SU769812A1 - Method for sterilizing products - Google Patents

Description

(54) METHOD OF PRODUCT STERILIZATION

This invention relates to the field of medicine and the medical industry, in particular to sterilization methods.

The known method of sterilization, which consists in processing them with ionizing radiation, followed by placement in a magnetic field 1.

I

In a number of cases, for example for sterilizing products made of heat-resistant polymers, the method of radiation sterilization is practically the only suitable one. For medical devices, more than 150 items, including disposable products made from polymeric materials, such as blood systems, syringes, catheters, etc., are sterilizing doses of 2.5-3.5 Mrad. Such large doses of radiation cannot be used to sterilize certain medical devices of biological preparations and grafts with relatively low radiation resistance. Large doses of ionizing radiation alter the physicochemical, biological and commercial properties of the objects to be sterilized, which leads to a significant deterioration in their quality, and in some cases makes it impossible to use the method of radiation sterilization.

The purpose of the invention is to reduce the radiation dose to the processed product.

The goal is achieved by the fact that the dose of ionizing radiation is 1.5- S 2.0 Mrad, and an alternating magnetic field with a strength of 240-750 Oe is used as the magnetic field, while processing in an alternating magnetic field is carried out for 3- 18 h.

In model experiments conducted by

10 microorganisms with different radioresistance, it is shown that the combined effect of an alternating magnetic field (PMF) with radiation exposure increases the bactericidal effect of radiation.

The irradiation was carried out on the installation “Researcher with a gamma-emitter source and ° Co, dose rate 7 krad / min An alternating magnetic field was created with a 20 using a solenoid, to which a voltage was applied from the mains (220 V and 127 V). A magnetic field of 240 and 750 Oe was recorded inside the coils. The irradiated microorganisms were kept in a PMP for 3-18 hours.

The effect of the combined effect of gamma radiation and PMP on microorganisms with high radioresistance (Sir. Faecium A2l) increases significantly with prolonged exposure time in a magnetic field.

The survival rate of E. coli K-12 after 3-hour exposure in MP 240 Oe

The survival of E. coli K-12 after a 3-hour exposure in the MP 750 E

Survival Sfr. faecium Aal after 3-hour exposure in the MP 750 Oe

Irradiation conditions Gamma radiation Gamma radiation and PMP I 2 TO 18 h. In this case, when samples were sown 16 hours after irradiation, 2.0-110% of microorganisms grew, and after irradiation and 18 hours exposure in a magnetic field , the growth of microorganisms was absent (O cells). Thus, the results of model experiments on microorganisms with different radioresistance allowed us to create a variant of the implementation of the radiation-electromagnetic sterilization method with a reduction in the dose of ionizing radiation by 1.5 times. Example I. Suture material catgut widely used in surgical practice is seeded with a large number of microorganisms of various types, including sterilization of catgut p

Sterilizing effect at a dose of izlereii, L1rad

Note: in the denominator the number of vials with catgut, in the numerator - the number of non-sterile samples.

Table 1

table 2

T a b l and c a 3

Percentage of surviving microorganisms,% and doses, stealing

500 spore-forming, characterized by a high level of radioresistance. The sterilization of the catgut by the radiation method is achieved by using a dose of ionizing radiation from 3 to 4.5 Mrad. The combined use of ionizing radiation with the action of PMP makes it possible to reduce the radiation dose by 1.5 times. When irradiated with chromium-plated and non-chromed catgut filaments of various calibers (from 3 to 10), the sterilizing effect occurred at a dose of 3.5 Mrad. Under irradiation of catgut filaments with subsequent exposure to PMP 240 Oe for 18 hours, sterility of catgut was achieved at a dose of 2.0 Mrad. Table 4 by the ion magnetic method

Thus, the sterilizing dose of ionizing radiation for catgut can be reduced by 1.5 times.

Example 2. Renpipmesenterin, an enzyme preparation used for coagulating milk in the production of cheese, should not have an infection rate of more than 10 cells per gram of substance. The drug is thermolabile and at 40 ° C for 3 hours is inactivated by 60%. During sterilization by irradiation at a dose of 5.0 Mrad, active reduction of dissemination and sterilization of rennine mesenterin by the radiation-magnetic method

nosti drug decreases by 40%. The sterilizing effect can: be achieved at doses of 2.5 Mrad in combination with the effect of an alternating magnetic field of 750 Oe for 18 hours. The reduction of contamination required by technical conditions to 1 10 per 1 g of substance is achieved with an isolated radiation effect of 1.0 Mrad The same effect of reducing contamination is achieved when irradiated at a dose of 0.5 Mrad with an exposure in MMM for 18 hours.

Table 5

Claims (1)

Claim A method of sterilizing products, which consists in processing them with ionizing radiation and then placing them in a magnetic field, characterized in that, in order to reduce the radiation dose to the processed product, the dose of ionizing radiation is 1.5-2.0 Mrad, and use as a magnetic field an alternating magnetic field with a strength of 240-750 Oe, while processing in an alternating magnetic field is carried out for 3-18 hours Source of information taken into account during the examination: 1. Bashkov V. I. Means and methods of sterilization used in medicine. M „1973, p. 140-141. -