Systems, Apparatus and Methods for Sterilizing Objects Using a Self-Contained Sterilization Chamber - Patent application

Abstract

A system is disclosed for providing a safe, conveniently on-site, rapid and effective method for delivering antibacterial and antiviral treatments to objects. Additionally, an isolation unit for sterilizing objects is disclosed, the isolation unit having a lockable hatch that, when unlocked, allows access to a sterilization chamber within the isolation unit. The hatch remains locked until the sterilization operation is complete. Furthermore, the hatch is prevented from being opened until the sterilization operation is complete. This feature, among other possible advantages, prevents potentially harmful sterilization chemicals from being released from the sterilization chamber.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 268,164, entitled "SYSTEMS, APPARATUS AND METHODS FOR STERILIZING AN OBJECT USING A SELF-CONTAINED STERILIZATION CHAMBER," filed February 17, 2022, the contents of which are incorporated by reference in their entirety herein.

[0002] The present invention relates to a system, apparatus and method for disinfecting or sterilizing objects, particularly by using a polymer composition with antimicrobial properties that releases a germicidal gas, such as chlorine dioxide gas, which, according to the present invention, functions as an antimicrobial agent that inhibits pathogens. Furthermore, the system herein provides a self-contained chamber for performing the sterilization operation using the polymer composition. The system herein is applied to reduce, inhibit, and eliminate the growth or infection of viruses, bacteria, fungi, and other microorganisms. Among other applications, the system herein can be used for disinfecting or sterilizing medical devices, including protective personal equipment, medical equipment, surgical instruments, and other reusable objects that require sterilization in a medical environment before use on or in a patient or medical professional. In this way, the device can be disinfected or sterilized and reused multiple times, increasing safety for medical professionals and patients and addressing the limited supply of such items. Disinfection or sterilization of any of a myriad of other objects is also contemplated, including cell phones, cosmetics, kitchenware, toys, glasses, mail, currency, and the like. [Background technology]

[0003] Medical professionals must ensure that reusable medical equipment and devices (e.g., surgical instruments and endoscopes) are free of pathogens before using such objects by themselves (e.g., by wearing an N95 mask) or on or in a patient. Various methods exist for sterilizing and therefore reprocessing medical equipment and devices, including ionizing radiation, sterilization with ethylene oxide (EtO), microwave-generated steam (MGS), ultraviolet germicidal irradiation (UVGI), gamma radiation, steam, bleach, liquid hydrogen peroxide (LHP), and hydrogen peroxide gas plasma (HPGP). However, these decontamination procedures require specialized materials and can result in equipment, facilities, and hazardous conditions unless properly performed by specially trained professionals.

[0004] The Battelle Critical Care Decontamination System® (Battelle Memorial Institute of Columbus, OH, USA) received FDA Emergency Use Authorization and became available in March 2020 in response to the Covid-19 pandemic. The Battelle decontamination system claimed successful testing for decontaminating N95 respirators demonstrating acceptable performance through 20 decontamination cycles for sporicidal activity, virucidal activity, filtration efficiency, breathability, form fit testing, and strap integrity testing per authorized respirator. The Battelle system is a self-contained decontamination device that uses vapor phase hydrogen peroxide (VPHP) for the decontamination of compatible N95 or N95-equivalent respirators that are or may be contaminated with SARS-CoV-2. Each decontamination cycle in the Battelle decontamination system consists of injecting VPHP into the decontamination chamber until a saturated atmosphere is achieved as indicated by microcondensation, maintaining VPHP exposure for a dwell time of 150 minutes, and off-gassing VPHP to a level of 1 ppm before post-decontamination processing. At least five calibrated chemical indicators are distributed throughout the system to indicate a successful decontamination cycle. One disadvantage of the Battelle system is that it requires complex and expensive specialized equipment to operate. For example, the Battelle system requires a complex means of generating VPHP from outside the sterilization chamber and a means of delivering the gas into the chamber to achieve sterilization.

[0005] Chlorine dioxide (ClO 2 ) has been shown to be effective as an antibacterial agent in reducing pathogens. It has also been shown to be effective against various viruses. 2Gas-containing products are used for antimicrobial applications in agricultural, commercial, industrial, medical, and residential applications. Specifically, the gaseous effect of chlorine dioxide against influenza A was studied by Ogata, Samp, and Shibata in 2008. The team used 0.03 ppm ClO 2 showed that when administered simultaneously with the virus and after, survival rates increased to 100% versus 30% for the untreated. Ogata, N., Shibata, T. Protective Effects of Low Concentrations of Chlorine Dioxide Gas against Influenza A Virus Infection. Journal of General Virology, 89(1), 60-67, (2008). Harakeh showed that certain viruses, including human rotavirus and coxsackievirus B5, were able to withstand 4 ppm ClO 5 minutes after exposure. 2 provides data showing that concentrations of 1.0 ppm ClO for 180 seconds inactivate viruses in excess of 99.9% of the virus. Echovirus 1, poliovirus 1, bacteriophage f2, and cyamian rotovirus. Harakeh, S. Behavior of viruses upon disinfection with chlorine dioxide and other disinfectants in effluents. FEMS Microbiology Letters, 44(3), 335-341, (1987). A study by Sanekata et al. showed that 1.0 ppm ClO for 180 seconds inactivates viruses in excess of 99.9% of the virus. 2showed that a concentration of 100 mg / kg / day can achieve 2-4 log kill against infectious flu virus (IFV), measles, and HHV-1. Sanekata, T., Fukuda, T., Miura, T., Morino, H., Lee, C., Maeda, K., Shibata, T. Evaluation of the Antiviral Activity of Chlorine Dioxide and Sodium Hypochlorite against Feline Calicivirus, Human Influenza Virus, Measles Virus, Canine Distemper Virus, Human Herpesvirus, Human Adenovirus, Canine Adenovirus and Canine Parvovirus. Biocontrol Science, 15(2), 45-49, (2010). Simonet, Samp, and Gantzer showed that polio can also be inactivated by exposure to chlorine dioxide. Simonet, J., Gantzer, C. Degradation of the Poliovirus 1 genome by chlorine dioxide. Journal of Applied Microbiology, 100(4), 862-870, (2006).

[0006] In light of its demonstrated safety and efficacy, ClO 2 Gas sterilization has shown great promise as an alternative to other gas sterilization methods. However, like other forms of gas sterilization, ClO 2 Conventional devices for generating and delivering gas into a sterilization chamber are complex and expensive. In view of this problem, the applicant has developed a ClO 2A new technology has been developed for generating gas simply, safely and effectively. This technology is described in International Patent Application PCT / US2019 / 060937 and US Patent Application Publication No. 2019 / 0335746. PCT / US2019 / 060937 discloses a chlorine dioxide gas former with a carrier material in a polymer composition, preferably including an acidified silica gel. Optionally, the chlorine dioxide gas former includes a carrier material (e.g., silica gel), an active compound (metal chlorite such as sodium chlorite), and a moisture trigger (hygroscopic compound, e.g., calcium chloride). The carrier material preferably includes an acidified silica gel having a pH of 1.4 to 3.1 and being 50% to 90% by weight based on the total weight of the antimicrobial releasing agent. The active compound is 5% to 30% by weight based on the total weight of the antimicrobial releasing agent. The trigger is 2% to 20% by weight based on the total weight of the antimicrobial releasing agent. In one optional embodiment, the chlorine dioxide gas former comprises 10% to 15% by weight of sodium chlorite, 5% to 15% by weight of calcium chloride, and 70% to 80% by weight of silica gel, based on the total weight of the chlorine dioxide gas former. Preferably, the carrier of the chlorine dioxide gas former has a pH of 1.0 to 3.5, optionally 1.4 to 3.1. Preferably, the chlorine dioxide gas former is a component of a polymer composition that includes a base polymer, a channeling agent, and a chlorine dioxide gas former.

[0007] The above techniques, particularly in the form of polymer compositions, require the addition of a given amount of ClO 2 This offers a significant advance in that it can be configured to generate gas precisely and within a predetermined time frame. Moreover, it may be embodied in a polymeric composition - what appears to be a simple piece of plastic - that, when exposed to moisture, is triggered to generate chlorine dioxide gas. The polymeric composition is a mixture of ClO 2 It does not require specialized equipment, electronics, pumps, etc. to generate the gas, and therefore it is easily portable, simple, and relatively inexpensive to use.

[0008] Challenges for any gas sterilization process include (1) ensuring that the gas is substantially contained so that it does not permeate the surrounding environment, and (2) ensuring that the treatment cycle is completed to achieve the required level of sterilization. 2 In the context of gas sterilization, it is important to prevent gas leakage during the cycle and to release ClO after the cycle. 2 There is a need to provide a chamber which ensures that gases are below acceptable levels within the chamber and which prevents inadvertent or deliberate interruption to the cycle or premature removal of objects subjected to sterilization.

[0009] There is a further need for a sterilization system for medical devices and equipment that is uncomplicated to use, with simple procedures for use and simple instructions so that medical personnel, as well as the average person without health care or scientific training, can easily understand and learn to utilize the system. Summary of the Invention

[0010] Thus, in one aspect, disclosed herein is a system for sterilization or disinfection, including a self-contained sterilization chamber that uses a non-lethal locking mechanism that remains locked once triggered and can only be unlocked when certain conditions are met. The system can be easily and quickly deployed worldwide and is easily scalable. The system herein is useful for disinfecting, decontaminating, sanitizing, and / or sterilizing any object, both general and specialized medical instruments and medical equipment. The system preferably includes the use of a polymer composition incorporating a chlorine dioxide gas former that can form and release chlorine dioxide gas as an active agent that functions to inhibit microbial growth. The system is intended for use in hospital environments, and is particularly suitable for small clinics, dental clinics, urgent care centers, nursing homes, university hospitals, military hospitals, tribal medical facilities, and rural medical facilities. Overall, it provides a very practical means of safely and effectively sterilizing medical instruments or devices for reuse, meeting government reprocessing guidelines. A particular advantage of the disclosed system is that it is scalable to as many treatment units as needed for the desired application.

[0011] The system may include an isolation unit, at least one hatch, at least one locking mechanism, at least one human machine interface (HMI) device, at least one output device, and a control system. Furthermore, the hatch may be laterally integrated into the isolation unit. Furthermore, the locking mechanism may be operatively coupled between the isolation unit and the hatch, the locking mechanism acting as a failed switch to prevent the hatch from opening when the locking mechanism is engaged. Furthermore, the HMI device may be laterally mounted on the isolation unit. Furthermore, the output device may be laterally mounted on the isolation unit. Furthermore, the control system may be disposed within the isolation unit. Furthermore, the control system may be communicatively coupled to the HMI device and the output device.

[0012] Additionally, the isolation unit may include a sterilization chamber and a component enclosure. Additionally, a hatch may be integrated into the sterilization chamber, with an interior compartment of the sterilization chamber being selectively accessible through the hatch. Additionally, the component enclosure may be laterally mounted on the sterilization chamber and offset from the hatch. Additionally, the HMI may include at least one control button and at least one key lock switch. Additionally, the key lock switch and the control button may be laterally mounted on the component enclosure. Additionally, the output device may include at least one status light, at least a first display device, and at least a second display device.

[0013] Further, the hatch may include an opening and a door. Further, the opening may traverse through the sterilization chamber into the interior compartment. Further, the door may be mounted over the opening. Further, a locking mechanism may be connected between the door and the sterilization chamber.

[0014] Further, the locking device may comprise an engagement device and a receptacle. Further, the engagement device may be mounted on the hatch. Further, the receptacle may be mounted on the sterilization chamber. Further, the engagement device may be selectively engaged with the receptacle, the engagement preventing the opening from being accessed through the door. Further, the engagement device may comprise at least one locking pin and at least one biasing device. Further, the locking pin may be operably coupled to the biasing device, the biasing device selectively engaging the locking pin with the receptacle. Further, the engagement device may comprise at least one reset lever. Further, the reset lever may be operably coupled to the biasing device, the reset lever force disengaging the locking pin from the receptacle.

[0015] Additionally, the disclosed concepts may include an environmental analysis instrumentation suite. Additionally, the environmental analysis instrumentation suite may be mounted within the interior compartment of the sterilization chamber. Additionally, the control system may be communicatively coupled to the locking mechanism and the environmental analysis instrumentation suite.

[0016] Additionally, the disclosed concepts may include a rack assembly, an element tray, and a sterilization element. Additionally, the rack assembly may be mounted within the interior compartment of the sterilization chamber. Additionally, the element tray may be mounted within the interior compartment. Additionally, the sterilization element may be disposed on the element tray.

[0017] In one particular embodiment, the active-Shield polymers are produced using three-phase entrained polymer technology (Aptar CSP Technologies Inc., Auburn AL, USA). TM Disclosed is a system that uses a germicidal element that is an antimicrobial strip formed using the chlorine dioxide gas generating technology. In an alternative embodiment, the chloride dioxide gas forming agent used herein comprises a chlorite salt, including an alkali metal chlorite, an alkaline earth metal chlorite, or a transition metal chlorite. Moisture activates the metal chlorite salt to form chlorine dioxide gas.

[0018] Three-phase polymers offer the ability to control small molecule transport through the polymer. The pathways created by the interaction of these components allow for the controlled transfer of chlorine dioxide gas into and out of the polymer. This is due to the fact that ClO 2 This has allowed the ability to manipulate the compounds to be permeable to gas molecules. When released into the sealed atmosphere of a package, the entrained polymers allow for maintaining an optimal environment while minimizing or reducing microbial counts.

[0019] One method according to any embodiment of the present invention comprises: (a) placing an object to be disinfected into an isolation unit having an interior space, the headspace being formed from a portion of the interior space not occupied by the object; (b) disposing a polymer composition within the interior space, the polymer composition comprising: (i) a base polymer; (ii) a chlorine dioxide gas former; and (iii) a channeling agent that forms channels through the base; (c) contacting the polymer composition with moisture to form chlorine dioxide gas; (d) enclosing the isolation unit sufficiently to allow chlorine dioxide gas to accumulate in the headspace, wherein the amount of chlorine dioxide gas is substantially or completely undetectable immediately after removing the object from the isolation unit, and optionally within 1 minute after removal, optionally within 5 minutes after removal, optionally within 10 minutes after removal, optionally within 1 hour after removal, or optionally within 1 hour after removal; the amount of chlorine dioxide gas on the disinfected object is less than 0.01 ppm immediately after removing the object from the isolation unit, and optionally within 1 minute after removal, optionally within 5 minutes after removal, optionally within 10 minutes after removal; the amount of chlorine dioxide gas in the ambient environment around the isolation unit is less than 0.01 ppm for the entire time after removal of the object from the isolation unit, and optionally within 1 minute after removal, or the amount of chlorine dioxide gas in the ambient environment around the isolation unit is considered generally recognized as safe (GRAS) in accordance with Sections 201 and 409 of the U.S. Federal Food, Drug, and Cosmetic Act, for the entire time the operation is performed, and optionally within 1 minute after removal of the object from the isolation unit; Includes.

[0020] The amount of chlorine dioxide formed by the polymer composition is controlled by several means. In one optional embodiment, the amount of chlorine dioxide gas released into the room is between 0.001 ppm and 0.1 ppm over an average of a 10 hour work shift. In an alternative optional embodiment, the amount of chlorine dioxide released is about 0.3 ppm over a 15 minute period. Such embodiments are within, but are not limited to, the range considered safe for human use by the U.S. Centers for Disease Control and Prevention (CDC).

[0021] Optionally, in any embodiment involving disinfection of objects contaminated with microorganisms, the concentration of chlorine dioxide gas formed within the isolation unit results in a reduction of infectious viruses or bacterial pathogens on the object being disinfected, which reduction is at least a 1 log base 10 reduction in the number of such particles, optionally at least a 2 log base 10 reduction in the number of such particles, optionally at least a 3 log base 10 reduction in the number of such particles, optionally at least a 4 log base 10 reduction in the number of such particles, optionally at least a 5 log base 10 reduction in the number of such particles, optionally at least a 6 log base 10 reduction in the number of such particles, optionally at least a 7 log base 10 reduction in the number of such particles, optionally at least an 8 log base 10 reduction in the number of such particles as compared to the initial number of such particles.

[0022] According to another aspect of the disclosed concepts, the profile release rate and duration of chlorine dioxide gas formation can be designed and controlled.

[0023] A further important component of embodiments of the present invention is that during the disinfection process, the amount of chlorine dioxide gas in the ambient environment around the isolation unit is substantially or completely undetectable the entire time the method is performed, and optionally immediately after removal of the object from the isolation unit, optionally within one minute after removal.

[0024] Optionally, a colorant or color indicator is added to the polymer composition as an independent indicator to indicate chlorine dioxide activity. Optionally, the concentration of the colorant is about 1% to 3%, optionally about 2%, of the total weight of the polymer composition. A marker or similar gauge can also be used to indicate and monitor the activity of chlorine dioxide gas in the system. [Brief description of the drawings]

[0025] The present invention will be described in conjunction with the following drawings, in which like reference numbers indicate like elements and in which: [Figure 1]FIG. 1 is a front view of an isolation unit that can be used in the disclosed concepts. [Diagram 2] FIG. 2 is a right side view of the isolation unit of FIG. [Diagram 3] FIG. 3 is a top view of the isolation unit of FIG. [Figure 4] FIG. 4 is a block diagram illustrating the arrangement of components within a compartment of an isolation unit according to any embodiment of the disclosed concepts. [Diagram 5] FIG. 5 is a block diagram illustrating a temperature control system and a humidity control system disposed within an interior compartment of an isolation unit, according to any embodiment of the disclosed concepts. [Figure 6] 6 is a block diagram illustrating an air purification system disposed within an interior compartment of an isolation unit, according to any embodiment of the disclosed concepts, where dashed lines indicate the direction of airflow through the air purification system. [Figure 7] FIG. 7 is a block diagram illustrating communicatively coupled components of an isolation unit according to any aspect of the disclosed concepts. [Figure 8] FIG. 8 is a flow chart illustrating a method for sterilizing an object using an isolation unit according to any embodiment of the disclosed concepts. [Figure 9] FIG. 9 is a flow chart illustrating a method for sterilizing an object using an isolation unit according to one embodiment of the disclosed concepts. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] As used herein, the terms "antimicrobial" or "antimicrobial agent" refer to a substance that inhibits microorganisms. Classes of antimicrobial agents include antiviral, antibacterial, antifungal, antiparasitic and other antipathogenic agents.

[0027] As used herein, the term "base polymer" refers to a polymer that can be formed with a chlorine dioxide gas forming agent and has a gas permeability of the selected material that is substantially lower than, lower than, or substantially equal to the gas permeability of the channeling agent that is optionally mixed into the base polymer. As an example, such a permeability is the water vapor permeability in an embodiment in which the chlorine dioxide gas forming agent is activated by moisture. The main function of the base polymer is to provide a structure having a polymer composition that includes the base polymer, the chlorine dioxide gas forming agent, and preferably the channeling agent.

[0028] As used herein, the term "channeling agent" is defined as a material that is immiscible with the base polymer and has an affinity to transport gas phase substances at a faster rate than the base polymer alone. Optionally, the channeling agent can form channels through the entrained polymer when formed by mixing the channeling agent with the base polymer. Optionally, such channels can transmit a selected material, e.g., water, chlorine dioxide, or other, through the entrained polymer at a faster rate than the selected material would have in the base polymer without the channeling agent. As used herein, the term "channels" or "interconnecting channels" is defined as passages formed with the channeling agent that can penetrate the base polymer and interconnect with each other.

[0029] As used herein, the term "chlorine dioxide gas former" refers to a compound that upon contact with moisture, or potentially in response to another trigger, reacts to form chlorine dioxide, which is released in gas form.

[0030] As used herein, the terms "close", "closed" and "closing" are used interchangeably with the terms "seal", "sealed" and "sealing", respectively, and refer to an isolation chamber of an isolation unit that is formed and sealed within the isolation unit such that the amount of chlorine dioxide gas remaining within the isolation unit is balanced with the amount of chlorine dioxide gas leaving the isolation unit when sealed, and that chlorine dioxide gas accumulates within the isolation unit and reaches a measurable concentration therein. The seal is necessary to minimize the penetration of both moisture and chlorine dioxide gas through the isolation unit wall and through the seal, which also factors into the time that an object is held within the isolation unit and dwells in the chlorine dioxide gas, thereby being sterilized or disinfected.

[0031] As used herein, the terms "decontamination," "disinfection," "sanitization," and "sterilization" (as well as "decontaminate," "disinfect," "sanitize," and "sterilize" and combinations thereof) are defined herein to mean the act of contacting an object with chlorine dioxide to inhibit infectious agents such as bacteria, viruses, fungi, parasites, or other.

[0032] The terms decontamination, disinfection, sterilization, and sterilization are often colloquially used interchangeably in common dictionaries. Although various definitions are available and are provided as background, information, and guidance for interpretation, the terms are used as defined herein. These terms have also acquired specific meanings within various fields of practice (e.g., chemistry, medicine, food science, etc.). These terms are also specifically defined by various organizations for specific purposes, such as the Centers for Disease Control (CDC), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). The definitions provided by the CDC, EPA, and FDA are provided only as examples and information, and are not intended to be limiting unless otherwise stated in a given case or in the claims. Further, for clarity, the terms "decontamination," "disinfection," "sanitization," and "sterilization" (as well as the terms "decontaminate," "disinfect," "sanitize," and "sterilize" and their conjugated forms) are used interchangeably herein, and one of these terms is used throughout this specification and the claims, and such term is intended to encompass and encompass all four terms and iterations enumerated, unless otherwise indicated in a given instance or claim.

[0033] The US CDC provides the following definition: "Decontamination: the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens" Making a surface or item safe to the point where it can no longer be handled, used, or disposed of with infectious particles. In healthcare facilities, the term is commonly used in the following ways: "Disinfection: the thermal or chemical destruction of pathogens and other types of microorganisms. Disinfection is less lethal to microorganisms than sterilization, as it destroys most recognized pathogens (e.g., bacterial spores)." "Sanitizer: an agent that reduces the number of bacterial contaminants to a safe level, as judged by public health requirements. The term is commonly used for substances applied to inanimate objects. According to official sanitizer testing protocols, a disinfectant is a chemical that, under test conditions, kills 99.999% of a specific test bacteria." "Sterilization" or sterility: the state of being free of all living microorganisms. In practice, these terms are usually explained as a probability function, e.g., the probability that a microorganism will survive sterilization, which is 1 in 1 million years. "Sterilization: A validated process used to render a product free of all forms of viable microorganisms. In a sterilization process, the presence of microorganisms on any individual item is determined by the probability Title 29 Section 1910.1030" (see https: / / www.cdc.gov / infectioncontrol / guidelines / disinfection / glossary.html). As used herein, in addition to and consistent with the above definition (meaning an object that is in contact with chlorine dioxide for a sufficient concentration and time to inhibit microorganisms), the term "sterilized" includes the object being free of all forms of viable microorganisms, described as the probability that a microorganism will survive sterilization, which is one in a million years, as defined by the US CDC pursuant to Title 21 of the Code of Federal Regulations, Section 110.3(o).

[0034] The U.S. EPA defines a "sanitizer" as "a substance or mixture of substances that significantly reduces the bacterial population in an inanimate environment but does not destroy or eliminate all bacteria."[CFR Title 40, Section 158.2203] The term "disinfectant" is defined as "a substance or mixture of substances that destroys or irreversibly inactivates bacteria, fungi, and viruses in an inanimate environment, but does not necessarily destroy bacterial spores."

[0035] The US Food and Drug Administration defines "sterilization" in the document entitled "Liquid Chemical Sanitizers / High Level Infectants Guidance" (https: / / www.cdc.gov / infectioncontrol / guidelines / disinfection / tables / table1.html) as "a validated method used to render a product free of all forms of viable microorganisms." In many cases, thermal methods such as steam are used to achieve sterilization. Thermal sterilization methods have been extensively studied and characterized. In addition, the viability kinetics of gas / steam / plasma pasteurization methods have also been well characterized. "Sanitation" is defined as "a method of adequately treating food-contact surfaces in a manner that is effective in destroying vegetative cells of microorganisms of public health importance and that substantially reduces the numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer." [21 CFR, Section 110.3(o).]

[0036] As used herein, the term "headspace" refers to the portion of the interior space of an isolation unit that is not occupied by objects within the isolation unit.

[0037] As used herein, the term "infectious agent" refers to any type of microorganism, such as a virus, bacteria, fungus, algae, parasite, or other microorganism that can infect a living organism and can be modified by contact with chlorine dioxide. An infectious agent is typically, but not necessarily, a pathogen. The terms "infectious agent," "microbial agent," and "pathogen" are used interchangeably herein.

[0038] As used herein, the term "inhibit" refers to the ability of chlorine dioxide to modify, impede, inhibit, inhibit, reduce, stop, inactivate, kill, stop or essentially prevent an infectious agent in its ability to grow and / or grow and / or infect another organism. All such terms are used interchangeably herein. Antimicrobial growth inhibition can further aid in the prevention of infectious diseases caused by viruses, bacteria, fungi, algae, parasites, or other microbial agents spread by people who touch infected objects, by airborne pathogenic transmission, or by other transmission mechanisms.

[0039] As used herein, the term "moisture" refers to and includes water (having the general chemical formula HO), water vapor (water in the form of steam), water vapor (water in its gaseous state also called water vapor that is usually vaporized by boiling or evaporation of water), the vapor of a liquid substance containing water, ambient air (ambient moisture in an environment that contains water molecules or water in gaseous form), water molecules in liquids other than water, and acetone, and / or alcohols, including methanol, ethanol, propanol, butanol or ethylene glycol, and polar solvents, and / or any combination of the foregoing.

[0040] As used herein, the term "monolithic composition" is defined as a material made from one essentially blended or mixed composition of materials such that it is not itself composed of two or more separate macroscopic layers or portions. Thus, a monolithic composition does not include a multi-layer composite, although a monolithic composition may form a layer of such a composite.

[0041] As used herein, the term "phase" is defined as a part or component of a monolithic composition that is uniformly distributed throughout the structure or composition to give it its monolithic character.

[0042] As used herein, the term "polymer composition" is defined as a monolithic material formed from a base polymer having at least a chlorine dioxide gas forming agent, and optionally a channeling agent distributed throughout the base polymer. Thus, polymer compositions include two-phase polymers (without a channeling agent) and three-phase polymers (with a channeling agent).

[0043] As used herein, the term "three-phase" is defined as a monolithic composition or structure that includes three or more phases. An example of a three-phase composition according to any embodiment of the present invention is an entrained polymer formed from a base polymer, a chlorine dioxide gas former, and a channeling agent in an amount sufficient to form channels. Optionally, the three-phase composition or structure may not include additional compounds (e.g., colorants), but is still considered "three-phase" due to the presence of the three main functional components.

[0044] As used herein, the term "N95" respirator is defined as a respirator that meets the definition of an N95 respirator according to National Institute for Occupational Safety and Health (NIOSH) regulations.

[0045] As used herein, the term "communicatively coupled" is intended to mean that two or more electrical components are connected so that power, information, or both may be exchanged between the coupled components. Polymer Composition

[0046] The chlorine dioxide gas forming agent is a component of the polymer composition, and is preferably a three-phase entrained polymer that includes a chlorine dioxide gas forming agent, a base polymer, and a channeling agent.The polymer composition herein is a three-phase formulation (i.e., includes a base polymer, an active agent, and a channeling agent).Polymer compositions that include an active agent (e.g., a desiccant) other than the entrained chlorine dioxide releasing agent are described, for example, in U.S. Patent Nos. 5,911,937, 6,080,350, 6,124,006, 6,130,263, 6,194,079, 6,214,255, 6,486,231, 7,005,459, and U.S. Patent Publication No.

[0047] No. 2016 / 0039955, each of which is incorporated herein by reference as if fully set forth herein. Entrained polymer compositions containing chlorine dioxide releasing agents are described in International Patent Application PCT / US2019 / 060937 and U.S. Patent Application Publication No. 2019 / 00335746 A1, each of which is incorporated herein by reference in its entirety as if fully set forth herein. Suitable base polymers include thermoplastic polymers, including, but not limited to, polypropylene, polyethylene, polyisoprene, polyhydroxyalkanoates (PHAs), polylactic acid (PLA), polybutylene succinate (PBS), polyhexene, polybutadiene, polybutene, polysiloxane, polycarbonate, polyamide, ethyl vinyl acetate, ethylene-vinyl acetate (EVA) copolymer, and ethylene-methacrylate. Copolymers, polyvinyl, chloride (PVC), polystyrene, polyester, polyanhydride, polyacrylonitrile, polysulfone, polyacrylate, acrylic acid, polyurethane, polyacetal, polyvinylpyrrolidone (PVP), copolymers, and combinations thereof.

[0048] Optionally, in any embodiment, the concentration of the base polymer in the polymer composition is in the range of 10% to 80%, optionally 20% to 70%, optionally 30% to 60%, optionally 40% to 50%, optionally 45% to 65%, optionally 45% to 60%, optionally 45% to 55%, optionally 50% to 70%, optionally 50% to 60%, optionally 55% to 65%, optionally 55% to 60% by weight of the total weight of the polymer composition.

[0049] The polymeric compositions herein preferably incorporate a channeling agent that forms channels between the surface and the interior of the polymeric composition to transmit moisture or gas, absorb or adsorb moisture or gas, and allow the moisture or gas to react with the chlorine dioxide gas forming agent. The channels are formed primarily from the channeling agent itself. The channeling agent used herein has a water vapor transmission rate that is at least twice that of the base polymer. In other embodiments, the channeling agent has a water vapor transmission rate that is at least 5 times that of the base polymer. In other embodiments, the channeling agent has a water vapor transmission rate that is at least 10 times that of the base polymer. In still other embodiments, the channeling agent may have a water vapor transmission rate that is at least 20 times, 50 times, or 100 times that of the base polymer.

[0050] Suitable channeling agents include polyglycols such as polyethylene glycol (PEG), ethylene vinyl alcohol (EVOH), polyvinyl alcohol (PVOH), glycerin polyamines, polyurethanes, and polycarboxylic acids including polyacrylic acid or polymethacrylic acid. Alternatively, the channeling agent can be a water insoluble polymer such as a propylene oxide polymer monobutyl ether, such as, for example, Polyglycol B01 / 240, manufactured by Clariant Specialty Chemicals. In other embodiments, the channeling agent can be a propylene oxide polymer monobutyl ether, such as Polyglycol B01 / 20, manufactured by Clariant Specialty Chemicals, a propylene oxide polymer, such as Polyglycol D01 / 240, manufactured by Clariant Specialty Chemicals, ethylene vinyl acetate, nylon 6, nylon 66, or any combination of the foregoing.

[0051] Optionally, in any embodiment, the concentration of the channeling agent in the polymer composition is in the range of 1% to 25% by weight, optionally 2% to 15% by weight, optionally 5% to 20% by weight, optionally 8% to 15% by weight, optionally 10% to 20% by weight, optionally 10% to 15% by weight, optionally 10% to 12% by weight, optionally 5% to 15% by weight, optionally about 7% by weight of the total weight of the polymer composition.

[0052] Isolation unit and system and method for using same - Patents.com Referring generally to Figures 1-9, the disclosed concept, in one aspect, is a system for sterilizing objects using a self-contained sterilization chamber of an isolation unit. Specifically, a system according to one aspect of the disclosed concept uses a sterilization element disposed within the sterilization chamber, thus making the chamber self-contained, to release a quantity of sterilant, preferably in gas form, into the self-contained sterilization chamber. This allows the system to sterilize objects without the need for an external power source or fluid delivery system to achieve sterilization. Optionally, the moisture used to activate the sterilant is sufficient to generate a desired relative humidity (RH) within the sterilization chamber. A system according to one aspect of the disclosed concept further uses a locking mechanism and a control system to ensure that the self-contained sterilization chamber remains sealed until a predetermined condition is met, as determined by the control system. In some embodiments, the control system includes a timer that instructs the locking mechanism to transition from the locked mechanism to an unlocked configuration after a desired time has elapsed. Preferably, the locking mechanism is a non-lethal device that remains engaged once tripped until the control system determines that a predetermined condition is met. Thus, the locking mechanism is accessed until a predefined condition is met that prevents the self-contained sterilization chamber from being present. Further, the locking mechanism prevents the sterilization chamber from being accessed even after a loss of power or other catastrophic failure. Thus, the disclosed concepts provide a sterilization system that prevents undesired dispersion of sterilant from the self-contained sterilization chamber into the surrounding environment.

[0053] To achieve the above-mentioned functionality, in one aspect, the disclosed concept comprises an isolation unit 1 having at least one hatch 2, at least one locking mechanism 3, at least one HMI device 4, at least one output device 5, and a control system 6. The isolation unit 1 is an enclosure used to perform sterilization operations, and the hatch 2 is coupled to the isolation unit 1 such that a user can access the interior compartment 13 of the isolation unit 1 through the hatch 2. The locking mechanism 3 is operatively coupled between the isolation unit 1 and the hatch 2. This coupling allows the locking mechanism 3 to function as a failed switch to prevent the opening of the hatch 2 once the locking mechanism 3 is engaged. Specifically, the locking mechanism 3 is designed to prevent the interior compartment 13 from being accessed until a predetermined condition is met. This prevents a user from opening the hatch 2 with the locking mechanism 3 engaged. Additionally, the user is not provided with a means to disengage the locking mechanism 3 once engaged. This functionality limits the user's potential exposure to harmful sterilizing agents.

[0054] With reference to FIG. 7, the disclosed concept is designed to provide an automated system for determining when to disengage the locking mechanism 3. Thus, the control system 6 is designed to act as a central processing hub for commands and data and can be any computing device used to direct the operation of the electrical components of the disclosed concept (e.g., a microcontroller, an integrated circuit, a personal computing device, a smartphone, or a tablet computer). Additionally, the control system 6 is designed to provide the control signals necessary to disengage the locking mechanism 3 when a predetermined condition is met. That is, the locking mechanism 3 remains locked until a disengagement signal is received from the control system 6. Furthermore, even a power loss will not forcefully disengage the locking mechanism 3. In some embodiments, an external system 8 (e.g., a remote server, a personal computing device, a smartphone, or a tablet computer) can be communicatively coupled to the control system 6 such that the external system 8 can monitor and control the isolation unit 1. The disclosed concept optionally utilizes an HMI device 4 to allow a user to initiate a sterilization operation and relay commands to the control system 6 (FIG. 7). The HMI device 4 is preferably at least one device selected from the group consisting of buttons, key lock switches, dials, keypads, switches, touch screens, and human input devices. The output device 5 is designed to relay information to the user. Preferably, the output device 5 is at least one member selected from the group consisting of speakers, displays, lamps, indicator lights, vibration motors, heating elements, and touch screens. The HMI device 4 and the output device 5 are optionally mounted laterally on the isolation unit 1. As a result, the HMI device 4 and the output device 5 are advantageously positioned to relay information between the user and the isolation unit 1. The control system 6 is disposed within the isolation unit 1 and is communicatively coupled to the HMI, the lock devices, and the output device 5. As a result, the control system 6 is isolated from hazards in the external environment and can manage the operation of all the electrical components of the disclosed concept.Additionally, the control system 6 can generate commands directing the locking mechanism 3 to be engaged and then disengaged. In some embodiments, the control system 6 is communicatively coupled to a timer 61 (FIG. 7) to determine when the locking mechanism 3 should be disengaged. The timer 61 is designed to track the amount of time that has elapsed between relevant events of the sterilization operation. Optionally, the timer 61 can include a built-in power source 62 (e.g., a battery, generator, or fuel cell) so that the timer 61 continues to function regardless of whether the remaining components of the isolation unit 1 are powered. In some embodiments, the timer 61 includes an internal counter to track the number of power interruptions and power cycles that occur within a given period of time (FIG. 8).

[0055] As seen in FIG. 9, an optional method for using the disclosed concept system to perform a sterilization operation is as follows. The method begins by loading the object to be sterilized into the internal compartment 13 of the isolation unit 1. The sterilization element 7 is then placed into the internal compartment 13. In some embodiments, the sterilization element may be a three-phase entrained polymer composition including a base polymer, a chlorine dioxide releasing agent, and a channeling agent, as described herein. The sterilization element 7 is activated by contact with water, as needed, either immediately before or after placing the sterilization element 7 into the internal compartment 13. Optionally, an automatic activation mechanism is placed into the internal compartment 13 and used to dispense a desired amount of the sterilization element 7 into the internal compartment 13 and then add the amount of fluid required to maintain the chemical reaction. The user then closes the hatch 2 and engages the locking mechanism 3. The sterilization element 7 begins to release the sterilizing agent into the internal compartment 13, preferably the sterilizing agent is a gas, preferably chlorine dioxide gas, to sterilize the object in the internal compartment 13 before it breaks down into benign compounds. The control system 6 then keeps track of time using a timer 61 to determine when it is safe to automatically disengage the locking mechanism 3. Once the control system 6 determines that it is safe to open the hatch 2, a command is sent to the locking mechanism 3 to disengage. A user can then remove sterilized objects from the interior compartment 13 by opening the hatch 2. Optionally, the timer 61 generates a release command if a predetermined time has elapsed.

[0056] In some embodiments, the isolation unit 1 comprises a sterilization chamber 11 and a component enclosure 12, as shown in FIG. 1. The sterilization chamber 11 serves as a housing for the sterilization operation. The hatch 2 is integrated into the sterilization chamber 11. Thus, a user can access the inner compartment 13 of the sterilization chamber 11 through the hatch 2. The component enclosure 12 is a housing for the electrical components of the disclosed concept. Optionally, the component enclosure 12 serves as a primary control panel for the isolation unit 1. Furthermore, the component enclosure 12 may be mounted laterally on the sterilization chamber 11. When so positioned, the component enclosure 12 does not impede the opening and closing of the hatch 2.

[0057] In some embodiments of the disclosed concepts, the HMI device 4 and the output device 5 are mounted on the component enclosure 12 such that the exterior surface of the component enclosure 12 operates as a control panel. Specifically, in some embodiments, the HMI device 4 comprises at least one control button 41 and at least one key lock switch 42 (FIG. 1). The control button 41 allows a user to input commands to the isolation unit, and preferably allows the user to start a timer 61 for the locking mechanism 3 to lock the hatch 2. The key lock switch 42 allows the user to manually reset the number of sterilization operation cycles that the disclosed concepts have recorded. Additionally, in some embodiments, the output device 5 comprises at least one status light 51, at least one first display device 52, and at least one second display device 53. In further embodiments, the at least one status light 51 is a plurality of status lights including a maintenance warning light and a system status light.

[0058] In some embodiments, the component enclosure 12 is a shell or casing that is mounted around the sterilization chamber 11 such that the sterilization chamber 11 is contained within the component enclosure 12. In these embodiments, a hatch 2 is optionally provided with the component enclosure 12 and the sterilization chamber 11 such that access to the interior compartment 13 is governed by opening and closing the hatch 2. Optionally, the hatch 2 is dorsally disposed on the isolation unit 1. The component enclosure 12 optionally includes at least one cooling fan disposed within the component enclosure 12 and communicatively coupled to the control system 6. Additionally, at least one ventrally disposed intake vent and at least one dorsally disposed vent vent are optionally integrated into the component enclosure 12 such that the cooling fans can move air through the component enclosure 12 to maintain the electronic components of the isolation unit 1 at a desired temperature. In any embodiment, the environmental sensor probe is disposed adjacent to the intake vent such that the environmental sensor probe is exposed to unaltered ambient air. The environmental sensor probe is communicatively coupled to the control system 6 such that the user is alerted whenever the ambient conditions (e.g., temperature and relative humidity) are not within predetermined ranges. Optionally, the user is not allowed to initiate a sterilization operation if the ambient conditions are not within predetermined ranges. Optionally, the environmental sensor probe functions as an environmental monitoring system (EMS) that monitors the ambient environment to detect leakage of sterilization gas from the sterilization chamber 11 and alerts the user if an unsafe concentration of sterilization gas is detected.

[0059] Since the sterilant can corrode or erode the materials of the sterilization chamber 11 and the hatch 2, some components may need to be replaced periodically. For example, if the sterilant is chlorine dioxide gas, the gas may degrade the elastomeric gasket that helps seal the hatch 2. Thus, the gasket may need to be replaced after a certain number of sterilization operation cycles. To facilitate timely replacement, the control system 6 tracks the number of sterilization operation cycles the system performs. The control system 6 then instructs the second display device 53 (FIG. 1) to visually output the number of sterilization operation cycles that have occurred since the user last activated the key lock switch 42 to reset the control system's six-cycle counter. If the number of cycles exceeds a maintenance threshold, the control system 6 optionally instructs the maintenance warning light to be turned on. The first display device 52 is optionally used to visually output the time remaining until the locking mechanism 3 is disengaged. In these embodiments, the control buttons 41, key lock switch 42, status light 51, first display 52, and second display 53 are all mounted in the component enclosure 12, which is oriented horizontally, and serve to form a control panel for relaying information between the user and the isolation unit 1.

[0060] The hatch 2 includes a door 22 and an opening 21. The opening 21 leads through the sterilization chamber 11 into the interior compartment 13, and the door 22 is mounted over the opening 21. As a result, the door 22 can prevent or allow access to the interior compartment 13. In some embodiments, as described above, a gasket is mounted around the opening 21 to ensure that the door 22 seals the interior compartment 13 after it is closed. In some embodiments, the sterilization chamber 11 and the hatch 2 are insulated. Optionally, the volume of the interior compartment 13 ranges from 64 cubic inches to 20,736 cubic inches. In one embodiment, the volume of the interior compartment 13 is 3888 cubic inches.

[0061] The locking mechanism 3 is designed to resist release once deployed. To facilitate this, in some embodiments of the disclosed concept, the locking mechanism 3 comprises an engagement device 31 and a receptacle 35. The engagement device 31 is a male protrusion system that engages with the receptacle 35 to lock the hatch 2. The engagement device 31 is attached to the hatch 2, and the receptacle 35 is attached to the sterilization chamber 11. More specifically, the engagement device 31 optionally comprises at least one locking pin 32, at least one biasing device 33, at least one detent 36, and at least one reset lever 34. The biasing device 33 is an actuator that continuously applies a force to the locking pin 32 that drives the locking pin 32 towards and into the receptacle 35. The detent 36 is operatively coupled between the locking pin 32 and the biasing device 33 such that the detent 36 prevents the locking pin 32 from being displaced until it is released. In some embodiments, the detents 36 are released under a command from the control system 6. When the detents 36 are released, the locking pin 32 is engaged in the receptacle 35 to lock the hatch 2 (FIG. 1). The biasing device 33 then provides the necessary force to maintain the locking pin 32 in this locked configuration. The biasing device 33 may be, for example, any component selected from the group consisting of a spring, a pneumatic cylinder, a linear actuator, and a rotary actuator. In further embodiments, when the locking pin 32 is deployed, the detents 36 are re-engaged, ensuring that the locking pin 32 remains engaged in the receptacle 35 until the control system 6 issues an appropriate command. Furthermore, this engagement may be designed to remain in place regardless of the power supplied to the insulation unit 1. A reset lever 34 protrudes from the locking pin 32 and is used to disengage the locking pin 32 from the receptacle 35. This causes the reset lever 34 to reset the detents 36 in an unlocked configuration that allows the locking mechanism 3 to move inward, holding the locking pin 32 in a charged state. In some embodiments, a reset actuator is used to disengage the locking pin 32 from the receptacle 35.In some embodiments, the reset lever 34 is prevented from disengaging the locking pin 32 without first receiving a command from the control system 6 or without another predetermined condition being met (e.g., the expiration of a time window). A portable power source (e.g., solar cell, generator, rechargeable battery) is optionally coupled to the isolation unit 1 to enable the system to function independently of an external power source.

[0062] In an alternative embodiment, the locking mechanism 3 comprises a magnetic lock. Additionally, alternative mechanical locking mechanisms 3 are contemplated as being within the scope of the locking mechanism 3 as that term is used herein. In an additional alternative embodiment, the user has no interaction with the locking mechanism 3. That is, the locking mechanism 3 is integrated between the hatch 2 and the sterilization chamber 11 such that the user does not need to actuate the reset lever 34 to open the hatch 2. Rather, the locking mechanism 3 is engaged or disengaged depending on commands from the control system 6. Additionally, a handle is optionally attached to the hatch 2 to facilitate opening and closing the hatch 2 when the locking mechanism 3 is disengaged.

[0063] As seen in FIG. 4, the disclosed concept is designed to facilitate the performance of a safe and efficient sterilization operation. To facilitate this, an embodiment of the disclosed concept optionally includes an environmental analysis instrumentation suite 16, a rack assembly 14, and an element tray 15. The environmental analysis instrumentation suite 16 is a collection of manipulators and measurement tools designed to monitor the environment within the interior compartment 13. In a supplemental embodiment, the control system 6 uses additional sensor data to determine if a predefined condition is met before disengaging the locking mechanism 3. The rack assembly 14 is mounted within the interior compartment 13 and serves as a mounting system for objects within the interior compartment 13. The element tray 15 is mounted within the interior compartment 13 and serves as a platform for the sterilization elements 7 during the sterilization operation.

[0064] Referring to FIG. 5, the isolation unit 1 may further include an environmental control system including a temperature control system 17 thermally coupled to the internal compartment 13 and a humidity control system 18 in fluid communication with the internal compartment 13. The temperature control system 17 may modify the temperature of the internal compartment 13, which may increase or decrease the temperature to change the characteristics of the chemical reactions occurring within the internal compartment 13 to facilitate completion of the sterilization operation. The humidity control system 18 may modify the relative RH within the internal compartment 13, which may increase or decrease the RH to change the characteristics of the chemical reactions occurring within the internal compartment 13 to facilitate completion of the sterilization operation. Both the temperature control system 17 and the humidity control system 18 are communicatively coupled to the control system 6. In some exemplary non-limiting embodiments, the internal compartment 13 is maintained between 23 degrees Celsius and 60 degrees Celsius during the sterilization operation. In some exemplary non-limiting embodiments, the internal compartment 13 is maintained within an RH of 50%-90% during the sterilization operation. In some exemplary non-limiting embodiments, the RH is limited to a range of 60%-70%.

[0065] Referring to FIG. 6, the isolation unit may further comprise an air purification system 19 in fluid communication with the internal compartment 13 and communicatively coupled to the control system 6. Optionally, the air purification system 19 is a recirculating filtration system that neutralizes or removes contaminants within the internal compartment 13 without discharging the contaminants to the external ambient environment. To facilitate this, the air purification system may comprise a filtration element 191 and a pump 192. In some embodiments, gas within the internal compartment 13 is drawn into the filtration element 191 and then discharged into the internal compartment by the pump once a desired amount of contaminants has been removed by the filtration element. Additionally, locating the filtration element 191 between the internal compartment 13 and the inlet of the pump 192 ensures that components of the pump 192 are not degraded or contaminated by contact with unfiltered gas within the internal compartment 13. In some embodiments, the air purification system 19 is activated after meeting a secondary predetermined condition. The secondary predetermined condition refers to a secondary event that the control system 6 looks for as a trigger to activate the air purification system 19. Optionally, the secondary predetermined condition is a time or an amount of the desired chemical composition in the headspace. The secondary predetermined condition is an event that occurs in addition to the event that satisfies the original (primary) predetermined condition for releasing the locking mechanism 3. Optionally, an emergency shutoff switch is communicatively coupled to the air purification system 19 and the control system 6, whereby a user can activate the air purification system 19 to neutralize the sterilizing element 7 and any sterilizing gas in the headspace. Optionally, the air purification system 19 is automatically activated to neutralize the sterilizing element 7 and any sterilizing gas in the headspace if the internal compartment 13 is breached before the predetermined condition is met. The filtration element 191 may further include an activated carbon component 193 arranged such that gas flowing through the filtration element passes through the activated carbon component 193. The activated carbon component 193 may be a removable cartridge, a refillable hopper, or a combination of the two. Optionally, an access door is integrated into the isolation unit 1 so that the activated carbon component 193 may be extracted or replaced. Optionally, the activated carbon component 193 contains 5 to 25 g of activated carbon.

[0066] The following exemplary embodiments further describe optional aspects of the disclosed technology with reference to FIG. 8 and are part of the detailed description of the present invention. These exemplary embodiments are substantially described in a format similar to claims, but they are not technical claims of this application. The following exemplary embodiments refer to each other in a dependent relationship as "embodiments" rather than "claims." 1. A method for sterilizing an object, comprising: prompting (100) for the hatch door of the isolation unit to be opened; Placing (102) an object to be sterilized in a sterilization chamber in an isolation unit; placing a sterilization element within the sterilization chamber, the sterilization element releasing a sterilization gas within the sterilization chamber (102); closing the hatch to seal the sterilization chamber from the ambient environment outside the isolation unit, thereby allowing the sterilization gas to accumulate within the sterilization chamber without substantially penetrating the ambient environment (104); a step (106) of facilitating initiation of a sterilization cycle and initializing a warning countdown timer; determining whether at least one cycle start condition is satisfied, where if the at least one cycle start condition is satisfied, a cycle countdown timer is initialized (110), and if the cycle start condition is not satisfied, allowing the hatch door to be opened (112); Based on the condition of the hatch door, (i) generating an alarm (116) if the hatch door is not closed before the alarm countdown timer expires, as described above; (ii) facilitating the initiation of a disinfection cycle and expiration of an alarm countdown timer when the hatch door is closed (118), as described above; (iii) executing step (114) if the hatch door is closed and if 110 is executed and the alarm countdown timer expires, as described above; and performing (114) one or more of: determining (120) whether at least one reaction completion condition is satisfied; enabling post-processing after the cycle countdown timer has expired, where at least one first post-processing procedure (124) is performed if at least one reaction completion condition is met and at least one second post-processing procedure (126) is performed if at least one reaction completion condition is not met; Specifying (128) that the sanitization cycle is complete after completion of one or more post-processing steps, including 124 and 126; facilitating the opening of the hatch door (130); facilitating execution of a next disinfection cycle (132); The method according to claim 1, 2. The method of embodiment 1, wherein step (102) is performed whenever it is acceptable to facilitate the performance of a subsequent disinfection cycle. 3. The method of embodiment 1, if the prompt to run a subsequent disinfection cycle is not accepted, closing the door (200); a step (202) of monitoring a power switch, the step (100) being performed when the power switch is not switched off, the step (204) including a locking mechanism being engaged to prevent the hatch from being opened when the power switch is switched off, and a step (206) in which the locking mechanism cannot be disengaged until a predetermined condition is met; determining whether a power cycle occurred due to an unplanned interruption or a planned event, where step (208) is performed if a power cycle did not occur due to an unplanned interruption; determining whether a power cycle occurred before a cycle countdown timer of a previously attempted sanitization cycle whenever a power cycle is determined to have occurred due to an unscheduled interruption, and performing step (100) if a power cycle did not occur before the cycle countdown timer of a previously attempted disinfection cycle expires; determining (212) whether at least one reaction completion condition occurred before the previously attempted sanitization cycle was satisfied whenever the power cycle is determined to have occurred before the cycle countdown timer for the previously attempted sanitization cycle expired; performing step (124) if a cycle countdown timer of a previously attempted sanitization cycle expired while the power was off; (216), restarting the cycle countdown timer for the previously attempted sanitization cycle if the cycle countdown timer has not expired, the previously attempted sanitization cycle subsequently being designated as the sanitization cycle, and upon expiration of the cycle countdown timer, step (124) is performed; determining whether power is resumed before the expiration of the reaction countdown timer, where if power is resumed before the expiration of the reaction countdown timer, step (110) is performed, and if power is not resumed before the expiration of the reaction countdown timer, step (216) is performed; and determining whether power has not been restored before the reaction countdown timer expires, where step (220) is performed if at least one reaction completion indicator became available during the power outage, and step (124) is performed if at least one reaction completion indicator did not become available during the power outage; and The method according to claim 1,

[0067] While the present invention has been described in detail for purposes of illustration based on what are currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is for this purpose only and that the present invention is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it will be understood that the disclosed concepts contemplate, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

[0068] In the claims, reference signs placed between parentheses shall not be interpreted as limiting the scope of the claims. The term "comprising" or "including" does not exclude the presence of elements or steps other than those listed in the claims. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

Claims

1. An isolation unit for sterilizing an object, A housing having an internal compartment including a sterilization chamber, At least one hatch, At least one locking mechanism, At least one human-machine interface (HMI) device, At least one output device, Control system and, It is equipped with, The hatch is coupled to the isolation unit to provide selective access to the sterilization chamber. The locking mechanism is operably coupled to the hatch, and when the locking mechanism is engaged, it functions as a faulty switch to prevent the hatch from opening. The HMI device is mounted on the isolation unit, The output device is mounted on the isolation unit. The control system is located within the isolation unit. The control system is communicatively coupled to the HMI device and the output device, and is configured to transmit a signal that operates to release the locking mechanism only when predetermined conditions are met. Isolation unit.

2. The isolation unit according to claim 1, The housing comprises a component enclosure, The aforementioned component enclosure is mounted on the chamber, The aforementioned component enclosure is positioned offset from the hatch, Isolation unit.

3. The isolation unit according to claim 2, The HMI device is equipped with at least one control button, The control button is mounted on the component enclosure. Isolation unit.

4. The isolation unit according to claim 2, The HMI device is equipped with at least one key lock switch, The key lock switch is mounted laterally on the component enclosure. Isolation unit.

5. The isolation unit according to claim 2, The output device includes at least one status light, The status light is mounted on the component enclosure. Isolation unit.

6. The isolation unit according to claim 2, The output device comprises at least one first display device, The first display device is mounted on the component enclosure. Isolation unit.

7. The isolation unit according to claim 6, The output device comprises at least one second display device, The second display device is mounted on the component enclosure. Isolation unit.

8. The isolation unit according to claim 1, The HMI device comprises one or more touchscreens. Isolation unit.

9. The isolation unit according to claim 1, The output device includes one or more touchscreens, Isolation unit.

10. The isolation unit according to claim 8, Both the HMI device and the output device are equipped with one or more touchscreens. Each of the one or more touchscreens receives user input and generates output. Isolation unit.

11. The isolation unit according to claim 1, The hatch includes an opening and a door, The opening enters the internal compartment through the chamber. The door is mounted above the opening. The locking mechanism is connected between the door and the chamber. Isolation unit.

12. The isolation unit according to claim 1, The locking mechanism includes an engaging device and a receptacle, The engagement device is mounted on the hatch. The receptacle is attached to the chamber, The engaging device selectively engages with the receptacle, thereby preventing the opening from being accessed through the door. Isolation unit.

13. The isolation unit according to claim 12, It comprises at least one locking pin and at least one biasing device, The locking pin is operably coupled to the biasing device, and the biasing device selectively engages the locking pin with the receptacle. Engagement device.

14. The isolation unit according to claim 12, The engagement device comprises at least one reset lever, The reset lever is operably coupled to the biasing device, and the reset lever disengages the lock pin from the receptacle by force. Isolation unit.

15. The isolation unit according to claim 1, Includes environmental analysis instrumentation suite, The environmental analysis instrumentation suite is installed within the internal compartment of the sterilization chamber. Isolation unit.

16. The isolation unit according to claim 15, The microcontroller is communicatively coupled to the locking mechanism and the environmental analysis instrumentation suite. Isolation unit.

17. The isolation unit according to claim 1, Includes a rack assembly that is installed in the internal compartment of the sterilization chamber, Isolation unit.

18. The isolation unit according to claim 1, Includes an element tray installed within the aforementioned internal compartment, Isolation unit.

19. The isolation unit according to claim 18, Includes a sterilization element placed on the element tray, Isolation unit.

20. The isolation unit according to claim 1, Once the aforementioned sterilizing element is activated, it generates chlorine dioxide gas. Isolation unit.

21. The isolation unit according to claim 1, The system includes a temperature control system thermally coupled to the internal compartment, The temperature control system is communicatively coupled to the control unit. Isolation unit.

22. The isolation unit according to claim 1, Includes a humidity control system that is in fluid communication with the aforementioned internal compartment, The humidity control system is communicatively coupled to the control unit. Isolation unit.

23. The isolation unit according to claim 1, The system includes an air purification system that is in fluid communication with the aforementioned internal compartment, The air purification system is connected to the control unit so as to be able to communicate with it. Isolation unit.

24. The isolation unit according to claim 23, The aforementioned air purification system includes a filtration element and a pump, A certain amount of gas from within the internal compartment is drawn into the filtration element, and then, once a desired amount of contaminants has been removed by the filtration element, it is discharged back into the internal compartment by the pump. Isolation unit.

25. The isolation unit according to claim 24, The gas flowing through the aforementioned filtration element passes through the activated carbon component. Isolation unit.

26. The isolation unit according to claim 25, The activated carbon component contains 5 to 25 g of activated carbon. Isolation unit.

27. The isolation unit according to claim 23, The aforementioned filtration element is a recirculation filter. Isolation unit.

28. The isolation unit according to claim 1, A timer equipped with a self-sufficient power supply, and the timer is communicatively coupled to the control system. Isolation unit.

29. A method for sterilizing an object, wherein the method is A step of providing an isolation unit for sterilizing an object, wherein the isolation unit is A housing having an internal compartment equipped with a sterilization chamber, A hatch integrated into the isolation unit to provide selective access to the sterilization chamber, A locking mechanism operably coupled to the hatch, wherein the locking mechanism functions as a faulty switch to prevent the hatch from opening when the locking mechanism is engaged. It is equipped with steps and The steps include placing the object to be sterilized into the sterilization chamber, A step of placing the sterilizing element inside the sterilizing chamber, wherein the sterilizing element releases sterilizing gas from inside the sterilizing chamber. A step of closing a hatch to seal the sterilization chamber from the surrounding environment outside the isolation unit, thereby allowing the sterilization gas to accumulate in the sterilization chamber without substantially penetrating the surrounding environment; A step of engaging the locking mechanism and starting a sterilization cycle to prevent the hatch from being opened, wherein the locking mechanism cannot be disengaged until predetermined conditions are met. A step that enables the object to be sterilized by exposure to the sterilizing gas, wherein the locking mechanism is automatically disengaged upon fulfilling a predetermined condition, the predetermined condition being a period of time, and the locking mechanism cannot be disengaged via an override initiated by the user before the locking mechanism is automatically disengaged. A method that includes this. method.

30. The method according to claim 29, The aforementioned amount of time is tracked by a timer. If power to the isolation unit is lost, when power to the isolation unit is restored, the timer will either continue from where it left off when the power was lost, or the timer will restart and begin tracking time again. The timer cannot be manually reset or overwritten so that the locking mechanism does not function. method

31. The method according to claim 29, The air purification system neutralizes the germicidal gas in the headspace after the secondary predetermined conditions are met. method.

32. The method according to claim 31, The aforementioned secondary predetermined condition is the amount of time. method.

33. The method according to claim 31, The secondary predetermined condition is a desired chemical composition within the headspace, and the headspace is formed from a portion of the internal space not occupied by an object. method.

34. A system for sterilizing objects, Isolation unit and, Sterilizing elements, Locking mechanism, Timer and It is equipped with, The steps include: transporting the object into the sterilization chamber, The steps include: placing the sterilization element inside the sterilization chamber; The steps include initializing the cycle countdown timer and A step of sealing the sterilization chamber using the locking mechanism, wherein the sealing is performed in such a way that the locking mechanism cannot be released until the cycle countdown timer expires. A system that has

35. The isolation unit according to claim 1, The sterilization chamber has a volume of 64 to 20,736 cubic inches. Isolation unit.

36. The isolation unit according to claim 1, The sterilization chamber has a volume of 3888 cubic inches. Isolation unit.

Images