JPH10101148A - Sterilizing package - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sterilizing package in which a sterilization treatment by use of high pressure steam, ethylene oxide gas, or the like can be securely executed and the residual gas does not remain in the bag after the sterilization treatment and hence the sterilized material is not contaminated again and the bag is prevented from peeling off during the sterilization treatment and further the bag hardly raises a nap on opening. SOLUTION: Thermoplastic resin coating films 6 are formed on fiber positioned at the most outside surface of at least one side face of a material 4 like non-woven cloth, in this sterilizing package. The package body is constituted of a permeable base material 1 at least provided with holes 7 formed by the surrounding fibers coated with the films 6 and an impermeable base material 2. The permeable base material 2 and the impermeable base material are connected to each other through the thermoplastic resin.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a sterilized package used for packaging medical instruments and the like when sterilizing the medical instruments and the like, and more particularly, to a sterilization treatment using high-pressure steam, ethylene oxide gas, or the like. The present invention relates to a sterilized package that can be carried out, has no gas remaining in a bag after a sterilization process, and can prevent recontamination of an object to be sterilized.

[0002]

BACKGROUND ART Sterilization of medical instruments and the like is performed for the purpose of preventing infectious diseases. As a sterilization method in medical institutions such as hospitals, a high-pressure steam method and an ethylene oxide gas method are generally used. In the sterilization method using these gases, a package for storing medical instruments composed of a breathable substrate is used. Conventionally, nonwoven fabrics such as paper and synthetic fibers are used for such a breathable base material, and the package itself is made of a non-breathable base material such as a synthetic resin film on the above breathable base material so that the inside thereof can be seen. Are laminated so as to form a bag-like body. In a conventional sterilized package, for bonding or bag making in this way, an adhesive layer is provided on a gas-permeable base material of the package, or a heat-adhesive fiber is mixed with the gas-permeable base material,
It is adhesively bonded to a non-permeable substrate.

[0003]

The above-mentioned setting of the adhesive layer on the air-permeable base material is a cause of impairing the air-permeability. A decrease in air permeability causes a problem of a decrease in sterilization efficiency and a residue of toxic gas, ethylene oxide gas, on the material to be sterilized. On the other hand, as a method of providing an adhesive layer so as not to lower the air permeability of the air permeable substrate, a water-soluble adhesive is applied to the air permeable substrate, and the adhesive layer is formed at a temperature equal to or lower than the minimum film forming temperature. The method is described in, for example, JP-A-1-153471.
No. pp. 139 to 163. However, even with such a method, it is not possible to sufficiently prevent the air holes of the air-permeable base material from being closed. In the case of mixing the heat-adhesive fibers with the air-permeable base material, air permeability may be ensured to some extent, but fluff may be generated when the sterilization bag is opened.

The inventors of the present invention have made intensive studies in view of the above problems, and as a result, have found that a thermoplastic resin film is formed on the fibers of the surface layer of a non-woven material such as a nonwoven fabric and that the film is composed of a plurality of fused fibers. The present inventors have found that the above problems can be solved by using a gas-permeable base material having pores formed therein as a material for a sterilized package, and have reached the present invention.

An object of the present invention is to ensure sterilization by high-pressure steam or ethylene oxide gas because the air permeability is maintained, there is no gas remaining in the bag after the sterilization, and the object to be sterilized is not removed. An object of the present invention is to provide a sterilized package that can prevent recontamination.

Another object of the present invention is to provide a sterilized package which does not peel off the air-permeable base material and the non-air-permeable base material during the sterilization treatment, and hardly fluffs when opened.

[0007]

DISCLOSURE OF THE INVENTION The present invention has been made to achieve the above object, and the sterilized package of the present invention comprises a nonwoven material having a thermoplastic resin on at least one outermost fiber. A resin (A) coating is formed, and a plurality of fibers having the coating are formed of a gas-permeable base material having at least holes constituting the periphery thereof, and a non-air-permeable base material. A sterilized package, wherein a joint portion between a gas-permeable base material and the non-air-permeable base material is bonded via the thermoplastic resin (A).

[0008] The sterilized package of the present invention includes the following preferred embodiments.

A. The non-breathable substrate is a film made of a thermoplastic resin.

B. The nonwoven material constituting the breathable substrate is a nonwoven fabric made of synthetic fibers. c. The melting point of the thermoplastic resin (A) is preferably 10 ° C. or lower than the melting points of the synthetic fiber and the non-permeable substrate.

D. The average fiber diameter of the fibers constituting the nonwoven is in the range of 0.5 μm to 10 μm.

E. The air permeability of the permeable substrate is 5 to 500.
Seconds / 100 ml.

F. The sterilized package of the present invention is used for sterilizing medical instruments.

[0014]

DESCRIPTION OF THE PREFERRED EMBODIMENTS A sterilized package of the present invention will be described with reference to FIGS. FIG. 1 is a schematic cross-sectional view for explaining an example of the sterilized package of the present invention. As shown in FIG. 1, the sterilized package of the present invention has a breathable thermoplastic resin (A) coating. It is composed of a base material 1 and a non-permeable base material 2, and these two base materials 1 and 2 are interposed via a thermoplastic resin (A) existing on a fiber located on the outermost surface of the breathable base material 1. It is joined at the joining portion 3. Thermoplastic resin (A)
Can be performed by a heat sealing method.

FIG. 2 is a schematic sectional view for explaining an example of the joint (heat-sealed portion) 3 of the sterilized package of the present invention shown in FIG. In FIG. 2, a joining portion 3 includes a permeable base material 1 and a non-permeable base material 2, and the permeable base material 1 includes a nonwoven material 4 made of fibers 5 and a heat And a coating 6 made of a plastic resin (A). A coating 6 is adhered to the surface of the fiber 5 of the nonwoven material 4. Specifically, as shown in FIG. 2, the coating 6 is adhered to the surface of the fiber 5 so that the side (surrounding) has a hole 7 constituted by a plurality of fibers 5. The holes 7 communicate with the voids inherent in the nonwoven material 4, thereby ensuring the air permeability of the air permeable substrate 1 as a whole.

In the air-permeable base material of the present invention, the surface of the non-woven material is formed of a film composed of the pores and the thermoplastic resin (A). And since the shape of a hole substantially corresponds to the space | interval between fibers of a nonwoven-like material, it can be said that the opening part which comprises a hole is formed by the fiber which the coating adhered. In addition, the coating of the thermoplastic resin (A) is present not only on the fibers but also on a part thereof between the fibers like a remote island.

In the sterilized package of the present invention, the joining portion 3 of the air-permeable base material 1 and the non-air-permeable base material 2 thus prepared, usually the outer peripheral portion of the bag-like material, is made of a thermoplastic resin (A). ) Is thermally bonded.

In the present invention, the thermoplastic resin (A) melts at a lower temperature than the melting point or the decomposition point of the fibers constituting the non-woven material such as a nonwoven fabric and the non-permeable base material. 1 from melting point or decomposition point of non-breathable substrate
The temperature is preferably 0 ° C. or higher, more preferably 20 ° C. or higher, and most preferably 50 ° C. or higher. When the air permeable substrate and the non-air permeable substrate are thermally bonded by the thermoplastic resin (A), the heat bonding is higher than the melting point of the thermoplastic resin (A) and the melting point or the decomposition of the nonwoven material and the non-air permeable substrate. Since the bonding is performed at a temperature equal to or lower than the temperature, the larger the difference between the melting points of the two, the easier the bonding by thermal bonding can be.

In the present invention, the melting point of the thermoplastic resin (A) is preferably 100 ° C. or more from the viewpoint of thermal adhesion at a high temperature. The melting point of the plastic resin (A) is desirably 150 ° C. or higher.

As the thermoplastic resin (A) of the present invention, for example, polyester, polyamide, polyolefin, polyurethane, ionomer resin, ethylene-vinyl acetate copolymer, ethylene-acrylate copolymer, polymethyl methacrylate and the like are used. Can be. Among them, polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, nylon, polypropylene, polyethylene or a copolymer thereof can be preferably used, and furthermore, polyethylene terephthalate, polypropylene, polyethylene or a copolymer thereof is preferably used. Can be. Particularly, a copolymer of polyethylene terephthalate is most preferable. This is because the copolymer of polyethylene terephthalate is excellent in heat resistance and the like.

In the present invention, the thermoplastic resin (A) is attached as a film having pores on at least one outermost fiber of a non-woven material such as a non-woven fabric. Is preferably from 0.5 μm to 10 μm, and more preferably from 0.5 μm to 5 μm. As shown in FIG. 2, there is at least a hole 7 in which a plurality of fibers having a coating constitute the periphery thereof. Such holes are
When the sterilized package of the present invention is used for sterilization by a high-pressure steam method or an ethylene oxide gas method, it functions suitably as a vent.

The air holes are close to the shape of the holes (voids) inherent in a nonwoven fabric or the like, and the air permeability of the nonwoven fabric itself is utilized. The shape and size of the holes are not fixed and thus cannot be specified. However, the air permeability is preferably 5 to 500 seconds / 100 ml, more preferably 10 to 100 seconds / 100 ml, as indicated by the air permeability described later.

The non-woven material constituting the air-permeable base material of the present invention includes non-woven fabric and paper, but non-woven fabric is preferably used from the viewpoint of preventing wet strength and fluffing.
In particular, a nonwoven fabric made of a synthetic fiber is preferable. Examples of the synthetic fibers include synthetic fibers made of polyester, polyamide, polyolefin, and polyurethane. Among these, synthetic fibers made of polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, nylon, polypropylene, and polyethylene can be preferably used, and synthetic fibers made of polyethylene terephthalate, polypropylene, and polyethylene can be preferably used. In particular, synthetic fibers made of polyethylene terephthalate and polypropylene are most preferable.

The average fiber diameter of the fibers constituting the non-woven material is preferably 0.5 μm to 10 μm from the viewpoints of air permeability and bacterial barrier properties. Non-woven material retains air permeability,
The appropriate basis weight depends on the average fiber diameter, but 1 g / m ²
-100 g / m ² , more preferably 10 g / m ^2.
is preferably ^{g / m 2 ~80g / m 2} .

The method for producing the nonwoven fabric preferably used in the present invention is not particularly limited, but a flash spinning method, a melt blow method, a spun bond method, a spun lace method and the like can be applied. For example, in the melt blow method, when discharging a molten polymer from a die, hot air is blown from a peripheral portion of the die to make the discharged polymer finer, and then sprayed onto a net conveyor arranged at an appropriate position. It is manufactured by collecting and forming a web. The obtained web is sucked together with the hot air by a suction device provided on the net conveyor, so that the fibers are collected before the fibers are completely solidified. That is, the fibers of the web are collected in a fused state. By appropriately setting the collection distance between the base and the net conveyor, the degree of fusion of the fibers can be adjusted. Further, by appropriately adjusting the amount of discharged polymer, the temperature of hot air, the flow rate of hot air, the moving speed of the conveyor, and the like, it is possible to arbitrarily set the basis weight of the web and the fineness of single yarn. Melt blow spun fibers are fined by hot air pressure, but are not drawn,
It is solidified in a so-called non-oriented state. The thickness of the fibers is not always uniform, and the web is formed with thick fibers and fine fibers dispersed appropriately. Further, since the polymer discharged from the die is rapidly cooled from a molten state to an atmosphere at room temperature, a polymer having a low crystallization rate, such as polyethylene terephthalate, solidifies in an amorphous state.

In the spunbonding method, the polymer discharged from the die is pulled by an air ejector, and the obtained filaments collide with a collision plate to spread the fibers, and are collected in a conveyor to form a web. Manufactured. By appropriately setting the polymer discharge rate and conveyor speed,
The fiber basis weight of the web can be set arbitrarily. In addition, by appropriately adjusting the pressure and the flow rate of the air ejector, the molecular orientation state of the filament can be arbitrarily adjusted. By reducing the spinning speed by reducing the pressure and flow rate, a fiber web having a low degree of molecular orientation can be obtained. Further, by adjusting the cooling rate of the discharged polymer, a fiber web having a different crystallinity can be obtained. The non-breathable substrate in the sterilized package of the present invention is preferably a film made of a thermoplastic resin, and preferably has transparency so that the object to be sterilized stored in the package can be observed. Examples of such a film include a polyester film, a polyolefin film, a polyamide film, a polyvinyl chloride film and a laminated film thereof, and a polyethylene terephthalate film is particularly preferable. Further, the film may be a single film film or a film in which a heat bonding layer is laminated in order to further enhance the heat bonding property with the air permeable base material.

The air-permeable base material used in the sterilized package of the present invention is formed by laminating a film-like material made of a thermoplastic resin (A) and a non-woven material, and using this laminated body as the melting point of the thermoplastic resin (A). It can be produced by heat treatment at a temperature not higher than the melting point or the decomposition point of the non-woven fibers.

The thermoplastic resin (A) film used in the present invention can be produced by a melt extrusion method. That is, a method in which a thermoplastic resin (A) heated and melted by a single-screw or twin-screw extruder is discharged from a slit-shaped die to a casting drum to form a film can be used. The lamination of the film-like material and the non-woven material made of the thermoplastic resin (A) can be performed by superposing the film-like material and the non-woven material while heating them. For example, a film-like material and a non-woven material can be fed between heated rolls and laminated by applying pressure.

As the film-like material made of the thermoplastic resin (A), it is preferable to use a film-like material stretched at least in a uniaxial direction, but after laminating an unstretched film-like material and a non-woven material, A method of stretching this laminate at least in a uniaxial direction is more preferable.

The heat treatment of the laminate of the film-like material and the non-woven material made of the thermoplastic resin (A) can be performed after the laminating step or the stretching step, and the treatment is performed for 0.5 to 60 seconds. Is preferred. In particular, by performing a heat treatment after the stretching step, the mechanical strength and dimensional stability of a nonwoven material such as a nonwoven fabric are also improved. When the laminate of the film-like material and the non-woven material made of the thermoplastic resin (A) is heat-treated at a temperature not lower than the melting point of the thermoplastic resin (A) and not higher than the melting point of the non-woven material, the thermoplastic resin (A) Melts on the nonwoven and adheres to the fibers. Further, the thermoplastic resin (A) covering the space between the fibers melts and contracts to open holes, thereby forming vent holes. The air-permeable base material thus manufactured has good air-permeability while having thermal adhesion.

In the sterilized package of the present invention, the two substrates are overlapped with the thermoplastic resin (A) -adhering surface of the air-permeable substrate facing the non-air-permeable substrate side, and the joints such as the outer peripheral portion are thermally bonded. And can be manufactured by joining.

Each characteristic in Examples and Comparative Examples described later is as follows.
It was measured by the following method.

(1) Air permeability The air permeability was measured in accordance with JIS-P-8117.

(2) Melting point Differential scanning calorimeter RDC220 manufactured by Seiko Denshi Kogyo KK
It was measured with a mold. The measurement conditions were as follows.
The temperature was increased from room temperature at a rate of 0 ° C./min. The melting point was the temperature of the melting peak. In the case where the sample did not show a clear melting peak as it was, it was measured after performing a crystallization operation such as redrawing or heat treatment.

(3) Morphological Observation Observation of the surface morphology of the nonwoven fabric and measurement of the fiber diameter of the nonwoven fabric are performed by depositing platinum on the surface of the sample. Observed with an electron microscope. For the film thickness and fiber diameter of the sample, 10
An average value was calculated by measuring 0 places.

(4) Weight of Nonwoven Fabric The nonwoven fabric was cut into a square of 10 cm square, and its weight was measured with a balance. Measurements were converted to grams per 1 m ^2.

[0037]

EXAMPLES The present invention will be described more specifically with reference to examples.

(Example 1) (Production of breathable non-woven fabric)
Using zero nozzles, a polyethylene terephthalate chip having an intrinsic viscosity of 0.55 was melted at 290 ° C. and discharged from the nozzle. Further, the fineness is reduced by an air ejector and sprayed on a net conveyor to give a basis weight of 250 g /
It was obtained m ² of non-woven fabric. Next, a polyethylene terephthalate copolymer having an ethylene isophthalate component of 25% by weight was charged into a melt extruder as a thermoplastic resin (A), melted at 280 ° C., and discharged from a die onto a casting drum to form a film. Things. Subsequently, after laminating the film-like material and the nonwoven fabric obtained as described above, the resultant was continuously passed through a heating roll and laminated by heat bonding. Subsequently, the laminate was guided to a stretching machine, stretched 2.5 times in the longitudinal direction by a difference in roll peripheral speed, and then stretched 2.5 times in the transverse direction by a tenter method. The stretched laminate is 2 more
Heat-treated at 40 ° C to allow air-permeable nonwoven fabric (air-permeable base material)
And The basis weight of this breathable nonwoven fabric was 40 g / m ² , and the air permeability was 25 seconds / 100 ml. Further, when the surface of the air-permeable nonwoven fabric was observed, a coating of the thermoplastic resin (A) was formed on the fibers, and the coating had a plurality of holes around the plurality of fibers.

(Manufacture of sterilized package) Separately, a polyethylene terephthalate film having a thickness of 25 μm and a melting point of 260 ° C. was prepared as a non-permeable base material, and cut into a size of 30 cm in length and 20 cm in width together with a breathable nonwoven fabric. Further, the surface of the air-permeable nonwoven fabric to which the thermoplastic resin (A) was attached was superimposed on the film side, and three sides of the outer peripheral portion were heat-bonded except for one portion on the opening side to produce a sterilized package. The results are shown in Tables 1 and 2.

Example 2 Composition of thermoplastic resin (A)
A sterilized package was obtained in the same manner as in Example 1 except that only the coating thickness and the fiber diameter of the nonwoven fabric were changed. The results are shown in Tables 1 and 2.

Comparative Example 1 A nonwoven fabric having a basis weight of 250 g / m ² , which was the same as that obtained in Example 1, was subjected to corona discharge treatment, and a copolymerized polyester adhesive (Vylon 20S manufactured by Toyobo Co., Ltd.) was used.
S) was coated and dried at 120 ° C. As a non-breathable substrate, the same thickness as in Example 1 was 25 μm and the melting point was 26.
Using a polyethylene terephthalate film at 0 ° C., the coated surface of the nonwoven fabric was overlaid on the film side, and the outer periphery was thermally bonded except for one opening to obtain a sterilized package. Table 2 shows the results.

[0042]

[Table 1]

[Table 2]

[0043]

According to the sterilized package of the present invention, a constant air permeability is ensured even during the sterilization process, so that the sterilization process using high-pressure steam, ethylene oxide gas, or the like can be reliably performed. There is no gas remaining in the bag, and recontamination of the object to be sterilized can be prevented. In addition, the sterilized package of the present invention does not peel off during the sterilization treatment and has little fuzz at the time of opening because the adhesive strength between the gas permeable substrate and the non-air permeable substrate is strong. The sterilized package of the present invention is optimal for sterilizing medical instruments and the like.

[Brief description of the drawings]

FIG. 1 is a schematic sectional view showing one example of a sterilized package of the present invention.

FIG. 2 is a schematic sectional view showing an example of a heat-sealed portion of the sterilized package of the present invention.

[Explanation of symbols]

 1: air-permeable base material 2: non-air-permeable base material 3: bonded part (heat-sealed part) 4: non-woven material 5: fiber 6: coating 7: hole

Claims (6)

[Claims] 1. A thermoplastic resin (A) coating is formed on at least one outermost fiber of a non-woven material, and a plurality of fibers having the coating form pores surrounding the coating. Is formed of a gas-permeable base material having at least a non-air-permeable base material, and a bonding portion between the gas-permeable base material and the non-air-permeable base material is bonded via the thermoplastic resin (A). A sterilized package comprising: 2. The sterilized package according to claim 1, wherein the non-permeable substrate is a film made of a thermoplastic resin. 3. The non-woven material constituting the air-permeable base material is a non-woven fabric made of synthetic fibers, and the melting point of the thermoplastic resin (A) is 10 ° C. lower than the melting points of the synthetic fibers and the non-air-permeable base material.
The sterilized package according to claim 1 or 2, wherein the temperature is low. 4. The sterilized package according to claim 1, wherein the average fiber diameter of the fibers constituting the nonwoven material is in a range of 0.5 μm to 10 μm. 5. The sterilized package according to claim 1, wherein the air permeability of the air-permeable base material is in a range of 5 to 500 seconds / 100 ml. 6. The sterilized package according to claim 1, which is used for sterilizing medical instruments.