Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUSRE34515 E
Publication typeGrant
Application numberUS 07/813,371
Publication dateJan 18, 1994
Filing dateDec 24, 1991
Priority dateJun 11, 1979
Also published asCA1148416A1, DE3069406D1, EP0022284A1, EP0022284B1, US4448548
Publication number07813371, 813371, US RE34515 E, US RE34515E, US-E-RE34515, USRE34515 E, USRE34515E
InventorsTheodore A. Foley
Original AssigneePymah Corporation
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Steam sterilization indicator
US RE34515 E
Abstract
An improved steam sterilization indicator is provided. The indicator includes a fusible material in tablet form, deposited in an embossment in one end of a thin aluminum backing. A wicking strip is attached to the backing with one end of the strip being in close proximity to the fusible tablet. A clear plastic material covers the tablet and the strip and is adhered to the backing. The melting point of the fusible tablet is depressed in the presence of saturated steam. Upon melt, the material in the tablet is absorbed by the wicking strip, producing a color front to provide an indication of the integration of time and temperature in the presence of steam. Various amounts of a binder are used in the tablet to provide a device which may be adjusted to reflect the thermal death curves of various types of microorganisms. The cover and the wick are bonded to the backing by an acyclic adhesive which also affects the rate of the indicator.
Images(2)
Previous page
Next page
Claims(13)
I claim:
1. A steam sterilization indicator comprising:
a tablet including a fusible material and a binder, said fusible material meltable at a predetermined temperature in the presence of substantially saturated steam, the melting point of said fusible material being substantially lower in the presence of saturated steam than when dry;
a wicking strip having one end in close proximity to said tablet whereupon attainment of said predetermined temperature, said fusible material melts and moves along said strip at a rate proportional to the temperature of said saturated steam;
a steam permeable membrane covering said tablet and said wicking strip, said binder holding said fusible material in tablet form prior to attainment of said predetermined temperature and further providing a mechanism for altering the rate movement of said fusible material along said wicking strip as a function of the amount of binder used for certain temperature ranges, such rate of movement being similar to spore death kinetics;
a backing; and
an acrylic adhesive, wherein said backing and said membrane enclose said tablet and said strip and said acrylic adhesive holds said membrane and said strip to said backing, said acrylic adhesive acting to further alter the rate of movement of said fusible material along said strip.
2. The indicator as set forth in claim 1 wherein said fusible material is salicylamide.
3. The indicator as set forth in claim 1 wherein said binder is .[.polyvinylpyrrolidine.]. .Iadd.polyvinylpyrrolidone.Iaddend..
4. The indicator as set forth in claim 1 further including a dye in said tablet for providing a moving color front on said strip.
5. An indicator as set forth in claim 4 wherein said dye is taken from the group consisting of Spirit Soluble Fast Black RE and Spirit Soluble Orange RR.
6. The device as set forth in claim 1 wherein said amount of binder is no greater than 3% by weight of said tablet.
7. The device as set forth in claim 1 wherein the amount of said binder is within the range of from 1% to 3% by weight of said tablet.
8. An indicator as set forth in claim 1 wherein at least a portion of said membrane is transparent.
9. A steam sterilization indicator comprising:
a backing and a cover; said cover being permeable to steam; a fusible material being meltable at and above a said predetermined temperature; a wicking strip in substantial contact with said fusible material; said fusible material and said strip being located between said backing and said cover; said fusible material having its melting point substantially depressed in the presence of steam; said fusible material upon melting moving along said strip at a rate in proportion to the temperature of the saturated steam;
an acrylic adhesive holding said cover to said backing and said strip to said backing for altering the rate of movement of said fusible material along said strip.
10. An indicator set forth in claim 9 wherein said fusible material is salicylamide.
11. A device as set forth in claim .[.10.]. .Iadd.12 .Iaddend.wherein said binder is .[.polyvinylpyrrolidine.]. .Iadd.polyvinylpyrrolidone.Iaddend..
12. An indicator as set forth in claim 9 further including a binder added to said fusible material for further slowing down the rate of movement of said fusible material along said strip.
13. A steam sterilization indicator comprising:
a metallic backing having an embossment near one end thereof;
a tablet including both an amount of salicylamide which is fusible at a predetermined temperature and having the quality of having its melting point depressed in the presence of a substantial amount of moisture and an amount of polyvinylpyrrolidone, said tablet received in said embossment;
a wicking strip adhered to said metallic backing, said wicking strip having a portion thereof received in said embossment and in contact with said tablet;
a steam permeable cover having a transparent portion and received over said backing and adhered thereto by acrylic adhesive for further controlling the rate of movement of salicylamide along said strip; and
a dye associated with said tablet for indicating the movement of said salicylamide along said wicking strip, said polyvinylpyrrolidone also controlling the rate of movement of molten salicylamide along said wicking strip.
Description
BACKGROUND OF THE INVENTION

This invention relates to steam sterilization indicators. More particularly, it relates to steam sterilization indicators which may be variable and/or adjustable in rate of indication at different sterilization temperatures.

Hospital utensils, such as surgical instruments, undergo sterilization for each use. In most instances, an autoclave is used to expose the utensils to live steam at various temperatures, usually between 250 F. and 275 F., although other temperatures are also used. The purpose for providing such sterilization is to destroy, with a high probability of success of safety factor, the microbial contamination which may be contained on these utensils. It is important to gauge the sterilization process so that the user may be assured that the utensils have, in fact, been subjected to those well-defined conditions necessary to render the material free of living organisms with a high probability of success. Several devices and techniques have been used to provide for such indication.

Of course, the materials which have been processed through the sterilizer could be biologically sampled to determine biological activity. However, this technique, while highly accurate, obviously would be very costly and impractical.

One very reliable method for providing indication of sterility is to utilize challenge spores which are placed in the autoclave during sterilization and then examined for their biological activity afterwards. For steam sterilizations, these challenge spores are usually Bacillus stearothermophilus and are used because they have a very high resistance to steam sterilization, thus giving a large safety factor. One example of this technique is set forth in U.S. Pat. No. 3,440,144, which provides a device for conducting such a test without the need to worry about subsequent contamination after the sterilization process is completed.

Another means to indicate sterilization is the use of sterilizer temperature recorder and gauges. These devices are usually attached to the sterilizer and measure the temperature in the sterilizer's exhaust line. While they are able to detect most malfunctions of the sterilizer, they cannot measure the condition at the place where the instruments were being sterilized.

A means for measuring the presence of steam, which is critical for steam sterilization, in an autoclave indicating tape. An example of such indicator tape is set forth in U.S. Pat. No. 2,889,799. A pressure-sensitive adhesive tape is used which includes a heat modifiable dye stuff impregnated thereon changing color at predetermined temperatures. However, these indicator tapes do not take into account the time that the instruments have been exposed to sterilizing temperature, and furthermore, are susceptible to prematurely changing color at low temperatures.

Another test which has been utilized is a so-called Bowie and Dick test. This test measures the uniformity of steam concentration in dressing packs. The test consists of several strips of autoclave indicating tape on a sheet of paper which is placed in the test pack. The tape on the paper is measured for uniformity of color change. One of the major limitations of this test is its failure to distinguish between high temperatures for a short period of time or low temperatures for a long period of time.

More recently, steam sterility indicators have been provided which integrate time, temperature and steam presence. Such a device is shown in U.S. Pat. No. 3,981,683. This device utilized a chemical such as 2-ethoxybenzamide or salicylamide as a fusible material. The melting points of these compounds are depressed by the presence of steam. A wicking strip is provided in close proximity to the chemical so that upon melt the chemical will slowly travel up the wick at a rate proportional to the sterilization temperature and time of exposure to such temperature, as well as the presence of steam. The device includes a cover strip which is a polymeric rate controlling film permitting water vapor (steam) to pass through thus depressing the melting point of the chemical. The strip cover and the wick are adhered to a backing by the use of an adhesive such as a silicone.

The device set forth in U.S. Pat. No. 3,981,683 is particularly useful where the exact temperature in the sterilization process it unknown. If it were known that the apparatus to be sterilized was an exact temperature, for example 250 F., then the stabilizer could be run for an exact amount of time so that the user could be assured of sterilization within a certain safety factor. However, without fitting the autoclave with some highly sophisticated and accurate monitoring equipment, it is impossible to know whether all areas of the autoclave are uniform at the same temperature. It is well known that the temperature of items being sterilized can vary due to many variables such as air entrapment, penetration of steam through packing material and position within the autoclave. Therefore, due to this unknown variable of temperature, it is a common practice for the microbiologist to investigate how a controlled change of temperature will affect the kill of the microorganism. He would do this by repeating the microbial death rate experiment at temperatures other than 250 F. After completing these experiments at other temperatures, a relationship can be obtained where the amount of time required to produce say 10-5 probability of surviving microorganisms, since this or some other safety factor producing a non-sterile item can be calculated. FIG. 3 shows an example of what the relationship of kill time vs. temperature might look like. The slope of the line is typical for microbial death rates, and, as can be seen, it is highly temperature sensitive. The death rate might be slowed down by a factor of 10 with a decrease of only 18 F. Conversely, an increase in temperature of only 18 F., will require only 1/10 the sterilization time. In other words, sterilizing to a probability of 10-5 in the example in FIG. 3 requires a 110 minutes at 232 F., 11 minutes at 250 F., and 1.1 minutes at 268 F. This value of 18 F. has been called the Z value and is defined as the number of degrees that are required to traverse a thermal death rate curve by one log. Thus this Z value becomes important when estimating spore death at different temperatures. This relationship has been defined mathmatically through the following equation:

t=(F.sub..)10.sup.[(250-T)/Z)]

where t=the amount of time required at the actual process temperature (T).

In other words, it would require t minutes at temperature T in order to do the equivalent amount of sterilization as Fo minutes at 250 F. (the reference temperature for steam sterilization). While a Z value of 18 F. is typical, it may vary quite often from between 16 F. to 23 F., and other values, depending on the type of microorganism, the pH and salt concentration as well as other variables. Therefore, if an adequate sterilization process is to be described, you must not only know the relative resistance at 250 F., but also the relative resistance at other temperatures. Thus the Z values must be known.

The graph in FIG. 4 graphically illustrates how a change in Z value can affect the sterilization times required at temperatures other than 250 F. Notice the different slopes of the lines for the various Z values. By using the standard sterilization equation set forth above, you can calculate that if Z is equal to 23 F., a time of 81.5 minutes is required at 230 F. to obtain an Fo of 11 minutes. Conversely, for the same Fo, the time would have to be increased to 195.5 minutes at 230 F. for a Z value equal to 16 F. Thus it may be seen that, at temperatures lower than 250 F., as the Z value decreases, the kill time at predetermined temperatures increases.

The device set forth in U.S. Pat. No. 3,981,683 provides an indicator which is useful in a steam sterility process for spores having a Z value of 18 F., but it is not very flexible in terms of measuring sterilization of devices contaminated with spores with other Z values. Furthermore, it is a rather long device, thus materials are wasted.

OBJECTS OF THE INVENTION

Accordingly, it is one object of this invention to provide an improved steam sterilization indicator.

It is another object of this invention to provide an improved indicator which integrates time and temperature in the presence of steam.

It is a further object of this invention to provide a steam sterilization indicator which may be made variable in rate indication for tracking the kill time of various microorganisms at various temperatures.

It is still another object of this invention to provide a steam sterilization indicator which uses less materials than many prior art indicators.

It is another object of this invention to provide a steam sterilization indicator which is easily and cheaply manufactured.

It is a further object of this invention to provide a steam sterilization indicator which is adapted to slowly integrate time and temperature in the presence of steam so that the device may be made shorter, thus using fewer materials.

It is still another object of this invention to provide a sterilization indicator with an additional safety margin but still clearly tracks the kill time of microbes at various temperatures.

SUMMARY OF THE INVENTION

In accordance with one form of this invention there is provided a steam sterilization indicator which includes a tablet made of a fusible material and an amount of a binder. The fusible material is meltable at and above a predetermined temperature in the presence of substantially saturated steam. A wicking strip having one end in close proximity to the tablet is mounted on a backing. The backing also receives the tablet. In a steam environment, when predetermined temperature of melt is reached for the tablet, the fusible material moves along the strip at a rate proportional to the integration of time and temperature. The binder holds the fusible material in tablet form and further provides a mechanism for altering the rate of movement of the fusible material along the strip in proportion to the amount of binder used. As acrylic adhesive may be used to adhere the strip to the backing, as well as a transparent cover layer to the backing. The acrylic will further alter the movement of the fusible material along the strip.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter which is regarded as the invention is set forth in the appended claims. The invention itself, however, together with further objects and advantages thereof, may be better understood with reference to the following description taken in conjunction with the accompanying drawings in which:

FIG. 1 is a plan view of the indicator incorporating the present invention with a portion of the cover peeled back;

FIG. 2 is a side view of the tablet which is utilized in FIG. 1;

FIG. 3 is a graph of the death curve of the microbe C. sporogenes at various temperatures showing how the Z value is calculated;

FIG. 4 is a graph depicting the effect of different Z values on thermal death curves of microbes;

FIG. 5 is a graph showing the running time of the indicator shown in FIG. 1 at several temperatures with various amounts of binder in the tablet;

FIG. 6 depicts the run time of one of the devices of the subject invention at various temperatures compared with a prior art device and the thermal death curve of a microbe.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now more particularly to FIG. 1, there is provided steam sterilization indicator 1 which indicates that an environment or utensils in close proximity to it, has undergone proper steam sterilization. The device includes backing 2 which may be made of a metallic material acting as a good moisture barrier. In the preferred embodiment, the backing 2 is constructed of 3 mil thickness dead soft aluminum. The backing acts as a carrier or substrate for tablet 4 and wicking strip 5. The aluminum backing includes embossment or depression 3 near one of its ends for receiving the temperature and moisture sensitive tablet 4. Tablet 4 is made primarily from a chemical which melts or fuses at a predetermined temperature and above. However, its melt temperature is depressed somewhat in the presence of saturated stream. In the preferred embodiment, the chemical is salicylamide.

In order to increase manufacturing efficiency, i.e., placing the chemical in the embossment in the backing, it is desirable to maintain the chemical in tablet form. To do this and to provide the surprising results as will be described below, an amount of a binder is added to the temperature and moisture sensitive chemical. In the preferred embodiment of this invention the binder utilized is .[.polyvinylpyrrolidine.]. .Iadd.polyvinylpyrrolidone .Iaddend.(PVP). The table also includes other constituents which are known to those skilled in the art of manufacturing tablets and may include such materials as talc and syloic.

In order to provide a color indication on strip 5 which will be described below, tablet 4 may also include a heat stable soluble dye which wicks onto and moves along strip 5 so long as the temperature and moisture content are sufficient to maintain the fusible chemical in its liquid state. Dyes such as Spirit Soluble Fast Black RE and Spirit Soluble Orange RR, both available from BASF Wyandotte Company, are suitable dyes.

The device is covered by .Iadd.a .Iaddend.clear plastic cover layer .[.6.]., which in this embodiment is a 2 mil thickness unoriented polypropylene film, one form of which is available from the Exxon Corporation as Extrel 50. This clear layer enables one to see the position of the color front along wick 5. It also provides a controlled exposure of the temperature and moisture sensitive chemical to the steam since the polypropylene is slowly permeable to moisture transmission. The cover layer .[.6.]. as well as indicator strip 5 is adhered to the backing 2 by an adhesive 7, which in the preferred embodiment is an acrylic adhesive. One such acrylic adhesive which has been utilized is 3M 467, available from Minnesota Mining & Manufacturing Company. The importance of the use of the acrylic adhesive as well as the binder in the tablet will be made more clear below.

Wicking strip 5 is normally a porous material capable of wicking a liquid by capillary action. In this embodiment, the wick was made of Whatman 1 Chrome, available from the Whatman Company. It is placed either in contact with or nearly in contact with tablet 4 such that one end of the strip is within embossment 3. The wicking strip absorbs the melted chemical and carries the dye down the strip so long as the temperature is high enough and steam is present in a sufficient density. The rate of movement of the color front as well as the kill rate of microbes results from an integration of time and temperature so that this device is useful as various temperatures. That is, the time required for the color front to move a certain fixed distance is very temperature dependent. The same is true for the kill time of microbes. Then the color front on the strip reaches a certain position on the indicator, such as that indicated at position 8, it is assumed that the environment has undergone proper sterilization, i.e., the probability that all of the microbes present have been killed is, say, 0.99999. The device may be covered on the outside of the clear plastic covering with another sheet of paper (not shown) having an elongated slot which provides for a visual indication of the strip. This paper may have various indicia thereon.

The device thus described operates in a similar manner with the device described in U.S. Pat. No. 3,981,683 filed Sept. 21, 1976, and the description in that patent is hereby incorporated by reference. However, the present device includes at least two important differences in composition and several important differences in operation. One of the differences in composition between the device of the subject invention and the previously patented device is that the temperature and moisture dependent chemical is in tablet form rather than just a glob of material. An acceptable tablet is shown in FIG. 2. It is much easier to deposit a solid tablet into the embossment 3 during the manufacturing of the device. Furthermore, the exact quantity of chemical may thus be inserted easily into the embossment.

As stated previously, a binder such as PVP was utilized to hold the chemical in tablet form in order to provide this improved manufacturing process. In doing so, a surprising result occurred. It was found that by the use of this binder a programmable device could be manufactured which has a color movement rate proportional to the percentage of binder contained in the tablet. Furthermore, an indicator which follows the rate of kill of microbes having various Z values could be obtained by varying the percentage of binder. The following table shows a comparison of kill times for a microbe having a Z value of 20.5 and a Z value of 18 and the run times along a strip 11.2 mm long utilizing a device incorporating the subject invention having salicylamide chemical with varying percentages of PVP binders.

              TABLE 1______________________________________Kill Times (Mins.)            Indicator Times (Mins.)Temp.  Z = 20.5 Z = 18   0%   1%    2%    3% PVP______________________________________230    113.5    155.0    93.7 133.0 174   210235    64.7     81.8     58   71.5  85    111240    36.9     43.1     35   38.5  44    48245    21.0     22.7     21.7 21.5  23.5  26250    12.0     12.0     13.0 12.5  13.0  13255    6.84     6.3      8.0  7.5   7.7   7260    3.90     3.34     4.9  4.8   4.7   4.4265    2.23     1.76     2.9  2.9   3.0   3.2270    1.27     0.93     1.8  1.9   2.1   2.6______________________________________

Table I shows the indicator times of the device of FIG. 1 using from 0% PVP binder to 3% binder at various temperatures. As can be seen from the chart in Table I, the indicator times may be increased by increasing the amount of binder in the tablet so as to conform with the Z value of the particular microbe which is to be killed.

A graphic example of how the Z value of the device may be altered by adding or changing the binder content may be seen from the graph in FIG. 5 which again shows three devices each having binders from 0 to 3%. The graph shows that the time for the device to run to completion increases, particularly at the lower temperatures, as the percentage of binder increases. As it further may be seen from FIG. 5, the changes in the binder content affects the range between 230 F. and 250 F. and the range of 260 F. to 270 F., much more than at the mid-range.

Further, as can be seen, adding a binder introduces a safety factor in the operation of the indicator. One may notice from Table I that a device with 0% binder to monitor a sterilization process with Z value of 20 F. will run in 93.7 minutes, while the kill time of the particular microbe is 113.5 minutes, thus giving a false and potentially dangerous indication of kill. However, it should be noted that by adding 1% binder the indicator times are lengthened such that there is a slight margin of safety at all temperatures, and therefore this device will never indicate sterilization prematurely. For the bacteria which has a Z of 18 F., a 2% binder would be utilized. It should be recognized from FIG. 5 and from Table I that at temperatures above 260 F. the lines of the various percentage binders tend to come together and substantially flatten out. However, it should be noted that the lines are always curving upwardly and on the safety side of any bacteria with such a Z curve and these should never provide premature indication of sterilization.

FIG. 6 shows a graph of a comparison of the device of the subject invention utilizing a 2% binder in comparison with the thermal death curve of B. stearothermophilus and a prior art device as set forth in U.S. Pat. No. 3,981,683. As can be seen, the device which utilizes a 2% binder PVP in salicylamide substantially tracks the death curve of B. stearothermophilus, but on the high safe side. However, as can be seen, the prior art device particularly at low temperature tracks the bacteria death curve on the lower unsafe side, and also shows a low "knee" at some high temperatures.

It has further been found that one may lower the temperature dependent reaction rate by utilizing an acrylic adhesive in the place of a silicone pressure sensitive adhesive which was used in the device set forth in U.S. Pat. No. 3,981,683. The adhesive is used to hold the wick and the cover onto the backing. It has also been found that there was a gross change in reaction rate of the device whereby its equivalent Z value was decreased from 26 F. to 20 F. by replacing the silicone base pressure sensitive adhesive with an acrylic. Table II below shows the actual time required for the device of the subject invention to indicate sterilization using a silicone adhesive, namely Densil 2078, provided by Dennison, Inc. and two brands of acrylics, namely Dencryl 410, also provided by Dennison, Inc., and Tackmaster 535, provided by the National Starch and Chemical Corporation.

              TABLE II______________________________________   Indicator Times (Mins.)Temp.     Silicone    Acrylic I Acrylic II______________________________________230 F.     110         137       154240 F.     29          51        53250 F.     12          12        12260 F.     5.1         4.7       3.6270 F.     3.1         1.85      1.9Approx.   26.0 F.                 20.9 F.                           20.0 F.EquivalentZ Values______________________________________

Thus it may seem that the indicator times are substantially lengthened and it may be seen that the equivalent Z value was decreased by approximately 5 to 6 by utilizing an acrylic in place of the silicone adhesive. It is not understood exactly what phenomenon is causing these changes in equivalent Z value and thus in indicator times; however, it is quite possible that the acrylic may be reacting with the salicylamide in some way to slow down the movement of the color front or the acrylic may be acting as a better seal as compared to the silicone to prevent some of the steam from penetrating into the chemical, thus affecting the depression in the melt point.

Thus, it may be seen that there is provided an improved steam sterilization indicator which may be made adjustable in its rate of indication and further may be provided with an additional safety margin over the prior art.

Furthermore, since the rates of indicator movement are slowed, the device may be made substantially shorter than the device described in U.S. Pat. No. 3,981,683, thus saving materials. The length of the device described in U.S. Pat. No. 3,981,683 is approximately 4 inches, while the length of a device incorporating one embodiment of the subject invention is approximately 2 inches.

From the foregoing description of the preferred embodiment of the invention it will be apparent that many modifications may be made therein. It should be understood, however, that this embodiment is intended merely as an exemplification of the invention and that the invention is not limited thereto. It should be understood, therefore, that it is intended that in the appended claims to cover all such modifications in the true spirit and scope of the invention.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US161118 *Feb 10, 1875Mar 23, 1875 Improvement in lamp-wicks
US197902 *Oct 1, 1877Dec 4, 1877 Improvement in lamp-wicks
US1000673 *Jan 20, 1911Aug 15, 1911Archibald W DiackPyrometer.
US1191572 *May 24, 1916Jul 18, 1916Charles T DavisSurgical package and method for indicating sterilization thereof.
US1238123 *Dec 9, 1915Aug 28, 1917Allan A FreemanAcid and alkali testing and indicating device.
US1426569 *Feb 26, 1921Aug 22, 1922Alonzo P IngramGummed tape
US1441307 *Dec 18, 1919Jan 9, 1923Swanberg JuliusTemperature indicator
US1535536 *Jan 29, 1924Apr 28, 1925Donald MacdonaldThermic telltale
US1558153 *Jan 4, 1924Oct 20, 1925Karl A FerkelTemperature-indicating means
US1676536 *Aug 26, 1925Jul 10, 1928Karl A FerkelTemperature-indicating means
US1703880 *Dec 30, 1924Mar 5, 1929 Thermoscope
US1788104 *May 31, 1930Jan 6, 1931Wilfrid HargreavesSterilizing test device
US1843234 *Mar 24, 1931Feb 2, 1932Karnes James CTesting sealed containers and method of testing containers
US1894015 *Dec 15, 1931Jan 10, 1933Bernstein Wilburn FSeptic indicator
US1917048 *Oct 30, 1931Jul 4, 1933 Thomas midgufiy
US1951650 *Oct 19, 1932Mar 20, 1934Archibald W DiackPyrometer and casing therefor
US2046863 *Mar 19, 1934Jul 7, 1936Macgregor Instr CompanyMeans for indicating sterilizing temperatures
US2049867 *Jun 7, 1935Aug 4, 1936Rca CorpRadio tube label
US2118144 *Aug 5, 1932May 24, 1938Berman PhoebusSterilizing indicator and ink
US2195395 *Oct 21, 1938Apr 2, 1940Chapman Arthur WilliamMeans for indicating the extent of a thermal treatment
US2222067 *Apr 22, 1939Nov 19, 1940Joe Crail JrSterilizing indicator
US2269038 *Jul 25, 1940Jan 6, 1942Nashua Gummed & Coated PaperTemperature-indicating instrumentality
US2277278 *Jan 24, 1939Mar 24, 1942Triplett Stanley FIndicator for frozen canned goods
US2278749 *Feb 9, 1939Apr 7, 1942American Seating CoChair arm
US2308087 *Mar 6, 1940Jan 12, 1943Hansens Lab IncTemperature indicator
US2335999 *Jul 31, 1941Dec 7, 1943Diack Archibald WPyrometer
US2337534 *Jun 14, 1941Dec 28, 1943Barber Alfred WDevice for indicating exposure time of printed pages
US2379459 *Feb 2, 1944Jul 3, 1945Lee William MccTemperature indicator
US2460215 *Jul 8, 1946Jan 25, 1949Chase Kenneth JTelltale for frozen food packages
US2490933 *Jul 19, 1943Dec 13, 1949Guyot William STemperature indicator
US2552477 *Jun 5, 1946May 8, 1951Cole James WebbTemperature time integrator
US2560537 *Jul 8, 1949Jul 17, 1951Andersen Ariel ADefrosting indicator
US2567445 *Aug 21, 1946Sep 11, 1951Elizabeth W ParkerMethod of measuring the ph of aqueous liquids, moist foodstuffs, and the like
US2579738 *Apr 2, 1948Dec 25, 1951Wilfrid HargreavesSterilizer test device
US2606654 *Apr 19, 1945Aug 12, 1952American Viscose CorpPackage combined with sterilization indicator
US2614430 *Feb 1, 1950Oct 21, 1952Eastman Kodak CoTemperature indicating device
US2677278 *Mar 21, 1950May 4, 1954Smith & UnderwoodFusible thermometer
US2708896 *May 12, 1954May 24, 1955Millard F SmithIndicating protective covers for pipe flanges and valves
US2716065 *Jun 4, 1951Aug 23, 1955Aseptic Thermo Indicator CompaTelltale for frozen food packages
US2798855 *Mar 19, 1954Jul 9, 1957Baxter Don IncSterilization indicator
US2798856 *Mar 19, 1954Jul 9, 1957Baxter Don IncSteam sterilization indicator
US2799167 *Feb 12, 1953Jul 16, 1957Joseph D LocontiTemperature indicators
US2826073 *Feb 20, 1956Mar 11, 1958Aseptic Thermo Indicator CompaSterilization indicator
US2847067 *Sep 1, 1955Aug 12, 1958Hynson Westcott & Dunning IncSterilization indicator
US2850393 *Jul 23, 1956Sep 2, 1958Aseptic Thermo Indicator CompaFrozen food telltale
US2854384 *Sep 17, 1956Sep 30, 1958John W BeakleyMethod and apparatus for sterilizer tests and control
US2889799 *Jan 20, 1955Jun 9, 1959Korpman RalfTemperature indicator
US2915405 *Mar 17, 1958Dec 1, 1959Hammond JrFrozen food indicator
US2918893 *Nov 17, 1955Dec 29, 1959Clyde A NortonLeakage indicator for liquid fuel systems
US2928791 *Jun 20, 1957Mar 15, 1960Joseph D LocontiTemperature indicators
US2932971 *Feb 11, 1957Apr 19, 1960Gen Dynamics CorpTemperature indicator
US2951764 *Jan 25, 1957Sep 6, 1960Chase Kenneth JSignal device for food package
US2971852 *Jul 23, 1956Feb 14, 1961Joseph SchuleinTemperature telltale
US2998306 *Apr 15, 1960Aug 29, 1961Aseptic Thermo Indicator CompaTelltale for ethylene oxide sterilization
US3002385 *Feb 12, 1960Oct 3, 1961Pyrodyne IncTemperature indicator
US3018611 *Aug 31, 1959Jan 30, 1962 Timer device and method for determination
US3046786 *Aug 12, 1958Jul 31, 1962Honeywell Regulator CoCondition responsive device
US3047405 *Jan 25, 1960Jul 31, 1962William M LauierIndicators
US3055759 *Apr 13, 1959Sep 25, 1962Busby John CTemperature indicators
US3059474 *Sep 24, 1959Oct 23, 1962Gen Dynamics CorpTemperature indicating device
US3065083 *Jan 2, 1958Nov 20, 1962Gessler Albert ETime-delay temperature indicator
US3067015 *Jan 29, 1960Dec 4, 1962Ray F LawdermiltSpoilage indicator for food containers
US3078182 *Sep 9, 1960Feb 19, 1963Shuford Mills IncColor-changing pressure-sensitive adhesive indicator tapes
US3082624 *Sep 11, 1961Mar 26, 1963Honeywell Regulator CoCondition responsive devices
US3093242 *Jul 10, 1961Jun 11, 1963Aseptic Thermo Indicator CompaPackaged article for ethylene oxide sterilization and subsequent storage
US3098751 *Jul 18, 1960Jul 23, 1963Aseptic Thermo Indicator CompaPrinting ink composition for ethylene oxide sterilization indicators
US3114349 *Apr 25, 1960Dec 17, 1963Propper Mfg Company IncSterilization indicators
US3118774 *Sep 1, 1960Jan 21, 1964Canada Nat Res CouncilDetection of spoilage
US3205158 *Oct 4, 1962Sep 7, 1965Honeywell IncCondition responsive devices
US3242733 *Jul 2, 1963Mar 29, 1966Atlantic Res CorpIndicator device
US3243303 *Jun 27, 1962Mar 29, 1966Johnson Leighton CTemperature monitor employing a flowable aqueous composition containing dispersed polyvinyl acetate as a flow retardant
US3288718 *Nov 26, 1963Nov 29, 1966Us Envelope CoSterilization indicator coating
US3311084 *Dec 24, 1964Mar 28, 1967Johnson & JohnsonIndicator tape
US3313266 *Aug 30, 1965Apr 11, 1967Propper Mfg Company IncFusible pellet tube control
US3324723 *Mar 4, 1965Jun 13, 1967Macarthys LtdIndicating devices for heat treatment
US3341238 *Jan 27, 1967Sep 12, 1967Propper Mfg Company IncSterilization indicating devices and method of securing leader string thereto
US3344670 *Dec 31, 1964Oct 3, 1967Ashland Oil IncTime/temperature integrators
US3352794 *Jul 7, 1964Nov 14, 1967Boeing CoProcess for making a temperature sensitive color reversible pigment and resulting product
US3360337 *Dec 24, 1964Dec 26, 1967Johnson & JohnsonIndicator tape
US3360338 *Dec 24, 1964Dec 26, 1967Johnson & JohnsonIndicator tape
US3360339 *Dec 28, 1964Dec 26, 1967Johnson & JohnsonIndicator tape
US3386807 *Dec 24, 1964Jun 4, 1968Johnson & JohnsonIndicator tape
US3399284 *Mar 23, 1966Aug 27, 1968Miles LabIndicating device
US3414415 *Oct 22, 1965Dec 3, 1968Robert L. Broad Jr.Thaw indicator
US3420205 *Mar 23, 1966Jan 7, 1969Miles LabIndicating device
US3430491 *Dec 27, 1966Mar 4, 1969Gignilliat Leigh RDisposable clinical thermometer
US3437070 *Jan 28, 1966Apr 8, 1969Campbell Lloyd BTemperature indicator
US3440144 *May 21, 1965Apr 22, 1969Andersen Prod H WMethod and apparatus for checking and testing the effectiveness of sterilization
US3460964 *Nov 19, 1964Aug 12, 1969Eastman Kodak CoHeat-sensitive recording element and composition
US3465590 *Aug 22, 1960Sep 9, 1969Sybron CorpThermometer
US3471422 *Jun 17, 1966Oct 7, 1969Tempil CorpTime-temperature responsive color changing typographic printing ink composition
US3479877 *Aug 28, 1968Nov 25, 1969Minnesota Mining & MfgTime-temperature indicator
US3523011 *May 7, 1968Aug 4, 1970Canadian Technical Tape LtdSterilization indicator material and tape containing the same
US3545400 *Mar 25, 1969Dec 8, 1970Von L SmithFreeze and thaw indicator
US3580079 *Mar 6, 1969May 25, 1971Abbott LabThermometer indicator
US3597976 *Jul 3, 1969Aug 10, 1971Paul J FryarClinical temperature bandage
US3616898 *Sep 8, 1969Nov 2, 1971Abbott LabPeelable seal package
US3620677 *Dec 18, 1961Nov 16, 1971Miles LabIndicating device
US3627469 *Apr 27, 1970Dec 14, 1971Kendall & CoExposure and sterilization indicators comprising substituted pyridines quinolines and/or isoquinolines
Non-Patent Citations
Reference
13M Autoclave Tape, "Minnesota Mining and Manufacturing Company" advertisement for 3M Autoclave Tape, 100(5) Modern Hospital at 141 (1963).
2 *3M Autoclave Tape, Minnesota Mining and Manufacturing Company advertisement for 3M Autoclave Tape, 100(5) Modern Hospital at 141 (1963).
3A. C. Scott and M. B. Glasg, "Gravity Air-Displacement Pressure Steam Sterilizers", Lancet at 633-637 (1957).
4 *A. C. Scott and M. B. Glasg, Gravity Air Displacement Pressure Steam Sterilizers , Lancet at 633 637 (1957).
5A. Hoyt, "Studies on Rubber Glove Sterilization and the Use of Sterility Indicators", J. Lab. Clin. Med. at 382-390 (1934).
6 *A. Hoyt, Studies on Rubber Glove Sterilization and the Use of Sterility Indicators , J. Lab. Clin. Med. at 382 390 (1934).
7A. Vecchi, "II Controllo Di `Sterilita` Sui Prodotti Farmaceutici Industriali", XIX(6) II Farmaco at 265-275 (1964).
8 *A. Vecchi, II Controllo Di Sterilita Sui Prodotti Farmaceutici Industriali , XIX(6) II Farmaco at 265 275 (1964).
9Agnes H. S. Brown and George Smith, "The Genus Paecilomyces Bainier and its Perfect Stage Byssochlamys Westling", 40(1) Transactions British Mycological Society at 17-89 (1957).
10 *Agnes H. S. Brown and George Smith, The Genus Paecilomyces Bainier and its Perfect Stage Byssochlamys Westling , 40(1) Transactions British Mycological Society at 17 89 (1957).
11Andrew W. Munster, "Combating Hospital Infections: New Concepts for the '70's", 49 Infection Control at 85-89 (1975).
12Armand Marinaro, "Panel Discussion: Biological Indicators--(II) Development of a Biological Indicator Program", 25 Bulletin of the Parenteral Drug Assoc. at 75-77 (1971).
13 *Armand Marinaro, Panel Discussion: Biological Indicators (II) Development of a Biological Indicator Program , 25 Bulletin of the Parenteral Drug Assoc. at 75 77 (1971).
14Arthur D. Little, Inc., "A Study of the Requirements, Preliminary Concepts and Feasibility of a New System to Process Medical/Surgical Supplies in the Field" (U.S. Army Medical Research and Development Command), National Technical Information Service, U.S. Department of Commerce, Report No. 72688 (1971).
15 *Arthur D. Little, Inc., A Study of the Requirements, Preliminary Concepts and Feasibility of a New System to Process Medical/Surgical Supplies in the Field (U.S. Army Medical Research and Development Command), National Technical Information Service, U.S. Department of Commerce, Report No. 72688 (1971).
16Arthur Hirsch, Ph.D. and Stan Manne, M.B.A., "Bioequivalent Chemical Steam Sterilization Indicators", 18(5) Medical Instrumentation at 272-275 (1984).
17 *Aseptic Thermo Indicator Company ( ATI ), Aseptic Thermo Indicator Company , advertisement for ATI Steriline Bags and Diack Controls, 97 Modern Hospital at 107 (1961).
18 *Aseptic Thermo Indicator Company ( ATI ), Aseptic Thermo Indicator Company , advertisement for Hi Temp Indicators, 97 Modern Hospital at 116 (1961).
19Aseptic-Thermo Indicator Company (ATI), "Aseptic-Thermo Indicator Company", advertisement for ATI Steriline Bags and Diack Controls, 97 Modern Hospital at 107 (1961).
20Aseptic-Thermo Indicator Company (ATI), "Aseptic-Thermo Indicator Company", advertisement for Hi-Temp Indicators, 97 Modern Hospital at 116 (1961).
21 *ATI Steam Clox, Aseptic Thermo Indicator Companuy advertisement for Steam Clox Indicator , 40 Hospital Topics at 55 (1962).
22 *ATI Steam Clox, Aseptic Thermo Indicator Company advertisement for ATI Steam Clox Control , 94 Modern Hospital at 184 (1960).
23ATI Steam-Clox, "Aseptic Thermo Indicator Company" advertisement for ATI Steam-Clox Control", 94 Modern Hospital at 184 (1960).
24ATI Steam-Clox, "Aseptic-Thermo Indicator Companuy" advertisement for Steam-Clox Indicator", 40 Hospital Topics at 55 (1962).
25ATI Steriline Bags, "Aseptic-Thermo Indicator Company" advertisement for A.T.I. sterilization aids including Steam-Clox Indicators, Steriline Bags and Tubing, 92 Modern Hospital at 142 (1959).
26ATI Steriline Bags, "Aseptic-Thermo Indicator Company", advertisement for Steriline Bags, 95 Modern Hospital at 120 (1960).
27 *ATI Steriline Bags, Aseptic Thermo Indicator Company , advertisement for Steriline Bags, 95 Modern Hospital at 120 (1960).
28 *ATI Steriline Bags, Aseptic Thermo Indicator Company advertisement for A.T.I. sterilization aids including Steam Clox Indicators, Steriline Bags and Tubing, 92 Modern Hospital at 142 (1959).
29B. Kirk and R. Hambleton, "Evaluation of an Phototype Micro-Electronic Autoclave Cycle Integrator", 33 J. Pharm. Pharmacol. at 69-74 (1981).
30B. Litsky, "Studies on the Performance of Sterilizer Control Devices Under Experimental Conditions", Smith & Underwood (1970).
31 *B. Litsky, Studies on the Performance of Sterilizer Control Devices Under Experimental Conditions , Smith & Underwood (1970).
32Bertha Yanis Litsky, Ph.D., "Private Evaluation: Chemical & Biological Steam Sterilization Indicator Evaluation", (1982).
33Bio-Medical Sciences, Inc., "Thermalog-S Steam Sterilization Integrator", Technical Monigraph at 2-11 (1976).
34Bio-Medical Sciences, Inc., "Thermalog-S Steam Sterilization Monitor", Laboratory Bulletin (1976).
35Biospore Biological Sterility Indicators, "Castle, Subsidiary of Ritter Company, Inc." advertisement for Spore Controls, 42(3) Hospital Topics at 13 (1964).
36 *Biospore Biological Sterility Indicators, Castle, Subsidiary of Ritter Company, Inc. advertisement for Spore Controls, 42(3) Hospital Topics at 13 (1964).
37Brian G. Fitzpatrick and Robert R. Reich, "EtO Sterilization Monitoring", Journal of Healthcare Material Management at 32-35 (1986).
38Brian G. Fitzpatrick and Robert R. Reich, "Sterilization Monitoring in Vacuum Steam Sterilizers", Journal of Healthcare Material Management at 82-85 (1986).
39C. Couturier, V. Goury, J. M. Bellocq, M. Callanquin and J. C. Darbord, "[A] Study for Validation of Sterilization Indicators", Pharmacie Centrale des Hospitaux Paris (translation) Hospital Louis Mourier, Colombes (1989).
40C. W. Bruch, "Levels of Sterility Probabilities of Survivors vs. Biological Indicators", 28 Bulletin of the Parenteral Drug Assoc. at 105-121 (1974).
41 *C. W. Bruch, Levels of Sterility Probabilities of Survivors vs. Biological Indicators , 28 Bulletin of the Parenteral Drug Assoc. at 105 121 (1974).
42C. W. Walter, "An Evaluation of Sterility Indicators", 2 Surgery at 585-589 (1937).
43 *C. W. Walter, An Evaluation of Sterility Indicators , 2 Surgery at 585 589 (1937).
44Carl W. Lawrence and Seymour S. Block, "Sterilization by Heat", Disinfection, Sterilization and Preservation at 714-734 (1968).
45 *Carl W. Lawrence and Seymour S. Block, Sterilization by Heat , Disinfection, Sterilization and Preservation at 714 734 (1968).
46Carl W. Walter, "Sterilization by Dry Heat", The Aseptic Treatment of Wounds at 92-96 (1948).
47 *Carl W. Walter, Sterilization by Dry Heat , The Aseptic Treatment of Wounds at 92 96 (1948).
48Charles Artandi, "Biological Indicators" (Ethicon, Inc.), 23 Bulletin Parenteral Drug. Assoc. at 254-257 (1969).
49 *Charles Artandi, Biological Indicators (Ethicon, Inc.), 23 Bulletin Parenteral Drug. Assoc. at 254 257 (1969).
50Cheri-Ho Lee, Thomas J. Montville and Anthony J. Sinskey, "Comparison of the Efficacy of Steam Sterilization Indicators", 37(6) Appl. Environ. Microbiol. at 1113 (1979).
51D. Hugh Starkey and Clifton K. Himmelsback, "On the Avoidance of Failures in Sterilization", Hospitals at 143-152 (1974).
52 *D. Hugh Starkey and Clifton K. Himmelsback, On the Avoidance of Failures in Sterilization , Hospitals at 143 152 (1974).
53Dennison MFG. Co., "Dennison Manufacturing Company" advertisement for Dennison Wrap Autoclave Tape, 97(4) Modern Hospital at 233 (1961).
54 *Dennison MFG. Co., Dennison Manufacturing Company advertisement for Dennison Wrap Autoclave Tape, 97(4) Modern Hospital at 233 (1961).
55Diack and Vac Controls, "New Developments in EO Sterilization", 21(5) Aorn Journal at 962 (1975).
56Diack and Vac Controls, "Smith & Underwood" advertisement for Diack and VAC Controls, 21(2) Aorn Journal (1975).
57Diack Sterilizer Control, "Smith & Underwood" advertisement for Diack Controls, 96 Modern Hospital at 10 (1961).
58 *Diack Sterilizer Control, Smith & Underwood advertisement for Diack Controls, 96 Modern Hospital at 10 (1961).
59Diack Sterilizer Controls, "Smith & Underwood" Ad for Diack Controls, 92 Modern Hospital at 10 (1959).
60Diack Sterilizer Controls, "Smith & Underwood" advertisement for Diack Control, 92 Modern Hospital at 8 (1959).
61Diack Sterilizer Controls, "Smith & Underwood" advertisement for Diack Controls, 98 Modern Hospital at 10 (1962).
62 *Diack Sterilizer Controls, Smith & Underwood Ad for Diack Controls, 92 Modern Hospital at 10 (1959).
63 *Diack Sterilizer Controls, Smith & Underwood advertisement for Diack Control, 92 Modern Hospital at 8 (1959).
64 *Diack Sterilizer Controls, Smith & Underwood advertisement for Diack Controls, 98 Modern Hospital at 10 (1962).
65Dr. W. A. Ritschel, "Die Tablette", Grundlagen und Praxis des Tablettierens, Granulierens und Dragierens (and translation, Principles and Practical Aspects of Tablet Formation, Granulation and Coating), 7 Der Pharmazeutische Betrieb at 103-104 (1966).
66 *Dr. W. A. Ritschel, Die Tablette , Grundlagen und Praxis des Tablettierens, Granulierens und Dragierens (and translation, Principles and Practical Aspects of Tablet Formation, Granulation and Coating), 7 Der Pharmazeutische Betrieb at 103 104 (1966).
67E. E. Ecker, "Sterilization Based on Temperature Attained and Time Ration", 48 Modern Hospital at 86-90 (1937).
68 *E. E. Ecker, Sterilization Based on Temperature Attained and Time Ration , 48 Modern Hospital at 86 90 (1937).
69E. M. Darmady, K. E. A. Hughes and J. D. Jones, "Thermal Death-Time of Spores in Dray Heat", 2 Lancet at 766-769 (1958).
70 *E. M. Darmady, K. E. A. Hughes and J. D. Jones, Thermal Death Time of Spores in Dray Heat , 2 Lancet at 766 769 (1958).
71E.O. Indicators (ATI Company), "Performance Certified E.O. Indicators", Hospital Topics at 72 (1974).
72 *E.O. Indicators (ATI Company), Performance Certified E.O. Indicators , Hospital Topics at 72 (1974).
73Earle H. Spaulding, "Uses and Abuses of Disinfectants", 5 Hospital Topics at 7-8 (1974).
74 *Earle H. Spaulding, Uses and Abuses of Disinfectants , 5 Hospital Topics at 7 8 (1974).
75Ernest O. McCulloch, "Bacteriological and Surgical Sterilization by Heat", Disinfection and Sterilization at 69-105 (1945).
76 *Ernest O. McCulloch, Bacteriological and Surgical Sterilization by Heat , Disinfection and Sterilization at 69 105 (1945).
77Four Autoclave Sterilization Indicators, "Aseptic-Thermo Indicator Company", 53 Hospital Topics at 42 (1975).
78Frances L. Clapp, "Panel Discussion: Proposed Changes in the USP--Microbiological Aspects", 23 Bulletin of the Parenteral Drug Assoc. at 252-262 (1969).
79 *Frances L. Clapp, Panel Discussion: Proposed Changes in the USP Microbiological Aspects , 23 Bulletin of the Parenteral Drug Assoc. at 252 262 (1969).
80Frances W. Bowman, "Panel Discussion: Biological Indicators--(III) Quality Control of Biological Indicators", 25 Bulletin of the Parenteral Drug Assoc. at 78-79 (1971).
81 *Frances W. Bowman, Panel Discussion: Biological Indicators (III) Quality Control of Biological Indicators , 25 Bulletin of the Parenteral Drug Assoc. at 78 79 (1971).
82Frank B. Engley, "Discusses Sterilization, Disinfection, Antisepsis for Infection Control", Hospital Topics at 61-69 (1974).
83 *Frank B. Engley, Discusses Sterilization, Disinfection, Antisepsis for Infection Control , Hospital Topics at 61 69 (1974).
84G. Franchi and E. Lencioni, "La Sicurezza Di Un Processo Di Sterilizzazione A Vapore In Campo Farmaceutico Mediante L'Impiego Degli Indicatori Thermalog-S" (and translation), 117 Boll. Chim. Farm. at 620-626 (1978).
85G. R. Wilkinson and D. E. Simpkins, "A Physical Indicator for Sterilization Procedures", 16 Suppl. J. Pharm. Pharmacol. at 108T-110T (1964).
86 *G. R. Wilkinson and D. E. Simpkins, A Physical Indicator for Sterilization Procedures , 16 Suppl. J. Pharm. Pharmacol. at 108T 110T (1964).
87G. R. Wilkinson and F. G. Peacock, "Improvement of Heating of Bottled Fluirds During Autoclave Sterilization Using Low Pressure Steam", 13 Supp. J. Pharm. Pharmacol. at 72T-74T (1961).
88G. R. Wilkinson and F. G. Peacock, "The Removal of Air During Autoclave Sterilization of Fabrics Using Low Pressure Steam", 13 J. Pharm. Pharmacol. Suppl. at 67T-71T (1961).
89G. R. Wilkinson and F. G. Peacock, "Thermocouples for Autoclaves", 1 The Lancet at 488 (1962).
90 *G. R. Wilkinson and F. G. Peacock, Improvement of Heating of Bottled Fluirds During Autoclave Sterilization Using Low Pressure Steam , 13 Supp. J. Pharm. Pharmacol. at 72T 74T (1961).
91 *G. R. Wilkinson and F. G. Peacock, The Removal of Air During Autoclave Sterilization of Fabrics Using Low Pressure Steam , 13 J. Pharm. Pharmacol. Suppl. at 67T 71T (1961).
92 *G. R. Wilkinson and F. G. Peacock, Thermocouples for Autoclaves , 1 The Lancet at 488 (1962).
93G. R. Wilkinson and L. C. Baker, "Contemporary Trends in Heat Sterilization", Advances in Pharm. Sci., vol. I, at 269-314 (1964).
94G. R. Wilkinson and L. C. Baker, "Modern Trends in Steam Sterilization", 5 Progr. Industr. Micro-Biol. at 231-282 (1964).
95 *G. R. Wilkinson and L. C. Baker, Contemporary Trends in Heat Sterilization , Advances in Pharm. Sci., vol. I, at 269 314 (1964).
96 *G. R. Wilkinson and L. C. Baker, Modern Trends in Steam Sterilization , 5 Progr. Industr. Micro Biol. at 231 282 (1964).
97G. R. Wilkinson, "The Correlation of Oven Testing and Field Storage of Pharmaceutical Products", 35 Pharm. Acta. Helv. at 327-332 (1959).
98G. R. Wilkinson, "The Correlation of Oven Testing and Field Storage of Pharmaceutical Products", 85 Pharmaceutica Acta Helvetiae at 327-332 (1960).
99G. R. Wilkinson, G. F. Peacock and E. L. Robins, "A Shorter Sterilizing Cycle for Solutions Heated in an Autoclave", 12 Supp. J. Pharm. Pharmacol. at 197T-202T (1960).
100 *G. R. Wilkinson, G. F. Peacock and E. L. Robins, A Shorter Sterilizing Cycle for Solutions Heated in an Autoclave , 12 Supp. J. Pharm. Pharmacol. at 197T 202T (1960).
101 *G. R. Wilkinson, The Correlation of Oven Testing and Field Storage of Pharmaceutical Products , 35 Pharm. Acta. Helv. at 327 332 (1959).
102 *G. R. Wilkinson, The Correlation of Oven Testing and Field Storage of Pharmaceutical Products , 85 Pharmaceutica Acta Helvetiae at 327 332 (1960).
103G. Reybrouck and H. Van De Voorde, "Evaluatie Van Sterilisatie-Indicatoren Voor Gebruik InDe Autoclaaf" (and translation), 29(4) Arch. Belg. Med. Soc. at 254-258 (1971).
104 *G. Reybrouck and H. Van De Voorde, Evaluatie Van Sterilisatie Indicatoren Voor Gebruik InDe Autoclaaf (and translation), 29(4) Arch. Belg. Med. Soc. at 254 258 (1971).
105G. Sykes, Disinfection and Sterilization, 2nd Ed., "Methods of Sterilization" at 108-119 (1965).
106 *G. Sykes, Disinfection and Sterilization, 2nd Ed., J. B. Lippincott Company, at 121 145 (1965).
107G. Sykes, Disinfection and Sterilization, 2nd Ed., J. B. Lippincott Company, at 121-145 (1965).
108 *G. Sykes, Disinfection and Sterilization, 2nd Ed., Methods of Sterilization at 108 119 (1965).
109H. F. Struppe, "Untersuchungen zur Eignung von Sterilisationsindikatoren fur Schnellautoklaven", 152(4) Arch. Hyg. Bakteriol at 360-365 (1968).
110 *H. F. Struppe, Untersuchungen zur Eignung von Sterilisationsindikatoren fur Schnellautoklaven , 152(4) Arch. Hyg. Bakteriol at 360 365 (1968).
111H. P. Werner and Ch. Vutuc, "Die Eignung Von Chemischen Und Biologischen Indikatoren Zur Uberprufung Des Sterilisationeffektes Von Autoklaven" (Chemical and Biological Indicators for Monitoring Sterilization in Autoclaves), Zentralblatt at 561-568 (1972).
112 *H. P. Werner and Ch. Vutuc, Die Eignung Von Chemischen Und Biologischen Indikatoren Zur Uberprufung Des Sterilisationeffektes Von Autoklaven (Chemical and Biological Indicators for Monitoring Sterilization in Autoclaves), Zentralblatt at 561 568 (1972).
113HIMA Report 78-4.4, "HIMA Medical Device Sterilization Monographs: Biological and Chemical Indicators; Manufacturing, Engineering and Quality Assurance Section Task Force on Biological & Chemical Indicators", Health Industry Manufacturers Assoc., August (1978).
114I. J. Pflug, "Heat Sterilization", Industrial Sterilization at 239-281 (1972).
115I. J. Pflug, "Some Observations Regarding Factors Important in Dry Heat Sterilization", COSPAR Technique Manual No. 4 at 51-58 (1968).
116 *I. J. Pflug, Heat Sterilization , Industrial Sterilization at 239 281 (1972).
117 *I. J. Pflug, Some Observations Regarding Factors Important in Dry Heat Sterilization , COSPAR Technique Manual No. 4 at 51 58 (1968).
118Inform Controls, "Smith & Underwood" advertisement for Inform Controls, 93 Modern Hospital at 6 (1959).
119 *Inform Controls, Smith & Underwood advertisement for Inform Controls, 93 Modern Hospital at 6 (1959).
120Irving J. Pflug, "Performance of Biological Indicators Designed for Monitoring", (1975).
121Irving J. Pflug, "Sterilization of Space Hardware" (University of Minnesota), 1 Environmental Biology and Medicine at 63-81 (1971).
122 *Irving J. Pflug, Sterilization of Space Hardware (University of Minnesota), 1 Environmental Biology and Medicine at 63 81 (1971).
123J. C. Darbord, "Indicateurs Biologiques De Sterilisation Interet Et Limites", Sci. Techn. Pharm. at 331-334 (1982).
124J. C. Kelsey, "The Bowie-Dick Test", 2 The Lancet at 911-912 (1966).
125J. C. Kelsey, "The Testing of Sterilizers", 1 Lancet at 306-309 (1958).
126J. C. Kelsey, "The Testing of Sterilizers", 14 J. Clin. Path. at 313-319 (1961).
127 *J. C. Kelsey, The Bowie Dick Test , 2 The Lancet at 911 912 (1966).
128 *J. C. Kelsey, The Testing of Sterilizers , 1 Lancet at 306 309 (1958).
129 *J. C. Kelsey, The Testing of Sterilizers , 14 J. Clin. Path. at 313 319 (1961).
130J. H. Bowie, "Bowie and Dick Test", I The Lancet at 1233 (1974).
131 *J. H. Bowie, Bowie and Dick Test , I The Lancet at 1233 (1974).
132J. H. Bowie, J. C. Kelsey and G. R. Thompson, "The Bowie and Dick" Autoclave Tape Test, 1 The Lancet at 586-587 (1963).
133 *J. H. Bowie, J. C. Kelsey and G. R. Thompson, The Bowie and Dick Autoclave Tape Test, 1 The Lancet at 586 587 (1963).
134J. H. Brewer and C. B. McLaughlin, "A Device for Determining Time and Temperature of Sterilization in the Autoclave or Hot-Air Oven", 120 Science at 501-502 (1954).
135 *J. H. Brewer and C. B. McLaughlin, A Device for Determining Time and Temperature of Sterilization in the Autoclave or Hot Air Oven , 120 Science at 501 502 (1954).
136J. J. Perkins, "Principles and Methods of Sterilization", Principles and Methods of Sterilization in Health Sciences, 2nd Ed., selected pages, particularly 488-493 (1969).
137 *J. J. Perkins, Principles and Methods of Sterilization , Principles and Methods of Sterilization in Health Sciences, 2nd Ed., selected pages, particularly 488 493 (1969).
138J. K. Pickerill and R. Perera, "Air Detection in Dressings Steam Sterilizers", 20 Laboratory Practice at 406-413 (1971).
139 *J. K. Pickerill and R. Perera, Air Detection in Dressings Steam Sterilizers , 20 Laboratory Practice at 406 413 (1971).
140J. W. Howie and Morag C. Timbury, "Laboratory Tests of Operating-Theatre Sterilizers", Lancet at 669-673 (1956).
141 *J. W. Howie and Morag C. Timbury, Laboratory Tests of Operating Theatre Sterilizers , Lancet at 669 673 (1956).
142J. W. Howie, "Sterilization by Steam Under Increased Pressure", 1 Lancet at 425-435 (1959).
143 *J. W. Howie, Sterilization by Steam Under Increased Pressure , 1 Lancet at 425 435 (1959).
144James Whitbourne and Keith West, "Sterility Testing: How Appropriate for the Hospital", 10 Medical Instrumentation at 291-292 (1976).
145Jan Hoborn, "Steam Sterilization: A Comparison of Steam-Clox and Some European Biological Indicators", 12 Health Laboratory Science at 225-229 (1975).
146John E. Doyle, "Sterility Indicator with Artificial Resistance to Ethylene Oxide", 25 Bulletin of the Parenteral Drug Assoc. at 98-104 (1971).
147 *John E. Doyle, Sterility Indicator with Artificial Resistance to Ethylene Oxide , 25 Bulletin of the Parenteral Drug Assoc. at 98 104 (1971).
148John J. Mayernik, "Biological Indicators for Steam Sterilization--A U.S.P. Collaborative Study", 26 Bulletin of the Parenteral Drug Assoc. at 205-211 (1972).
149 *John J. Mayernik, Biological Indicators for Steam Sterilization A U.S.P. Collaborative Study , 26 Bulletin of the Parenteral Drug Assoc. at 205 211 (1972).
150John R. Gillis, "Biological Indicators for Steam Sterilization Process Monitoring", 29 Bulletin Parenteral Drug Assoc. at 111-121 (1975).
151K. Kereluk and R. Gammon, "A Comparative Study of Biological Indicators for Steam Sterilization", 15 Developments in Industrial Microbiology at 411-416 (1974).
152 *K. Kereluk and R. Gammon, A Comparative Study of Biological Indicators for Steam Sterilization , 15 Developments in Industrial Microbiology at 411 416 (1974).
153K. Kereluk, "Quality Control in Sterilization Procedures: Biological Indicators", 53 Hospital Topics at 25-39 (1975).
154Karl Kereluk and Robert S. Lloyd, "Ethylene Oxide Sterilization" (American Sterilizer Company), 7 The Journal of Hospital Research at 55-59 (1969).
155 *Karl Kereluk and Robert S. Lloyd, Ethylene Oxide Sterilization (American Sterilizer Company), 7 The Journal of Hospital Research at 55 59 (1969).
156L. F. Ortenzio, L. S. Stuart and J. L. Friedl, "The Resistance of Bacterial Spores to Constant Boiling Hydrochloric Acid", 36 Journal of the Assoc. of Official Agricultural Chemists at 480-485 (1953).
157 *L. F. Ortenzio, L. S. Stuart and J. L. Friedl, The Resistance of Bacterial Spores to Constant Boiling Hydrochloric Acid , 36 Journal of the Assoc. of Official Agricultural Chemists at 480 485 (1953).
158L. Joslyn, "Sterilization Process Efficiences as Measured by Biological Indicators Versus Physical Indicators", 22 Dev. Indust. Micro. at 341-343 and 345-347 (1981).
159Larry Day, et al., "Panel Discussion: Biological Indicators--Manufacture and Quality Control for a Biological Indicator", Bulletin Parenteral Drug Assoc. (1970).
160 *Larry Day, et al., Panel Discussion: Biological Indicators Manufacture and Quality Control for a Biological Indicator , Bulletin Parenteral Drug Assoc. (1970).
161Lawrence P. Garrod, "Sterilization Methods", British Medical Journal at 350-351 (1955).
162 *Lawrence P. Garrod, Sterilization Methods , British Medical Journal at 350 351 (1955).
163M. Callanquin, F. Bourillet, J. C. Darbord, R. Hajjar, S. Klein, A. Le Guyader, J. L. Mazert, P. Montenoise and J. L. Prugnaud, "Indicateurs Physicochimiques Et Biologiques En Sterilisation" (and translation), STP Pharma 3 at 148-154 (1987).
164M. Furuhashi and T. Miyamae, "A New Method to Confirm the Efficiency of Steam Sterilization Relation Between Thermalog-S Integrator and the Thermal Destruction of Microbiol Spores" (translation only), Presentation at the 51st Meeting of the Japanese Association for Infectious Diseases (1977).
165M. Gay, "Les Indicateurs Biologiques De Sterilisation" (no translation), 32(5) J. Pharm. De Belgique at 520-524 (1977).
166M. Karki, "Performance Standards for Chemical Indicators", 52(2) Score at 19 (1980).
167Michael Korczynski, C. L. Peterson and C. C. Loshbaugh, "An Approach to Establishing Parenteral Solution Sterilization Cycles", 28 Bulletin of the Parenteral Drug Assoc. at 270-277 (1974).
168 *Michael Korczynski, C. L. Peterson and C. C. Loshbaugh, An Approach to Establishing Parenteral Solution Sterilization Cycles , 28 Bulletin of the Parenteral Drug Assoc. at 270 277 (1974).
169O. Rahn, "Physical Methods of Sterilization of Microorganisms", 1 Bacteriological Reviews at 1-47 (1945).
170 *O. Rahn, Physical Methods of Sterilization of Microorganisms , 1 Bacteriological Reviews at 1 47 (1945).
171Patrick P. Caporino, "How Effective are Chemical and Biological Sterilization Indicators?", Journal of Healthcare Material Management at 32-44 (1991).
172Peter Jancke, "Superheated Steam in Porous Load Sterilizers", circa (1980).
173Pijck, "A New Biological Indicator System for Testing Sterilization Efficiency (English), 26(2) J. De Pharmacie De Belgique at 211-212 (1971).
174 *Pijck, A New Biological Indicator System for Testing Sterilization Efficiency (English), 26(2) J. De Pharmacie De Belgique at 211 212 (1971).
175 *Pro Tex Mor Medical Division, Central States Paper & Bag Co. advertisement for Sterilizer Bags with Indicator Marks , 38 Hospital Topics at 115 (1960).
176Propper Mgf., "Propper Sterilization Indicators", 24 Hospital Topics (1973).
177 *Propper Mgf., Propper Sterilization Indicators , 24 Hospital Topics (1973).
178Pro-Tex-Mor Medical Division, "Central States Paper & Bag Co." advertisement for Sterilizer Bags with Indicator Marks", 38 Hospital Topics at 115 (1960).
179R. A. Caputo and C. C. Mascoli, "The Design and Use of Biological Indicators for Sterilization-Cycle Validation", MD & DI at 23-26 and 42 (1980).
180R. Hajjar and A. Cuine, "Validation Des Methodes De Sterilisation Per Voie Humide Et Par Voie Seche", Sci. Techn. Pharm. at 323-330 (1982).
181R. J. Witonsky, "A New Tool for the Validation of the Sterilization of Parenterals", 31 Bulletin of the Parenteral Drug Assoc. at 274 (1977).
182R. J. Witonsky, "An Overview of Thermalog-S" (Bio-Medical Sciences, Inc.), BMS Report at 1-19 (1976).
183Rex O. Astrid and Zunino V. Hugo, "Chemical Monitors of Autoclave Sterilization (Translation), 100 Revista Medica de Chile at 1087-1090 (1972).
184 *Rex O. Astrid and Zunino V. Hugo, Chemical Monitors of Autoclave Sterilization (Translation), 100 Revista Medica de Chile at 1087 1090 (1972).
185Robert F. Smith, "Modified Bowie-Dick Test", I The Lancet at 1349 (1974).
186Robert F. Smith, "Quality Assurance in Hospital Steam Sterilization", Smith & Underwood Laboratories (1972).
187 *Robert F. Smith, Modified Bowie Dick Test , I The Lancet at 1349 (1974).
188 *Robert F. Smith, Quality Assurance in Hospital Steam Sterilization , Smith & Underwood Laboratories (1972).
189Robert J. Witonsky, "Chemical Indicators, More Sense, Less Dollars", Speech at 213-224 circa (1980).
190Robert R. Reich and Brian G. Fitzpatrick, "Flash Sterilization", Journal of Hospital Surgical Processing and Distribution, May-Jun. at 60-63 (1985).
191S. Stanley Schneierson and edited by R. B. Roberts, "Sterilization by Heat", 10(2) Infections and Sterilization Problems at 67-83 (1972).
192 *S. Stanley Schneierson and edited by R. B. Roberts, Sterilization by Heat , 10(2) Infections and Sterilization Problems at 67 83 (1972).
193Scotch Hospital Tapes, "Minnesota Mining and Manufacturing Company" advertisement for Scotch Brand Hospital Tapes by Minnesota Mining and Manufacturing Company, 92 Modern Hospital at 113 (1959).
194 *Scotch Hospital Tapes, Minnesota Mining and Manufacturing Company advertisement for Scotch Brand Hospital Tapes by Minnesota Mining and Manufacturing Company, 92 Modern Hospital at 113 (1959).
195Spordex, "American Sterilizer" advertisement for Sporde-X Spore Strips, 100 Modern Hospital at 5 (1963).
196 *Spordex, American Sterilizer advertisement for Sporde X Spore Strips, 100 Modern Hospital at 5 (1963).
197Sterilometer, "Sterilometer Laboratories, Inc." advertisement for Sterilometer, 1(2) Aorn Journal at 86 (1963).
198Sterilometer, "Sterilometer Laboratories, Inc." advertisement for Sterilometer, 41(12) Hospital Topics at 74 (1963).
199 *Sterilometer, Sterilometer Laboratories, Inc. advertisement for Sterilometer, 1(2) Aorn Journal at 86 (1963).
200 *Sterilometer, Sterilometer Laboratories, Inc. advertisement for Sterilometer, 41(12) Hospital Topics at 74 (1963).
201Surgicot, Inc., "Sterilization Bag" advertisement, 3 Hospital Topics at 67 (1973).
202 *Surgicot, Inc., Sterilization Bag advertisement, 3 Hospital Topics at 67 (1973).
203Sybron/Castle, "UniSpore Biological Indicators", Castle/Sybron Service Bulletin at 1035 (1975).
204 *Sydney D. Rubbo and Joan F. Gardner, A Review of Sterilization and Disinfection, Year Book Medical Publishers, Inc. at 6 65 (1965).
205Sydney D. Rubbo and Joan F. Gardner, A Review of Sterilization and Disinfection, Year Book Medical Publishers, Inc. at 6-65 (1965).
206T. B. Owen, J. J. Perkins, A. S. Irons, A. W. Reichert and S. J. Mannarino, "Prevacuum High Temperature Steam Sterilization", 1 The Journal of Hospital Research, 5-30 (1963).
207 *T. B. Owen, J. J. Perkins, A. S. Irons, A. W. Reichert and S. J. Mannarino, Prevacuum High Temperature Steam Sterilization , 1 The Journal of Hospital Research, 5 30 (1963).
208Thomas J. Macek, "Biological Indicators, A U.S.P. Review", 26(1) Bulletin of the Parenteral Drug Assoc. (1972).
209 *Thomas J. Macek, Biological Indicators, A U.S.P. Review , 26(1) Bulletin of the Parenteral Drug Assoc. (1972).
210Thomas Laskaris and Albert L. Chaney, "Reliability of Biologic Autoclave Sterilization Indicators" 52(4) The American Journal of Clinical Pathology at 495-500 (1969).
211 *Thomas Laskaris and Albert L. Chaney, Reliability of Biologic Autoclave Sterilization Indicators 52(4) The American Journal of Clinical Pathology at 495 500 (1969).
212Thomas Macek, "Some Thoughts on Sterilization and Sterility Control", 25(1) Bulletin of the Parenteral Drug Assoc. (1971).
213 *Thomas Macek, Some Thoughts on Sterilization and Sterility Control , 25(1) Bulletin of the Parenteral Drug Assoc. (1971).
214 *Time Duo Strip, Professional Tape Company, Inc. 73 Hospital Topics (1973).
215Time Duo-Strip, "Professional Tape Company, Inc." 73 Hospital Topics (1973).
216TSI Tape, "Professional Tape Co., Inc." advertisement for TSI Tape, 98(3) Modern Hospital at 125 (1962).
217 *TSI Tape, Professional Tape Co., Inc. advertisement for TSI Tape, 98(3) Modern Hospital at 125 (1962).
218V. G. Adler and W. A. Gillespie, "The Sterilization of Dressings", 10 J. Clin. Path. at 299-306 (1957).
219 *V. G. Adler and W. A. Gillespie, The Sterilization of Dressings , 10 J. Clin. Path. at 299 306 (1957).
220 *Vac Sterilizer Controls ( Diack ), Diack Controls advertisement for VAC Sterilizer Control, 101 Modern Hospital at 10 (1963).
221Vac Sterilizer Controls (Diack), "Diack Controls" advertisement for VAC Sterilizer Control, 101 Modern Hospital at 10 (1963).
222W. A. Hennig, H. S. Stern, R. J. Laza and Y. S. Murthy, "Use of Bacillus stearothermophilus as a Biological Indicator", 1 Bulletin of the Parenteral Drug Assoc. at 30-37 (1973).
223 *W. A. Hennig, H. S. Stern, R. J. Laza and Y. S. Murthy, Use of Bacillus stearothermophilus as a Biological Indicator , 1 Bulletin of the Parenteral Drug Assoc. at 30 37 (1973).
224W. B. Underwood, "Methods of Testing", A Textbook of Sterilization at 98-105 (1941).
225 *W. B. Underwood, Methods of Testing , A Textbook of Sterilization at 98 105 (1941).
226Weckink Control, "Edward Weck & Company" advertisement for Weck Catheter Sterilizing Papers, 93 Modern Hospital at 182 (1959).
227 *Weckink Control, Edward Weck & Company advertisement for Weck Catheter Sterilizing Papers, 93 Modern Hospital at 182 (1959).
228William C. Beck, "A New Integrator for Monitoring Time and Temperature of Steam Sterlizers", 10(6) Med. Inst. Nov.-Dec. at 293-296 (1976).
229Wm. A. Altemeier, "The Significance of Infection in Trauma", Scudder Oration on Trauma at 7-16 (1971).
230 *Wm. A. Altemeier, The Significance of Infection in Trauma , Scudder Oration on Trauma at 7 16 (1971).
231Wm. C. Beck, "A New Instrument for Measuring and for Monitoring the Time and Temperature of Steam Sterilizers", 45(4) Guthrie at 197-204 (1976).
232Wm. S. Miller, "Panel Discussion: Biological Indicators--(IV) Types of Biological Indicators Used in Monitoring Sterilization Processes", 25 Bulletin of the Parenteral Drug Assoc. at 80-86 (1971).
233 *Wm. S. Miller, Panel Discussion: Biological Indicators (IV) Types of Biological Indicators Used in Monitoring Sterilization Processes , 25 Bulletin of the Parenteral Drug Assoc. at 80 86 (1971).
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US5745039 *Feb 21, 1997Apr 28, 1998Minnesota Mining And Manufacturing CompanyRemote sterilization monitor
US5830683 *Oct 24, 1996Nov 3, 1998North American Science Associates, Inc.Indicator systems for determination of sterilization
US6218189Apr 13, 1999Apr 17, 2001Johnson & Johnson Medical, Inc.Detecting antiseptic incubation; incubation of surface with bleachable dye, monitoring color change
US6485978Aug 5, 1999Nov 26, 20023M Innovative Properties CompanyMethod of using a chemical indicator
US6488890Aug 5, 1999Dec 3, 20023M Innovative Properties CompanyMachine readable sterilization indicator for monitoring articles to be sterilized
US6551555Dec 19, 2000Apr 22, 2003Ethicon, Inc.Apparatus with a chemical indicator for indicating exposure to an oxidative sterilant or disinfectant
US6737645Aug 30, 2002May 18, 2004Tropicana Products, Inc.Method for qualifying bottle rinser
US7074280 *Jul 3, 2003Jul 11, 2006Healthmark Industries Co.Method and system to represent a temperature experienced by a medical device in a medical washing machine
US7105350Aug 30, 2002Sep 12, 2006Tropicana Products, Inc.Closure integrity test method for hot-fill bottling operation
US7560082Oct 13, 2004Jul 14, 2009Allegiance CorporationSterilization wraps and methods for sterilizing articles
US7906070Jun 11, 2009Mar 15, 2011Allegiance CorporationSterilization wraps and methods for sterilizing articles
EP2340853A1Jul 10, 2000Jul 6, 20113M Innovative Properties CompanyElectronic system for tracking and monitoring articles to be sterilized
EP2347772A1Jul 10, 2000Jul 27, 20113M Innovative Properties CompanyMethod for tracking articles to be sterilized
Classifications
U.S. Classification374/160, 252/408.1, 374/162, 426/88, 435/31, 422/426
International ClassificationA61L2/28, A61L2/26, G01N31/22
Cooperative ClassificationG01N31/226, A61L2/28
European ClassificationA61L2/28, G01N31/22F
Legal Events
DateCodeEventDescription
Feb 12, 1997ASAssignment
Owner name: MINNESOTA MINING AND MANUFACTURING COMPANY, MINNES
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PYMAH CORPORATION;REEL/FRAME:008334/0418
Effective date: 19970123