APPARATUS AND METHODS FOR DECONTAMINATING ENCLOSED SPACES
20230125244 · 2023-04-27
Inventors
Cpc classification
B01B1/005
PERFORMING OPERATIONS; TRANSPORTING
A61L2202/15
HUMAN NECESSITIES
A61L9/02
HUMAN NECESSITIES
A61L2209/111
HUMAN NECESSITIES
International classification
Abstract
The invention relates to an apparatus for vapour decontamination of an enclosed space. The apparatus comprises: (a) a reservoir comprising a supply of a liquid decontaminant; and (b) a vaporiser unit in fluid communication with the reservoir. The vaporiser unit comprises: a body that defines a lumen that passes along the length of the body, the lumen comprising a first end and a second end, wherein the first end receives liquid decontaminant from the reservoir; and a heating element that is configured to deliver sufficient thermal energy to effect rapid boiling of the liquid decontaminant within the lumen so that it exits the lumen via an exit port at the second end of the lumen as a vapour. The exit port is configured to deliver the vapour into a flow of a non-heated carrier gas, thereby facilitating distribution of the decontaminant vapour within the enclosed space. The invention also relates to a method for decontaminating surfaces within an enclosed space.
Claims
1-29. (canceled)
30. An apparatus for vapour decontamination of an enclosed space, the apparatus comprising: (a) a reservoir comprising a supply of a liquid decontaminant; (b) a vaporiser unit in fluid communication with the reservoir, the vaporiser unit comprising, a body that defines a lumen that passes along a length of the body, the lumen comprising a first end and a second end, wherein the first end receives liquid decontaminant from the reservoir, and a heating element that is configured to deliver sufficient thermal energy to effect vaporisation through rapid boiling of the liquid decontaminant within the lumen so that it exits the lumen via an exit port at the second end of the lumen as a vapour; wherein the exit port is configured to deliver the vapour into a flow of a non-heated carrier gas, thereby facilitating distribution of the decontaminant vapour within the enclosed space.
31. The apparatus of claim 30, wherein the vaporiser unit comprises a distribution header in fluid communication with the exit port of the lumen, the distribution header comprising, a chamber for receiving the vapour, and one or more distribution outlets; such that the decontaminant vapour is delivered into the carrier gas via the distribution outlets.
32. The apparatus of claim 31, wherein the distribution header defines a volume greater than that of the lumen.
33. The apparatus of claim 31, wherein the chamber of the distribution header is heated.
34. The apparatus of claim 31, wherein the one or more distribution outlets are located on a face of the distribution header that is arranged at an angle to the flow of the carrier gas.
35. The apparatus of claim 30, wherein the vaporiser unit comprises a vapour sieve that separates the lumen into a first chamber and a second chamber, wherein the vapour sieve is configured to prevent the passage of liquid decontaminant from the first chamber to the second chamber.
36. The apparatus of claim 30, wherein the apparatus comprises ducting to direct the flow of the carrier gas.
37. The apparatus of claim 36, wherein the ducting comprises separator panels configured to separate the vapour emanating from each distribution outlet.
38. The apparatus of claim 30, wherein the apparatus further comprises: (c) an impeller that provides the flow of carrier gas.
39. The apparatus of claim 38, wherein the impeller is located below the vaporiser unit.
40. The apparatus of claim 38, wherein the impeller is located within the ducting.
41. The apparatus of claim 30, wherein the heating element comprises a cartridge heater.
42. The apparatus of claim 30, wherein the apparatus further comprises a transport mechanism for transporting the liquid decontaminant to the vaporiser unit, wherein the transport mechanism comprises a pump.
43. The apparatus of claim 30, wherein the apparatus comprises a plurality of vaporiser units.
44. The apparatus of claim 30, wherein the liquid decontaminant comprises an aqueous solution of hydrogen peroxide.
45. A method for decontaminating surfaces within an enclosed space comprising: locating an apparatus of claim 30 within the enclosed space, or within a structure surrounding the enclosed space; creating a decontaminant vapour from a solution of a liquid decontaminant by rapidly boiling the liquid decontaminant within the vaporiser unit comprised of the apparatus; introducing the vaporised decontaminant into the enclosed space until the atmosphere within the enclosed space is saturated with vapour such that the dew-point of the decontaminant is reached and micro-condensation of the decontaminant occurs on surfaces within the enclosed space so as to effect decontamination of the surfaces, wherein introducing the vaporised decontaminant into the enclosed space comprises introducing the vaporised decontaminant into a non-heated carrier gas stream.
46. The method of claim 45, wherein after the decontaminant has resided on the surface for sufficient time to effect the required decontamination, the decontaminant is removed from the sealed enclosure.
47. The method of claim 45, wherein the enclosed space is maintained at a lower atmospheric pressure than the surrounding environment.
48. The method of claim 45, further comprising repositioning the apparatus within the enclosed space.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The present invention can take many forms and arrangement of the steps. One or more embodiments of the invention will now be described, by way of example only and not to be construed as limiting the invention, with reference to the accompanying drawings, in which
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DETAILED DESCRIPTION OF THE INVENTION
[0029] The present invention directed, in part, towards a desire to improve upon previous approaches to vapour decontamination methods and apparatus by providing systems that are less demanding in terms of manufacturing resources and energy consumption as well as easier to control. First generation hydrogen peroxide vapour (HPV) technology was developed and commercialized in the late 1990s with using a so-called “single-loop” approach (see US 5906794, mentioned above). This approach involved high energy demand as well as substantial manufacturing complexity. The single-loop approach required the hydrogen peroxide vapour to be injected into an enclosed space, such as a chamber or room, and then broken down, dehumidified and more peroxide added - all in a single circuit. Second generation technology was developed and commercialized in the 2000s using an alternative “dual-loop” technology (see WO0121223A1, mentioned above). Whilst this simplified the technology and reduced the energy demand by splitting the process into two circuits it required the hydrogen peroxide vapour to be injected into a pre-heated air-stream - which consumes significant amounts of energy and requires associated heating and control equipment. As described above, the aim of the current technology is to introduce a vapour phase decontaminant into a chamber or room and have it laid down on all surfaces in a uniform layer a few microns thick through condensation in order to inactivate micro-organisms on the surfaces.
[0030] The present invention has sought to further improve upon first and second generation systems, which still represent the industry standard, by providing methods and apparatus that further reduce the energetic demand of the systems and make the systems easier to control and/or integrate into enclosures (e.g. enclosures incorporating robots used for the sterile manufacture of drugs or other advanced therapeutic medicinal products) as well as providing components that are far less complex to manufacture, thereby further simplifying the process.
[0031] Prior to setting forth the invention, a number of definitions are provided that will assist in the understanding of the invention. All references cited herein are incorporated by reference in their entirety. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
[0032] As used herein, the term ‘comprising’ means any of the recited elements are necessarily included and other elements may optionally be included as well. ‘Consisting essentially of’ means any recited elements are necessarily included, elements that would materially affect the basic and novel characteristics of the listed elements are excluded, and other elements may optionally be included. ‘Consisting of’ means that all elements other than those listed are excluded. Embodiments defined by each of these terms are within the scope of this invention.
[0033] The term “enclosed space” is intended to refer to an enclosed volume of space that is defined by solid boundaries, such as walls, that are relatively impermeable to gas transfer. Suitably the enclosed space is defined within an enclosure, for example, such as a room, vessel, conduit, cupboard, tent or a chamber. The enclosed space will typically comprise an atmosphere as well as one or more windows, ports, doors or other access channels. The enclosed space may be in intermittent or continuous gaseous communication with an external ventilation system such as a heating, ventilation and air conditioning (HVAC) system. The enclosed space may incorporate atmospheric pressure control apparatus in order to generate a negative pressure within it as compared to an external environment.
[0034] The term “vapour” is used herein to denote the use of chemical sterilant, such as hydrogen peroxide (H.sub.2O.sub.2) in solution with water. Typically aqueous concentrations of hydrogen peroxide are used of not less than around 27% weight by weight (w/w), and typically between 30%w/w to 35%w/w. However, lower concentrations may also be utilised with corresponding alteration of operating parameters and concomitant reductions in microbial inactivation performance to accommodate any alteration in physical properties of the solution. The aqueous solution is converted to vapour phase typically via a rapid boiling process. In typical use, the hydrogen peroxide vapour is introduced into the atmosphere of an enclosed space continuously until the atmosphere reaches saturation or “dew point” when the vapour may condense on surfaces contained within the enclosed space.
[0035] The term “rapid boiling” as used herein refers to a process in which a liquid is exposed to thermal energy over a very short period of time sufficient to achieve full or partial transition to the vapour phase. The term “flash evaporation” conventionally involves depressurisation in combination with phase change, however in the field of vapour decontamination technology the term is used to refer also to the vaporisation of a stream of hydrogen peroxide solution applied under gravity or by way of a pump to a heated surface, typically within a heated airflow. This dropping of liquid peroxide onto a hot plate in order to achieve near instant phase change is more fully described in, for example, US20140037496A1. In contrast, rapid boiling occurs when a supply of hydrogen peroxide solution is introduced into a passageway or conduit which is heated sufficiently to enable progressive rapid boiling of the solution as it progresses through the passageway and exits as a vapour. In embodiments of the present invention, rapid boiling of hydrogen peroxide in aqueous solution occurs prior to combination of the subsequent vapour with a non-heated carrier gas.
[0036] The term “vapour generator” is used herein to denote apparatus that houses inter alia one or more of: a supply of hydrogen peroxide; vapour generation systems - such as one or more vaporiser units; transport mechanisms - e.g. one or more pumps - for conveying the hydrogen peroxide from a supply reservoir, through the apparatus and to vent to the atmosphere; one or more sensors; one or more controllers; communication systems to permit operational telemetry and remote control if desired; atmospheric control and distribution mechanisms; and a power supply. The aforementioned list is not limiting and it is appreciated that the apparatus of the invention may further comprise a range of units, modules and mechanisms that may permit for mobile or static installation, as well as devices that permit cooperation or communication with ancillary apparatus including but not limited to: atmospheric control and distribution systems, catalytic scrubbers, irradiation devices, heaters, chillers, refrigeration systems, robotics and automation, autonomous vehicles, process supervisory control and data acquisition systems (e.g. SCADA), and such like. The vapour generator may be comprised within a static unit or comprised within a mobile apparatus. In an embodiment of the invention the mobile apparatus is comprised within a robotic system or autonomous vehicle.
[0037] The term “vaporiser” or “vaporiser unit” is used herein to denote a device comprised within or in communication with the vapour generator that effects conversion of aqueous hydrogen peroxide to vapour phase via a rapid boiling step prior to venting the vapour into a carrier gas stream.
[0038] The term “carrier gas” is used herein to denote a gas that is used to distribute the hydrogen peroxide from the vapour generator into an atmosphere comprised within an enclosed space. Typically the carrier gas will be relatively inert and will not interact chemically or physically with the hydrogen peroxide vapour. Suitably, the carrier gas is selected from one or more of air (including dehumidified air); nitrogen; argon; and carbon dioxide. The vapour may be applied to the carrier gas via one or more vents or injection ports. Typically, the carrier gas is accelerated into a gas flow or stream that passes through or by such vents or ports.
[0039] The term “non-heated” in relation to the carrier gas is used herein to denote that the gas may be employed at a temperature substantially ambient to that of the vapour generator - e.g. the ambient temperature of the enclosed space to which the vapour is to be applied. According to embodiments of the present invention the carrier gas is not subjected to any thermal treatment within the apparatus prior to combination with the hydrogen peroxide vapour. Such a gas may also be referred to as unheated.
[0040] Utilising a stream of carrier gas that is unheated and substantially ambient to the enclosed space to which the vapour is applied is desirable not just from an energy saving perspective, but also from a practical point of view. Firstly, a heated stream of carrier gas presents issues for products that display high levels of temperature sensitivity, such as cell or gene-based products. This is becoming a more important issue with increasing investment and research into cell and gene-based therapies, including stem cells, as current decontamination systems can result in temperature increases of up to at least 5° C. in the space to which the decontaminant vapour is applied as well as the formation of local ‘hot-spots’ in the direct line of the heated airstream.
[0041] Secondly, current systems employing heated carrier gas streams can encounter issues when decontaminating relatively small chambers due to the introduction of excessive heat. The heated carrier gas causes the temperature of the atmosphere and surfaces to increase, driving away the dew-point of the decontaminant vapour and preventing the laying down of sufficient decontaminant for effective inactivation of micro-organisms. This leads to the requirement to prolong the gassing phase of the decontamination treatment so more decontaminant is introduced into the chamber. However, since the carrier gas is heated, this also introduces more heat into the chamber. In addition to exacerbating the issues described above when dealing with temperature-sensitive products or reagents, the additional heat drives away the dew-point of the decontaminant vapour even more and also provides more heat to surfaces in the chamber. Both of these factors make it harder for the decontaminant to condense out of the carrier gas stream and onto the surfaces, which can result in challenges with the decontamination performance. The use of heated carrier gas streams in small chambers or enclosures therefore leads to a recurring feedback loop which is never able to adequately solve the issues experienced with unsatisfactory decontamination performance.
[0042] It is therefore clear that vapour decontamination methods and apparatus would benefit from the use of an unheated stream of carrier gas. However, with current systems, this has proven to be a challenge, with a reduction in the temperature of the carrier gas causing the process to ‘stall’ and have the decontaminant vapour condense out of the carrier gas stream in characteristic puffs of white ‘smoke’ which comprise locally condensed vapour, thereby reducing the effective operation of the system. Operating current systems without any heating of the stream of carrier gas can lead to immediate condensation of the decontaminant, with puddles of liquid decontaminant forming under the apparatus. The embodiments of the present invention aim to address these issues and provide a vapour decontamination system that can operate successfully without requiring the use of a heated stream of carrier gas.
[0043] With reference to
[0044] The apparatus (1) may also be accompanied by environmental sensors to determine the efficacy of the decontamination process such as biological indicators, chemical indicators, enzymatic indicators or any other indicator that measures the decontamination process. These indicators (4) are positioned at challenge locations within the enclosed space, such as in corners and behind furniture or installed equipment, or may be placed in locations within the enclosed space where the temperature is identified as being higher - e.g. localised hot-spots where dew formation is least likely to occur. The sensors may also measure the environmental conditions within the enclosed space such as an instrumentation module (5) that can contain one or more sensors such as a humidity sensor, a pressure sensor, a temperature sensor or decontaminant concentration sensor. It is possible to include one or more of these sensors in the vapour generating apparatus (1) as an alternative embodiment of the instrumentation module.
[0045] An embodiment of the vapour generating apparatus (1) is shown in
[0046] The vaporiser unit (8) comprises a body that is constructed from a thermally conductive material, such as anodised aluminium, stainless steel, etc. The body comprises a hollow lumen (10) in the form of a bore extending longitudinally therethrough that receives liquid decontaminant at a first end and vents vaporised decontaminant from a second end (see
[0047] The vaporiser unit (8) is heated and controlled to a temperature in excess of the boiling point of the decontaminant solution. The decontaminant solution enters the vaporiser via a port (9) located at the first end of the lumen (10). The temperature of the decontaminant solution is rapidly elevated to boiling point and transitions from liquid to vapour phase, in turn causing gaseous expansion that contributes to accelerated travel along the vaporiser lumen (10) to exit the unit (8) at the second end. The decontaminant is maintained in the vapour phase as it travels along the lumen (10). In an embodiment, the unit (8) further includes a baffle (13) which restricts any non-vaporised decontaminant droplets from continuing along and exiting the unit (8). Non-vapour droplets remain within the main section of the lumen (10) and are subsequently vaporised and may then pass through the baffle unhindered. In an alternative embodiment, the unit (8) is angled substantially vertically or slightly off vertical, for example between about 1 and about 89° of the horizontal, allowing for the use of gravity to segregate the vaporised and non-vaporised decontaminant.
[0048] In the embodiments shown in
[0049] The heated and expanding decontaminant vapour is vented from the second end of the lumen (10). An impeller (14), such as a fan, can be used to mix the vapour with the atmosphere and distribute it within the enclosed space. In an alternative embodiment, the vapour may exit the vaporiser unit (8) into a conduit. A fan or other form of impeller (14) may be located within or proximate to the conduit. In one embodiment, the apparatus (1) may comprise ducting whose ends are open to the enclosed space and in which the impeller (14) is located. The conduit may vent the vapour into the ducting to enable mixing of the vapour with the carrier gas, such as air, prior to dispersal in the enclosed space. It is apparent that there is no requirement for preheating or other thermal treatment of the carrier gas within the apparatus (1) prior to combination with the decontaminant vapour either in the conduit, ducting or in the enclosed space.
[0050] In use, at a point dictated by the starting humidity and temperature of the air within the enclosed space and the partial vapour pressure of the decontaminant, the atmosphere within the enclosure becomes saturated and no longer capable of supporting further addition of decontaminant vapour. At this point, termed the “dew-point”, the decontaminant starts to lay down onto the surfaces within the enclosure as micro-condensation. The micro-condensation is not always visible to the naked eye and droplets can be less than 3 microns in diameter. Addition of further vapour to the enclosure, results in a thickening of the condensation on the surface. Micro-organisms on the surfaces within the enclosure are subject to the decontaminant micro-condensation, inactivating them (see Unger-Bimczok & Kottke (2008) J. Pharm Innov. 3:123-133). The required contact time of the decontaminant micro-condensation with the micro-organism is dependent on the physiological structure of the micro-organism and its relative resistance to inactivation by decontaminants such as hydrogen peroxide. Once sufficient contact time has elapsed, the decontaminant decomposition units (2) are activated removing the decontaminant and rendering the enclosed space fully decontaminated and safe for reoccupation and use. The vapour decontamination cycle may be repeated to provide increased assurance of microbial inactivation, if required.
[0051]
[0052] An alternative configuration is presented in
[0053] An alternative embodiment of the invention is shown in
[0054] As with previous embodiments, the walls of the vaporiser unit (8), and consequently the lumen (10), are heated by a heating element (11) embedded in the vaporiser unit (8) to enable the liquid decontaminant that enters the lumen (10) to be vaporised. As before, a temperature sensor (12, not shown in
[0055] The heating of the lumen (10) by the heating element (11) ensures vaporisation of the liquid decontaminant by rapid boiling while it is in the first chamber (10a). As discussed above, rapid boiling involves a liquid being exposed to sufficient thermal energy over a short period of time to ensure full or partial transition to the vapour phase. As such, when in the first chamber (10a), the liquid decontaminant is heated under the action of the heating element (11) to rapidly elevate its temperature by rapid boiling, so it transitions from the liquid to vapour phase. The rapid expansion of the liquid decontaminant as it vaporises creates a pressure gradient that drives the vapour from the first chamber (10a) towards the second chamber (10b).
[0056] The vapour sieve (13) works to prevent liquid decontaminant from entering the second chamber (10b). As in the embodiments described above, the vapour sieve (13) may take the form of a baffle, or an arrangement of baffles, but it may equally take the form of a physical sieve to prevent the passage of liquid decontaminant between the first and second chambers. Through the action of the vapour sieve (13), non-vaporised decontaminant remains in the first chamber (10a), where it is eventually vaporised and passes through to the second chamber (10b). It should be noted, however, that the residency time of the decontaminant within both the first and second chambers (10a, 10b) is extremely short, such that there is effectively no breakdown of the decontaminant when travelling through the lumen (10). This is especially important when using a volatile decontaminant, such as hydrogen peroxide.
[0057] The second chamber (10b) is heated by the action of the heating element (11) and keeps the temperature of the vaporised decontaminant high to avoid so-called ‘stalling’ of the vapour, where it condenses. As a further mode of protection against the passage of liquid decontaminant through the lumen (10), the vaporiser unit (8) can be arranged so that the lumen (10) is aligned vertically or angled to the horizontal. In this way, gravity provides an extra force to resist the passage of liquid decontaminant through the system. The lumen arrangement described above may also be incorporated into the embodiment of the vaporiser apparatus (1) shown in
[0058] The distribution header (20) is, shown schematically in
[0059] The distribution header (20) shown in
[0060] The aim of the distribution header (20) is to provide greater control of the vapour that is vented into the carrier gas stream, such that the carrier gas stream does not need to be heated to avoid the vapour stalling. The vaporised decontaminant upon leaving the second chamber (10b) has high thermal energy and also a high kinetic energy, driven by the large pressure gradient arising from the rapid boiling of the decontaminant in the first chamber. The distribution head (20), having a greater volume then the first or second chambers (10a, 10b), acts to partially neutralise the effect of the pressure gradient, thereby reducing the kinetic energy of the vaporised decontaminant while keeping the thermal energy high through thermal contact with the heating element (11). It should be understood that only the base of the distribution header (20) is provided with thermal energy, thus negligible heat transfer occurs into the carrier gas. The distribution header (20) can also be insulated to prevent unwanted heating of the carrier gas. By venting the vaporised decontaminant with lower kinetic energy, the decontaminant is more easily entrained within the flow of the carrier gas stream, enabling the carrier gas to perform its function without requiring additional heating.
[0061] Depending on the number and position of the impellers (14), the number and position of the distribution outlets (22) on the surface of the distribution header (20) may vary in order to optimise take-up of the vaporised decontaminant by the carrier gas stream. In a certain embodiment, the distribution header (20) takes the form of a triangular prism, as seen in
[0062] In certain embodiments, the impeller (14) may be positioned below the vaporiser assembly (1), such that the carrier gas stream is generated upstream of the distribution outlets (22). Such a configuration avoids interference with the vaporised decontaminant from cavitational effects arising from pressure differentials at tips of the blades of the impeller (14), which can trigger stalling of the vapour and failure of the system, with droplets of condensed decontaminant being produced.
[0063] The vaporiser apparatus (1) may additionally comprise a ducting system to guide the flow of the carrier gas before and after entrainment of the vaporised decontaminant. The ducting system may comprise separator panels (not shown) above the distribution header (20) to separate the vaporised decontaminant emanating from each distribution outlet (22). This ensures even take-up of vapour across the carrier gas stream and more even distribution of decontaminant around the enclosure.
[0064] The ducting system of the vaporiser apparatus (1) may further comprise guide panels (not shown) to guide the carrier gas stream and the entrained vaporised decontaminant as it exits the vaporiser and assist with the distribution of the carrier gas and vaporised decontaminant throughout the enclosure. In certain embodiments, the guide panels comprise a substantially horizontal cover panel for the vaporiser apparatus (1) in combination with angled panels to define a vent through which the carrier gas and vaporised decontaminant can leave the apparatus (1) and enter the enclosure. The angled panels may be contiguous with the separator panels.
[0065] The embodiments described above allow the utilisation of unheated carrier gas by minimising the risk of stalling of the decontaminant vapour. As discussed above, the use of an unheated carrier gas stream presents solutions to the issues experienced with the use of current systems employing heated carrier gas streams in small spaces and for temperature sensitive products.
[0066] However, the use of an unheated carrier gas stream has other advantages. By obviating the need to heat the carrier gas, the apparatus (1) of the invention requires a significantly lower power draw, consumes significantly less energy than systems where the carrier gas is heated and can be designed with smaller volume and lower weight. Without the need to heat the carrier gas, the apparatus (1) provides faster operation with smaller and lighter equipment and shorter decontaminating cycles, as there is no need to get the equipment needed to heat the carrier gas up to temperature. Taken together, these advantages lead to a significantly reduced carbon footprint.
[0067] With only one heater, electrical control of the apparatus is significantly simplified. In addition, the simplicity of design of the vaporiser apparatus allows for significant reductions in the complexity of manufacture compared to prior art systems, reducing manufacturing costs and improving reliability. These benefits are therefore also significant contributors to the enhanced environmental credentials of the methods and apparatus described.
[0068] The aforementioned embodiments are not intended to be limiting with respect to the scope of the appended claims, which follow. The choice of decontaminant, its rate of vaporisation, the specific design of the vaporiser unit and the quantity of carrier gas is believed to be a routine matter for the person of skill in the art with knowledge of the presently described embodiments. It is contemplated by the inventors that various substitutions, alterations, and modifications may be made to the invention without departing from the spirit and scope of the invention as defined by the claims.