JPS60198157A - Sterilizing and antiseptic preservation method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for sterilizing equipment, clothing, etc., which is required to be used in a sterile state, such as medical tools, and a method for aseptically preserving the same. There are various types of equipment, tools, clothing, etc. that are required to be used in aseptic conditions, but among those that are related to medical equipment and food processing, bacterial contamination is likely to cause side effects such as fever and nausea, or infections. Therefore, it is strongly required that it be sterile. Commonly used sterilization methods include high-pressure steam sterilization, dry heat sterilization, boiling sterilization, methods using gaseous or liquid drugs, and sterilization using radiation.

In recent years, in order to avoid bacterial contamination due to reuse, products are often disposable1, and therefore products made from high molecular weight polymers are frequently used. Products made from high molecular weight polymers generally cannot withstand the heat load that is effective for sterilization when heat-based sterilization is used. Furthermore, when a sterilization method using radiation irradiation is adopted, if an amount effective for sterilization is irradiated, the product often deteriorates and cannot withstand its intended use. Therefore, the method of using a gaseous drug even when the product is sterilized by a drug is superior in that it enables sterilization even when the product is packaged, and is widely adopted.

Conventionally, the method of sterilizing products using sterilizing gas and storing them aseptically until just before use is to seal the product in a bag made of a polymer sheet, place it in a pressure container, and then use sterile gas. A method has been adopted to sterilize the product by pressurizing the bag and introducing sterilizing gas into the bag using the permeability of the polymer sheet to the sterilizing gas. The problem with this method is that it takes a lot of time to introduce the sterilizing gas. Further, the sterilizing gas can be gradually removed by leaving the bag in the air before use, but this takes a lot of time. If the product is applied to a living body with sterile gas remaining, various side effects will occur.

For example, in the case of medical equipment, when ethylene oxide is used as a sterilizing gas, hemolytic cytotoxicity 1 tissue reaction is known as a side effect due to the residual ethylene oxide.

Therefore, when a method using sterile gas is adopted, the sterile gas must be completely removed from the inside of the bag, which takes a lot of time. Various methods for improving these problems have been proposed, but they are not sufficient. For example, in order to increase the permeation rate of sterile gas, when introducing sterile gas into the bag, there is a method of first reducing the pressure in the pressure vessel and then pressurizing it with sterile gas, and when removing it, there is a method of placing the bag under reduced pressure. . However, with this method, the bag is often damaged, and the problem cannot be said to have been satisfactorily solved.

As a result of intensive research into sterilization methods using sterilizing gas, the present inventors have solved these problems and completed the present invention. That is, the present invention provides a belt made of a material (A) at least a part of which has high permeability to sterile gas and is impermeable to bacteria, and a belt made only of a material (B) with low permeability. After storing and enclosing the object in a bag composed of 1. After sterilizing the bag and removing the sterilizing gas from the bag, the object is stored only in the material (B) having low permeability. This is a sterilization and aseptic preservation method characterized by sealing and preserving in a state in which the product is stored.

The sterilizing gas used in the present invention is ethylene oxide, propylene oxide 1β-
Propiolactone, formaldehyde, ozone, etc. can be used as is.

It is also possible to use these compounds together or in combination with other gaseous compounds. For example, when ethylene oxide is employed in carrying out the present invention, it is desirable to mix carbon dioxide gas or chlorofluorocarbon gas in order to prevent the risk of explosion. In the present invention, the material (A) having high permeability to sterilizing gas means that the permeation rate of the gas used is approximately 10,000.
"/j-aay" Refers to materials that are atm or higher and have properties that do not allow bacteria to pass through.Various microporous material filters Neck paper 1 cloth 1 nonwoven fabric 1 sintered body, glass filter 1
Includes membrane filters, etc. In the present invention, the material (B) having low permeability to sterilizing gas is one whose permeation rate of the gas used is approximately 600"/m'-day-a.
tm or less, and includes various organic and inorganic materials, but among them, high molecular polymers or sheet-like materials containing high molecular polymers are easy to mold into bags, and as described later, they can be easily sealed. Excellent in that respect.

Examples of such materials include polyethylene, polypropylene, polyvinylidene chloride, polyvinyl acetate, LI) polyester, nylon, cellulose acetate, polyvinyl alcohol, ethylene-vinyl acetate copolymer, Teflon, and various rubbers. Also included in the present invention are laminates of these materials, laminates with non-high-molecular polymer materials, or cases containing fillers. When carrying out the present invention, a bag is formed using material (A) and material (B), and a target product is housed and enclosed within the bag. Subsequently, a sterilizing gas is introduced into the bag using the conventional means 1 method. For example, the material is placed in a pressure vessel and the pressure is reduced in advance, and then sterilizing gas is introduced into the pressure vessel and pressurized, thereby introducing the sterilizing gas into the noklug and sterilizing it. In this case, temperature, humidity, time, etc. are appropriately selected depending on the product to be sterilized and the type of gas employed. Subsequently, the pressure inside the pressure vessel is reduced to remove the sterilizing gas from inside the bag. Introducing sterilizing gas into the bag (1) As for sterilization and removal, basically all conventional methods can be implemented, and the present invention is not limited to the above-mentioned examples. After sterilization, the material (B) part is sealed with the product stored in the material (B) part, and the product is sealed in the material (B) part and stored until use. When sealing the part of material (B), a heat sealing method, an ultrasonic sealing method, a method of applying an adhesive to the part to be sealed of material CB) in advance and pressure bonding, etc. are used, but the method is not limited to these methods. Any method that seals the inside of the bag in a state where it is isolated from the outside is included in the present invention. Furthermore, after sealing is completed, it is preferable to remove the portion where the product containing the material (A) is not stored.

Next, the present invention will be explained in more detail with reference to Examples.

Example L A shear bag (4) and a nylon glove (5) were sealed in a bag (8) shown in FIG. In Figure 1, (1) is a polyester nonwoven fabric and corresponds to material (A). (2) is a polyethylene film and corresponds to material (B). Subsequently, it was placed in a pressure vessel and the pressure was reduced to a degree of vacuum of 740WH9, and then a mixed gas consisting of 15% ethylene oxide and 85% carbon dioxide gas was introduced and sterilized at 55° C. and 1.0 atm for 8 hours.

Subsequently, the pressure was reduced to a degree of vacuum of 740+wHg, and the pressure was reduced for 50" and 81 hours, after which atmospheric pressure was introduced to normal pressure. After repeating this process three times to remove the sterilizing gas from inside the bag, the bag was removed from the pressure vessel and the pressure was reduced (Figure 1). The part 6) was heat-sealed and cut at the part 7) to obtain a product packaged in a polyethylene bag. After leaving it in the air for 10 days, the petri dish was taken out from the polyethylene bag and the ordinary agar medium was sealed.
・The cells were cultured at C for 48 hours and the presence or absence of cords was observed. In addition, the amount of ethylene oxide remaining in the nylon gloves was determined.

The results are shown in Table-1.

Example 2 The same treatment as in Example 1 was performed. However, material (A) is a sheet made by sandwiching absorbent cotton with gauze, and material (B)
) was an aluminum laminated polyethylene film. The results are shown in Table-1.

Comparative Example L An attempt was made to make a bag using only polyethylene and perform the same treatment as in the example, but the bag burst under reduced pressure and ambient air, making it impossible to continue the test.

Comparative Example 2 A bag was made only from polyethylene and treated in the same manner as in Example. However, the pressure reduction condition was 508 tag.

The results are shown in Table-1.

The same treatment as in Comparative Example & Example 2 was performed. However, heat sealing was not performed after sterilization. The results are shown in Table-1.

Comparative Example A bag was made from this full mini-neel mN polyethylene film chisel and treated in the same manner as in the example.

The results are shown in Table-1.

It can be seen from Table 1 that the present invention is extremely useful.

Table-l ・Bacteria is the number of bacteria or colonies per petri dish unit.

・Residual ethylene oxide was measured by Soxhlet extraction of the gloves with water and gask quadrography. If ethylene glycol was also detected, it was assumed to be derived from ethylene oxide.

・In the case of Comparative Example 4, many colonies appeared and the specimen was labeled as "Kagashi" because it was unable to be used as a needle.

[Brief explanation of drawings]

FIG. 1 explains the method of the invention. (1); Polyester non-woven fabric band 1 (2); Polyethylene film band N (4) j Petri dish, (5); Nylon gloves 1 (
6); Heat-sealed part (γ); Cutting part patent applicant Toyobo Co., Ltd.

Claims (1)

[Claims] L At least a portion thereof has high permeability to sterilizing gas,
The object is housed and sealed in a bag consisting of a band made of a material (A) that is impermeable to bacteria and a band made only of a material (B) that has low permeability. (1) After the sterilizing gas is removed from the inside of the bag, the object has low permeability (B)
A sterilization and aseptic preservation method characterized by sealing and preserving the product in a sealed state. 2. Claim 1, wherein the material (B) is a high molecular weight polymer or a sheet-like material containing a high molecular weight polymer.
Sterilization and aseptic preservation methods.