METHODS AND APPARATUS FOR DECONTAMINATING ENCLOSED SPACES
A portable apparatus for decontaminating an enclosed room or other space includes a passageway having an air inlet at one end and an outlet at the other end. A pump causes a flow of air through the passageway from the inlet to the outlet. A heater heats the air flowing through the passageway to a predetermined temperature, a evaporator being in communication with the passageway. Liquid decontaminant is pumped from a supply of decontaminant to the evaporator to be evaporated and for the evaporant to be delivered to the air flow in the passage to flow in the air flow from the outlet to the rooms to be decontaminated. A universally rotating nozzle is provided at the outlet to distribute the decontaminant containing air throughout the enclosure.
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This application is a divisional of U.S. patent application Ser. No. 10/509,192 filed Sep. 24, 2004, which is a U.S. nationalization of PCT Application No. PCT/GB03/01386, filed Mar. 28, 2003, which claims priority to United Kingdom Application Nos. 0207452.4, filed Mar. 28, 2002 and 0211851.1, filed May 22, 2002, the disclosure of which are incorporated herein by specific reference.
BACKGROUND OF THE INVENTION1. The Field of the Invention
This invention relates to methods and apparatus for decontaminating enclosed spaces such as hospital wards and clean rooms in which a manufacturing or other processes take place in sterile conditions.
2. The Relevant Technology
Vaporized aqueous solution of hydrogen peroxide has been used to decontaminate the internal surfaces of enclosures used for aseptic processing in the pharmaceutical industry since about 1990, but it has always been difficult to use the same technology to decontaminate larger enclosed volumes such as rooms.
The conventional apparatus for decontaminating enclosures comprises a gas generator in a closed circuit including the enclosure such as described in U.S. Pat. No. 5,173,258. In this design the hydrogen peroxide and water vapors are produced by flash evaporation of an aqueous solution into a heated air stream, which then carried the gas to the space to be decontaminated. The air and mixture of gases then mixes with the air inside the chamber before being returned to the gas generator, where the gas is decomposed, dried, heated and more liquid is flash evaporated and the air mixture is returned to the chamber.
The processes performed on the returned gas are complex, and include the steps of decomposing the gas, drying and re-heating. This complete process was considered necessary because it was understood that the hydrogen peroxide gas decomposed according to a half-life rule and hence to maintain an adequate concentration inside the chamber a circulating system that decomposed the gas was thought to be necessary.
Recent work by Watling, ISPE Conference Zurich, September 1999 has shown that the gas does not decompose but is stable. It is therefore not necessary to remove the returning gas from the chamber.
S. S. Block reports in the 5th Edition of Disinfection, Sterilization and Preservation page 189 that a 3% hydrogen peroxide aqueous solution gives a log 8 reduction of Staphylococcus aureus in under 20 minutes. A slower rate of deactivation has been found in experimental work when exposing Staphylococcus aureus to gas generated from 35% solution, when the process was operated at a temperature below the dew point thus causing condensation. Under these gassing conditions the first droplets of dew form on the organism at a much higher concentration than that of the original liquid, typically about 65% w/w, the exact value depending on the moisture content of the carrier gas.
As stated above, in the conventional system the air in the chamber to be decontaminated is dried prior to injecting the decontaminating gas. This is done either to allow a high level of gas concentration to be achieved before the onset of condensation, or to operate the process avoiding condensation maintaining the gas in a dry state. The vapor pressure equations for hydrogen peroxide and water may be used to calculate the concentration of the hydrogen peroxide and water vapor that will cause condensation and hence may be used either to avoid the conditions that will cause the onset of condensation or to calculate the concentration of any condensate that may be formed as a result of passing the flash evaporated vapors into the sealed enclosure. If the RH in the chamber is high the condensation will form quickly but as a relatively weak solution. Evaporating 35% w/w hydrogen peroxide into a chamber at 20° C. and 85% RH will cause the condensate to form at in excess of 6% w/w, although the concentration of the vapor will be about 120 ppm. It is well known that 6% hydrogen peroxide is active against microorganisms and will cause bio-deactivation of surfaces. If it is intended to operate a process where condensation is formed it is therefore not necessary to reduce the humidity in the chamber under normal operating conditions as the RH will be less than 85% and hence the condensation will form at a concentration greater than 6%. The same is not true when operating a process that is intended to avoid condensation, in such a process it is essential to ensure that the moisture content of the air inside the enclosed space at the start of the process is low.
It is believed that the difference between the liquid process as reported by Block and a gaseous dew process is the rate of delivery of the hydrogen peroxide condensation. It follows that using a standard recirculating gas generator placed outside the space to be bio-decontaminated; there may not be an adequate evaporation capacity to achieve a sufficiently high condensation rate to deactivate the organism inside the chamber. The deactivation process may be enhanced by the use of mixtures of chemicals but the principal of the rate of delivery still remains. Whilst for a dry gas process the rate of delivery of hydrogen peroxide and water vapor are not so critical it is still important to evaporate the liquid as fast as is practical as this will shorten the time required to raise the gas concentration and achieve a satisfactory bio-decontamination.
An analysis of the equations governing the vapor pressure of water and hydrogen peroxide by Watling et al and published in the PDA Journal of Science and Technology November/December 2002 vol 56, No 6 291-299, shows that the gas concentration inside a chamber may be raised to the dew point by passing flash evaporated vapor into the sealed enclosure, but as soon as the dew point is reached condensation will form at a higher concentration than the evaporated liquid thus reducing the gas concentration. The gas concentration will continue to fall as more liquid is evaporated until the equilibrium vapor pressure for the evaporated liquid is reached at the temperature of the chamber.
There are two views about the mechanisms involved in the bio-decontamination using hydrogen peroxide and water vapor. The first is that it is important to ensure that the gas remains in the dry state and the second that condensation is essential. It has been well established that dry hydrogen peroxide gas at elevated temperatures will bio-deactivate micro-organisms, and the same dry process has been shown to work at room temperatures. The condensation process in which the gas concentration is raised to the dew point and condensation is allowed to form appears to be faster at room temperatures.
SUMMARY OF THE INVENTIONThe apparatus and method described in the present invention will work equally well with both the dry and condensation processes. When operating a dry process it is essential to monitor the water and hydrogen peroxide concentration in the gaseous phase to ensure that they remain below the saturated vapor concentrations. When operating a condensation process it is helpful to have an indication of the point during the cycle when condensation starts to form and the subsequent rate of formation. A technique and apparatus to make such a measurement of condensation is described patent application UK 0291983.1
An ideal bio-decontamination cycle is in three phases. The first phase is to bring all of the equipment to thermal stability but may also be used to adjust the relative humidity in the chamber to a pre-set level, the second is used to raise the gas concentration to the required level and maintain that concentration for a sufficient length of time to achieve the required level of bio-decontamination, and the third and last phase to reduce the concentration of the sterilant in the enclosed space to a predetermined value.
U.S. Pat. No. 4,863,688 discloses a method of selectively destroying organisms within a chamber such as an incubator comprising the steps of introducing vapor phase hydrogen peroxide into the chamber at a rate sufficient to cause a predetermined concentration of hydrogen peroxide to be reached while preventing a substantial change in pressure or condensation of the hydrogen peroxide in the chamber. When the predetermined period of time has elapsed, the vapor phase hydrogen peroxide is removed from the chamber. In a preferred embodiment disclosed an incubator is provided with a separate apparatus for producing a flow or air containing hydrogen peroxide vapor which is delivered to the incubator. Alternatively the apparatus for producing the air flow containing hydrogen peroxide vapor may be built into the incubator.
RU-C-2054295 discloses a device for sanitary treatment of air for use in livestock and poultry facilities and in various branches of industry including biological, food, light industry, chemical, coal, construction and other applications. The device includes a housing with an inlet and an outlet, a heating element, disinfected evaporator in the form of a perforated header closed at one end and enclosed in a porous sheath, the header is installed along the housing axis. The device has a reservoir containing disinfectant solution secured to the housing and connected to the open end of the evaporator. The tubular evaporator is arranged in the porous sheath along a spiral line and the heating element is mounted within the centre of the spiral.
This invention provides a method of decontaminating an enclosed space comprising the steps of providing an aqueous solution of hydrogen peroxide in the enclosed space, producing hydrogen peroxide/water vapor from said aqueous solution, creating an air stream in the enclosed space, introducing hydrogen peroxide/water vapor into the air stream, distributing the hydrogen peroxide/water vapor containing air stream throughout the space to be decontaminated and then removing the hydrogen peroxide/water vapor from the space; characterized in that the air stream is heated before hydrogen peroxide/water vapor is introduced to it, the hydrogen peroxide/water vapor is flash evaporated from an aqueous solution of hydrogen peroxide/water vapor from said supply into the air stream, and the air stream carrying the flash evaporated hydrogen peroxide/water vapor is distributed throughout the enclosed space to achieve bio-decontamination of the enclosed space.
By placing the gas generator inside the room and simply heating the carrier gas and then evaporating this sterilant into the air stream it is possible to use the available energy much more efficiently. The increase in efficiency is derived from the removal of the system for decomposing and drying the carrier gas, and also because there is no need for any pipe work to transport the carrier gas and decontaminant from an external generator.
This increased efficiency provides more energy for the primary function of heating the carrier gas and flash evaporating the liquid. The efficiency increase is so great as it allows a trebling of the rate of flash evaporation from the same energy source and hence the rate of increase in the gas concentration or the achievable rate of formation of condensation once the dew point has been reached is also trebled.
The simplified design is also much smaller and lighter than a conventional gas generator and hence considerably less expensive to manufacture. It is therefore realistic to place a number of such devices inside a sealed enclosure to be decontaminated. This reduction in size and weight makes the apparatus portable and hence makes it practical to use the same apparatus to bio-decontaminate a number of facilities either on the one site or at different locations. As stated above it is important to make measurements of the hydrogen peroxide and water vapor concentrations.
To satisfy this requirement an instrument module that is placed inside the enclosed space has been devised that will also link back to the control system that is external to the enclosed space. Provision has been made within the control systems both at the gas generator (s) and the instrument module to connect a number of condensation sensors so that the process may be operated either as a dry gas or as a saturated vapor process Each simplified generator will have its own control system, which is linked to a control box external to the room and connected by a single control cable. By using a central control system, such as a laptop computer, it is possible to control a number of generators that are linked together from outside the enclosed space. With the present arrangement it is possible to control eight generators from a single laptop, should a larger number be required a second computer would be needed. It is also possible to control multiple aeration units and dehumidifiers from the same laptop computer.
Because the apparatus is portable and may therefore be used at different sites in order to ensure that the apparatus does not carry contamination from one location to another it is essential that all of the external and internal surfaces are bio-decontaminated during the gassing cycle. To achieve this objective components have been mounted in such a way to ensure that they are exposed to the sterilizing gas. The tubular steel frame has been sealed and the control box is purged with the sterilizing gas drawn from the room. Tests have been performed to check that following a bio-decontamination cycle all of the surfaces of the apparatus have been rendered safe.
Various embodiments of the present invention will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.
The gas generator apparatus will be described firstly with reference to
The heated air then passes into an evaporator 14 where a liquid sterilant comprising aqueous hydrogen peroxide is flash evaporated. By way of example, the sterilant may comprise an aqueous solution containing 30 to 35% hydrogen peroxide. If the sterilent includes peracetic acid, the proportion of hydrogen peroxide can be reduced to 15% with 0.5% peracetic acid and a balance of water. In practice the heater 13 and the evaporator 14 are combined in a single unit as shown in
A supply of aqueous hydrogen peroxide liquid is stored in a container 15 and is pumped to the evaporator 14 by a liquid pump 16. The carrier gas and vapors are delivered from the evaporator through a conduit 17 to a distribution nozzle 18 for delivery of the sterilant vapor to the space to be decontaminated. The liquid container is demountable from the frame 19 to reduce the weight of the unit and make it more easily hand carried.
The tubular framework is sealed to prevent any contamination being introduced to the enclosure by the frame. Ideally, the apparatus should not be placed inside a housing unit. Any covering of the apparatus would restrict the sterilant gas movements around and through the apparatus, which is essential to ensure that the apparatus itself is also surface decontaminated because otherwise it may contaminate the area in which it is placed.
Multiple units may be provided as necessary and separate fan units may also be provided to circulate the sterilant atmosphere throughout the room or enclosure.
An ideal decontamination cycle may have three distinct phases. In the first optional phase, the relative humidity in the room or other enclosure is adjusted to a pre-set level. In the second phase the gas concentration of sterilant gas is raised to form a required layer of condensation over all surfaces in the enclosure for a sufficient length of time to achieve the required level of decontamination. In the third and last phase the sterilant is removed from the enclosure. This is achieved using the room aerator system described and illustrated in International Patent Publication No. WO 02/11864.
If a HVAC system is available for the room or enclosure then this may be used to achieve the required level of relative humidity at the start of the process, and if the HVAC exhausts to a safe area to remove the sterilant at the end. Alternatively a portable dehumidifier may be used to adjust the initial relative humidity and a catalytic scrubber used to circulate the gas to remove the sterilant.
In the decontamination cycle referred to above the initial phase of treatment in the adjustment of the relative humidity in the room or chamber may be omitted and the process commenced at the current prevailing conditions in the enclosure since the relative humidity in the enclosure would normally be well below dew point and so a considerable amount of sterilant/water vapor would need to be generated in the enclosure before condensation would occur.
Reference is now made to
The upper end of the block also has a cylindrical recess 34 and a central top plate 35 is mounted on the periphery of the block over the recess by set screws 36. The top plate 35 has a central aperture 39 in which an outlet conduit 40 from the block is mounted.
The block is formed with a central cylindrical cavity 37 extending into the block from the upper end thereof in which the outlet conduit 40 extends stopping short of the bottom of the cavity. The block 30 has a multiplicity of axially extending passageways 38 adjacent the outer surface of the block and spaced around the block leading from the lower recess 31 and the block upper recess 34 for flow of air from the bottom recess to the top recess from where the air can flow into the cavity 37 and thence into the outlet conduit 40. The liquid sterilant from the storage container 15 is delivered via one or more inlet conduits 41 providing injection points which extend through the top plate 35 adjacent to the outlet conduit 40. The conduits 41 lead into the cavity 37 in the block but stop short of the bottom of the cavity. A second inlet conduit 41 is shown and preferably three such conduits are provided at spaced locations around the outlet conduit.
The body 30 is encircled by a cylindrical jacket in which an electrical resistance heater 42 is mounted for heating the body 30 to a requisite temperature to pre-heat the airflow through the block and also to ensure that sterilant delivered by the conduit 41 to the bottom of the cavity 37 of the block is flash evaporated from the bottom of the cavity to produce a vapor which is entrained in the flow of air through the flow of heated air through the outlet conduit 40 for delivery into the room to be sterilized.
The heating unit of the heater-evaporator is coupled to the control unit to the apparatus and a temperature probe 44 is mounted in a radial drilling 45 in the body 30 below the cavity 37 to measure the temperature of the body for adjusting, through the control unit, the power supply to the resistance heating element to enable the body to be maintained at a requisite temperature for pre-heating the air flowing through the body and flash evaporating the sterilant delivered to the body.
The heater has an upper chamber 57 in which an outlet conduit 58 is mounted having ports 59 spaced around the conduit through which air can enter the conduit from the upper chamber as indicated by the arrows. The lower end of the conduit is closed by an air deflector 61 which partially overlies the evaporation plate and causes the air flow emerging from the port 54 in the evaporator heater to disperse outwardly over the evaporator plate before flowing upwardly and hence through the port 59 into the inlet conduit. Delivery tubes for aqueous hydrogen peroxide extend downwardly through the upper chamber 57 to stop just short of the surface of the evaporation plate to drip aqueous hydrogen peroxide onto the plate which flash evaporates and is entrained in the air flow over the plate which passes upwardly into the outlet conduit 58. The arrangement is otherwise similar to that of
Reference is now made to
A liquid pump 74 is mounted on one side of the box powered by an electric motor for delivering aqueous hydrogen peroxide to the evaporator. A mains cable connection for the unit for the various motors and other devices requiring power supply is indicated at 75. The cable also provides couplings to the controllers 76 for the unit which are mounted on the inside of the lid 71.
To ensure that contamination does not reach the enclosure from the interior of the control box for the gas generator, a fan 77 is mounted on one side of the control box to deliver air carrying sterilant from the surrounding atmosphere in the enclosure through the control box to sterilize the interior surfaces of the control box.
Reference is now made to
The apparatus described particularly with reference to
Thus each of the components of the equipment required to sterilize a room, that is the gas generating apparatus, the gas distribution system, the instrument-module, the dehumidifier and the aeration unit are all manufactured such that they can readily be carried by a single person.
Reference is now made to a further form of apparatus in accordance with the invention shown in
The heated air carrying the sanitant vapor is passed to a distribution plenum 108 and exits to the room at high velocity through one or more nozzles 109.
Provision is made either to connect a number of optical type condensation monitors 120 directly to the gas generator and hence to a control module 121 (see
Connecting condensation monitors to the gas generator has the advantage of reducing the number of connections to the control module, especially when a number of gas generators are used.
The condensation monitors are placed around the room at the locations where the rate of condensation is the lowest.
A complete multiple installation is shown in
The normal technique to establish if a decontamination process has been successful is to place Biological Indicators (BIs), in those parts of the chamber where it is the most difficult to achieve a kill. It is often undesirable or not permitted to place BIs in a room, but it is necessary to know that deactivation to the required level has been achieved.
To overcome this difficulty condensation monitors may be used to establish that the mass and the rate of formation of condensate are sufficient to achieve deactivation of the microorganisms on the surfaces. It has been well established that once the required conditions have been achieved that the “D” value for the most resistant organisms is about two minutes.
Therefore an exposure of the organisms under the correct conditions for twelve minutes will achieve a log 6 reduction in the count of viable organisms.
Satisfactory decontamination will only be achieved in a room if a sufficiently high rate of liquid sanitant vapor is delivered into the room to provide an adequate rate of formation of condensation.
But to be assured that decontamination has been achieved it is necessary to measure the condensation levels with time in multiple locations in the room.
The data from the condensation monitors together with the information from the other instruments in the room may then be used to establish that a satisfactory deactivation cycle has been completed.
The condensation sensors may be used in one of two ways. The first is to measure and then control the level of condensation by adjusting the liquid evaporation rate and the second is simply to use the monitor as a switch. When used as a switch it simply gives a signal when an adequate amount of condensation has formed and the process is then considered to be complete or allowed to dwell in that state giving a sufficient period during which the organisms are killed. There is a further variation to the “switch” method in which two sensors are used at each location set at different levels of condensation. The first indicates when condensation has started and the second when the level of condensation is sufficient to have caused a satisfactory level. It may then be necessary to have a “dwell” period during which the kill occurs.
The condensation monitors of the above apparatus are optical devices which measure the layer of condensation. An electronic device may be used instead that gives a switch signal when a known level of condensation has arrived. The switch level depends on the construction of the sensor plate. Sensor plates are single use disposable items and hence are inexpensive. The plates plug into a box which may be placed at a remote location within the room.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
Claims
1. An apparatus for decontaminating an enclosed space comprising:
- means for providing a flow of heated air;
- means for delivering a liquid decontaminant to the heated air to be evaporated into the heated air to produce an air stream containing a vapor of the decontaminant for delivery to a space to be decontaminated; and
- a self contained unit comprising a duct to be positioned within the enclosed space having an inlet end and an outlet end, a fan for causing air to flow from the enclosed space through the duct, a filter for filtering air at the inlet end of the duct, means for holding a supply of aqueous hydrogen peroxide solution, means for delivering aqueous hydrogen peroxide solution from the means for holding to a heater to evaporate the aqueous hydrogen peroxide to produce hydrogen peroxide/water vapor which is entrained in the air flow passing through the duct, and a nozzle at the outlet end of the duct, all internal and external surfaces of the apparatus open to the enclosure being exposed to the hydrogen peroxide/water vapor carrying air in the enclosure to decontaminate the surfaces.
2. The apparatus as claimed in claim 1, wherein the components of the apparatus are mounted to a support for transport of the apparatus.
3. The apparatus as claimed in claim 2, wherein the self-contained unit is a mobile or portable unit for movement from location to location where it is to be used.
4. The apparatus as claimed in claim 3, wherein the supply of hydrogen peroxide/water vapor and/or the nozzle are readily removable for transport of the apparatus.
5. The apparatus as claimed in claim 1 further comprising a control box for controlling operation of the apparatus, wherein means are provided for delivering air causing hydrogen peroxide/water vapor from the atmosphere in the enclosure through the control box to decontaminate inner surfaces of the control box.
6. The apparatus as claimed in claim 1 further comprising a separate monitoring unit for monitoring the temperature of the atmosphere in the enclosure and the concentration of hydrogen peroxide/water vapor in the atmosphere, wherein means are provided for delivering a flow of air carrying hydrogen peroxide/water vapor through the enclosure of the monitoring unit to decontaminate interior surfaces of the monitoring unit.
7. The apparatus as claimed in claim 1 further comprising means for rotating the nozzle universally to deliver hydrogen peroxide/water vapor throughout the enclosure.
8. The apparatus as claimed in claim 1 further comprising means for continuously rotating the nozzle while the hydrogen peroxide/water vapor is dispersed therethrough.
9. An apparatus for decontaminating a space comprising:
- an elongated duct having a first end with an inlet opening formed thereat for receiving air from the environment surrounding the duct and having an opposing second end with a nozzle formed thereat for dispensing the air within the duct into the environment surrounding the duct;
- a fan coupled with the duct, the fan being configured to draw air from the environment into the duct through the inlet opening and to blow the air out of the duct through the nozzle into the environment;
- a heater coupled with the duct, the heater being configured to heat the air traveling through the duct;
- a container housing a supply of an aqueous hydrogen peroxide solution;
- an evaporator coupled with the duct downstream of the heater so that the heated air passes through the evaporator, the evaporator also being in fluid communication with the container so that when the aqueous hydrogen peroxide solution is delivered from the container to the evaporator, the aqueous hydrogen peroxide solution is evaporated by the evaporator to produce a hydrogen peroxide/water vapor that is entrained into the heated air flowing through the duct; and
- a pump configured to deliver the aqueous hydrogen peroxide solution from the container to the evaporator.
10. The apparatus for decontaminating a space as recited in claim 9, further comprising a support frame that supports the duct.
11. The apparatus for decontaminating a space as recited in claim 9, wherein the nozzle is freely exposed at the second end of the duct so that the air having the hydrogen peroxide/water vapor entrained therein can be dispensed therefrom into the environment surrounding the duct.
12. The apparatus for decontaminating a space as recited in claim 9, further comprising means for continuously rotating the nozzle while the air having the hydrogen peroxide/water vapor entrained therein is dispensed therefrom.
13. The apparatus for decontaminating a space as recited in claim 9, wherein the duct, fan, heater, container, evaporator and pump from a manually transportable unit.
14. The apparatus for decontaminating a space as recited in claim 9, wherein the evaporator is configured to perform flash evaporation of the aqueous hydrogen peroxide solution.
Type: Application
Filed: Jan 16, 2008
Publication Date: Oct 9, 2008
Applicant: Bioquell UK Limited (Andover)
Inventors: Nicholas Mark Turner Adams (Hampshire), David Watling (Dorking)
Application Number: 12/015,417
International Classification: A61L 2/20 (20060101);