Sterilization steam generator system

Abstract

A steam generation system for a sterilization device can include a steam generator, a water supply line, a makeup line, and a flow regulator. The steam generator can be configured to generate and discharge steam therefrom. The steam generator can include an enclosure. The water supply line can be configured to deliver supply water to the steam generator. The makeup line can be connected to the water supply line and a top portion of the enclosure of the steam generator. The flow regulator can be located in the makeup line between the steam generator and the water supply line. The flow regulator can control a steam flow from the steam generator. The flow regulator can control a makeup water flow from the makeup line to the steam generator.

Description

International Application Docket: P151417PC00 / STES.24001 STERILIZATION STEAM GENERATOR SYSTEMCLAIM OF PRIORITY

[0001] This patent application claims the benefit of priority to U.S. Patent Application Serial Number 63 / 725,745, entitled “STERILIZATION STEAM GENERATOR SYSTEM,” filed on November 27, 2024, which is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] Embodiments pertain to the cleaning and reprocessing of reusable medical equipment. More particularly, this disclosure relates to, but not by way of limitation, steam production for cleaning and reprocessing.BACKGROUND

[0003] Specific decontamination procedures and protocols are utilized to clean reusable medical equipment. In one example in the medical setting involving reusable medical equipment, components can be subjected to a high temperature for sterilization using steam as a source. In many procedures, steam (and optionally one or more chemicals) can be used to clean, decontaminate, or sterilize medical equipment.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0005] FIG. 1 illustrates a schematic view of a system.

[0006] FIG. 2 illustrates a schematic view of a system.

[0007] FIG. 3 illustrates a schematic view of a portion of a system.

[0008] FIG. 4 illustrates a schematic view of a method.International ApplicationDocket: P151417PC00 / STES.24001DETAILED DESCRIPTION

[0009] The European Union issued an Annex defining requirements for sterilizer water supply that may be pertinent to steam generation for sterilization or sanitization equipment such as for medical device reprocessing. According to the Annex, in general, higher risk utilities are those that directly contact product such as water for washing and rinsing, gases and steam for sterilization. The Annex required that water treatment plants and distribution systems should be designed, constructed, installed, commissioned, qualified, monitored and maintained to prevent microbiological contamination and to ensure a reliable source of water of an appropriate quality. Further requirements include that measures should be taken to minimize the risk of presence of particulates, microbial contamination / proliferation and endotoxin / pyrogen (e.g., to avoid dead legs). The Annex also mandated that water flow should remain turbulent through the pipes in water distribution systems to minimize the risk of microbial adhesion, and subsequent biofilm formation. And, it mandated that water for injections (WFI) should be produced from water meeting specifications that have been defined during the qualification process, stored and distributed in a manner which minimizes the risk of microbial growth (e.g., by constant circulation at a temperature above 70 degrees Celsius).

[0010] The present disclosure helps to address these issues and requirements by including a fluid supply line that enters an enclosure at the top and is sloped for gravity drainage into the enclosure. The supply line or fill line can also be connected to a top portion of the enclosure such that the line will receive steam from the steam generator, which will sanitize the fill line.

[0011] Among other benefits, this configuration helps to solve an issue when feed water consumption is small and the correct feed water pipe size would be too small to drain with gravity. With this configuration, the pipe diameter can be increased, while limiting the water flow and enabling gravity draining.

[0012] The above discussion is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustiveInternational Application Docket: P151417PC00 / STES.24001 explanation of the invention. The description below is included to provide further information about the present patent application.

[0013] FIG. 1 illustrates a schematic view of a system 100A, which can be a system configured to generate steam or other hot liquids or gases, such as for sterilization for equipment, such as medical equipment. FIG. 2 illustrates a schematic view of a system 100B. FIGS. 1 and 2 are discussed together below. The systems 100A and 100B can be similar except the system 100 A can include one or more nozzles 118, where the system 100B can omit nozzles, as discussed in further detail below. The systems 100A and 100B are discussed together as the system 100 below, except where the differences are noted.

[0014] The system 100 can include a steam generator 102, which can be configured to generate or produce steam or other hot fluids or liquids. The steam generator 102 can include an enclosure 104 configured to support one or more fluids, such as liquid L and steam S, within the enclosure 104. The enclosure 104 can be a housing or other structure such as a rigid or semi-rigid body made of materials such as one or more of foam, polymer, ceramic, metals, or the like, such as one or more of steels, aluminums, titanium, or the like. The enclosure 104 can be configured to at least partially support a return pipe 106 and a discharge pipe 108. The return pipe 106 can be configured to receive one or more of steam, condensed steam, cooled steam, or another fluid. The discharge pipe 108 can be configured to discharge or deliver steam or another liquid or fluid. The steam generator 102 can also include one or more heating source such as an electric heater or combustion device for heating the fluid of the return pipe 106 prior to discharge.

[0015] The system 100 can also include a makeup circuit 110 that can be connected to a fluid supply source, such as a source of filtered or otherwise treated water or liquid (e.g., distilled, reverse osmosis, or the like), such that the system 100 can be or can include a makeup water line. The makeup circuit 110 can be configured to circulate fluid therethrough. The makeup circuit 110 can be configured to circulate fluid at a relatively high flowrate or velocity such that the flow rate is turbulent through the makeup circuit 110 (e.g., a Reynolds number greater than 4,000). Optionally, the flow rate can be non- laminar and non-turbulent (transitional) (e.g., a Reynolds number between 2000 and 4000).International Application Docket: P151417PC00 / STES.24001

[0016] The makeup circuit 110 can be connected to the enclosure 104 via a makeup line 112 (or supply line), such that the makeup line 112 can connect directly or indirectly to the system 100 and the makeup line 112 can connect directly or indirectly to the enclosure 104. The makeup line 112 can be sloped for natural or gravity drainage out of the makeup line 112, through the enclosure 104, and through or into a top portion of the steam generator 102. The makeup line 112 can be sloped at a ratio of 1 millimeter (mm) of fall or drop for every 50 to 100 mm of length, which can be a ratio of 1 :50 to 1: 100. The slope can have other ratios in other examples.

[0017] The system 100 can also include a control valve 114, which can be a manual valve or an automatically controlled valve connected to a controller. For example, the control valve 114 can include or can be connected to an actuator 115 or motor (shown in FIG. 3), which can be controlled to operate the control valve 114. The control valve 114 can be operable to move between an open position and a closed position based on a control signal. For example, the control valve 114 can be opened to let water or liquid into the makeup line 112 from the makeup circuit 110.

[0018] The system 100 can also include a flow regulation device 116 connected to the makeup line 112. The flow regulation device 116 can be located downstream of the control valve 114 and upstream of the connection to the steam generator 102 with respect to fluid flow from the makeup circuit 110 to the steam generator 102, but the flow regulation device 116 can be located downstream of the steam generator 102 with respect to flow of steam from the steam generator 102, as discussed in further detail below. The flow regulation device 116 can be or can include one or more check valves, one-way valves, regulators, triple duty valves, or the like. Generally, the flow regulation device 116 can allow fluid or liquid from the makeup circuit 110 through the makeup line 112 and to the enclosure 104, while limiting flow of steam from the enclosure 104 back through the flow regulation device 116 to the makeup circuit 110.

[0019] The flow regulation device 116 can be large enough to be self-draining (and not blocking of drainage (e.g., due to capillary action, meniscus formation, or airlocks)). On the other hand, the flow regulation device 116 can be large enough for proper operation of the filling of the enclosure 104 with fluid from the makeup line 112 (fromInternational Application Docket: P151417PC00 / STES.24001 the makeup circuit 110). The flow regulation device 116 can be relatively small enough that the flow regulation device 116 can create a flow blocking device of steam from the steam generator 102. By letting steam into the makeup line 112, the makeup line 112 can be automatically sterilized. Steam can also be used through the makeup line 112 to enhance drainage from the makeup line 112 and can help to heat up tubing or piping of the makeup line 112.

[0020] As shown in FIG. 1, the system 100 A can include one or more nozzles 118, which can be configured to emit or discharge fluid (e.g., at a controlled rate) from the makeup line 112 into the enclosure 104. As shown in FIG. 2, the system 100B can omit the one or more nozzles 118. In the system 100B, a fluid flow rate of liquid into the steam generator 102 can be controlled via one or more of the control valve 114 and the flow regulation device 116.

[0021] In either the system 100 A of FIG. 1 or the system 100B of FIG. 2, the system 100 can deliver water or fluid directly to or through a top (or near top) portion of the enclosure 104 to the steam volume, instead of a more traditional location under the water level. By connecting the makeup line 112 on top, the makeup line 112 can be sterilized via the steam and can be more easily drained. The flow regulation device 116 can also allow steam to flow upstream through the makeup line 112 and through the flow regulation device 116 to heat up and to enhance self-draining, thereby providing a system that can include a fluid supply system that is self-sterilizing and configured to limit bacterial or biological growth.

[0022] FIG. 3 illustrates a schematic view of a portion of the system 100 indicated by indicator 3 of FIG. 2. In other words, FIG. 3 shows an enlarged view of a portion of the system 100, specifically the flow regulation device 116.

[0023] The flow regulation device 116 can include an inlet pipe 120 and a discharge pipe 122 connected to a body 121 of the flow regulation device 116. The flow regulation device 116 can be connected to a downstream side of the control valve 114 such as via the inlet pipe 120. And, the flow regulation device 116 can be connected to the makeup line 112 via the discharge pipe 122. The flow regulation device 116 can include a first passage 124 and a second passage 126 located at least partially within the body 121. EachInternational Application Docket: P151417PC00 / STES.24001 of the first passage 124 (which can be a first channel) and the second passage 126 (which can be a second channel) can be directly or indirectly connected to the inlet pipe 120 and the discharge pipe 122 (or can be connected to internal volumes of the flow regulation device 116 that connect to the inlet pipe 120 and the discharge pipe 122). The first passage 124 and the second passage 126 can be a parallel flow arrangement between the inlet pipe 120 and the discharge pipe 122 (and therefore between the makeup circuit 110 and the makeup line 112 (and the steam generator 102)). As such the steam can flow through the second passage 126 as the liquid flows through the first passage 124, allowing a single valve or flow control device to control flow of two fluids therethrough.

[0024] Optionally, the flow regulation device 116 can include more than one of the first passage 124 and can include more than one of the second passage 126. In some examples, a gap 125 can be a void, space, or solid portion of the body 121, which can prevent or limit fluid (e.g., the liquid L or the steam S) from bypassing the first passage 124 or the second passage 126, helping to ensure the flow regulation device 116 operates as intended. Each of the first passage 124 and the second passage 126 can be a channel, passage, pipe, tube, or the like.

[0025] In operation of some examples, when steam S travels up from the steam generator 102 and through the makeup line 112, the steam S can occupy a portion of the discharge pipe 122, which can obstruct or limit travel of fluid from the makeup circuit 110 through the makeup line 112 and to the steam generator 102. To help address this issue, the first passage 124 can have a diameter DI or can be sized such that it is large enough (e.g., has a large enough diameter or size) to permit water or liquid to flow from the makeup circuit 110 to the makeup line 112. For example, the diameter DI can be larger than the diameter D2.

[0026] To further help address this issue, the second passage 126 can have a diameter D2 or can be sized to operate as a steam discharge or vent such that the steam S can escape through the second passage 126 and can rise through the liquid L (when present) and into the inlet pipe 120 thereby creating downward pressure or a downward force on the liquid L and helping to force the liquid L into the discharge pipe 122 and therefore into the makeup line 112 and the enclosure 104, helping to limit or prevent steam S fromInternational Application Docket: P151417PC00 / STES.24001 limiting or blocking flow from the makeup circuit 110 through the makeup line 112 to the steam generator 102, while still allowing the steam S to be vented from the steam generator 102 to help sterilize the makeup line 112 (and the flow regulation device 116).

[0027] In some examples, the flow regulation device 116 can include a first control device 128 and a second control device 130. The first control device 128 can be connected to (or can form or can be part of) an inlet of the second passage 126. The second control device 130 can be connected to (or can form or can be part of) an outlet of the second passage 126. The first control device 128 and the second control device 130 can be a flow control device, such as an orifice, restrictor, or the like. In some examples, the first control device 128 can be sized, shaped, or otherwise configured to allow the entry of stream and to limit the entry of water or fluid. Also, the second control device 130 can be sized, shaped, or otherwise configured to allow the exit of stream and to limit the entry of water or fluid.

[0028] In some examples, the diameter DI can be a diameter or a size between 0.1 millimeters (mm) and 20 mm. In some examples, the diameter DI can be between 0.5 mm and 6 mm, such as 0.5, 1, 2, 3, 4, 5, 6 mm, or the like. In some examples, the diameter D2 can be a diameter or a size between 0.1 millimeters (mm) and 20 mm. In some examples, the diameter D2 can be between 0.5 mm and 10 mm, such as 1, 2, 3, 4, 5, 6 mm, or the like. In some examples, the diameter DI can be 6mm and the diameter D2 can be 0.5 mm. In some examples, a ratio of the diameter DI to the diameter D2 can be between 1 : 1 and 1 :20. In some examples, a ratio of the diameter DI to the diameter D2 can be between 1 : 1 and 1 :12. In some examples, a ratio of the diameter DI to the diameter D2 can be between 2 and 6.

[0029] With this arrangement, the makeup line 112 does not need to be drained using automatic valving because the steam and sloping of the makeup line 112 can cause the makeup line 112 (and other pipes) to naturally drain into the steam generator 102. The makeup line 112 also does not need to be externally heated because the steam S will (or can) travel to the makeup line 112 (and as high as the inlet pipe 120) which can help to sanitize or sterilize the makeup line 112, flow regulation device 116, and inlet pipe 120, thereby providing a self-draining and self-sanitizing or sterilizing makeup system.International Application Docket: P151417PC00 / STES.24001

[0030] FIG. 4 illustrates a schematic view of a method 400. The method 400 can be a method of controlling steam and makeup water through a makeup water line. More specific examples of the method 400are discussed below. The steps or operations of the method 400 are illustrated in a particular order for convenience and clarity; many of the discussed operations can be performed in a different sequence or in parallel without materially impacting other operations. The method 400 as discussed includes operations performed by multiple different actors, devices, or systems. It is understood that subsets of the operations discussed in the method 400 can be attributable to a single actor, device, or system could be considered a separate standalone process or method.

[0031] The method 400 can begin at step 402, where steam can be generated using a steam generator. The steam generator (e.g., the steam generator 102) can be connected to a makeup line (e.g., the makeup line 112), and the makeup line can be connected to a water supply line (e.g., the makeup circuit 110). At step 404, steam can be discharged from the steam generator (e.g., the steam generator 102) into the makeup line and into a flow regulator (e.g., flow regulation device 116).

[0032] At step 406, a makeup water flow can be supplied from the water supply line to the flow regulator. At step 408, a steam flow from the steam generator through the makeup line can be controlled using the flow regulator. At step 410, the makeup water flow through the flow regulator to the makeup line and the steam generator can be controlled using the flow regulator.

[0033] In some examples, the method 400 can include starting and stopping the makeup water flow from the water supply line to the makeup line using a control valve connected to the makeup line upstream of the flow regulator. In some examples, the method 400 can include limiting the steam flow and the makeup water flow through only a first passage and a second passage of a body of the flow regulator.

[0034] In some examples, the method 400 can include limiting the makeup water flow to flow through only a first passage of a body of the flow regulator. In some examples, the method 400 can include limiting the steam flow to flow through only a second passage of the body of the flow regulator, the second passage in parallel flow to the first passage.International ApplicationDocket: P151417PC00 / STES.24001NOTES AND EXAMPLES

[0035] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.

[0036] Example l is a steam generation system for a sterilization device, the steam generation system comprising: a steam generator configured to generate and discharge steam therefrom, the steam generator including an enclosure; a water supply line configured to deliver supply water to the steam generator; a makeup line connected to the water supply line and a top portion of the enclosure of the steam generator; and a flow regulator located in the makeup line between the steam generator and the water supply line, the flow regulator configured to: control a steam flow from the steam generator; and control a makeup water flow from the makeup line to the steam generator.

[0037] In Example 2, the subject matter of Example 1 optionally includes wherein the flow regulator includes a body including a first passage and a second passage, the body configured to limit the steam flow and the makeup water flow through only the first passage and the second passage.

[0038] In Example 3, the subject matter of any one or more of Examples 1-2 optionally include wherein the body includes a first passage and a second passage parallel to the first passage, the first passage configured to control the makeup water flow from the makeup line to the steam generator, and the second passage configured to control the steam flow from the steam generator.

[0039] In Example 4, the subject matter of Example 3 optionally includes wherein the first passage is configured to allow the makeup water flow to flow from the makeup line to the steam generator, and wherein the second passage is configured to allow the steam flow from the steam generator to pass therethrough.International Application Docket: P151417PC00 / STES.24001

[0040] In Example 5, the subject matter of any one or more of Examples 3-4 optionally include wherein the first passage is larger than the second passage.

[0041] In Example 6, the subject matter of Example 5 optionally includes wherein the first passage has a diameter of 6 millimeters and the second passage has a diameter of 0.5 millimeters.

[0042] In Example 7, the subject matter of any one or more of Examples 5-6 optionally include wherein a ratio of the first passage to the second passage is between 1 : 1 and 1 : 12.

[0043] In Example 8, the subject matter of any one or more of Examples 1-7 optionally include a control valve connected to the makeup line upstream of the flow regulator, the control valve operable to start and stop the makeup water flow from the water supply line to the makeup line.

[0044] In Example 9, the subject matter of any one or more of Examples 1-8 optionally include wherein the makeup line is sloped for gravity draining between the water supply line and the steam generator.

[0045] In Example 10, the subject matter of any one or more of Examples 1-9 optionally include wherein the water supply line is configured to circulate water at a flow rate that is turbulent.

[0046] Example 11 is a method of operating a steam generation system for a sterilization device, the method comprising: generating steam using a steam generator, the steam generator connected to a makeup line, and the makeup line connected to a water supply line; discharging steam from the steam generator into the makeup line and into a flow regulator; supplying a makeup water flow from a water supply line to the flow regulator; controlling a steam flow from the steam generator through the makeup line using the flow regulator; and controlling the makeup water flow through the flow regulator to the makeup line and the steam generator using the flow regulator.

[0047] In Example 12, the subject matter of Example 11 optionally includes starting and stopping the makeup water flow from the water supply line to the makeup line using a control valve connected to the makeup line upstream of the flow regulator.International Application Docket: P151417PC00 / STES.24001

[0048] In Example 13, the subject matter of any one or more of Examples 11-12 optionally include limiting the steam flow and the makeup water flow through only a first passage and a second passage of a body of the flow regulator.

[0049] In Example 14, the subject matter of any one or more of Examples 11-13 optionally include limiting the makeup water flow to flow through only a first passage of a body of the flow regulator; and limiting the steam flow to flow through only a second passage of the body of the flow regulator, the second passage in parallel flow to the first passage.

[0050] In Example 15, the subject matter of Example 14 optionally includes wherein the first passage is larger than the second passage.

[0051] Example 16 is a steam generation system for a sterilization device, the steam generation system comprising: a steam generator configured to generate and discharge steam therefrom, the steam generator including an enclosure; a water supply line configured to deliver supply water to the steam generator, the water supply line sloped for gravity draining between the water supply line and the steam generator.; a makeup line connected to the water supply line and a top portion of the enclosure of the steam generator; and a flow regulator connected to the makeup line between the steam generator and the water supply line, the flow regulator configured to: control a steam flow from the steam generator through the makeup line; and control a makeup water flow from the makeup line to the steam generator.

[0052] In Example 17, the subject matter of Example 16 optionally includes wherein the body includes a first passage and a second passage parallel to the first passage, the first passage configured to control the makeup water flow from the makeup line to the steam generator, and the second passage configured to control the steam flow from the steam generator.

[0053] In Example 18, the subject matter of Example 17 optionally includes wherein the first passage is larger than the second passage.

[0054] In Example 19, the subject matter of Example 18 optionally includes wherein a ratio of the first passage to the second passage is between 1 : 1 and 1 : 12.International Application Docket: P151417PC00 / STES.24001

[0055] In Example 20, the subject matter of any one or more of Examples 16-19 optionally include a control valve connected to the makeup line upstream of the flow regulator, the control valve operable to start and stop the makeup water flow from the water supply line to the makeup line.

[0056] In Example 21, the apparatuses or method of any one or any combination of Examples 1 - 20 can optionally be configured such that all elements or options recited are available to use or select from.

[0057] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0058] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim.

[0059] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A andB,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” andInternational Application Docket: P151417PC00 / STES.24001 “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0060] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

International ApplicationDocket: P151417PC00 / STES.24001CLAIMS:

1. A steam generation system for a sterilization device, the steam generation system comprising: a steam generator configured to generate and discharge steam therefrom, the steam generator including an enclosure; a water supply line configured to deliver supply water to the steam generator; a makeup line connected to the water supply line and a top portion of the enclosure of the steam generator; and a flow regulator located in the makeup line between the steam generator and the water supply line, the flow regulator configured to: control a steam flow from the steam generator; and control a makeup water flow from the makeup line to the steam generator.

2. The steam generation system of claim 1, wherein the flow regulator includes a body including a first passage and a second passage, the body configured to limit the steam flow and the makeup water flow through only the first passage and the second passage.

3. The steam generation system of claim 2, wherein the body includes a first passage and a second passage parallel to the first passage, the first passage configured to control the makeup water flow from the makeup line to the steam generator, and the second passage configured to control the steam flow from the steam generator.

4. The steam generation system of claim 3, wherein the first passage is configured to allow the makeup water flow to flow from the makeup line to the steam generator, and wherein the second passage is configured to allow the steam flow from the steam generator to pass therethrough.

5. The steam generation system of any of claims 3-4, wherein the first passage is larger than the second passage.International ApplicationDocket: P151417PC00 / STES.240016. The steam generation system of claim 5, wherein the first passage has a diameter of 6 millimeters and the second passage has a diameter of 0.5 millimeters.

7. The steam generation system of claim 5, wherein a ratio of the first passage to the second passage is between 1 : 1 and 1 : 12.

8. The steam generation system of any of claims 1-7, comprising: a control valve connected to the makeup line upstream of the flow regulator, the control valve operable to start and stop the makeup water flow from the water supply line to the makeup line.

9. The steam generation system of any of claims 1-8, wherein the makeup line is sloped for gravity draining between the water supply line and the steam generator.

10. The steam generation system of any of claims 1-9, wherein the water supply line is configured to circulate water at a flow rate that is turbulent.

11. A method of operating a steam generation system for a sterilization device, the method comprising: generating steam using a steam generator, the steam generator connected to a makeup line, and the makeup line connected to a water supply line; discharging steam from the steam generator into the makeup line and into a flow regulator; supplying a makeup water flow from the water supply line to the flow regulator; controlling a steam flow from the steam generator through the makeup line using the flow regulator; and controlling the makeup water flow through the flow regulator to the makeup line and the steam generator using the flow regulator.International ApplicationDocket: P151417PC00 / STES.2400112. The method of claim 11, comprising: starting and stopping the makeup water flow from the water supply line to the makeup line using a control valve connected to the makeup line upstream of the flow regulator.

13. The method of any of claims 11-12, comprising: limiting the steam flow and the makeup water flow through only a first passage and a second passage of a body of the flow regulator.

14. The method of any of claims 11-13, comprising: limiting the makeup water flow to flow through only a first passage of a body of the flow regulator; and limiting the steam flow to flow through only a second passage of the body of the flow regulator, the second passage in parallel flow to the first passage.

15. The method of claim 14, wherein the first passage is larger than the second passage.

16. A steam generation system for a sterilization device, the steam generation system comprising: a steam generator configured to generate and discharge steam therefrom, the steam generator including an enclosure; a water supply line configured to deliver supply water to the steam generator, the water supply line sloped for gravity draining between the water supply line and the steam generator; a makeup line connected to the water supply line and a top portion of the enclosure of the steam generator; and a flow regulator connected to the makeup line between the steam generator and the water supply line, the flow regulator configured to:International Application Docket: P151417PC00 / STES.24001 control a steam flow from the steam generator through the makeup line; and control a makeup water flow from the makeup line to the steam generator.

17. The steam generation system of claim 16, wherein the flow regulator includes a body including a first passage and a second passage parallel to the first passage, the first passage configured to control the makeup water flow from the makeup line to the steam generator, and the second passage configured to control the steam flow from the steam generator.

18. The steam generation system of claim 17, wherein the first passage is larger than the second passage.

19. The steam generation system of claim 18, wherein a ratio of the first passage to the second passage is between 1 : 1 and 1 : 12.

20. The steam generation system of claim 16, comprising: a control valve connected to the makeup line upstream of the flow regulator, the control valve operable to start and stop the makeup water flow from the water supply line to the makeup line.

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