JPH0696034B2 - High-pressure steam sterilization method for medical containers - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an improved method for high-pressure steam sterilization of bag-shaped medical containers such as drug solution containers and blood bags. Provided is a high-pressure steam sterilization method for a medical container that can be carried out without using it. An example of the blood bag will be described below.

[0002]

2. Description of the Related Art Blood bags currently used are made of a soft polyvinyl chloride resin or a polyolefin resin, and are subjected to high-pressure steam sterilization before being shipped as products. The high-pressure steam sterilization process is
Since it is usually performed in a batch system, blood bags are stacked and stored in the sterilization tank in order to increase the throughput of one treatment.

In a blood bag of two or more lines, in a child bag in which a liquid is not sealed, the sheet forming the container is blocked after the high-pressure steam sterilization process, and it is difficult to remove the sheet.

In order to reduce or eliminate these blockings, for example, in JP-A-1-230360, a sheet is embossed to form irregularities, and in JP-A-2-114963, an average particle diameter is 2 to 30 μm. A soft vinyl chloride resin containing 1 to 30% by weight of particles of the crosslinked vinyl chloride resin is used as a constituent material of the sheet.

However, in the former method, the embossed roll is very expensive, and the surface of the roll must be formed of a soft metal such as copper in order to form unevenness having a more precise shape. For this reason, the surface of the roll is easily damaged and must be replaced frequently, resulting in a large economic loss. In addition, there are drawbacks such as variations in the blocking prevention effect.

In the latter means, the crosslinked vinyl chloride resin itself appears on the sheet surface and cannot be completely covered with the uncrosslinked vinyl chloride resin, so that the particle size distribution is wide and uniform. It was hard to get the surface. Further, there is a drawback that there are few crosslinking agents suitable for medical use. Therefore, the present inventor has earnestly studied to solve the above problems, and as a result, arrived at the following invention.

[0007]

The present invention provides a high-pressure steam sterilization method for a bag-shaped medical container, which comprises the following steps. A step of enclosing an easily permeable gas in a bag-shaped medical container, a step of subjecting the described container to high-pressure steam sterilization treatment, and a step of spontaneously permeating an easily permeable gas from the container after completion of high-pressure steam sterilization, The easily permeable gas is a gas that passes through the medical container during sterilization and almost through the medical container after the sterilization, for example, carbon dioxide gas and helium are preferable, but any gas that can be applied to medical purposes may be used. . In the present invention, the amount of the easily permeable gas sealed in the medical container is 10 m.
1 or more, preferably 20 to 40 ml is desirable.

[0008]

[Example] As shown in FIG. 1, a flexible bag consisting of two bags, a parent bag 2 (with a blood sampling capacity of 200 ml and a preservative solution of blood sealed inside) and a child bag 3 (with a blood sampling capacity of 150 ml) connected by a connecting tube 6. A blood bag 1 made of polyvinyl chloride resin is prepared, and carbon dioxide gas 9 is supplied to the child bag 3 at 0, 20,
A sample of blood bag 1 with 40, 60 and 80 ml of each volume enclosed was prepared and subjected to high pressure steam sterilization treatment (121 ° C,
0 minutes, the pressure inside the can: 1.5 kg / cm ² , and the load applied to the blood bag 1: 500 g) were applied. The results are shown in Table 1.

[0009]

[Table 1]

[0010]

From the results of Examples and Table 1, the easily permeable gas permeates the medical container during sterilization and almost permeates after sterilization. For this reason, the medical container is swollen by the easily permeable gas while it is heated to a high temperature during the high-pressure steam sterilization treatment, so that the sheets constituting the medical container are separated from each other and no blocking occurs. In addition, after sterilization, the medical container does not become bulky because it is deflated. Further, it is generally said that if a large amount of air is enclosed in a medical container, it has an adverse effect on the collected platelets, but in the present invention, there is almost no air left in the medical container, so there is no such concern. Absent.

[Brief description of drawings]

FIG. 1 Schematic diagram of blood bag

[Explanation of symbols]

 1 Blood Bag 2 Parent Bag 3 Child Bag 4 Blood Collection Needle 5 Blood Collection Tube 6 Connection Tube 7 Blood Transfusion Port 8 Storage Solution 9 Easy Permeation Gas

Claims (1)

[Claims] 1. A method for high-pressure steam sterilization of a bag-shaped medical container, which comprises the following steps. A step of enclosing an easily permeable gas in a bag-shaped medical container, a step of subjecting the described container to high-pressure steam sterilization treatment, and a step of spontaneously permeating an easily permeable gas from the container after completion of high-pressure steam sterilization of