JPH03671A - Package for high pressure steam sterilization - Google Patents

Abstract

PURPOSE:To prevent a permeable member from being damaged and maintain sterile state by a method wherein a part of a box having a specific rigidity and an opened upper face is constituted of a permeable member while the opening of the box is sealed by a non-permeable member. CONSTITUTION:A medical object is stored in a box 2 whose small hole 6 is closed by a permeable member 7. Then a transparent non-permeable member 4 is fused to be sealed to the flange 3 of the box 2 by ultrasonic waves or the like to seal the box 2. Then a package 1 is put into a high pressure steam sterilizer to be sterilized while it is heated under appropriate conditions. High pressure steam enters the package 1 from the small hole 6 of the box 2 via the permeable member 7 to be saturated steam to completely sterilize the medical object and inside the package 2. At this time since the permeable member 7 is water repellent, it cannot be easily wet to have permeability maintained, and it is exhausted outside the package 1 when the package is taken out of the high pressure steam sterilizer. Further since the permeable member 7 does not allow admission of micro-organism so that the medical object and the package 1 can be subsequently maintained under aseptic conditions.

Description

Detailed Description of the Invention [Industrial Application Field 1] The present invention relates to a packaging container for high-pressure steam sterilization.
The present invention relates to a packaging container for high-pressure steam sterilization used when medical products such as plasma separators, dialyzers, artificial lungs, and their blood circuits are sterilized with high-pressure steam in a packaged state. [Prior art 1] In order to maintain a sterile state when shipping the above-mentioned medical products,
Otherwise, it is usually packaged in a packaging container to prevent contamination from the outside. Therefore. These medical products are sterilized while being packaged in packaging containers. In other words, 5. When packaging this medical article, for example, a plasma separator, first fill the plasma separator with water or an aqueous solution of a drug, seal all openings of the plasma separator, and use water-impermeable packaging. The plasma separator is placed in a packaging container made of a sheet, and the packaging container is sealed.The plasma separator is then sterilized with high pressure steam while being packaged in the packaging container. At this time, if the packaging container is hermetically sealed, air acts as a kind of heat insulating material, which deteriorates the heat transfer effect and requires a long time to completely sterilize the plasma separator. For this reason, a packaging container for high-pressure steam sterilization (hereinafter simply referred to as packaging container) l', which is entirely made of a flexible sheet, as shown in FIG. 4, is known. This packaging container 1°
is made up of several small holes 6, which are closed with an air-permeable member 7 such as a stretched polypropylene film that allows steam to pass through and does not allow microorganisms to pass through after high-pressure sterilization (Japanese Patent Laid-Open No. 60-251057). ), this packaging container
According to °, when high-pressure steam sterilization is performed, high-pressure steam enters the packaging container l' through the air-permeable member 7 that closes the small hole 6, and the packaging container l' is filled with saturated steam to sterilize medical items. It can be completely sterilized in a short period of time. [Problems to be Solved by the Invention] However, in the above-mentioned conventional example, the packaging container for high-pressure steam sterilization is made entirely of a soft sheet, the medical article is stored in this packaging container, and the medical article is stored in this state. It was sterilized by high pressure steam at i! It is being transported. For this reason, the hard parts of the medical articles stored in the packaging container 1'' hit or rub against each other through the soft sheet, causing damage to the soft sheet.In particular, the breathable member 7 is easily damaged and damaged. As a result, the medical articles inside the packaging container 1' are directly contaminated from the outside and cannot be maintained in a sterile state.Furthermore, since the above-mentioned packaging container 1' is made of a soft sheet, it is difficult to store the medical articles therein. When I did it, it didn't stay in the regular state for a while,
There were disadvantages such as difficulty in stacking and storage. Therefore, the present invention was made in view of the above circumstances, and 5. the breathable member is less likely to be damaged and can maintain a sterile state.
Another object of the present invention is to provide a packaging container for high-pressure steam sterilization that is easy to store. [Means for Solving the Problems] In order to solve the above problems, the packaging container for high-pressure steam sterilization of the present invention is provided with a box-like body that is given a predetermined rigidity and whose top surface is open, and a part of which is made of a breathable member. , and the opening portion of the box-like body is sealed with a non-ventilating member. In addition, the breathable member preferably has water repellency, and furthermore, the breathable member preferably does not allow microorganisms to pass through the high-pressure steam sterilizer. [Function 1] According to the packaging container for high-pressure steam sterilization having the above-mentioned structure, when a medical article is stored in a box-like body that has been given a predetermined rigidity and then sterilized with high-pressure steam or transported as is, the medical article The hard parts of the medical article hit or rub against each other through the box-like body and the non-ventilated member, which are given a predetermined rigidity. are dispersed, and the box-shaped body and non-ventilated member are not easily damaged. Furthermore, since the box-shaped body has a certain rigidity, it maintains its regular shape even when medical articles are stored therein, and is easy to stack. In addition, since the breathable member has water contact properties, it does not get wet with water and maintains breathability even after high-pressure steam sterilization, so the steam contained in the container easily escapes to the outside. Furthermore, since the air-permeable member does not allow microorganisms to pass through the autoclave, the sterilized state continues to be maintained after sterilization. [Embodiment 1] Hereinafter, an embodiment of the present invention will be described in detail based on FIGS. 1 to 3. Fig. 1 is a perspective view of the packaging container for high-pressure steam sterilization of the present invention, Fig. 2 is a sectional view taken along line II-II in Fig. 1, and Fig. 3 is a high-pressure steam sterilization state in which the plasma component W1 device is housed. In FIG. 1, which is a plan view of a packaging container for high-pressure steam sterilization, l indicates a packaging container for high-pressure steam sterilization (hereinafter simply referred to as a packaging container), and the packaging container l is a box-shaped container with a predetermined rigidity and an open top surface. body 2
Then, the opening part 2a on the top surface of the box-like body 2 is closed, and the flange part 3
The main component is an air-impermeable member 4 that is sealed. The box-shaped body 2 has a rectangular parallelepiped shape and has a space in which a medical article 5 can be stored. This box-shaped body 2 is designed to have a predetermined rigidity (for example, a bending strength of 3 to 3).
15Kg/s 3) It is made of a plastic sheet with some thickness and hardness. This plastic sheet may be made of, for example, polypropylene, polyethylene, nylon, polyester, polyvinyl chloride, etc., or may be a laminate of these and other plastics. Further, four small holes 6 are provided in the bottom surface 2b of this box-like body 2, and these small holes 6 are closed by a breathable member 7. This breathable member 7 has micropores through which vapor can pass,
In addition, a material that does not allow microorganisms to pass through after high-pressure steam sterilization is used. The material constituting the breathable member 7 is, for example, biaxially oriented polypropylene having a film thickness of 5 to 110 ml, preferably about 10 um, and a porosity of 40 to 80%, preferably 70 to 80%, and having micropores. Film, thickness 50
~60 μm, preferably about 60 μm, is used. This laminate may be further laminated with a two-wheel stretched polypropylene film, the polypropylene nonwoven fabric, or a polypropylene screen, if necessary. Examples of such combinations include biaxially oriented polypropylene film-biaxially oriented polypropylene film-polypropylene screen, polypropylene nonwoven fabric-biaxially oriented polypropylene film-polypropylene nonwoven fabric-biaxially oriented polypropylene film, and the like. Such a reinforcing body to be laminated to the stretched polypropylene film may be anything that reinforces the strength of the stretched polypropylene film (to prevent it from being damaged during sterilization or transportation), or any other material that is suitable for high-pressure steam sterilization. For example, the material is not particularly limited. After the medical article 5 is put into the box-like body 2 through the opening 2a on the top surface of the box-like body 2, the non-breathable member 4 is sealed to the brim 3 of the box-like body 2 to form a box-like body. This is for sealing the inside of the body 2. This non-breathable member 4 may be a plastic sheet that is replaceable and does not allow water to permeate at room temperature. More preferably, it is a transparent or translucent plastic sheet. , polypropylene, polyethylene, nylon, polyester, polyvinyl chloride, etc., or a laminate of these and other plastics.Next, a method of using the packaging container 1 for high-pressure steam sterilization having the above structure will be described. First, a medical article 5 such as a plasma separator shown in FIG. A transparent impermeable member 4 is fused and sealed to 3 using ultrasonic waves or the like, and the box-like body 2 is sealed.Then, the packaging container 1 is placed in a high-pressure steam source (li (not shown)) and the pressure is increased. Sterilization is performed by heating under suitable conditions of 1.0 to 2.0 KgW/cm'', 0 to 125°C, and 30 to 300 minutes.
The steam enters the packaging container l through the small hole 6 through the air-permeable member 7, becomes saturated steam, and completely sterilizes the medical article 5 and the packaging container l. During such high pressure steam sterilization, the packaging container 1
The steam that has entered the inside is difficult to get wet because the breathable member 7 is wetted with water (and since the breathable member 7 maintains its breathability, it is discharged outside the packaging container after being taken out from the high-pressure steam source m. After steam sterilization, the air-permeable member 7 does not allow microorganisms to pass through, so the medical article 5 and the packaging container l are maintained in a sterile state thereafter.The packaging container n1 containing the medical article 5 is then shipped as a product. [Effect of the invention 1] As detailed above, according to the packaging container for high-pressure steam sterilization of the present invention, a medical article can be stored in a box-shaped body that has been given a predetermined rigidity and then exposed to high-pressure steam as it is. When sterilized or transported, the hard parts of the medical article may hit or rub against each other through the box-shaped body and the non-ventilated member, which have a predetermined rigidity. The force of the parts touching or rubbing against each other is dispersed, preventing these box-shaped bodies and non-ventilated members from being damaged (therefore, during sterilization, steam can easily enter the container from the non-porous members).
To completely sterilize a medical article and the inside of a container, and then maintain a sterile state without being contaminated from the outside. or,
Since the box-shaped body has a certain degree of rigidity, there is little deformation and there is a low possibility of damage to the breathable member (in addition, the box-like body does not lose its shape even when storing medical items, and is easy to stack and store. In addition, since the breathable material has hydrophobicity, it is difficult to get wet with water and maintains breathability even after high-pressure steam sterilization, so the steam contained in the container does not escape to the outside. Therefore, in addition to the above-mentioned effects, the product image is also good because water does not accumulate inside the packaging container.Furthermore, the breathable member does not allow microorganisms to pass through the high-pressure steam sterilizer, so it continues to maintain a sterile state after sterilization. Therefore, in addition to the above-mentioned effects, the medical articles housed in the packaging container are always kept in a sterile state, so safety is high.

[Brief explanation of the drawing]

Claims (3)

[Claims] (1) For high-pressure steam sterilization, a box-like body with a predetermined rigidity and an open top is partially constructed of a breathable member, and the opening of the box-like body is sealed with a non-breathable member. packaging container. (2) The packaging container for high-pressure steam sterilization according to claim (1), wherein the breathable member has water repellency. (3) The packaging container for high-pressure steam sterilization according to claim 1 or 2, wherein the breathable member does not allow microorganisms to pass through after high-pressure steam sterilization.