Composition for temperature-time indicator for steam sterilization

 

The invention relates to the field of medicine. The composition contains partially soluble or insoluble in water salt or mixture of salts of polyvalent metal - 30,0 to 99.9 wt.%, which in the conditions of steam sterilization change their color, and component-controller - 0,1-70,0 wt.%, allows you to adjust the speed of hydrolysis of the salt or mixture of salts of polyvalent metal, which composition contains a salt or mixture of salts of iron, manganese, cobalt, copper and/or Nickel. As a component of the control composition may contain alkaline salts, alkaline earth metal, ammonium carbonates, phosphates, oxalates, sulfates, rodonite, tartratami, borates, salt dihydroxybenzoic acid. The invention provides rapid control in the absence of plaque formation of sulfur on sterilized products, with adjustable time ending color at a given temperature. 2 C.p. f-crystals, 1 table.

The invention relates to thermometry, namely, controls the operation of sterilizers, and can be used in the manufacture of chemical thermo-time indicators, designed to monitor the processes of sterilization and disinfection, and used in the food industry the core technology of sterilization is the handling of the sterilized objects saturated with water vapor. Pre-sterilization cleaning and disinfection of medical devices, sterilizing filtration of drugs provides no guarantee of sterility. To achieve sterility always used methods of sterilization: radiation, gas, air, steam. The most reliable method is sterilization with saturated steam.

The reliability of steam sterilization is provided by many factors - pre-sterilization cleaning products used sterilization equipment, and methods of control. For control of the sterilization process are mainly two methods of control using bacterial and chemical indicators.

The most informative method is the use of bacteriological indicators (backtest), indicating sterility. These indicators are placed in the most difficult for the sterilizing agent. Using bacastow, which is the most heat-resistant spore-forming strains of bacteria, is limited by its disadvantages.

The disadvantage of this method is that backtest cannot be used for current control. This control is carried out periodically special organisms is tov after the control cycle.

For the current Express of control currently widely used chemical indicators, where the result is known immediately after completion of the sterilization cycle. Chemical indicators operate on the principle that change their color when exposed to the sterilizing agent (for steam sterilization - steam), with the longer exposure to the sterilizing agent, the more it changes color. The color of the indicator when steam sterilization is changed as a result of the reaction between its components and water vapor or reactions between the components of the indicator that is activated with water vapor.

Closest to the proposed invention is an indicator composition described in patent 238902 (Czech Republic, class G 01 T 31/22, 1985).

In this patent is provided a composition consisting of a mixture of lead carbonate with sulfur in a polymeric binder. The composition of the chemical reaction only occurs in the presence of water vapor, which activate the sulfur molecules, which leads to the formation of lead sulfide, the indicator of beige becomes dark brown, almost black.

The disadvantage of this composition is the release of gaseous products (plet dark color (sulfides of metals).

The technical result achieved by the invention is the elimination of formation of gaseous products with sulfur, which, in turn, prevents the formation of plaque on sterilized products, and providing the possibility of regulation time ending color at a given temperature.

This result is achieved due to the fact that the claimed composition for temperature-time indicator for steam sterilization contains partially soluble or insoluble in water salt or mixture of salts of polyvalent metal, which in the conditions of steam sterilization change their color, and the component controller to regulate the speed of hydrolysis of the salt or mixture of salts of polyvalent metal, the salt or mixture of salts of polyvalent metal composition comprises a salt or mixture of salts of iron, manganese, cobalt, copper and/or Nickel in the following ratios, wt.%: Salt or mixture of salts of polyvalent metal - 30,0-99,9 Component-controller - 0,1-70,0 as a salt or mixture of salts of polyvalent metal composition may contain carbonates, bicarbonates, phosphates, oxalates, stearates, palminate, citrates and other salts of weak sour the phosphate, rodanet anions. As a component of the control composition may contain alkaline salts, alkaline earth metal, ammonium carbonates, phosphates, oxalates, sulfates, rodonite, tartratami, borates, salt dihydroxybenzoic acid.

In this song, both the original and the final painted components are slightly soluble or insoluble in water and water vapour, do not contain sulfur or sulfide sulfur emitted in the reaction gaseous products (carbon dioxide, nitrogen, inert and do not affect sterilized products.

The composition is in the form of salts of polyvalent metals may contain colored carbonates of iron, manganese, copper, Nickel and cobalt - F3, Soso3, MPMs3and others, hydroxocobalamin cobalt, copper, Nickel - Co2(CO3)(OH)2H2O Co3(CO3)2(OH)25H2O CO5(CO3)2(HE6)H2And others , oxalates of iron, manganese, copper, Nickel and cobalt - FeC2O4and others, the phosphates of iron, cobalt, copper, Nickel - FePO (4, FePO (42H2O Co3(RHO4)2and others, stearates, palminate, citrates, tartratami iron, manganese, copper, Nickel and cobalt, sub>2)6], iron blue Fe43+[Fe2+(CN)6]3K4[Fe(CN)6]nH2O, and other Color transitions of some salts of polyvalent metals listed in the table.

As a component of the controller can be used salts of alkali, alkaline earth metals, ammonium carbonates, phosphates, oxalates, sulfates, rodonite, tartratami, malonate, salt dihydroxybenzoic acid, etc.

The component controller in the composition allows you to create a specific pH environment. The rate of hydrolysis of salts of polyvalent metals strongly depends on the pH of the environment, the introduction of the component controller in the composition provides the necessary time color change of the indicator. Thus, the composition consisting of iron carbonate and ammonium sulfate, the rate of hydrolysis of the carbonate is accelerated through the creation of acidic sulfate, the composition of the beige color is dark brown. While iron carbonate without ammonium sulfate at a speed of paired girlswada very slowly and for real values sterilization of the extracts does not reach the destination color.

In another composition consisting of iron oxalate and calcium carbonate, the process of hydrolysis of oxala the Ki ferry acquires a dark brown color due to the formation of hydroxides, the composition thus does not emit gaseous products. Source components and final products are slightly soluble in water.

In the manufacture of the indicator composition is applied on a carrier or substrate wetting, seal, etc., in the form of a mixture of the composition and a polymeric binder. As binders it is possible to use water-insoluble polymers: simple and complex polyether - esters of cellulose, polyvinyl chloride, polystyrene, etc., as solvent - alcohols and ethers, aliphatic, aromatic and chlorinated hydrocarbons, etc. To improve the processing properties to the composition ligaments allow the imposition of emulsifiers, defoamers, thickeners, stabilizers. To make different colors of the original indicator composition in its composition can be introduced water-insoluble inert organic and inorganic pigments and dyes.

When mixing this paint it is recommended that the mass ratio of the binder and composition to support from 4:1 to 1:1, within which time the color change of the indicator remains constant. The use of water-insoluble binder allows you to delay the penetration of steam to the particles of the composition, prevents erosion indicator spot the ferry and allow to produce chemical indicators in a wide range of temperature and time parameters of operation: temperature 90oWith (from 1 minute to 2 hours), 150oWith (from 10 seconds to 10 minutes).

Indicators treated in a steam sterilizer as changed color, and changed the color for a long time (over 2 years) retain their color, which allows the use of indicators to document, i.e. to use these indicators or their fragments in technological archived documents or work logs.

The hallmark of the invention is the use in the composition as an active and dye components soluble and water-insoluble salts of polyvalent metals (iron, cobalt, manganese, copper, Nickel or mixtures thereof in combination with a component-regulator - salts of alkali, alkaline earth metals, and ammonium.

Example 1.

100 g finely ground iron oxalate and 20 g of calcium carbonate is introduced into 50 g of 8% (mass) aqueous solution of polyvinyl butyral in butanol. All thoroughly pounded in kraskoterke to a homogeneous state. The resulting paint is applied by screen printing on a paper or polymeric polozka and dried. The original color of the indicator compositions of the indicator is yellow. When exposed to water vapor from the composition highlights the From: within 3 minutes the color of the indicator composition yellow; within 5 minutes - dark yellow; within 10 minutes - yellow-brown; within 20 minutes - dark brown.

If the shutter speed indicator in the conditions of steam sterilization at 132oFrom: within 3 minutes the color of the indicator compositions dark yellow;
within 5 minutes - yellow-brown;
within 10 minutes - dark brown.

If the shutter speed indicator in dry air at a temperature of 140oC for 30 minutes, the color does not change.

With increase in the composition of the content of calcium carbonate time ending color in the conditions of steam sterilization at 132 the following:
- 100 g of the oxalate of iron and 100 g calcium carbonate 5 minutes
- 100 g of the oxalate of iron and 200 g of calcium carbonate - 2 minutes.

Indicators, both the original and changed its color when steam treatment during long-term storage (over 3 years) retain their color.

Example 2.

A mixture of 100 g of hexanitrocobaltate potassium, 10 g of the oxalate of iron and 100 g of magnesium carbonate, thoroughly ground in a planetary mill, is introduced into 300 g of 60% (mass) aqueous solution of polystyrene in tetraline and thoroughly pounded in kraskoterke to a homogeneous state. The resulting paint is applied by screen printing on a paper or polymer substrate and is Itachi in the form of a gaseous product highlights inert components nitrogen and carbon dioxide, which does not affect the sterilized product.

Extract the received indicator in the conditions of steam sterilization at 121oWith gives the following color changes:
within 3 minutes the color of the indicator composition yellow;
within 5 minutes - dark yellow;
within 10 minutes - yellow-brown;
within 20 minutes - dark brown.

If the shutter speed indicator in the conditions of steam sterilization at 132oWith:
within 3 minutes the color of the indicator compositions dark yellow;
within 5 minutes - yellow-brown;
within 10 minutes - dark brown.

If the shutter speed indicator in dry air at a temperature of 140oC for 30 minutes, the color does not change.

In the same way as in example 1, the change in the components of the composition leads to a change in time of the ending color.

Indicators, both the original and the changed color when steam treatment during long-term storage (over 3 years) retain their color.

Example 3.

100 g finely ground manganese carbonate and 50 g of ammonium sulfate are introduced into 150 g of a 10% (mass) aqueous solution of nitrocellulose in acetone. All thoroughly pounded in kraskoterke to a homogeneous state. The obtained paint nanosuits and indicator - pinkish-beige. When exposed to water vapor in the sterilization experiencing the allocation of only inert carbon dioxide.

If the shutter speed indicator in the conditions of steam sterilization at 121oWith:
within 3 minutes the color of the indicator composition beige;
within 5 minutes brown;
within 10 minutes - dark brown.

If the shutter speed indicator in the conditions of steam sterilization at 132oWith:
within 1 minute the color of the indicator compositions brown;
within 2 minutes - dark brown.

If the shutter speed indicator in dry air at a temperature of 140oC for 30 minutes the color of the indicator composition is not changed.

Change the content of ammonium sulfate in the composition allows you to adjust the time of the ending color, decrease in the content of the sulfate lengthens the time, increasing reduces the time to reach the final color.

Indicator, both the original and the changed color when steam treatment during long-term storage (over 3 years) retain their color.

Example 4.

100 g finely ground copper oxalate and 30 g of sodium salt dihydroxybenzoic acid are introduced into 200 g of a 10% (mass) aqueous solution of nitrocellulose in alcohol. All carefully races of the paper substrate and dried. The original color of the indicator compositions of the indicator is blue.

If the shutter speed indicator in the conditions of steam sterilization at 121oWith:
within 1 minute the color of the indicator composition blue;
within 5 minutes greenish-blue;
after 10 minutes - black.

In this composition component controller is salt dihydroxybenzoic acid, by changing the content of the song you can adjust the time to reach the final color.

Indicators, both the original and the changed color when steam treatment during long-term storage (over 3 years) retain their color.


Claims

1. Composition for temperature-time indicator for steam sterilization, containing the poorly soluble or insoluble in water salt or mixture of salts of polyvalent metal, which in the conditions of steam sterilization change their color, characterized in that it further contains the component controller to regulate the speed of hydrolysis of the salt or mixture of salts of polyvalent metal, and as a salt or mixture of salts of polyvalent metal contains salt or mixture of salts of iron, manganese, cobalt, copper and/or Nickel in the following soothing /> 2. The composition according to p. 1, characterized in that the quality of the salt or mixture of salts of polyvalent metal contains carbonates, bicarbonates, phosphates, oxalates, stearates, palminate, citrates and other salts of weak acids, iron, manganese, cobalt, copper, and Nickel complex salt of iron, cobalt, manganese, copper, Nickel nitrite, phosphate, rodanet anions.

3. The composition according to PP. 1 and 2, characterized in that as component controller contains alkaline salts, alkaline earth metal, ammonium carbonates, phosphates, oxalates, sulfates, rodonite, tartratami, borates, salt dihydroxybenzoic acid.

 

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