JPH068973A - High pressure steam sterilization packaging bag - Google Patents

Abstract

PURPOSE:To obtain a large-sized sterilization packaging bag which can produce an assured sterilization effect on its contents by subjecting the bag to high pressure steam sterilization with its opening part closed, regardless of the evacuation process of a high pressure steam sterilizer. CONSTITUTION:The bag 1 having a width of 200-500mm and a length of 500-1000mm and consisting of a gas-impermeable film is provided with a portion 2 formed of the nonwoven fabric consisting of the thermoplastic resin having small holes, a Gurley permeability of 0.1-15sec/100-ml and a melting point of at least 140 deg.C and impermeable to water under normal pressure. This nonwoven fabric portion 2 comprises at least 20% of the surface area of the bag and an opening part 5 of the bag is sealed by heat fusing or fastening after receiving therein its contents to be sterilized.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION The present invention, after containing a sterilized object,
The present invention relates to a bag-shaped structure for high-pressure steam sterilization, which is subjected to high-pressure steam sterilization by a vacuum exhaust system or a pressure exhaust system with its opening sealed to surely obtain a sterilizing effect.

[0002]

2. Description of the Related Art High-pressure steam sterilization is not only used for medical and scientific experiments, biochemical experiments, medical procedures, and the like to sterilize equipment and materials, but also used and contaminated equipment and materials. It is also carried out when it is reused or disposed of after making it aseptic and confirming its safety. The necessary and sufficient conditions are that after removing residual air from the pressure vessel by vacuum exhaust or pressurized exhaust, the sterilized object is saturated steam of high temperature and high pressure for a certain time (generally 121 ° C., 20 minutes). To expose.

Most conventional sterilization bags are intended to prevent re-contamination during sterilization of instruments or materials and storage after sterilization, and most of them also consider prevention of contamination when disposing of a sterilized object. There was no situation.

Further, conventionally, a sterilization bag used for high-pressure steam sterilization on the assumption of disposal is made of a material having no air permeability. For this reason, one side of the bag must be open in order to remove the air remaining inside the sterilization bag and allow the vapor to permeate, and secondary contamination occurs during transportation or sterilization work for sterilization. Could cause. In addition, the sterilization temperature must be raised or the sterilization time must be lengthened to ensure the sterilization effect (practical example: 132 ° C, 30 minutes), and the material used for the sterilization bag is also heat resistant. Excellent ones (for example, a thermoplastic polyester resin film having a heat resistant temperature of 180 ° C.) had to be used.

When viewed from the side of the sterilizer, except for a few practical examples, generally, in a high-pressure steam sterilizer having a pressure vessel capacity of 60 liters or more, the residual air elimination capacity and high-pressure steam are high. A vacuum exhaust system is adopted for the purpose of shortening the time of the sterilization process. In that case, the penetration depth of steam is deep, and sterilization failure is unlikely to occur even if a sterilization bag is used. However, in a high-pressure steam sterilizer with a pressure of less than 60 liters, which removes residual air with the steam generated in the pressure vessel, air tends to remain and the penetration depth of steam becomes shallow. If you use a sterilization bag,
Poor sterilization was likely to occur. Furthermore, in a high-pressure steam sterilizer in which the sterilization target storage port of the pressure vessel is provided in the horizontal direction, there is a possibility that the sterilization target will protrude from the opening of the bag, so the storage capacity should be reduced. It was the situation that the capacity of the pressure vessel should be smaller than that of the pressure vessel, or that the pressure vessel should be stored separately.

[0006]

Many sterilization bags are aimed at preventing recontamination during storage of instruments and materials after sterilization. However, as described above, a packaging bag for high-pressure steam sterilization that can withstand actual use is not provided on the premise of sterilization for disposal. The problem to be solved by the present invention consists of a packaging bag of a specific size on the premise of disposal, and the opening is heat-sealed regardless of the vacuum exhaust system or the pressurized exhaust system of the high-pressure steam sterilizer. Or, it is intended to provide a packaging bag for high-pressure steam sterilization that ensures a sterilizing effect when it is subjected to high-pressure steam sterilization in a sealed state by binding, and prevent poor sterilization and recontamination after sterilization work. It is possible to prevent the secondary pollution during transportation or work and improve the workability.

[0007]

The gist of the present invention is to provide a width 20
A bag body made of a non-breathable film having a length of 0 to 500 mm and a length of 500 to 1000 mm has fine pores, a Gurley air permeability of 0.1 to 15 sec / 100 ml, and a water-permeable melting point at normal pressure. A portion formed of a non-woven fabric made of a thermoplastic resin having a temperature of 140 ° C. or higher is provided, and the surface area ratio of the non-woven fabric is 20% or more of the surface area of the bag body. It is to be used for sterilization work after being sealed by wearing or binding.

[0008]

EXAMPLE A packaging bag of the present invention is a bag-like structure having a shape as shown in FIGS. 1 and 2, in which 1 is a bag body using a polyester film and 2 is one side of the bag body. The band-shaped non-woven fabric portion provided in the center of 3 is a heat fusion bonding portion, 4 is a bottom heat fusion bonding portion, and 5 is an opening. As the non-woven fabric material, polypropylene non-woven fabric (Luxar registered trademark manufactured by Asahi Kasei Corporation) P1060ZZ was used. For the part other than the non-woven fabric, any thermoplastic film can be used as long as it can withstand the heating temperature during sterilization, but its melting point is preferably 140 ° C. or higher in view of the performance of the non-woven fabric. used. 1 is a plan view,
FIG. 2 is a sectional view taken along the line AA in FIG.

The quality of sterilization performance was judged by the following method. When Attest No.1262 manufactured by 3M Pharmaceutical Co., Ltd. is used as a biological indicator for steam sterilization and stored in a bag-like structure, gauze that easily contains air and vapor is difficult to penetrate is used, and the indicator is placed at the deepest part. In order to prevent this, two indicators were wound around two pieces of gauze, and this was used as an object to be sterilized. This sterilized object is stored in a high-pressure steam sterilizer in an amount corresponding to the outer size of the bag-shaped structure, and high-pressure steam sterilization (121 ° C,
After setting to minutes), the cells were cultured in a constant temperature bath. After crushing the indicator before culturing,
It was judged by culturing for 8 hours.

Example 1 A bag-like structure (surface area ratio: 25%) was produced with outer dimensions of 400 mm width × 800 mm length and non-woven fabric dimensions of 200 mm width × 800 mm length.
After accommodating a total of 15 units (pieces) in a row, the openings were bound with a nylon band and subjected to high-pressure steam sterilization.
As a result of the judgment, all 15 credits passed.

Example 2 A bag-shaped structure (surface area ratio: 50%) having an outer dimension of 400 mm width × 800 mm length and a nonwoven fabric dimension of 400 mm width × 800 mm length (all on one side) was manufactured. After accommodating 10 units in total of 3 rows in 3 rows and 1 row in the top row, the openings were bound with a nylon band and subjected to high-pressure steam sterilization. As a result of the judgment, all 10 credits passed.

Example 3 Example 10 except that the outer dimensions were 200 mm in width and 800 mm in length, and a bag (surface area ratio: 25%) having a width of 100 mm in nonwoven fabric and a length of 800 mm was used to store 10 units of the sterilized object. The same procedure as in 1 was performed. As a result of the judgment, all 10 credits passed.

Example 4 A bag having outer dimensions of 450 mm width, 800 mm length, nonwoven fabric dimension width of 225 mm and length of 800 mm (surface area ratio: 2
The same procedure as in Example 2 was performed except that 5%) was used. As a result of the judgment, 10 units were passed.

COMPARATIVE EXAMPLE 1 A bag-shaped structure was prepared with outer dimensions of 400 mm width × 800 mm length and non-woven fabric dimensions of 100 mm width × 800 mm length. The surface area ratio of the non-woven fabric is 12.5%. Using this bag, a sterilized object was stored in 3 rows and 3 rows and 1 row in the top row, and a total of 10 units (pieces) were stored. The openings were bound with a nylon band and subjected to high-pressure steam sterilization. When the quality of the sterilization performance was judged by the above method, 3 out of 10 units passed and 7 out of 10 units failed.

Comparative Example 2 A bag-shaped structure (surface area ratio: 18.75%) having an outer dimension of 400 mm width × 800 mm length and a non-woven fabric dimension of 150 mm width × 800 mm length was manufactured.
After accommodating 10 units in total in 3 rows and 1 row in the uppermost row, the openings were bound by a nylon band and subjected to high-pressure steam sterilization. Judgment result is 9 out of 10 credits
The number was 1 and the number was rejected.

In the above-mentioned Examples 1 to 4, good sterilization results were obtained for all the stored indicators. In Comparative Example 1, each of the lower and middle three rows has a total of 6
The piece was sterilized poorly. Furthermore, in Comparative Example 2,
Only one row in the middle of the middle stage (deepest part of vapor permeation) had a sterilization failure.

As in the above-described embodiment, the bag-like structure which is supposed to be disposed of has a large shape and a large amount of space. As a result, the saturated vapor must reach a deeper depth, but if the ratio of the surface area of the non-woven fabric is 20% or more of the surface area forming the bag-like structure, the residual air will remain regardless of the exhaust method of the sterilizer. Is sufficiently eliminated, the object to be sterilized is exposed to saturated steam of high temperature and high pressure, and sterilization performance is reliably obtained.

In the case of the high-pressure steam sterilizer adopting the pressurized exhaust system, the time for removing the residual air is about 25 minutes until the inside of the pressure vessel reaches the boiling point. There must be. For that purpose, the Gurley type air permeability of 0.1 to 15 sec / 100 ml is a necessary condition, and if it is lower than this, the residual air cannot be removed and sterilization failure may occur.

[0019]

According to the present invention, a large bag-like structure is used to store an object to be sterilized, and the opening is closed by heat fusion or binding, and high pressure is applied by an arbitrary exhaust method. Sterilization effect can be obtained reliably even when subjected to steam sterilization,
Since it can be processed in a closed state, there is no possibility of recontamination after sterilization. Further, the workability of disposal and the effect of preventing secondary pollution are remarkable.

[Brief description of drawings]

FIG. 1 is a plan view of a packaging bag for high-pressure steam sterilization according to the present invention.

FIG. 2 is a sectional view taken along the line AA in FIG.

[Explanation of symbols]

 1 bag body 2 non-woven fabric part 3,4 heat fusion bonding part 5 opening

Claims (1)

[Claims] 1. A width of 200 to 500 mm and a length of 500 to 1
The bag body made of a non-breathable film of 000 mm has fine holes and has a Gurley type air permeability of 0.1 to 15 sec / 1.
00 ml, provided with a portion formed of a non-woven fabric made of a thermoplastic resin having a melting point of 140 ° C. or higher that does not pass water at normal pressure
The surface area ratio of the non-woven fabric is 20% or more of the surface area of the bag body, and after accommodating an object to be sterilized, its opening is sealed by heat fusion or binding to be used for sterilization work. Packaging bag for high-pressure steam sterilization.