JP2868291B2 - Autoclave sterilization package - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a package for autoclave sterilization. More specifically, the present invention relates to a package for autoclave sterilization using a microporous membrane or a nonwoven fabric that does not allow water to pass therethrough at normal pressure and having no water pool inside after autoclave sterilization.

[Conventional technology]

In recent years, sterilization of hospital equipment has shifted from gas sterilization to autoclave sterilization. A conventional package for autoclave sterilization uses paper on one side and a thermoplastic resin film or thermoplastic resin sheet on the other side.

[Problems to be solved by the invention]

The conventional autoclave sterilization package having the above-described configuration has various problems depending on the handling of the autoclave sterilization operator. That is, since paper is used on one side, it is easily torn and bacteria may enter. Particularly when wet, the strength is remarkably reduced, and the paper is more easily torn. Also, even if the paper is prevented from being torn by careful handling by the autoclave sterilizer, bacteria can easily invade with water,
Further, when the package is opened, paper dust is likely to be generated. Therefore, when the object to be sterilized is an injection needle or the like, there is a risk that the paper powder may enter the human body.

In order to compensate for these drawbacks in paper strength, there is a method of impregnating paper with a thermoplastic resin, but in order to obtain sufficient strength, the amount of resin impregnation must be increased, and On the contrary, it becomes difficult to obtain a high air permeability, and the occurrence rate of incomplete sterilization and bursting of the packaging material increases. Therefore, although there has been a strong demand for a package using a sterile packaging material for an autoclave instead of paper, there has not been anything satisfactory in practice.

An object of the present invention is to provide an autoclave sterilization package that overcomes the above-mentioned drawbacks of the conventional autoclave sterilization package. In other words, taking advantage of the property that the strength is high and the strength does not decrease when wet and the paper dust is not generated even when wet, it is easy to handle in hospitals, it is difficult to break, it does not pass bacteria, and after autoclaving sterilization treatment, there is a puddle inside. The aim is to provide a package for autoclave sterilization.

[Means for solving the problem]

An object of the present invention is to provide an autoclave sterilization package comprising an upper layer A and a lower layer B, which are used by inserting an object to be sterilized therein and joining the peripheral portions of the upper layer A and the lower layer B when used. Has micropores and Gurley air permeability of 0.1
~ 1000sec / 100ml, melting point 140 ° C which is impermeable to water at normal pressure
Having a microporous membrane made of the above thermoplastic resin, or having fine pores, Gurley air permeability is 0.1 to 1000 sec / 100 ml,
The lower layer B is made of a non-woven fabric made of a thermoplastic resin having a melting point of 140 ° C. or more that is impermeable to water at normal pressure. A sheet made of the above thermoplastic resin or a molded article made of a thermoplastic resin having a melting point of 140 ° C. or more, and at least a part of the surface of the microporous film or the nonwoven fabric of the upper layer A is subjected to a hydrophilic treatment. The present invention is achieved by an autoclave sterilization package characterized in that:

As described above, at least a part of the surface of the microporous membrane or the nonwoven fabric of the upper layer A is subjected to the hydrophilic treatment, and thus, in the autoclave sterilization package of the present invention, no water remains inside the package after the autoclave sterilization. .

The present inventors have found that the strength disadvantage of paper-based sheet materials used for autoclave sterilization packaging is that a microporous film made of a thermoplastic resin having a melting point of 140 ° C or higher and a nonwoven fabric having micropores are used. And proposed a new packaging material for autoclave sterilization in Japanese Patent Application No. 2-116745 (Japanese Patent Application Laid-Open No. 4-15058). However, when an object to be sterilized is enclosed in a package made of such a packaging material and used, if the amount of the object to be sterilized is large, the water after autoclave sterilization is higher than that of a package using paper. It was found that puddles were easily generated and drying was difficult. Then, the present inventors have further studied diligently, and as a result, as described below, by appropriately performing the hydrophilic treatment, the puddle can be eliminated, and the present invention has been achieved.

When a microporous membrane is used as the upper layer A of the autoclave sterilization package, the microporous membrane has micropores, and has a Gurley air permeability of 0.1 to 1000 sec / 100 ml, preferably 0.5
~ 100sec / 100ml and water impervious at normal pressure, melting point 14
It is made of a thermoplastic resin having a temperature of 0 ° C or higher, preferably 150 ° C or higher and 300 ° C or lower. The Gurley air permeability (unit: sec / 100 ml) is the gas permeability of a film measured according to JISP8117. The size of the fine pores of the microporous membrane is preferably 0.01 to 20 μm, and the maximum pore size is preferably 5 μm or less.

When a non-woven fabric is used as the upper layer A, the non-woven fabric has fine pores, a Gurley air permeability of 0.1 to 1000 sec / 100 ml, preferably 0.5 to 100 sec / 100 ml, and is impermeable to water at normal pressure and has a melting point of 140. It is made of a thermoplastic resin having a temperature of not less than 150 ° C., preferably not more than 150 ° C. and not more than 300 ° C. The maximum pore diameter of the opening of the nonwoven fabric is preferably 5 μm or less.

Preferred examples of the thermoplastic resin include polypropylene, polyethylene terephthalate, and nylon having a melting point of 150 ° C. or higher.

In the present invention, when a sheet-like material made of a thermoplastic resin having a melting point of less than 140 ° C. is used for the upper layer A, heat is applied at 135 ° C. during the autoclave sterilization step, so that the package melts and cannot maintain the shape of the package. Can not function as a packaging for food.

In the present invention, the hydrophilic treatment is the application of a hydrophilic processing agent,
It means that the surface of the microporous membrane or the nonwoven fabric is partially or entirely changed to an appropriate hydrophilicity by using a widely known technique such as corona discharge or imparting a hydrophilic group by graft polymerization.

When a hydrophilic processing agent is used, a hydrophilicity / hydrophobic balance (HLB) of 5 to 10 is preferable in that water resistance at normal pressure is not lost and puddles are prevented. Examples of the hydrophilic processing agent to be used include, for example, glycerin fatty acid ester, sorbitan fatty acid ester, sucrose fatty acid ester, and propylene glycol fatty acid ester, which do not pose a problem in food hygiene, and the amount of adhesion depends on the HLB of the processing agent. However, 0.01 to 3.0 g / m ² is preferable.

Examples of the adhesion method include a spray method, a gravure coating method, a kiss roll method, a screen printing method, and the like, and can be partially or wholly adhered to one or both surfaces. The upper layer A is not limited to the hydrophilic treatment by the processing agent, and when the upper layer A is subjected to the hydrophilic treatment in a lattice or stripes, the diffusion of moisture easily spreads to the packaging material, and
Since the non-hydrophilized portion is not clogged by water droplets, it is preferable that the portion is not broken by reduced pressure during autoclave sterilization.

In addition, a hydrophilic group such as a sulfonic acid type, a carboxylic acid type, or an ester type thereof is radicalized with a gamma ray or benzoyl peroxide into a part or the entire surface of a microporous membrane or a nonwoven fabric, and introduced. A hydrophilic treatment can be performed by introducing a hydrophilic group by a commonly used grafting technique.

Further, the surface of the microporous membrane or the nonwoven fabric can be subjected to a hydrophilic treatment using a corona treatment machine or a plasma treatment machine used for ordinary cloths, nonwoven fabrics and films. The degree of hydrophilization of the surface of the microporous membrane or nonwoven fabric subjected to hydrophilic treatment by these known hydrophilization treatments is 10 ° or more and 110 ° or less in terms of the contact angle formed between the water droplets and the surface subjected to the hydrophilic treatment. When a package for autoclave sterilization is used, water is not allowed to pass at normal pressure, and no water pool is generated inside the autoclave after sterilization.

The lower layer B in the present invention is a sheet-like material using a film made of a thermoplastic resin having a melting point of 150 ° C. or more such as polypropylene, polyethylene terephthalate, and nylon, or a polypropylene, polyethylene terephthalate, and nylon having a melting point of 150 ° C. It is preferable that the molded body is made of the above thermoplastic resin. The thickness of the lower layer B is 5 μm to 1000 μm in view of strength and heat sealing property.
Is preferred.

The package for autoclave sterilization of the present invention can be obtained by making the upper layer A and the lower layer B face each other and bonding the peripheral portion with heat or resin.

If the autoclave is sterilized for a long time after being sterilized in an autoclave, only one side of the microporous membrane or the nonwoven fabric is subjected to hydrophilic treatment, and the lower layer B is placed so that the hydrophilic treated surface is the inner surface of the package. It is preferable to join with the above because even if the package is wet for a long period of time, since the outer surface of the package is dry, invasion of bacteria can be prevented.

(Operation)

In the present invention, a microporous membrane that does not allow water to pass through the upper layer A at normal pressure,
Alternatively, by using a nonwoven fabric that does not allow water to pass through at normal pressure, the strength does not decrease when wet, and because it is high in strength, the possibility of tearing of the upper layer A during sterilization is significantly reduced, the use efficiency is increased, and the handling of workers is increased. It will be easier. Further, since no paper dust is generated during use, the object to be sterilized can be used sanitarily and safely.
Further, since water is impermeable at normal pressure and there is no water pool inside after the autoclave sterilization treatment, there is no invasion of bacteria due to water wetting and bacterial barrier properties can be always maintained.

Hereinafter, the present invention will be described in more detail with reference to Examples.
Obviously, the invention is not limited to what is described here, as long as the objects of the invention are achieved.

〔Example〕

 Example 1 Weight 80g / m^TwoWith Gurley type air permeability 13sec / 100cc
Polypropylene nonwoven fabric (Luxa manufactured by Asahi Kasei Corporation)
ー ) Commercially available sorbitan hydrophilic treatment on one side of P1060ZZ
Agent (Solgen manufactured by Daiichi Kogyo Seiyaku) 90) 0.1% aqueous dispersion in 1
Apply stripes at intervals of 1 cm with brushes and dry at 100 ° C with hot air
The upper layer A, which was dried for 1 minute in a
Produced. Next, the lower layer B
Using a 50μ thick polyester film,
Heat bonded and sealed with 250mm stainless steel tweezers
100 mm x 300 mm package for autoclave sterilization of the present invention
I got

Example 2 Weight 60g / m^Two, With Gurley air permeability 50sec / 100cc
Polypropylene microporous membrane (NF Sea manufactured by Tokuyama Soda Co., Ltd.)
G ) Gravure coater on both sides of SB100 (7)
The aqueous dispersion of 0.02% hydrophilic treatment agent used in Example 1
To form an upper layer A that has been hydrophilized on both sides.
Made.

Using a 50 μm thick polyester film for the lower layer B, the peripheral portion was adhered with a resin, and 250 mm stainless steel tweezers were sealed inside to obtain a 100 mm × 300 mm autoclave sterilization package of the present invention.

Example 3 A polypropylene melt-blown nonwoven fabric and a polyethylene terephthalate spunbonded nonwoven fabric for reinforcement were laid on top of each other and bonded together with a hot roll, followed by crushing and Gurley air permeability of 20 sec / 100 cc. The agent and a 0.05% aqueous dispersion were spray-treated on the polyethylene terephthalate spunbonded nonwoven fabric side and dried to prepare an upper layer A. Next, the lower layer B with the hydrophilic surface
A 250 μm stainless steel tweezers was placed inside using a molded product of a 100 μm-thick polyethylene terephthalate sheet, and the periphery was thermally bonded to obtain a package for autoclave sterilization of the present invention.

Example 4 Weight 80g / m^TwoWith Gurley type air permeability 13sec / 100cc
Polypropylene nonwoven fabric (Luxa manufactured by Asahi Kasei Corporation)
ー ) Using a commercially available corona treatment device on one side of P1060ZZ
And a corona discharge at 30 kV x 3 A and a distance of about 3 mm between the electrode and the nonwoven fabric.
Then, the upper layer A having one surface entirely subjected to hydrophilic treatment was obtained. Next
Then, the same film used in Example 1 was used for the lower layer B.
Thermal bonding of the peripheral part with the hydrophilic surface of upper layer A inside
And 250mm stainless steel tweezers inside and 100mm
× 300 mm of the autoclave sterilization package of the present invention is obtained.
Was.

Comparative Example 1 The upper layer A was made of a non-permeable polypropylene film having a thickness of 50 μm, and the lower layer B was heat-sealed around the periphery using a film of the same quality as that used for the upper layer A, and 250 mm stainless steel tweezers were enclosed inside. Autoclave package for sterilization 10
0 mm x 300 mm was obtained.

Comparative Example 2 Upper layer A has a basis weight of 70 g / m ² and a Gurley air permeability of 30 sec / 100 c
Using a 50-polyester film for the lower layer B, bonding was performed using a 50 μ polyester film for the lower layer B, and 250 mm stainless steel tweezers were sealed inside to obtain a 100 mm × 300 mm autoclave sterilization package.

Comparative Example 3 As upper layer A, SB100 (7) basis weight 60 g / m^Two, Gurley
Air permeability 50sec / 100cc polypropylene microporous membrane (Tokuyama
Soda Corporation NF sheet ) And use 50μ poly for lower layer B
Using an ester film to bond the periphery with resin
Enclose 250mm stainless steel tweezers in the section and 100mm x 300m
m of autoclave package for sterilization was obtained.

Each of Examples 1 to 4 and Comparative Examples 1 to 3 was put after autoclaving, and put at 135 ° C, 2.3 atm, 20 minutes, 100 ° C, 500
When the autoclave sterilization treatment was performed through the process of 30 mmHg for 30 minutes, the autoclave sterilization packages of Examples 1 to 4 could be sterilized without any abnormality such as rupture or puddles. The sterile package had burst.

In Comparative Example 3, a puddle was observed inside at a rate of 20%.

When the above Examples 1 to 4 and Comparative Example 2 were respectively dropped onto a steel plate from a height of 50 cm, the autoclave sterilization packages of Examples 1 to 3 were not damaged, and Comparative Example 2 was 50%
The upper layer A was broken at the rate of. (Test number 10 samples each) In addition, when the contact angle by the water drop of the upper layer A used in Examples 1-4 and Comparative Examples 1-3 was measured with the FACE contact angle meter CA-P type, Examples 1-4 were All were between 10 ° and 110 °, Comparative Examples 1 and 3 exceeded 110 °, and Comparative Example 2 was less than 10 °.

〔The invention's effect〕

The package for autoclave sterilization of the present invention is stronger than paper, withstands the autoclave sterilization process, does not drop strongly when wet, and does not have bacteria inside with water because there is no water pool inside after autoclave sterilization. Paper dust is not generated.

Therefore, the present invention has the effects of improving the ease of handling by an autoclave sterilizer, enhancing the bacterial barrier properties, and improving safety.

Claims (1)

(57) [Claims] 1. An autoclave sterilization package comprising an upper layer A and a lower layer B, wherein an object to be sterilized is inserted into the inside thereof and a peripheral portion of the upper layer A and the lower layer B are joined at the time of use. , With fine pores, Gurley air permeability is 0.1 ~ 1000s
ec / 100 ml, having a microporous membrane or a micropore made of a thermoplastic resin having a melting point of 140 ° C. or higher that is impermeable to water at normal pressure,
Gurley-type air permeability is 0.1 to 1000 sec / 100 ml, is formed of a nonwoven fabric made of a thermoplastic resin having a melting point of 140 ° C. or more that is impermeable to water at normal pressure, and the lower layer B is made of a thermoplastic resin having a melting point of 140 ° C. or more. The film is partially or entirely formed of a sheet made of a thermoplastic resin having a melting point of 140 ° C. or more or a molded body made of a thermoplastic resin having a melting point of 140 ° C. or more, and the microporous film of the upper layer A or A package for autoclave sterilization, wherein at least a part of the surface of a nonwoven fabric is subjected to a hydrophilic treatment.