Electron beam integration for disinfection of radiopharmaceuticals in hot cell

Abstract

A disinfection system for radiopharmaceuticals includes a hot chamber disposed within a clean room environment. The disinfection well extends between a first end and a second end and defines an interior. A first end of the well is disposed within the hot chamber and a second end of the well is disposed outside the clean chamber. The electron beam accelerator assembly is disposed inside the sterilization well such that a transmitting end of the electron beam accelerator is adjacent a first end of the sterilization well.

Description

[0001] Priority declaration

[0002] This application is based upon and claims the benefit of U.S. Provisional Application No. 63 / 343,780, filed on May 19, 2022, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] The present invention relates generally to sterilization systems and processes. More particularly, the present invention relates to systems and processes used during the sterilization of radiopharmaceuticals. Background Art

[0004] Many products produced in a cleanroom environment are packaged for shipment and subsequently transported to a separate area where the packaged product is sterilized. Sterilization can be performed with autoclaves, electron beam emitters, etc., and is performed in many locations, such as warehouses, storage rooms, etc. For example, such processes are performed on products such as, but not limited to, sterile wraps, syringes, medical devices, etc. However, in cases where the product to be sterilized is intended for medical use and is radioactive, various challenges exist.

[0005] The present invention recognizes and addresses the concerns of prior art configurations and methods. Summary of the invention

[0006] One aspect of the present invention provides a sterilization system for radiopharmaceuticals, including a hot chamber disposed within a clean room environment. A sterilization well extends between a first end and a second end and defines an interior. The first end of the well is disposed within the hot chamber, and the second end of the well is disposed outside the clean room. An electron beam accelerator assembly is disposed within the interior of the sterilization well such that an emission end of the electron beam accelerator is adjacent to the first end of the sterilization well.

[0007] According to some exemplary embodiments, the disinfection channel can be disposed in the hot chamber adjacent to the first end of the disinfection well. A transmission window can be positioned at the first end of the disinfection well to separate the interior of the disinfection well from the clean room environment while allowing energy from the emission end of the electron beam accelerator to pass through. For example, the transmission window can preferably include titanium. The electron beam accelerator can be vertically mounted in the disinfection well, and the disinfection channel is located vertically below the disinfection well. The electron beam accelerator assembly can be vertically removed from the interior of the disinfection well.

[0008] Some exemplary embodiments further include a shuttle assembly operable to move the radiopharmaceutical product into and out of the sterilization channel. For example, the shuttle assembly is operable to move the radiopharmaceutical product into and out of the sterilization channel twice, thereby producing a first sweep and a second sweep. Embodiments are contemplated in which the shuttle assembly orients the radiopharmaceutical product in a first orientation during the first sweep and orients the radiopharmaceutical product in a second orientation during the second sweep. Preferably, the second orientation can be rotated 180° relative to the first orientation. In addition,

[0009] The shuttle assembly is operable to automatically rotate the radiopharmaceutical product from the first orientation to the second orientation at a time between the first sweep and the second sweep.

[0010] According to some exemplary embodiments, the shuttle assembly is operable to separate the radiopharmaceutical product from the nest carrying the radiopharmaceutical product.

[0011] Another aspect of the present invention provides an electron beam sterilization system, which includes an electron beam accelerator assembly having an emission end. A structure defining a sterilization zone is also provided, and the sterilization zone is positioned so that energy from the emission end of the electron beam accelerator assembly will be present in the sterilization zone when the electron beam accelerator assembly is activated. The shuttle assembly is operable to move the product to be sterilized into and out of the sterilization zone in a reciprocating manner. For example, the shuttle assembly is operable to simultaneously move multiple units of the product to be sterilized into and out of the sterilization zone in a reciprocating manner.

[0012] According to some exemplary embodiments, the shuttle assembly is operable to separate the product to be sterilized from a nest in which the product is carried by lifting the product from the nest.

[0013] According to another aspect, the present invention provides a method for sterilizing a radiopharmaceutical using at least one electron beam accelerator assembly. One step of the method includes moving the radiopharmaceutical through a first sterilization region in a first orientation so as to be exposed to energy from at least one electron beam accelerator assembly. According to another step, the radiopharmaceutical product is oriented to a second orientation different from the first orientation. A further step includes moving the radiopharmaceutical product through a second sterilization region in the second orientation so as to be exposed to energy from at least one electron beam accelerator assembly.

[0014] According to some exemplary methods, the second orientation may be rotated 180° relative to the first orientation.

[0015] According to some exemplary methods, the at least one electron beam accelerator comprises a single electron beam accelerator, and the first sterilization area and the second sterilization area are a single sterilization area. For example, the radiopharmaceutical product can be moved into and out of the single sterilization area twice in a reciprocating manner by the first sweep and the second sweep.

[0016] According to some exemplary methods, the radiopharmaceutical product can be separated from the nest carrying the radiopharmaceutical product (e.g., by lifting from the nest) before the radiopharmaceutical product is moved into and out of the single sterilization area. After the radiopharmaceutical product is exposed to energy from the electron beam accelerator assembly, the radiopharmaceutical product can be placed in the nest.

[0017] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more embodiments of the present invention and, together with the description, serve to explain the principles of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] A full and enabling disclosure of the invention, including the best mode thereof, to one of ordinary skill in the art is set forth in the specification, which refers to the accompanying drawings, in which:

[0019] Figure 1 is a front view of a hot chamber including an electron beam sterilization system according to an embodiment of the present invention;

[0020] Figure 2 It was taken along line 2-2 Figure 1 A top cross-sectional view of the hot cell is shown;

[0021] Figure 3 It was taken along line 3-3 Figure 1 a left side cross-sectional view of the hot cell shown;

[0022] Figure 4 yes Figure 1 A partial cross-sectional view of the hot chamber shown;

[0023] Figure 5 yes Figure 1 A partial cross-sectional isometric view of the sterilization tunnel and shuttle assembly of the hot chamber is shown;

[0024] Fig. 6A is a perspective view of a nest assembly holding radiopharmaceutical products through manufacturing steps, with six products being held therein;

[0025] Figure 6B yes Fig. 6A A cross-sectional view of a nest-shaped member device;

[0026] Figures 7A to 7K For similar Figure 5 , but showing a sterilization sequence according to certain aspects of the present invention;

[0027] Figure 8 yes Figure 1 A partial cross-sectional view of the sterilization tunnel of the hot chamber shown schematically illustrating the sterilization of the product;

[0028] Fig. 9 is similar to Figure 8 , but also showing the cooling of the window through which the electron beam passes;

[0029] Fig. 10A and 10B yes Figure 1 A perspective cross-sectional view of the hot cell and other adjacent structures shown in;

[0030] Fig.11 is a top view of another embodiment of a hot chamber including a sterilization zone according to another embodiment of the present invention; and

[0031] Fig.12 is a top view of an alternative embodiment of a hot chamber including a sterilization zone according to an alternative embodiment of the present invention.

[0032] Repeat use of reference characters in the present specification and drawings is intended to represent the same or analogous features or elements of the invention according to the present disclosure. DETAILED DESCRIPTION

[0033] Reference will now be made in detail to the currently preferred embodiments of the present invention, one or more examples of which are shown in the accompanying drawings. Each embodiment is provided by way of explanation rather than limitation of the present invention. In fact, it will be apparent to those skilled in the art that modifications and variations may be made to the present invention without departing from the scope and spirit of the present invention. For example, features shown or described as part of one embodiment may be used in another embodiment to produce yet another embodiment. Therefore, the present invention is intended to cover these modifications and variations within the scope of the appended claims and their equivalents.

[0034] As used herein, terms referring to directions or positions relative to the orientation of a hot cell comprising a system for sterilizing pharmaceuticals, such as, but not limited to, "vertical," "horizontal," "top," "bottom," "above," or "below," refer to directions and relative positions relative to the orientation of a hot cell in its normal intended operation, such as, for example, Figures 1 to 3 Thus, for example, the terms "vertical" and "top" refer to Figures 1 to 3 The vertical orientation and relatively upper position in the perspective views of the present invention should be understood in this context, even with respect to a hot cell that may be arranged in a different orientation.

[0035] In addition, the term "or" used in the present application and the appended claims is intended to mean an inclusive "or" rather than an exclusive "or". That is, unless otherwise specified or clear from the context, the phrase "X adopts A or B" is intended to mean any natural inclusive arrangement. That is, the phrase "X adopts A or B" is satisfied by any of the following examples: X adopts A; X adopts B; or X adopts both A and B. In addition, unless otherwise specified or clearly pointed to the singular form from the context, the article "one" used herein should generally be interpreted as meaning "one or more". Throughout the specification and claims, unless otherwise specified by the context, the following terms at least adopt the meanings clearly associated herein. The meanings identified below do not necessarily limit the terms, but only provide illustrative examples of the terms. The meanings of "one", "a kind" and "the" may include plural references, and the meaning of "in..." may include "in..." and "on...". The phrase "in one embodiment" as used herein does not necessarily refer to the same embodiment, although it may refer to the same embodiment.

[0036] Aspects of the present invention are particularly applicable to use in the sterilization of molybdenum-99 (Mo-99) used in the production of technetium-99m (Tc-99m). As known to those skilled in the art, Tc-99m is a radioactive isotope commonly used in nuclear medicine (e.g., medical diagnostic imaging). Tc-99m (m is metastable) is typically injected into a patient's body, where it is used to image the patient's internal organs using certain equipment. Tc-99m has a half-life of only about six (6) hours.

[0037] Given the short half-life of Tc-99m, Tc-99m is typically obtained at the location and / or time it is needed (e.g., in pharmacies, hospitals, etc.) via Mo-99 / Tc-99m generators. A Mo-99 / Tc-99m generator is a device for extracting a metastable isotope of technetium (i.e., Tc-99m) from a decaying molybdenum-99 (Mo-99) source by passing salt water through the Mo-99 material. Mo-99 is unstable and decays to Tc-99m with a half-life of 66 hours. Mo-99 is typically produced by irradiation of a highly enriched uranium target (93% uranium-235) in a high flux nuclear reactor and transported to a Mo-99 / Tc-99m generator manufacturing site. Mo-99 / Tc-99m generators are then distributed to hospitals and pharmacies from these centralized locations. Due to the limited number of production sites, coupled with the limited number of available high-throughput nuclear reactors, the supply of Mo-99 is susceptible to frequent interruptions and shortages, resulting in delayed nuclear medicine procedures.

[0038] Mo-99 is typically contained in an elution column, and when it is needed to be used, Mo-99 is removed from the elution column by a saline solution. Examples of elution columns that can benefit from aspects of the present invention are shown in U.S. Patent Application Publication No. 2022 / 0208407, which is incorporated herein by reference in its entirety for all purposes. During manufacture, the elution column itself must be sterilized before further packaging for shipment. Since Mo-99 has a short half-life and the number of existing production sites is limited, it is desirable to minimize the amount of time required to reduce the irradiated Mo-99 material to a usable form. For example, the extended sterilization process is extended far beyond the half-life of Mo-99, reducing the amount of product available for end use. Embodiments of the present invention desirably provide effective sterilization within a few minutes (e.g., two minutes).

[0039] Reference now Figures 1 to 4 , a hot cell 10 for use in the production of radiopharmaceuticals is shown. The hot cell 10 is further disposed within a clean room environment 12 where production occurs. In addition, the hot cell 10 includes at least one electron beam (E-beam) sterilization system 14 disposed within the hot cell 10. In this case, two such E-beam sterilization systems 14 are provided, either of which can be used to sterilize the product, as described more fully below. Each E-beam sterilization system 14 includes a sterilization channel 16 that is integrated into the lining of the hot cell 10. The channel 16 for conveying the product to be sterilized is located below a sterilization shaft 18. As will be described below, the shaft 18 facilitates maintenance of the components of the E-beam sterilization system 14 while eliminating interference with the drug assembly area of ​​the clean room 12. In addition, the configuration of the disclosed sterilization channel 16 facilitates cleaning of the system when necessary. In this regard, the sterilization channel 16, which can be mounted coplanar with the bottom surface of the hot cell 10, is preferably configured to include reentrant angles on all joints.

[0040] A barrier is preferably provided to separate the environment of the clean room 12 from the sterilization well 18. In this case, the barrier is configured as a sealed titanium transmission window 20 so that the electron flux of the scan horn 22 of the electron beam accelerator is reliably transmitted into the channel 16 to impinge on the radiopharmaceutical product therein. The transmission window 20 is hermetically sealed with the interior of the hot cell 10 so that when the sterilization well 18 in which the electron beam accelerator 24 (and its scan horn 22) is located is opened, the environment of the hot cell 10 is not disrupted, and therefore the environment of the clean room 12 is not disrupted. The transmission window 20 is the primary environmental seal for the hot cell class environment (Class 100,000 or ISO 8 / EV Class C). The transmission window 20 can be very thin (e.g., 0.002 inches) and comprises titanium. Note that the emission end of the electron beam accelerator 24 also preferably includes a transmission window 26 constructed similarly to the window 20. The sterilization channel 16 preferably has a connection component for vaporized hydrogen peroxide (VHP) sterilization. In addition, the main ventilation system of the hot chamber 10 is preferably connected to the sterilization channel 16 to draw air from the hot chamber 10 for exhausting the heat and ozone generated by the electron beam.

[0041] As described above, the hot chamber in this embodiment includes a pair of electron beam sterilization systems 14 in a side-by-side manner, allowing each sterilization system to be operated independently. In this regard, an operator utilizing one of the control panels 28 can operate the associated one of the electron beam sterilization systems 14 while observing the operation through the corresponding window 30. Preferably, the radiopharmaceutical product to be sterilized enters the hot chamber 10 from a previous manufacturing step through the inlet 32 ​​on the left side of the hot chamber 10, and leaves the hot chamber 10 through the outlet 34 on the right side of the hot chamber 10 after the sterilization process.

[0042] Now also refer to Figure 5, the sterilization channel 16 includes a shuttle assembly 36, which is operable to move the product to be sterilized into and out of the channel 16, in particular, so that it passes through the beam emitted by the scanning horn 22. In the illustrated embodiment, the shuttle assembly 36 is actuated by a pair of servo-driven rod linear actuators 38 located on each lateral side. Preferably, the rod actuators 38 are sealed to the lining of the hot chamber 10 using a radiation-resistant sealing system to ensure cleanability and airtightness. As shown, the rod actuators 38 are attached to a removable front plate assembly 40 in this case, allowing the entire shielded shuttle ("slide") 42 to be removed. (In alternative embodiments, the disclosed rod linear actuators 38 are not applicable, but alternative linear transmission devices, such as rollers, chain drives, tracks, etc., can be used to support and move the shielded shuttle). Removal of the shuttle 42 allows easy access to the sterilization channel 16 for cleaning and inspection. A plate 43, for example an aluminium plate of sufficient thickness, is located at the bottom of the channel 16 to prevent further travel of the electron beam.

[0043] As will be described below, the shuttle 42 includes a mechanism for manipulating and positioning the product for sterilization. Although various suitable mechanisms for achieving such manipulation are contemplated, some embodiments of the present invention utilize pneumatic mechanisms. The shuttle 42 is also preferably internally cooled by water to prevent overheating. The front plate 38 may include seals for transmitting pneumatic fluid, electrical signals, and water cooling to the shuttle assembly. It should be understood that the shuttle 42 prevents excessive radiation from reaching the operator of the hot chamber 10 during the sterilization process.

[0044] Now also refer to Fig. 6A and 6B , the radiopharmaceutical products 44 (e.g., elution columns) to be sterilized are typically received into the hot chamber in groups (e.g., groups of six) carried vertically by nests 46. In this regard, the nests 46 define apertures in which column portions 48 of the products 44 are received. The shuttle 42 preferably includes an elevator assembly 50 operable to remove the products 44 from the nests 46 before the products enter and exit the channel 16 so that the nests 46 do not attenuate the energy of the electron beam emitted from the horns 22. In addition, removing the products 44 from the nests 46 prior to sterilization increases the useful life of the nests 46 due to the lack of electron beam exposure. As will be described, the elevator assembly 50 also preferably rotates the products 44 so that the products 44 can be reintroduced into the channel 16 to ensure that both sides of the products 44 are introduced into the flux.

[0045] Reference Figures 7A to 7K The operation of the shuttle assembly 36 is further described. Fig. 7AAs shown, a nest 46 carrying a plurality of products 44 to be sterilized is placed in an elevator assembly 50. As can be seen, the elevator assembly 50 is rotated upward to a vertical orientation for receiving the nest 46. Figure 7B As shown, the clamps 52 are initially opened to allow insertion of the nest 46 and then move inwardly to clamp the nest 46. A product lifter (such as the product lifter indicated at 54) then moves from a retracted position to an extended position to lift the product 44 away from the nest 46 (as indicated by arrow 55). Now referring briefly to Figure 8 , the product lifter 54 may have an extendable rod 56 that carries a flexible cup 58 at its distal end that gently engages the column portion 48 of the product 44. In this case, the rod 58 is attached at its opposite end to a piston 60 that reciprocates in a pneumatic cylinder 62.

[0046] Reference now Figure 7C , the elevator assembly 50 is then rotated (as indicated by arrow 64) until the product 44 is oriented horizontally. FIG. 7D to FIG. 7F As shown, shuttle 42 is then moved into channel 16 (as indicated by arrow 66) and out of channel 16 (as indicated by arrow 68) due to the action of actuator 38. Thus, the upward facing sides of products 44 will reciprocate under window 20. Preferably, the product groups can be rotated slightly about the shuttle axis as the product groups are moved in and out (i.e., "acted") to enhance uneven exposure to the flux field.

[0047] like Figure 7G As shown, the elevator assembly 50 then rotates the group of products 44 180° (as shown by arrow 70) so that the side that was previously facing downward will now face upward. Figure 7H As shown, the shuttle 42 is then moved into and out of the channel 16 (as shown by arrow 71) in a manner similar to the first pass. Fig.7I , the lifter assembly 50 then rotates the product group 180° (as indicated by arrow 72) so that the side that was originally facing upward will again do so. Figure 7J As shown in FIG. 7 , the elevator assembly 50 is rotated back to vertical (as indicated by arrow 73). Figure 7K As shown, the product 44 is then lowered back into the nest 46 and the grippers 52 are retracted. At this point, with both sides of the product exposed twice, sterilization is complete and the nest 46 can then be passed to the next stage of the manufacturing process.

[0048] Figure 8 and Fig. 9The electron beam flux 74 is shown passing through the window 20 so as to impinge on the product 44 as it enters and leaves the tunnel 16. Note that the nest 46 will not pass through the flux line due to the operation of the elevator assembly 50 as described above. To maintain optimal service life, the titanium transmission windows 20 and 26 on the top wall of the sterilization tunnel 16 and the emission end of the electron beam accelerator 24 each require cooling. This cooling can be achieved in a variety of ways, including: a water-cooled heat exchanger with a blower fan and duct system, which is attached to the electron beam accelerator 24; a cold air ventilation duct in the sterilization tunnel 16, which has ducts that direct the cold air flow to the windows 20 and 26, where the sterilization tunnel 16 is attached to the nuclear ventilation device; and a water-cooled configuration is also possible.

[0049] Reference now Fig. 10A and 10B , the electron beam accelerator 24 is mounted in the sterile well 18 as described above. The sterile well 18 extends vertically so that it can be accessed through the floor 76 of the chamber 78 above the hot chamber 10. Preferably, the well 18 can be a stainless steel clad tungsten shielded and sealed on the top and bottom to maintain a redundant isolation barrier between the environment of the clean room 12 and the maintenance area including both the sterile well 18 and the chamber 78. By removing the sealed top mounted shielded well 80, the accelerator 24 (with the scan horn 22) can be withdrawn upward from the sterile well 18 for routine maintenance, such as Fig. 10B As shown. Guide rails 82 may be mounted to the walls of the sterilization well 18 to aid in the precise installation and removal of the electron beam accelerator components. Preferably, these guide rails 82 taper inwardly and fit within end stops near the insertion operating position of the accelerator 24 for repeatable, rapid installation. When in the raised position, the sterilization well 18 preferably maintains an energy chain that supplies power, electronic connections, and cooling water to the electron beam accelerator 24 so that maintenance activities on the accelerator 24 can continue with the accelerator 24 in the retracted position.

[0050] As shown, various control cabinets 84 are located in the chamber 78 to allow electrical access outside the clean room 12. The configuration of the sterilization tunnel 18 extending downward into the hot chamber 10 (and therefore into the environment of the clean room 12) allows a two to three hour maintenance window without compromising the hot chamber 10 and clean room 12 environment below, because the sterilization well 18 is sealed and there is no air exchange between the sterilization well 18 and the clean room 12 at the bottom. Preferably, a positive pressure is maintained in the clean room 12 relative to the well 18 so that any breach (such as a crack in the window 20) will not cause air to flow into the clean room 12. Instead, air will flow from the clean room 12 into the well 18. Maintaining a power connection to the accelerator 24 in the raised position allows electrical testing of the sterilization well 18 while performing cleaning operations thereof.

[0051] Fig.11 An alternative embodiment of the hot cell 110 is shown, which includes a sterilization system 114 with a recirculating conveyor concept. Specifically, after entering the hot cell 110 from the entrance 132, the nests 46 including the radiopharmaceutical product are placed on the conveyor 186 by manipulators. Each nest 46 moves along the conveyor 186 until it is exposed to the electron beam flux in the active area 116 (sterilization area) below the accelerator 24, where the sterilized nests 46 are removed from the hot cell 110 through the exit 134. Note that two windows 128 may preferably be provided to allow one operator to position the nests 46 on the conveyor 186 with one set of manipulators, while another operator removes the nests 46 from the conveyor with a second set of manipulators.

[0052] Reference now Fig.12 Another alternative embodiment of the hot chamber 210 has a disinfection system 214, which operates similarly to Fig.11 2, except that two active areas 216a and 216b are provided for exposure to electron beam flux. As shown, each nest 46 moves along the conveyor 286 until it is exposed to electron beam flux in the first active area 216a, after which the nest is rotated 180° and exposed to electron beam flux in the second active area 216b. Flipping each nest between electron beam flux exposures allows the use of a plurality of nests. Fig.11 The embodiment shown is a lower power electron beam accelerator 24 assembly.

[0053] Although one or more preferred embodiments of the present invention have been described above, it will be appreciated by those skilled in the art that various modifications and changes may be made to the present invention without departing from the scope and spirit of the present invention. The present invention is intended to cover these modifications and changes within the scope and spirit of the appended claims and their equivalents.

Claims

1. A sterilization system for radiopharmaceutical products, comprising: Hot chamber, set up in a clean room environment; a sterilization well extending between a first end and a second end and defining an interior, the first end being disposed within the hot chamber and the second end being disposed outside the clean chamber; and An electron beam accelerator assembly is disposed within the sterilization well such that an emission end of the electron beam accelerator is adjacent to a first end of the sterilization well.

2. The disinfection system according to claim 1, further comprising a disinfection channel, wherein the disinfection channel is disposed within the hot chamber adjacent to the first end of the disinfection well.

3. The sterilization system of claim 2, further comprising a transmissive window at the first end of the sterilization well to separate the interior of the sterilization well from the clean room environment while allowing energy from the emission end of the electron beam accelerator to pass therethrough. The disinfection system of claim 3 , wherein the transmissive window comprises titanium.

5. The disinfection system according to claim 3, wherein: The electron beam accelerator is vertically mounted in the disinfection well; and The disinfection channel is located vertically below the disinfection well.

6. The sterilization system of claim 2, further comprising a shuttle assembly operable to move the radiopharmaceutical product into and out of the sterilization channel.

7. The disinfection system according to claim 6, wherein: The shuttle assembly is operable to move the radiopharmaceutical product into and out of the sterilization channel twice, thereby producing a first sweep and a second sweep.

8. The disinfection system according to claim 7, wherein: The shuttling assembly orients the radiopharmaceutical product in a first orientation during the first sweep and orients the radiopharmaceutical product in a second orientation during the second sweep.

9. The disinfection system according to claim 8, wherein: The second orientation is rotated 180° relative to the first orientation.

10. The disinfection system according to claim 9, wherein: The shuttle assembly is operable to automatically rotate the radiopharmaceutical product from the first orientation to the second orientation at a time between the first sweep and the second sweep.

11. The disinfection system according to claim 6, wherein: The shuttle assembly is operable to separate the radiopharmaceutical product from a nest carrying the radiopharmaceutical product.

12. The disinfection system according to claim 1, wherein: The electron beam accelerator assembly is vertically removable from within the sterilization well.

13. An electron beam sterilization system comprising: an electron beam accelerator assembly having an emission end; a structure defining a sterilization zone, the sterilization zone being positioned so that energy from an emission end of the electron beam accelerator assembly will be present in the sterilization zone when the electron beam accelerator assembly is activated; and A shuttle assembly is operable to move product to be sterilized into and out of the sterilization area in a reciprocating manner.

14. The disinfection system according to claim 13, wherein: The shuttle assembly is operable to move the product to be sterilized into and out of the sterilization channel twice, thereby producing a first sweep and a second sweep.

15. The disinfection system according to claim 14, wherein: The shuttle assembly orients the product to be sterilized in a first orientation during the first sweep and orients the product to be sterilized in a second orientation during the second sweep.

16. The disinfection system according to claim 15, wherein: The second orientation is rotated 180° relative to the first orientation.

17. The disinfection system according to claim 15, wherein: The shuttle assembly is operable to automatically rotate the product to be sterilized from the first orientation to the second orientation at a time between the first sweep and the second sweep.

18. The disinfection system according to claim 13, wherein: The shuttle assembly is operable to separate a product to be sterilized from a nested set carrying the product.

19. The disinfection system according to claim 18, wherein: The shuttle assembly is operable to separate the product to be sterilized by lifting the product from the nest.

20. The disinfection system according to claim 13, wherein: The shuttle assembly is operable to simultaneously move multiple units of product to be sterilized into and out of the sterilization area in a reciprocating manner.

21. The disinfection system according to claim 13, wherein: The sterilization zone is environmentally isolated from the electron beam accelerator by a transmission window that allows energy from an emission end of the electron beam accelerator to pass through.

22. The disinfection system according to claim 13, wherein: The electron beam accelerator is vertically mounted relative to the sterilization area so that the sterilization area is located below the electron beam accelerator.

23. A method of sterilizing a radiopharmaceutical product using at least one electron beam accelerator assembly, comprising: moving a radiopharmaceutical product in a first orientation through a first sterilization region for exposure to energy of at least one electron beam accelerator assembly; orienting the radiopharmaceutical product to a second orientation different from the first orientation; and The radiopharmaceutical product is moved in a second orientation through a second sterilization zone for exposure to energy from at least one electron beam accelerator assembly.

24. A method of sterilizing a radiopharmaceutical product according to claim 23, wherein: The second orientation is rotated 180° relative to the first orientation.

25. The method of sterilizing a radiopharmaceutical product according to claim 23, wherein: The at least one electron beam accelerator comprises a single electron beam accelerator, and the first sterilization zone and the second sterilization zone are a single sterilization zone.

26. A method of sterilizing a radiopharmaceutical product according to claim 25, wherein: The radiopharmaceutical product is moved into and out of the single sterilization area twice in a reciprocating manner, thereby producing a first sweep and a second sweep.

27. The method of sterilizing a radiopharmaceutical product of claim 26, further comprising the step of separating the radiopharmaceutical product from a nest supporting the radiopharmaceutical product prior to moving the radiopharmaceutical product into and out of the single sterilization area.

28. A method of sterilizing a radiopharmaceutical product according to claim 27, wherein: The separating step includes lifting the radiopharmaceutical product from the nest.

29. The method of sterilizing a radiopharmaceutical product of claim 27, further comprising the step of placing the radiopharmaceutical product into the nest after the radiopharmaceutical product has been exposed to energy from the electron beam accelerator assembly.

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