RU2002466C1 - Method of monitoring sterilization process and sterilized articles of medical designation - Google Patents

Abstract

The invention relates to medical microbiology and technology of medical devices and can be used in any industries where the process of sterilization of products takes place. A method for controlling a sterilization process and sterilized disposable products is based on that. that the carrier of technological microflora is placed in the sterilized product before sterilization in an amount of at least 500 microbial cells or the product is seeded with the same amount of microflora Biotest is placed in the sterilization chamber in the most convenient places for sterilization in the amount of not less than 13 and not more than 30 pcs. Sterilization is carried out either by steam, or by gas, or by radiation or in another way. The control is carried out after 24 hours by thermo-testing the biotest in the indicator nutrient medium at a temperature characteristic of this microflora for 2-8 days, and sterility or non-sterility of the product and the sterilization process are controlled by changing the color of the nutrient medium. While maintaining the initial color of the nutrient medium, the product is sterile, and the sterilization process is maintained in the technological mode, when the color of the nutrient medium is changed, the product is unsterile, the sterilization process is violated or the product technology is violated.

Description

The invention relates to medical microbiology and technology of medical devices and can be used in any industries where the process of sterilization of products takes place.

A known analogue method is carried out in accordance with the guidelines approved by the Ministry of Health of the RSFSR of April 14, 69 No. 09 / 33-680.

The following crops are used as a carrier:

staphylococcus, resistant to a temperature of 60 ° C with a 25-minute exposure and to a 2% formalin solution at a 20-minute exposure;

acid-resistant saprophyte, B-5 mycobacteria, resistant to 60 ° C at 60 minutes exposure and to 5% formalin solution at 25 minutes exposure;

spores of anthracoid, resistant to deformation of flowing steam for 4-6 minutes or to boiling for 25 minutes.

Sterilization control is carried out on base test objects. A flask of tissue 1.1x0.6 cm in size is sterilized for 30 min at 120 ° C, infected with a two-billion-dollar suspension of a one-day culture of staphylococcus, a four-day culture of B-5 and a two-day culture of anthracoid, kept at 5–7 room temperature in a dark place.

The infected tissue strips are dried twice between two sheets of filter paper and placed in a Petri dish for final drying, the lid is slightly opened and thermostat is placed for 15-20 minutes. Then the test objects are clamped-vases into sterile envelopes of cotton or paper 4x5 cm in size (2 tests per envelope), and the envelope is placed in bags of 10-15 cm in size. Bags with test objects are wrapped in sterile paper and placed among things in the camera at 15 points.

After sterilization, the bags are removed from the chamber, under aseptic conditions, the tubes are inoculated with 5 ml of m-peptone or 2% glycerin broth,

If growth is detected in crops, it is necessary to reseed on solid nutrient media in order to verify the presence of the original culture.

This method allows you to control only the sterilization process and if it is violated, it is possible to seed the material with this microflora.

The prototype of the invention is a method carried out according to the order of the Ministry of Health of the USSR No. 60 of 17.01.79 g (Appendix 6 Guidelines for monitoring the sterility of medical devices. 1989).

Sterility control of single-use products is carried out in specially equipped rooms in compliance with aseptic rules. The number of samples for sterility control is determined by the formula 0.4 p, where n is the number of products sterilized simultaneously in one sterilizer per cycle (at least 13 products).

Sterilized products are completely immersed in nutrient media: Hottinger sugar broth (0.5 or 1% glucose), thioglycol medium and Saburo broth. When controlling sterility of products sterilized by the radiation method, Hottinger broth with 1% glucose is used, sterilized by gas and steam methods with 0.5% glucose.

Large volume products are milled under sterile conditions before being immersed in culture media. Crop media is placed in a thermostat at a temperature of 32 ° C (Hottinger broth and thioglycol medium) and 22 ° C (Saburo broth). Results are taken into account after 8 (up to 14) days.

In case of germination of crops in at least one test tube (flask) - clouding of the medium, film formation, sediment, smears are prepared to bacterioscopically confirm the growth of microorganisms and the sterility is double checked for twice the number of samples in a given batch.

If seedlings are not observed during the second sowing, the products of this batch are considered sterile. In the case of repeated sprouting of crops, this batch of products is considered non-sterile and rejected.

The disadvantages of the prototype method include: h

the efficiency of the technique is low, it allowed yush.a to reveal a non-sterile product only with massive social cantamation of all products. Up to 700 thousand products are subjected to simultaneous sterilization, 13 are selected for control, this does not allow to catch the contamination of products;

the production process of sterile products with modern technology and sanitary production gives the absence or low initial contamination, which makes it difficult to control the sterility of manufactured products. If the sterilization process is violated by this technique, it is impossible

identify non-sterile products (fictitious well-being);

lack of control of the sterilization process;

the time duration of the entire control procedure, which leads to a delay in the release of finished products;

the use of a large number of culture media;

the possibility in the process of controlling secondary contamination;

the technique is complex, time-consuming.

The problem to be solved by the inventive method is the simultaneous monitoring of the sterilization and sterility of various types of medical devices (injection syringes, needles, blood transfusion system, hemodialyzer, etc.) for single use.

As a result of solving this problem, it becomes possible to 100% control the sterilization process for the production of sterile products for a given type of sterilization, sterility or non-sterility of products, and to identify the process error.

The inventive method of controlling the sterilization process and sterilized products can be carried out with steam, gas and radiation sterilization.

The technological result is achieved by the fact that a test with microflora is placed in the finished product, or the product is seeded. Technological microflora, which is a mixture of non-virulent strains of heat-resistant, capsular, spore-forming microorganisms (a single strain is possible), is used to seed the carrier.

Given the low initial contamination with modern technology for the production of medical devices, each biotest contains at least 500 microbial bodies. Explanation of applicable terms:

A test is an infected filter paper, an article with an infected filter paper embedded in it, a seeded product. The tests are dried in air by lyophilization in a thermal chamber and in another way;

A biotest is a test packaged in standard material for a controlled medical device technology. Biotests are placed in a batch of sterilized products in quantities depending on the volume of the sterilization chamber (not more than 30 and not less than 13). The biotests are laid in the most convenient places for the sterilization process - at the doors of the sterilization chamber, along the diagonals of the chamber on the shelves from top to bottom.

Sterilization is standard for this product.

5 Biotests incubated for 24 hours,

then taken for analysis. Biotest analysis is carried out in boxes under strictly aseptic conditions.

0 Biotests - the needles are immersed in the indicator nutrient medium, the syringes are filled with the indicator nutrient medium, they are removed from the blood transfusion system, hemodialyzer and other complex products

5 carrier, immerse it in the indicator nutrient medium, from the inner surface of the product indicator nutrient medium make a flush. Use appropriate to this technological

0 microflora nutrient media; Hottinger sugar broth (0.5 or 1% glucose), thioglycolic medium and Saburo broth with the addition of an indicator.

Crops are placed in a thermostat at

5 standard temperature for a given microflora for a period of 48 hours to 8 days. If within 48 hours (max. 8 days) the culture media do not change color, sterilization is maintained at a predetermined

0 technological mode, and the product is sterile.

If the color of the nutrient medium indicator has changed, either sterilization or process conditions are violated. 5 carry out a check of the technological regime, eliminate the cause of the violation of the sterilization process, for which additional control is carried out by standardized biotests.

0 The time required to take into account the results of sterility control can be adjusted upwards for the production of summer cottages of this production.

5 Salient features of the claimed method for controlling sterilization and sterilized products are:

simultaneous control

0 sterilization process and sterile products;

seeding of the finished product with technological microflora in an amount of at least 500 microbial bodies;

5 control after 24 hours by using indicator nutrient medium (up to a maximum of 8 days);

temperature control in an indicator nutrient medium at a standard temperature for a given microflora;

time mode of thermostating from 2 to 8 days;

the implementation of controls for changing the color of the nutrient medium;

the correlation between the color of the indicator medium and the sterility of the product and the efficiency of the sterilization process is established: the color is unchanged - the product is sterile, and the sterilization process is maintained in technological mode, the color is changed - the product is unsterile, the sterilization process or the technological process of the product are disrupted.

A causal relationship between the salient features and the technical result:

simultaneous control of the sterilization process and sterile products allows to detect violations of the sterilization process and sterility and non-sterility of products, eliminate violations of the sterilization process and possible violations in the technological process of products;

the high initial contamination of the bi1 response with respect to the low contamination of products gives a 100% guarantee of control of sterility or non-sterility of products and the sterilization process;

the use of indicator nutrient medium and biotest with the inventive method can significantly simplify the control procedure compared to that used by order of the USSR Ministry of Health No. 60 (Appendix 6), reduce the number of nutrient media prepared from meat, reduce analysis time, and accelerate product sales process, reduces storage areas of finished products;

during radiation sterilization of products using biotest, a reduction in the dose of radiation is possible, which increases the shelf life of the products (elimination of polymer degradation, metal corrosion);

the claimed biotest can be used to monitor the effectiveness of the sterilization process and sterilized products in all industrial enterprises manufacturing sterile products;

the biotest can be made in any bacteriological laboratory of a given production or unit.

Violation of the sterilization process; violation of the temperature regime, with gas sterilization - insufficient pressure, contamination of filters, lack of ethylene oxide in the container, with radiation sterilization - insufficient or excessive dose, irregular location of the objects being sterilized, etc.

Violation of the process: errors in the assembly, defect in materials. The choice of these modes and quantitative ratios,

The choice of technological microflora in

the amount of at least 500 microbial bodies is due to the fact that the maximum initial contamination of finished products should be no more than 10 microbial bodies. At

During initial contamination of more than 10 microbial bodies, products are discarded before sterilization, since increased microbial contamination carries the antigenicity of products with subsequent possible complications in humans when using products.

Thermostating of products or 2 to 8 days is optimal, it eliminates the effects of residual ethylene oxide when

0 gas sterilization, and ozone during radiation sterilization. This period is sufficient for germination of vegetative and spore microflora.

Reduced temperature control

5 will not allow microflora to be detected due to its suppression of growth by ethylene oxide or ozone. An increase in time over 8 days is inappropriate. For two years of experimental work, the biotest analysis was monitored for 14 days. At the same time, the positive or negative result obtained after 2-6 days has never changed over the next time.

5 EXAMPLE 1. Biotest - single-use 2-gram polymer syringes packed in a standard package were loaded into a gas sterilizer in places for sterilization - at doors, on all racks diagonally from top to bottom, identical to all products being sterilized party. After a full sterilization cycle, after 24 hours, the biotest was taken for analysis. In aseptic conditions, the syringes were released from the packaging, filled with indicator nutrient medium — Hottinger sugar broth (0.5 or 1% glucose), thioglycol rumpled, Saburo broth. Thermostated Saburo broth at 22 ° С, the rest

0 medium at 32 ° C and 37 ° C for 48 hours

The color of the indicator medium during thermostating did not change. The batch of products is sterile, the sterilization process is maintained in a technological mode. At

5 parallel control according to Appendix 6 of the order of the Ministry of Health of the USSR N 60 products are sterile.

PRI me R 2, Biotest - injection needles, packed in a standard package, loaded into a radiation sterilizer according to

scheme, After a full sterilization cycle after 24 hours, biotests were taken for analysis. In boxing under aseptic conditions, the needles were unpacked, immersed in indicator nutrient media — Hotinger's sugar broth (0.5 or 1% glucose), thioglycol medium, Saburo broth. Saburo media were thermostatted at 22 ° C, the rest of the media at + 32 ° C and + 37 ° C for 2 days. The color of the medium has not changed.

The batch of products is sterile, the sterilization process is maintained in a technological mode.

In parallel, the products are controlled by the methodology of Appendices 6 of the order of the Ministry of Health of the USSR No. 60. The products are sterile.

Example 3. Biotest - a blood transfusion system, packed in a standard package, was loaded into a radiation sterilizer in places for sterilization

at the camera door, diagonally on the shelves from top to bottom. After a complete sterilization cycle, after 24 hours, the biotests were taken for analysis. The carrier was removed from the biotest, immersed in indicator nutrient media.

-Hotginger broth broth (0.5 or 1% glucose), thioglycol medium, Saburo broth, were washed with these nutrient media from the inner surface of the product, placed in test tubes. They were inoculated on Szburo media at a temperature of 22 ° C, on the remaining media & x at a temperature of 32 ° C and 37 ° C for 6 days.

The color of the indicator culture medium has not changed.

The product is sterile, the sterilization process is maintained in the technological mode.

In parallel monitoring the sterility of the finished product in accordance with Appendix 6 of Order No. 60 of the USSR Ministry of Health, the result is that the products are sterile.

Example 4. Biotest - 2-gram polymer syringes for various applications were placed in a gas sterilizer according to the scheme. After a complete sterilization cycle, for 24 hours in a box under aseptic conditions, the syringes were filled with indicator nutrient medium - Hottinger sugar broth (0.5 or 1% glucose), thioglycol medium, Saburo broth. Saburo media were thermostated at a temperature of 22 ° C, the rest of the media at 32 ° C and -37 ° C for 2 days.

The color of the indicator culture medium has changed.

The batch of products is non-sterile, the sterilization process is not maintained in the technological mode, or the technological process is violated.

With parallel monitoring of the sterility of products according to Appendix 6 to the order of the USSR Ministry of Health No. 60, the products are sterile.

An additional countermemory revealed a violation of the syringe assembly technology - with the addition of Selicon grease (permitted by GOST and TU), the rod tightly adhered to the cylinder and ethylene oxide did not penetrate the infected part of the syringe.

PRI me R 5. Biotest - 2 gram disposable polymer syringes

0 laid in a gas sterilizer according to the scheme. After a complete sterilization cycle, after 24 hours, the syringes were filled in aseptic conditions with indicator nutrient medium - Hottinger sugar broth (0.5 or

51% glucose), thioglycol medium and Saburo broth. Saburo media were thermostated at 22 ° C, the rest at 32 ° C and 37 ° C.

The color of the indicator culture medium has changed.

0 The batch of products is non-sterile, the sterilization process is not maintained in the technological mode, or the technological process is violated. With additional control, a violation of the temperature regime during sterilization was revealed. With parallel control according to Appendix 6 to the order of the Ministry of Health of the USSR No. 60, syringes are non-sterile.

PRI me R b. Biotest - 5 grams

0 disposable polymer syringes were placed in a gas sterilizer according to the scheme. After a full sterilization cycle, after 24 hours in the box under aseptic conditions, the syringes were filled with indicator nutrient medium - Hottinger sugar broth (0.5 or 1% glucose), thioglycol medium “t Saburo broth. Saburo media were thermostated at a temperature of 22 ° С, the remaining media at 32 ° С and 37 ° С for 2 days.

The color of the indicator culture medium has changed. The products are non-sterile, during the control an insufficient amount of ethylene oxide was detected in the cylinders.

5 With parallel monitoring in accordance with Appendix B. Order of the Ministry of Health CCCP-N 60, the products are sterile.

Example. Biotest - 2 grams of 0 polymer disposable syringes were placed in a gas sterilizer according to the scheme. After a complete sterilization cycle, after 24 hours in the box under aseptic conditions, the syringes were filled with indicator nutrient medium — Hottinger sugar broth (0.5 or 1% glucose), thioglycol medium and Saburo broth.

Saburo media were thermostated at a temperature of 22 ° C, the rest of the media at 32 ° C and 37 ° C for 6 days.

11200246612

The color of the indicator nutrient ery-Parallel control has changed, the products are non-sterile. According to Appendix 6 to the order of the Ministry of Health - With the additional control, you have been taken out of USSR No. 60; the products are sterile, violation of the sterilization process is a shortened time cycle of the strip-5 (56) Methodical instructions of the Ministry of Health. RSFSR dated 04.14.69 No. 09 / 33-680.

Claims (1)

Formula of the invention The bottom method, the control is carried out after 24 hours by incubation METHOD FOR MONITORING THE STE-10 PROCESS PROCESS OF PRODUCTS IN THE INDICATOR NUTRITIONAL SURILIZATION AND STERILIZED WITH THE O-PRODUCTS STANDARD FOR THIS MICROPHONE. A SINGLE-TIME EXAMPLE at a temperature of 2-8 days and by changing the NII using nutrient media, the coloration of the nutrient medium is also carried out by thermostatting, characterized in that they control sterility or non-sterility, which simultaneously control 1§ of the product, sterilization and sterilization process, at the same time, in a controlled nological process, while the product is laid, the carrier is used to preserve the initial coloring of food microflora before sterilization in the boiler medium - the product is sterile and spilled ETS least 500 microbial cells or is maintained in the sterilization process of the product dissolved obsemen same quantitative process mode, and when changing the AOM microflora packaged in standard culture medium coloring neste- hydrochloric product for a given article. packaging, sterile and broken sterilization process is sterilized with steam, gas or radio or technological regime.