JPS6024847A - Pasturization packing method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION (Technical Field) The present invention relates to an improved sterilization packaging method that causes less discoloration of the blister and less deterioration of the physical properties of the blister 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 vacuum forming or pressure forming, and after the packaged item is inserted, it is attached to a mount, so that the contents can be seen through from the outside. It has the advantage that it can be reliably protected by being molded to match the shape of the contents.

In recent years, attempts have been made to apply blister packaging to the packaging of syringes, needles, and other medical devices. The contents are sterilized by sterilization, 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 molded into the shape of
When polyvinyl chloride resin sheets and unstretched polypropylene resin sheets are irradiated with electron beams or gamma rays, their color changes and their physical properties, especially their impact strength, deteriorate, which not only impairs their appearance but also prevents them from being transported before use. It also has the disadvantage that the packaging may be damaged and sterile conditions cannot be maintained.

(Objectives of the Invention) Therefore, it is an object of the present invention to provide a sterilization packaging method that eliminates the two 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 involves storing an item to be packaged between a blister obtained by molding a resin sheet having benzene rings in repeating units and a mount, and then placing the blister and the mount together. The peripheral edges of these parts are sealed together to form a package, and then the packaged body is sterilized by irradiating the package with electron beams or gamma rays! It is a thing with 11 characteristics.

First, the blister prepared in the method of the present invention is made using a sheet of resin having a benzene ring in the repeating unit. Here, the resin in which the benzene ring is incorporated into the repeating unit is polycarbonate resin,
Specific examples include polyester resins such as polyethylene terephthalate resins, polystyrene resins, butadiene/styrene copolymer resins, and blend resins of polystyrene resins and butadiene/styrene copolymer resins. The thickness of the sheet of these resins is usually about 3,000 to 1,000 ttm, taking into consideration the application and moldability. The resin notebook mentioned above is formed into a blister by molding it into a shape that matches the shape of the packaged object using a molding method such as vacuum forming, pressure forming, or vacuum pressure forming. Figure 1 shows vacuum forming using a resin notebook, Peak-1 and mold 2, and vacuum suction from hole 3. This figure shows how to create a large blister 4.

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 is coated with polyethylene resin on the side that will be in close contact with the mount, in order to increase the strength of the blister with the mount, which will be described later.
It is preferable to form a blister using the above-mentioned sheet containing a layer with good heat sealability such as ethylene/vinyl acetate copolymer resin or ethylene/vinyl acetate copolymer resin.

Next, as shown in FIG. 2, a packaged object 6 is stored between the blister 1 and the mount 5 as described above, and the blister and the mount are honeymooned together at their peripheral edges to form a package 8. .

Here, the mount 5 must be one that can at least prevent bacteria from entering the package 8 from the outside, and that does not change color or exhibit physical properties due to electron beam irradiation or γ-ray type '14. You must use one that is not likely to deteriorate. Those that meet these conditions are 40~
95! The first example is sterilized paper with a paper size of about 1.5 cm, but other papers such as high-quality paper, pure white roll paper, glossy or bleached kraft paper can also be used.Alternatively, you can also use these papers with aluminum foil pasted on them. Good.These papers are usually used with the blister to improve the adhesion strength with the blister, and to prevent paper fibers from scattering due to separation between the layers of paper when opening the packaging, causing ρj staining on the packaged item. The surface to be brought into close contact may be coated with a polyethylene resin layer.Alternatively, wax may be further applied to the surface of the polyethylene resin layer to make it easy to separate the blister from the mount during use, creating a so-called easy beer. .Easy Beer Bamata,
2~: This can also be achieved by laminating three layers of coextruded films on paper, since the adhesion strength between the coextruded layers is smaller than that of heat sealing.

Alternatively, the following forms of (a) and (b) can also be used as the mount: (a) From the group consisting of polyethylene, polypropylene, ethylene acrylic acid copolymer, ionomer, and ethylene-vinyl acetate copolymer. Polyester, ionomer, ethyne-vinyl acetate copolymer, ethyne-acrylic acid copolymer are coated on one side of the apertured composite film, which is made of a selected resin and has micropores that communicate between the front and back surfaces. Paper is laminated via an adhesive layer made of a resin selected from KimiT consisting of (2) the ability of the apertured composite film (2) polyethylene, pop-1-copylene, ethylene-acrylic acid copolymer, The perforated metal backing film is made by co-extruding a resin selected from the group consisting of ionomer and ethylene lactate-resistant vinyl copolymer, and has fine pores that penetrate through the front and back sides of the film. , ethylene ~ ML m vinyl co-m
Union 1. When the above (a) and (b) from the group consisting of J'-terene and acrylic acid copolymers are used as a mount, it can be used for electron beam sterilization and gamma ray sterilization as well as for ethyne oxide gas sterilization. reactor.

The items to be packaged in the above packaging process may be anything that needs to be sterilized and maintained in a sterile state, but are usually the following medical equipment: blood circuits, injections, etc. Needle, catheter, syringe, heart-lung machine, artificial kidney, S upper set A V 1v set, three-way stopcock,
Surgical scalpels, etc.

After storing the item to be packaged 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 sealant method using Evaheat Sealer 7, or by other methods depending on the usage. Let's do it.

The entire package 8 thus obtained is irradiated with electron beams or gamma rays (indicated by 9 in FIG. 3). A relatively high energy beam is best as an electron beam, and the dose is 0.
5 to 1.0 Mrat1, and 0.5 to 5.0 for gamma rays. OMrad, usually 1.5 Mrad
is 2.5 Mrad (Effects of the Invention) According to the present invention, the blister does not discolor or the physical properties of the blister deteriorate. It does not require sterilization, weighs 7 tons, has an excellent appearance, and is easy to use.
It is also possible for the packaging to be damaged while handling 1q.

(Example) Below, examples are given which specifically illustrate the present invention.

Example A laminated sheet made by laminating the following ■~■ in order is '-('= (
+iii.

■ High quality, 64';jam'' ■ Primer (ethylene/vinyl nitrate copolymer) ■
Ethylene/acid-resistant vinyl copolymer film (thickness 30μ
, 50 pieces/cm of ischemia with diameter θ and 3 mm have been formed) ■ Heat sealing agent (ethylene/l'l'111 & vinyl copolymer) Using the above laminated sheet as a mount, the syringe as the content, and the pre-sealer. After heat-sealing the periphery of the mount and packaging in a blister, the whole was irradiated with gamma rays (2,5Mra+1). As abrasive material for the blister, polycarbonate resin notebook (PC), unstretched polyethylene terephthalate resin sheet) (C-PET) is used.
), and polyethylene-coated polyethylene copolymer resin (manufactured by Philips Speller, r-Ream International, K-1?, Ishi SIN, (IJs)). used. In these examples, the puncture strength before and after irradiation with 7′ rays (substitute for rain resistance) and the discoloration after irradiation with γ rays are compared with JJJ Nobuoki Polypropylene Resin Note (CPP) as an example.
and polyvinyl chloride resin sheet (VC) coated with polyethylene resin (JI E) are shown below. In addition, paper as a backing material and sterile paper coated with polyethylene resin are used for protection. However, similar results were obtained.

[Brief explanation of the drawing]

Figures 1 to 3 show the steps of the method of the present invention.
It is a υte side view. l・・・・・・・・・Heater 2・・・・・・・・・
Mold 3... Hole 4...
Blister 5... Mount Paper 6...
・・・・Packaged item 7・・・・・・Heat sealer 7′・・・・・・・Receiver is on stand 8・・・・・・・・・
Packaging body 9...... Engraving of electron beam or R-ray drawings (
No change in content) Fang 1 Drawing 2 Figure ↓ 1 ↓ Ill ↓ ↓ 1-9 '4'i Correction Agency Director Kazuo Wakasugi 1, 1 display Showa RG year Q'f j'l request No. / Name of ar/qa invention, Name of sterile packaging method amendment “Relationship with 1f Patent applicant address Bunko; Part 2 Ji Yado 1 x, Yamaya Kafli 2-1-112 address name (4, (289) Dai 14 Hon Printing Co., Ltd. (1st generation! Yoshitoshi Kitajima 1st generation j111 people fj, lsui 〒] 62 Higashi 3; Toto; 1i??i-ku Yamaya J111Ml"E'l'l-, j12 No. 1fl + Showa S
g year 10Jj/IJ (Shipping [-1゛Sho II s
g '1101125 El) Class of invention increased by sleeve correction None '7'', /Clean up Figure 3 as per the attached sheet of 'Sleeve'. that's all

Claims (2)

[Claims] (1) A packaged item is stored between a blister obtained by molding a sheet of resin having benzene rings in repeating units and a mount, and then the blister and the mount are sealed together at their peripheral edges. A sterilization packaging method, comprising: preparing a package, and then sterilizing the package by irradiating the package with electron beams or gamma rays. (2) The sealing portion of the blister has a heat seal layer made of polyethylene or ethylene/vinyl acetate copolymer resin.
1) Sterilization packaging method.