WO2021258182A1

WO2021258182A1 - Core thermal sensor (cts) in bio-sterilization system

Info

Publication number: WO2021258182A1
Application number: PCT/CA2020/050868
Authority: WO
Inventors: Alin A. TANFI; Rania ESSAYYED
Original assignee: Tanfi Alin A
Priority date: 2020-06-22
Filing date: 2020-06-22
Publication date: 2021-12-30

Abstract

This invention of a novel Core Thermal Sensor (CTS) device in bio-sterilization system relates to a multilayer biological sterilization method and apparatus comprising of a novel Core Thermal Sensor (CTS) device, a multi-use double jacket enclosure which incorporates a combination of electromagnetic heat radiation and C-band ultraviolet radiation to sterilize deep into material core and layers. This method and apparatus can be implemented on a wide range of articles including medical equipment. The Core Thermal Sensor (CTS) will ensure in real time a high efficiency and efficacy of the sterilization cycle at a target temperature between 75°C (167°F) and 250°C (482°F) within a period ranging from 15 to 180 minutes. This novel Core Thermal Sensor (CTS) innovation have a wide variety of application in many industries and research that requires noninvasive real time core temperature measurements.

Description

TITLE OF INVENTION: CORE THERMAL SENSOR (CTS) IN BIO-STERILIZATION SYSTEM

TECHNICAL FIELD This invention relates generally to a Core Thermal Sensor (CTS) innovation in a biological sterilization systems particularly, a fixed or potable biological sterilizer combined heat and ultraviolet sterilizer to attain a high Log reduction in inactivating microorganisms such as fungi, bacteria, prions, viruses (including COVID-19) , viroids and spores. The novel Core Thermal Sensor (CTS) innovation introduced here for the first time, controls the sterilization cycle ensuring its efficacy and efficiency. This Core Thermal Sensor (CTS) sensor innovation have a wide range of application in many industries and scientific research that requires such real time core temperature measurements and controls without affecting the processed material and without any invasive manipulation to the material under process or test. BACKGROUND ART During the COVID-19 pandemic in 2020, multiple challenges have faced the public, organizations, first responders, laboratories, and medical teams in sterilization, including but not limited to, daily used articles, face masks, personal protective equipment (PPE), special PVC materials, enveloped correspondence (mail), ID cards medical paper work (medical report), handheld articles, multi-layer fabrics, project files, sealed classified reports, books, mail, medical tools, reports, handheld electronics, special metals, wallets, money, books, and many other material of such category.

In general, to illustrate the challenges, sterilization is performed by using different proven methods, including chemical (gas or liquid), heat, steam or their combination. These processes are commonly known in sterilization industries. However, these sterilization process requires experts’ personal, controlled facilities, special material, dedicated sites and resources. In addition to that, many articles cannot be processed with such technologies, can’t be deployed at site easily, can’t be operated with minimum requirements or resources, have deteriorating or damaging effects on many articles, have high safety risks or long adverse effects on health, and may have impact on the environment. On the other hand, the UV sterilization is well established in disinfection of water, air and surface under certain conditions. Other studies reinforces the limitation of using UV -C light, the research data shows that UV -C light sterilization is adversely impacted by not only the exposure time to the UV -C light source, but also the orientation or angles of the surfaces (shades or direct exposure) to the UV light source, power density and time period exposed.

There is also a growing amount of claims about ozone sterilization despite the fact that it’s widely unacceptable to use ozone in occupied spaces. The EPA published several documents which highlight the risks and dangers of ozone and why it should be avoided. Thorough review of scientific research has shown that at concentrations that do not exceed public health standards, ozone cannot effectively remove viruses, mold, bacteria, or other biological pollutants. In addition, chemicals reacts to ozone resulting in a variety of harmful by-products.

Another important challenge of using UV -C or ozone or its combination is that it is impossible to predict exposure levels in real time without adding a well-designed sensors in place, which in result affect the efficacy and efficiency of the sterilization process as well as the cost price factor.

Sterilizers using UV -C or ozone or heat or its combinations in the prior art may be commercially offered in the markets or well established methodology of sterilization. These sterilizers manufacturer may have conducted testing proving adequate sterilization for their intended purposes, none of these prior art devices or methods have controls or methodology that is adequately to the device or its intended applications that can be used as multilayer or core sterilization apparatus that replaces the conventional sterilization methods.

The recent COVID-19 epidemic in the year 2020 has enforced the needs for a new high grade and efficient multilayer (and or Core) sterilization system controls to expand on the prior art and technologies, and in particular, a system that can efficiently measures/controls the multilayer (and or core) sterilization process, have a broad-spectrum sterilization effects, easily operated, installed, transferred (mobile), adaptable to many applications and overcome the limitations of the prior art. This integrated well measured and controlled technology will have positive impact on sterilization methodology and in many other industrial and research applications worldwide. DISCLOSURE OF THE INVENTION

In accordance with the present invention, there is provided a Core Thermal Sensor (CTS) innovation integrated with a sterilization unit consisting of double jacket enclosure that uses a C band wave length ultra violet radiation and heat radiation to efficiently sterilize deep into articles core and surfaces by inactivating fungi, bacteria, prions, viruses (including COVID-19) , viroids and spores.

The apparatus sterilization process is collectively irradiates and expos heat radiation on articles with germicidal radiation wavelengths (actual at 253.7 to about 255 nm (ozone free)). The invention is not about the enclosure which can be designed as per standardized medical grade material and insulations in any shape, however, it is important to illustrate the inventive concepts and sizes as general as X, Y and Z variables.

The structure has an access opening or door that must be airtight and well insulated as per medical device directives or standards or as per end user special requirements, for our invention, any commercial readymade medical or laboratory grade high precision enclosure type can be used as well for the purpose of integrating our technology as well as any custom made medical grade, double jacket insulated enclosure can be used.

These enclosures can be accessed via air sealed access port or enclosure airtight door to access the interior sterilization enclosure. A double door design is also acceptable as long as it fit the purpose of entering the articles to be sterilized easily. As described before, the enclosure have a quartz shelf s, or hangers or steel mesh shelf s placed either in the central portion of the enclosure or at the sides so that articles can be placed on it.

The two main integrated elements used for sterilization, namely UV -C lamp and heat radiations emitters adapts new methodology in sterilization and are mounted on the interior or behind the interior enclosures surface namely the UV -C lampas and the heat emitters. The UV -C lamps are added and positioned in the inner enclosure to provide the maximum efficiency and power that must achieve the direct surface and air sterilization. It can cover the entire inner enclosure or opposite to each other and or are distributed in certain engineered positions to ensure equal energy distribution on all surfaces and surrounding air.

The shelfs or hangers are positioned in between them to ensure full surface exposure. The heat radiation elements are either placed equally within the interior surface away from the UV -C lamps or directly behind the enclosure.

The articles intended to be sterilized are placed though the door or access port into the shelfs at the interior of the enclosure. The door must be closed after loading the articles or items so the sterilization system can be started.

Once the operator starts the unit by pressing the on button or start key, the UV -C lamps and the heat emitters will be electrically energized.

Once the system starts, in the interior of the enclosure the heat emitters will radiate heat to achieve uniform heat distribution at a preset temperatures ranging from 75°C (167°F) to 250°C (482°F); in parallel, the UV -C will emit UV radiation at 253.7 to about 255 nm with a power density range rate of about 1 w/cm to 80 w/cm and a UV C-band radiation output of about < 2000 pW/cm.

The Core Thermal Sensor (CTS) monitors in real time the core temperature of the articles, the Core Thermal Sensor (CTS) will feed the control system the accurate real time core temperature for each selected method type and will control the time needed to achieve full sterilization process for each cycle. The Core Thermal Sensor (CTS) is also instrumental in achieving active calibration each time the sterilizer works, thus eliminating any major deviation or faulty components. UV -C lamps are also monitors with electronic circuit to ensure high efficiency and reliability at all time.

This combined apparatus approach and methodology as stated in the previous art ensure active sterilization of the enclosure and its articles safely and effectively. In addition no cross contamination can occur as a result of active heat emissions and UV radiations during or after the system use. The dual advantages of such technology enclosed in sealed and airtight enclosure allows extended time exposure of all surface to heat at any time, thus eliminating any cross contamination even in case of power failure or accidental switching off the unit.

Therefore, the purpose of the present invention is to present a novel Core Thermal Sensor (CTS) invention which can be implemented in a wide applications and in this invention to be used in sterilization system apparatus that has none of the disadvantages of prior art.

It is yet another article of the present invention to provide a controlled sterilizer that maximize efficiency and efficacy of the sterilization system without operator supervision.

It is yet another article of the present invention to provide a sterilizer to inactive COVID-19 virus

It is yet another article of the present invention to provide a sterilizer for core articles sterilization, such as laboratory & hospital reports, handheld electronics, special metals, handheld articles, multi layer fabrics, wallets, money, books, project files, sealed classified reports, Protective Personal Equipment, special rubber/PVC materials, enveloped correspondence, ID cards and many other material of such category.

It is yet another article of the present invention to provide a sterilizer that eliminates any pressure requirements of the sterilization system.

It is yet another article of the present invention to provide a sterilizer that greatly reduces the operator supervision or resource requirements of the sterilization system.

It is yet another article of this invention to provide a biological combined sterilizer that is rigid and stable for durable and longtime operations.

It is yet another article of this invention to provide a design and method to monitor and control articles layer and or internal core thermal heat by a Core Thermal Sensor (CTS) invention.

It is yet another article of this invention is that it is flexible to carry on other design embodiments and of being practiced and applied in various ways. While there are several embodiments of the present invention, these embodiment may meet one or several and or its combination in any way possible of the foregoing recited articles. It is not intended that each embodiment and or its combinations will necessarily meet each article objective and or its combination.

Thus, having broadly defined or embodied the more important features of the present invention in order that the detailed description thereof may be better understood, and that the present contribution of the drawings may be better valued, obviously, additional features or functions of the present invention that will be described herein and will form a part of the subject matter of the claims appended to this specification.

In this respect, before explaining at least anyone embodiment of the invention in detail, it is to be understood clearly that the invention is not limited in its application to the details of construction and the arrangements of the components set forth in the following description or illustrated in the drawings. Also it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be described by reference to the specification and the drawings, in which like numerals refer to like elements, and wherein: Figure 1 is a top right front perspective view of the fixed or potable biological heat and ultraviolet sterilizer according to the present invention. Figure 2 is a top left front perspective view of the fixed or potable biological combined heat and ultraviolet sterilizer of Figure 1 with the entrance access port or door open and showing the interior of a device enclosure. Figure 3 is a top right front perspective view of the fixed or portable biological combined heat and ultraviolet sterilizer of Figure 1 with the entrance access port or door removed to further illustrate the construction and integration of the device enclosure and parts.

Figure 4 is a partially transparent left side orthogonal view of the fixed or portable biological sterilizer of Figure 1 illustrating the spatial relationships of heat radiation elements and the UV -C lamps, Core Thermal Sensor, a quartz glass shelf and other parts of the present invention.

Figure 5 is a front perspective view of the fixed or potable biological combined heat and ultraviolet sterilizer of Figure 1 with the entrance access port or door removed and showing the interior of a device enclosure 13 from front.

Figure 6 is a top right front perspective view of the novel Core Thermal Sensor (CTS) according to the present invention.

Figure 7 is a partially transparent right side orthogonal view of novel Core Thermal Sensor of Figure 6 illustrating the construction of the Core Thermal Sensor (CTS) sensor housing and parts of the present invention.

Figure 8 is a partially transparent front cross section orthogonal view of novel Core Thermal Sensor of Figure 6 illustrating the layers of the Core Thermal Sensor in several sandwich layers and parts of the present invention.

Figure 9 is a front perspective view of the novel Core Thermal Sensor (CTS) of Figure 6 according to the present invention.

Figure 10 is a partially transparent left side top orthogonal view of novel Core Thermal Sensor of Figure 6 illustrating the construction of the Core Thermal Sensor (CTS) sensor housing and parts of the present invention.

Figure 11 is a top view of novel Core Thermal Sensor of Figure 6 illustrating the Core Thermal Sensor (CTS) sensor housing and its connection from top view of the present invention. Figure 12 is a block diagram of one preferred embodiment of the present invention.

Figure 13 is a flow chart depicting a present novel biological sterilization method used to kill or inactivate and destroy any biological organisms on or within contaminated articles being sterilized. The drawings are not to scale, in fact, some aspects have been emphasized for a better illustration and understanding of the written description.

BEST MODE FOR CARRYING OUT THE INVENTION

PARTS LIST A biological sterilized B enclosure housing C control box height

1 power switch

2 emergency stop switch

3 cancel switch

4 control box compartment

5 display

6 entrance or access port or door

7 ceiling of enclosure

8 floor of enclosure

9 front wall of sterilizer

10 access switch or keypad

11 electrical magnetic lock

12 gasket

13 sterilizer enclosure

14 side wall of enclosure

15 quartz glass shelf (to place articles being sterilized)

16 user input interface

17 heat sensors

18 humidity senor

19 core thermal sensor (cts)

20 heat radiation element(s) 21 heat distribution fan

22 UV -C lamp

23 width of enclosure

24 height of enclosure

25 depth of enclosure

26 thickness of isolation

27 buzzer

28 motion sensor

29 cooling device

30 thermal camera

31 level sensor

32 thermal protection switch

33 toxic gas detector

34 access sensor

35 variable frequency heat radiation monitor and power supply

36 UV -C lamp monitor and power supply

37 access electrical magnetic lock control

38 memory

39 backup battery

40 control unit

41 electronic keypad or mechanical lock

42 wireless port

43 control timer

44 network interface

45 chart data recorder

46 step of turning on the device

47 step for checking all components function and turning on or off the heat radiation elements and the UV -C lamps

48 step of checking whether condition met to advance to step of function control of sterilization cycle starts or not

49 step of checking whether duration ends condition are met

50 Step of checking whether condition met to advance to step of sterilization cycle complete

51 step of checking whether condition met to advance to step of sterilization cycle incomplete 52 step of checking whether condition met to advance to step of terminating of sterilization cycle incomplete As stated in prior paragraph, figure 1 which represent the top right front perspective view of the integrated biological sterilizer. Figure 2 which represent the top left front perspective view of the integrated biological sterilizer of Figure 1 with the entrance access port or door open and showing the interior of the integrated sterilization device enclosure. Figure 6 which represent the top right front perspective view of the Core Thermal Sensor (CTS). Figure 7, 8, 9, 10 and Figure 11 which represent the several perspective views of the Core Thermal Sensor (CTS) invention of Figure 6. Figure 7 is a partially transparent left side orthogonal view of novel Core Thermal Sensor of Figure

6 illustrating the construction of the Core Thermal Sensor layers and parts of the present invention. In the embodiment depicted in Figures 7, 8 and 10, showing minimum five layers that embeds high sensitivity temperature sensor (not depicted). The layers can be in any number or order or thickness or sizes and the design is not limited by these factors. In one preferred embodiment the inventions of the core thermal sensor (CTS) is so well designed to be made out of any material or its combinations that simulate that actual material under measurements. For example, layers material can be paper, fibers, and metal, PVC, garments, alloys, liquid, gases or any other form of material or its combinations to achieve an actual core material replication that is under test. This novel measurement methods not only allow us to create simulated measurement method of high accuracy, but also allow us to measure in real time the core temperature of any related material underset.

In the embodiment depicted in Figures 11, each sensor reading from the core thermal sensor (CTS) 19 is measured though IE, 2D, 3C, 4B, 5A. The control board and program adjust the sterilization cycle based on the real time reading of these output.

In the embodiment depicted in Figures 6, the core thermal sensor (CTS) 19 the Core Thermal Sensor (CTS) has a length 91 of 120mm, width 1 IK of 50mm and height 10J of 30mm, however, there is no limitation of the size or design aspect of the core thermal sensor (CTS) 19 as it can be used in

3 any industry or application avoiding invasive insertion of the sensor in the material under process.

We believe strongly that this simple and direct approach of noninvasive thermal measurements

4 provides a revolutionary method’s and applications across and for all industries and scientific research.

5

For the sterilization real time control, the embodiments in figures 7, 8, 9, 10 and Figure 11 represent all several perspective views of the novel Core Thermal Sensor (CTS) 19 invention design intended for this application but not limiting the design or application or implementation of the Core Thermal Sensor (CTS) 19 in any way or form. While its worth mentioning that the housing B or its enclosure 13 design by itself or any embodiments of the housing B and enclosure 13 design, metal works or manufacturing techniques or illustration related to housing B frame and material maybe or are available commercially in many

7 standard medical grade incubators or medical sterilizers or ovens, the housing B and enclosure 13 by itself can either be an aftermarket device solutions or tailored Original Equipment Manufacturer apparatus (OEM) or tailored made apparatus depending on the sterilization requirements. g The integration of the novel core thermal sensor (CST) invention with the heat radiation element(s) and UV -C light in part or in combination within the housing B and enclosure 13 to form a controlled biologic sterilizer that maximize efficiency and efficacy of the sterilization system without operator supervision is the intent of this invention. _g The term Ultraviolet C band is abbreviated as UV -C and used throughout the document.

The UV -C can be produced by any commercially available source as a generally denoted as germicidal lamp which produces UV -C wavelength at 253.7 to about 255 nm (Ozone free).

10 In the embodiment depicted in Figures 1 and 2, an integrated bio-sterilizer A according to the present invention comprises a housing B which forms two compartments, a control box compartment 4 that houses electrical / electronic components and a cooling device and the integrated sterilizer enclosure 13 that is used for the biological sterilization process. The control box compartment 4 houses all the functional and control components of the unit such as a Programmable Logic Controllers, display screen, control board, monitor and sensor boards, interface circuits, access control sensor, buzzer, camera processing and recoding electronic board, electronic chart data recorder, electronic ballasts, buzzer, main electrical switch, emergency switch , cancel switch, operator interface input device, circuit breakers, step motor, cooling fan or platter device, wireless modem, network interface, power supply, wiring and circuit fuses. In the embodiment depicted in Figure 2, the power switch (on-off) 1 affixed on the side of the control box compartment 4 next to the emergency stop switch 2. Once the switch 1 is on, the display 5 will indicate that the unit is operational and will boot up the unit. Alternatively, location of these switches depends on the final design and size of the integrated biological sterilizer to fit the appropriate location selected by the sterilization requirements. In the on state, the power switch 1 energize the control board and all components operably connected to it including any power indicators or buzzer sounds. In the off sate selected by the power switch 1 off position or by pressing emergency stop switch 2, all electrical and electronics components will isolated from the main power source instantly and the unit is turned off. The biological sterilized A in Figure 1 typically receives power through its main supply cored (no depicted) from any AC power source rated 110 v to 240 v AC source or generator or solar panels power or any other main AC sources. It shall be appreciated that other equivalent means of power sources may be suitably employed as long as they provide the rated standard power supply. In the embodiment depicted in Figures 1, the integrated biological sterilizer enclosure 13 and housing A are generally manufactured as a tailored made design in a rectangular double jacket cavity. Generally, this enclosure 13 will be having a ceiling 7, a floor 8 installed opposing to the ceiling 7 and surrounded by three fixed walls 9 and 14, and a movable wall on the detachable access port 6 opposing to wall 9 of the enclosure 13 defining a three-dimensional volume sufficient for exposing the article to electromagnetic thermal heat radiation and directly exposed to UV -C irradiation. The enclosure 13 is preferably design as per medical or laboratory grade rectangular shape design in any size required for the specific use or general use. In specific, most tailored designs enclosures should be made of high quality stainless steel, metal, plastic, glass, insulation material, or other material that is medical grade and made of mirror stainless steel to reflect the electromagnetic and thermal radiation within the enclosure 13, withstand extreme UV radiation and thermal radiation, withstand extreme usage conditions and able to block UV and thermal radiation to outside of the enclosure 13. This includes building the enclosure 13 within a room or container or any space as per application requirements. While the enclosure 13 may also be made in various shapes or material, the exact size or shape is decided at the time of design and implementation and based on article types and sizes as variable X, Y, Z and enclosure 13 as variable XI, Yl, Zl, thus the size of the housing B and the enclosure 13 may vary depending upon the application. In the embodiment depicted in Figure 1, the biological sterilizer typical embodiments may comprise an enclosure volume of any desired size. Access port (or door) 6 to the interior of the enclosure 13 for placing the articles to be sterilized. In the embodiment depicted in Figure 1, the access port 6 have affixed digital lock keypad 10. And or (not depicted) it can be a handle with mechanical lock any size or configuration and is affixed to the entrance access port 6 to facilitate easy opening of access port 6.

In embodiment of Figure 2, the access port 6 is secured using a mechanical latch, solenoid or electric magnetic coil. For ease of description, this side wall 14 provided by the entrance access port 6 or door 6 will be referenced as the front, however, it is to be understood that any side may contain an entrance door or even several walls of the enclosure 13 may feature an entrance access port 6 or door 6.

In embodiment of Figure 2, the outer surface of enclosure 13 opposing access port 6 have a gasket

12. The access port 6 is attached to the enclosure 13 by hinges and secured. The access port 6 is secured by a magnetic lock that is energized to latch to the opposing steel flat edges above the gasket 12 outside of the chamber 13 or by mechanical latch or any other type of locking mechanism that fits away from gasket 12. In embodiment of Figure 2 and 3, provided a shelf 15 formed of quartz glass and or (not depicted) hangers or steel mesh shelf s disposed substantially centrally in the enclosure 13 and/or between the two groups of UV -C lamps on the ceiling 7 and on the floor 8 with the shelf s 15 plane substantially parallel to the ceiling 7 or floor 8. Referring to Figure 4, the shelf 15 is supported by one or more stainless steel holder (not depicted) or other mounting means known in the art. The quartz glass have six or more circular hollowed holes that allows at least 95% transmission of heat follow and more than 70% UV -C radiations when no obstacles are present. Any other type of shelf can be used provided its type and orientation can achieve above art follow and transmission percentage. Any shelf material that hinders or obstruct electromagnetic thermal transfer to below above art values must not be used.

In the embodiment depicted in Figure 2, of this invention access port 6 is integrated with one or combination of a level sensor 31 detecting articles fallibility and size, access sensor 34 detecting access port 6 status (opened or closed), motion sensor 28 detecting any movement within the enclosure 13, a thermal camera 30 recording or monitoring articles within the chamber, and an additional UV -C Lampe 22 to provide additional exposure angle on articles in the enclosure 13. Also not depicted, these devices 31, 34, 28, 30 can be installed in any location within the enclosure 13 or viewing the enclosure 13 though protective glass windows or in any other manner that enables their functionality as a part or in combination.

In the embodiment depicted in Figure 1, on the exterior of the enclosure housing B, on the front wall of control box compartment 4 above the enclosure 13, it is provided visual LCD display 5 , cancel switch 3, and the user input interface 16 as may be required by the final design and implementation. In one embodiment, the user input interface 16 comprises a keypad or a touch display or soft touch keys or buttons for inputting user commands to the control unit 40 to operably the integrated biological sterilizer device. In an embodiment not shown, inside the control box compartment 4 the control board and the programmable logic controller are interconnected with the network cable I/O interface, chart data recorder and wireless communication device or board. These devices are capable of transmitting data from the control board via the display directly, or by network wire or and wirelessly to any peripheral device or from any peripheral device. 3 The embodiment display 5 visually displays any number of gauges, alarms, or any parameter relating to the active sterilization cycle or any status of the device A. In one embodiment, a value is displayed to indicate the current core temperature, digital sterilization time target setting, biological sterilization cycle time or the total usage elapsed time, parameters regarding the components functions, sterilization cycle progress bar, sterilization cycle states, system alarms, sterilization

4 cycle chart data, alarm history, cycle interruption history, power failure, error log, camera output and any other information that can added or programmed to be displayed to aid the operator. The display also provide the operator important information about the preventive maintenance requirements, quick help videos, component health, efficacy statics of the sterilization cycle.

In another embodiment not shown, the core thermal sensor (CTS) invention is connected to the

5 control board providing surface and core thermal variations from core to control software to ensure efficient control of sterilization cycle target time, exposure and the efficacy of the sterilization cycle. The control software based on the CTS input we continue or terminate successfully the sterilization g cycle precisely. It also automatically modifies the targeted sterilization time set by the user to archive efficient sterilization cycle in real time. User can set the time based on standard sterilization protocols for a certain article from 15 to 180 minutes period, however, the CTS will adjust that time and continue the cycle if the sterilization parameters have not been met.

Referring to Figure 3 is a top left front perspective view of the integrated fixed or portable combined thermal heat and ultraviolet biological sterilizer of Figure 1 with the entrance access port 6 removed to further illustrate enclosure 13 and devices and components within the enclosure 13 of Figure 2.

8 In the embodiment depicted in Figure 4 is a partially transparent right side section view of the fixed or portable biological sterilizer of Figure 1 illustrating in two dimensional at least one proposed position of the heat radiation elements 20, UV -C lamps 22, partly hollowed quartz glass shelf 15 and the core thermal sensor (CTS) 19 of the present invention. Installed and integrated clearly inside the interior of the enclosure 13 in such a way that exposure of thermal heat radiation and

9 electromagnetic radiation are uniformly distributed in all directions of the enclosure 13 when its access port or door is tightly closed. In the enclosure 13 we integrated at least four heat radiation elements 20, eleven UV -C lamps 22 that are symmetrically provide calibrated exposure of thermal and electromagnetic radiation uniformly across all directions inside the enclosure 13. However, (not depicted) the total number of the heat radiation elements 20 and the UV -C lamps 22 and other components depicted in figure 4 could be more or less and depends entirely on the size of the enclosure 13 and the required sterilization process to ensure calibrated exposure of thermal and electromagnetic radiation uniformly across all directions inside the enclosure 13 and accurate functionality of other components and sensors.

4 Not limiting the design to any other variables, alignment or any constrains, the symmetrical distribution (not depicted) of the heat radiation elements 20 and the UV -C lamps 22 is based on the actual size of the enclosure 13 width 23, depth 25 and height 24 to achieve maximum exposure power form the heat radiation elements 20 at 75°C (167°F) to 250°C (482°F) and direct UV -C light

^ to deliver power density of about 1 w/cm to 80 w/cm at output of about < 2000 pW/cm at 253.7 to about 255 nm. There is no limit to where all of these components to be installed inside the enclosure 13, either on any surface, walls, roof, floor, access port or any other configuration to achieve optimal power and exposure distribution within the enclosure 13 are met.

6 In this design, the combined emissions power output is measure by several components in the apparatus, namely heat sensors 17, core thermal sensor 19, thermal camera 30, and the UV -C lamp monitor 36 to actively take into account any variation factor in sterilization power and dynamically adjust it.

7 The heat generated as a result of the electromagnetic radiation is scientifically proven biological sterilization method that not only sterilize surfaces but also penetrate deep into article core, thus sterilizes any difficult to reach places such as multi layers material, any size cavities or any place or surface void where microbes, fungi, yeast, viruses and other germs that residue in. g This novel approach of integrating heat radiation elements, UV-C and core thermal sensor Core Thermal Sensor (CTS), as depicted in Figure 2, 4, and 5 provides all directional tight electromagnetic and UV -C radiations. Although not depicted, the orientation and place of any component in particular 19, 20, 22 or any other component of this approach can be in any location, direction and or enveloping the enclosure 13 or and be disposed substantially centrally on the ceiling and parallel to and substantially multiple parts can be spanning the width and or the height of the enclosure 13. This method and apparatus clearly resolve issues related to direct or indirect exposure to sterilization material and is technically capable of monitoring and measuring the core thermal penetration by the Core Thermal Sensor (CTS) 19 achieving high efficacy and efficacy. As well established in literature and international certifying bodies and or federal agencies such as FDA, world health organization, CDC, European Union directives and many others bodies that thermal and UV -C is an effective approach in biological sterilization. In addition, and based on these well-established data and research, most articles can be safely sterilized from any cross contamination. Laboratory or medical specific surgical tools can also be sterilized using our invention provided that full medical sterilization protocols are conducted including preparations and material manufacturer sterilization requirements.

The heat radiation element(s) 20 are designed (not depicted) so that they emit heat at variable frequencies and time intervals, thus providing a broad-spectrum thermal emissions allowing the penetration of articles layers and ensure that efficient thermal transfer within articles is possible. For example, to ensure penetration of several material than may composed of multiple layer such as paper, the thermal diffusivity of copy paper is about 0.08771 (mm2/s), thus the multi frequency approach ensures that thermal electromagnetic waves can easily propagate and excite within the layers and distribute heat equally on all core material surfaces to ensure that the required heat target has been achieved and distributed equally. The Core Thermal Sensor (CTS) 19 measures the actual heat within such material and adjust the sterilization cycle based on material type and thickness to achieve the uniform heat exposure.

Research data on heat inactivation of microorganisms shows that 100% inactivation of Giardia at 70°C within 15 minutes, viruses at 75°C (167°F) within 30 minutes including the SARS-CoV-2 (the virus that causes COVID-19) and so on. The inactivation of microorganisms is also supported by UV -C emissions to cover surrounding air and exposed surfaces, this way the thermal heat and UV -C sterilizing the entire by inactivating bacteria, viruses, fungi, prions, viroids and spores in enclose 13.

The present device and method provides an effective biological sterilization against transmittable diseases or diseases caused by cross contamination and or biosecurity threats or any combination as the sterilization method and apparatus is combining the power of their methods that occur At both 75°C (167°F) and UV -C emissions (253.7 to 255 nm) under the Core Thermal Sensor (CTS) control, thus achieving the maximum efficacy. The biological sterilization device A is effective in killing and or inactivating SARS-CoV-2 (COVID-19), E. histolytica, Helminth eggs, Larvae, cercariae Cryptosporidium, Nematode cysts, E. coli, Salmonella, Shigella, Vibrio cholera, Viruses, Hepatitistis E, Bacterial spores and so on. Another example, the combination of 19, 20, 22 at the programed dosage time (not depicted) in the specification is capable of inactivating microorganisms such as viroids, SARS, AIDS, prion, e- coli and many other Strains of microorganisms or and biological agents.

As a technical example, the present invention kills the SARS-CoV-2 (COVID-19) at 75°C (167°F) for less than 30 minutes direct exposer and UV -C emissions (253.7 to 255 nm) at the same time and direct exposure conditions. Survival time of viruses at 75°C is not less than 30 minutes based on many published studies, for every 10 degrees centigrade rise above 56°C, kill time for this virus for complete inactivation (at least 6 log), gets shorter significantly. Noting that time required Bacterial spores > 100°C. Research has also shown that one can deduce that above 100°C, kill time will be around 15 minutes to 5 minutes at 250°C at core or within the article layers and surface or its combination. In the embodiment depicted in Figure 12 is a preferred block diagram of the present invention.

In the embodiment not depicted and after the power switched on though power switch 1, the control unit is commanded though control unit 40 is provided to control operations of the biological sterilizer A. An emergency stop switch 2 is provided in case of emergency and to assist immediate shut down off all devices instantly at ease. The power switch also can switch off the unit, however the emergency switch can provide additional emergency stop in many different locations, mainly in large sterilization encloses. Access control sensor 34 provides the control unit 40 access port or door 6 status information. This sensor 34 might be a proximity sensor, a normally open normal close switch or any industrial type switch that change status once the port is opened or closed. This sensor 34 will aid the control unit 40 to switch off the heat radiation and UV -C lamps to protect he user. In addition, will calculate how many times the sterilization cycle has been interpreted or not and assist the control unit to calculate the remaining sterilization cycle time. The access sensor 34 will not hinder any other programing operations and will not switch off the unit, all functionality of the apparatus will be accessible and maintained.

The access port 6 in one preferred embodiment is provided with access door lock 42, this might be a mechanical or electronic keypad 42 that provide order to the magnetic lock 37 to keep the access port or door 6 closed or opened (accessible) to avoid any unauthorized interruption of sterilization cycle. The lock will disengage in case of any power shut down or emergency stop of the apparatus.

The control unit 40 will only starts the stylization cycle if access port 6 or door 6 is closed, the magnetic lock 37 is immediately activated once the cycle begins so that the access port or door 6 is securely locked. This preferred locking mechanism or method embodiment is not limited to the above design and can be in any other design or shape. In another preferred embodiment, the apparatus is equipped with humidity sensor 18, thermal camera 42, toxic gas sensor 33, cooling device 29, motion sensors 17, heat distribution device 21, buzzer 27, and a level sensor 31. The cooling device in one preferred embodiment is a cooling fan that maintains cooling conditions to the control box. The humidity sensor 18 provides the control unit 40 all relevant information regarding the enclosure

13 real time humidity reading feedback, the control unit 40 will adjust parameters or terminate the sterilization cycle in accordance to the sterilization protocol programed by the user. The thermal camera 42 provides the operator a visual inspection of the enclosure 13 and provides the control unit 40 a thermal distribution map feedback of the enclouserl3 thermal radiation. The control unit 40 will control the heat distribution device 21 to adjust its performance to ensure heat distribution is at optimal performance. The heat distribution device 21 (not depicted) can be a stainless steel fan, a natural air driven flow or any combination or apparatus that allow uniform control of heat distribution. The toxic gas sensor 33 monitors any toxic fumes generation within the enclosure 13. This toxic gas sensor 33 is connected to the control unit 40 to provide direct reading and real time monitor in case of any fumes has been generated due to the process. There are a wide range of commercial available sensors types that can be connected to the control unit 40, the exact type or types is selected based on material requirements and sterilization protocols without limitation. The level sensor 31 provide the control unit real time information about the thickness size of the articles intended for sterilization, thus the program in correlation with the core thermal sensor 19 adjust the sterilization cycle to achieve efficient sterilization or terminate it due to over size.

The motion sensors 17 is essential in large enclosures sterilizers, it provides control unit with information to shut down the sterilization cycle or not even to start the sterilization cycle if movement is detected within the enclosure 13. There is no limitation of the type, size and location of such sensor to provide maximum protection and safety. The buzzer 27 provides immediate alarm or notification sound to aid the operator response to an event or fault situation. There are no limitation on size or location of such safety device. The thermal protection switch 32 provides immediate shut down of heath in case of overheating or deviation from programed cycle, protecting sterilizer from any overheating scenarios. There is no limitation of the type, size and location of such switch to provide maximum protection and safety. A user Input interface 16 functionally connected to the control unit 40 to enter the required settings or request special information. By way of example and not limitation, the input device is a touch screen, keypad, touch pad, input network computer, input wireless keypad, , an digital phone or input device, wireless device reader and any such devices. The output information from the control unit 40 is displayed through a digital display 5, sound buzzer 27 and through the network wireless 42 or wired interface 44. Display 5 provides all information regarding the system functionality, system settings, parameters, faults, sterilization usage history, entry access data, alarms, sterilization cycle status, and or any other relevant information or its combinations. The wireless port 42 and or the network interface can provide a direct connection to the device and control unit 40 to perform all functions in additions to programing and calibration of the unit. This is a standard IP computer interface protocols to ensure interoperability with any computer base devices or plug and play devices, such as printers, displays, keyboard and mouse.

The heat radiation elements 20 are powered by a variable frequency power supply and monitor board 35. This board 35 communicate the status with the control unit 40 or independently or in combination. These heat radiation elements 20 emitters electromagnetic thermal radiation at different frequency range from 0 to 120 Hz in this embodiment. The frequency range setting is automatically fixed or programed or dynamically set and adjusted by the control unit 40 to achieve best penetration protocols based on the material or articles in the sterilizer enclosure 13. An example parameter in case of failure of components 20, the control unit 40 or 35 send a visual alarm to the display 5 and sound alarm through busser 27 through reading the values of temperature sensor 17 values, current and frequency measurements.

Similarly, the UV -C 20 are powered and operated by ballasts supply and monitor devices board 36. The board is interconnected with the control unit 40 to ensure UV -C 20 operations is monitored and controlled through monitoring the UV -C current load. If UV -C failed, the control unit 40 or 36 send a visual alarm to the display 5 and sound alarm through busser 27 through reading the values of current measurements and or UV -C 20 intensity measurements (not depicted) or in combination. An example current load is monitored by the lamp monitor board 36 is by comparing the variation of the actual electrical current to the optimal specified operational current of the UV -C lamps 22 that is expected to provide maximum peak output power.

In case of any deviation from the preset values is determined, a fault signal is triggered from the UV -C lamp operation monitor and power supply 36 to the control unit 40. Control board 40 and UV -C lamp operation monitor and power supply 36 in combination or and in part are designed to display this fault directly to the buzzer 27 and display 5.

In one embodiment, all control unit 40 values, faults and settings are communicated through wireless 42 or wired 44 network adaptors. These communication protocols are interoperable with any computer servers, laptop devices or any electronic IP electronic based devices. The backup 3 battery 39 is designed to support the memory 38 hold and storage of information in case of power outage, the control unit 40 stores all values, programs, faults or any value related to the operation of the apparatuses for retrieval or command based decision or and any operations needed. The control timer 43 aids the control unit 40 to measure the actual dates and times period for UV -C operation, service interval times/date, sterilization cycle times/dates. The control unit 40 stores all of that time date related information in the memory 38.

4

The memory 38 architecture in one preferred embodiments not depicted is divide into ready only memory section for the main source program, read and write nonvolatile memory section for long term storage of all data including but not limited to device serial number, source code revisions, updates, access port operations, faults readout, actual sterilization cycle data and any other information.

^ These two parts of the memory 38 section in a preferred method can be set on an SD card for easy service and programing. They are only accessible through the input interface 16 or any external device through protected passcodes to avoid any tempering.

6 The nonvolatile memory 38 facilitates many services, tracking functions, help service or perform compliance measures for extended time periods and measure the performance tracking in real time or back dated times period or in combinations.

7

In general, a successfully sterilization cycle can be defined as a cycle in which a complete sterilization preparation and protocols has been met with no error or fault occurring during the entire duration of the sterilization process. g In the present embodiment, to verify successful sterilization cycle (efficiency and efficacy of each sterilization cycle), the novel Core Thermal Sensor (CTS) 19 feedback the actual core temperature of article layers thus the control units 40 actively measuring the sterilization cycle by measuring the targeted core temperature, enclosure 13 temperature, electromagnetic thermal emissions and UV -

9 C output in correlation to the targeted sterilization time period. Other programmable protocols are also possible even for thin material as the core thermal sensor (CTS) 19 has the ability and design to measure temperature at thin surface on its first layer. Combination of such measurement and control allow precise sterilization cycle to be achieved. The current innovation of combining several sterilization and measurement control methods in the embodiment ensures successful implementation and quantification of the sterilization cycle. At the end of a sterilization cycle, the quantification results and sensitive parameters such as core surface temperature values (curves or data points) and chart data recorded information are stored in the memory for archiving or actively displayed or transmission through a network. Not limiting the ability to use other test methods to confirm efficient sterilization cycle, the device can have any laboratory or clinical additional test method to confirm the sterilization cycles. The access magnetic lock can also be programmed no to disengage unless a password is entered as another secure approach to retrieve sterilized articles if required by the operator. Once the cycle ends, the device will automatically indicates a successful sterilization cycle by sound, indicate that on the display 5 and disengage access port electric magnetic lock 37. The sound buzzer 27 can be muted, the displayed information type and type can also be programmed. Figure 13 is a flow chart depicting the present novel biological sterilization method capable to kill or inactivate microorganisms or and biological agents on and within article being sterilized. To perform the sterilization, the article is placed on the shelf or the hanger or the quartz glass shelf 15 through the access port 6 inside the enclosure 13 as depicted in Figure 2 and Figure 5. The entrance access port 6 is then closed. The method runs once a program or sterilization protocol is selected to run by selecting start 46 to start the sterilization cycle. The function control 47 monitors all components and ensures run test for all components prior to ready mode. Once the unit pass functional test all heating elements and UV -C and apparatus parts are switched on to sanitize the enclosure 13 structure and air prior to use.

Once the function control receives the start command to run the sterilization cycle, a duration controller 48 correlate data from the program set values, Core Thermal Sensor (CTS) 19 and other components to ensure duration has been completed on the specified time. 2 The timer receives a predetermined duration and will be started and monitored till duration ends 49 is achieved at the on the specified time. The duration control 48 and function control 47 may adjust the duration time during the sterilization cycle based on the Core Thermal Sensor (CTS) 19 active feedback. Any interruption of the sterilization cycle will prompt the duration ends 49 to recalculate and update the sterilization cycle through control unit 40. If all parameters are met the control unit 40 will end the sterilization cycle.

4 At any time, the cycle can be terminated 52 by cancelling it or by pressing the emergency switch button. The control unit 40 continues to execute the preprogrammed next step. In addition, if function control 47 or duration control 48 detects any fault condition, the decision 51 will terminate sterilization cycle. This is displayed as sterilization failed.

5 The method further comprises step of turning on 46 immediately switch heat elements and the UV -C lamp till Core Thermal Sensor (CTS) 19 achieve a predetermined values and maintain it.

6 Regardless of the initial timer value, the control unit 40 checks whether the timer updated time period has been achieved 49. If the timer period has been achieved, the control unit release the access port 6 to be opened by the user and it displays Sterilization Cycle End massage on display 5 and buzzer 27 sound notification.

7 If any fault is detected by the control unit 40, the system will not clear any massage unless the problem error is been resolved and system can’t be used during this time. If fault occurs during sterilization cycle, the sterilization cycle will be terminated, and error sound alarm will notify user of the situation. The display 5 will display Sterilization Failed massage alongside any error codes or information available. g In one or more recommended methods, especially recommend as a general serialization protocol for medical equipment, in certain aspect, the medical equipment to be sterilized is first rinsed with clean water and sprayed or washed or immersed in a chemical agent sterilizer solution as recommended by the manufacturer or the healthcare setting and local regulations. The medical equipment is then be sterilized by inserting it the enclosure 13 and programmer the sterilizer to the required values. While this disclosure of a Thermal Sensor (CTS) innovation in a fixed or portable biological sterilization system includes particular examples, it is to be understood that the disclosure is not so limited. Numerous modifications, changes, applications, variations, substitutions, and equivalents will occur to those skilled in the art without departing from the spirit and scope of the present disclosure upon a study of the drawings, the specification, and the following claims. It is important, therefore, that the claims be regarded as including such equivalent construction insofar as they do not depart from the spirit and scope of the conception regarded as the present invention. INDUSTRIAL APPLICABILITY

The ability to actively measure surface and core temperature of materials without direct invasive interface with the material under process opens up a new opportunity in measuring and control industries and research. In this invention, the Core Thermal Sensor (CTS) has been used to measure, control and ensures the efficacy of the biological sterilization process using novel combination methods. The apparatus and methods introduced here, is an innovative novel way for a biological broad-spectrum sterilization of articles, including but not limited to face masks, goggles, high durability gloves, daily used articles, containers, reusable items, paperwork, books, mail, medical tools, reports, handheld electronics, special metals, handheld articles, multi-layer fabrics, wallets, money, books, project fries, sealed classified reports, personal protective equipment (PPE), special PVC materials, enveloped correspondence (mail), ID cards and many other material of such category with high degree of efficacy and efficiency. The Core Thermal Sensor (CTS) has been demonstrated in at least one or more embodiment in this innovation to be an effective way for noninvasive measurement tool and efficient control feedback. However, the Core Thermal Sensor (CTS) has a very wide range of industrial and scientific applications that does not limits its applications, usage and measurement method in any field.

Claims

1. A method and apparatus for Core Thermal Sensor in Biological Sterilization System which is comprising of:

(a) tailored made medical grade enclosure that is tailored designed (X : length, Y : hight, Z: depth) and built to fit the size of article or application intended for sterilization;

(b) multiuse double jacket insulated enclosure (tailored dimensions) with an airtight double layer insulated access door, wherein the enclosure has one or more hangers, shelves or stainless steel mesh racks;

(c) an Integrated UV lamps emitting C-band radiation (Ozone free);

(d) variable frequency controlled heat radiation elements or and any type of heat emitters sources;

(f) one or more Core Thermal Sensor (CTS) device invention that consist of multilayer core thermal sensor design , one or more precision temperature air and surface temperature sensor contained in a novel sensor special design housing to control the efficacy and efficiency of the bio-sterilization process and or any other processes;

(g) continuously exposing enclosure air and surfaces to UV C-band radiation at a power density range rate of about 1 w/cm to 80 w/cm and a UV C-band radiation of about < 2000 pW/cm;

(e) exposing enclosure articles with induced temperature emissions ranging from 75°C (167°F) to 250°C (482°F) for a time period between 15 to 180 minutes; h) have a adequate UV -C fault and intensity sensor

2. The method of claim 1, wherein one or more interior surfaces of said enclosure are medical grade material sealed together to form a sealed unit in any tailored made design.

3. The method of claim 1 or 2, wherein said high efficiency, high quality UV C-band radiation tubes with emission peak (monochromatic) at from about 253.7 to about 255 nm (ozone free).

4. The method of any one of claims 1 to 3, wherein said heat is emitted at different wavelength and ripples to achieve efficient thermal multilayer penetration for wide range of materials.

5. The method of any one of claims 1 to 4, wherein the one or more compartments with composed of hangers, stainless steel vertical dividers, quartz, stainless steel mesh racks or wherein to allows emission pass at least 65% and higher of the UV C-band radiation.

6. The method of any one of claims 1 to 5, wherein the one or more components emits thermal wide spectral emissions at about 80% to 100% thermal heat pass.

7. The method of any one of claims 1 to 6, wherein the one or more components are installed internally around the inner surfaces, or at the top and bottom surface or at the middle of inner enclosure or any combinations in the inner chamber as UV C-band lamps.

8. The method of any one of claims 1 to 7, wherein the one or more components are installed internally around the inner surfaces, or at the top and bottom surface or at the middle of inner enclosure or any combinations in the inner chamber as heat emitters.

9. The method of any one of claims 1 to 8, wherein the one or more components are installed internally behind the inner surfaces, or behind the top or bottom surface or behind the middle of inner enclosure or any combinations in behind inner chamber as a variable frequency heat emitters lamps or any other heat emitters sources.

10. The method of any one of claims 1 to 9, wherein the one or more components are installed in or at the inner enclosure at any location in the inner chamber as Core Thermal Sensor (CTS).

11. The method and apparatus of any one of claims 1 to 10, wherein the Core Thermal Sensor (CTS) device controls the efficacy and efficiency of the sterilization cycle.

12. The enclosure as claimed in any one of the preceding claims formed of austenitic type series AISI 304 and/or AISI 316L grade stainless steel material capable of withstanding internal temperatures of at least 300 degrees Celsius for at least 400 minutes.

13. The method of any one of claims 1 to 12, wherein the exposing of step (c) or step (d) or both occurs for more than 15 minute.

14. The method of any one of claims 1 to 13, wherein the exposing steps occur for 15 to 180 minutes.

15. The method of any one of claims 1 to 14, further comprising of sterilization cycle electronic controller to manage sterilization efficacy and efficiency.

16. The method of any one of claims 1 to 15, wherein the UV C-band emitters sterilizes the articles exposed surfaces and surrounding air.

17. The method of any one of claims 1 to 16, further comprising of and providing a UV C-band electronic monitor or test strips or both.

18. The method of any one of claims 1 to 17, wherein the material is plastic, metal, conductive cables, semiconductor materials, thermal insulators, and or stainless steel.

19. The method of any one of claims 1 to 18, wherein one or more items within the chamber are composed of insulation material.

20. The method of any one of claims 1 to 19, wherein the chamber is composed of a blocking UV radiation windows, and or absorbent material or altogether.

21. The method and apparatus of any one of claims 1 to 20, wherein an adequate UV -C fault and intensity sensor monitors the apparatus UV -C light performance and prevent any operations in case of fault detection if triggered below the set limits.

21. The method and apparatus of any one of claims 1 to 21, wherein the integrated apparatus archives 99.99% biological sterilization into articles