Electron beam integrator for sterilizing radiopharmaceuticals inside a hot cell

Abstract

A sterilization system for radiopharmaceutical products comprising a hot cell disposed within a clean room environment. A sterile shaft extends between a first end and a second end and defines an interior. The first end of the shaft is disposed within the hot cell and the second end of the shaft is disposed outside the clean room. An electron beam accelerator assembly is disposed within the sterile shaft such that a firing end of the electron beam accelerator is adjacent the first end of the sterile shaft.

Description

[Technical field]

[0001] (Priority Claim) This application is based on and claims priority to U.S. Provisional Patent Application No. 63 / 343,780, filed May 19, 2022, which is incorporated by reference in its entirety and for all purposes.

[0002] The present invention relates generally to sterilization systems and procedures, and more particularly to systems and procedures used during the sterilization of radiopharmaceuticals. [Background technology]

[0003] Many products manufactured in a clean room environment are packaged for shipment and then transported to a separate area where sterilization is performed on the packaged product. Sterilization can be performed by autoclaves, electron beam (E-beam) transmitters, etc., and can be performed in a number of locations, such as warehouses, storage facilities, etc. For example, such processes are performed on products such as, but not limited to, sterile packaging materials, syringes, medical instruments, etc. However, challenges are presented when the product being sterilized is intended for medical use and is radioactive.

[0004] The present invention recognizes and addresses prior art arrangements and methods. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent Application Publication No. 2022 / 0208407 Summary of the Invention

[0006] One aspect of the invention provides a sterilization system for radiopharmaceutical products comprising a hot cell disposed within a clean room environment. A sterile shaft extends between a first end and a second end and defines an interior. The first end of the shaft is disposed within the hot cell and the second end of the shaft is disposed outside the clean room. An electron beam accelerator assembly is disposed within the sterile shaft such that a launch end of the electron beam accelerator is adjacent the first end of the sterile shaft.

[0007] According to some illustrative embodiments, the sterilization tunnel can be positioned within the hot cell adjacent to a first end of the sterilization shaft. A transparent window can be positioned at the first end of the sterilization shaft to separate the interior of the sterilization shaft from a clean room environment and to allow energy from the launch end of the electron beam accelerator to pass therethrough. For example, the transparent window can preferably comprise titanium. The electron beam accelerator can be mounted vertically within the sterilization shaft and the sterilization tunnel can be positioned vertically below the sterilization shaft. The electron beam accelerator assembly can be vertically removable from the interior of the sterilization shaft.

[0008] Some exemplary embodiments further include a shuttle assembly operable to move the radiopharmaceutical product into and out of the sterilization tunnel. For example, the shuttle assembly may be operable to move the radiopharmaceutical product into and out of the sterilization tunnel twice, providing a first sweep and a second sweep. Embodiments are envisioned in which the shuttle assembly orients the radiopharmaceutical product in a first orientation during the first sweep and in a second orientation during the second sweep. Preferably, the second orientation may be rotated 180° relative to the first orientation. Additionally, the shuttle assembly may be operable to automatically rotate the radiopharmaceutical product from the first orientation to the second orientation during the time between the first sweep and the second sweep.

[0009] According to some illustrative embodiments, the shuttle assembly may be operable to separate the radiopharmaceutical product from the housing in which the radiopharmaceutical product is carried.

[0010] Another aspect of the invention provides an electron beam sterilization system including an electron beam accelerator assembly having a launch end. A structure defining a sterilization compartment is also provided, the sterilization compartment being located such that energy from the launch end of the electron beam accelerator assembly is present within the sterilization compartment when the electron beam accelerator assembly is activated. The shuttle assembly is operable to move articles to be sterilized in a reciprocating manner into and out of the sterilization compartment. For example, the shuttle assembly may be operable to move a number of articles to be sterilized in a reciprocating manner into and out of the sterilization compartment simultaneously.

[0011] According to certain exemplary embodiments, the shuttle assembly operates to separate an article to be sterilized from a housing in which the article is carried by lifting the article from the housing.

[0012] According to another aspect, the present invention provides a method for sterilizing a radiopharmaceutical product using at least one electron beam accelerator assembly. One step of the method relates to moving the radiopharmaceutical product in a first orientation through a first sterilization compartment so as to be exposed to energy from the at least one electron beam accelerator assembly. According to another step, the radiopharmaceutical product is oriented in a second orientation different from the first orientation. A further step relates to moving the radiopharmaceutical product in the second orientation through a second sterilization compartment so as to be exposed to energy from the at least one electron beam accelerator assembly.

[0013] According to some exemplary methods, the second orientation may be rotated 180 degrees relative to the first orientation.

[0014] According to some exemplary methods, the at least one electron beam accelerator comprises a single electron beam accelerator and the first sterilization compartment and the second sterilization compartment are a single sterilization compartment, For example, the radiopharmaceutical product may be moved twice back and forth in and out of the single sterilization compartment through a first sweep and a second sweep.

[0015] According to some exemplary methods, the radiopharmaceutical product may be separated from the carrying container (e.g., by lifting it from the container) prior to movement in and out of the single sterile compartment. The radiopharmaceutical product may be placed in the container after exposure to energy from the electron beam accelerator assembly.

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more embodiment(s) of the invention and, together with the description, serve to explain the principles of the invention.

[0017] A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the following specification, which makes reference to the accompanying drawings. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a front view of a hot cell equipped with an electron beam sterilization system according to one embodiment of the present invention. [Diagram 2] FIG. 2 is a top cross-sectional view of the hot cell shown in FIG. 1 taken along line 2-2. [Diagram 3] FIG. 3 is a left side cross-sectional view of the hot cell shown in FIG. 1 taken along line 3-3. [Figure 4] FIG. 2 is a partial cross-sectional view of the hot cell shown in FIG. 1. [Diagram 5] FIG. 2 is a partial cross-sectional isometric view of the sterilization tunnel and shuttle assembly of the hot cell shown in Figure 1. [Figure 6A] FIG. 1 is a perspective view of a container device carrying radiopharmaceutical products through the manufacturing steps, with six products being carried by the container device. [Figure 6B] FIG. 6B is a cross-sectional view of the container device of FIG. 6A. [Figure 7A] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7B] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7C]FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7D] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7E] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7F] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7G] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7H] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7I] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7J] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 7K] FIG. 6 is a diagram similar to FIG. 5, but showing a sterilization sequence according to some embodiments of the present invention. [Figure 8] FIG. 2 is a partial cross-sectional view of the sterilization tunnel of the hot cell shown in FIG. 1, illustrating the sterilization of the product. [Figure 9] FIG. 9 is a diagram similar to FIG. 8, but showing cooling of the window through which the electron beam passes. [Figure 10A] FIG. 2 is a perspective cross-sectional view of the hot cell shown in FIG. 1 and other adjacent structures. [Figure 10B] FIG. 2 is a perspective cross-sectional view of the hot cell shown in FIG. 1 and other adjacent structures. [Figure 11] FIG. 13 is a top view of an alternative embodiment of a hot cell with a sterilization compartment in accordance with an alternative embodiment of the present invention. [Figure 12] FIG. 13 is a top view of an alternative embodiment of a hot cell with a sterilization compartment in accordance with an alternative embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Repeat use of reference characters in the present specification and drawings is intended to indicate identical or similar features or elements of the invention disclosed.

[0020] Reference is made in detail below to presently preferred embodiments of the invention, one or more examples of which are illustrated in the accompanying drawings. Each example is provided to illustrate, not limit, the invention. Indeed, it will be apparent to those skilled in the art that modifications and variations can be made in the present invention without departing from the scope and spirit of the invention. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still a further embodiment. Thus, it is intended that the present invention cover such modifications and variations as come within the scope of the appended claims and their equivalents.

[0021] As used herein, terms that refer to a direction or position relative to the orientation of a hot cell comprising a system for sterilizing pharmaceutical products, such as, but not limited to, "vertical," "horizontal," "top," "bottom," "above," or "below," refer to a direction and relative position relative to the orientation of the hot cell in normal intended operation, as shown, for example, in Figures 1-3. Thus, for example, the terms "vertical" and "top" refer to a vertical orientation and a relative upper position in the perspective of Figures 1-3, and should be understood in this sense even though the hot cell may sometimes be positioned in a different orientation.

[0022] Furthermore, the word "or" as used in this application and the appended claims shall mean inclusive "or" rather than exclusive "or". That is, unless otherwise specified or clear from the context, the phrase "X uses A or B" shall mean any of the natural inclusive permutations. That is, the phrase "X uses A or B" shall be satisfied by any of the following cases: "X uses A", "X uses B", or "X uses both A and B". In addition, the articles "a" and "an" as used herein shall generally be construed to mean "one or more", unless otherwise specified or clear from the context as being in the singular. Throughout the specification and claims, the following terms shall have at least the meaning expressly associated therewith in this paragraph, unless the context dictates otherwise. The meanings specified below do not necessarily limit the terms, but merely provide illustrative examples of the terms. The meanings of "a," "an," and "the" may include plural referential and the meaning of "in" may include "in" and "on." The phrase "in one embodiment" is used herein to refer to the same embodiment, although it may, but does not necessarily, do so.

[0023] Aspects of the present invention are particularly suitable for use in sterilizing Molybdenum-99 (Mo-99), which is used to produce Technetium-99m (Tc-99m). As known to those skilled in the art, Tc-99m is a radioisotope commonly used in nuclear medicine (e.g., medical imaging). Tc-99m (m being "metastable") is typically injected into a patient and used to image the patient's internal organs using certain instruments. Tc-99m has a half-life of only about six hours.

[0024] Given the short half-life of Tc-99m, Tc-99m is typically obtained when and where it is needed (e.g., at pharmacies, hospitals, etc.) through Mo-99 / Tc-99m generators. Mo-99 / Tc-99m generators are devices used to extract metastable isotopes of technetium (e.g., Tc-99m) from a source of molybdenum-99 (Mo-99), which decays by passing salt water through the Mo-99 feedstock. Mo-99 is unstable and decays to Tc-99m with a half-life of 66 hours. Mo-99 is typically produced by irradiating highly enriched uranium targets (93% uranium-235) in a high neutron flux reactor and transported to the manufacturing site of the Mo-99 / Tc-99m generator. The Mo-99 / Tc-99m generators are then distributed from these centralized locations to hospitals and pharmacies. Due to the limited number of manufacturing sites, compounded by the limited number of available high flux reactors, the supply of Mo-99 is subject to frequent interruptions and shortages, resulting in delays in nuclear medicine procedures.

[0025] Mo-99 is often contained in an elution column from which it is removed via saline when needed for use. An example of an elution column that may benefit from aspects of the present invention is shown in US Patent Application Publication No. 2022 / 0208407, the entirety of which is incorporated herein by reference for all purposes. Upon manufacture, the elution column itself must be sterilized before further packaging for shipment. Due to the short half-life of Mo-99 and the limited number of existing manufacturing sites, it is desirable to minimize the time required to convert the irradiated Mo-99 material into a usable form. For example, a longer sterilization process would far exceed the half-life of Mo-99, thereby reducing the amount of product available for ultimate use. An embodiment of the present invention desirably provides effective sterilization in a few minutes, e.g., 2 minutes.

[0026] 1-4, a hot cell 10 for use in the manufacture of radiopharmaceuticals is shown. The hot cell 10 is further disposed within a clean room environment 12 in which manufacture takes place. 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 may be used to sterilize products as described more fully below. Each E-beam sterilization system 14 includes a sterilization tunnel 16 integrated within the liner of the hot cell 10. The tunnel 16, into which products to be sterilized are transported, is located below a sterilization shaft 18. As described below, the shaft 18 facilitates maintenance of the components of the E-beam sterilization system 14 while eliminating interference with the pharmaceutical assembly area of ​​the clean room 12. In addition, the disclosed configuration of the sterilization tunnel 16 facilitates cleaning of the system when necessary. In this regard, the sterilization tunnel 16, which may be mounted flush with the floor of the hot cell 10, is preferably constructed with arcuate corners at all joints.

[0027] Preferably, a barrier is provided to separate the clean room 12 environment from the sterile shaft 18. In this case, the barrier is configured as a sealed titanium transmission window 20 to ensure that the electron flux of the E-beam accelerator's scan horn 22 is transmitted into the tunnel 16 and impinges on the radiopharmaceutical product therein. The transmission window 20 is hermetically sealed from the interior of the hot cell 10 such that the hot cell 10 environment, and therefore the clean room 12, is not breached upon opening the sterile shaft 18 in which the E-beam accelerator 24 (and its scan horn 22) is located. The transmission window 20 is the primary environmental seal for a hot cell grade environment (Class 100,000 or ISO 8 / EV Class C). The transmission window 20 is very thin (e.g., 0.002 inches) and may comprise titanium. Note that the launch end of the E-beam accelerator 24 also preferably includes a transmission window 26 configured similarly to window 20. The sterilization tunnel 16 preferably has a connection for gaseous hydrogen peroxide (VHP) sterilization. In addition, the primary ventilation system of the hot cell 10 is preferably connected to the sterilization tunnel 16 to draw air from the hot cell 10 to vent both the heat and the ozone generated by the E-beam.

[0028] As noted above, the hot cell of this embodiment includes a pair of side-by-side E-beam sterilization systems 14, allowing each sterilization system to operate independently. In this regard, an operator may operate an associated one of the E-beam sterilization systems 14 using one of the control panels 28 while viewing the operation through a corresponding window 30. Preferably, the radiopharmaceutical product to be sterilized enters the hot cell 10 from a previous manufacturing step through an inlet 32 ​​on the left side of the hot cell 10 and exits the hot cell 10 after the sterilization process through an outlet 34 on the right side of the hot cell 10.

[0029] Referring now also to FIG. 5, the sterilization tunnel 16 includes, among other things, a shuttle assembly 36 that operates to move products to be sterilized in and out of the tunnel 16 as the products pass through the beam projected by the scan horn 22. In the illustrated embodiment, the shuttle assembly 36 is operated by a pair of servo-driven rod linear actuators 38 located on each side. Preferably, the rod actuators 38 are sealed to the liner of the hot cell 10 using a radiation-resistant sealing system to ensure that they are cleanable and airtight. As shown, the rod actuators 38 in this case are attached to a removable front plate assembly 40 to allow for removal of the entire shielded shuttle ("slider" 42). (In alternative embodiments, alternative linear transport devices such as rollers, chain drives, rails, etc. can be used to support and move the shielded shuttle rather than the disclosed rod linear actuators 38.) Removal of the shuttle 42 allows for easier access to the sterilization tunnel 16 for both cleaning and inspection. A plate 43, for example an aluminium plate of sufficient thickness, is placed at the bottom of the tunnel 16 to stop the electron beam from progressing further.

[0030] As described below, the shuttle 42 includes mechanisms for manipulating and positioning the articles for sterilization. While a variety of suitable mechanisms for accomplishing such manipulation are contemplated, some embodiments of the present invention utilize pneumatic mechanisms. The shuttle 42 is also preferably internally water cooled to prevent it from overheating. The front plate 38 may include seals for transmitting air fluids, electrical signals, and water for cooling the shuttle assembly. It will be appreciated that the shuttle 42 prevents excessive radiation from reaching the operator of the hot cell 10 during the sterilization process.

[0031] 6A and 6B, radiopharmaceutical products 44 (e.g., elution columns) to be sterilized are typically received in the hot cell in groups (e.g., groups of six) supported vertically by containers 46. In this regard, containers 46 define bores into which column portions 48 of the products 44 are received. Shuttle 42 preferably includes a lifter assembly 50 operable to remove the products 44 from containers 46 before the products 44 are passed in and out of tunnel 16 so that containers 46 do not attenuate the energy of the electron beam emitted by horn 22. In addition, removing the products 44 from containers 46 prior to sterilization should increase the useful life of containers 46 since they will not be exposed to the electron beam. To ensure that both sides of the products 44 are introduced into the flow stream, as described below, lifter assembly 50 also preferably rotates the products 44 so that they can be reintroduced into tunnel 16.

[0032] The operation of the shuttle assembly 36 will be further described with reference to Figures 7A-7K. As shown in Figure 7A, a container 46 carrying a number of products 44 to be sterilized is placed in a lifter assembly 50. As can be seen, the lifter assembly 50 is rotated to a vertical orientation to receive the container 46. As shown in Figure 7B, the clamps 52 are initially open so that the container 46 can be inserted, and then move inward to grip the container 46. A product lifter (such as that shown at 54) then moves from a retracted position to an extended position to lift the products 44 away from the container 46 (as shown by arrow 55). Referring now 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 lightly engages the column portion 48 of the products 44. In this case, rod 58 is attached at its opposite end to a piston 60 which reciprocates within a pneumatic cylinder 62 .

[0033] 7C, the lifter assembly 50 is then rotated (as indicated by arrow 64) until the products 44 are oriented horizontally. As shown in FIGS. 7D-7F, the shuttle 42 is then moved (as indicated by arrow 66) and out of the tunnel 16 by the action of the actuator 38. As a result, the side of the products 44 facing up passes under the window 20 as it passes back and forth. Preferably, the product group is rotated slightly (i.e., "rolled") about the shuttle axis as it passes in and out to improve uniform exposure to the flux field.

[0034] As shown in FIG. 7G, the lifter assembly 50 then rotates the group of products 44 180° (as indicated by arrow 70) so that the side that was previously facing down now faces up. As shown in FIG. 7H, the shuttle 42 is then moved in and out of the tunnel 16 as in the first pass (as indicated by arrow 71). Now referring to FIG. 7I, the lifter assembly 50 then rotates the group of products 180° (as indicated by arrow 72) so that the side that was originally facing up again does so. Next, as shown in FIG. 7J, the lifter assembly 50 is rotated back to vertical (as indicated by arrow 73). As shown in FIG. 7K, the products are then lowered back into the container 46 and the clamp 52 is tightened. At this point, both sides of the products have been exposed twice, sterilization is complete, and the container 46 can then be moved to the next stage of the manufacturing process.

[0035] 8 and 9 show the electron beam flux 74 passing through the window 20 to impinge on the product 44 as it travels in and out of the tunnel 16. Note that the enclosure 46 does not pass through the flux line due to the action of the lifter assembly 50 as described above. To maintain optimal service life, the titanium transmission windows 20, 26 in the upper wall of the sterilization tunnel 16 and the launch end of the E-beam accelerator 24 both require cooling. Such cooling can be accomplished in several ways, including a water-cooled heat exchanger with blower fan and ducting system attached to the E-beam accelerator 24, a cold air ventilation duct within the sterilization tunnel 16 with ducts directing cold air flow to the windows 20, 26 and attached to the nuclear ventilation of the sterilization tunnel 16, and a water cooling configuration is also possible.

[0036] 10A and 10B, the electron beam accelerator 24 is mounted within the sterile shaft 18 as described above. The sterile shaft 18 extends vertically such that it is accessible through the floor 76 of the chamber 78 above the hot cell 10. Preferably, the shaft 18 may be shielded and sealed with stainless steel clad tungsten at the top and bottom to maintain a redundant isolation barrier between the clean room 12 environment and the maintenance area comprising both the sterile shaft 18 and the chamber 78. As shown in FIG. 10B, once the sealed top-mounted shielding plug 80 is removed, the accelerator 24 (along with the scan horn) may be pulled up and out of the sterile shaft 18 for routine maintenance. To aid in the accurate installation and removal of the E-beam accelerator assembly, guide rails 82 may be attached to the walls of the sterile shaft 18. Preferably, the guide rails 82 narrow inwardly for repeatable and rapid installation and fit into end stops near the inserted operating position of the accelerator 24. The sterile shaft 18 preferably maintains the energy systems that supply power, electronic connections, and cooling water to the E-beam accelerator 24 when in the raised position so that maintenance procedures on the accelerator 24 can continue when the accelerator 24 is in the retracted position.

[0037] As shown, various control cabinets 84 are installed in the room 78 to allow electrical access outside the clean room 12. The configuration of the sterile tunnel 18 extending downward into the hot cell 10 (and thus the clean room 12 environment) allows for a 2-3 hour maintenance window without compromising the hot cell 10 and clean room 12 environment below, since the sterile shaft 18 is sealed at the bottom floor and there is no air exchange between the sterile shaft 18 and the clean room 12. Preferably, a positive pressure is maintained on the shaft 18 within the clean room 12, so that any breach (such as a crack in the window 20) would not allow airflow into the clean room 12. Instead, air would flow from the clean room 12 into the shaft 18. Maintaining the power connection to the accelerator 24 in an elevated position allows for electrical testing of the accelerator 24 at the same time that cleaning operations are being performed on the sterile shaft 18.

[0038] Fig. 11 shows an alternative embodiment of the hot cell 10 with a sterilization system 114 with a recirculating conveyor concept. Specifically, the containers 46 containing the radiopharmaceutical products enter the hot cell 110 through the entrance 132 and are then placed on the conveyor 186 by the manipulators. Each container 46 is moved along the conveyor 186 until it is exposed to the E-beam flux in the active area 116 (sterilization section) under the accelerator 24, and the sterilized containers 46 are removed from the hot cell 10 through the exit 134. It should be noted that preferably, two windows 128 may be provided so that one operator can position the containers 46 on the conveyor 186 with one set of manipulators while another operator can remove the containers 46 from the conveyor with a second set of manipulators.

[0039] 12, there is provided another alternative embodiment of a hot cell 10 having a sterilization system 214 that operates similarly to the embodiment discussed in FIG. 11 except that there are two active areas 216a, 216b for exposure to the E-beam flux. As shown, each enclosure 46 moves along a conveyor 186 until it is exposed to the E-beam flux in a first active area 216a, after which the enclosure 46 rotates 180° and is exposed to the electron beam flux in a second active area 216b. By flipping each enclosure between exposures to the E-beam flux, it is possible to use a lower power E-beam accelerator 24 assembly than the embodiment shown in FIG. 11.

[0040] While one or more preferred embodiments of the present invention have been described above, those skilled in the art should recognize that various modifications and variations are possible in the present invention without departing from the scope and spirit of the present invention. The present invention is intended to include such modifications and variations as come within the scope and spirit of the appended claims and equivalents thereto.

Claims

1. a hot cell disposed within a clean room environment; a sterile shaft extending between a first end and a second end and defining an interior, the first end being disposed within the hot cell and the second end being disposed outside the clean room; an electron beam accelerator assembly disposed within the interior of the sterile shaft, whereby a launch end of the electron beam accelerator is adjacent the first end of the sterile shaft; 1. A sterilization system for a radiopharmaceutical product comprising:

2. 10. The sterilization system of claim 1, further comprising a sterilization tunnel disposed within the hot cell adjacent the first end of the sterilization shaft.

3. 3. The sterilization system of claim 2, further comprising a transmissive window at the first end of the sterile shaft to separate the interior of the sterile shaft from the clean room environment while allowing the passage of energy from the launch end of the electron beam accelerator.

4. 4. The sterilization system of claim 3, wherein the transmission window comprises titanium.

5. the electron beam accelerator is mounted vertically within the sterile shaft; the sterilization tunnel is disposed vertically below the sterilization shaft; 4. The sterilization system of claim 3.

6. 3. A sterilization system according to claim 2, further comprising a shuttle assembly operable to move said radiopharmaceutical product into and out of said sterilization tunnel.

7. 7. The sterilization system of claim 6, wherein the shuttle assembly is operative to move the radiopharmaceutical product into and out of the sterilization tunnel twice to provide a first sweep and a second sweep.

8. 8. The sterilization system of claim 7, wherein the shuttle assembly directs the radiopharmaceutical product in a first orientation during the first sweep and in a second orientation during the second sweep.

9. 9. The sterilization system of claim 8, wherein the second orientation is rotated 180 degrees relative to the first orientation.

10. 10. The sterilization system of claim 9, wherein the shuttle assembly is operative to automatically rotate the radiopharmaceutical product from the first orientation to the second orientation during the time between the first sweep and the second sweep.

11. 7. The sterilization system of claim 6, wherein the shuttle assembly is operative to separate the radiopharmaceutical product from a container in which the radiopharmaceutical product is carried.

12. 10. The sterilization system of claim 1, wherein the electron beam accelerator assembly is vertically removable from the interior of the sterile shaft.

13. an electron beam accelerator assembly having a launch end; a structure defining a sterilization compartment, the sterilization compartment being positioned such that, when the electron beam accelerator assembly is activated, energy from the launch end of the electron beam accelerator assembly is present within the sterilization compartment; a shuttle assembly operative to move articles to be sterilized in and out of said sterilization compartment in a reciprocating manner; An electron beam sterilization system having

14. 14. The sterilization system of claim 13, wherein the shuttle assembly is operative to move the articles to be sterilized into and out of the sterilization tunnel twice to provide a first sweep and a second sweep.

15. 15. The sterilization system of claim 14, wherein the shuttle assembly directs the articles to be sterilized in a first orientation during the first sweep and in a second orientation during the second sweep.

16. 16. The sterilization system of claim 15, wherein the second orientation is rotated 180 degrees relative to the first orientation.

17. 16. The sterilization system of claim 15, wherein the shuttle assembly is operative to automatically rotate the article to be sterilized from the first orientation to the second orientation during the time between the first sweep and the second sweep.

18. 14. The sterilization system of claim 13, wherein the shuttle assembly is operative to separate the article to be sterilized from a container in which the article to be sterilized is carried.

19. 20. The sterilization system of claim 18, wherein the shuttle assembly is operative to separate the article to be sterilized from the container by lifting it.

20. 14. The sterilization system of claim 13, wherein the shuttle assembly is operative to move multiple units of the product to be sterilized simultaneously into and out of the sterilization compartment in a reciprocating manner.

21. 14. The sterilization system of claim 13, wherein the sterilization compartment is environmentally isolated from the electron beam accelerator by a transmissive window that allows the passage of energy from the emitting end of the electron beam accelerator.

22. 14. The sterilization system of claim 13, wherein the electron beam accelerator is mounted vertically relative to the sterilization compartment such that the sterilization compartment is located below the electron beam accelerator.

23. 1. A method for sterilizing a radiopharmaceutical product using at least one electron beam accelerator assembly, comprising: moving the radiopharmaceutical product in a first orientation through a first sterilization compartment so as to be exposed to energy of the at least one electron beam accelerator assembly; orienting the radiopharmaceutical product in a second orientation different from the first orientation; moving the radiopharmaceutical product in the second orientation through a second sterilization compartment so as to be exposed to energy from the at least one electron beam accelerator assembly; 13. A method for sterilizing a radiopharmaceutical product comprising:

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

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

26. 26. A method of sterilizing a radiopharmaceutical product as claimed in claim 25, wherein the radiopharmaceutical product is moved in and out of the single sterilization compartment twice in a reciprocating manner to provide a first sweep and a second sweep.

27. 27. A method of sterilizing a radiopharmaceutical product according to claim 26, further comprising the step of separating the radiopharmaceutical product from a container in which it is carried prior to moving the radiopharmaceutical product into and out of the single sterilization compartment.

28. 28. A method of sterilizing a radiopharmaceutical product according to claim 27, wherein said separating step comprises lifting said radiopharmaceutical product from said container.

29. 30. The method of sterilizing a radiopharmaceutical product according to claim 27, further comprising the step of placing said radiopharmaceutical product within said containment chamber after exposing said radiopharmaceutical product to energy from said electron beam accelerator assembly.

Images