Equipment and process for sterilizing objects

Abstract

The present invention concerns a new equipment and process for the sterilization at cold or at room temperature of objects or instruments of different nature and extraction.

Description

[0001] Angiover S.r.l.

[0002] Description of the Industrial Invention Patent entitled:

[0003] “EQUIPMENT AND PROCESS FOR STERILIZING OBJECTS”

[0004] Designated Inventor: DR. Andrea Preto

[0005] TECHNICAL FIELD OF THE INVENTION

[0006] The present invention concerns a new equipment and process for the sterilization at cold or at room temperature (< 45 °C) of objects or instruments of different nature and extraction, including "critical" invasive medical devices according to the Spaulding classification", which among one patient and the other need to be sterilized and the semi- critical devices which also include the thermosensitive endoscopes.

[0007] This equipment allows these devices to be kept sterile over time until their next use. As such it can also be used to sterilize and keep sterile water of any origin.

[0008] STATE OF TECHNIQUES

[0009] Sterilization must be seen as the result of a process, which, thanks to the advancement of technology, tends to guarantee the condition in which the survival of microorganisms is highly unlikely. A population of objects is considered sterile if one in a million or more objects is contaminated.

[0010] A material is defined as sterile if the SAL (safe sterility level) is less than 10-6, i.e. when the probability of finding a microorganism in it is less than one in a million.

[0011] Pursuant to the law, every article belonging to Category 1 (Critical Articles) which includes all instruments and objects introduced into the blood or into normally sterile areas of the body, or which meet skin and mucous membranes that are not intact, require the sterility requirement.

[0012] This applies to both surgical and diagnostic and therapeutic activities, including administration sets, syringes, drainage tubes, parenteral solutions, surgical gloves, angiography catheters and all secondary instruments, drapes, gowns that enter the operating field.

[0013] Current methods of sterilizing objects and in particular critical medical-surgical instruments, such as scalpels, scissors, and other steel instruments, require the use of physical and chemical methods.

[0014] Sterilization methods adopted in healthcare include:

[0015] - steam sterilization;

[0016] - ethylene oxide (ETO);

[0017] - plasma gas with hydrogen peroxide;

[0018] - formaldehyde vapour;

[0019] - high level disinfection with peracetic acid;

[0020] - dry heat (now out of use).

[0021] Steam sterilization or rather sterilization with a steam autoclave, which is the most used for non-thermosensitive medical- surgical instruments, is a proven process for killing microorganisms, which occurs using moist heat, that is steam saturated introduced under pressure. Heat, as can be imagined, damages the cellular structures of these microorganisms (even particularly resistant ones such as bacterial spores), including the cytoplasmic membrane, making them effectively non-viable.

[0022] The entire sterilization process carried out with moist heat (high temperature steam) as described above is a process that requires a lot of electricity and therefore has an extremely impact on public and private healthcare spending.

[0023] In the sterilization process with a steam autoclave, the critical values to be kept under control and recorded to verify complete compliance are the operating temperature, the steam overpressure, and the time.

[0024] As regards sterilization with ethylene oxide or (ETO), it is mainly used in the industrial sector given its danger, since it is an explosive and flammable gas. ETO is included in the toxic gas legislation.

[0025] Ethylene oxide has the characteristic of impregnating treated objects for a long time, so to avoid damage to the body, before using these objects it is necessary to store them in ventilated environments or in ventilated cabinets until the sterilant has been eliminated.

[0026] The contraindications of this method are related to the cost and its toxicity, the long sterilization and aeration times, the need for installation in an appropriate room for intervention by personnel with a license for the handling of toxic gases. Furthermore, the same method must be reserved for all those sterilizable materials that meet the compatibility requirements and it is not possible to re-sterilize materials previously processed with gamma rays (formation of ethylene chlorine).

[0027] With reference instead to sterilization with hydrogen peroxide, the latter can be used in the form of plasma gas or steam. With this method it is possible to treat plastic materials, metals, optical fibres, electronic components, and very delicate instruments (microsurgery), but materials capable of absorbing peroxide cannot be used, such as cellulose (paper and cloth), liquids and dust.

[0028] This represents one of the most advanced techniques for sterilization, which involves the possibility of preserving sterility for up to 12 months.

[0029] As for formaldehyde, it has been used in the past as a chemical sterilant, but its use has been severely limited by law as it has shown signs of being carcinogenic.

[0030] Another chemical medium used for sterilization is peracetic acid which is a powerful oxidizing agent. This characteristic allows it to have antimicrobial properties comparable to that of saturated steam even at minimal concentrations. Furthermore, the degradation products are not toxic and dissolve easily in water.

[0031] This system is elective, for example, for all instruments used in the endoscopic field (flexible endoscopes) for which high-level disinfection is required between one use and another.

[0032] This procedure cannot be considered a real sterilization since the application of the liquid peracetic acid, both manual by immersion in a tray and automated with recirculation in an endoscope washing machine (Washer Disinfector), involves contact with the liquid solution for a given contact time, such as 10 minutes at 0.15% w / w, even at room temperature and the subsequent removal of the liquid disinfectant by rinsing with water, which although filtered is never completely sterile.

[0033] Furthermore, the exposure of the reprocessed objects or instruments to ambient air, at the end of the cycle, represents a further critical element of the process as it subjects the object to recontamination by the microorganisms present in the air.

[0034] With dry heat, sterilization occurs through contact of the object with hot air (with a dry stove or Pasteur oven) which acts by oxidation of the cellular components. On average, for complete sterilization it is necessary to reach a temperature of 160°C for one hour or 180°C for 30 minutes. To these times must then be added the heating and cooling times which lead to a cycle of 180-240 minutes.

[0035] This is a technique now in disuse and supplanted by steam sterilization, having the disadvantage, due to the very high temperatures, of not being able to use many heatsensitive materials. In addition to the shortcoming of such a long time for a sterilization routine, there is the impossibility of verifying that sterilization has taken place and that the result achieved is maintained over time until it is used (impossibility of packaging). In any case, sterilization in an autoclave, with ethylene oxide, plasma gas and peracetic acid is only the final phase of the entire reprocessing procedure of reusable objects or instruments, which necessarily requires previous mandatory steps to also guarantee effectiveness, of the last one.

[0036] These previous steps or phases are:

[0037] - decontamination of instruments;

[0038] - wash;

[0039] - control of instruments;

[0040] - packaging;

[0041] - labelling and traceability of instruments.

[0042] - loading of instruments to be processed;

[0043] - sterilization cycle.

[0044] For each of the phases preceding autoclave sterilization, over time we have moved from a manual approach to an increasingly automated one that is decidedly more effective and efficient.

[0045] Various models of such equipment are now present on the world market which perform both decontamination with the dilution of a concentrated decontaminant, washing with the addition of a concentrated liquid detergent and high-level disinfection of endoscopic instrumentation. Most of them use concentrated peracetic acid as a high-level disinfectant (for example at 5%, 15% and 35%) which, when suitably diluted in the immersion tank, gives rise to a ready-to-use solution with low concentrations of active ingredient. This solution, for a short contact time, can break down at room temperature the same microbial load that breaks down saturated steam in the autoclave in a standard sterilization cycle. On the chemical-physical and microbiological characteristics of peracetic acid and hydrogen peroxide, as well as their strengths and weaknesses in this field of application, please refer to the description of patent EP2388246B1.

[0046] The only substantial difference between the autoclave cycle and the room temperature cycle with peracetic acid is that in the former, following degassing and cooling, the steam disappears from the bags or boxes containing the instruments. However, to remove peracetic acid from the surface of the instruments, rinsing with sterile water is necessary. Furthermore, at the end of the cycle, the sterilized and rinsed objects or instruments must be kept for the pre-established storage time in an aseptic environment, which means that its container must not be opened or meet external air filled with different microorganisms. Despite the mains water pre-treatment and filtration system provided in the various models of these machines, the sterility of the rinse water is never guaranteed. Furthermore, almost all models of endoscope washing machines include the opening of the washing and disinfection chamber at the end of the cycle for the removal of the instrument and its repositioning and storage in closed cabinets equipped with recirculation of filtered air.

[0047] PURPOSES OF THE INVENTION

[0048] One of the purposes of the present invention is to provide a new equipment for the sterilization and sterile conservation of objects or instruments, in particular for healthcare use.

[0049] Another object of the present invention is to provide a new equipment for the sterilization and sterile preservation of objects or instruments which is harmless to human health.

[0050] Another purpose of the present invention is to provide a new equipment for sterilizing objects or instruments with an increased biocidal potential compared to the solutions proposed so far.

[0051] Another purpose of the present invention is to provide a new equipment for sterilizing objects or instruments which guarantees savings in terms of energy compared to traditional equipment.

[0052] Another object of the present invention is to provide a new equipment for sterilizing objects or instruments which does not require dangerous gases for its use.

[0053] Another object of the present invention is to provide a new equipment for sterilizing objects or instruments which does not require the use of accessories, such as bags, cassettes with filters or other for the containment or conservation of the objects or instruments, nor clearly of the phases associated with them.

[0054] Another object of the present invention is to provide a new equipment for sterilizing objects or instruments which entails significant time savings for each sterilization cycle compared to what has been proposed so far.

[0055] In accordance with one aspect of the invention, an equipment according to claim 1 is provided.

[0056] In accordance with another aspect of the invention, a method according to claim 19 is provided.

[0057] The dependent claims refer to preferred and advantageous embodiments of the invention.

[0058] BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Other characteristics and advantages of the invention will be more evident from the description of examples of the implementation of an equipment, illustrated by way of example in the attached drawings in which:

[0060] - figures 1 and 2 schematically illustrate respective examples of implementation of equipment according to the present invention,

[0061] - figures 3 and 4 schematically illustrate a first example of the creation of a casing component for an equipment according to the present invention,

[0062] - figures 5 and 6 schematically illustrate a second example of realization of a casing component for an equipment according to the present invention, - figures 7 and 8 schematically illustrate a third example of the creation of a casing component for an equipment according to the present invention,

[0063] - figures 9 to 12 show operating diagrams underlying the present invention,

[0064] - figure 13 schematically illustrates a fourth example of realization of a casing component for an equipment according to the present invention.

[0065] In the attached drawings, identical parts or components are identified by the same reference numbers.

[0066] EXAMPLES OF IMPLEMENTATION OF THE INVENTION

[0067] With reference to the attached figures, an equipment for the sterilization and sterile conservation 1 of objects has been illustrated, preferably cold, i.e. without heating and / or at room temperature or slightly above (< 45 °C) in order to guarantee the treatment, among other things, thermosensitive instruments, which equipment internally delimits at least one RC chamber which can be hermetically closed by means of a special door or wall or closing / opening component, optionally with the interposition of one or more gaskets, including safety ones.

[0068] In this description, the expression "hermetically sealable" means that following the closure of the RC chamber, it is isolated or not connected to the air outside it, or, alternatively, is connected to it solely by means of one or more vents. These vents may be equipped with filters, for example absolute filters capable of retaining microorganisms, like those currently used in sterilization boxes. The vents would clearly have the function of allowing the exit of air when filling the RC chamber with specific liquids and the entry of air when it is emptied of liquids.

[0069] The equipment 1 comprises a main body or frame la, which can be configured in any suitable way, for example as a piece of furniture, for example parallelepiped or not.

[0070] This equipment 1 is designed to reprocess and sterilize objects or instruments of different nature and extraction, including administration sets, syringes, drainage tubes, surgical gloves, angiography catheters and all secondary instruments, drapes, gowns that enter the operating field or invasive medical devices "critical according to the Spaulding classification", which need to be sterilized between one patient and another, or semi- critical devices which also include thermosensitive endoscopes.

[0071] The equipment 1 in the RC chamber also includes at least one photocatalyst component, for example in the form of a coating layer, for example from 1 nanometre to 100 microns thick on all or part of its internal surface and / or particle dispersion crystalline particles measuring nanometres inside a membrane permeable to liquids and / or vapours (this depends in particular on the state of the oxidizing compound) and impermeable to the crystalline particles of the photo-catalyst component 3a (illustrated in figures for illustrative purposes only and not limiting) as well as at least one lamp 4 emitting near ultraviolet (UVA) radiation on the photo-catalyst component 3a.

[0072] Preferably, the photocatalyst component 3 a includes an element selected from zinc oxide, cerium oxide, zirconium oxide, tin oxide, cadmium and zinc sulphide, titanium oxide, for example as titanium dioxide (TiO2) or combinations thereof; Even more preferably, the photo-catalyst component 3a comprises titanium dioxide in the anatase crystalline form alone or with its crystals combined with nickel, copper, silver, gold, and rhodium. According to a less preferred alternative, titanium dioxide in the rutilium and / or brookite crystalline form is provided, if desired also with titanium dioxide in the anatase crystalline form.

[0073] If desired, at least one layer of photo-catalyst 3a covers the surface in whole or in part, if desired, between 10% and 100%, for example between 50% and 100% or between 80% and 100%. internal of one, some or all the walls of the equipment or of one of its components delimiting the RC chamber.

[0074] Preferably, the at least one layer of photo-catalyst 3a has suitable porosity, for example of a few nanometres, to allow the entry into it of the humidity, necessary for triggering the photo-catalysis reaction.

[0075] With reference to the at least one lamp 4, it is designed to emit radiation if desired < than 400 nm, preferably < than 385 nm.

[0076] If desired, at least one lamp 4 is a medium or low mercury vapor lamp, or a mercury amalgam lamp, a LED lamp or a similar or equivalent lamp emitting near ultraviolet radiation. Advantageously, two or more are provided, for example any internal number between two and ten or more lamps 4. According to the non-limiting embodiments illustrated in figures 3 to 6, six lamps 4 are provided, each mounted in any suitable way, for example, on a respective delimiting wall of the RC reaction chamber or supported by a specific support element or component.

[0077] The equipment 1 then comprises a container of at least one oxidising or sterilizing compound, preferably chemical and operating or cold acting (in the sense indicated several times here) in fluid communication with the RC chamber, or has means for placing it in fluid communication fluid with such container or with a source of such compound, such as one or more openings for supplying SO and / or exhausting or emptying DO in / from the RC chamber of the oxidizing or sterilizing compound taken from the container or source of such compound, if desired served by one or more specific ducts with a specific circuit, for example integrated into the equipment or one of its components. Such opening(s) can naturally be intercepted by special valves.

[0078] In this case, pumps would clearly also be provided to push the oxidizing or sterilizing compound into these ducts and there could also be special flow meters to measure the quantity.

[0079] The oxidizing or sterilizing compound is preferably based on peracetic acid or hydrogen peroxide.

[0080] The at least one oxidizing or sterilizing compound can be in the state or in the form of liquid, vapor, gas and / or mist (micronized particles) generated for example at room temperature by any means, such as for example a sonicator. In the present description, reference will mainly be made to a liquid oxidizer or sterilizer. But it is clarified that the scope of protection of the present invention also extends to solutions where instead of a liquid, an oxidizing or sterilizing gas, vapor or mist is envisaged. Without having to repeat every time the liquid can be replaced by the latter.

[0081] Peracetic acid can be obtained with any suitable method, including in particular an extemporaneous preparation system by mixing two components, such as for example the one described in EP2388246B 1.

[0082] Preferably, the equipment 1 includes at least one measuring instrument, such as for example a potentiometer 5 or other suitable dosing and measuring instrument for measuring (direct or indirect) and possibly recording the concentration of the oxidizing or sterilizing liquid in the container from which it is taken into the RC reaction chamber and / or into the equipment or any preparation chamber of the sterilizing concentrated liquid, which will be discussed in more detail later.

[0083] This measuring instrument could be provided in correspondence with at least one SO supply and DO discharge opening or in any case inside the sampling container and / or the reaction and / or preparation chamber of the concentrated sterilizing liquid so as to remain immersed in the sterilizing or rinsing liquid solution.

[0084] If desired, the equipment 1 is also provided with a dilution or rinsing circuit in fluid communication with the RC chamber, which circuit is designed to feed a specific rinsing liquid, such as water into the RC chamber.

[0085] In this case, the equipment could advantageously include a tank of dilution or rinsing liquid defining a second chamber, like the RC chamber, in which this liquid, which serves both for the dilution of the chemical disinfectant or sterilant and for the final rinse, is sterilized or pre- sterilized by sterilization means, for example in a similar way as described above. That is, by lighting with lamps that emit UVA radiation integrated in the dilution or rinsing liquid tank and with a photo-catalyst component (for example with internal walls coated with titanium dioxide or titanium dispersed in the form of powder in an air-permeable casing water and not dust) in the second chamber.

[0086] In this case, the dilution or rinse water would remain stable in this second chamber for the necessary time, before being introduced (sterilized) into the RC reaction chamber to rinse the objects and / or instruments.

[0087] With reference to this aspect, this water, being drinkable, already has a low content of microorganisms, but to maintain the sterility of the instruments reprocessed with the chemical ingredient (e.g. peracetic acid), the rinsing water needs to be free of any microorganisms. That is, sterile, just as any drops of this water should stagnate in the reaction chamber, they remain sterile thanks to the continuous lighting and therefore the entire internal environment as well as the instruments remain sterile until the drawer is opened. Advantageously, the equipment 1 is also provided with at least one basket component 6 designed to contain the objects to be sterilized, which is mounted or suspended or hooked inside the RC chamber, so that the oxidizing or sterilizing liquid can encounter all the surfaces of the objects contained or suspended in the basket component.

[0088] The basket component 6 can have any suitable configuration, but is preferably open and / or with walls, for example, grid-like or delimiting one or more openings or holes to connect the outside and inside of the basket.

[0089] The equipment 1 can include at least one main casing component 7 (two or three according to the non-limiting examples of figures 1 and 2) delimiting the RC chamber, which main casing component 7 includes the photo-catalyst component 3a, 1 at least one lamp 4 and, if provided, the basket 6. Naturally, the at least one supply opening SO and / or exhaust opening DO flows into the RC chamber defined by the casing component 7.

[0090] The casing component 7 can be permanently arranged (unless the fastening means, such as screws, bolts, etc. are dismantled) in a specific area or zone defined by the equipment 1 or can only be placed or hooked into a specific area or internal zone of the equipment 1 and, in particular in this case, it can be extracted from the equipment 1, after opening a specific door 2a or extraction / insertion component 2b, if desired by means of release or disconnection, preferably rapid, of specific coupling means or connection.

[0091] Especially in the second case, the casing component 7 advantageously includes an electrical power supply module or component of at least one lamp 4, so that it is possible to transport the main casing component 7 with the respective lamp or lamps 4 powered by the module or component power supply outside the equipment and close to the points of use of the sterilized objects.

[0092] The casing component 7 can be in the form of a drawer or box, which, as mentioned, can preferably be removed, and reinserted into / from the equipment 1 or from a respective housing area or zone.

[0093] With reference to this aspect, to extract a casing component 7 from the equipment, any interlocking ducts of the supply opening(s) SO and / or exhaust or emptying DO should be disconnected, as well as any other liquid supply ducts and electrical power cables. This could clearly be done manually or even by providing automatic interconnections, both ducts and of the electrical connections.

[0094] The RC chamber is completely hermetic, i.e. isolated from the external environment or at least from the external ambient air with which it can only communicate through vent holes preferably equipped with filters, if desired absolute (for example < 0.2 micron) capable of retaining microbes, and can be opened / closed using a special door or wall or closing / opening component.

[0095] Naturally, if a drawer-shaped casing component 7 is provided, it, as mentioned, contains at least one lamp 4, the possible basket 6 and, if provided, the door or wall or closing / opening component is an element of this casing component, if desired pivoted or slidably mounted or in any case connected to the other walls of the drawer 7 defining or delimiting the at least one RC reaction chamber.

[0096] According to a variant illustrated in figure 7, the equipment 1 includes at least a membrane 3b of stainless steel or plastic or fabric or polymers resistant to oxidizing agents, permeable to liquids and not to solid particles and in this case the component or layer of photo - the catalyst is stored, in the form of granules or crystals each with a diameter from 0.5 microns to 10 mm or a volume (if not spherical) between 0.065 microns3 and approximately 520 mm3, in a quantity dosed based on the volume of the RC Chamber, internal or on the membrane 3b.

[0097] According to this variant, the photocatalyst can also be provided as a coating on the internal surface of the RC reaction chamber (as indicated above) or on the membrane itself.

[0098] As regards in detail the electrical power supply module or component, the equipment 1 or the casing component 7 could comprise one or more pairs of electrodes 9, 10, in each pair there being one positive electrode and the other negative, placed one at the depth, non-illuminated or external part of the photocatalytic component or photocatalytic layer and the other on the internal or illuminated surface of the photocatalytic component or photocatalytic layer 3 a, so that during the operation of the equipment, the chemical reaction of the photocatalytic component , for example zinc oxide, cerium oxide, zirconium oxide, tin oxide, cadmium sulphide, zinc sulphide, titanium oxide, causes a current flow between such electrodes 9, 10 and therefore supplies electric current components of the equipment 1, for example lamp(s) 4 or other components of equipment 1 or enclosure component 7.

[0099] Alternatively, or, in addition to this, at least one photovoltaic cell 11 is provided which is illuminated by the radiation emitted by at least one lamp 4, which is always responsible for generating electric current to power components of the equipment 1 or a component casing 7.

[0100] Alternatively, or, in addition to this, at least one battery is provided, rechargeable or not, for example rechargeable and also powered by the electrodes 9, 10 and / or the photovoltaic cell 11.

[0101] The equipment 1 or a respective casing component 7 can also include a chronometer 12a and / or thermometer 12b.

[0102] Preferably, the equipment 1 or a respective casing component 7 can include at least two potentiometers or other suitable instruments, one of which 15 acts as a control of the dosage operated by the equipment and of the minimum effective concentration (CME) of the oxidizing forms present in the solution (e.g. H2O2, HOOCOCH3, -OH, -O2-, - O2COCH3) above which the sterilizing effectiveness is guaranteed for a given contact time, while the other 16 acts as a recorder of the concentration of the oxidizing forms over time in solution, in the form of potential, to be reported in the sterilization cycle report. Naturally, the equipment 1 or a respective casing component 7 can also be provided with inlet openings 10 for a specific detergent and / or liquid decontaminant, whether in fluid communication with a respective container 17 of the equipment or not.

[0103] Clearly, the equipment 1 or a respective casing component 7 can also include a control unit designed to appropriately operate and pilot the various components, such as the lamp 4, any valves, electrodes 9, 10, photovoltaic cell, timer, thermometer, potentiometers, etc. Thus, for example, the control unit is responsible for keeping lamp 4 on throughout the liquid action phase, if the reaction chamber is hermetically closed, starting from the introduction of the objects. Preferably, the control unit is designed to turn off the lamp 4 only when or not before the reaction chamber RC is opened to remove the objects or instruments inside it.

[0104] If desired, the control unit, during the sterilization process of the first objects or instruments, is responsible for recording, in a specific memory section, the significant parameters (temperature, time, etc.) of each treatment phase, so that can then use the recorded parameters to conduct a new sterilization process always of the first objects (after they have been used) or of second objects different from the first ones, although also with a structure / configuration substantially corresponding to the latter, depending on than what was carried out or validated previously during the first treatment of the first objects.

[0105] As will be understood, this guarantees that once parameters have been identified during the various phases of an initial carrying out of the sterilization process, the information acquired can be used to conduct the process again on the same objects or on other objects, preferably similar in structure and / or or materials.

[0106] Naturally, the switching on / off lamp 4 can also be controlled using a specific button or remote control.

[0107] The present invention therefore exploits the biocidal properties of cold chemical sterilant or in any case without the need for heating, such as inorganic (hydrogen peroxide) and organic (peracetic acid) peroxides, whose mechanism of action is based on oxidation and consequent destruction of the various protective structures of microorganisms including those of bacterial spores as well as the destructive action carried out by the moist heat of a steam autoclave, all through simple contact with the liquid solution at room temperature (for example 20-30°C ), at a given concentration of active ingredient and for a given contact time.

[0108] This destructive action is simultaneously enhanced by the photocatalytic properties of the photo-catalytic component, such as one of those indicated above, if desired titanium dioxide (TiO2), which forms a coating layer 3 a of the internal surface of the sterilization chamber and / or the membrane 3b and / or dispersed in the form of solid particles inside a containment membrane, by irradiation with light for example in the near ultraviolet UVA range (absolutely harmless to human health), such as that emitted by medium or medium mercury vapor lamps low pressure, triggers the formation of hydroxyl radicals (-OH) and / or superoxide anions (-O2-) both with high reactivity, a greater oxidation potential compared to undissociated forms and a consequent increased biocidal potential. An equipment according to the present invention is therefore an equipment for sterilizing objects through the combined action of at least one chemical oxidizing or sterilizing liquid, in particular cold with a photocatalytic component.

[0109] With specific reference to titanium dioxide (TiO2), it is known to possess specific structural and photocatalytic characteristics, but the key elements of interest for the present invention will be reported below.

[0110] 1. Mechanism of photocatalytic reactions of titanium dioxide

[0111] 1.1 Semiconductor band structure and band gap energy

[0112] As is known, "valence electrons" are those responsible for the bonding of atoms.

[0113] When there are few atoms, the energy values of the electrons in the orbits are dispersed. However, as the number of bonded atoms increases, the values become continuous within a certain range, rather than being dispersed. This range is referred to as an “energy band”. The area between two energy bands, where there is no electron energy, is referred to as the “band gap”.

[0114] Among the bands filled with electrons, the one with the highest energy level (the orbit of the electron furthest from the nucleus of the respective atom) is referred to as the “valence band”, and the band outside of this is called “conduction band”.

[0115] The energy width of the band gap between the valence band and the conduction band is referred to as the “band gap,” which is a kind of wall that electrons must jump or overcome to become free. The amount of energy needed to jump over that wall is referred to as “band gap energy”.

[0116] Clearly, only electrons that “jump over the wall” and enter the conduction band (which are referred to as “conduction electrons”) can move freely.

[0117] In the case of silicon for example, the band gap energy is about 1.1 eV, which is equal to about 1100 nm when converted to a wavelength of light.

[0118] As for titanium dioxide, if the same is in the crystalline forms rutilium and anatase, irradiated with light of 413 nm or less, or 388 nm or less respectively, the electrons of the valence band shift towards the high conduction band. At the same time, as many "positive holes" are created in a number equal to the electrons that have jumped into the conduction band. 1.2 Energy structure and photo effect of titanium oxide

[0119] In a semiconductor compound made up of different atoms, the processes of valence and conduction band formation are complicated, but the principles involved are the same. Thus, for example, it is known that the valence band of titanium oxide is made up of the 2-p orbital of oxygen (O), while the conduction band is made up of the 3-d orbital of titanium (Ti).

[0120] In a wide band gap semiconductor, electrons in the valence band cannot jump to reach the conduction band.

[0121] However, if energy is applied to such a semiconductor from outside, the electrons in the valence band can jump (this is referred to as “excitation”) into the conduction band. As a result, many electron holes (holes left by electrons moving upwards in the conduction band) as well as an equal number of excited electrons are created in the valence band. This is equivalent to the movement of electrons from the bonding orbital to the antibonding orbital. In other words, the photo-excited state of a semiconductor is generally unstable and can easily break.

[0122] Titanium oxide, on the other hand, remains stable even when photoexcited and this is one of the reasons why titanium oxide is an excellent photocatalyst.

[0123] The following three factors related to the semiconductor band structure have the greatest effect on photocatalytic reactions:

[0124] - gap band energy,

[0125] - position of the lowest point of the conduction band,

[0126] - position of the highest point in the valence band.

[0127] In photocatalytic reactions, the band gap energy mainly determines which wavelength of light is most effective, and the position of the highest point in the valence band is the main determinant of the oxidative decomposition power of the photocatalyst (see Figure 9).

[0128] 1.3 Crystal structures and photocatalytic activity of titanium oxide

[0129] There are three types of titanium oxide crystal structures in nature, namely rutilium, anatase and brookite.

[0130] All three of these types are expressed using the same chemical formula (TiO2), but their crystal structures are different.

[0131] Naturally, if a layer of titanium oxide is subjected to light rays with an energy level higher than that of the gap band, the electrons jump into the conduction band and positive holes are generated in the valence band instead.

[0132] In this regard, although the band gap value is 3.0 eV for rutilium and 3.2 eV for anatase, both absorb only ultraviolet rays, but rutilium can absorb rays slightly closer to visible light rays.

[0133] Since rutilium can absorb light over a wider range, it would seem logical to assume that this crystal is better suited to use as a photocatalyst, but in reality anatase exhibits greater photocatalytic activity, due to the difference in energy structure between the two types of crystalline structures.

[0134] In both types, the position of the valence band is deep, and the resulting positive holes show sufficient oxidizing power, but the conduction band is positioned close to the oxidation-reduction potential of hydrogen, indicating that both types are relatively weak in terms of reducing power. It is known that the conduction band in anatase is closer to the negative position than in rutilium, so the reducing power of anatase is stronger than that of rutilium. Depending on the difference in the position of the conduction band, the anatase type shows an overall higher photocatalytic activity than the rutilium type.

[0135] Preferably therefore the photocatalytic component 3 a comprises titanium dioxide (TiO2) in the crystalline form of anatase alone or with its crystals combined with nickel, copper, silver, gold, and rhodium, but according to a less preferred alternative the dioxide is provided with titanium in the crystalline form rutilium and brookite.

[0136] 1.4 Effect of ultraviolet rays in titanium oxide activation

[0137] Referring, for example, to anatase-type titanium oxide, the respective band gap is 3.2 eV, which is equivalent to a wavelength of 388 nm, whereby the absorption of ultraviolet rays with a wavelength wave lower than this promotes reactions.

[0138] These rays are in the near ultraviolet (UVA) contained in sunlight reaching the earth and emitted by ambient light and have a very limited range of faint light across the sunlight and ambient light spectrums. As will be understood, the development of a visible light photocatalyst can be considered a solution for the sterilization of objects and among this titanium oxide is certainly the most effective.

[0139] In this regard, a semiconductor with a lower band gap than that of titanium oxide undergoes autolysis if it receives light in the presence of water.

[0140] In titanium oxide, however, the absorption of ultraviolet rays with a wavelength of 388 nm or less promotes reactions. However, 254 nm (UVC) rays are known to have a higher energy level, are used in germicidal lamps, and are absorbed by the DNA of living organisms forming pyrimidine dimers, resulting in DNA damage. The titanium oxide photocatalyst does not require ultraviolet rays which have an energy level of 254 nm and which are dangerous for humans. It allows reactions that are initiated by near-ultraviolet rays with relatively high wavelengths contained in sunlight and emitted by fluorescent lamps.

[0141] 1.5 Decomposition power of the titanium dioxide photocatalyst

[0142] When light is absorbed by titanium oxide, two free electrons and two positive holes (h+) are formed. In ordinary substances, electrons and positive holes recombine rapidly, but in the titanium dioxide photocatalyst they recombine more slowly. The recombination percentage has an important effect on the photocatalytic efficiency (see in this regard the electronic structure of titanium dioxide in figure 10).

[0143] One of the main characteristics of titanium oxide is the strong oxidative decomposition power of positive holes, which is greater than the reducing power of electrons excited at the conduction band. Furthermore, the water deposited on the surface of a photo-catalyst, which is referred to as "absorbed water", when oxidized by positive holes, forms hydroxyl radicals (-OH), which have a strong oxidative decomposition power and then react with organic material.

[0144] If oxygen is present when this process occurs, intermediate radicals of organic compounds and oxygen molecules can undergo radical chain reactions. In this case, the organic matter decomposes, eventually becoming carbon dioxide and water. Furthermore, under some conditions, organic compounds can react directly with positive holes, resulting in oxidative decomposition. Meanwhile, the reduction of oxygen in the air occurs because of a coupling reaction.

[0145] Since oxygen is an easily reducible substance, if oxygen is present, oxygen reduction occurs instead of hydrogen generation. The reduction of oxygen results in the generation of superoxide anions (-O2-). Superoxide anions attach to the intermediate product in the oxidative reaction, forming peroxide or transforming into hydrogen peroxide and then into water.

[0146] In relation to this, see the oxidation mechanism in figure 11 and the reduction mechanism in figure 12.

[0147] Since reduction tends to occur more easily in organic matter than in water, when the concentration of organic matter becomes high, the possibility of using positive holes in oxidative reactions with organic matter increases, thus reducing the rate of carrier recombination.

[0148] It is known that, under conditions where positive holes are sufficiently consumed, the process of electron transfer to oxygen molecules on the reduction side determines the rate of the entire photocatalytic reaction. In other words, by allowing easier transfer of electrons to oxygen molecules, the efficiency of photocatalytic reactions can be improved. This can be achieved according to the present invention by allowing titanium oxide to carry a metal as a support.

[0149] Similar considerations apply to other photocatalyst components, such as zinc oxide, cerium oxide, zirconium oxide, tin oxide, cadmium sulfide and zinc sulfide, although titanium dioxide is preferred based on the test results obtained.

[0150] In the context of the present invention, the key parameters that are preferably monitored to ensure the correct repetition of the standard sterilization cycle are:

[0151] - the "oxidation-reduction potential" using a measuring instrument, such as a suitably calibrated potentiometer 16, to verify that the minimum concentration value of all forms of oxidation present in the solution (e.g. H2O2, -OH, -O2-) is constantly exceeded for as long as necessary to achieve the complete elimination of all forms of microbial life = sterilization;

[0152] - time by stopwatch 12a; - the temperature using thermometer 12b.

[0153] Apart from the last two, the first parameter replaces the "steam overpressure" measured with the different pressure switches in the sterilization chamber of the steam or ethylene oxide (ETO) autoclave, since while in the steam and ethylene oxide autoclave respectively ETO it is necessary to guarantee for the entire cycle an overpressure and therefore a heat or ethylene oxide gas equally distributed in all points of the chamber, according to the present invention it is necessary to guarantee maintenance in the sterilizing liquid solution in contact with the objects to be sterilized , a minimum of power which represents an indirect measurement of the minimum concentration of all the oxidative forms present in it.

[0154] It will therefore be understood that the new photochemical sterilization equipment which preferably takes place at room temperature or at a slightly higher temperature (< 45 °C) without the use of dangerous gases, guarantees the same results obtained with both the most widespread sterilization processes in the world today which is "moist heat" and "ethylene oxide", which also with the others seen above, but involves:

[0155] - a significant saving in terms of energy;

[0156] - failure to use dangerous gases such as ETO;

[0157] - failure to use various accessories (envelopes) and respective practices;

[0158] - an important time saving for each sterilization cycle.

[0159] In other words, with the present invention a cold chemical and physical sterilization process (meaning at room temperature) is introduced which:

[0160] - it no longer requires a significant expenditure of energy to heat the water vapor which acts as a heat vehicle to high temperatures;

[0161] - it is safe and harmless to human health.

[0162] - it does not require bagging or arranging the medical devices in the sterilization boxes, but simply their arranging, without particular precautions or provisions in the containment basket 6 suspended in the RC reaction chamber, hermetically closed and internally coated with a layer of component photo-catalyst, such as titanium dioxide or with a membrane of such component or titanium dioxide or with the photo-catalyst component particles suspended within a grid with membrane impermeable to solid particles and permeable to liquids, preferably in the form crystalline anatase, all preferably constantly illuminated by a mercury vapor lamp or equivalent capable of emitting radiation in the near ultraviolet (UVA) range, i.e. having a wavelength < 400 nm, preferably at 365 nm; - with a duration of the entire cycle that is decidedly more limited than the current times, i.e. minutes and no more than hours, all resulting in greater efficiency of the entire process.

[0163] It will be possible to ascertain that the new sterilization equipment overcomes and completely solves the age-old problem of many endoscope washer-disinfectors (Washer Disinfector) with peracetic acid as the biocidal active ingredient, all at room temperature as it is a thermosensitive material, that is:

[0164] - The need for rinsing with filtered water to remove peracetic acid residues from the surface of reprocessed devices; due to the ineffectiveness of the filtering systems, this water is very often not sterile and therefore nullifies the entire sterilization process with peracetic acid;

[0165] - The need to remove objects or instruments after rinsing from the disinfection chamber to store them in a storage cabinet; this practice, like the previous one, exposes the instrument to recontamination due to microorganisms present in the ambient air.

[0166] The presence of a photo-catalyst component, for example a layer or membrane of titanium dioxide constantly illuminated with UVA (near ultraviolet) radiation, preferably constantly illuminated in all reprocessing phases of the instrument, including the rinsing and final conservation, guarantees that any drops of stagnant water inside the chamber, thanks to the photocatalytic process in progress, are loaded with hydroxyl radicals (-OH) and / or superoxide anions (-O2-) both with high reactivity and a consequent increased biocidal and detoxifying potential.

[0167] It will be understood that the new concept of photochemical sterilization of the present invention can find various uses from an application point of view, especially in the medical field and sometimes also in the industrial and domestic field in all the washing, disinfection, and sterilization equipment currently present on the world market.

[0168] Therefore, thanks to an equipment according to the present invention it is possible to carry out a sterilization process, preferably cold, i.e. at room temperature or slightly higher, in any case < 45 °C, of even thermosensitive objects, comprising the following phases: - Introduce objects into said RC reaction chamber,

[0169] - Hermetically close the RC reaction chamber,

[0170] - Insert the oxidizing or sterilizing liquid into the RC reaction chamber, through the supply opening SO, so that it acts for a certain contact time, for example between 5 and 15 minutes and, preferably at a temperature < 45 °C, for example < 25 °C,

[0171] - Illuminate said photo-catalyst component using said at least one lamp 4, preferably starting from the introduction of the objects into the RC reaction chamber or after it has been closed and for the entire action phase of the oxidizing liquid,

[0172] - So that the photo-catalyst, once illuminated by the lamp 4, triggers the formation of hydroxyl radicals OH and / or superoxide anions 02- or other oxidizing radicals, with a high reactivity, a greater oxidation potential compared to the undissociated forms and a consequent increased biocidal potential.

[0173] It is important to keep the photocatalytic process constant inside at least one RC reaction chamber, with consequent maintenance of sterility and at the same time increased energy saving of the entire system.

[0174] In this regard, preferably the at least one lamp 4 is turned off, if desired by the control unit, only when the RC reaction chamber is opened for the removal of objects or instruments, for example at the point of use, to guarantee the sterile condition until subsequent use.

[0175] Clearly, other optional steps are possible before photochemical sterilization using at least one lamp 4, such as:

[0176] - One or more rinsing phases of the RC reaction chamber, if desired with water, for example with nozzles which will also be discussed later,

[0177] - A mechanical cleaning phase of the reaction chamber, for example using a rotating blade or like facilitate the internal movement of the liquid and facilitate the detachment of organic and inorganic dirt from the surfaces,

[0178] - A cleansing and / or decontamination phase, with a specific detergent and / or decontaminant, for example water with alkaline or enzymatic detergent with no biocidal active ingredient, possibly followed by a neutralization phase of the alkaline residues again using a rotating blade or similar such as above. Furthermore, it is possible to provide a detection phase in the RC reaction chamber and / or in the sampling container or in the cell or container for the formation of concentrated peracetic acid, if desired obtained according to the teachings of patent EP2388246B1, of the concentration of active ingredient with consequent phase dosage via the control unit, of the adequate quantity in the oxidizing liquid solution.

[0179] After the sterilization phase with lit lamps and oxidising and sterilizing liquid, it is possible to carry out a further rinsing phase, if desired by filling the reaction chamber with water, for example filtered or other, possibly followed by a drying phase.

[0180] Furthermore, clearly, at the end of the procedure, the oxidizing or sterilizing compound or liquid and the rinsing water are eliminated by means of the DO discharge or emptying opening.

[0181] It will then be understood that the objects, preferably shortly before their use, can be removed from the equipment or from the respective casing or basket component 6 (after opening any doors or doors) appropriately sterilised.

[0182] Furthermore, as indicated above, the control unit, during the sterilization process of the first objects or instruments, could conduct a recording phase, in a specific memory section, of the significant parameters of each treatment phase, to then use the parameters recorded to conduct a new sterilization process always of the first objects (after they have been used) or of second objects different from the first ones, although also with a structure / configuration substantially corresponding to the latter, depending on what has been carried out or validated previously during the first processing of the first objects.

[0183] 2. Examples

[0184] Some examples of (non-exhaustive) implementation of equipment according to the present invention will now be described, also in replacement of specific existing equipment.

[0185] 2.1 Example 1

[0186] In the healthcare market, equipment known as thermal disinfection washer-disinfection machines are very widespread today, which perform an automatic cleaning and thermal disinfection cycle on thermostable medical surgical instruments. In this equipment there is a chamber with a single entry / exit door or a double door, one for entry and on the opposite side for exiting the trolley with several shelves in which the baskets containing the medical-surgical instruments to be reprocessed are positioned. Once the baskets containing the dirty instruments have been positioned on the shelves of the trolley and once this trolley has been inserted inside the chamber, the equipment carries out cleaning by:

[0187] - pressurized cold-waterjet (initial rinse).

[0188] - cleansing with a waterjet added with a pre-established dose of alkaline detergent with low foaming surfactants, sometimes added with enzymes;

[0189] - neutralization of the alkaline residues of the detergent by means of a jet of water added with a pre-established dose of an acid neutralizer (organic or inorganic) - this phase can be omitted if a non-alkaline but neutral detergent with an enzymatic mixture is used in the cleansing phase;

[0190] - thermal disinfection, i.e. heating to around 90°C to eliminate a good part of the microbial load present on the surface of the instrumentation.

[0191] The instrumentation resulting from this process is clean and disinfected, but is not sterile and therefore must subsequently be individually bagged or placed in the appropriate containers, for sterilization in a steam autoclave.

[0192] An equipment according to the present invention can be used to replace these instrument washers, thus being able to carry out the entire process of cleaning and sterilization of medical- surgical instruments using a single equipment with a notable saving of energy, time and manipulation.

[0193] Such an equipment according to the present invention would essentially be a photochemical washer-sterilizer, i.e. an equipment for washing and photochemical sterilization of medical- surgical instruments.

[0194] This equipment would be made as described above, optionally with one or more basket components 6 to contain the objects or instruments. In the case of several basket components 6, for example any number between two and ten or fifteen, they could be positioned in the different shelves of a trolley which in turn is inserted in an external washing chamber or, alternatively, several components in hermetic enclosures or drawers 7, if desired kept suspended or placed in a specific area of the equipment.

[0195] These casing or drawer components 7 could be provided with nozzle systems for emitting water or a washing liquid, if desired under pressure 13 and / or drainage openings for the liquids present in current equipment, to guarantee the possibility of creating in they use the same cleaning process that respects the regulations in force regarding traditional equipments.

[0196] The nozzles 13 can be mounted or positioned on the walls of the RC chamber and / or on a component in the chamber, if desired a rotatable component 14, for example a mechanical cleaning component of the RC reaction chamber, such as a rotating blade, to ensure a 'distributed pressure supply of water or washing liquid and also a mechanical removal of dirt. In this case, the rotation of the blade could be due to the force imparted by the pressurized washing liquid coming out of the nozzles 13.

[0197] In other words, inside each hermetic drawer the same cleaning operations can be carried out that are normally carried out in the washing chamber of a thermal disinfection washer. Clearly, as indicated above, the internal surface of one or more of the walls of these drawers 7 is coated in whole or in part, if desired at least between 10% and 100%, if desired between 50% and 100% or between 80% and 100%, using suitable deposition techniques, with a layer of photo-catalyst component, such as one or more of those indicated above, for example titanium dioxide (TiO2), for example in the anatase crystalline form, or with crystals of titanium dioxide combined with nickel, copper, silver, gold and rhodium to create a superior synergistic catalyst.

[0198] Preferably, in order to ensure that the entire surface is irradiated by ultraviolet radiation in the near ultraviolet (UVA) with a wavelength < 388 nm, preferably 365 nm, the edges of the cassette can be rounded and on one, two, three lamps 4 are provided on all sides, preferably with medium, low vapor and mercury amalgam or equivalent capable of emitting such radiation with a "fan" beam.

[0199] In this regard, see figures 3 and 4.

[0200] This arrangement is only an example and representative of the fact that the UVA lamps inside the chamber must illuminate the entire internal surface coated with a layer of photocatalyst. This lighting, moreover, by creating an electrical separation in the photocatalyst layer between the flow of negative charges on the surface and positive gaps in depth, can become the source of direct electric current (DC) which, when suitably converted into alternating current (AC), can, through a circuit closed, in turn power the lamp(s) themselves.

[0201] Clearly, to increase the efficiency of this circuit, photovoltaic cells, or modules 11 can also be inserted. This circuit, appropriately calibrated, becomes a self-power supply of the lamp / s when the hermetic chamber is extracted from the equipment to be able to be brought to the point of use (e.g. operating room or clinic).

[0202] In this case, the amplification system operated by the UVA lamps and the capture of part of the light energy by the titanium dioxide coating should be sufficient to continuously power the lamp(s). Naturally, if this were not sufficient, this recovered energy could integrate any batteries housed in the chamber as an energy source, all with the aim of always keeping the photocatalytic process constant inside the chamber with consequent maintenance of sterility and at the same time a increased energy saving of the entire system.

[0203] Preferably, only when the door of drawer 7 is open to remove the instrumentation from the point of use can the lamp(s) 4 be turned off.

[0204] From a functional point of view, this equipment, exploiting the new photochemical sterilization system, the subject of this patent application, simultaneously carries out both the cleaning process currently operated by iron washing equipments with or without thermodisinfection and the sterilization process operated by steam or oxide autoclaves, of ethylene.

[0205] With such equipment, while the lighting system with UVA radiation is in operation on some or all of the internal surfaces of the "hermetic drawer" and, if desired, suspended at half height, a closed basket is housed, if desired with a double lattice containing all the instrumentation medical- surgical to be reprocessed, it is possible to carry out a sterilization process, preferably at cold or at room temperature or below 45 °C.

[0206] Thus, for example, according to a preferred but non-limiting example, the following phases are carried out in sequence, which once standardized in terms of time, temperature and / or dosage of the active ingredients could be recorded, if desired using a specific cycle printout.

[0207] Initially, a rinse is preferably carried out, if desired with cold water (< 25°), if desired using a system of pressurized water emission nozzles 13 arranged on the walls and on the possible rotating or revolving blade 14 for greater pressure and mechanical removal of the dirt, especially organic dirt of a protein nature which is difficult to remove with hot water. In this phase, time and temperature can be measured and, if desired, recorded, with appropriately calibrated instruments.

[0208] At this point, cleansing can be carried out, always using the same pressure dispensing nozzles with water added to the pre-set quantity of neutral alkaline or enzymatic detergent or both depending on the chosen cleaning process. In this phase, the time, temperature, and dosage of the detergents used can be measured and, if desired, recorded, with appropriately calibrated instruments.

[0209] If you opt for cleaning with an alkaline detergent, it is necessary to follow a neutralization of the alkaline residues as required by current washing equipments, with an organic or inorganic acid neutralizer which is appropriately introduced into the RC reaction chamber through special ducts; also in this phase any parameters measured and recorded are the same as in the cleansing phase, i.e. time, temperature and dosage of neutralizer.

[0210] Subsequently, a rinse is preferably carried out to remove any residue from the previous phase.

[0211] If at the end of the cleaning phases above, some residue of organic material is deposited on the surface of the chamber, the photocatalytic oxidation (PCO) of the titanium dioxide irradiated by the UVA lamps with humidity degrades these residues, transforming them into CO2 and nitrogen oxides, according to a photocatalytic oxidation (PCO) mechanism of titanium dioxide.

[0212] At this point a photochemical sterilization takes place, if desired without the aid of the pressure nozzles 13, but preferably simply rotation of the possible blade 14 to facilitate mixing and rapid formation of the solution for use, by dilution of the concentrated cold chemical sterilant chosen (for example peracetic acid or hydrogen peroxide) in the water, obtaining the complete filling of the chamber. In this way the entire surface of the instruments suspended in the solution inside the RC reaction chamber, if desired on basket 6, is involved in contact with the sterilizing solution. At the same time, thanks to the photocatalytic action of the titanium dioxide irradiated by the UVA lamps, this solution is enriched with strongly oxidizing reagents such as hydroxyl radicals (-OH), superoxide anions (-O2-) and / or peracetic radicals (- O2COCH3), all these forms increasing the biocidal potential of the basic molecules, thus allowing the reduction of contact time with the same effect.

[0213] Since the sterilizing biocidal active ingredients (peracetic acid in particular) are not completely stable over time, in the sense that their concentration can decrease depending also on the storage temperature, the insertion of a suitably calibrated potentiometer 5 in the sampling tank would allow to constantly detect the concentration of the active ingredient (e.g. C = % w / w of peracetic acid) and consequently dose, using the control unit, the adequate quantity in the solution for use according to the formula:

[0214] V (Volume) 1 * C (Concentration)! = V (Volume)2 * C (Concentration^

[0215] Preferably, one or better at least two potentiometers are then provided in the casing or chamber component 7, one of which 15 acts as a control of the dosage operated by the equipment and of the minimum effective concentration (CME) of the oxidizing forms present in the solution (e.g. H2O2 , H00C0CH3, -OH, -O2-, -O2COCH3) above which the sterilizing efficacy is guaranteed for a given contact time, while the other 16 acts as a recorder over time of the concentration of the oxidizing forms in solution, in the form of potential, to be reported in the sterilization cycle report.

[0216] As will be understood, the parameters measured and recorded in this phase with appropriately calibrated instruments are, preferably, time, temperature and potential.

[0217] A rinse is therefore preferably carried out, for example if desired by filling the chamber twice with filtered water to remove any residue of cold chemical sterilant from the surface of the instruments. The time in which the instruments are left to soak in the water in the second rinse is a function of the potential measured by any control potentiometer 15 immersed in the solution, the value of which must advantageously fall within the range in which a concentration range of oxidizing radicals (-OH, -O2-), formed by photocatalysis, such as to guarantee its sterility, in the case of residual drops on the internal surface of the chamber following emptying. The parameters measured and possibly recorded in this phase with appropriately calibrated instruments are, preferably time, temperature and potential.

[0218] Subsequently, optional drying can be carried out using special means, for example through filtered air, for example with a filter, if desired absolute (HEPA), to remove any drops of water from the drawer or reaction chamber and from the instrumentation. The parameters measured and possibly recorded in this phase with appropriately calibrated instruments are, preferably, time and temperature.

[0219] Once the cycle is finished, the records of all phases in terms of time, temperature, dosage of detergent and / or neutralizing products, potential during the sterilization phase = minimum effective concentration of oxidizing forms and rinsing, can be kept in the eventual memory of the equipment and / or printed on a strip of paper to be able to verify at any time compliance with the standard parameters set during validation, for cycle compliance, as happens in current sterilization processes (for example steam autoclave or ethylene oxide).

[0220] As will be understood, like current sterilization systems, also in the equipment according to the present invention, the sterilized instruments are stored in an aseptic state, in the hermetically closed drawer and continuously illuminated by UVA lamps, until the moment immediately before their use.

[0221] Furthermore, the drawer 7 can be left inserted in the appliance, or removed from it, if desired, always guaranteeing lighting through self-power with the above circuit or with the aid of batteries integrated with this system.

[0222] As already indicated, to guarantee sterility for the entire storage period, the lighting is preferably never interrupted. In this regard, a lighting detection system can be provided in the equipment.

[0223] As regards the withdrawal and use phases, the drawer, once positioned in the immediate vicinity of the point of use, is opened, for example by means of a simple shutter or door and the instruments are extracted from the drawer 7 or from the respective suspended basket 6 or the basket 6 containing the instruments is completely extracted from the drawer.

[0224] Upon opening, the lamps 4, depending on the needs, can be turned off or remain on to guarantee continuity of the photocatalytic oxidation process.

[0225] 2.2 Example la

[0226] The equipment described above, while fully exploiting the new concept of photochemical sterilization according to the present invention, from a structural point of view, can be conceived instead of with the walls of the drawer 7 or of the delimitation of the RC reaction chamber coated with a photo- catalyst, such as one or more of those indicated above, for example titanium dioxide, with a filtering membrane 3b coated with titanium dioxide, permeable to liquids and not to solids of predetermined dimensions. This membrane 3b is, preferably, constantly illuminated by the lamp(s) 4 (see figures 7 and 8).

[0227] 2.3 Example lb

[0228] A further variant of the equipment 1 described in example la provides that the filter membrane whether or not coated with a photo-catalyst component, such as one or more of those indicated above, for example titanium dioxide, permeable to liquids and not to solids with dimensions pre-established, is positioned above the instrument basket to become the support bed for the titanium dioxide in granules or powder or crystals.

[0229] In the cold chemical sterilization phases (intended as room temperature < 45 °C) and final rinsing, when the hermetic drawer is completely filled with the liquid, the photocatalytic oxidation process induced by the TiO2 particles in suspension or adhered to the membrane under the action of ultraviolet radiation occurs in the area segregated by the membrane, producing strongly oxidizing radicals which spread into the solution beneath the membrane with consequent involvement of the instrumentation immersed or wet in it.

[0230] 2.4 Example 1c

[0231] A further variant of the equipment described in examples 1, la and lb provides that the basket 6 containing the instrumentation is made up of steel mesh coated with a photocatalyst component, such as one or more of those indicated above, for example titanium dioxide, in such a way that during the cleaning and sterilization cycle, as well as acting as a photo-catalyst, it cleans itself independently of any impurities of organic and / or inorganic dirt.

[0232] 2.5 Example 2

[0233] For the disinfection of flexible endoscopes (WD), endoscope washing machines are usually used, in which the flexible endoscopes, both on the external surface and on the appropriately connected internal channels, are cleaned, and disinfected by recirculating a high-quality detergent and disinfectant solution in the reprocessing chamber, level, which is generally obtained by diluting a concentrated solution of peracetic acid (5%, 15% or 35%), with or without the addition of a buffer system.

[0234] As a replacement for this machine, an equipment according to the present invention could be structured to provide a photochemical washer- sterilizer for endoscopes, i.e. an equipment for washing and photochemical sterilization of thermolabile medical-surgical instruments.

[0235] This equipment and the related operating procedure would have similar characteristics to what is described in examples 1 or la, lb and 1c, possibly with the following modifications or replacements.

[0236] Clearly, the medical-surgical instrumentation to be treated would be replaced by thermolabile medical- surgical instrumentation, for example rigid or flexible endoscopes. Cleaning could be done with detergent alone, without the need for neutralizer.

[0237] The procedure performed by the new equipment would no longer be a disinfection, but a sterilization, as this new equipment would overcome and resolve the critical points of the current equipments, in terms of final rinsing and exposure to the ambient air of the reprocessed endoscope, as these last phases nullify the sterilization process carried out by peracetic acid, placing the instruments to be treated in contact with liquids and polluting environments.

[0238] 2.6 Example 3

[0239] In the healthcare market today, steam autoclaves are very widespread for the sterilization of thermostable medical- surgical instruments, while for thermolabile ones, such as rubber, plastic, fabrics, etc., those with ethylene oxide. These equipments perform a standard sterilization cycle of instruments that are cleaned, dried and individually bagged or placed in sterilization baskets. In the case of the steam autoclave, the parameters to be monitored for each cycle are:

[0240] - temperature, for example 134 °C;

[0241] - time, for example 15 minutes;

[0242] - saturated vapor overpressure, for example 1 atm.

[0243] Clearly, the positive or negative outcome of the process depends on compliance with these parameters, taken together.

[0244] As a replacement for this machine, an equipment according to the present invention could be structured to provide a photochemical sterilizer, i.e. a photochemical sterilization equipment for medical-surgical instrumentation.

[0245] In this new equipment, the thermostable and / or thermolabile instrumentation, instead of being individually bagged or placed in sterilization boxes, could be arranged in different containment baskets 6 which, in accordance with example 1, are suspended at approximately half the height of the "hermetic drawers ” 7 whose internal surface is coated, through modern deposition techniques, with a layer of titanium dioxide (TiO2) alone or combined with nickel, copper, silver, gold and rhodium crystals to create a superior synergistic catalyst.

[0246] Also in this case, in order to ensure that the entire surface is irradiated by ultraviolet radiation in the near ultraviolet (UVA) range with a wavelength < 400 nm, preferably 365 nm, the edges of the cassette are preferably rounded and on one, some or all sides are positioned with lamps, preferably with medium or low vapours, mercury amalgam or equivalent capable of emitting such radiation with a fan-shaped beam.

[0247] See figures 5 and 6.

[0248] This arrangement is only illustrative and representative of the fact that the lamps 4, for example UVA inside the equipment or the casing component 7 must illuminate all or part (between 10% and 100% if desired, between 50% if desired and 100% or between 80% and 100%) the internal surface coated with a layer of photocatalyst.

[0249] This lighting, which also creates an electrical separation in the photocatalyst layer between the flow of negative charges on the surface and positive gaps in depth, can be used as a source of direct electric current (DC), which can be conveniently converted into alternating current (AC), through a closed circuit, in turn powers the lamp(s) themselves. Also in this case, to increase the efficiency of this circuit, photovoltaic cells or modules can also be inserted. This circuit, appropriately calibrated, becomes a self -power supply for the lamp(s) when the hermetic drawer is extracted from the equipment to be taken to the point of use (e.g. operating room or clinic).

[0250] It is assumed that the amplification system operated by the UVA lamps and the capture of part of the light energy by the titanium dioxide coating is sufficient to continuously power the lamp(s); but, if this were not sufficient, this recovered energy could integrate any batteries (batteries) housed in the drawer as an energy source, which can be self-powered while the drawer is housed in the sterilization equipment, all with the aim of maintaining the photocatalytic process inside the RC reaction chamber is always constant with consequent maintenance of sterility and at the same time increased energy saving of the entire system.

[0251] From a functional point of view, this equipment, exploiting the new photochemical sterilization system object of the present invention, can carry out a sterilization process in an energetically more advantageous way without any risk of toxicity for people compared to expensive and dangerous steam autoclaves, or ethylene oxide.

[0252] In relation to this aspect, while the lighting system with UVA radiation on all the internal surfaces of the "hermetic chamber" is activated, and, if desired, a casing component is housed, for example at half height, if desired with a closed basket with double lattice containing all the medical-surgical instrumentation to be reprocessed, the following phases are carried out in sequence, which once standardized in terms of time, temperature and / or dosage of the sterilizing active ingredient can, if desired, be recorded by printing a report.

[0253] First, a photochemical sterilization takes place by diluting the chosen concentrated cold chemical sterilant (for example peracetic acid or hydrogen peroxide) in water, obtaining the complete filling of the RC reaction chamber or drawer 7.

[0254] In this way, the entire surface of the instruments suspended in the solution inside the basket is involved in contact with the sterilizing solution.

[0255] At the same time, thanks to the photocatalytic action of the titanium dioxide irradiated by the UVA lamps, this solution is enriched with strongly oxidizing reagents such as hydroxyl radicals (-OH), superoxide anions (-O2-) and / or peracetic radicals (- O2COCH3); all these forms increase the biocidal potential of the basic molecules, thus allowing the reduction of contact time with the same effect.

[0256] Since the sterilizing biocidal active ingredients (peracetic acid in particular) are not completely stable over time, in the sense that their concentration can decrease depending also on the storage temperature, the possible insertion of a suitably calibrated potentiometer 5 in the sampling tank, it would allow the concentration of active ingredient to be constantly detected and consequently the adequate quantity to be dosed in the solution for use according to the formula:

[0257] V (Volume) 1 * C (Concentration)! = V (Volume)2 * C (Concentration^

[0258] In the RC reaction chamber, at least one or two potentiometers are then advantageously provided, one of which 15 acts as a control of the dosage operated by the equipment and of the minimum effective concentration (CME) of the oxidizing forms present in the solution (e.g. H2O2, H00C0CH3, - OH, -O2-, -O2COCH3) above which the sterilizing effectiveness is guaranteed for a given contact time, while the possible second potentiometer 16 acts as a recorder over time of the concentration of the oxidizing forms in solution, in the form of potential , to be reported in the sterilization cycle report. The parameters possibly measured and / or recorded in this phase with appropriately calibrated instruments are time, temperature and potential.

[0259] At this point, rinsing is preferably carried out, optionally filling drawer 7 once or twice with a specific liquid, such as filtered water, to remove any residue of cold chemical sterilant from the surface of the instruments. The time in which the instruments are left to soak in water in the second rinse is a function of the potential measured by any control potentiometer immersed in the solution, the value of which must fall within the range in which a concentration range of oxidizing radicals is guaranteed (-OH, -O2-), formed by photocatalysis, such as to guarantee its sterility, in the case of residual drops on the internal surface of the drawer following emptying. The parameters possibly measured and / or recorded in this phase with appropriately calibrated instruments are time, temperature and potential. Any drying can therefore be carried out, which clearly must not negatively affect the aseptic conservation phase of the instrumentation. In this regard, for example, drying using filtered air, for example with an absolute filter (HEPA), can be envisaged to remove any drops of water from the drawer and / or from the reprocessed medical- surgical instruments. The parameters possibly measured and / or recorded in this phase with appropriately calibrated instruments are time and temperature.

[0260] Once the cycle is finished, any records of all the phases in terms of time, temperature, potential during the sterilization and rinsing phase, can be stored in the memory of the equipment and / or printed on a strip of paper to be able to verify compliance with the standard parameters set during validation at any time, for cycle compliance, as occurs in current sterilization processes (for example steam or ethylene oxide autoclave).

[0261] Like current sterilization systems, even in the one according to the present invention, the sterilized instruments are stored in an aseptic state, in the hermetically closed drawer and continuously illuminated by UVA lamps, until the moment immediately before their use. The drawer 7 can be left inserted in the appliance, or removed from it, preferably always guaranteeing lighting through self-power with the above circuit or with the aid of batteries integrated with this system. If continuous lighting is a critical and necessary parameter for maintaining sterility, the drawer, the equipment, or the respective reaction chamber are preferably integrated with a brightness detector that can signal any interruption.

[0262] Subsequently, the drawer 7, once positioned in the immediate vicinity of the point of use, is opened, for example by means of a simple shutter or door and the instruments extracted from the suspended basket or the basket containing the instruments extracted completely from the drawer. Upon opening, the lamps can be turned off or left on, depending on needs, to ensure continuity of the photocatalytic oxidation process.

[0263] The critical parameters to be monitored in the specific case, to ensure compliance of the sterilization cycle are:

[0264] - temperature, for example = 25 °C;

[0265] - time, for example 15 minutes;

[0266] - potential difference, for example 3 Amperes or corresponding Volts;

[0267] The same variants (la, lb and 1c) as in example 1 also apply to this equipment. 2.7 Example 4

[0268] Washer-disinfectors are known, which are appliances for washing and disinfecting thermolabile medical-surgical instruments that use an extemporaneous preparation system by mixing two components, such as that described in patent EP2388246B1.

[0269] An equipment according to the present invention can be used as a photochemical sterilizer, i.e. a photochemical sterilization equipment for thermolabile medical- surgical instruments, which uses the extemporaneous preparation system by mixing two components, including the one described in patent EP2388246B1.

[0270] This equipment differs from that described in example 2 only in that it does not use a preformed concentrated peracetic acid as a cold chemical sterilant, but an extemporaneous preparation system, for example that taught by patent EP2388246B1.

[0271] See for example figure 8.

[0272] The structural and operating characteristics of both the washer- sterilizer and the photochemical sterilizer are the same as examples 1, 2 and 3 respectively, with the only difference that instead of using concentrated peracetic acid as a cold chemical sterilant, its two precursors are used, generator and activator whose composition and mixing system are taught, for example in patent EP2388246B1.

[0273] In particular, to produce a concentrated peracetic acid, a predetermined dose of the liquid generator 18 (for example 19% hydrogen peroxide) is reacted with a predetermined dose of the activator 19 (formulation for concentrated peracetic acid), in an auxiliary mixing and reaction chamber 20, optionally equipped with a calibrated potentiometer that can detect the concentration of active ingredient formed.

[0274] From this measurement, always with the same calculation principle:

[0275] V (Volume) 1 * C (Concentration)! = V (Volume)2 * C (Concentration^ a certain dose of the concentrated peracetic acid mixture is then taken to provide the ready-to-use solution with the concentration of active ingredient equal to or greater than the minimum level of effectiveness, in the cold photochemical sterilization phase.

[0276] Knowing the reaction kinetics, i.e. the time in which the concentrated peracetic acid mixture is prepared and its stability (for example 15 days from activation) it is possible to program the mixing of the two components (generator + activator) in the mixing chamber and auxiliary reaction 20, a few minutes before its use, or well in advance and in a quantity such as to allow the execution of several sterilization cycles.

[0277] The variations taught in examples la, lb and 1c also apply to this example.

[0278] To these is added a further variant (d) represented by the fact that the auxiliary mixing and reaction chamber, like the sterilization chamber, can be coated with titanium dioxide (TiO2) and illuminated with UVA lamps in order to make it more the synthesis reaction of concentrated peracetic acid is fast and with a richer concentration of peroxyl radicals endowed with greater biocidal activity and therefore requiring less contact time to carry out the elimination of any form of microbial life described with the term sterilization.

[0279] In all the application examples indicated above, in the cold photochemical sterilization phase, as a liquid biocidal agent, steam, gas and / or mist (micronized particles), the use of a other inorganic oxidant such as hydrogen peroxide in the form of a liquid, vapor, gas or mist (micronized particles) generated at room temperature by any means such as a sonicator.

[0280] 2.8 Example 5

[0281] Pass-boxes are known, dedicated to the disinfection / sterilization of objects during the transfer phase from a non-sterile environment to a sterile environment, or rather pass boxes which allow an aseptic transfer of materials within the cleanrooms. These passage boxes delimit double-opening passage chambers, in which objects are sterilized by means of an integrated bio-decontamination system using vaporized hydrogen peroxide (HP) for very rapid cycles. The objects to be disinfected / sterilized are inserted through a door that opens on the so-called "polluted" side and arranged on several grid shelves. Once the door is closed, the chamber is saturated with hydrogen peroxide vapor which carries out its biocidal activity (including sporicidal activity) for a certain contact time in order to obtain disinfection. Once the cycle is finished, the disinfected material is taken in an aseptic manner from the door located on the opposite side and which overlooks the so-called "clean" room or "cleanroom".

[0282] An equipment according to the present invention can be used as a pass-box or photochemical sterilization tunnel, i.e. delimiting a hermetically closable RC chamber, optionally with double opening 21, 22 with two or more doors 23, 24, 25 or similar, at least one for the hermetic opening / closing of a respective opening, so that the objects to be sterilized can be inserted into a first opening (when the other or second one is closed) and removed, sterilized, from the other or second one (when the first it's close). As will be understood, inside the chamber all the objects or all the reprocessed material is made and kept sterile as indicated above, for example by means of the photochemical sterilization process which is the object of the present invention. Clearly, the first opening would lead into a first area of a set-up environment, i.e. the so-called "polluted" side, while the second opening would lead into a second area, i.e. a clean or "white" or decontaminated side, for example a clean room.

[0283] This RC chamber can also be agreeably used for sterilizing the external surface of the drawers or hermetic casings 7 before entering a clean room. In this case, sterilization is also more efficient if this external surface (like the internal one if desired) is coated with a photocatalyst component, such as titanium dioxide, to facilitate the photocatalytic process.

[0284] See for example figure 13.

[0285] The structural characteristics of this pass-box are the same as the equipments 1 of the casing or drawer components 7 referred to in the previous examples, although in this case instead of using peracetic acid in the liquid state as a cold chemical sterilant, an oxidizing compound is preferably used or sterilizing agent, for example hydrogen peroxide, in the form or state of gas, steam or mist so as to saturate the entire internal volume of the RC reaction chamber.

[0286] Also in this case, lamps 4 can be provided which can for example reflect their rays on the entire internal surface coated with photo-catalyst component 3a, for example titanium dioxide and / or in the presence of the membrane 3b and / or photo-catalyst component catalyst dispersed in the form of solid particles inside a containment membrane. Furthermore, as indicated above, the lamps 4 advantageously remain constantly lit even during the insertion and removal of the objects to be transferred from one room to another as well as during the sterilization phase with steam of an oxidizing or sterilizing compound such as for example peroxide of hydrogen, so as to guarantee the aseptic state of the internal environment over time.

[0287] In this case, in addition to the parameters measured and recorded during the entire photochemical sterilization process and referred to in the previous examples, such as time, power = concentration of the oxidizing forms and / or temperature, the overpressure inside the chamber can also be considered RC with respect to the external one, being able to then act, if necessary, on the supply of oxidizing compound, with the aim of controlling that the vapor of this compound, for example hydrogen peroxide, is distributed throughout the RC sterilization chamber.

[0288] The equipment can also include one or more probes 26 designed to detect the overpressure or pressure inside the RC chamber of the steam, gas or mist of the oxidizing compound. Or each probe 26 may include, for example, a pressure switch that measures, directly or indirectly, the degree of saturation of the chamber in the event that the oxidizing compound is in the state or form of vapor, gas or mist.

[0289] Clearly, also with reference to this example, the description proposed above applies in relation to the photo-catalyst component 3 a as well as to the other mechanical and electronic elements described above.

[0290] The variations taught in examples la, lb and 1c also apply to this example.

[0291] The applications of the new "cold photochemical sterilization" process taught by this patent application represent non-limiting examples of this innovation.

[0292] In fact, its pre-eminent application for the healthcare world can easily be extended to all other areas such as industrial, pharmaceutical, agri-food and others, to obtain and maintain "sterile" objects or products or products with controlled contamination over time, until their subsequent reuse.

[0293] Modifications and variations of the invention are possible within the scope of protection defined by the claims.

Claims

CLAIMS1. Equipment for the sterilization and sterile conservation of objects, internally delimiting at least one hermetically closable chamber (RC), said equipment comprising at least one photo-catalyst component (3a) as well as at least one lamp (4) emitting radiation in the near ultraviolet (UVA) range on said at least one photo-catalyst component (3a), said equipment also including one or more feeding (SO) and emptying (DO) openings in the chamber (RC) of at least one oxidizing or sterilizing compound, said equipment including at least one casing component (7) delimiting said chamber (RC), said casing component including said at least one lamp (4), wherein said at least one casing component (7) can be removed from said equipment, wherein said at least one casing component (7) comprises an electrical power supply module or component of said at least one lamp (4), so that it is possible to transport said at least one casing component (7) with the respective lamp (4) powered by said electrical power supply module or component (7) outside the equipment and close to the points of use of the sterilized objects, and in which said one or more supply (SO) and emptying (DO) openings are served by one or more specific ducts with a specific integrated circuit in the equipment.

2. Equipment according to claim 1 , wherein said photocatalyst component is selected from zinc oxide, cerium oxide, zirconium oxide, tin oxide, cadmium sulfide, zinc sulfide, titanium oxide or combinations thereof.

3. Equipment according to claim 1 or 2, wherein said photocatalyst component comprises titanium dioxide (TiO2).

4. Equipment according to claim 3, wherein said titanium dioxide (TiO2) is in the crystalline form anatase alone or with its crystals combined with nickel, copper, silver, gold, and rhodium.

5. Equipment according to claim 1, 2, 3 or 4, wherein said at least one photo-catalyst component comprises at least one layer of a photo-catalyst component (3a) disposed in the chamber (RC).

6. Equipment according to claim 5, in which said at least one layer of a photo-catalyst component (3 a) completely or partially covers the internal surface of one or more walls of said at least one casing component (7) delimiting the reaction chamber (RC).

7. Equipment according to any of the previous claims, comprising at least one membrane (3b) permeable to liquids and vapours and not to solids and in which said at least one photo-catalyst component (3a) is inside or on said at least one membrane (3b).

8. Equipment according to any of the previous claims, wherein said at least one lamp (4) is designed to emit radiation in the near ultraviolet (UVA) range and with a wavelength < 400 nm, preferably < 365 nm.

9. Equipment according to any one of the previous claims, wherein said at least one lamp (4) is a medium or low mercury vapor lamp, or mercury amalgam lamps emitting near ultraviolet (UVA) radiation.

10. Equipment according to any one of the previous claims, wherein said oxidizing or sterilizing compound is based on peracetic acid or hydrogen peroxide.

11. Equipment according to any one of the preceding claims, wherein said at least one oxidizing or sterilizing compound is in the state or form of liquid, vapor, gas and / or micronized particles.

12. Equipment according to any of the preceding claims, comprising:- at least one instrument, such as a dosing and measurement potentiometer (5) for measuring and possibly recording the concentration of the oxidizing or sterilizing compound in the container from which it is taken, in the reaction chamber (RC) and / or in said equipment, and / or- at least one probe (26) designed to detect the overpressure or internal pressure of the reaction chamber (RC) in the event that the oxidizing compound is in the state or in the form of steam, gas or mist.

13. Equipment according to any of the previous claims, comprising at least one basket component (6) designed to contain the objects to be sterilized and arranged within said chamber (RC) so that said oxidizing or sterilizing compound can meet all the surfaces of the objects contained or suspended in the basket component (6).

14. Equipment according to any one of the previous claims, wherein said at least one casing component (7) is in the form of a drawer or box.

15. Equipment according to any one of the previous claims, comprising a dilution or rinsing liquid tank and a rinsing circuit in fluid communication with said rinsing liquidtank and with said reaction chamber (RC), which circuit is responsible for to feed dilution or rinsing liquid from said dilution or rinsing liquid tank to said reaction chamber (RC), said dilution or rinsing liquid tank defining a second chamber and means for sterilizing the rinsing liquid are then provided in said second bedroom.

16. Equipment according to claim 15, wherein said sterilization means include at least one photo-catalyst component (3a) as well as at least one lamp (4) emitting nearultraviolet (UVA) radiation on said at least one photo-catalyst component (3a).

17. Equipment according to any of the preceding claims, wherein said electrical power supply module or component comprises: a) at least two electrodes (9, 10) placed one in correspondence with the internal surface directly illuminated by the lamps and the other in the deep, non-illuminated part of the photo-catalyst layer, and / or b) at least one photovoltaic cell (11) illuminated by the radiation emitted by said at least one lamp (4); and / or c) one or more rechargeable or non-rechargeable batteries.

18. Equipment according to any one of the previous claims, comprising nozzles for emitting water or a washing liquid, if desired under pressure (13) in the chamber (RC).

19. Equipment according to any of the preceding claims, comprising a rotating cleaning component or blade in the chamber (RC).

20. Equipment according to any one of the previous claims, comprising a control unit designed to keep at least one lamp (4) lit until the chamber is hermetically closed.

21. Equipment according to any of the previous claims, in which said control unit is designed to turn off said at least one lamp (4) only when or not before the chamber (RC) is opened to remove the objects or instruments inside it.

22. Equipment according to any of the previous claims, consisting of a cold sterilization equipment or in any case at a temperature < 45 °C.

23. Equipment according to any one of the preceding claims, comprising a container of an oxidizing or sterilizing compound in fluid communication with said chamber (RC) via said one or more feed openings (SO).

24. Equipment according to any of the previous claims, internally delimiting at leastone hermetically closable chamber (RC) with double opening (21, 22) with two or more doors (23, 24, 25), at least one for hermetic opening / closing of a respective opening (21, 22), so that the objects to be sterilized can be inserted into a first opening, when the other or second one is closed and removed, sterilized, from the other or second opening, when the first one is closed.

25. Process for sterilizing objects, carried out using an equipment according to any of the previous claims, comprising the following phases:- introduce objects into said room (RC),- insert into said chamber (RC) said oxidizing or sterilizing compound in the state or in the form of liquid, vapour, gas, or mist, so that it acts for a specific contact time,- illuminate said photo-catalyst component (3a) using said at least one lamp (4) starting from the introduction of said objects and throughout the entire action phase of said compound, said photo-catalyst component once illuminated by said at least one lamp (4) triggering the formation of hydroxyl radicals (OH) and / or superoxide anions (O2-) or other oxidizing radicals such as peracetic radicals (-O2COCH3).

26. Process according to claim 25, wherein said at least one lamp (4) is turned off only when or not before said at least one chamber (RC) is opened for the removal of the objects or instruments inside it, to guarantee the sterile condition until further use.

27. Process according to claim 25 or 26 with an equipment according to claim 12, comprising:- a phase for detecting the active ingredient of said oxidizing or sterilizing compound in said chamber (RC) using said instrument or potentiometer (15, 16) and / or a phase for detecting the overpressure or internal pressure of the reaction chamber (RC) in the case in which the oxidizing compound is in the state or form of vapor, gas or mist, e- a dosing phase of the quantity of said oxidizing or sterilizing compound introduced into said chamber (RC) as a function of said detection phase.

28. Process according to any one of claims 25 to 27, wherein said equipment comprises a control unit, which during the execution of the sterilization process of first objects records, in a specific memory section, the significant parameters of each phase oftreatment, so that it can then use the recorded parameters to conduct a new sterilization process always of the first objects or of second objects different from the first ones depending on what was carried out or validated previously.

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