JPS60251057A - Packaging vessel for sterilizing autoclave - 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 10. Background Technical Field of the Invention The present invention relates to a packaging container for autoclave sterilization (high-pressure steam sterilization I1i). To be more specific, when medical instruments such as an artificial kidney 1 an artificial lung 2 an artificial liver 9 are sterilized in an autoclave, the packaging for autoclave sterilization allows for sterilization of the surface of internal items and is easy to dry. It concerns containers.

Prior art medical mass transfer devices, such as artificial kidneys used for hemodialysis, include a cylindrical housing, a hollow fiber bundle consisting of a number of dialysis hollow fiber membranes inserted into the housing, and the hollow fibers. a dialysis chamber formed by the outer surface of the membrane and the inner surface of the housing; a dialysate supply port and outlet communicating with the dialysis chamber; and a dialysis chamber that supports each end of the hollow fiber membrane and is isolated from the dialysis chamber. A hollow fiber type artificial kidney is known, which comprises a partition wall that connects the membrane, and a blood inlet and outlet that communicate with the inner space of the hollow fiber membrane (Kagaku Review Vol. 21, "Chemistry of Medical Materials J, pp. 144-146," November 2, 1978
Published by Gakkai Publishing Center Co., Ltd.).

Such a medical substance transfer device is constructed by filling the main body of the medical substance transfer device with reverse osmosis water, physiological saline, etc., then sealing the container each day, and storing the device in a packaging container made of plastic film such as polypropylene, polyamide, or polyethylene terephthalate. Sterilization was performed by storing the material in a container, then placing it in an autoclave and heating it with high-pressure steam. However, since such conventional packaging containers are sealed, air still exists inside the packaging containers even after autoclave sterilization, and this air acts as a type of heat insulating agent, resulting in poor heat transfer. In addition, due to heat, moisture may come out from inside through the constituent materials of the medical mass transfer device, and a small amount of moisture may come out from inside the medical mass transfer device due to volumetric expansion due to heat. There is a problem that the surface of the internal article cannot be sterilized because the moisture remains in the packaging container and there is no saturated steam inside the packaging container.

On the other hand, there is a gas sterilization bag in which ventilation holes are formed in a heat-adhesive film or sheet or a package made of a heat-adhesive film or sheet and are blocked by a bacteria filter that is gas permeable and does not allow microorganisms to pass through. It has been proposed (Special Publication No. 50-20,964). However, in such a gas sterilization bag, the sterilization filter has a fiber diameter of 5μ or less and an average pore diameter of o, oi
~5 μm, preferably 0.1 to 1 μm, or an effective film of polyethylene, silicone rubber, etc. having a similar pore size; therefore, polyethylene nonwoven fabrics and films cannot be used for gas sterilization. However, it cannot be used in autoclave sterilization, which uses pressurized steam, due to problems with heat resistance. Furthermore, it is actually impossible to manufacture the above-mentioned nonwoven fabric from silicone rubber.

In addition, when the above-mentioned effective film made of silicone rubber has a pore diameter of 1 to 5 μm, it is easy for bacteria to pass through.
On the other hand, in the case of 0.01 to 0.1 μm, there is a problem that water vapor passes slowly during autoclave sterilization.

(1) Objective of the Invention Therefore, an objective of the present invention is to provide a novel packaging container for autoclave sterilization. Another object of the present invention is to sterilize medical instruments such as an artificial kidney, an artificial lung, and artificial blood vessels and blood circuits in an autoclave, with fast sterilization speed, easy drying of the internal articles, and sterilization of the surfaces of the internal articles. The purpose of the present invention is to provide a packaging container for autoclave sterilization.

The purpose of these developments is to block the vent provided in at least a portion of the non-breathable package with a filter equipped with a stretched polypropylene film having micropores through which water vapor and water can pass, and the filter to be used after sterilization. This is achieved by an autoclave sterilized packaging container that is characterized by its impermeability to microorganisms.

Further, in the present invention, the polypropylene film has a film thickness of 5 to 1
This is a packaging container for autoclave sterilization that has micropores of 0 μm and a porosity of 40 to 80%. Furthermore, the present invention provides a packaging container for autoclave sterilization, in which the micropore diameter of the polypropylene film has an average short diameter of 0.08 to 0.1 μm and an average long diameter of 0.1 to 0.2 μm. The present invention also provides a packaging container for autoclave sterilization, in which the polypropylene film is further laminated with a polypropylene nonwoven fabric having a thickness of 50 to 60 μm. Furthermore, the present invention is a packaging container for autoclave sterilization, in which at least the inner surface of the film or sheet forming the sealed package is made of a fusible material. Further, the present invention is a packaging container for autoclave sterilization in which the fusible material is polypropylene. Furthermore, the present invention is a packaging container for autoclave sterilization in which the stretched polypropylene film has heat shrinkability.

(9) Specific structure of the invention Next, an embodiment of the invention will be described with reference to the drawings. That is, in the packaging container 1 for autoclave sterilization according to the present invention, as shown in FIGS.
Sealed portions 3a, 3b, 3c are fused by ultrasonic waves, etc.
Ventilation holes 5a, 5b, 5c of a desired shape, for example circular, are formed in at least one place, for example four places, on at least one side of the bag-shaped film or sheet formed by forming a bag.

5d, and a filter medium 6 is provided to block the ventilation hole. Of course, the shape of these vents is not limited at all. The filter medium 6 can be attached by attaching one film or sheet 2a, for example, as shown in FIG.
A ventilation hole 5a is bored at an appropriate location, for example, at the center of the short side.
, 5b, 5c.

5d, a rectangular filter medium 6 is brought into contact with the inner surface so as to reach both ends thereof, and its two opposing sides 7a,
7b is fused and sealed using high frequency, ultrasonic waves, etc., another film or sheet 2b is superimposed on the film or sheet 2a, and the peripheral portions of the three sides are fused to form the filter medium 6. is sealed.

In the present invention, the air-impermeable film or sheet forming the bag-like object 4 has a heat-fusible coating laminated on at least the inner surface side, at least the peripheral edge forming the sealing part, and usually the entire surface. The sealing performance is ensured when the peripheral edge is fused using high frequency, ultrasonic waves, etc. Such laminated films or sheets include polypropylene, etc., as a heat-sealable coating layer on the inner surface, and the film thickness is 60 to 80 μm.
m1 is preferably about 70μ open. The film or sheet forming the outer layer includes plastics with high mechanical strength such as polyethylene terephthalate, polybutylene terephthalate, nylon 6, nylon 66, etc., and the film thickness is 20 to 30μ11, preferably about 25μ.
It is m.

The filter medium used in the present invention includes a stretched polypropylene film having micropores through which water vapor can pass. This stretched polypropylene film is produced, for example, by an extrusion stretching method, and has preferable heat shrinkability due to being stretched. As a filter medium equipped with such stretched polypropylene film,
For example, a biaxially oriented polypropylene film having a film thickness of 5 to 10 μm, preferably about 10 μm and a porosity of 40 to 80%, preferably 70 to 80% and having micropores, has a thickness of 5 μm.
There is one made by laminating polypropylene nonwoven fabrics of 0 to 60 μm, preferably about 60 μm. This laminated filter medium has
Furthermore, if necessary, the polypropylene film, the polypropylene nonwoven fabric, or the polypropylene screen may be laminated. Such a combination is
Examples include two-wheel oriented polypropylene film-polypropylene nonwoven fabric-polypropylene screen, polypropylene nonwoven fabric-biaxially oriented polypropylene film-biaxially oriented polypropylene nonwoven fabric, two-wheel oriented polypropylene film-polypropylene nonwoven fabric-biaxially oriented polypropylene film, and the like. Such reinforcements laminated to the oriented polypropylene film add to the strength of the oriented polypropylene film (so that it does not tear during sterilization or transportation)
The material is not limited as long as it is suitable for autoclave sterilization. Moreover, the pore diameter of the biaxially stretched polypropylene film has a short diameter of 0.02 to 0.0.
1 μl, preferably 0.08 to 0.1 μm,
In addition, the major axis is 0.1 to 0.4 μm, preferably 0.1 to 0
．． It is 2μ yuan. In addition, the polypropylene nonwoven fabric has a filament diameter of 0.005 to 0.1 ttm, preferably 0.01 to 0.05 μIll, and a bulk density of 0.3 to 0.1 ttm.
0.8o/Cll13, preferably 0.4-0.7i1
1/C113.

FIG. 3 shows another embodiment of the present invention, in which a bag-like object 14
Ventilation holes 15a, 15c are provided on the long sides of one of the non-breathable and transparent films or sheets 12a forming the
, . . . are bored, and a filter medium 16 is fused and provided as in the case of FIGS. 1 and 2 so as to block the ventilation holes. In addition, in the figure, the reference numerals with 10 added to the reference numerals shown in FIG. 1 represent the same members as in FIG. 1.

After storing a medical substance transfer device 8 such as an artificial kidney 9, an artificial lung 2, and an artificial liver in the bag-like object 4 formed in this way, as shown in FIG. After welding and sealing 2d using sonic waves, etc., place it in an autoclave and press at a pressure of 1.0 to 2.0 kg/Cm2.110 to 1.
It is sterilized by heating under appropriate conditions at 25°C for 30 to 300 minutes. Bacteria is carried out. The water vapor that has entered the packaging container 1 during such autoclave sterilization is discharged to the outside of the container by taking it out from the autoclave and allowing it to stand naturally.

Further, FIG. 5 shows still another embodiment of the present invention, and is an example of a packaging container 21 using a bag-like material 24 of the gusset type. A rectangular paper 22a and a thinner paper 22b are formed into a rectangular transparent and air-impermeable polypropylene film 2.
High frequency via 2c.

The paper 22a and the paper 22b are fused by ultrasonic waves to form fused parts 23a and 23b, and the paper 22a and the paper 22b are further fused in the same manner to form a fused part 23c to form a cylindrical body, The paper strip 22a is bent inward at a position 29 corresponding to the fused portion 23C to form a cylindrical body, and one end of the cylindrical body is fused in the same manner to form a fused portion 23d. This is what happens. In this case, the inner surfaces of the papers 22a and 22b are coated or laminated with a fusible plastic film. However, the polypropylene film 2
2c is provided with ventilation holes 25a, 25b, 25c, .

FIG. 6 shows another embodiment of the present invention, and is another example of a bag container 31 using a gusset type bag-like material 34. A cylindrical body is formed by welding rectangular transparent and air-impermeable polypropylene films 32b at both ends of a flat paper 32a using high frequency, ultrasonic waves, etc. to form fused parts 33a and 33b. The fused portion 33 is formed by bending the cylindrical body inward at each of the upper and lower portions 39a, 39b so that the polypropylene film portion 32b becomes a side portion, and fusing one end using the method described above. In this case as well, the same paper as in the case of FIG. 5 is used. Thus, the polypropylene film 32bGCG*vents 35a, 35b, 35c.

A filter medium 36 as described above is brought into contact with the inner surface of the filter medium 35d, and the peripheral edges 37a and 37b of the filter medium 9 are fused.

The bag-like article 24 shown in FIGS. 5 and 6 formed in this way
．． As in the case of FIG. 4, 34 accommodates a medical substance transfer device such as an artificial kidney, seals the open end by fusion, and then is subjected to autoclave sterilization.

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

Examples As shown in Figures 1 and 2, a polypropylene film (weight average molecular weight 1,50,000 to 260,000) with a thickness of 60 μm was coated on the inner surface of a film of polyethylene terephthalate (weight average molecular weight 250,000 to 260,000) with a film thickness of 25 μm. 10,000), and a filter medium made of a combination of two-wheeled stretched polypropylene film, polypropylene nonwoven fabric, and polypropylene screen is formed so as to block the ventilation holes, and the polypropylene screen side is in contact with the laminated film. Then, another similar laminated film was superimposed and high frequency welded on three sides to obtain a bag-like product. At this time, the biaxially stretched polypropylene film had a weight average molecular weight of 120,000 yen, a film thickness of 75 μm, and a porosity of 60%.
The pore diameter is 0°08μ in the short diameter of steel and 0.2μ in the long diameter, and the filament diameter of the polypropylene nonwoven fabric is approximately 0.
．． 01μm, bulk density 0.5a/as3. Thickness 25μ
Met.

After storing the artificial kidney filled with physiological saline in this bag-like material, the open end was fused and sealed, and the bag was heated to 90°C at 116°C.
Autoclave sterilization was performed by supplying steam for 0 minutes.

Comparative Example 1 When the same method as in Example was carried out except that a polyethylene nonwoven fabric was used as the filter medium, the polyethylene nonwoven fabric was damaged due to heat.

Comparative Example 2 When the same method as in Example was carried out except that a silicone rubber film with a pore size of 0.08 μm was used as the filter medium, it took 120 minutes to obtain the same sterilization effect as in Example. . In addition, the comparison of sterilization effect is 10% before sterilization.
The time required for the number of surviving bacteria to decrease to 10-6 was measured.

(0) Specific Effects of the Invention As described above, the present invention provides a method for replacing the ventilation section provided in at least a portion of a non-breathable package with a filter equipped with a stretched polypropylene film having micropores through which water vapor can permeate. Since the filter is an autoclave sterilization container characterized by not allowing microorganisms to pass through after sterilization, the filter not only sufficiently withstands the high temperatures during autoclave sterilization, but also has micropores that allow water vapor to pass through. Because of this, water vapor permeation is good, and during sterilization, the pressure is equalized and balanced between the inside and outside of the packaging container, which was conventionally equivalent to dry heat sterilization. (if applicable), the surfaces of the instruments to be accommodated can also be sterilized, thereby reducing sterilization time. Furthermore, since the filter medium made of stretched polypropylene has a lower surface tension than water, it allows water vapor to pass through it but not water.

Therefore, after autoclave sterilization, it is possible to cool the packaging material by directly pouring water on it from outside, and the inside of the packaging material will not get wet even if water is poured on it. Therefore, cooling can be performed efficiently in a short time. In this case, the effect can be further expected if the package is also made of a water-impermeable material. Furthermore, since the biaxially stretched polypropylene film of the filter medium shrinks due to the heat generated during autoclave sterilization, the pore diameter becomes smaller after sterilization, making it impossible for bacteria etc. to pass through. In other words, the pore diameter before sterilization can be increased in accordance with the pore diameter necessary to prevent passage of sterilization after heat shrinkage, so that water vapor can pass through easily and the sterilization time can be shortened. Also,
Since water vapor can enter the packaging container, the sterilization effect is high, and the surface of the medical instruments contained therein can also be sterilized.Moreover, after sterilization, the moisture remaining in the packaging container evaporates through the filter medium. This eliminates the problem of moisture remaining in the packaging container when the five products are shipped.

[Brief explanation of the drawing]

FIG. 1 is a perspective view showing an example of a packaging container for autoclave sterilization of a medical substance transfer device according to the present invention, FIG. 2 is an enlarged sectional view taken along line 1[-I[ of FIG. 1, and FIG. A perspective view showing another example, FIG. 4 is a perspective view showing a usage state,
Moreover, FIGS. 5 and 6 are perspective views showing still other examples. 1.11, 21.31...Packaging container, 2a, 2b, 1
2a, 12b, 22a, 22b. 22c, 32a, 32b...film or sheet, 5a, 5b, 5c, 5d, 15a, 15b, 15
c, 25a, 25b, 25c, 35a, 35b. 350.35d...Vent hole, 6.16,26.36...Filtering material. Patent applicant Terumo Co., Ltd.

Claims (7)

[Claims] (1) A ventilation section provided in at least a portion of the non-breathable package is blocked by a filter equipped with a stretched polypropylene film having micropores through which water vapor can pass;
An autoclave sterilization packaging container characterized in that the filter does not allow microorganisms to pass through after sterilization. (2) The packaging container for autoclave sterilization according to claim 1, wherein the polypropylene film has micropores with a thickness of 5 to 10 μm and a porosity of 40 to 80%. (3) The micropore diameter of the polypropylene film is such that the average short axis is 0.08 to 0.1 μm, and the average long axis is 0.08 to 0.1 μm.
The packaging container for autoclave sterilization according to claim 1 or 2, which has a particle diameter of 1 to 0.2 μm. (4) The packaging container for autoclave sterilization according to claims 1 to 3, wherein the polypropylene film is further laminated with a polypropylene nonwoven fabric having a thickness of 50 to 60 μm. (5) At least the inner surface of the film or sheet forming the sealed package is made of a fusible material.
The packaging container for autoclave sterilization according to items 1 to 4. (6) The packaging container for autoclave sterilization according to claim 5, wherein the fusible material is polypropylene. (7) The packaging container for autoclave sterilization according to claim 1, wherein the stretched polypropylene film has heat shrinkability.