JPS59105808A - Pasteurization of apparatus using permeable membrane - Google Patents

Abstract

PURPOSE:To perfectly pasteurize a permeable membrane apparatus without generating the lowering of membrane capacity or a leak, in pasteurizing the permeable membrane apparatus with high pressure steam, by vacuum packing said apparatus in which a predetermined amount of water is received. CONSTITUTION:Water in an amount sufficient to saturate the interior of a permeable membrane used apparatus with steam in performing high temp. pasteurization is received in said apparatus and the water filled apparatus is packed under vacuum while pasteurization due to high pressure steam is performed in an autoclave. By this method, air is not almost present in the vacuum packed apparatus because of the vacuum state and, therefore, the interior of the apparatus is saturated with steam in performing high temp. pasteurization, sufficient pasteurization effect is obtained. Because steam is penetrated into the permeable membrane after pasteurization and over-humidification is not generated, the deterioration of the permeable membrane due to freezing is not generated. When the perfect pasteurization of the apparatus outer wall is required, a small amount of water interposed between the outer wall and the packing sheet. In addition, when there is such a fear that the plasticity of the membrane is lost under high pressure, glycerine-water is used as filling water.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for sterilizing an apparatus for extracorporeal blood treatment or reverse osmosis in which a hollow fiber, sheet, or flat tube-shaped osmotic membrane is housed in a casing.

- Some methods of sterilizing the equipment mentioned above use high-pressure steam, gamma rays, and ethylene oxide gas. High-pressure steam sterilization is preferred because of the drawbacks that pose a hazard.

However, when a device using a osmotic membrane is sterilized with high-pressure steam in an autoclave, the osmotic membrane dries and shrinks due to aeration during the sterilization process, resulting in damage to the osmotic membrane and reduced performance. In some cases, high-pressure steam sterilization is carried out by encasing a osmotic membrane in the sterilization process, which is said to be safer than gamma ray or ethylene oxide sterilization, but has the disadvantage of reducing the permeability by about 20%. be.

As a countermeasure to the above-mentioned drawbacks, high-pressure steam sterilization in an autoclave of a device using a osmotic membrane filled with water and sealed with a rubber stopper has been widely adopted, but the weight of the device is Its large size makes it inconvenient for transportation and handling, and it still has the disadvantage of causing deterioration and leakage of the permeable membrane due to freezing.

The present invention provides a sterilization method using high-pressure steam, in which the device after sterilization is lightweight and compact, and which does not cause deterioration of the permeable membrane or IJ-reduction due to freezing.

The present invention is characterized in that an amount of water sufficient to saturate the inside of the device with water vapor during high-temperature sterilization is stored in a device using a permeable membrane, and the device is vacuum-packaged. The inside of the device is under reduced pressure and there is almost no air, and during high-temperature sterilization, the inside of the device is saturated with water vapor, so a sufficient sterilization effect can be obtained. Since it does not penetrate into the permeable membrane and cause excessive humidity, the permeable membrane does not deteriorate due to freezing.When a complete FAR of the outer wall of the equipment is required, a small amount of moisture is added between the outer wall of the equipment and the packaging sheet during the vacuum packaging process. It is best to use water.

The inlet/outlet for processing fluid provided in the device in the vacuum packaging mentioned above may be sealed with an elastic stopper, or may be sealed only with the sheet material of the vacuum packaging with an air permeable column. When using an elastic stopper, it is possible to perform high-pressure steam sterilization inside the device even in a high-temperature room at normal pressure, which has the advantage of allowing a continuous sterilization process.Of course, high-pressure steam sterilization can also be performed in an autoclave. Can be implemented.

The method of the present invention is realized by omitting the drying step of the device which is finally washed with water in the manufacturing process and the permeable membrane is sufficiently wetted, and then vacuum-packaged as it is, and does not require any extra steps up to sterilization. It is extremely economical and can be sterilized in an autoclave while still in vacuum packaging or high-pressure steam sterilization in a strongly sealed back pressure chamber. The amount of water absorbed is so large that the amount of water absorbed is sufficient to fill the inside of the apparatus with saturated steam during high temperature sterilization.

Furthermore, if there is a risk that plasticity will be lost due to high-pressure steam sterilization depending on the material of the permeable membrane, it is preferable to use glycerin water as the filling water.

patent applicant Nissho Co., Ltd.

Claims (1)

[Claims] ■ A device using a permeable membrane, characterized in that a sufficient amount of water is contained in the device using the permeable membrane to saturate the inside of the device with steam during high-temperature sterilization, and the device is vacuum packaged. Sterilization method. (2) A method for sterilizing a device using a permeable membrane according to claim 1, characterized in that water is contained in a wet state of the permeable membrane.