JPH0580224B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (Technical Field) The present invention relates to an improved sterilization packaging method that causes less discoloration of the blisters and less deterioration of the physical properties of the blisters even when sterilized by irradiation with electron beams or gamma rays. . (Prior art) Blister packaging is a packaging method in which a transparent plastic film is formed by means such as vacuum forming or pressure forming, and after inserting the packaged item, it is attached to a mount. By molding it to match the shape of the material, it has the advantage of being able to reliably protect it. In recent years, attempts have been made to apply blister packaging to the packaging of syringes, needles, and other medical devices.The molded plastic film (blister) and backing paper are glued together to seal the contents and sterilize them with ethylene oxide gas. Alternatively, the contents are sterilized by electron beam sterilization or gamma ray sterilization, and then used for medical purposes. Among the above sterilization methods, the electron beam sterilization method and the gamma ray sterilization method have the advantage that the time required for the step of irradiating the electron beam or gamma ray is shorter than the ethylene oxide gas sterilization method. However, conventionally, single polyvinyl chloride resin sheets, laminates of polyvinyl chloride resin sheets and polyethylene resin layers, or laminates of unstretched polypropylene resin sheets and polyethylene resin layers, which are used for blister packaging of medical devices, have been used in blister packaging. When used after being molded into a shape, polyvinyl chloride resin sheets and unstretched polypropylene resin sheets change color when irradiated with electron beams or gamma rays, reducing their physical properties, especially impact resistance, and reducing their appearance. In addition to damage, the package also has the disadvantage of being damaged during transportation before use, making it impossible to maintain a sterile state. (Object of the Invention) Therefore, an object of the present invention is to provide a sterilization packaging method which eliminates the above-mentioned drawbacks of the prior art and eliminates the discoloration and deterioration of the physical properties of the blister. (Structure of the Invention) The sterile packaging method of the present invention stores an item to be packaged between a blister obtained by molding a sheet of polycarbonate resin or polyester resin and a mount, and then separates the blister and the mount between them. It is characterized in that the peripheral edges are sealed together to form a package, and then the package is sterilized by irradiating the package with electron beams or gamma rays. First, the blister prepared in the method of the present invention is constructed using a sheet of polycarbonate resin or polyester resin. The thickness of these resin sheets is usually about 100 to 1000 μm, taking into consideration the use and moldability. The resin sheet described above is formed into a blister by a molding method such as vacuum forming, pressure forming, or vacuum pressure forming into a shape that matches the shape of the object to be packaged. 1st
The figure uses a resin sheet, heater 1, mold 2,
This shows how the blister 4 is created by vacuum forming using a vacuum suction action from the hole 3. Note that the blister may be constructed from a single resin sheet as described above, or may be constructed from a multi-layered laminate using the resin sheets, if necessary. In addition, the blister has a layer with good heat-sealing properties such as polyethylene resin or ethylene/vinyl acetate copolymer resin on the side that is in close contact with the mount, in order to increase the adhesion strength with the mount, which will be described later. It is best to form a blister using a sheet. Next, as shown in FIG. 2, the packaged item 6 is stored between the blister 4 and the mount 5 as described above,
The blister and the mount are sealed together at their peripheral edges to form a package 8. Here, as the mount 5, at least the bacteria are contained in the package 8.
It is necessary to use a material that can prevent the material from entering from the outside to the inside, and that is not likely to change color or deteriorate its physical properties due to electron beam irradiation or gamma ray irradiation. Sterilized paper with a weight of about 40 to 95 g/m ² is first mentioned as a material that meets these conditions, but other papers such as high-quality paper, pure white roll paper, and glossy or bleached kraft paper can also be used. Alternatively, aluminum foil may be attached to these papers for use. These papers are usually used on the side that comes into close contact with the blister, in order to improve the adhesion strength with the blister, and to prevent paper fibers from scattering and contaminating the packaged items due to delamination of the paper when the package is opened. may be coated with a polyethylene resin layer. Alternatively, wax can be further applied to the surface of the polyethylene resin layer to make it easy to peel off the blister and the mount during use, so-called easy peel. Easy peel is also 2~
This can also be achieved by laminating three layers of co-extruded films on paper because the adhesion strength between the co-extruded layers is lower than that of heat sealing. Alternatively, the following forms of (a) and (b) can also be used as the mount; (a) Polyethylene, polypropylene, ethylene ~
On one side of an apertured composite film made of a resin selected from the group consisting of acrylic acid copolymer, ionomer, and ethylene-vinyl acetate copolymer, micropores penetrating the front and back sides are formed on the entire surface, Paper is laminated via an adhesive layer made of a resin selected from the group consisting of polyester, ionomer, ethylene-vinyl acetate copolymer, and ethylene-acrylic acid copolymer, and
A heat sealing agent layer is laminated on the other side of the apertured composite film for adhesion to the blister (filed in May 1982 by the same applicant as the present application).
Utility model registration application (1)) filed on March 13th, (b) Polyethylene, polypropylene, ethylene ~
An apertured composite film made by coextruding a resin selected from the group consisting of an acrylic acid copolymer, an ionomer, and an ethylene-vinyl acetate copolymer, and having micropores penetrating the front and back surfaces formed on the entire surface. However, polyester, ionomer,
Laminated on paper via an adhesive layer made of a resin selected from the group consisting of ethylene-vinyl acetate copolymer and ethylene-acrylic acid copolymer (May 9, 1982, filed by the same applicant as the present application) Utility model registration application filed in Japan (2)). When using the above (a) and (b) as a mount,
In addition to electron beam sterilization and gamma ray sterilization, it can also be used for ethylene oxide gas sterilization. The packaged items to be stored in the above packaging process may be anything that can be sterilized and maintained in a sterile state, but usually include the following medical equipment: blood circuits, Syringe needles, catheters, syringes, heart-lung machines, artificial kidneys, SV sets, AVF sets, three-way stopcocks, surgical scalpels, etc. After the object to be packaged is stored between the blister 4 and the mount 5, the blister and the mount may be sealed together at their peripheral edges by a known sealing method, such as a heat sealing method using a heat sealer 7. In addition to this, other methods may be used depending on the materials used. The entire package 8 thus obtained is irradiated with electron beams or gamma rays (indicated by 9 in FIG. 3). A relatively high-energy electron beam is best, with a dose of about 0.5 to 10 Mrad, and γ
The line dose is 0.5-5.0 Mrad, usually 1.5 Mrad
or 2.5 Mrad. (Effects of the Invention) According to the present invention, the blister does not discolor or its physical properties deteriorate, and therefore, the blister package obtained by the method of the present invention is sterilized. Moreover, it has an excellent appearance, and the packaging will not be damaged during handling before use. (Example) Examples are listed below to more specifically illustrate the present invention. Example A laminated sheet was prepared in which the following ~ were laminated in order. High-quality paper (64 g/m ² ) Primer (ethylene/vinyl acetate copolymer) Ethylene/vinyl acetate copolymer film (thickness 30 μ, ⁸⁰ through holes with a diameter of 0.3 mm already formed) Heat sealing agent (ethylene / Vinyl acetate copolymer) Using the above laminated sheet as a mount, the syringe is used as the content, and the periphery of the blister and mount is heat-sealed for blister packaging, and then the whole is exposed to gamma rays (2.5 Mrad). was irradiated. The material for the blister is polycarbonate resin sheet (PC).
coated with polyethylene, unstretched polyethylene terephthalate resin sheet (C-PET)
Each material was coated with polyethylene. Regarding the puncture strength (substitute for impact resistance) before and after irradiation with γ-rays and the discoloration after irradiation with γ-rays in these examples, as a comparative example, polyethylene was added to an unoriented polypropylene resin sheet (CPP) and a polyvinyl chloride resin sheet (PVC). It is shown below along with one coated with resin (PE). Note that similar results were obtained even when paper or sterile paper coated with polyethylene resin was used as the mount. 【table】

[Brief explanation of the drawing]

1 to 3 are sectional views showing the steps of the method of the present invention. 1... Heater, 2... Mold, 3... Hole, 4...
... Blister, 5 ... Mounting paper, 6 ... Item to be packaged, 7
...Heat sealer, 7'... cradle, 8... packaging, 9... electron beam or gamma ray.

Claims (1)

[Claims] 1. An item to be packaged is stored between a blister obtained by molding a sheet of polycarbonate resin or polyester resin and a mount, and then the blister and the mount are sealed together at their peripheral edges. 1. A sterilization packaging method, comprising: forming a package by irradiating the package with electron beams or gamma rays to sterilize the package. 2. The sterilization packaging method according to claim 1, wherein the sealed portion of the blister has a heat seal layer made of polyethylene or ethylene/vinyl acetate copolymer resin.