E-beam sterilization system and uses thereof

Abstract

The disclosure relates to systems and methods for electron-beam (EB)-based sterilization, and more particularly, to an improved solution for sterilizing a product using EB radiation.

Description

E-BEAM STERILIZATION SYSTEM AND USES THEREOFBACKGROUND

[0001] The disclosure is directed to systems and methods for electron-beam (EB)-based sterilization, and more particularly, to an improved solution for sterilizing a product using EB radiation.

[0002] Electron beam (EB) sterilization is a versatile method employed to ensure the microbial safety of various products in the medical devices, pharmaceuticals, surgical equipment, and food industries. In medical devices, e-beam sterilization is utilized for such devices as catheters, syringes, and empty vials for sample collection. Pharmaceuticals require e-beam sterilization for drug products and packaging materials such as filled vials, liquid medicines, and blister packs, preserving their sterility throughout shelf life. Surgical equipment, including instruments and implants, undergo electron beam 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 electron beam 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] The widespread adoption of electron beam (e-beam) sterilization faces several challenges across the relevant industries. Primarily, the substantial initial capital investment required for e-beam equipment and facilities has delegated this treatment to outsourced services required increased transportation logistics, cost and increased carbon footprint. Hence, poses a barrier, particularly for smaller enterprises. Energy consumption is another concern, as the process demands a considerable amount of power, impacting both operational costs and environmental considerations. The outsource facilities and the technology used for generating the e-Beams are such that the sterilization is feasible only in bulk, i.e. boxes containing multiple product units or at the pallet level. Meeting stringent regulatory standards adds complexity and cost to the adoption of e-beam technology. The limited penetration depth of e-beams may compromise the uniform sterilization ofdense or bulky items. Additionally, productivity and throughput limitations can affect scalability in high-volumc production settings.

[0004] Overcoming these challenges through technological advancements could pave the way for broader acceptance and integration of e-beam sterilization in various industries. The following disclosure and claims intend to address current deficiencies.SUMMARY

[0005] Disclosed, in various exemplary implementations, are systems, assemblies and methods for electron-beam (EB)-based sterilization and their use in various applications.

[0006] In an exemplary implementation provided herein is a system for sterilizing a target using an electron-beam (e-beam) source, the system comprising: a shielded processing chamber having a ceiling forming at least one opening, an entry port upstream from the shielded processing chamber and an exit port downstream from the shielded processing chamber; an E-Beam generator, coupled to the at least one opening formed in the shielded processing chamber; and a target transfer stage, or a conveyor belt and the like, operable to convey the target to be sterilized through the shielded processing chamber, wherein the E-Beam generator is operable to adjust irradiation between about 0.1 MeV and about 40.0 MeV in response to at least one parameter of the target sought to be sterilized.

[0007] In another exemplary implementation, the system further comprises a buffering chamber, disposed upstream to the entry to the sterilization chamber; an inspection module, disposed downstream to the exit of the sterilization chamber, the inspection module operable to validate the radiation absorbed by the target to be sterilized.

[0008] These and other features of systems and methods for dynamic, product-specific electron-beam (EB)-based sterilization, will become apparent from the following detailed description when read in conjunction with the figures and examples, which are exemplary, not limiting.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] For a better understanding of the systems and methods for e-beam-based sterilization, with regard to the exemplary implementations thereof, reference is made to the accompanying examples and figures, in which:

[0010] FIG. 1, illustrates a schematic of an exemplary implementation of product flow in the systems disclosed;

[0011] FIG. 2, is a basic schematic of an exemplary implementation of the system components;

[0012] FIG. 3, is a schematic illustrating an exemplary implementation of the control and traceability modules;

[0013] FIG. 4 is yet another exemplary implementation of the mechanical components integrated into the system; and

[0014] FIG. 5, illustrates a schematic of an exemplary implementation of e-beam rastering used in the system.

[0015] FIG. 6 illustrates the actual electron beam irradiation dose as a function of the target sample stage speed at a target sample to the electron beam entry window of 20 cm.

[0016] FIG. 7 illustrates the actual electron beam irradiation dose as a function of the distance from the target sample to the electron beam entry window at a fixed speed of 0.2 cm / sec.

[0017] FIG 8 shows the effect of CPM varying the sample stage speed in the x scan direction on generating different electron doses at different locations of a sample at the target sample to the electron beam entry window distance of 20 cm. The CPM varied the speed from 0.12 to 0.5 cm / sec with a sinusoidal signal. Fig 8a shows the dose in a fixed Y direction, while Fig. 8b shows a 3D image of the dose irradiated, showing uniformity of the irradiation in the Y direction that was scanned at a constant speed.DETAILED DESCRIPTION

[0018] Provided herein are exemplary implementations of systems and methods for systems and methods for electron-beam (EB)-based sterilization.

[0019] Accordingly and in exemplary implementations as disclosed in FIG.s 2-5, provided herein is system 10 for sterilizing target 701, 702, 703 (see e.g., FIG. 2) using electron-beam (e-beam) source 650 (see e.g., FIG. 5), system 10 comprising: shielded processing chamber 200 (300, 400) having ceiling 203 forming at least one opening, entry port 201 upstream from shielded processing chamber 200 and exit port 202 downstream from shielded processing chamber 200 (300, 400); e-beam generator 500, coupled to at least one opening 205i See e.g., FIG. 2 formed in shielded processing chamber 200 (300, 400); and target transfer stage 220, or conveyor belt and the like, operable to convey target 701, 702, 703 to be sterilized through shielded processing chamber 200 (300, 400), wherein e-beam generator 500 is operable to adjust irradiation between about 0.1 MeV and about 40.0 MeV in response to at least one parameter of target sought to be sterilized.

[0020] As further illustrated, system 10, further comprises: buffering chamber 230, disposed upstream to entry 201 to sterilization chamber 200 (300, 400); inspection module 240, disposed downstream to exit 202 of sterilization chamber 200 (300, 400), inspection module 240 operable to validate radiation absorbed by target 701, 702, 703 to be sterilized. Moreover, buffer chamber 230 can comprised of a dual load lock, where the first load lock is configured to supply target 701 to be sterilized to shielded processing chamber 200 (300, 400), while the second load lock is configured to be loaded with additional targets 7000 to be sterilized (see e.g., 700, FIG. 1), the first load lock and the second load lock are configured to alternate, such that at any point, target 702 is available to be loaded. Furthermore, in yet another exemplary implementation, system 10, can comprise a plurality of shielded processing chamber 200, 300, 400, each configured to receive a chamber- specific target.

[0021] In an exemplary implementation, the electron beam source 500 used with the systems disclosed can be, for example; a linear accelerator (LINAC), a circular accelerator (CAC), a synchrotron, a betatron, a cyclotron, a microtron, a free electron laser (FELs), or any other electron accelerator system operable to produce electron beams with energies in the range of 0.1 MeV to 40 MeV.

[0022] By way of example, a linear accelerator (LINAC) employs a multi-step process to generate a high-energy e-beam suitable for sterilizing various products. Using e.g., a tungsten filament as an electron source - producing electrons through thermionic emission. These electrons are then directed into an electron gun, where an electric field initiates their acceleration. Subsequently, the accelerated electrons enter a waveguide structure within the LINAC, for example, a tube-like pathway that guides and propels them forward using radiofrequency (RF) fields. As the electrons traverse this path, they encounter RF cavities, resonant structures that further contribute to their energy through the application of RF fields. Magnetic focusing elements within the LINAC assist in maintaining the focus and trajectory of the e-beam, ensuring it remains collimated. Upon exiting the LINAC, the electrons have attained a significant level of energy, which is directed toward the target material, such as medical devices or food products, for sterilization.

[0023] The interaction between the energetic electrons and the target material disrupts the genetic material of microorganisms, rendering them incapable of reproduction and achieving the desired sterilization effect. The LINAC's capability to precisely control factors such as electron energy (E), beam focus, and dose rate (D) allows for the tailored sterilization of diverse products.

[0024] Additionally, or alternatively, the electron beam source 500 used with the systems disclosed is a cyclotron, whereby electrons or other charged particles arc injected into the central region of the cyclotron's magnetic field which is in the order of several tens of milliTeslas (mT) to a few Tesla (T). As these particles traverse the circular or spiral path dictated by the magnetic field, passing through a gap between Dees (D-shaped electrodes), the particles undergo acceleration via an oscillating electric field during each cycle, steadily gaining energy with each revolution due to the increasing centrifugal force. Following 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 sought to be sterilized. In an exemplary implementation, the flexibility to adjust magnetic field strength and radiofrequency parameters provides the cyclotron with a controlled and efficient means of generating high-energy electron beams.

[0025] Further, shielded processing chamber 200 (300, 400) further comprises: platform 206 (see e.g., FIG. 2) sized adapted and configured to carry target 702 to be sterilized, platform 206 being operable to adjust distance between target 702 to be sterilized and ceiling 203 of shielded processing chamber 200 (300, 400). Shielded processing chamber 200 (300, 400) can further comprise at least one of: a collimator, and e-beam raster (see e.g., FIG. 5), in communication with at least one opening 205i defined in (e.g., ceiling 203, or in other facets see e.g., FIG. 2) of shielded processing chamber 200 (300, 400), between electron beam source 500 and shielded processing chamber 200 (300, 400), collimator and / or e-beam raster, and / or a magnetic quadrupole, each configured to vary at least one of: E-beam’ s cross-sectional shape, E-beam’ s angular spread, and E-beam’ s focus. Additionally, or alternatively, the system can have an electron beam rastering (e-beam raster) module, disposed in communication with and operably coupled to at least one opening, between electron beam source and shielded processing chamber, the rastering configured to irradiate electron beam in direction perpendicular (transverse) to the target moving direction.

[0026] In an exemplary implementation, the collimator is an adjustable collimator. In the context of the disclosure, the term "collimator" or "adjustable collimator" refers to a device that shapes a radiation beam 650 into a desired geometry 6500. Typically the shape of the radiation beam is adjusted as well as other geometries may also be adjusted, for example, but not to be considered limiting, its height or both its height and width, as required. It is also contemplated that non- rectangular cross-sections of the beam are also possible (e.g., fan-shaped). The collimator defines an aperture through which radiation passes. The collimator may have a shallow profile, or may have anelongated profile. An elongated collimator can be useful in another exemplary implementation to focus the radiation beam by altering the penumbra. Adjustments to the aperture of the collimator shape can be done using a central control module (see e.g., 350, FIG. 3), adjusting the radiation beam 650 into the desired geometry and dimension required to produce a dose uniformity ratio (DUR, or D) approaching 1 for target 701, 702, 703 with particular characteristics (such as geometry and density)

[0027] In the context of the 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 = Dosemax / Doscmin Dosemax. (also referred to as Dmax) is the maximum radiation dose received at some location within the target 701, 702, 703 in a given pass, and Dosemin is the minimum radiation (also referred to as Dmin) dose received at some location within the same target 701, 702, 703 in a given pass.

[0029] Likewise and in another exemplary implementation, a high-energy electron beam 650 is generated using e.g., a particle accelerator 500 such as a linear accelerator, a microtron, or cyclotron. Once generated, the electron beam undergoes manipulation through a series of electron deflection module 510 that control its trajectory and focus. The introduction of a deflection system 520, often composed of electromagnetic or electrostatic deflectors, is configured to alter the path of the electron beam. Raster pattern generation follows, where the electron beam is systematically deflected in both horizontal (X) and vertical (Y) directions, creating a scanning pattern designed to cover the entire target 701, 702, 703 area. A scanning controller (see e.g. central processing module (CPM) 350) executes instructions to the deflectors for precise movement coordination. CPM 350 allows for variable speed and density control, allows for dynamically adjusting the speed at which the beam traverses the target and the density of the scan pattern, by for example, adjusting the target transfer mechanism speed. The electron beam 650 interacts with target target 701, 702, 703 material as it scans across. The scanning process can continue until the entire target area has been scanned according to the predetermined raster pattern.

[0030] 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 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), dictates the speed at which energy is deposited during the sterilization process. Beam current, measured inamperes and measured using various AMP- meters disposed along the process flow, 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 in certain exemplary implementations, to facilitate complete coverage of the product.

[0031] Additionally, product characteristics, such as, for example; density, composition, and packaging materials, 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 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.

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

[0033] 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 701, 702, 703. The cameras used in the imaging modules of the systems and methods disclosed, can be a digital camera. The term “digital camera” refers in an exemplary implementation to a digital still camera, a digital video recorder that can capture a still image of an object and the like. The digital camera can comprise an image capturing unit or module, a capture-controlling module, a processing unit (which can be the same or separatefrom the central processing module). The systems used herein can be computerized systems further comprising the central processing module 350; a display module; and a user interface module.

[0034] As indicated, the systems disclosed, used to sterilize target 701, 702, 703 can further comprise: a radiation dose sensor (208, not shown), coupled to platform 206; entry gate 201 coupled to entry to shielded processing chamber 200 (300, 400), operable to seal entry to shielded processing chamber 200 (300, 400); and an exit gate 202, coupled to exit to shielded processing chamber 200 (300, 400), operable to seal exit to shielded processing chamber. For example, Faraday cups are used in certain exemplary implementations for collecting and measuring the charge carried by the electron beam, providing a quantifiable measure of the delivered dose. 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. Furthermore, photodiodes, converting photons into an electric current, can be used in combination with scintillation counters that transform the electron beam's energy into photons for detection. Additionally, radiochromic film dosimeters dispensed in buffer chamber 230 onto e.g., target 703 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. Moreover, thermoluminescent dosimeters (TLD) are used in yet additional implementations, to trap energy when exposed to radiation, releasing it as light during heating, with the emitted light intensity mirroring the radiation dose. Also, the scintillation detectors utilize materials that emit light upon exposure to ionizing radiation, their measured light intensity providing a direct correlation to the radiation dose delivered. Accordingly and in an exemplary implementation, the radiation dose sensor is at least one of: a Faraday cup, a semiconductor diode, a photodiode, a scintillation counter, a radiochromic film dosimeter, a gaf chromic dosimeter film, and a thermoluminescent dosimeter (TLD).

[0035] In an exemplary implementation, the systems disclosed further comprise a gas reservoir in liquid communication with the shielded processing chamber, configured to modify the atmosphere inside the sealed shielded processing chamber, as well as a pathogen trap downstream from the gas reservoir to retain pathogens present in the gas reservoir. An exemplary implementation of the integrated gas purging system is illustrated schematically in FIG. 4. As illustrated, gas reservoir 410 is in liquid communication through duct 4100 to filtration module 420, in liquid communication with shielded processing chamber 400, and buffering chamber 440 via ducts 4200, and 4201. Once purging commences, exhaust 4300 is used to maintain liquid communication with filtering system430, acting as pathogen trap. In addition, shielded processing chamber can be maintained at a predetermined atmosphere, of for example dry air, nitrogen, argon, helium or a combination thereof.

[0036] Turning now to FIG.s 2-5, in an exemplary implementation, the systems disclosed further comprising central processing unit 350 (CPU) in communication with e-beam source 500, target transfer mechanism 220 (320), platform 206, collimator, or e-beam rastering module 50 (see e.g., FIG. 5), inspection module 240 (340, 450), radiation dose sensor 304, entry gate 201, and exit gate 202, CPU 350 being further coupled to at least one processor in communication with non- transitory memory device, storing thereon computer-readable media with set of executable instructions configured, when executed, to cause at least one processor to: receive at least one parameter of target 701, 702, 703 to be sterilized; using target transfer mechanism 220, advance target701 to be sterilized into shielded processing chamber 200 (300, 400) and onto platform 206; seal shielded processing chamber 200 (300, 400) using entry gate 201 and exit gate 202 based on at least one parameter of target 701 to be sterilized, using e.g., platform 206, adjust distance between platform 206 and shielded processing chamber 200 (300, 400) ceiling 203; based on at least one parameter of target 701 to be sterilized, using collimator or rastering module 50, vary at least one of: e-beam’ s 650 cross-sectional shape, e-beam’s angular spread, and e-beam’s focus; and irradiate and or scan target702 using e-beam source 500.

[0037] In an exemplary implementation, the set of executable instructions are further configured when executed by the at least one processor, and following executing instruction to irradiate and / or scan target 702, to cause the at least one processor to: using inspection module 304, validate radiation dose adsorbed by target 702 sought to be sterilized; and if radiation dose adsorbed is equal to radiation dose determined to effectively sterilize target sought to be sterilized, open at least exit gate 202 and remove target 702 sought to be sterilized from shielded processing chamber; else execute the set of instructions between: adjusting distance between platform 206 and shielded processing chamber ceiling 206, or distance to e-beam source and irradiate and / or scan target 702 using e-beam source 500.

[0038] In an exemplary implementation, a metal sheet, a metal rod, a metal ball, or their combination, is inserted between target 701, 702, 703 sought to be irradiated, and the e-beam source, using for example, a mechanical actuator controlled by the CPU 350 based on a desired sterilization program. When e-beam 650 interacts with certain heavy metals, X-rays can be generated through a bremsstrahlung radiation. In certain exemplary implementation, the metals used for the metal sheet,the metal rod, the metal hall, or their combination, is configured to modify the characteristics of the generated X-rays, such as their energy spectrum. For example, Tungsten (W) which increases the efficiency of X-ray production through bremsstrahlung radiation is used in certain exemplary implementations, while molybdenum (Mo) and tantalum (Ta), can also be used to generate X-rays when exposed to high-energy electron beams. The choice of metal will depend on the specific requirements of the application, including the desired energy range of the X-rays and the characteristics of the target material being scanned. Accordingly, in yet another exemplary implementation, the metal of the metal sheet, the metal rod, the metal ball, or their combination is Tantalum, Tungsten or an element with atomic numbers between 20 and 84, except for 36, 43, and 61, as well as elements with atomic numbers 90 and 92 that are capable of generating X-rays.

[0039] The X-ray intensity increases with the electron beam current, the kinetic energy of the electrons, 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.

[0040] The evaluation of shielding for an e-beam processing chamber involves careful consideration of key parameters to ensure effective radiation protection. For example, the energy of the electron beam guides the selection of shielding material, with metals like lead or tungsten commonly chosen for their high atomic numbers. Likewise, thicker shields generally provide higher attenuation, and the attenuation coefficient, influenced by material characteristics, is beneficial for effective radiation reduction. Moreover, managing scattering effects within the shielding material is essential for optimizing protection. In addition, occupancy (% of the shielded processing chamber occupied by the target) and distance considerations, as well as regulatory compliance, and practical factors like cost also contribute to the overall shielding design. While single-layer shielding may suffice for some applications, the complexity of environments or higher energy electron beams may necessitate the use of multi-layer shielding to achieve the desired level of radiation safety in e-beam shielded processing chambers.

[0041] Accordingly and in an exemplary implementation, the shielding comprises a single layer structure formed of lead, tungsten, or their alloy. In another exemplary implementation, the shielding comprises a multi-layered structure, wherein at least one layer is composed of a high-Z material configured to attenuate e-Beam 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 material" refers to a substance with a high atomic number (Z), indicating the number of protons in its nucleus. Elements with higher atomic numbers, such as lead (Z = 82) or tungsten (Z = 74), are considered high-Z materials. These materials are effective at attenuating ionizing radiation due to their increased interaction with photons, making them suitable for shielding against gamma rays and X-rays. The unit for atomic number (Z) is dimensionless. Conversely, "low-Z material" refers to substances with lower atomic numbers. Examples include materials like plastics or water, with low atomic numbers such as carbon (Z = 6) and oxygen (Z = 8). Low-Z materials are often used as moderators or shielding for neutrons and are effective for shielding against beta particles.

[0043] In an exemplary implementation, integration of both high-Z (high atomic number) and low-Z (low atomic number) materials can be configured to improve overall shielding effectiveness against a diverse spectrum of radiation. High-Z materials such as lead and tungsten attenuate high- energy gamma rays and X-rays due to their increased interaction with electrons, photons and the like. Placing a layer of high-Z material closer to the radiation source helps efficiently mitigate these high- energy particles. Low-Z materials like plastics or water, with their lower atomic numbers, are advantageously adept at moderating beta particles and attenuating neutrons. Incorporating both high- Z and low-Z materials in a multi-layer configuration allows for a more holistic strategy. For example, in an exemplary implementation, the initial high-Z layer effectively attenuates high-energy photons, and the subsequent low-Z layer further moderates particles and reduces backscattering effects. This combined approach not only addresses a broader spectrum of radiation but also optimizes shielding thickness based on the unique properties of each material. For example, in an exemplary implementation, the high-Z material is: lead, tungsten, bismuth or an alloy comprising one or more of the foregoing, configured to attenuate e-beam radiation and reduce the transmission of secondary radiation through the shielding, while the low-Z material is: Carbon nano-tubes, graphene, Polyethylene, Polypropylene, Polyvinyl Chloride, Polyethylene Terephthalate, Polytetrafluoroethylene, Polyurethane, their co-polymers, their ter-polymers, their combination of any, each comprising the foregoing, configured to scatter and dissipate secondary radiation generated by the interaction of e-beam radiation with the high-Z materials within the shielding.

[0044] In another exemplary implementation, an electromagnetic field generator positioned around the periphery of the shielded processing chamber, the field generator configured to deflect and disperse E-Beam radiation, e.g., leveraging the Lorentz force to dynamically deflect and disperse e-beam radiation, thereby enhancing shielding, reducing backscattering, and providing a versatile and controllable means of managing electron beams in the various processing applications.

[0045] Additional clean-in-place systems can be integrated to system 10. These can be, for example, an ozone generator, disposed upstream (not shown) and being in liquid communication with the shielded processing chamber. Likewise, the shielded processing chamber further comprises at least one UV lamp, or an array of UV lamps, adapted, sized and configured to affect surface sterilization of at least a portion of internal walls 2000 of shielded processing chamber, in compliance with good manufacturing processes (GMP).

[0046] As illustrated in FIG. 3, system 10 further comprises: a dispensing module 301, operable to dispense: a dosimetry detection tag, such as, for example at least one of: a radiochromic film dosimeter, a gafchromic dosimeter film, and a thermoluminescent dosimeter (TLD); and a traceability tag such as a barcode, and / or a quick response (QR) code. For example, at least one imaging module, is operable to provide a user with: traceability to the target sought to be sterilized; and an indication of the energy absorbed by the target sought to be sterilized as described herein.

[0047] As illustrated in FIG. 1, system 10 further comprises a rework module 114, coupled to the target transfer stage 220. Turning to FIG. 1, where work in process (WIP) 700 is assembled, and loaded 111 to system 10. Imaging module included with the system will determine the presence of a traceability tag (e.g., QR code), and if 112 the traceability tag is not present, the sample will be diverted to rework module 114 for providing the necessary traceability tag. If 112 the traceability tag is detected by the imaging module (see e.g., 303 FIG. 3), the target 701, will be transferred to dosimetry dispenser 301, where a dosimetry tag can be affixed 113, following which the sample will be transferred 110 to buffer chamber 230, and purged (potentially intermittently) with gas (e.g., dry house air, house nitrogen, argon, or helium), and from there to shielded processing chamber 100 (or 200, 300, 400 in case of multiple shielded processing chamber, based on determination of the specific target characteristics). Following irradiation, and using inspection module 101 (see e.g., 304, FIG. 3), determining 102 whether the dose irradiated is the correct dose, and if so unload the sample 103, and remove the dosimetry tag 104. Otherwise, if the dose determination 102 indicates the sample was not exposed to the predetermined radiation dose, a determination on the feasibility of rework 105 is made and if rework is feasible, the sample will be transferred to the dosimetry tag dispenser 113 and the sample will enter the process again, otherwise, the sample will exit the process 106.

[0048] In the context of the disclosure, the term "operable" means the system and / or the device and / or the program, or a certain clement 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.

[0049] 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.

[0050] 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

[0051] 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.

[0052] 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 exemplary implementation is included in at least one exemplary implementation described herein, and may or may not be present in other exemplary implementations. In addition, it is to be understood that the described elements may be combined in any suitable manner in the various exemplary implementations.

[0053] 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.

[0054] 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.

[0055] In exemplary implementations, FIG.s 6-8 provide herein the actual 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 an EPSON V600 scanner with parameters set by the dose calculation software Risoe Scan 1.3 software, developed at DTU’s Risoe National Laboratory, Roskilde, Denmark. A fixedelectron beam provided irradiation with a 2 cm x 2cm 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.

[0056] Fig 6 shows the dose as a function of the sample stage speed in the x direction for the velocities varying from 0.1 to 1.0 cm / sec. As the speed increases, fewer electrons hit the sample target, yielding a lower dose. The target sample to the electron beam entry window distance was 20cm

[0057] Fig 7 shows the dose resulting from varying the target sample to the electron beam entry window distance at a fixed target sample speed of 0.2 cm / sec. The larger the distance the lower the dose as the electron beam spreads out into the free space after passing through the window between the electron beam source and the irradiation chamber.

[0058] Fig 8 shows the dose variation capabilities as the CPM adjusts the sample stage speed based on a user-defined wave. This wave can increase or decrease in magnitude based on the user- selectable form factor: sinusoidal, trapezoid, linear, etc. Fig 8a shows the programmed dose variations at a fixed y 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.

[0059] Accordingly and in an exemplary implementations, provided herein is a system for sterilizing a target using an electron-beam (E-Beam) source, the system comprising: a shielded processing chamber having a ceiling defining at least one opening, an entry and an exit; an E-Beam generator, coupled to the ceiling of the shielded processing chamber; and a target transfer stage, operable to convey the target to be sterilized through the sterilization chamber, wherein the E-Beam generator is operable to adjust irradiation between about 0.1 MeV and about 40.0 MeV in response to at least one parameter of the target sought to be sterilized, and (i) a buffering chamber, disposed upstream to the entry to the sterilization chamber; an inspection module, disposed downstream to the exit of the sterilization chamber, the inspection module operable to validate the 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, a betatron, a cyclotron, a microtron, a free electron laser (FELs), or any other electron accelerator system operable to produce electron beams with energies in the range of 0.1 MeV to 40 MeV, for example, between 0.8 MeV and 10 MeV, or between 3 MeV and 8 MeV, wherein (iii) the shielded processing chamber further comprises: a platform sized adapted and configured to carry the target to be sterilized, the platform being operable to adjust the distancebetween the target to be sterilized and the ceiling of the shielded processing chamber; a collimator in communication with the at least one opening defined in the ceiling of the shielded processing chamber, between the electron beam source and the shielded processing chamber, the collimator configured to vary at least one of: the E-beam’s cross-sectional shape, the E-beam’s angular spread, and the E- beam’s focus; a quadrupole upstream of the opening defined in the ceiling of the shielded processing chamber and the sample stage: and an electron beam rastering disposed in the in the at least one opening, between the electron beam source and the shielded processing chamber, the rastering configured to scan the electron beam in a direction perpendicular to the target moving direction, (iv) the shielded processing chamber further comprises a sample holding stage configured to modulate the distance between the sample stage and the shielded processing chamber ceiling, the speed of the target in the x direction, the speed of the target in x and y directions, or any combination of one or more of the foregoing, (v) the quadrupole configured to provide a programable fixed electron beam shape, wherein (vi) the shielded processing chamber further comprises an imaging module, the system further comprising (vii) a radiation dose sensor coupled to the platform; an entry gate coupled to the entry to the shielded processing chamber, operable to seal the entry to shielded processing chamber; and an exit gate, coupled to the exit to the shielded processing chamber, operable to seal the exit to the shielded processing chamber, and (viii) a gas reservoir in liquid communication with the shielded processing chamber, configured to modify the atmosphere inside the sealed shielded processing chamber (ix) a pathogen and / or endotoxin trap downstream from the gas reservoir to retain pathogens present in the gas reservoir, wherein (x) the at least one parameter of the target sought to be sterilized is: target size, target density, target composition, target 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, the system further comprising (xi) comprising a central processing unit (CPU) in communication with the E-Beam source, the target transfer mechanism, the platform, the collimator, the rastering, the inspection module, the radiation dose sensor, the entry gate, and the exit gate, the CPU being further coupled to at least one processor in communication with a non-transitory memory device, storing thereon a computer-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: receive at least one parameter of the target to be sterilized; using the target transfer mechanism, advance the target to be sterilized into the shielded processing chamber and onto the platform; seal the shielded processing chamber using the entry gate and the exit gate based on the at least oneparameter of the target to be sterilized, adjust the distance between the platform and the shielded processing chamber ceiling; and irradiate the target using the E-Bcam source, wherein (xii) the set of executable instructions are further configured when executed, and following the instruction to irradiate the target using the E-Beam source, to cause the processor to: using the inspection module, validate the radiation dose adsorbed by the target sought to be sterilized; and if the radiation dose adsorbed is equal to a radiation dose determined to effectively sterilize the target sought to be sterilized, open at least the exit gate and remove the target sought to be sterilized from the shielded processing chamber; else execute the set of instructions between: to adjust the distance between the platform and the shielded processing chamber ceiling, and irradiate the target using the E-Beam source, wherein (xiii) a metal sheet, a metal rod, a metal ball, or their combination, is inserted between the target sought to be irradiated, and the opening, (xiv) the metal sheet, the metal rod, the metal ball, or their combination is inserted by a mechanical actuator controlled by the CPU based on a desired sterilization program, (xv) the metal of the metal sheet, the metal rod, the metal ball, or their combination is Tantalum, Tungsten or an element with atomic numbers between 20 and 84, except for 36, 43, and 61, as well as elements with atomic numbers 90 and 92 that are capable of generating X-rays, wherein (xvi) the target sought to be sterilized is: a consumable, a medical instrument, a pharmaceutical, cosmetics, food or a target comprising one or more of the foregoing, wherein (xvii) the shielding comprises a single layer structure, (xviii) the layer is formed of lead, tungsten, or their alloy, or (xix) the shielding comprises a multi-layered structure, at least one layer is composed of a high-Z material configured to attenuate E-Beam and / or X-ray radiation; and 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 shielded processing chamber, the field generator configured to deflect and disperse x-rays created by the E- Beam radiation, (xxi) the shielding further comprises a magnetic confinement system, configured to guide and focus E-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 E-Beam radiation and reduce the transmission of secondary radiation through the shielding, (xxiii) the low-Z material is: Carbon nano-tubes, graphene, Polyethylene, Polypropylene, Polyvinyl Chloride, Polyethylene Terephthalate, Polytetrafluoroethylene, Polyurethane, their co-polymers, their terpolymers, their combination of any, each comprising the foregoing, configured to scatter and dissipate secondary radiation generated by the interaction of E-Beam radiation with the high-Z materials withinthe shielding, wherein (xxiv) the shielding material is a composite layer of mixture of low- and high- Z particles suspended in a polymer, wherein (xxv) the buffer chamber is comprised of a dual load lock, where a first load lock is configured to supply the target to be sterilized to the shielded processing chamber, while a second load lock is configured to be loaded with additional targets to be sterilized, (xxvi) the first load lock and the second load lock are configured to alternate, the system further comprising (xxvii) a plurality of shielded processing chamber, each configured to receive a chamberspecific target, and (xxviii) an ozone generator, disposed upstream and being in liquid communication with the shielded processing chamber, (xxix) the shielded processing chamber further comprises at least one UV lamp having a frequency of between 196 nm and 400 nm, adapted, sized and configured to affect surface sterilization of at least a portion of the shielded processing chamber, the system further comprising (xxx) effluent disposal module, disposed downstream from the shielded processing chamber, (xxxi) the effluent disposal module comprises a furnace configured to operate at a temperature between 121 °C and 700 °C, at pressures of between 0.9 ATM and 1.1 ATM, the system further comprising (xxxii) a dispensing module, operable to dispense: a dosimetry detection tag; and a traceability tag at least one imaging module, operable to provide a user with: traceability to the target sought to be sterilized; and an indication of the energy absorbed by the target sought to be sterilized and (xxxiii) a rework module, coupled to the target transfer stage.

[0060] 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 sterilizing a target using an electron-beam (E-Beam) source, the system comprising: a) a shielded processing chamber having a ceiling defining at least one opening, an entry and an exit; b) an E-Beam generator, coupled to the ceiling of the shielded processing chamber; and c) a target transfer stage, operable to convey the target to be sterilized through the sterilization chamber, wherein the E-Beam generator is operable to adjust irradiation between about 0 1 MeV and about 40.0 MeV in response to at least one parameter of the target sought to be sterilized.

2. The system of claim 1, further comprising: a) a buffering chamber, disposed upstream to the entry to the sterilization chamber; b) an inspection module, disposed downstream to the exit of the sterilization chamber, the inspection module operable to validate the 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, a betatron, a cyclotron, a microtron, a free electron laser (FELs), or any other electron accelerator system operable to produce electron beams with energies in the range of 0.1 MeV to 40 MeV.

4. The system of claim 3, wherein the shielded processing chamber further comprises: a) a platform sized adapted and configured to carry the target to be sterilized, the platform being operable to adjust the distance between the target to be sterilized and the ceiling of the shielded processing chamber; b) a collimator in communication with the at least one opening defined in the ceiling of the shielded processing chamber, between the electron beam source and the shielded processing chamber, the collimator configured to vary at least one of: the E-beam’s cross-sectional shape, the E-beam’s angular spread, and the E-beam’s focus; c) a quadrupole upstream of the opening defined in the ceiling of the shielded processing chamber and the sample stage: and d) an electron beam rastering disposed in the in the at least one opening, between the electron beam source and the shielded processing chamber, the rastering configured to scan the electron beam in a direction perpendicular to the target moving direction.

5. The system of claim 4, wherein the shielded processing chamber further comprises a sample holding stage configured to modulate the distance between the sample stage and the shielded processing chamber ceiling, the speed of the target in the x direction, the speed of the target in x and y directions, or any combination of one or more of the foregoing.

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

7. The system of claim 4, wherein the shielded processing chamber further comprises an imaging module.

8. The system of Claim 7, further comprising: a) a radiation dose sensor coupled to the platform; b) an entry gate coupled to the entry to the shielded processing chamber, operable to seal the entry to shielded processing chamber; and c) an exit gate, coupled to the exit to the shielded processing chamber, operable to seal the exit to the shielded processing chamber.

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

10. The system of claim 8, further comprising a pathogen and / or endotoxin trap downstream from 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 sought to be sterilized is: target size, target density, target composition, target 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.

12. The system of claim 11, further comprising a central processing unit (CPU) in communication with the E-Beam source, the target transfer mechanism, the platform, the collimator, the rastering, the inspection module, the radiation dose sensor, the entry gate, and the exit gate, the CPU being further coupled to at least one processor in communication with a non-transitory memory device, storing thereon a computer-readable media with a set of executable instructions configured, when executed, to 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, advance the target to be sterilized into the shielded processing chamber and onto the platform; c) seal the shielded processing chamber using the entry gate and the exit gate d) based on the at least one parameter of the target to be sterilized, adjust the distance between the platform and the shielded processing chamber ceiling; and e) irradiate the target using the E-Beam source.

13. The system of claim 12, wherein, the set of executable instructions are further configured when executed, and following the instruction to irradiate the target using the E-Beam source, to cause the processor to: a) using the inspection module, validate the radiation dose adsorbed by the target sought to be sterilized; and b) if the radiation dose adsorbed is equal to a radiation dose determined to effectively sterilize the target sought to be sterilized, open at least the exit gate and remove the target sought to be sterilized from the shielded processing chamber; else c) execute the set of instructions between: to adjust the distance between the platform and the shielded processing chamber ceiling, and irradiate the target using the E- Beam source.

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

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

16. The system of claim 15 wherein the metal of the metal sheet, the metal rod, the metal ball, or their combination is Tantalum, Tungsten or an element with atomic numbers between 20 and 84, except for 36, 43, and 61, as well as elements with atomic numbers 90 and 92 that are capable of generating X-rays.

17. The system of claim 16 wherein the target sought to be sterilized is: a consumable, a medical instrument, a pharmaceutical, cosmetics, food or a target comprising one or more of the foregoing.

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

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

20. The system of claim 1 , wherein the shielding comprises a multi-layered structure, at least one layer is composed of a high-Z material configured to attenuate E-Bcam and / or X-ray radiation; and at least one other layer is composed 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 shielded processing chamber, the field generator configured to deflect and disperse x-rays created by the E-Beam radiation.

22. The system of claim 20, wherein the shielding further comprises a magnetic confinement system, configured to guide and focus E-Beam radiation within the chamber.

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 E-Beam radiation and reduce the transmission of secondary radiation through the shielding.

24. The system of claim 20, wherein the low-Z material is: Carbon nano-tubes, graphene, Polyethylene, Polypropylene, Polyvinyl Chloride, Polyethylene Terephthalate, Polytetrafluoroethylene, Polyurethane, their co-polymers, their ter-polymers, their combination of any, each comprising the foregoing, configured to scatter and dissipate secondary radiation generated by the interaction of E-Beam radiation with the high-Z materials within the shielding.

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

26. The system of claim 2, wherein the buffer chamber is comprised of a dual load lock, where a first load lock is configured to supply the target to be sterilized to the shielded processing chamber, while a second load lock is configured to be loaded with additional targets to be sterilized.

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

28. The system of claim 1, comprising a plurality of shielded processing chamber, each configured to receive a chamber- specific target.

29. The system of claim 1, further comprising an ozone generator, disposed upstream and being in liquid communication with the shielded processing chamber.

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

31. The system of claim 1, further comprising an effluent disposal module, disposed downstream from the shielded processing chamber.

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

33. The system of claim 1, further comprising: a) a dispensing module, operable to dispense: i. a dosimetry detection tag; and ii. a traceability tag b) at least one imaging module, operable to provide a user with: i. traceability to the target sought to be sterilized; and ii. an indication of the energy absorbed by the target sought to be sterilized.

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

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