CN115779111A - Radiation sterilization method for medical liquid repair dressing - Google Patents

Abstract

The invention provides an irradiation sterilization method of a medical liquid repair dressing. Relates to the technical field of medical appliances. The method comprises the steps of putting the medical liquid repairing dressing in a refrigerant in a constant temperature state to obtain a packaging box; placing the packaging box in a container, and placing the container on a lifting appliance, wherein the lifting appliance is operated to an irradiation area by an automatic conveying system; and circularly irradiating the irradiated area for multiple times to obtain the sterilized medical liquid repair dressing, wherein the irradiation dose of the multiple times of irradiation is required to be 25.0-40.0kGy, and the medical liquid repair dressing is kept in a low-temperature state of lower than 5 ℃ in the whole irradiation process through a refrigerant. The sterilization is carried out under the condition that the activity of bacteria is lower, the sterilization is still carried out in the environment which is not beneficial to the survival of bacteria, the sterilization effect is always kept in the transfer process between the storage devices, and the effectiveness of the sterilization effect is improved.

Description

Radiation sterilization method for medical liquid repair dressing

Technical Field

The invention relates to the technical field of medical instruments, in particular to an irradiation sterilization method of a medical liquid repair dressing.

Background

The medical liquid repairing dressing can be divided into two categories of artificial biological dressing and xenogenic tissue wound surface covering material. The common artificial biological dressing is prepared from materials such as collagen, chitosan, hyaluronic acid and the like, has the effects of stopping bleeding and promoting coagulation, can induce proliferation and differentiation of various cells, and has the defects of poor stability, weak capability of absorbing seepage and the like. The foreign body tissue wound surface covering materials comprise pigskin, frog skin, fish skin and the like, the commercialized pigskin is supplied in America, english, japan and other countries, and the pigskin is mainly cross-linked by glutaraldehyde, irradiated pigskin and the like. Dressings are medical materials that can serve to temporarily protect wounds, prevent infection, and promote healing. The dressings can be divided into traditional dressings such as absorbent cotton yarn, biological dressings, synthetic dressings and the like according to the material quality.

The medical liquid repair dressing is a novel wound repair and protection material developed on the basis of the theory of 'moist healing' of wound repair proposed by Winter and the like. Compared with the traditional dressing, the biological dressing has the advantages of reducing infection, improving the quality of wound healing, relieving the pain of patients, facilitating the operation of medical personnel and the like, thereby being favored by people.

As the medical liquid repairing dressing needs to be in contact with a human body, the risk of invasion of pathogenic bacteria into the human body through the contact part is directly influenced by the sterilization effect, and the technical problem of how to improve the sterilization effect is urgently needed to be solved.

Disclosure of Invention

The invention aims to provide an irradiation sterilization method of a medical liquid repair dressing, which solves the technical problem of poor sterilization effect in the prior art.

In a first aspect, the present invention provides a method of radiation sterilization of a medical fluid repair dressing, comprising:

placing the medical liquid repairing dressing in a refrigerant in a constant temperature state to obtain a packaging box;

placing the packaging box in a container, and placing the container on a lifting appliance, wherein the lifting appliance is operated to an irradiation area by an automatic transmission system;

and circularly irradiating the irradiation area for multiple times to obtain the sterilized medical liquid repair dressing, wherein the irradiation dose of the multiple times of irradiation is required to be 25.0-40.0kGy, and the medical liquid repair dressing is kept in a low-temperature state of lower than 5 ℃ in the whole irradiation process through a refrigerant.

In an alternative embodiment, the volume of the container is 112 × 51 × 125 cubic centimeters, the container is divided into three surfaces, namely a surface, a surface and a surface, in the height direction of the container, parallel to the source plate, the two surfaces, close to the stainless steel plate of the container, are the surfaces a and C, and the surface B is a plane where a point of Y =0 is located in the container;

the length direction of the whole container is divided into 10 layers from bottom to top by 7 vertical lines at equal intervals from left to right in the height direction, and the intersection point of the horizontal line and the vertical line is the position point for placing the dosimeter.

In an alternative embodiment, the vertical line spacing is 18cm.

In an alternative embodiment, the areas of highest and lowest absorbed dose are determined, and the interlamellar spacing in the vicinity of the areas of highest and lowest absorbed dose is encrypted.

In an alternative embodiment, the layer spacing in the vicinity of the highest and lowest absorbed dose regions is set to 10cm, the others to 20cm.

In an alternative embodiment, the lowest absorbed dose region is a region of height 0.

In an alternative embodiment, the height H =0 for the first layer, H =10 for the second layer, H =20 for the third layer, H =40 for the fourth layer, H =50 for the fifth layer, H =60 for the sixth layer, H =70 for the seventh layer, H =80 for the eighth layer, H =100 for the ninth layer, and H =120 for the tenth layer.

In an alternative embodiment, a dosimeter is placed at each or a portion of the metering sites within the cargo box.

In an optional embodiment, after the irradiation is finished, taking out the dosimeter placed on a product box, measuring the change of absorbance according to a dosage operation instruction measured by a T6 type visible spectrophotometer, and calculating the absorbed dosage of the product;

and determining whether the initial irradiation dose meets the irradiation dose required by the product based on the determination result.

In an alternative embodiment, the dosage is a potassium dichromate dosage.

The invention provides an irradiation sterilization method of a medical liquid repair dressing. Placing the medical liquid repairing dressing in a refrigerant in a constant temperature state to obtain a packaging box; placing the packaging box in a container, and placing the container on a lifting appliance, wherein the lifting appliance is operated to an irradiation area by an automatic conveying system; and circularly irradiating the irradiated area for multiple times to obtain the sterilized medical liquid repair dressing, wherein the irradiation dose of the multiple times of irradiation is required to be 25.0-40.0kGy, and the medical liquid repair dressing is kept in a low-temperature state of lower than 5 ℃ in the whole irradiation process through a refrigerant. Make and disinfect under the lower circumstances of bacterial activity, still be in the environment that is unfavorable for the bacterium to live after the sterilization to transfer in-process between the storage facilities keeps the sterilization effect always, has promoted the validity of sterilization effect.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a schematic flow chart illustrating a method for radiation sterilization of a medical fluid repair dressing according to an embodiment of the present application;

fig. 2 is a schematic structural diagram of a box body according to an embodiment of the present application;

fig. 3 is a schematic view of a position coordinate orthographic view of a dose test point provided in the embodiment of the present application;

fig. 4 is a top view of the position coordinates of each layer of the dosage test point provided in the embodiment of the present application.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be obtained by a person skilled in the art without inventive step based on the embodiments of the present invention, are within the scope of protection of the present invention.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined or explained in subsequent figures.

Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.

Fig. 1 is a schematic flow chart of a method for radiation sterilization of a medical fluid repair dressing according to an embodiment of the present application. As shown in fig. 1, the method includes:

s110, placing the medical liquid repairing dressing in a constant-temperature refrigerant to obtain a packaging box;

for example, cold water, or an antifreeze may be used as the low-temperature refrigerant. The cold water or antifreeze can be directly prepared in a freezing chamber, and the initial temperature is 0-5 ℃. The cold water or antifreeze described in this embodiment may be prepared by any conventional method, and may be, for example, direct freezing or freezing with the addition of a coolant. Experiments prove that in the embodiment, the temperature of the low-temperature refrigerant is increased in the whole irradiation process, but the low-temperature state of lower than 5 ℃ can be basically maintained in the whole irradiation process, so that the low-temperature state basically identical to the temperature of the refrigerant is maintained in the heat-insulating container.

The medical liquid repair dressing can be soaked in a low-temperature refrigerant after being subjected to plastic package, and then is packaged in a packaging box. The shape and the size of the packaging box can be determined according to actual needs, the shape can be a regular cube or a cuboid, the size can be determined according to the low-temperature duration needing to be maintained, and the longer the low-temperature duration needing to be maintained, the larger the packaging box is, the more low-temperature refrigerant is filled in the packaging box.

S120, placing the packaging box in a cargo box, and placing the cargo box on a lifting appliance, wherein the lifting appliance is operated to an irradiation area by an automatic transmission system;

s130, circularly irradiating for multiple times in the irradiation area to obtain the sterilized medical liquid repair dressing, wherein the irradiation dose of the multiple times of irradiation is required to be 25.0-40.0kGy, and the medical liquid repair dressing is kept in a low-temperature state of lower than 5 ℃ in the whole irradiation process through a refrigerant.

The sterilization is carried out under the condition that the activity of bacteria is lower, the sterilization is still carried out in the environment which is not beneficial to the survival of bacteria, the sterilization effect is always kept in the transfer process between the storage devices, and the effectiveness of the sterilization effect is improved.

In some embodiments, as shown in fig. 2, the volume of the container is 112 × 51 × 125 cubic centimeters, the container is divided into three surfaces a, B, and C in the height direction of the container and in the direction parallel to the source plate, two surfaces close to the stainless steel plate of the container are the surfaces a and C, and the surface B is a plane where a point Y =0 is located in the container;

the length direction of the whole container can be divided into 10 layers from bottom to top in the height direction by 7 vertical lines at equal intervals from left to right, and the intersection point of the horizontal line and the vertical line is the position for placing the dosimeter.

Wherein the vertical line spacing is 18cm.

The highest and lowest absorbed dose regions can be determined, and the interlamellar spacings near the highest and lowest absorbed dose regions can be encrypted.

The interlayer distance in the vicinity of the highest and lowest absorbed dose regions may be set to 10cm, and the others to 20cm.

Wherein the lowest absorbed dose region is a region having a height of 0.

For example, as shown in fig. 3 and 4, fig. 3 is a schematic front view of the position coordinates of the dosage test point; fig. 4 is a top view of the position coordinates of each layer of the dose test site. The length direction of the whole container is equally divided by 7 vertical lines from left to right, and the distance between the vertical lines is 18cm; in the height direction, dosage test surfaces are divided into 7 dosage test layers at intervals of 20cm, and according to the operation and identification experiments of the irradiation device, the highest absorbed dose and the lowest absorbed dose are respectively in the regions of H =57 and H =0, in order to ensure that the test points of the dosage distribution can approach the actual highest absorbed dose points and the actual lowest absorbed dose points as much as possible, the density of the dosage is increased in the regions of H =60 and H =0, the interlayer interval is 20cm, the other interlayer intervals are 10cm, namely, each test surface of A, B and C is divided into 10 dosage test layers, and each layer has 7 test points from left to right.

At this time, the height H =0 of the first layer, the height H =10 of the second layer, the height H =20 of the third layer, the height H =40 of the fourth layer, the height H =50 of the fifth layer, the height H =60 of the sixth layer, the height H =70 of the seventh layer, the height H =80 of the eighth layer, the height H =100 of the ninth layer, and the height H =120 of the tenth layer.

In some embodiments, a dosimeter is placed at each or a portion of the metering sites within the cargo box. The dosimeter can be a potassium dichromate dosimeter.

After irradiation is finished, taking out the dosimeter placed on the product box, measuring the change of absorbance according to a dosage operation instruction of a T6 type visible spectrophotometer and calculating the absorbed dosage of the product; and determining whether the initial irradiation dose meets the required irradiation dose of the product or not based on the determination result. If not, adjustment of dose control parameters, which may include irradiation duration and irradiation intensity, is required.

As an example, the detected cargo box dose distribution data is shown in tables 1-3 below.

TABLE 1

TABLE 2

TABLE 3

Based on the above measured data, the following conclusions can be drawn as shown in table 4 below:

TABLE 4

The maximum non-uniformity of the above test data was 1.41 and the lowest absorbed dose of the product was 15.8kGy and the highest absorbed dose was 22.7kGy under the above process conditions in the loading mode of this report. All meet the confirmed dosage requirements of the product.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims (10)

1. A method for radiation sterilization of a medical fluid repair dressing, comprising:

placing the medical liquid repairing dressing in a refrigerant in a constant temperature state to obtain a packaging box;

placing the packaging box in a container, and placing the container on a lifting appliance, wherein the lifting appliance is operated to an irradiation area by an automatic conveying system;

and circularly irradiating the irradiated area for multiple times to obtain the sterilized medical liquid repair dressing, wherein the irradiation dose of the multiple times of irradiation is required to be 25.0-40.0kGy, and the medical liquid repair dressing is kept in a low-temperature state of lower than 5 ℃ in the whole irradiation process through a refrigerant.

2. The method of claim 1, wherein the container has a volume of 112 x 51 x 125 cubic centimeters, is divided into three surfaces, a, B, and C, in a direction parallel to the source plate in the height direction of the container, and the two surfaces proximate to the stainless steel plate of the container are the surfaces a and C, and the surface B is a plane where a point Y =0 is located in the container;

the length direction of the whole cargo box is divided into 10 layers from bottom to top in the height direction by 7 vertical lines at equal intervals from left to right, and the intersection point of the horizontal line and the vertical line is the position for placing the dosimeter.

3. The method of claim 2, wherein the vertical line spacing is 18cm.

4. The method of claim 2, wherein the areas of highest and lowest absorbed dose are determined and the interlamellar spacing in the vicinity of the areas of highest and lowest absorbed dose is encrypted.

5. A method according to claim 4, characterized in that the layer spacing in the vicinity of the area of highest and lowest absorbed dose is set to 10cm, the other 20cm.

6. The method of claim 4, wherein the lowest absorbed dose region is a region of height 0.

7. The method of claim 6, wherein the height of the first layer H =0, the height of the second layer H =10, the height of the third layer H =20, the height of the fourth layer H =40, the height of the fifth layer H =50, the height of the sixth layer H =60, the height of the seventh layer H =70, the height of the eighth layer H =80, the height of the ninth layer H =100, and the height of the tenth layer H =120.

8. A method according to claim 2, characterized by placing a dosimeter at each or at least a part of the meter sites within the cargo box.

9. The method of claim 8,

after the irradiation is finished, taking out the dosimeter placed on the product box, measuring the change of absorbance according to a dosage operation instruction measured by a T6 type visible spectrophotometer, and calculating the absorbed dosage of the product;

and determining whether the initial irradiation dose meets the irradiation dose required by the product based on the determination result.

10. The method of claim 8, wherein the dosimeter is a potassium dichromate dosimeter.

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