METHOD AND APPARATUS FOR STERILIZING EQUIPMENT
Field of the Invention The invention relates to the sterilization of equipment such as medical equipment including surgical equipment, gloves, food preparation equipment and utensils.
Background of the Invention Hospitals and other related medical facilities clearly attract and retain microorganisms and enzymes which must be removed so as to maintain a hygienic environment. Many methods of sterilization are known such as the application of heat and pressure through high pressure steam or merely the application of heat such as baking ovens etc. Whilst the spread of microorganisms is vast, the equipment that can suffer heat pressure and moisture are more limited and, therefore, these traditional methods of sterilization will not work on certain heat and moisture sensitive items without causing damage.
Other methods for the sterilization of apparatus, materials, gases, liquids and waste products include compressed industrial steam for up to 20-30 minutes, administering antibiotics, chlorination, and irradiation with gamma-radiation or ultraviolet light.
Traditional methods such as steam/hot air sterilization whilst well established suffer from the problems of controlling the heat load associated with the steam or hot air. The risk to operators is clear, as is the restriction of such methods to articles that are not susceptible to heat damage or effect.
Further, because sterilization requires elevating the article and microorganisms to the specified temperature, there is also a time lag for the complete sterilization of such an article. For instance, such sterilization methods may take from 10 to 40 minutes. Irradiation techniques avoid the issues of controlling heat, but are limited to exposure to a particular radiation source. Whereas heat-based methods are effective in infiltrating the entire article, after the time lag for elevating the temperature, radiation methods rely on exposing the article to the radiation. Folds, inclined surfaces and other arrangements that shield a portion of the radiation will result in incomplete sterilization.
Further radiation techniques may have a mutagen effect on pathogenic germs, increasing the threat of hyper-resistant strains of the germ developing.
Statement of Invention
In a first aspect, the invention provides a sterilization system for sterilizing an object comprising: a pair of electrodes in spaced relation to each other so as to define a sterilization zone there between; an electrical supply connected to the said electrodes
and arranged to cause a high voltage discharge between said electrodes, and a control unit in communication with the electrical supply for controlling the rate of high voltage discharges, and the polarity of the electrical supply; wherein said electrodes each include an array of discharges sites for emanating and terminating the high voltage discharges.
In a second aspect, the invention provides a method of sterilizing an object, the method comprising the steps of: placing the object in a sterilization zone between a pair of electrodes each include an array of discharges sites for emanating and terminating the high voltage discharges; causing a high voltage discharge between said electrodes, and controlling the rate of high voltage discharges, and the polarity of the electrical supply; consequently providing a discharge density corresponding to the spacing of the array of discharges sites, and so; sterilizing the object. The invention relates to providing a high voltage large spectra discharge greater than 45kVand preferably 70kV. It has been found that a high voltage discharge creates a shock wave capable of rupturing the cell membrane of a micro organism, that is, acting like "electrical blast wave". In some prior art systems, to increase the efficiency, a gas is injected into the sterilization zone so as to create plasma when excited by current and so immerse the object in an ionized gas. Prior art systems often include a dielectric layer to the electrodes so as to specifically increase a corona discharge. Whilst the sterilization
system according to the present invention uses air in the sterilization zone, this is more for convenience and below cost as the sterilization system according to the present invention does not rely only on ionization for sterilization. Similarly, other gases which may be injected into this sterilization zone of prior art systems such as ozone are not required as again sterilization occurs as a result of the high voltage discharge.
The discharge may be varied such as changing polarity of the electrodes on a cyclical basis. A variation may include the rate of discharge such as at least 70 discharges per exposure. That is, for any given portion of the object to be sterilized, it will be subjected to a minimum 70 discharges. To this end, given the shock wave created by the discharge, a petite type of failure may also be observed in the membrane of the micro-organism.
Further still, the discharge may be a particular frequency and preferably in the range of 63 to 110 Hz so as to maximize membrane damage. This range, whilst harmful for human tissue and so avoided by prior art systems, has been observed to cover the range of resonant frequencies of water and so tends to remove water film around microorganisms which may act as a barrier around the cell membrane. Thus, by activating the discharge within this range, the efficacy of the shock wave applied to the cell membrane is increased through the removal of the water layer adhering through surface tension to the surface of the microorganism. Accordingly, the water layer surrounding the microorganism may be subject to detachment which may further impact the cell membrane and further assist the rupturing of said membrane.
This combination of varying the high voltage discharge at the specific frequency permits an object to be fully decontaminated in the range 3-30 seconds. Such process may be suitable for batch and continuous processes. To this end, objects for sterilization may be delivered to the sterilization zone using a conveyor. Because the sterilization system according to the present invention only requires air as a media, no special conditions for sealing the sterilization zone so as to maintain a gas concentration or pressure is required. With regard to the electrodes, whilst many materials will function as electrodes such as silver, copper, gold, etc, aluminum is a particularly useful material as the energy threshold in order to remove an electron for aluminum is somewhat lower than that of other metals and so is a more efficient ejector and so favouring a discharge. Because the system according to the present invention depends on maintaining a discharge density within the sterilization zone, electrodes are selected so as to include an array of discharge sites so as to promote a discharge to form. In one embodiment, the electrode may be perforated having discontinuous sharp edges of the perforation acting as discharge sites The perforations may be circular, rectangular, etc, and designed so as to provide the most efficient discharge sites as well as discharge density required for the specific application.
By providing these discharge sites a greater uniformity or homogeneity of discharge is possible as compared to the prior art. The prior art consistently teaches away from generating a high voltage discharge, one reason being the lack of control of said discharge, in terms of timing and/or location. By providing a known array of discharge sites, and maintaining the rate of discharge at minimum 70 per second, such parameters can be controlled in a manner unavailable to the prior art.
An individual discharge maintains an area of influence of about 5 to 20 mm in diameter and so it is not required that point on the object to be sterilized actually contact the discharge itself. Instead, with a discharge influence zone of 20 mm around the discharge, the number of discharge sites can be calculated so as to provide sufficient discharge within the required time. In a further embodiment, the rate of discharge may be 70 to 110 discharges per sec. An alternative arrangement for the electrode having discharge sites is to assemble the electrode using a plurality of sub-electrodes. In this case, each sub-electrode is connected to a power supply and is arranged to correspond to a sub-electrode in the opposing electrode assembly. In this way, the path of a discharge from one sub- electrode to the next may be predicted with great accuracy. Such an electrode may be said to be a "pixilated" plate or "pixilated" electrode. In this case, the power supply of each electrode may be separately controlled or alternatively there may be a single control unit which controls the individual sub-electrodes collectively.
In a further embodiment, as an alternative to a single fixed electrode of sufficient surface area to span the entire sterilization zone, a smaller electrode that is movable in a reciprocal movement relative to the object in a sweeping action, may be used. Accordingly, a pair of sweeping electrodes, moving reciprocally so as to define the sterilization zone may be used.. Alternatively, the system may include one sweeping electrode and one a fixed large electrode, with the sweeping electrode moving relative to the fixed electrode.
In a still further embodiment, rather than move the electrodes, instead the strip electrode may be fixed in place and the object mounted to a system to move the object relative to the fixed strip electrode and so be the reverse of the former arrangement.
Because of the lack of an enclosed space or the addition of gas under controlled conditions, the system according to the present invention may also be used in the sterilization of food, water or other liquids, and even air, subject to a sufficient density of discharges.
Brief Description of Drawings It will be convenient to further describe the present invention with respect to the accompanying drawings that illustrate possible arrangements of the invention. Other arrangements of the invention are possible, and consequently the particularity of the accompanying drawings is not to be understood as superseding the generality of the
preceding description of the invention.
Figure 1 is an elevation view of a sterilization system according to one embodiment of the present invention;
Figure 2 is an elevation view of an electro for a sterilization system according to a further embodiment of the present invention;
Figure 3 is an elevation view of an electro for a sterilization system according to a further embodiment of the present invention;
Figure 4 is an elevation view of an electro for a sterilization system according to a further embodiment of the present invention; Figures 5 A to 5C are various views of a sterilization system according to a further embodiment of the present invention;
Figures 6 A and 6B are various view of a sterilization system according to a further embodiment of the present invention;
Figure 7A is an isometric view of a glove sterilization system according to one embodiment of the present invention;
Figure 7B is an isometric view of a glove sterilization system according to a further embodiment of the present invention;
Figure 7C is an isometric view of a glove sterilization system according to a further embodiment of the present invention;
Figures 8A and 8B are experimental results of cultures showing with and without exposure to a sterilization system according to one embodiment of the present invention;
Figure 9 are experimental results showing various intensities of exposure to a sterilization system according to one embodiment of the present invention.
Detailed Description
Figure 1A shows a sterilization system 5 comprising a pair of electrodes 10, 15, defining a sterilization zone 20. A power supply 35 creates a potential difference across the electrodes 10, 15, such that a discharge 25 occurs. The system is arranged such that a sufficient density of discharge occurs within the sterilization zone during a sterilization period so as to sterilize or disinfect an object within the sterilization zone. Further, a control unit 40 in communication with the power supply 35 is capable of varying the potential difference and/or the polarity of the power supply so as to control
the potential difference, rate of discharges between the electrodes, the number of discharges during the sterilization period and reversing polarity between the electrodes. Further, the control unit 40 may perform each, or some, of these actions on a periodic or cyclical basis so as to vary conditions within the sterilizing zone. Such a variation in conditions within the sterilization zone may better aid the sterilization process so as to make it more efficient, effective or both. It will be noted that the sterilization zone may be at atmospheric pressure and further allow air within the system and so not rely on any further effects that a specific gaseous environment may provide. Figure IB is a cross-sectional view of the discharge 25 and the area of influence 30 around the discharge 25. In order to fully sterilize an object within the sterilization zone, it is necessary that the effects of the discharge cover each portion of the object. Whilst the cross-section of a discharge itself is relatively small, its sterilizing effects extend beyond that of the actual discharge into the area of influence 30. Thus, to expose an object for sterilization to a discharge-effective environment, the area covering the object will in fact be that of the area of influence and not merely the discharge itself. The size of the area of influence will vary under conditions, particularly the potential difference. For instance, at 70kV, the area of influence 30 is approximately 20 mm in diameter.
An essential characteristic of the invention is the generation of discharge so as to create a discharge density sufficient to sterilize the object. To this end, the electrodes include discharge sites in predetermined arrays so that the discharge density or concentration of
discharge from one electrode to the next is a matter of design and not mere randomness. To this end, the electrodes include discharge sites in a predetermine array in a predetermined space arrangement with each other. Figure 2 shows an electrode 45 having an array of discharge sites. In this case the discharge sites are circular perforations 50 in the electrode 45. Spacing of the perforations is such so as to ensure a specific discharge density, such as having an area of influence of a discharge of 5mm in diameter may place the perforations in a spaced arrangement so as to be less than 5mm and so create an overlap of area of influence between adjacent discharges. The discharge sites corresponding to the perforations include the discontinuous edges of the perforations leading to a concentration of charge and hence the discharge. The shape of the perforations may vary according to maximizing the number of discontinuous edges for the perforations as well as for manufacturing convenience. Said perforations may be rectangular, circular or such shape so as to achieve the desired discharge density within the sterilization zone.
Figure 3 shows an alternative electrode 55. In this case, the electrode is in fact a pixilated electrode comprising an array of sub-electrodes 60, each in communication with a power supply 65. Each sub-electrode 60 corresponds to a similarly placed sub- electrode in the corresponding electrode (now shown) such that the direction of a discharge from one sub-electrode is controlled so as to correspond with the next electrode. This is advantageous in controlling the size, space and operation of the sterilization zone by controlling the direction of each discharge. This is in contrast to
the perforated electrode of Figure 2 whereby one discharge may terminate at a discharge site in the corresponding electrode in a more unpredictable manner. Thus, whilst the pixilated electrode of Figure 3 may provide a degree of certainty, the perforated electrode of Figure 2 will have a cost benefit in manufacture. It will be within the selection of the designer to determine which alternative is best suited.
It will further be appreciated that an electrode comprising both perforations and sub- electrodes may be selected, such as having a central portion of sub-electrodes near the centre of the sterilization zone, and perforations for the remainder of the electrodes such that certainty is achieved near the centre but discharge density is maintained throughout the sterilization zone from the perforations. Such a hybrid electrode may be an appropriate balance in manufacturing cost and discharge control.
Figures 4 A and 4B are various views of a further electrode arrangement. Here, a U- shaped object 70 comprises a first electrode 75 A and a second electrode 75B separated by an insulator 80. As can be seen from Figure 4B, the electrodes are mere strips and so not having the surface area of a conventional electrode. However, the U-shaped electrode 70 is mounted to a motorized slide such as a rack and pinion or a belt-drive, or other similar arrangement which allows the vertical reciprocal motion 85 of the electrode. In this way, by creating a discharge between the electrodes 75A, 75B, and moving the electrodes 70 in a reciprocal motion 85, a virtual sterilization zone is created within the range of the reciprocal motion 85.
Such a moving electrode has a number of advantages, including a reduced number of materials of the electrode. Thus, the movable electrode may be a pixilated electrode without the large number of power supplies or connections required. Of course, the electrodes according to Figure 4 may also be a perforated electrode or other such electrode having an array of discharges sites. Further, with a virtual sterilization zone defined by the reciprocal motion 85, should it be necessary to sterilize objects of varying sizes, the sterilization system shown in Figure 4 can be adjusted to accommodate the different sizes by merely modifying the range of reciprocal motion 85 to accommodate the size. Figures 5A to 5C show similar variations to that shown in Figure 4. Figure 5B shows a pair of electrodes 100, 105 defining a sterilization zone 107. Both electrodes 100, 105 have a reciprocal motion range 95 similar to that of Figure 4. Figure 5C shows a further variation whereby a single movable electrode 110 moves in a reciprocal range 115. However, the movable electrode corresponds to a fixed electrode 120. It will be noted that as with Figure 4 each of the variations shown in Figures 5 A, 5B and 5C may be perforated electrodes, pixilated electrodes or combinations thereof.
Figure 6 shows a further variation whereby strip electrodes 125, 130, similar to those shown in Figure 5B. However, the strip electrodes of Figure 6 are fixed in place. The object 135, however, may be mounted to a motorized slide or belt drive, and moves in a reciprocal motion 140 passed the fixed strip electrodes 125, 130. Thus, Figure 6 is the reverse arrangement to that shown in Figure 5B whereby the object moves and the strip electrode are stationery.
By way of further example, Figures 7A to 7C show a further arrangement of the sterilization system according to several embodiments. Figure 7 A shows a first arrangement 150 where two electrodes 155, 160 are placed in proximity to each other, with an interstitial space defining a sterilization zone. The interstitial space is of sufficient size to accommodate a glove 180 to be sterilized through coronal discharge between the electrodes 155,160. Here the glove 180 is mounted to a bracket 175, which may in turn be mounted to a conveyor (not shown) or other such device to bring the glove into the sterilization zone.
The electrodes 155, 160 include arrays of perforations 165, 170 from which the coronal discharges emanate. Figure 7B shows a different arrangement 185 having a first electrode 195, which is similar to the electrodes of Figure 7A. On the opposed side of the sterilization zone is a second electrode 190 of much reduced size, but movable 200 in a reciprocal movement relative to the first electrode 195. The range of movement of the second electrode 190 is equivalent to either the length of the first electrode, or if different, at least for the full length of the object to the sterilized, in this case a glove 180.
The second electrode includes a similar array of perforations to that of the first electrode 195. This arrangement 185 operates by the coronal discharge being progressively
generated as the second electrode passes corresponding perforations of the first electrode.
Hence, whilst for the first arrangement 150 the coronal discharge is consistent and simultaneous throughout the sterilization zone, for the second arrangement 185 the high voltage discharge will only occur at the region where the second electrode corresponds to a portion of the first electrode. Consequently, the movement of the second electrode provides a "wave" of high voltage discharge sweeping over the glove 180. Figure 7C shows a third arrangement 205 whereby both electrodes 210, 215 are movable 220, 225 in a reciprocal movement. In this case, the movable electrodes 210, 215 move together, such that the sweeping wave of high voltage discharge generated between the electrodes 210, 215 corresponds to the desired sterilization zone, which again, has a glove 180 therein.
Experiment - Series A
Necessary materials (Inventory / Requisite)
-Escherichia Coli ATCC 25922
-Geobacillus stearothermophilus (ATCC 7953)
-sterile Petri plates in 120 mm. diameter
-thermostat at 37° C
-sterile physiological salt (serum)
-nutritive broth culture medium for bacteria (BioRad)
-nutritive agar (tryptone soy agar : TSA)
-Drigalski medium (BioRad)
-sterile latex gloves
-sterile test tubes and vials
-surgical scissors
-sterile 1,5 and 10 ml dropper with gradation
-thermostat at 37 ± 1° C
-water bath for 20° C ± 1° C si 45° C ± 1° C temp.
- pH meter with ± 0,1 pH units at 25° C accuracy
-Vortex agitator
-class 2 hood with laminar flow
Experiment 1.
A culture obtained from Bacillus stearothermophilus spores was inseminated in liquid medium (glucose broth). After the growth phase the culture was uniformly allocated into tubes with glucose broth medium, the microorganisms being quantified with the haemocytometer.
A sterile sectioned (with a sterilized scissors) glove finger was immersed in the culture medium. It was let to dry and then with a plastic hanger was placed between the electrodes, for 10 seconds at maximum intensity (36 W). After exposure, the glove
fragment was inserted in sterile nutritive broth in a vial. The culture was incubated at 37° C for 24 hours. After 24 hours incubation at 37° C, 0 germs/mm2 counted with the haemocytometer. The culture obtained from Bacillus stearothermophilus is shown in Figure 8 A, with the culture after 10 seconds exposure, at maximum intensity shown in Figure 8B.
Experiment 2
The following result was obtained by variations of intensity exposures, starting from ½ intensity up to maximum intensity, each for an exposure time of 6 sec, on Escherichia Coli ATCC 25922.
After the exposure of the glove fragment for 6 sec. at ½ intensity, the fragment was placed in tubes and incubated for 24 hours at 37° C. After this time a Petri plate with Drigalski medium was inseminated. At the end of the incubation phase UFC was counted. The UFC was incalculable.
The experiment was repeated in the same conditions with the intensity set to ¾. It was found that the number of UFC it was 12.
In conditions of maximum intensity after incubation the number of UFC was zero.
Figure 9 shows various cultures, from left to right unexposed culture, maximum intensity exposure, ¾ intensity exposure, ½ intensity exposure. Exposure time 6 seconds.
Experiment - Series B
Test Organisms : Escherichia coli ATCC 25952
Culture Preparation:
1. Each bacterial organism is plated onto Tryptic Soy Agar (TSA), and incubated for 24 hrs at 35°C.
2. Then a single loopful of inoculum is taken and inoculated in 200 mL of Casein
Soy Broth (CSB) at 35°C for 36 h before contamination of gloves was conducted.
Glove contamination:
1. For glove 1 to 6, immerse the gloves' fingers in the respective bacterial
suspension for 1 min to allow the 5 fingers to become wet.
2. The gloves were turned inside out and the above procedure repeated for the inner surface of the gloves.
3. For glove 7 to 12, contaminate the upper portion and the fingers of the glove, the glove was immersed up to the palm area of the glove in the respective bacterial suspension for 1 min.
4. The gloves were turned inside out and we repeated the above procedure for the inner surface of the gloves.
5. The contaminated gloves were allowed to dry in a Biosafety Cabinet for 24 hrs.
6. The dried gloves were packed in sterile clean plastic bags and stored at 4 C until decontamination.
Decontamination Procedure
1. Two sets of contaminated gloves were exposed to a sterilization system
according to the present invention, on two different electrical parameter arrangements;
2. The contaminated gloves labeled 2 to 6 are inserted in the sterilization system with electrical monitoring performed by multi meter and a High Voltage Probe Fluke 1 : 10000 on the electrodes with reading Results during decontamination: 2.4V with a fluctuation in frequency up to 1.3KHz.
The gloves labeled 2 and 3 are exposed 2 times during 4 seconds with interval between exposures of 1 second.
The gloves labeled 4 and 5 are exposed 2 times during 8 seconds with interval between exposures of 1 second.
The glove labeled 6 is exposed during 30 seconds.
The contaminated gloves labeled 8 to 12 are inserted in the sterilization system with electrical monitoring performed by multi meter and a High Voltage Probe Fluke 1 : 10000 on the electrodes with reading Results during decontamination: 0.55V and a fluctuation in frequency up to 750 KHz.
The gloves labeled 8 and 9 are exposed 2 times during 4 seconds with interval between exposures of 1 second.
The gloves labeled 10 and 11 are exposed 2 times, 8 seconds interval between exposures 1 second.
The glove labeled 12 is exposed during 30 seconds.
Determination of bacterial count:
1. The gloves are cut into small pieces and immersed in 100 mL phosphate buffer in a stomacher bag.
2. The gloves are stomached for 1 min.
3. 1 mL of this suspension is plated by the pour plate method using Casein Soy Agar (CSA).
4. The plates are inverted and incubated at 35 C for 48 hrs.
Analysis Results :
Parameter Sample Units Results Media Used and Incubation
Marking Conditions
Total Bacteria Count 1 CFU/glove 2.6x10" CSA, 35 degree Celsius for 48 hours
2 CFU/glove 1.0x10"
Tab e #1 : Analysis Result for Initial Glove from Factory
Parameter Sample Units Results Media Used and Incubation
Marking Conditions
Total Bacteria Count 1 (Initial) CFU/glove 1.2X10" CSA, 35 degree Celsius for 48 hours
2 CFU/glove No growth
3 CFU/glove No growth
4 CFU/glove No growth
5 CFU/glove No growth
6 CFU/glove No growth
7(Initial) CFU/glove 3.3X10"
8 CFU/glove No growth
9 CFU/glove No growth
10 CFU/glove No growth
11 CFU/glove No growth
12 CFU/glove No growth
Table #2: Analysis Result for Latex Glove (contaminated with E. coli)
Note 1 : Samples 1-6: fingers contaminated; samples 7-12: fingers and upper portion contaminated. Note 2 : Analysis Results for Samples 2-6 and 8-12 are after decontamination process.
Parameter Sample Units Results Media Used and Incubation
Marking Conditions
Total Bacteria Count Control CFU/glove No growth CSA, 35 degree Celsius for 48 hours El(l)
Control CFU/glove No growth
E2(l)
Table #3 : Analysis Result for Control Gloves
Conclusion: From the analysis result, the gloves contaminated with E.coli showed at least 6 log reduction after the sterilization process.