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Publication numberUS3704096 A
Publication typeGrant
Publication dateNov 28, 1972
Filing dateOct 16, 1970
Priority dateOct 16, 1970
Publication numberUS 3704096 A, US 3704096A, US-A-3704096, US3704096 A, US3704096A
InventorsEskil L Karlson, Christ J Verses
Original AssigneePollution Control Ind Inc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Sterilizing package and method and means for sterilizing an article and thereafter checking its sterility
US 3704096 A
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Description  (OCR text may contain errors)

Nov. 28, 1912 c J. VERSES Em 3,704,096


Filed Oct. 16, 1970, Ser. No. 81,256 Int. Cl. G01d 21/00; G01n 31/22 US. Cl. 23-230 R 4 Claims ABSTRACT OF THE DISCLOSURE Means are provided to indicate by color change or lack of color change occurring within a predetermined time interval whether a sterilizing environment has been attained in a sealed container filled with ozone mist. A new package is provided comprising a transparent, sealed container having therein an ozone mist sterilizing environment, an article to be made and kept sterile by said environment, and an indicator adapted to visually signal whether such environment has in fact been attained.

FIELD OF USE This invention relates to sterilizing an article and maintaining it in sterile condition ready for use at any future time, by placing it in an ozone mist environment, and to means for indicating whether a sterilizing environment has actually been attained; and to a sealed package containing ozone mist, the article and the indicator means. While applicable to a wide range of articles, use is particularly contemplated in connection with surgical instruments, surgical gloves and other items of hospital equip- SUMMARY OF THE DISCLOSURE An article to be made sterile is placed in a transparent container such as a plastic bag which, after being evacuated, is refilled with a mixture of ozone gas and water particles under pressure. When this mixture encounters the low pressure within the newly evaucated container the water particles explode forming an intimate mixture of ozone gas and finely divided water particles, referred to herein as ozone mist. The amount of ozone in the mixture of ozone gas and water particles forced into the bag under pressure is suflicient to provide in the container an ozone concentration of one thousand (1,000) parts per million (1,000,000) by weight. The amount of water in the mixture which is forced into the bag is sufiicient to establish a condition of saturation, or at least 80% humidity, within the bag after it is sealed. The container is then vibrated or tumbled to expose the entire surface of the article to the ozone mist. As a check, in order to be 3,704,096 Patented Nov. 28, 1972 sure that in the sealed bag there is sufiicient ozone concentration and suflicient humidity to kill all germs and viruses which may be on the article or on the inner surface of the bag, means are provided and included in the bag which are adapted to indicate by a color change occurring within a predetermined period of time after sealing of the bag that a sterile condition has been attained within the bag, or to warn by lack of color change that a sterile condition has not been attained.

The invention will be best understood by reading the following description in connection with the drawing, in which the figure is an elevation of a sealed flexible plastic bag having therein an article to be sterilized in an environment of ozone mist, and containing also color speci mens adapted to indicate by complete color change or lack of such change whether a dependable sterilizing condition has been attained within the sealed bag.

DESCRIPTION In practicing the invention in accordance with the embodiment thereof disclosed herein an article 10 to be sterilized is placed in a container, preferably in a transparent container such as a plastic bag 12 and along with two color specimens 22 and 26 the function of which is described below, the bag is first evacuated and then filled with ozone mist, the presence of which is indicated by numeral 18, and sealed. A mixture of ozone gas and water is preferably supplied into this bag under pressure and expands to form a fine mist. The article in the container is made to move and expose all of its surfaces to the ozone mist. The exhausting of the bag 12, refilling it with ozone mist and vibrating the article within the bag may desirably be done by the method and apparatus disclosed in copending US. patent application Ser. No. 81,255 filed Oct. 16, 1970.

The concentration of ozone necessary to kill all germs and viruses on an article enclosed in the bag 12 may vary with the locality and altitude but tests indicate that a concentration on the order of one thousand (1,000) parts by weight of ozone per million (1,000,000), in an environment sufficiently humid to promote the effectiveness of the ozone and to bring the ozone into contact with the entire surface of the article, will produce a reliable overkill situation. The humidity should be or more at room temperature.

If the amounts of ozone and water supplied into the bag 12 are controlled to give the ozone concentration and humidity percentage referred to above, optimum results will be attained, but as a check to determine, after the bag 12 is sealed, whether the article therein has been made completely sterile, the color change indicator means referred to above are employed.

In the drawing a pair of surgical shears is shown as the article 10 to be rendered sterile and maintained in sterile condition. A strip of adhesive tape 20 having on it a spot 22 of Safranin O dye is shown applied on one handle of the shears and a strip of adhesive tape 24 having on it a spot 26 of cobaltous chloride is shown applied on theother handle of the shears. The spots 22 and 26 can be seen through the wall of bag 12 and any change in color of these spots can be observed.

Safranin O is a dye, also known as aniline rose or aniline pink, prepared by oxidizing para-toluylenediamine aniline and ortho-toluidine. It is made by National Aniline Division of Allied Chemical Corporation. When exposed to ozone, Safranin O bleaches and loses its characteristic TABLE Concentration of Safranin (by weight): 25

Time for complete bleach (minutes) Dehydrated cobaltous chloride, CoCl 6H O, which is blue, turns red almost immediately when placed in an environment where the humidity is 80% or more. Since this humidity indicator reacts much faster than the said ozone concentration indicator both color indicators may be observed at the end of the time interval required to eifect a complete color change of the Safranin indicator.

By observing both indicators 22 and 26 promptly after the periods of time indicated in the table, one can visually determine whether in fact a condition has been obtained in the bag to render the article 10 therein completely sterile.

What we claim is:

1. The method of indicating whether ozone mist, comprising mixture of ozone gas and finely divided water particles, sealed in a transparent container along with an article to be sterilized has high enough ozone concentration and humidity to sterilize the said article, which comprises, enclosing in the container, along with the article and ozone mist, a specimen of Safranin O and a specimen of dehydrated cobaltous chloride and observing the said specimens for color change after a time interval within which said Sa-franin O and said dehydrated cobaltons chloride are known to change color in a concentration of ozone and under conditions of humidity known to kill germs and viruses.

2. A package comprising a sealed transparent container having therein, ozone mist, an article to be rendered sterile by the ozone mist, and specimens of Safranin O and dehydrated cobaltous chloride to indicate by change of color, occurring within a predetermined time interval following sealing of the container, whether the desired sterile condition within the container has been attained.

3. The package claimed in claim 2 in which the indicator responsive to a germ-killing concentration of ozone is Safranin O and in which the indicator responsive to the humidity of the environment is dehydrated cobaltous chloride.

4. The package claimed in claim 2 in which the specimens of Safranin O and dehydrated cobaltous chloride comprises thin strips of adhesive tape applied to the article and stained respectively with Safranin O' and dehydrated eohaltous chloride.

References Cited UNITED STATES PATENTS 1/1949 Davis 23253 TP 11/1969 Andersen et al 2191 OTHER REFERENCES Kolling et a1., Chem. Abstr. 55, 2559lh (1961).

MORRIS O. WOLK, Primary Examiner R. M. R-EESE, Assistant Examiner

Referenced by
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U.S. Classification436/1, 422/29, 116/207, 116/201, 206/459.1, 422/186, 422/28, 436/41, 206/210, 422/3, 206/363, 436/135, 422/87
International ClassificationA61L2/28, A61L2/26, G09F3/00, A61B19/00
Cooperative ClassificationA61B2019/5437, A61B2019/4868, G09F3/00, A61L2/28, A61L2/26
European ClassificationA61L2/26, G09F3/00, A61L2/28