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Development of Medical Disinfector Using Ozone

KAMASE Yukihiro : Manager, Project Development Group, R&D Project Center, Research & Development MURAKAMI Hiroki : Manager, System Engineering Department, Technical Development & Engineering Center, Research & Development TAKAHASHI Ryoji : System Engineering Department, Technical Development & Engineering Center, Research & Development TAKAOKA Keigo : Manager, Environmental Equipment Department, Ishikawajima-Shibaura Machinery Co., Ltd. NAKAMURA Yasuo : Environmental Equipment Department, IshikawajimaShibaura Machinery Co., Ltd.

Ozone is one of the strongest oxidizers and is also environmental-friendly because it decomposes to oxygen. Ozone is widely utilized in various fields such as disinfection, deodorization and decolorization. IHI fundamental disinfection tests of several types of bacilli proved that ozone showed high level disinfection effects by optimizing the ozone gas concentration and exposure time. Ozone also has adequate disinfecting properties against bacilli in medical disinfecting equipment.

1. Introduction
Ozone exists in the sea and in mountains in small amounts and exists in the stratosphere as an ozone layer, and protects us from hazardous ultraviolet light falling down from outer space. Ozone is a colorless gas at ordinary temperatures composed of three oxygen atoms, and has a strong oxidizing power that is next to fluorine in nature. Its oxidizing power is said to be seven times that of chlorine, and its application has been in progress in diverse fields such as oxidization, disinfection, decolorization and deodorization.(1) Ozone uses a method for disinfecting microorganisms by its oxidative effect, and research on the disinfection has been in progress from long ago. However, the utilization of ozone as a disinfectant in a gas phase and on a solid surface has been limited only to preservation of foods. Ethylene oxide and gamma irradiation have been applied for the gas phase disinfection of medical devices and pharmaceutical containers. Formaldehyde fumigation and ultraviolet irradiation have been used for disinfecting operating rooms in hospitals, clean rooms and lockers. However, these methods have the following problems: (1) the operation required for disinfection is complicated; (2) the used drug remains; and (3) sufficient ventilation is needed after use. Ozone, which has a strong disinfecting power, is getting into the limelight as an alternative technology. This article introduces a disinfector utilizing ozone and ozone disinfection technology.

2. Disinfection with ozone

Disinfection and inactivation mechanism with ozone The disinfection and inactivation mechanisms with ozone have long been known. It is said that its disinfecting effect on pathogenic bacteria was first .. studied in 1892 by Ohlmuller, using Salmonella typhimurium, Vibrio cholerae and Bacillus anthracis. After this, disinfection and inactivation with ozone have been studied even until today and have become widespread in countries in Europe. The disinfection and inactivation with ozone is based on the strong oxidative effect that is inherent to ozone on the cell components of target microorganisms. As described above, this oxidative effect is strong, next to fluorine, and is estimated to be highly effective. This oxidative effect is particularly significant to organic substances and is known to oxidatively decompose organic compounds having double bonds, thiol groups and disulfide bonds. Disinfection effects on cells and fungi, and inactivation effects on viruses are based on the fact that various biological components composing cells and particles in these microorganisms are directly oxidatively decomposed by ozone and undergo serious modification and damage, and finally these microorganisms become impossible to breed and to live.(2) By the destruction mechanism based on the strong oxidizing power, the ozone treatment method has the advantage of preventing the production of resistant bacteria that is a problem
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2.1

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for drug disinfection. 2.2 Characteristics and disinfection effect of ozone The disinfection effect of a disinfectant is generally represented by the following Chick-Watson equation for a specific condition: -log (m/N) = kCaT ......................................(1) wherein m : Bacterial number of survivals N : Bacterial number of initiation k : Rate constant C : Disinfectant concentration a : The power of disinfectant concentration T : Contact time The m/N refers to the survival rate, so that the left side means the death rate index, the unit being D. The irregular equation in which a negative sign is attached to the left side is intended for changing the death rate index to a positive number. Hypochlorous acid, iodine and ozone are said to have a = 1, so that the product of the concentration C and the contact time T is defined as the CT value, to which the death rate index is proportional. The characteristics of ozone in the disinfection treatment are summarized as follows: q Ozone has the strongest oxidizing power next to fluorine, so that a high disinfecting power can be expected, compared to other disinfectants. w The disinfection mechanism of ozone is the oxidative effect that dissolves nucleic acids (DNA, RNA) that are cell components, so that resistant bacteria in which genes are altered are not built. e Room temperature disinfection is provided, so that it can also be applied to non-heat-resistant materials.

Fig. 1

Ozone disinfector

3. Ozone disinfector
We have developed an ozone disinfector utilizing the strong disinfecting power of ozone in collaboration with Ishikawajima-Shibaura Machinery Co., Ltd. 3.1 Ozone disinfector One example of the ozone disinfector developed this time is shown in Fig. 1. The disinfector has a chamber in which the objects for disinfection treatment are placed, and high-concentration ozone gas is discharged into the chamber to perform disinfection. The source gas for generating ozone can be obtained by concentrating oxygen from ambient atmospheric gas using a PSA oxygen generator. The source gas is converted to highconcentration ozone gas by being exposed to highvoltage electric discharge within the ozone gas generator. The resultant high-concentration ozone gas is discharged into the chamber and the ozone gas concentration within the chamber can be uniformly increased to a set concentration in a short time by a diffusion mechanism disposed inside the chamber. The objects to be treated are disinfected with ozone gas in the chamber, and the ozone is decomposed to oxygen by an ozone132

decomposing mechanism after a lapse of the set time before finishing the operation. Moreover, there is provided a system in which a lock mechanism works for the upper and lower doors during operation, and the doors cannot be carelessly opened. The basic specifications are given below. Name Ozone disinfector (HZ-40) The amount of ozone generated 2 g/h Power source AC 100V (50/60 Hz) Outer dimensions 820 (Width) 630 (Depth) 1 750 (Height) mm Disinfection mode Select from 5 types In addition, Fig. 2 shows an ozone disinfection system. This is a system that is used in the form of a wallrecessed installation between a bioclean room and a common room in research institutions for pharmaceutical companies and regenerative medicine. In this system,
Control side Take-out side

Fig. 2

Ozone disinfection system

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when non-heat resistant articles that cannot be subjected to autoclaving are to be carried into the clean room, the articles are carried into the ozone disinfection system from the control room side and subjected to ozone treatment; then the articles that have been subjected to disinfection treatment are received from the clean room side. 3.2 Ozone gas disinfection effect A disinfection test was carried out using the developed ozone disinfector. Bacillus subtilis was used as the bacteria to be treated with ozone gas. A biological indicator was prepared by dropping the bacterial solution of test bacteria on a millipore filter. The bacterial number of initiation was 1 104/carrier. The prepared indicator was placed in the petri dishes which were mounted in 10 locations in total at the respective positions of the upper part, the center and the lower part of the ozone disinfector, in order to confirm whether all of them can be disinfected uniformly or not. Moreover, the ozone gas concentration in the chamber of the disinfector was measured by an ozone gas concentration meter. It is an online concentration meter, which was used for measuring the change of the ozone gas concentration in the chamber with time from the start of the operation to the decomposition of ozone. The ozone gas concentration at each of the locations in the chamber (upper part, center and lower part) was measured before the disinfection test and was verified to be substantially uniform. It was confirmed that the ozone gas concentration that was measured this time increased with the generation of ozone to the maximum concentration exceeding 1 000 ppm. Table 1 shows the results of disinfection when the operation was changed from mode 1 (CT value of 3 000 ppmmin) to mode 5 (CT value of 300 000 ppmmin). It was found that the bacterial number of survivals for the ozone treatment of mode 3 or above was zero and all bacteria were killed. In addition, common heterotrophic bacteria (Escherichia
Table 1
Mode CT value ( ppmmin ) Mounting location 1 Mounting location 2 Mounting location 3 Mounting location 4 Mounting location 5 Mounting location 6 Mounting location 7 Mounting location 8 Mounting location 9 Mounting location 10 Control

Disinfection data
1 3 000 0 0 0 0 0 0 0 0 1 1 +++ 2 10 000 1 0 0 0 0 0 0 0 0 0 +++ 3 30 000 0 0 0 0 0 0 0 0 0 0 +++ 4 5

coli : ATCC11229, Pseudomonas aeruginosa : ATCC27853, Staphylococcus aureus : ATCC43300) were subjected to the disinfection test in a similar manner under the condition of the bacterial number of initiation of 1 104/carrier. They were subjected to the ozone treatment at a CT value of 3 000 ppm-min (mode 1), and the killing effect was obtained in which the bacterial number of survivals was zero. 3.3 Ozone gas permeability to objects to be treated The disinfection test using the ozone disinfector revealed that the disinfector can achieve a high disinfection effect by appropriately setting the ozone treatment conditions. Considering a practical case where the objects to be treated are placed in the chamber of the disinfector, a typical case is assumed to be one where a plurality of objects for the disinfection treatment are stacked to be treated. In such a case, it is considered that the amount of ozone exposure inside the stack is lower than the value at the surface. Thus, the difference of the amount of ozone exposure between the surface and the inside was determined by placing a plurality of the expected objects to be treated in the chamber of the disinfector and subjecting them to the ozone treatment. The disinfection effect in this study is proportional to the CT value as described above. Usually, when the CT value is checked in the practical field for disinfection, a high-priced instrument could be used, but it would be labor-intensive. Alternatively, when it is incorporated into the disinfector itself, the cost of the disinfector would significantly increase. Therefore, the test was carried out by using an ozone indicator(3) that can be used by anyone for determining the CT value at a very low cost. The ozone indicator utilizes the principle that an indigocarmine reagent (blue) changes to white when exposed to ozone. The ozone indicators are placed in locations to be exposed to ozone, and the CT values can be read by checking afterwards the scale of the ozone indicators to which the color has changed to white. The ozone gas treatment was carried out in the ozone disinfector using masks, hats, gloves and socks as the

100 000 300 000 0 0 0 0 0 0 0 0 0 0 +++ 0 0 0 0 0 0 0 0 0 +++

(Note) +++ : Incapable of measurement due to too many colonies

Fig. 3

Indicator installation conditions for objects to be processed

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CT values of indicators 10 000 (100%) 10 000 (100%) 8 000 (88%) 8 000 (88%) 8 000 (88%)

CT values of indicators 10 000 (100%) 10 000 (100%) 10 000 (100%) 10 000 (100%) 11 000 (100%)

11 000 (100%) 10 000 (100%) 10 000 (100%) 8 000 (88%) 8 000 (88%) (Note) CT value : 9 105 ppm-min Objects to be treated : Masks/socks (10 each) Gloves/socks (20 each)

12 000 (100%) 10 000 (100%) 10 000 (100%) 10 000 (100%) 10 000 (100%) 11 000 (100%)

Fig. 4

Ozone osmosis conditions for objects to be processed

objects to be treated. Ten to twenty pieces of each of the test articles were placed in the chamber for one treatment. The conditions of ozone gas permeation inside the test articles were checked by mounting the ozone indicators on the objects to be treated. The indicator mounting conditions for objects to be treated are shown in Fig. 3. The ozone gas concentrations in the chamber of the ozone disinfector were measured with the ozone gas concentration meter. The measured ozone gas concentrations were integrated with respect to the elapsed time for calculating the CT value to give 9 105 ppmmin. The results of the color change at this time of the ozone indicators mounted in each part of the objects to be treated are shown in Fig. 4. Twenty of each of the gloves and socks were stacked, and the indicated values of the indicators for the inside of each of the stacks were in the range from 8 000 to 11 000 ppmmin. This means that CT values for the inside that were almost the same as those for the surface were obtained. Moreover, when 10 pieces of each of the masks and hats were stacked, the permeation into the inside in the range from 8 000 to 12 000 ppmmin was confirmed. From these results, it was found that ozone had permeated sufficiently into the inside of the stacks of the objects to be treated at this time. Furthermore, although the permeability of ozone depends on the objects to be treated, it is possible to apply ozone to various objects to be treated so long as the amount of permeation is checked once for each of the objects to be treated to determine the conditions for the ozone treatment.

of the ozone gas permeation to practical objects to be treated was also studied. The results have shown that the disinfector is sufficiently applicable. Moreover, the disinfection effect depends on temperature and humidity, although it was not discussed in this article. Higher temperature increases the chemical activity to increase the disinfection effect, which is not significant. Higher atmospheric humidity significantly increases the disinfection effect. This may be due to the fact that water drops are changed to ozone water, which increases the contact with the objects for disinfection, but the influence of the fact that ozone reacts with water to produce an OH radical may be great. However, since the disinfection effect of ozone is high even in low humidity conditions, it will be unnecessary to positively increase humidity except for the case when a very intense disinfection effect is intended. Ozone has a strong oxidizing power as well as high environmental friendliness, in that it finally returns to oxygen. Thus, it is considered that ozone can be applied further to various fields in the 21 century that is called The Century of Environment. REFERENCES (1) Hidetoshi Sugimitsu : The Fundamental and Application of Ozone, Korin 1996 (2) Tsuguo Sasaki : The sterilizing method and the microbe sterilizing method based on the Japanese Pharmacopoeia, Japanese Standards Association 1998 (3) Katsuji Yamamoto, Masami Shimizu and Ryouji Takahashi : Development of Sterilization and Deodorizing Systems, Ishikawajima-Harima Engineering Review Vol.36 No.3 May 1996 pp.173-178

4. Conclusion
A disinfector using ozone gas has been developed. Its ozone disinfection effect was verified, and the extent
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