, and each sensor in communication with the first, the second and the third portions of the holding stage, the CPM 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 to cause the at least one processor to perform the steps of: receive an input indicating a presence of the target on the first portion of the holding stage; receive a plurality of target parameters configured to affect the predetermined dose configured to effectively sterilize the target; based on the plurality of parameters, determine the radiation dose configured to effectively sterilize the target; using the e-beam source and the e-beam raster, initiate scanning of the target at the energy density configured to irradiate the target at the predetermined dose configured to effectively sterilize the target; using the at least one sensor, detect the resistance, current, capacitance, photons, or color change of a radio-chromatic film at each portion of the holding stage; using the differential in the detected resistance, current, capacitance, or color between the first, the second, and the third portions of the holding stage, calculate the dose adsorbed by the target; and if the dose adsorbed by the targetis between about 80% and about 120% of the predetermined dose configured to sterilize the target, release the target for further processing; else adjust a parameter that is: an energy density of the e- beam, a scanning rate of the e-beam rastering, an electromagnetic deflection of the e-beam rastering, a raster fan width, the number of passes under the rastering beam, beam pulse frequency or their combination, wherein (i) the set of executable instructions, is further configured when executed to cause the at least one processor to perform the steps of: using the e-beam source and e-beam raster, initiate scanning of the target at the energy density configured to irradiate the target at the predetermined dose; using the at least one sensor, detect the resistance, current, capacitance, photons, or color change of a radio-chromatic film at each portion of the holding stage; using the differential in the detected resistance, current, capacitance, or color between the first, the second, and the third portions of the holding stage, calculate the dose uniformity across the target; and if the dose level across the target is between about +5% of the predetermined dose uniformity configured to sterilize the target, release the target for further processing; else adjust a parameter that is: a scanning rate of the e-beam rastering and / or stage x, y speeds, an electromagnetic deflection of the e-beam rastering, a raster fan width, the number of passes under the rastering beam, beam pulse frequency or their combination; and using the e-beam source and e-beam raster, initiate scanning of the target at the adjusted energy density configured to irradiate the target at the predetermined dose configured to effectively sterilize the target, wherein (ii) the first, the second, and the third portion of the holding stage are each plated with a composition that is a copper plate coated with a metal alloy configured to reflect or adsorb high-energy electrons (iii) the metal alloy configured to reflect or adsorb high-energy electrons is nickel / gold (Ni / Au) film, wherein (iv) the holding stage is further temperature controlled by the CPM to a temperature range of between about -18 °C and about 300 °C, (v), the stage is in communication with the CPM and is further operable to move in an x’ axis direction and a y’ axis direction relative to the e-beam source, wherein (vi) the set of executable instructions, is further configured, when executed, to cause the at least one processor while performing the step of scanning of the target at the energy density configured to irradiate the target at the predetermined dose to: not use the e-beam raster (in other words, have the e-beam be fixed); and translate the stage along the x’ axis and / or the y’ axis at a predetermined pattern relative to the e-beam source, whereby the predetermined pattern configured to cause the target to be irradiated at the predetermined dose configured to effectively sterilize the target; or, alternatively, (vii) translate the stage along the x’ axis and / or the y’ axis at a predetermined pattern relative to the e-beam raster (which remains operational), the predetermined pattern configured to irradiate the target at the predetermined dose configured to effectively sterilize the target, wherein (viii) the holding stage is voltage biased between about 0.1V and about 25KV, wherein (ix) the at least one sensor associated with each of the first, second, and third portion is an Ampere meter (configured to respond to both alternating (AC) and direct currents (DC), such as moving iron ammeters (interchangeable), and / or moving Coil Ammeters which move in response to the magnetic fields generated by direct current), wherein (x) the plurality of target parameters configured to affect the predetermined dose configured to effectively sterilize the target are: target size, target density, target composition, target contaminant type, target contaminant composition, target contaminant concentration, target intended use, target packaging type, or a parameter combination comprising two or more of the foregoing, wherein (xi) the first portion is comprised of an array of sub-regions, each region associated with a corresponding sensor configured to measure the change in resistance, current, or capacitance in response to irradiation, and wherein at least one of the sub-region-corresponding sensor is in further communication with the CPM, (xii) the second portion is further divided to sub-regions along the longitudinal axis of the second portion, each sub-region associated with at least one sensor configured to measure the change in resistance, current, or capacitance in response to irradiation, and wherein each sensor associated with the sub-region is in further communication with the CPM (xiii) the third portion is further divided to sub-regions along the longitudinal axis of the third portion, each sub-region associated with a sensor configured to measure the change in resistance, current, or capacitance in response to irradiation, and wherein each sensor associated with the sub-region is in further communication with the CPM, the system (xiv) further comprising an imaging module in communication with the CPM, wherein the set of executable instructions are further configured when executed by the at least one processor to: detect the presence of the target on the first portion of the holding stage; and calculate the fractional area of the first portion shielded by the target, wherein (xv) the holding stage further comprises: a fourth portion, disposed between the first portion and the second portion relative to the scan direction, configured to be completely exposed to irradiation, the fourth portion defining a longitudinal axis transverse to the longitudinal scan direction; and a fifth portion, disposed between the first portion and the third portion relative to the scan direction, configured to be completely exposed to irradiation, the fifth portion defining a longitudinal axis transverse to the longitudinal scan direction, wherein the surface of the fourth and fifth portions are each covered with a tape configured to provide an optical response proportional to adsorbed radiation, wherein (xvi) the set of executable instructions are furtherconfigured when executed by the at least one processor to: using the imaging module, detect the energy density (D) adsorbed in each of the fourth and fifth portions, wherein (xvii) the fourth portion is further divided to sub-regions along the longitudinal axis of the fourth portion, wherein the surface of each sub-region of the fourth portions (discretely per sub region), is covered with a tape configured to provide an optical response proportional to adsorbed radiation, wherein (xviii) the fifth portion is further divided to sub-regions along the longitudinal axis of the fifth portion, wherein the surface of each sub-region of the fifth portions (discretely per sub region), is covered with a tape configured to provide an optical response proportional to adsorbed radiation, wherein (xix) the composition that the first, the second, and the third portion of the holding stage are each plated with, is a metal sheet configured to generate x-rays when irradiated with the e-beam or X-rays, (xx) the metal of the metal sheet is Tantalum, Tungsten or an element with atomic numbers between 20 and 84, except for 36, 43, and 61, elements with atomic numbers 90 and 92 that are capable of generating X-rays (e.g., Thorium and Uranium), or an alloy comprising one or more of the foregoing, wherein (xxi) the holding stage further comprises a plated material, or a plated metal alloy, configured to absorb x-rays not adsorbed by the target, (xxii) the plated material, or the plated metal alloy, configured to absorb x- rays not adsorbed by the target is: anodized aluminum, lead, platinum, titanium, chromium, manganese, iron, copper, cobalt, nickel, zinc, brass, potassium, tellurium, iodine, uranium, neptunium, lanthanide series, molybdenum, lead-tin alloy, lead-copper-tin alloy, lead-bismuth alloy, leadcadmium alloy, lead-antimony alloy, tungsten-nickel-copper alloy, tungsten-nickel-iron alloy, tungsten-nickel-cobalt alloy, or tungsten-nickel-iron-cobalt alloy, the system (xxiii) further comprising creating a controlled atmosphere environment above the holding stage (and within the chamber) using Nitrogen, Helium, Argon, or a composition comprising one or more of the foregoing, and further comprising (xxiv) at least one sensor operable to convert x-ray intensity to a digital signal, for example (xxv) an ionization chamber, a solid-state detector, a scintillation detector, a filmless digital detector, or a sensor array comprising one or more of the foregoing.

[0058] 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 system for closed-loop monitoring and inspection of e-beam and / or x-ray radiation comprising: a) an e-beam source, operable to generate an electron-beam and / or x-ray having an energy density (D) configured to irradiate a target at a predetermined dose (E) configured to effectively sterilize the target; b) an e-beam raster coupled to the e-beam source, the e-beam raster configured to scan the target across a given longitudinal direction; c) a holding stage, having an upper surface defining: i. a first portion sized and configured to be at least partially shielded from irradiation by the target; ii. a second portion, upstream from the first portion relative to the scan direction configured to be completely exposed to irradiation, the second portion defining a longitudinal axis transverse to the longitudinal scan direction; and iii. a third portion, downstream from the first portion relative to the scan direction configured to be completely exposed to irradiation, the third portion defining a longitudinal axis transverse to the longitudinal scan direction wherein the first, second, and third portion are each in communication with at least one sensor operable to detect resistance, current, or capacitance, and are each plated with a composition configured to interact with the e-beam and generate a change in the resistance, current, or capacitance that is proportional to an absorbed radiation; and d) a central processing module (CPM), in communication with the e-beam source, the e- beam raster, and each sensor in communication with the first, the second and the third portions of the holding stage, the CPM 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 to cause the at least one processor to perform the steps of: i. receive an input indicating a presence of the target on the first portion of the holding stage; ii. receive a plurality of target parameters configured to affect the predetermined dose configured to effectively sterilize the target;iii. based on the plurality of parameters, determine the radiation dose configured to effectively sterilize the target; iv. using the e-beam source and the e-beam raster, initiate scanning of the target at the energy density configured to irradiate the target at the predetermined dose configured to effectively sterilize the target; v. using the at least one sensor, detect the resistance, current, capacitance, photons, or color change of a radio-chromatic film at each portion of the holding stage; vi. using the differential in the detected resistance, current, capacitance, or color between the first, the second, and the third portions of the holding stage, calculate the dose adsorbed by the target; and vii. if the dose adsorbed by the target is between about 80% and about 120% of the predetermined dose configured to sterilize the target, release the target for further processing; else viii. adjust a parameter that is: an energy density of the e-beam, a scanning rate of the e- beam rastering, an electromagnetic deflection of the e-beam rastering, a raster fan width, the number of passes under the rastering beam, beam pulse frequency or their combination.2 The system of claim 1, wherein the set of executable instructions, is further configured when executed to cause the at least one processor to perform the steps of: a) using the e-beam source and e-beam raster, initiate scanning of the target at the energy density configured to irradiate the target at the predetermined dose; b) using the at least one sensor, detect the resistance, current, capacitance, photons, or color change of a radio-chromatic film at each portion of the holding stage; c) using the differential in the detected resistance, current, capacitance, or color between the first, the second, and the third portions of the holding stage, calculate the dose uniformity across the target; and d) if the dose level across the target is between about ±5% of the predetermined dose uniformity configured to sterilize the target, release the target for further processing; else e) adjust a parameter that is: a scanning rate of the e-beam rastering and / or stage x, y speeds, an electromagnetic deflection of the e-beam rastering, a raster fan width, the number of passes under the rastering beam, beam pulse frequency or their combination; andf) using the e-beam source and e-beam raster, initiate scanning of the target at the adjusted energy density configured to irradiate the target at the predetermined dose configured to effectively sterilize the target.

3. The system of claim 1, wherein the first, the second, and the third portion of the holding stage are each plated with a composition that is a copper plate coated with a metal alloy configured to reflect or adsorb high-energy electrons.4 The system of claim 3, wherein the metal alloy configured to reflect or adsorb high-energy electrons is nickel / gold (Ni / Au) film.5 The system of any one of claims 1, wherein the holding stage is further temperature controlled by the CPM to a temperature between -18 °C and 300 °C.6 The system of claim 1, wherein the stage is in communication with the CPM and is further operable to move in an x’ axis direction and a y’ axis direction relative to the e-beam source.7 The system of claim 6, wherein the set of executable instructions, is further configured, when executed, to cause the at least one processor while performing the step of scanning of the target at the energy density configured to irradiate the target at the predetermined dose to: a) not use the e-beam raster; and b) translate the stage along the x’ axis and / or the y’ axis at a predetermined pattern relative to the e-beam source, the predetermined pattern configured to irradiate the target at the predetermined dose configured to effectively sterilize the target.8 The system of claim 6, wherein the set of executable instructions, is further configured, when executed, to cause the at least one processor while performing the step of scanning of the target at the energy density configured to irradiate the target at the predetermined dose to translate the stage along the x’ axis and / or the y’ axis at a predetermined pattern relative to the e-beam raster, the predetermined pattern configured to irradiate the target at the predetermined dose configured to effectively sterilize the target.9 The system of any one of claims 1-8, wherein the holding stage is voltage biased between about 0.1V and about 25KV.10 The system of any one of claims 1-9, wherein the at least one sensor associated with each of the first, second, and third portion is an Ampere meter.11 The system of any one of claims 1-9, wherein the plurality of target parameters configured to affect the predetermined dose configured to effectively sterilize the target are: target size, targetdensity, target composition, target contaminant type, target contaminant composition, target contaminant concentration, target intended use, target packaging type, or a parameter combination comprising two or more of the foregoing.

12. The system of any one of claims 1-11, wherein the first portion is comprised of an array of sub-regions, each region associated with a corresponding sensor configured to measure the change in resistance, current, or capacitance in response to irradiation, and wherein at least one of the subregion-corresponding sensor is in further communication with the CPM.

13. The system of any one of claims 1-12, wherein the second portion is further divided to subregions along the longitudinal axis of the second portion, each sub-region associated with at least one sensor configured to measure the change in resistance, current, or capacitance in response to irradiation, and wherein each sensor associated with the sub-region is in further communication with the CPM.

14. The system of any one of claims 1-12, wherein the third portion is further divided to subregions along the longitudinal axis of the third portion, each sub-region associated with a sensor configured to measure the change in resistance, current, or capacitance in response to irradiation, and wherein each sensor associated with the sub-region is in further communication with the CPM.

15. The system of any one of claims 1-14, further comprising an imaging module in communication with the CPM, wherein the set of executable instructions are further configured when executed by the at least one processor to: a) detect the presence of the target on the first portion of the holding stage; and b) calculate the fractional area of the first portion shielded by the target.

16. The system of claim 15, wherein the holding stage further comprises: a) a fourth portion, disposed between the first portion and the second portion relative to the scan direction, configured to be completely exposed to irradiation, the fourth portion defining a longitudinal axis transverse to the longitudinal scan direction; and b) a fifth portion, disposed between the first portion and the third portion relative to the scan direction, configured to be completely exposed to irradiation, the fifth portion defining a longitudinal axis transverse to the longitudinal scan direction, wherein the surface of the fourth and fifth portions are each covered with a tape configured to provide an optical response proportional to adsorbed radiation.

17. The system of any one of claims 16, wherein the set of executable instructions are further configured when executed by the at least one processor to: using the imaging module, detect the energy density (D) adsorbed in each of the fourth and fifth portions.

18. The system of claim 16, wherein the fourth portion is further divided to sub-regions along the longitudinal axis of the fourth portion, wherein the surface of each sub-region of the fourth portions is covered with a tape configured to provide an optical response proportional to adsorbed radiation.

19. The system of claim 16, wherein the fifth portion is further divided to sub-regions along the longitudinal axis of the fifth portion, wherein the surface of each sub-region of the fifth portions is covered with a tape configured to provide an optical response proportional to adsorbed radiation.

20. The system of any one of claims 4-19, wherein the composition that the first, the second, and the third portion of the holding stage are each plated with is a metal sheet configured to generate x- rays when irradiated with the e-beam or X-rays.

21. The system of claim 20, wherein the metal of the metal sheet is Tantalum, Tungsten or an element with atomic numbers between 20 and 84, except for 36, 43, and 61, elements with atomic numbers 90 and 92 that are capable of generating X-rays, or an alloy comprising one or more of the foregoing.

22. The system of claim 21, wherein the holding stage further comprises a plated material, or a plated metal alloy, configured to absorb x-rays not adsorbed by the target.

23. The system of claim 22, wherein the plated material, or the plated metal alloy, configured to absorb x-rays not adsorbed by the target is: anodized aluminum, lead, platinum, titanium, chromium, manganese, iron, copper, cobalt, nickel, zinc, brass, potassium, tellurium, iodine, uranium, neptunium, lanthanide series, molybdenum, lead-tin alloy, lead-copper-tin alloy, lead-bismuth alloy, lead-cadmium alloy, lead-antimony alloy, tungsten-nickel-copper alloy, tungsten-nickel-iron alloy, tungsten-nickel-cobalt alloy, or tungsten-nickel-iron-cobalt alloy.

24. The system of claim 22, further comprising creating a controlled atmosphere environment above the holding stage using Nitrogen, Helium, Argon, or a composition comprising one or more of the foregoing.

25. The system of claim 21, further comprising at least one sensor operable to convert x-ray intensity to a digital signal.

26. The system of claim 25, wherein the at least one sensor is an ionization chamber, a solid- state detector, a scintillation detector, a filmless digital detector, or a sensor array comprising one or more of the foregoing.