Electron beam sterilization system and uses thereof

Abstract

The present disclosure relates to systems and methods for electron beam (EB) based sterilization, and more particularly to improved solutions for sterilizing products using EB radiation.

Description

Background Technology

[0001] This disclosure relates to systems and methods for electron beam (EB)-based sterilization, and more specifically to improved solutions for sterilizing products using EB radiation.

[0002] Electron beam (EB) sterilization is a flexible method for ensuring the microbiological safety of a wide range of products in the medical device, pharmaceutical, surgical equipment, and food industries. In medical devices, EB sterilization is used for devices such as catheters, syringes, and empty vials for sample collection. Pharmaceuticals require EB sterilization of pharmaceutical products and packaging materials, such as filled vials, liquid medications, and blister packs, to maintain their sterility throughout their shelf life. Surgical equipment, including instruments and implants, undergoes EB treatment in medical settings to achieve a sterile state. In the food industry, EB technology is applied to spices, herbs, packaged foods, fresh foods, and ingredients to extend shelf life and enhance safety. Medical supplies such as disposable items and dressings, as well as certain cosmetic products, benefit from EB sterilization's ability to effectively penetrate materials without leaving chemical residues. The flexibility and effectiveness of this method make it a valuable tool for maintaining the integrity and safety of a wide range of products in these critical industries.

[0003] The widespread adoption of electron beam sterilization faces several challenges in relevant industries. First, the substantial initial capital investment required for electron beam equipment and facilities has outsourced this process, increasing logistics, costs, and carbon footprint. This presents a significant obstacle, particularly for smaller businesses. Energy consumption is another concern, as the process demands a considerable amount of electricity, impacting both operating costs and environmental considerations. Outsourced facilities and technologies for generating electron beams limit sterilization to a holistic approach, i.e., at the level of boxes or pallets containing multiple product units. Meeting stringent regulatory standards adds to the complexity and cost of adopting electron beam technology. The limited penetration depth of electron beams can impair uniform sterilization of dense or bulky items. Furthermore, capacity and throughput limitations can affect the scalability of high-volume production setups.

[0004] Overcoming these challenges through technological advancements can pave the way for wider acceptance and integration of electron beam sterilization across industries. The following disclosure and claims aim to address the current deficiencies. Summary of the Invention

[0005] In various exemplary embodiments, systems, components, and methods for electron beam (EB)-based sterilization, and their use in various applications, are disclosed.

[0006] In an exemplary embodiment provided herein, a system for sterilizing a target using an electron beam (e-beam) source is provided. The system includes: a shielded processing chamber having a top plate forming at least one opening, an inlet port located upstream of the shielded processing chamber, and an outlet port located downstream of the shielded processing chamber; an electron beam generator coupled to at least one opening formed in the shielded processing chamber; and a target transfer table or conveyor belt, operable to transfer a target to be sterilized through the shielded processing chamber, wherein the electron beam generator is operable to adjust the irradiation between about 0.1 MeV and about 40.0 MeV in response to at least one parameter of the target to be sterilized.

[0007] In another exemplary embodiment, the system further includes a buffer chamber located upstream of the inlet of the sterilization chamber; and an inspection module located downstream of the outlet of the sterilization chamber, the inspection module being operable to verify radiation absorbed by the target to be sterilized.

[0008] These and other features of systems and methods for dynamic, product-specific electron beam (EB) sterilization will become apparent from the following detailed description when read in conjunction with the exemplary and non-limiting accompanying drawings and examples. Attached Figure Description

[0009] To better understand the systems and methods for electron beam-based sterilization, reference is made to the accompanying examples and figures for exemplary implementations, wherein:

[0010] Figure 1 A schematic diagram illustrating an exemplary specific implementation of the product flow in the disclosed system is provided;

[0011] Figure 2 This is a basic schematic diagram of an exemplary specific implementation of a system component;

[0012] Figure 3 This is a schematic diagram illustrating an exemplary specific implementation of the control module and the traceability module;

[0013] Figure 4 This is yet another exemplary embodiment of a mechanical component integrated into a system; and

[0014] Figure 5 A schematic diagram illustrating an exemplary specific implementation of an electron beam grating used in the system is shown.

[0015] Figure 6 The actual electron beam irradiation dose varies with the target sample stage speed from the target sample to the electron beam inlet window of 20 cm.

[0016] Figure 7The actual electron beam irradiation dose varies with the distance from the target sample to the electron beam inlet window at a fixed velocity of 0.2 cm / sec.

[0017] Figure 8 illustrates the effect of CPM varying the stage speed in the x-scan direction on generating different electron doses at different locations on a sample 20 cm from the electron beam inlet window. CPM utilizes a sinusoidal signal to vary the speed from 0.12 cm / sec to 0.5 cm / sec. Figure 8a shows the dose in a fixed y-direction, while Figure 8b shows a 3D image of the irradiated dose, demonstrating the uniformity of irradiation in the y-direction scanned at a constant speed. Detailed Implementation

[0018] This document provides exemplary implementations of systems and methods for electron beam (EB)-based sterilization.

[0019] Therefore, and in such Figures 2 to 5 In the disclosed exemplary embodiments, this document provides for using an electron beam (e-beam) source 650 (see, for example...) Figure 5 For targets 701, 702, and 703 (see example) Figure 2 A sterilization system 10 is provided, comprising: a shielded treatment chamber 200 (300, 400) having a top plate 203 forming at least one opening, an inlet port 201 located upstream of the shielded treatment chamber 200, and an outlet port 202 located downstream of the shielded treatment chamber 200 (300, 400); and an electron beam generator 500 coupled to at least one opening 205i formed in the shielded treatment chamber 200 (300, 400) (see example...). Figure 2 ); and a target transfer station 220 or conveyor belt, etc., which is operable to transfer targets 701, 702, 703 to be sterilized through shielded processing chambers 200 (300, 400), wherein the electron beam generator 500 is operable to adjust the irradiation between about 0.1 MeV and about 40.0 MeV in response to at least one parameter of the target to be sterilized.

[0020] As further illustrated, system 10 also includes: a buffer chamber 230 disposed upstream of the inlet 201 of sterilization chambers 200 (300, 400); and an inspection module 240 disposed downstream of the outlet 202 of sterilization chambers 200 (300, 400), the inspection module 240 being operable to verify radiation absorbed by the targets 701, 702, 703 to be sterilized. Furthermore, the buffer chamber 230 may include dual loading locks, wherein a first loading lock is configured to supply the target 701 to be sterilized to the shielded treatment chambers 200 (300, 400), and a second loading lock is configured to load an additional target 7000 to be sterilized (see, for example...). Figure 1 The first loading lock and the second loading lock are configured to alternate, such that target 702 is available for loading at any point. Furthermore, in yet another exemplary embodiment, system 10 may include a plurality of shielded processing chambers 200, 300, 400, each configured to receive a chamber-specific target.

[0021] In an exemplary embodiment, the electron beam source 500 used with the disclosed system may be, for example, a linear accelerator (LINAC), a circular accelerator (CAC), a synchrotron, an electron induction accelerator, a cyclotron accelerator, an electron cyclotron accelerator, a free electron laser (FEL), or any other electron accelerator system capable of operating to produce an electron beam with an energy range of 0.1 MeV to 40 MeV.

[0022] For example, a linear accelerator (LINAC) employs a multi-step method to generate a high-energy electron beam suitable for sterilizing a variety of products. Using, for example, a tungsten filament as the electron source, electrons are generated via thermionic emission. These electrons are then guided into an electron gun, where an electric field induces their acceleration. The accelerated electrons then enter a waveguide structure (e.g., a tubular path) within the LINAC, which uses a radio frequency (RF) field to guide and propel them forward. As the electrons traverse this path, they encounter an RF cavity, a resonant structure that further contributes its energy by applying an RF field. Magnetic focusing elements within the LINAC help maintain the focus and trajectory of the electron beam, ensuring it remains collimated. Upon exiting the LINAC, the electrons have acquired a significant level of energy, which is directed toward the target material (such as a medical device or food product) for sterilization.

[0023] The interaction between high-energy electrons and target materials disrupts the genetic material of microorganisms, preventing them from reproducing and achieving the desired sterilization effect. The LINAC can precisely control coefficients such as electron energy (E), beam focus, and dose rate (D), enabling customized sterilization for a wide variety of products.

[0024] Alternatively, the electron beam source 500 used with the disclosed system is a cyclotron, whereby electrons or other charged particles are injected into the central region of the cyclotron's magnetic field, which is approximately tens of millitalas (mT) to several tesla (T). As these particles traverse a circular or helical path determined by the magnetic field, while passing through the gap between Dee electrodes (D-shaped electrodes), the particles are accelerated via an oscillating electric field during each cycle, steadily gaining energy with each rotation due to the increase in centrifugal force. After electron stripping, which selectively removes electrons from the charged particles, the high-energy electron beam is then extracted from the cyclotron and directed toward the target material to be sterilized. In the exemplary embodiment, the flexibility to adjust the magnetic field strength and radio frequency parameters provides the cyclotron with a controlled and efficient means of generating a high-energy electron beam.

[0025] In addition, the shielding chamber 200 (300, 400) also includes: platform 206 (see, for example, see...) Figure 2 The platform is sized, adapted, and configured to carry the target 702 to be sterilized. The platform 206 is operable to adjust the distance between the target 702 to be sterilized and the top plate 203 of the shielded treatment chamber 200 (300, 400). The shielded treatment chamber 200 (300, 400) may also include at least one of the following: a collimator and an electron beam grid (see, for example...). Figure 5 The collimator and electron beam grating are located in a shielded processing chamber 200 (300, 400) (e.g., in the top plate 203 or other facets, see example). Figure 2 At least one opening 205i is connected between the electron beam source 500 and the shielding chamber 200 (300, 400); a collimator and / or electron beam grid; and / or a magnetic quadrupole, each configured to change at least one of the following: the cross-sectional shape of the electron beam, the angular span of the electron beam, and the focal point of the electron beam. Alternatively, the system may have an electron beam grating module configured to communicate with and be operatively coupled to at least one opening, located between the electron beam source and the shielding chamber, the grating being configured to irradiate the electron beam in a direction perpendicular (transverse) to the target movement direction.

[0026] In an exemplary embodiment, the collimator is an adjustable collimator. In the context of this disclosure, the term "collimator" or "adjustable collimator" refers to a means of shaping the radiation beam 650 into a desired geometry 6500. Typically, the shape of the radiation beam is adjusted as needed, and other geometries can also be adjusted, for example, but not considered to limit its height or both its height and width. It is also contemplated that non-rectangular cross-sections of the beam are possible (e.g., fan-shaped). The collimator defines the aperture through which the radiation passes. The collimator may have a shallow profile or may have an elongated profile. In another exemplary embodiment, an elongated collimator may be used to focus the radiation beam by changing the penumbra. A central control module (e.g., see [link to relevant documentation]) may be used. Figure 3 The aperture of the aligner is adjusted to align the beam 650 to the desired geometry and size to produce a dose uniformity ratio (DUR or D) close to 1 for targets 701, 702, 703 with specific characteristics such as geometry and density.

[0027] In the context of this disclosure, the term "dose uniformity ratio" or "DUR" refers to the ratio of the maximum radiation dose to the minimum radiation dose, typically measured in Grays (Gy) received within a product or product stack, and is expressed as follows:

[0028] DUR = Dose max / Dose min Dose max (Also known as D) max ) is the maximum radiation dose received at a location within targets 701, 702, and 703 in a given iteration, and Dose min It is the minimum radiation received at a certain location within the same target 701, 702, 703 in a given iteration (also known as D). min )dose.

[0029] Similarly, in another exemplary embodiment, a high-energy electron beam 650 is generated using, for example, a particle accelerator 500 (such as a linear accelerator, electron cyclotron, or cyclotron). Once generated, the electron beam is manipulated by a series of electron deflection modules 510 that control its trajectory and focus. The introduction of a deflection system 520, typically composed of electromagnetic or electrostatic deflectors, is configured to alter the path of the electron beam. A grid pattern is then generated, in which the electron beam is systematically deflected in the horizontal (X) and vertical (Y) directions, resulting in a scanning pattern designed to cover the entire target regions 701, 702, and 703. A scan controller (e.g., see Central Processing Module (CPM) 350) executes instructions to the deflectors for precise movement coordination. The CPM 350 allows for variable speed and intensity control, allowing dynamic adjustment of the beam's speed across the target and the density of the scanning pattern, for example, by adjusting the speed of the target transfer mechanism. As the electron beam 650 scans across targets 701, 702, and 703, it interacts with the target material. The scanning process can continue until the entire target area has been scanned according to the predetermined grid pattern.

[0030] Various parameters are configured and used to ensure both process effectiveness and product integrity. These energies can be, for example, the energy of an electron beam measured in kiloelectron volts (keV) or megaelectron volts (MeV), which affects the penetration depth necessary for complete sterilization. The dose rate, expressed as grays per second (Gy / s), determines the rate at which energy is deposited during the sterilization process. The beam current, measured in amperes and using various amperometers set up along the processing flow, affects the overall intensity of the electron beam, thus influencing sterilization efficiency. Another parameter can be beam uniformity, ensuring consistent exposure across the product surface. In some exemplary implementations, scanning pattern parameters, including velocity and density, are calibrated to facilitate complete product coverage.

[0031] Additionally, product characteristics such as density, composition, and packaging materials are used to determine the required energy level and penetration depth. Similarly, dose mapping is used to ensure that the radiation dose is evenly distributed across the product, thereby avoiding overexposure or underexposure. Furthermore, product parameters such as, for example, target size, target density, target composition, target biocontaminant, type, target contaminant composition, target contaminant concentration, target intended use, target location in the transfer station, or parameters including one or more of the foregoing are used.

[0032] In an exemplary embodiment, the shielded processing chamber 200 (300, 400) and / or inspection module 240 also include an imaging module (270, not shown) configured to detect the effectiveness and efficiency of the process using, for example, dosimetry tags coupled to targets 701, 702, 703.

[0033] Note that, as used herein, the term "imaging module" refers to a unit that includes multiple built-in image and / or optical sensors and outputs an image as an electrical signal obtained through photoelectric conversion, while the term "module" refers to software, hardware (e.g., a processor), or a combination thereof programmed with instructions for executing algorithms or methods. The modules described herein can communicate via wired connections (e.g., hardwired connections), local area networks, or wirelessly. Imaging modules may include electrocoupling devices (CCDs), complementary metal-oxide-semiconductor (CMOS) cameras, RGB-D cameras, thermal infrared cameras, or combinations thereof. If still images are required, the imaging module may include a digital frame camera, wherein the field of view (FOV) can be predetermined by, for example, camera size and distance from targets 701, 702, 703. The camera used in the imaging module of the disclosed systems and methods may be a digital camera. In exemplary embodiments, the term "digital camera" refers to a digital still camera, a digital video recorder capable of capturing still images of objects, etc. A digital camera may include an image capture unit or module, a capture control module, and a processing unit (which may be the same as or separate from the central processing module). The system used in this article may also include the following computerized system: central processing module 350; display module; and user interface module.

[0034] As noted, the disclosed system for sterilizing targets 701, 702, and 703 may further include: a radiation dose sensor (208, not shown) coupled to platform 206; an inlet gate 201 coupled to the entrance of shielded processing chambers 200 (300, 400) and operable to seal the entrance of shielded processing chambers 200 (300, 400); and an outlet gate 202 coupled to the outlet of shielded processing chambers 200 (300, 400) and operable to seal the outlet of shielded processing chambers. For example, in some exemplary embodiments, a Faraday cup is used to collect and measure the charge carried by the electron beam, thereby providing a quantifiable measurement of the delivered dose. Similarly, semiconductor diodes (e.g., those made of silicon) can be used as solid-state detectors sensitive to ionizing radiation, where changes in conductivity are proportional to the radiation dose. Furthermore, photodiodes that convert photons into current can be used in conjunction with a scintillation counter that converts the energy of the electron beam into photons for detection. Additionally, in some exemplary embodiments, a radiation-chromatic dosimeter assigned to, for example, target 703 in buffer chamber 230 serves as a dynamic indicator that exhibits a color change corresponding to the radiation dose and acts as a visual marker of exposure when imaging is performed using an imaging module. Furthermore, in another embodiment, a thermoluminescent dosimeter (TLD) is used to trap energy upon exposure to radiation, thereby releasing it as light during heating, wherein the intensity of the emitted light reflects the radiation dose. Additionally, a scintillation detector utilizes a material that emits light upon exposure to ionizing radiation, and the measured light intensity is directly related to the delivered radiation dose. Therefore, and in exemplary embodiments, the radiation dose sensor is at least one of the following: a Faraday cup, a semiconductor diode, a photodiode, a scintillation counter, a radiation-chromatic dosimeter, a Gafchromic dosimeter film, and a thermoluminescent dosimeter (TLD).

[0035] In an exemplary embodiment, the disclosed system further includes: a gas reservoir in liquid communication with a shielded treatment chamber, configured to alter the atmosphere within the sealed shielded treatment chamber; and a pathogen trap located downstream of the gas reservoir for retaining pathogens present in the gas reservoir. An exemplary embodiment of the integrated gas purging system is described in... Figure 4 The diagram is illustrated schematically. As shown, the gas reservoir 410 is in liquid communication with the filter module 420 via conduit 4100, and with the shielded processing chamber 400 and buffer chamber 440 via conduits 4200 and 4201. Once purging begins, the exhaust port 4300 is used to maintain liquid communication with the filter system 430, thereby acting as a pathogen trap. Furthermore, the shielded processing chamber can be maintained under a predetermined atmosphere, such as dry air, nitrogen, argon, helium, or a combination thereof.

[0036] Now go to Figures 2 to 5 In an exemplary embodiment, the disclosed system also includes a central processing unit (CPU) 350, which is connected to the electron beam source 500, the target transfer mechanism 220 (320), the platform 206, and the collimator or electron beam grating module 50 (see, for example...). Figure 5 The CPU 350 communicates with inspection modules 240 (340, 450), radiation dose sensor 304, inlet gate 201, and outlet gate 202. The CPU 350 is also coupled to at least one processor communicating with a non-transitory memory device storing a computer-readable medium having a set of executable instructions configured to, when executed, cause at least one processor to: receive at least one parameter of the targets 701, 702, 703 to be sterilized; advance the target 701 to be sterilized into the shielded processing chamber 200 (300, 400) and onto the platform 206 using the target transfer mechanism 220; and use the inlet gate 201 and outlet gate 202 to... The shielding chamber 200 (300, 400) is sealed; based on at least one parameter of the target 701 to be sterilized, the distance between the platform 206 and the top plate 203 of the shielding chamber 200 (300, 400) is adjusted using, for example, platform 206; based on at least one parameter of the target 701 to be sterilized, a collimator or rasterization module 50 is used to change at least one of the following: the cross-sectional shape of the electron beam 650, the angular spread of the electron beam, and the focal point of the electron beam; and an electron beam source 500 is used to irradiate and / or scan the target 702.

[0037] In an exemplary embodiment, the set of executable instructions is further configured to, when executed by at least one processor and after executing the instruction to irradiate and / or scan the target 702, cause at least one processor to: use inspection module 304 to verify the radiation dose absorbed by the target 702 to be sterilized; and, if the absorbed radiation dose is equal to the radiation dose determined to be effective for sterilizing the target, at least open the exit gate 202 and remove the target 702 to be sterilized from the shielded processing chamber; otherwise, execute the set of instructions between: adjusting the distance between the platform 206 and the top plate 206 of the shielded processing chamber or the distance to the electron beam source, and irradiating and / or scanning the target 702 using the electron beam source 500.

[0038] In some exemplary embodiments, a metal sheet, metal rod, metal ball, or combination thereof is inserted between the target 701, 702, 703 to be irradiated and the electron beam source using a mechanical actuator, for example, controlled by CPU 350 based on a desired sterilization procedure. X-rays can be generated by bremsstrahlung when the electron beam 650 interacts with certain heavy metals. In some exemplary embodiments, the metal used for the sheet, rod, ball, or combination thereof is configured to modify the properties of the generated X-rays, such as their energy spectrum. For example, tungsten (W) is used in some exemplary embodiments to enhance X-ray generation efficiency through bremsstrahlung, while molybdenum (Mo) and tantalum (Ta) can also be used to generate X-rays upon exposure to a high-energy electron beam. The choice of metal will depend on the specific requirements of the application, including the desired energy range of the X-rays and the properties of the target material being scanned. Therefore, in yet another exemplary embodiment, the metal sheet, metal rod, metal ball, or combination thereof is tantalum, tungsten, or elements other than 36, 43, and 61 with atomic numbers between 20 and 84, and elements with atomic numbers 90 and 92 capable of generating X-rays.

[0039] X-ray intensity increases with electron beam current, electron kinetic energy, and the atomic number of the target material. In health sterilization, alternatives to gamma irradiation are needed, with radiation energies in the range of 0.5 MeV to 12 MeV.

[0040] The evaluation of shielding for electron beam processing chambers involves careful consideration of key parameters to ensure effective radiation protection. For example, the energy of the electron beam guides the selection of shielding materials, with metals such as lead or tungsten often chosen due to their high atomic numbers. Similarly, thicker shielding typically provides higher attenuation, and the attenuation coefficient, influenced by material properties, contributes to effective radiation reduction. Furthermore, managing scattering effects within the shielding material is essential for optimizing protection. Additionally, occupancy rates (the percentage of the shielded processing chamber occupied by the target) and distance considerations, as well as compliance and practical factors such as cost, also contribute to the overall shielding design. While a single layer of shielding may be sufficient for some applications, the complexity of the environment or higher-energy electron beams may necessitate the use of multiple layers of shielding to achieve the desired level of radiation safety in electron beam shielded processing chambers.

[0041] Therefore, and in an exemplary embodiment, the shielding member comprises a single-layer structure formed of lead, tungsten, or alloys thereof. In another exemplary embodiment, the shielding member comprises a multi-layer structure, wherein at least one layer is composed of a high-Z material configured to attenuate electron beams and / or X-ray radiation; and at least one other layer is composed of a low-Z material for scattering and dissipating secondary radiation.

[0042] In the context of radiation shielding, "high-Z materials" refer to substances with a high atomic number (Z), which indicates the number of protons in their nucleus. Elements with high atomic numbers, such as lead (Z=82) or tungsten (Z=74), are considered high-Z materials. These materials effectively attenuate ionizing radiation due to their increased interaction with photons, making them suitable for shielding gamma rays and X-rays. The unit of atomic number (Z) is dimensionless. Conversely, "low-Z materials" refer to substances with a low atomic number. Examples include materials such as plastics or water, which have low atomic numbers, such as carbon (Z=6) and oxygen (Z=8). Low-Z materials are often used as neutron modifiers or shielding agents and are effective for shielding beta particles.

[0043] In exemplary embodiments, the integration of high-Z (high atomic number) and low-Z (low atomic number) materials can be configured to improve the overall shielding effect across different radiation spectra. High-Z materials, such as lead and tungsten, attenuate high-energy gamma rays and X-rays due to their increased interactions with electrons, photons, etc. Placing high-Z material layers closer to the radiation source helps to effectively attenuate these high-energy particles. Low-Z materials (such as plastics or water), due to their lower atomic numbers, are advantageously suited for mitigating beta particles and attenuating neutrons. Combining both high-Z and low-Z materials in a multilayer configuration enables a more comprehensive strategy. For example, in an exemplary embodiment, an initial high-Z layer effectively attenuates high-energy photons, and subsequent low-Z layers further mitigate particles and reduce backscattering effects. This combined approach not only addresses a broader radiation spectrum but also optimizes the shielding thickness based on the unique properties of each material. For example, in an exemplary embodiment, the high-Z material is lead, tungsten, bismuth, or an alloy including one or more of the foregoing, configured to attenuate electron beam radiation and reduce the transmission of secondary radiation through the shield, while the low-Z material is carbon nanotubes, graphene, polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polytetrafluoroethylene, polyurethane, copolymers thereof, terpolymers thereof, or combinations thereof, each including any of the foregoing substances, configured to scatter and dissipate secondary radiation generated by the interaction of electron beam radiation with the high-Z material within the shield.

[0044] In another exemplary embodiment, an electromagnetic field generator is positioned around the perimeter of the shielded processing chamber. This field generator is configured to deflect and disperse electron beam radiation, for example, by using the Lorentz force to dynamically deflect and disperse the electron beam radiation, thereby enhancing shielding, reducing backscattering, and providing a universal and controllable means of managing the electron beam in a variety of processing applications.

[0045] Additional in-situ cleaning systems can be integrated into system 10. These systems may be, for example, ozone generators located upstream (not shown) and in liquid communication with the shielded treatment chamber. Similarly, the shielded treatment chamber also includes at least one UV lamp or array of UV lamps adapted, sized, and configured according to Good Manufacturing Practices (GMP) to influence the surface sterilization of at least a portion of the inner wall 2000 of the shielded treatment chamber.

[0046] like Figure 3 As illustrated, system 10 also includes: a dispensing module 301 operable to dispense: dosimetry detection tags, such as at least one of, for example, a radiochromic dosimeter, a Gafchromic dosimeter membrane, and a thermoluminescent dosimeter (TLD); and traceability tags, such as barcodes and / or quick response (QR) codes. For example, at least one imaging module operable to provide the user with: traceability of the target to be sterilized; and an indication of the energy absorbed by the target to be sterilized as described herein.

[0047] like Figure 1 As illustrated, system 10 also includes a rework module 114 coupled to the target transfer stage 220. (Go to...) Figure 1 Work-in-process (WIP) 700 is assembled and loaded 111 into system 10. The imaging module included in the system will determine the presence of a traceability label (e.g., a QR code), and if the traceability label is not present at 112, the sample will be redirected to rework module 114 to provide the necessary traceability label. If the imaging module detects a traceability label at 112 (see, for example...), the traceability label will be removed. Figure 3 If the target 701 is transferred to a dosimeter dispenser 301, where a dosimeter tag 113 can be affixed, the sample is then transferred 110 to a buffer chamber 230 and purged with a gas (e.g., dry room air, room nitrogen, argon, or helium) (possibly intermittently), and transferred from the buffer chamber to a shielding chamber 100 (or, in the case of multiple shielding chambers, to 200, 300, or 400, based on the determination of the specific target characteristics). After irradiation, and using an inspection module 101 (see, for example...) Figure 3 (304) Determine if the dose irradiated by 102 is the correct dose, and if so, unload the sample 103 and remove the dosimetry tag 104. Otherwise, if the dose determination 102 indicates that the sample was not exposed to the predetermined radiation dose, determine the feasibility of rework 105, and if rework is feasible, the sample will be transferred to the dosimetry tag dispenser 113 and the sample will re-enter the process; otherwise, the sample will exit the process 106.

[0048] In the context of this disclosure, the term "operable" means that the system and / or device and / or program or specific element or step is fully functional, size-designed, adapted, and calibrated, including elements for and meeting applicable operational requirements to perform the described functions when initiated, coupled, implemented, actuated, influenced, achieved, or when the executable program is executed by at least one processor associated with the system and / or device. Regarding systems and circuits, the term "operable" means that the system and / or circuitry is fully functional and calibrated, including logic with the necessary hardware and firmware, and circuitry for and meeting applicable operational requirements to perform the described functions when executed by at least one processor.

[0049] The term “coupling” (including its various forms, such as “operably coupled,” “coupled,” or “couplingable”) refers to and includes any direct or indirect structural coupling, connection, or attachment, or the adaptation or capability for such direct or indirect structural or operational coupling, connection, or attachment, including integrally formed components and components coupled via or through another component or through a forming process. Indirect coupling may involve coupling through an intermediate member or adhesive, or abutment and otherwise abutment, whether frictionally or through separate devices without any physical connection. Similarly, “operably coupled” means that two components are directly or indirectly engaged with each other. This engagement may be inherently fixed or inherently movable. This engagement may be achieved by the integral formation of two components (or two components and any additional intermediate member) into a single unit, or by the attachment of two components or two components and any additional member to each other. This engagement may be inherently permanent or inherently removable or releasable.

[0050] Furthermore, the word "connected" (and its derivatives, such as "connected" or "connected to" a first component and a second component) and its grammatical variations are used to indicate a structural, functional, mechanical, electrical, optical, or fluid relationship between two or more components or elements, or any combination thereof. Therefore, the fact that a component is described as being connected to a second component does not preclude the possibility that an additional component may exist between and / or be operatively associated with or engaged with both the first and second components.

[0051] As used herein, the term "comprising" and its derivatives are intended as open-ended terms that specify the presence of 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 with similar meanings, such as the terms "comprising," "having," and their derivatives.

[0052] All scopes disclosed herein include endpoints, and endpoints may be combined independently of each other. "Combination" includes blends, mixtures, alloys, reaction products, etc. The terms "a / an" and "the" do not imply a limitation on quantity herein and should be construed as encompassing both the singular and plural unless otherwise stated herein or clearly contradicted by the context. As used herein, the suffix "(s)" is intended to include both the singular and plural of the term it modifies, thereby including one or more of that term (e.g., a protrusion includes one or more protrusions). Throughout the specification, references to "an exemplary embodiment," "another exemplary embodiment," "exemplary embodiment," etc. (where applicable) indicate that a particular element (e.g., feature, structure, and / or characteristic) described in connection with an exemplary embodiment is included in at least one exemplary embodiment described herein and may or may not be present in other exemplary embodiments. Furthermore, it should be understood that the described elements may be combined in any suitable manner in the various exemplary embodiments.

[0053] All scopes disclosed herein include endpoints, and endpoints may be combined independently of each other. Furthermore, the terms “first,” “second,” etc., are not used herein to indicate any order, quantity, or importance, but are used to distinguish one element from another.

[0054] Similarly, the term “about” means that a quantity, size, formulation, parameter, or other quantity and characteristic is not and need not be precise, but may be approximate and / or larger or smaller as required, reflecting tolerances, conversion factors, rounding, measurement errors, and other factors known to those skilled in the art. Generally, a quantity, size, formulation, parameter, or other quantity or characteristic is “about” or “approximate,” whether or not it is explicitly stated so.

[0055] In an exemplary specific implementation, Figure 6Figure 8 shows the actual irradiation dose on the sample stage using a 30cm × 18cm radiochromic B3 film purchased from GeX Corporation (reference: https: / / www.gexcorp.com / b3-dosimeters.html). The irradiated B3 film was scanned using an EPSON V600 scanner, with parameters set using the dose calculation software Risoe Scan 1.3, developed by DTU's Risoe National Laboratory, Roskilde, Denmark. A fixed electron beam provided irradiation using a 2cm × 2cm spot area shaped by a quadrupole from a single electron beam accelerator source, resulting in a beam with a diameter of 100μm. 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.

[0056] Figure 6 The dose is shown as a variation of the sample stage velocity in the x-direction, with velocity ranging from 0.1 cm / sec to 1.0 cm / sec. As the velocity increases, fewer electrons strike the sample target, resulting in a lower dose. The distance from the target sample to the electron beam inlet window is 20 cm.

[0057] Figure 7 The dose produced by varying the distance between the target sample and the electron beam inlet window at a fixed target sample velocity of 0.2 cm / sec is shown. The greater the distance, the lower the dose, because the electron beam expands into free space after passing through the window between the electron beam source and the irradiation chamber.

[0058] Figure 8 illustrates the dose variation capability when the CPM adjusts the sample stage speed based on a user-defined wave. This wave can be increased or decreased in amplitude based on user-selectable shape factors (sine, trapezoidal, linear, etc.). Figure 8a shows the programmed dose variation at a fixed y-position depending on the x-position. Similarly, Figure 8b shows a 3D analysis of the same irradiated radiochromic B3 film, with a uniform dose shown in the y-direction.

[0059] Therefore, and in an exemplary embodiment, this document provides a system for sterilizing a target using an electron beam (E-Beam) source, the system comprising: a shielded processing chamber having a top plate defining at least one opening, an inlet, and an outlet; an electron beam generator coupled to the top plate of the shielded processing chamber; and a target transfer stage operable to transfer a target to be sterilized through the sterilization chamber, wherein the electron beam generator is operable to adjust the irradiation between about 0.1 MeV and about 40.0 MeV in response to at least one parameter of the target to be sterilized; and (i) a buffer chamber disposed upstream of the inlet of the sterilization chamber; and an inspection module disposed at the outlet of the sterilization chamber. Downstream, the inspection module is operable to verify radiation absorbed by the target to be sterilized, wherein (ii) the electron beam source is a linear accelerator (LINAC), a circular accelerator (CAC), a synchrotron, an electron induction accelerator, a cyclotron accelerator, an electron cyclotron accelerator, a free electron laser (FEL), or any other electron accelerator system operable to generate an electron beam with energies in the range of 0.1 MeV to 40 MeV (e.g., between 0.8 MeV and 10 MeV, or between 3 MeV and 8 MeV), and wherein (iii) the shielding chamber further includes: a platform sized, adapted, and configured to carry the target to be sterilized, the platform being operable to adjust the target to be sterilized relative to the shielding chamber. The shielding chamber includes: (iv) the distance between the top plates of the shielding chamber; a collimator communicating with at least one opening defined in the top plate of the shielding chamber, located between the electron beam source and the shielding chamber, the collimator being configured to change at least one of the following: the cross-sectional shape of the electron beam, the angular span of the electron beam, and the focal point of the electron beam; a quadrupole located in the opening defined in the top plate of the shielding chamber and upstream of the sample stage; and an electron beam grating disposed in at least one opening, located between the electron beam source and the shielding chamber, the grating being configured to scan the electron beam in a direction perpendicular to the direction of target movement; (iv) the shielding chamber further includes a sample stage, the sample stage being configured to adjust the distance between the sample stage and the top plate of the shielding chamber. The distance between the targets, the velocity of the targets in the x-direction, the velocities of the targets in the x and y directions, or any combination of one or more of the foregoing, (v) the quadrupole is configured to provide a programmable fixed electron beam shape, wherein (vi) the shielding chamber also includes an imaging module, the system further includes (vii) a radiation dose sensor coupled to the platform; an inlet gate coupled to the inlet of the shielding chamber and operable to seal the inlet of the shielding chamber; and an outlet gate coupled to the outlet of the shielding chamber and operable to seal the outlet of the shielding chamber; and (viii) a gas reservoir in liquid communication with the shielding chamber and configured to alter the atmosphere inside the sealed shielding chamber;(ix) A pathogen and / or endotoxin trap, located downstream of a gas reservoir to retain pathogens present in the gas reservoir, wherein at least one parameter of the target to be sterilized is: target size, target density, target composition, target contaminant type, target contaminant composition, target contaminant concentration, intended use of the target, target location in a target transfer station, or parameters including one or more of the foregoing, and the system further includes: (xi) a central processing unit (CPU) communicating with an electron beam source, a target transfer mechanism, a platform, a collimator, a grating, an inspection module, a radiation dose sensor, an inlet gate, and an outlet gate. The CPU is also coupled to at least one processor communicating with a non-transitory memory device storing a computer-readable medium having a set of executable instructions configured to, when executed, cause at least one processor to: receive at least one parameter of a target to be sterilized; advance the target to be sterilized into a shielded processing chamber and onto a platform using a target transfer mechanism; seal the shielded processing chamber using inlet and outlet gates; adjust the distance between the platform and the top plate of the shielded processing chamber based on at least one parameter of the target to be sterilized; and irradiate the target using an electron beam source, wherein (xii) the set of executable instructions is further configured to, when executed and while using an electron beam source, cause at least one parameter of the target to be sterilized to: receive at least one parameter of a target to be sterilized; advance the target to a shielded processing chamber into a shielded processing chamber and onto a platform using an electron beam transfer mechanism; seal the shielded processing chamber using inlet and outlet gates; adjust the distance between the platform and the top plate of the shielded processing chamber based on at least one parameter of the target to be sterilized; and irradiate the target using an electron beam source. Following the instruction to irradiate the target with an electron beam source, the processor shall: use a check module to verify the radiation dose absorbed by the target to be sterilized; and if the absorbed radiation dose is equal to the radiation dose determined to be effective for sterilizing the target, at least open the exit gate and remove the target to be sterilized from the shielded processing chamber; otherwise, execute the set of instructions between: adjusting the distance between the platform and the top plate of the shielded processing chamber, and irradiating the target with an electron beam source, wherein (xiii) a metal sheet, metal rod, metal ball, or combination thereof is inserted between the target to be irradiated and the opening, and (xiv) a metal sheet, metal rod, metal ball, or combination thereof is inserted by a mechanical actuator, which is controlled by C PU is based on the desired sterilization procedure control, (xv) the metal sheet, metal rod, metal ball or combination thereof is tantalum, tungsten or elements other than 36, 43 and 61 with atomic numbers between 20 and 84, and elements with atomic numbers 90 and 92 capable of generating X-rays, wherein (xvi) the target to be sterilized is: consumables, medical devices, pharmaceuticals, cosmetics, food or targets including one or more of the foregoing, wherein (xvii) the shielding comprises a single-layer structure, (xviii) the layer is formed of lead, tungsten or alloys thereof, or (xix) the shielding comprises a multi-layer structure, at least one layer being made of a high-Z material configured to attenuate electron beam and / or X-ray radiation;Furthermore, at least one other layer is composed of a low-Z material for scattering and dissipating secondary radiation, wherein (xx) the shielding includes an electromagnetic field generator positioned around the periphery of the shielding chamber, the field generator being configured to deflect and disperse X-rays generated by electron beam radiation; (xxi) the shielding also includes a magnetic confinement system configured to guide and focus electron beam radiation within the chamber; (xxii) the high-Z material is: lead, tungsten, bismuth, or an alloy comprising one or more of the foregoing, configured to attenuate electron beam radiation and reduce the transmission of secondary radiation through the shielding; (xxiii) the low-Z material is: carbon nanotubes, graphene, Polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polytetrafluoroethylene, polyurethane, copolymers thereof, terpolymers thereof, and combinations thereof, each comprising any of the foregoing substances, are configured to scatter and dissipate secondary radiation generated by the interaction of electron beam radiation with a high-Z material within a shield, wherein (xxiv) the shielding material is a composite layer of a mixture of low-Z and high-Z particles suspended in a polymer, wherein (xxv) the buffer chamber comprises a dual loading lock, wherein a first loading lock is configured to supply the target to be sterilized into the shielding chamber, and a second loading lock is configured to load an additional target to be sterilized, (x xvi) The first loading lock and the second loading lock are configured to alternate. The system also includes (xxvii) a plurality of shielded treatment chambers, each configured as a receiving chamber-specific target, and (xxviii) an ozone generator disposed upstream of and in liquid communication with the shielded treatment chamber. (xxix) The shielded treatment chamber also includes at least one UV lamp having a frequency between 196 nm and 400 nm, adapted, sized, and configured to affect the surface sterilization of at least a portion of the shielded treatment chamber. The system also includes: (xxx) an effluent disposal module, the effluent... The disposal module is located downstream of the shielded treatment chamber. The (xxxi) effluent disposal module includes a furnace configured to operate at a temperature between 121°C and 700°C and a pressure between 0.9 ATM and 1.1 ATM. The system also includes (xxxii) a dispensing module operable to dispense: a dosing assay label; and a traceability label; at least one imaging module operable to provide the user with: traceability of the target to be sterilized; and an indication of the energy absorbed by the target to be sterilized; and (xxxiii) a rework module coupled to a target transfer station.

[0060] Of course, the examples and descriptions above are provided for illustrative purposes only and are not intended to limit the disclosed techniques in any way. As those skilled in the art will understand, the disclosed techniques can be implemented in a variety of ways, employing more than one of the techniques described above, all without departing from the scope of the invention.

Claims

1. A system for sterilizing a target using an electron beam (E-Beam) source, the system comprising: a) A shielded treatment chamber having a top plate defining at least one opening, an inlet, and an outlet; b) An electron beam generator coupled to the top plate of the shielded processing chamber; and c) A target transfer station operable to transfer a target to be sterilized through a sterilization chamber, wherein the electron beam generator is operable to adjust the irradiation between about 0.1 MeV and about 40.0 MeV in response to at least one parameter of the target to be sterilized.

2. The system according to claim 1, further comprising: a) A buffer chamber, said buffer chamber being located upstream of the inlet of the sterilization chamber; b) An inspection module located downstream of the outlet of the sterilization chamber, the inspection module being operable to verify radiation absorbed by the target to be sterilized.

3. The system of claim 2, wherein the electron beam source is a linear accelerator (LINAC), a circular accelerator (CAC), a synchrotron, an electron induction accelerator, a cyclotron accelerator, an electron cyclotron accelerator, a free electron laser (FEL), or any other electron accelerator system capable of operating to generate an electron beam with an energy in the range of 0.1 MeV to 40 MeV.

4. The system according to claim 3, wherein the shielding chamber further comprises: a) A platform, which is sized, adapted, and configured to carry the target to be sterilized, and the platform is operable to adjust the distance between the target to be sterilized and the top plate of the shielded treatment chamber; b) A collimator communicating with at least one opening defined in the top plate of the shielding chamber, located between the electron beam source and the shielding chamber, the collimator being configured to change at least one of the following: the cross-sectional shape of the electron beam, the angular spread of the electron beam, and the focal point of the electron beam; c) A quadrupole, the quadrupole being located in the opening defined in the top plate of the shielded treatment chamber and upstream of the sample stage; and d) An electron beam grating disposed in the at least one opening, located between the electron beam source and the shielding chamber, the grating being configured to scan the electron beam in a direction perpendicular to the target movement direction.

5. The system of claim 4, wherein the shielding chamber further comprises a sample fixing platform configured to adjust the distance between the sample platform and the top plate of the shielding chamber, the velocity of the target in the x-direction, the velocity of the target in the x-direction and the y-direction, or any combination of one or more of the foregoing.

6. The system of claim 4, wherein the quadrupole is configured to provide a programmable fixed electron beam shape.

7. The system according to claim 4, wherein the shielding processing chamber further includes an imaging module.

8. The system according to claim 7, further comprising: a) A radiation dose sensor, said radiation dose sensor being coupled to the platform; b) An entrance gate coupled to the entrance of the shielding chamber and operable to seal the entrance of the shielding chamber; and c) An outlet gate coupled to the outlet of the shielding chamber and operable to seal the outlet of the shielding chamber.

9. The system of claim 8, further comprising a gas reservoir in liquid communication with the shielded treatment chamber and configured to alter the atmosphere inside the sealed shielded treatment chamber.

10. The system of claim 8, further comprising a pathogen and / or endotoxin trap located downstream of the gas reservoir to retain pathogens present in the gas reservoir.

11. The system of claim 10, wherein the at least one parameter of the target to be sterilized is: target size, target density, target composition, target contaminant type, target contaminant composition, target contaminant concentration, target intended use, target position in the target transfer station, or a parameter including one or more of the foregoing.

12. The system of claim 11, further comprising a central processing unit (CPU) communicating with the electron beam source, the target transfer mechanism, the platform, the collimator, the grating, the inspection module, the radiation dose sensor, the inlet gate, and the outlet gate, the CPU further coupled to at least one processor communicating with a non-transitory memory device storing a computer-readable medium having a set of executable instructions configured to, when executed, cause the at least one processor to: a) Receive at least one parameter of the target to be sterilized; b) Using the target transfer mechanism, the target to be sterilized is pushed into the shielded processing chamber and onto the platform; c) Seal the shielding chamber using the inlet gate and the outlet gate. d) Adjust the distance between the platform and the top plate of the shielded treatment chamber based on at least one parameter of the target to be sterilized; as well as e) Irradiate the target using the electron beam source.

13. The system according to claim 12, wherein, The set of executable instructions is also configured to, when executed and after an instruction to irradiate the target with the electron beam source, cause the processor to: a) Using the inspection module, verify the radiation dose absorbed by the target to be sterilized; as well as (b) If the absorbed radiation dose is equal to the radiation dose determined to be effective in sterilizing the target to be sterilized, at least the exit gate shall be opened and the target to be sterilized shall be removed from the shielded treatment chamber. otherwise c) Execute the set of executable instructions between the following operations: adjusting the distance between the platform and the top plate of the shielding chamber, and irradiating the target with the electron beam source.

14. The system of claim 13, wherein a metal sheet, a metal rod, a metal ball, or a combination thereof is inserted between the target to be irradiated and the opening.

15. The system of claim 14, wherein the metal sheet, the metal rod, the metal ball, or a combination thereof is inserted by a mechanical actuator controlled by the CPU based on a desired sterilization procedure.

16. The system of claim 15, wherein the metal sheet, the metal rod, the metal ball, or combinations thereof is tantalum, tungsten, or an element other than 36, 43, and 61 with atomic numbers between 20 and 84, and an element with atomic numbers 90 and 92 capable of generating X-rays.

17. The system of claim 16, wherein the target to be sterilized is: a consumable, a medical device, a pharmaceutical, a cosmetic, a food, or a target including one or more of the foregoing.

18. The system of claim 1, wherein the shielding element comprises a single-layer structure.

19. The system of claim 18, wherein the layer is formed of lead, tungsten, or alloys thereof.

20. The system of claim 1, wherein the shielding comprises a multilayer structure, at least one layer being made of a high-Z material configured to attenuate electron beam and / or X-ray radiation; and at least one other layer being made of a low-Z material for scattering and dissipating secondary radiation.

21. The system of claim 1, wherein the shielding includes an electromagnetic field generator positioned around the periphery of the shielding chamber, the field generator being configured to deflect and disperse the X-rays generated by the electron beam radiation.

22. The system of claim 20, wherein the shielding further comprises a magnetic confinement system configured to guide and focus electron beam radiation within the room.

23. The system of claim 20, wherein the high-Z material is lead, tungsten, bismuth, or an alloy comprising one or more of the foregoing, configured to attenuate electron beam radiation and reduce the transmission of secondary radiation through the shield.

24. The system of claim 20, wherein the low-Z material is: carbon nanotubes, graphene, polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polytetrafluoroethylene, polyurethane, copolymers thereof, terpolymers thereof, or combinations thereof, each comprising any of the foregoing substances, configured to scatter and dissipate secondary radiation generated by the interaction of electron beam radiation with the high-Z material within the shield.

25. The system of claim 20, wherein the shielding material is a composite layer of a mixture of low-Z particles and high-Z particles suspended in a polymer.

26. The system of claim 2, wherein the buffer chamber includes a dual loading lock, wherein a first loading lock is configured to supply the target to be sterilized to the shielded processing chamber, and a second loading lock is configured to load an additional target to be sterilized.

27. The system of claim 26, wherein the first loading lock and the second loading lock are configured to alternate.

28. The system of claim 1, wherein the system comprises a plurality of shielding chambers, each of the plurality of shielding chambers being configured as a target specific to the receiving chamber.

29. The system according to claim 1, further comprising an ozone generator disposed upstream of the shielding treatment chamber and in liquid communication with the shielding treatment chamber.

30. The system of claim 1, wherein the shielded treatment chamber further comprises at least one UV lamp having a frequency between 196 nm and 400 nm, adapted, sized, and configured to affect the surface sterilization of at least a portion of the shielded treatment chamber.

31. The system according to claim 1, further comprising an effluent disposal module disposed downstream of the shielded treatment chamber.

32. The system of claim 31, wherein the effluent treatment module includes a furnace configured to operate at a temperature between 121°C and 700°C and a pressure between 0.9 ATM and 1.1 ATM.

33. The system according to claim 1, further comprising: a) An allocation module, which is operable to allocate: i. Dosage measurement detection label; and ii. Traceability Labels b) At least one imaging module, said at least one imaging module being operable to provide to a user: i. The traceability of the target to be sterilized; and ii. An indication of the energy absorbed by the target to be sterilized.

34. The system according to claim 1, further comprising a rework module coupled to the target transfer station.

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