JP2002128155A - Case, package and method of shipping sterilized product - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a transport or carry case which can stand irradiation for sterilization such as electron beams(EB) or γ rays. SOLUTION: A foamed polyethylene terephthalate(PET) sheet is assembled into a box, and a product such as a medicine container is received. While a product is packed in this shipment case, the product is sterilized by irradiation, and the package is shipped.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a case for accommodating and transporting or transporting a product such as a pharmaceutical container which is sterilized by irradiation with electron beam (EB) or γ-ray, and passing the case into a box. And a method of shipping a sterilized product using the package.

[0002]

2. Description of the Related Art Many products requiring sterility, such as pharmaceutical containers such as ophthalmic ointment tubes and medical devices, are sterilized by ethylene oxide gas (EOG). It is known that such EO sterilization has high permeability and can sterilize in detail, but EO is adsorbed not only on the surface of the product but also inside the material. Therefore, when EO sterilization is performed, the product cannot be shipped immediately after sterilization, and a period of 1 to 2 weeks is required for degassing. Also, during sterilization, such as rubber materials such as chlorinated butyl,
Some of them react with O gas to generate harmful substances such as ethylene chlorohydrin. These harmful substances are detected in the dissolution test of the Japanese Pharmacopoeia and are incompatible with the product and cannot be shipped.

As a sterilization method replacing EO gas sterilization, a method of irradiating radiation having a sterilizing action such as electron beam (EB) or γ-ray is known.

[0004]

By the way, when a large number of ointment tubes before filling with medicines are packed in a box made of a resin and shipped to a pharmaceutical manufacturer, sterilization by irradiation before the shipment is performed. When the packing case is made of PP or PE, it cannot withstand a large number of irradiations, and if the used packing case is collected and reused many times, various kinds of deterioration, yellowing, reduced strength, odor, etc. Problems arise.

Accordingly, an object of the present invention is to make the packing case made of resin in order to secure the strength and circulate the material, and to endure irradiation with sterilizing radiation. It is another object of the present invention to provide a product package suitable for sterilization by irradiation and subsequent shipment. Another object of the present invention is to provide a method of sterilizing and shipping products using such a package.

[0006]

In order to achieve the above object, the present invention takes the following technical measures.

[0007] That is, the case of the present invention is characterized in that it is formed of a resin having durability against irradiation with radiation for sterilization, and has a housing portion for a product to be irradiated with the radiation for sterilization. According to this, while the product is stored in the case of the present invention for packing the product during transportation or transportation,
The case can be carried into the sterilizing radiation irradiation equipment for sterilization, and the case can be shared for both transportation and sterilization, eliminating the need to refill products one by one and reducing labor. Can be. Furthermore, since radiation sterilization resin for sterilization is used as the molding material of the case,
The resin is less deteriorated even by repeated use (repeated use) many times, and yellowing, strength reduction and odor are reduced. Therefore, the recycling of the sterilized product packaging case can be promoted, and since the case is made of resin, the strength is relatively large and the case is less likely to be damaged by the cyclic use.

The sterilizing radiation includes an electron beam (E
B) and γ-rays. Also, the case may be of any structure, and may be a square middle frame, and an upper lid and a lower lid mounted above and below the middle frame. Or a box shape having six surfaces, or any other appropriate structure. Further, the product to be housed may be of any type, and can be applied to any product requiring sterilization, in addition to medical containers such as ophthalmic ointment tubes and medical containers such as scalpels. In addition, the structure and shape of the housing portion may be appropriately determined, and may have a concave portion (for example, formed by deep drawing) that matches the shape of the product.

[0009] In the case of the present invention, the resin constituting the case is a PE made by experiments of the present inventors.
It has been found that T can be used. That is, PET, more preferably foamed PET, can be used as the resin.

[0010] The case of the present invention is preferably made of foamed PET.
The product storage portion can be formed by assembling a plate member made of

The resin may be a virgin material, but is preferably a recycled material.

In the package of the present invention, a product (for example, a tube for pharmaceuticals) is packed in a product accommodating portion of the above-described case of the present invention, and the case is multiplex-wrapped with a plurality of plastic films. One or a plurality of cases provided are passed through a box and packed in a box. According to the package of the present invention, the package produced by the product producer up to the final packaging is transported to a radiation sterilization facility of a sterilizer (for example, Kansai Electron Irradiation Center of West Japan Irradiation Service Co., Ltd.) and A contractor can be entrusted with irradiation of radiation for sterilization, and the package returned after the irradiation can be inspected and inspected and shipped. Therefore, while the producer can eliminate and guarantee the inclusion of foreign matter, it is possible to outsource radiation sterilization of the product packed inside. Also, at the shipping destination (pharmaceutical maker), when the package is unpacked and then transported to the drug filling chamber via a plurality of intermediate clean rooms, the packing of the outermost layer is sequentially removed to remove the drug filling chamber. The product in the case can be taken out without contamination, and the stability of the cleaning degree of the product can be maintained.

The method of shipping a sterilized product according to the present invention includes a step of transporting or transporting the package to which sterilizing radiation has been applied and shipping the product, wherein the case in the package includes: The empty case from which the product is taken out of the storage section is collected and reused. According to this, since the reused resin packaging case is used, it is possible to significantly reduce the amount of packaging material discarded while securing the packaging strength. Furthermore, since the case is made of a resin such as foamed PET having durability to radiation irradiation for sterilization, problems such as deterioration, yellowing, reduction in strength, and odor due to radiation irradiation can be suppressed while using a reused product.

[0014] In the present invention, "having durability to radiation for sterilization" means that an irradiation dose (eg, about 25 kGy) required for sterilization of a product such as a pharmaceutical container.
Practical use in repeated use in the case of irradiating electron beams or γ rays. For example, it is possible to consider using an index that the change in hue is extremely small, that the tensile strength does not greatly decrease, that no odor is generated, and the like. Specifically, for example, when an irradiation amount of electron beam or γ-ray necessary for sterilization of a product is applied, an average color difference (2 in the CIE L * a * b * color space) with respect to an unirradiated product is obtained. A resin material having a distance of three colors in three-dimensional coordinates) of 2.0 or less, more preferably 1.0 or less, and more preferably 0.5 or less can be used. In addition, when the irradiation amount of electron beam or γ-ray necessary for sterilization of the product is applied, the average reduction rate of the tensile strength measured in accordance with JIS K6301 (compared with the non-irradiated product) is shown. It is possible to use a resin material that is 10% or less, more preferably 5% or less, and the average reduction rate of the elongation at break is 60% or less, more preferably 40% or less, and more preferably 20% or less. it can. The irradiation dose required for product sterilization is:
The dose is appropriately determined according to the shape, size, structure, type, and the like of the product, and can be a dose within a predetermined range equal to or higher than a predetermined lower limit and equal to or lower than an upper limit. The lower limit is, for example, 20 kG.
y, 25 kGy, 30 kGy, 40 kGy, 50 kG
y, 100 kGy, 200 kGy, etc., and the upper limit is, for example, 25 kGy, 30 kGy, 40 kGy,
kGy, 50 kGy, 100 kGy, 200 kGy, 4
00 kGy or the like.

[0015]

Embodiments of the present invention will be described below with reference to the drawings.

FIGS. 1 to 3 show a packing case 1 according to an embodiment of the present invention.
It is configured in a hollow shape having a housing portion 2 capable of housing 29 rows, that is, 899 rows / rows, 31 rows per row, that is, 899 rows. The product contained in the case 1 is a pharmaceutical container such as an ointment tube to be shipped to a pharmaceutical manufacturer. The container is sterilized and then shipped to the pharmaceutical manufacturer, and the pharmaceutical manufacturer fills the container with the pharmaceutical. Is done.

As shown in FIG. 2, the case 1 includes a middle frame 3 formed in a rectangular frame shape, and an upper cover 4 and a bottom cover 5 which are fitted to the middle frame 3 above and below. The upper lid 4 and the bottom lid 5 have the same structure. For example, as shown in FIG. 3, a rectangular plate-shaped lid 6 covering one opening of the middle frame 3 is provided.
There are front, rear, left and right side walls 7a, 7b. Tongue pieces 8 are provided at both left and right ends of the front and rear side wall portions 7a, and the tongue pieces 8 are bent to form left and right side wall portions 7a.
b is fixed to the outer surface side.

The middle frame 3 is formed by bending a substantially belt-shaped foamed PET sheet into a square shape and bonding both ends 3a. The top cover 4 and the bottom cover 5 are formed by punching or cutting a foamed PET sheet into a developed state including the cover 6, the side walls 7 a and 7 b, and the tongue 8. It is formed by fixing to the left and right side walls 7b. Thus, the case 1 of the present embodiment is configured by assembling a plate-like foamed PET into a box shape. In the embodiment, the thickness of each of the middle frame 3, the top cover 4 and the bottom cover 5 is set to 4 mm. However, the thickness and the size of each part can be appropriately changed according to the required strength and the like.

The middle frame 3, the top cover 4, and the bottom cover 5 of the case 1
Can be used as the resin material to form a PET foam sheet continuously extruded from PET resin. The PET foam sheet is an aggregate of PET resin foam, and a PET foam sheet having a honeycomb structure in which small foams are arranged in a honeycomb shape can be used. Further, preferably, a PET foam sheet formed of a recycled material mainly composed of PET bottle flakes obtained by pulverizing a used PET bottle can be used. As such a PET foam sheet, for example, “Selpet F” manufactured by Sekisui Chemical Co., Ltd. can be used.

As shown in FIG. 4, the case 1 in which the product is stored is affixed with a label 10 and individually shrink-wrapped with a plastic film 11 for each case 1. The shrink-wrapped case 1 is further packaged with a plastic bag 12 made of a plastic film and a sealing member 13 (such as a twist tie) as shown in FIG. In the illustrated embodiment, the plastic bag 1
The packaging by 2 is done twice. Thus, multiple packaging with a plastic film is performed by the shrink packaging and the packaging with double plastic bags.

The case 1 in which the multiple packaging is performed is shown in FIG.
As shown in (1), the package is finally packaged in a returnable box 14 made of a cardboard case to form a package 15 of the present invention. In the fourteenth embodiment, a double carton specification is used as a cardboard case, and two cases 1 are packed in one returnable box 14.

The ophthalmic ointment tube as a product is sterilized by irradiating the package 15 with an electron beam.
The electron beam irradiation is preferably performed by placing the package 15 on a tray-like cart and irradiating one surface thereof, inverting it by 180 ° C., and irradiating the opposite surface again, that is, so-called double-sided irradiation. . The electron beam irradiation may be performed by a tube maker, or may be entrusted to a specialized company having an electron beam irradiation facility. In carrying out such a sterilization method, the dose of the electron beam inside the case 1 is measured in advance, and the dose required for sterilization is secured, and the dose falls within the practical range of the resin material constituting the case 1. It is preferable to confirm that there is.

After sterilization by electron beam irradiation, after confirming that the cardboard case is not damaged or sterilized by a dosimeter, appropriate transportation / transportation means such as a conveyor, a truck, and a freight train are used. Is used to ship to pharmaceutical manufacturers (users).

The pharmaceutical manufacturer unpacks the package 15 and carries the case 1 through a plurality of intermediate clean rooms into a medicine filling room maintained in an aseptic condition. At this time, by sequentially removing the multiple wrapped plastic films in each intermediate clean room, it is possible to carry in the product without contaminating the chemical filling room.

After the product is taken out of the case 1, the empty case 1 is temporarily stored in a warehouse of a pharmaceutical manufacturer, and the case 1 is collectively collected periodically. The collected case 1 is washed and reused. Examples of the cleaning method include vacuum suction of dust or the like attached to the case 1 and wiping with alcohol.

According to the present embodiment, the case 1 as a packaging material
Because it is recycled, it also meets the legal system of the Containers and Packaging Recycling Law. Further, the case 1
Is made of a foamed resin to secure desired strength and cushioning property, so that it can be recycled many times. In addition, since a foamed PET sheet having radiation durability for sterilization is used as a resin material constituting the case 1, the product is housed in the case 1 used as a wrapping material at the time of shipment, and is irradiated with the radiation. Sterilization can be performed.

The present invention is not limited to the above embodiment, and can be appropriately designed and changed. For example, the case itself of the present invention can be used as a return box, a container for radiation irradiation, or the like.

[0028]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The inventors of the present invention have developed "Cellpet F CLF-G" which is a foamed PET sheet manufactured by Sekisui Plastics Co., Ltd.
Y160EA (5 times expanded product) "was subjected to an electron beam irradiation durability test. JI consisting of the above foamed PET sheet
A number of S4 type tensile test pieces were prepared, and 0 kGy and 30 kG
y, 90 kGy, 200 kGy, 400 kGy and 8
The average value of the hue and the average value of the tensile strength of 10 samples were calculated for each electron beam irradiation dose of 00 kGy. Tables 1 and 2 show the test results.

[0029]

[Table 1]

[0030]

[Table 2]

As is clear from Table 1, the hue tended to slightly decrease in brightness and redness as the electron beam irradiation dose increased, but the color difference was 0.92 even in the 800 kGy-irradiated product, indicating that the color changed. It could not be detected with the naked eye.

As shown in Table 2, even when the irradiation dose increases, the maximum point tensile strength does not decrease as much as the difference, but the tensile elongation at break decreases greatly as the irradiation amount increases, and it can be used practically. Was found to be up to about 400 kGy.

Further, it was confirmed by an experiment whether or not the inside of the case 1 was uniformly irradiated with the electron beam by the electron beam irradiation from the outer surface side of the multiple-packaged package 15 of the above embodiment. 3 at the measurement position where the dose is highest
1.7 kGy, 23.7 kGy at the minimum measurement position, it was confirmed that electron beam irradiation was performed almost uniformly and sterilization by the irradiation could be guaranteed.

[0034]

According to the present invention, it is possible to obtain a resin case for transportation or transportation made of a material that can withstand the irradiation of electron beams and γ-rays. The product can be shipped quickly later.

[Brief description of the drawings]

FIG. 1 is a half sectional front view of a case according to an embodiment of the present invention.

2A and 2B show a middle frame constituting the case, wherein FIG. 2A is a plan view and FIG. 2B is a front view.

FIG. 3 shows a bottom lid (upper lid) constituting the same case,
(A) is a plan view, (b) is a right side view, and (c) is a front view.

FIG. 4 is a perspective view showing a state where the case is shrink-wrapped.

FIG. 5 is a perspective view showing a state in which the case is multi-wrapped in a plastic bag.

FIG. 6 is a perspective view showing a package obtained by finally packaging the case with a cardboard case.

[Explanation of symbols]

 1 Case 2 Product Storage Unit 15 Package

 ──────────────────────────────────────────────────続 き Continued on the front page F term (reference) 3E067 AA04 AB81 AB83 AC03 BA05B BA18C BB14C BB15B BC06B BC06C CA30 FA03 FC01 GC10 4C058 AA16 BB06 EE12 EE24 KK03 KK04

Claims (7)

[Claims] 1. A case characterized in that the case is formed of a resin having irradiation durability for sterilization radiation and has a storage section for a product to be irradiated with the sterilization radiation. 2. The case according to claim 1, wherein the resin is PET. 3. The case according to claim 1, wherein the resin is foamed PET. 4. The case according to claim 1, wherein said product accommodating portion capable of accommodating a plurality of products is formed by assembling a plate-like member into a box shape. 5. The case according to claim 1, wherein the resin is a recycled material. 6. A case according to claim 1, wherein a product is packed in a box in the product accommodating portion of the case, and the case is wrapped in a plurality of plastic films, and the wrapped one or a plurality of the wrapped cases are provided. A package that is packed in a box through a case. 7. The method according to claim 6, wherein irradiation with sterilizing radiation is performed.
Transporting or transporting the package according to the above, and shipping the product, wherein the case in the package is an empty case from which the product has been taken out of the storage unit and collected and reused. A method of shipping a sterilized product, characterized in that: