JP2006181368A - Sterilization method of medical sterilization packing - Google Patents

Sterilization method of medical sterilization packing Download PDF

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JP2006181368A
JP2006181368A JP2006001454A JP2006001454A JP2006181368A JP 2006181368 A JP2006181368 A JP 2006181368A JP 2006001454 A JP2006001454 A JP 2006001454A JP 2006001454 A JP2006001454 A JP 2006001454A JP 2006181368 A JP2006181368 A JP 2006181368A
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hydrogen peroxide
sterilization
peroxide gas
chamber
packaging container
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JP3845110B2 (en
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Mitsuru Hasegawa
充 長谷川
Shuichi Maeda
秀一 前田
Tokuji Mitomi
得司 三富
Takeshi Kanaguchi
剛 金口
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Seikagaku Corp
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/208Hydrogen peroxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/001Apparatus specially adapted for cleaning or sterilising syringes or needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/13Biocide decomposition means, e.g. catalysts, sorbents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/18Aseptic storing means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Diabetes (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

<P>PROBLEM TO BE SOLVED: To provide a sterilization method of a medical sterilization packing which enables the efficient processing and can certainly prevent the hydrogen peroxide gas from remaining behind. <P>SOLUTION: The sterilization method is to execute the sterilization processing of a syringe containing a medicine as a medical product enclosed in a packaging container with the hydrogen peroxide gas as it remains packed. A container comprised of a main body of the container which has a gas barrier property, has a totally open bottom and is integrally formed from synthetic resin, and the sterilization paper as a covering material which allows the hydrogen peroxide gas to penetrate and can be deposited on the whole bottom of the main body of the container is used as the packaging container. Also, after the syringe containing the medicine is stored in a chamber which is a sterilization apparatus and the sterilization processing is executed by repeating the operation of supplying the hydrogen peroxide gas into the chamber with the reduced pressure of 10-30 torr for two or more times, the degassing processing of the hydrogen peroxide gas from the inside of the packaging container is executed while heating is executed. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

本発明は、医療用滅菌包装における滅菌方法に関するものであり、詳しくは、包装容器に封入された医療品、例えば、薬剤入り注射器などをパッケージのまま過酸化水素ガスで滅菌処理する滅菌方法であって、効率的に処理でき且つ過酸化水素ガスの残留を確実に防止できる滅菌方法に関するものである。   The present invention relates to a sterilization method in medical sterilization packaging, and more particularly, to a sterilization method in which a medical product enclosed in a packaging container, for example, a medicine-filled syringe, is sterilized with hydrogen peroxide gas in the package. In addition, the present invention relates to a sterilization method that can be efficiently processed and can reliably prevent the residual hydrogen peroxide gas.

薬剤入り注射器などは、他のディスポーザブル医療機器などと同様に、医療用滅菌包装を施されて流通されることが好ましい。医療用滅菌包装は、ガスバリヤー性を有する合成樹脂製の容器本体と、滅菌ガスを透過可能で且つ容器本体に溶着可能な蓋材としての滅菌紙とから構成される包装容器を使用し、医療品を封入した後に包装状態のまま滅菌ガスに晒すことにより、滅菌紙を透過させた滅菌ガスによって内部を滅菌処理する形態の包装である。   As with other disposable medical devices, the medicine-filled syringes are preferably distributed with medical sterilization packaging. Medical sterilization packaging uses a packaging container composed of a synthetic resin container body having gas barrier properties and sterilized paper as a lid material that is permeable to sterilization gas and can be welded to the container body. This is a packaging in a form in which the inside is sterilized with a sterilizing gas permeated with sterilized paper by exposing it to a sterilizing gas in a packaged state after enclosing the product.

上記の医療用滅菌包装においては、滅菌ガスの毒性の問題から、エチレンオキサイドに代えて過酸化水素ガスの利用が各種の医療品に対して検討されているが、エチレンオキサイド又は過酸化水素ガスの何れを使用する場合でも、流通過程での人体に対する残留ガスの有害性を排除するため、包装容器の内部から滅菌ガスを除去する後処理が不可欠である。なお、過酸化水素を利用した殺菌、滅菌に関する技術は、以下の公報などに開示されている。
特公昭61−4543号公報 特開平1−121057号公報
In the above-mentioned medical sterilization packaging, the use of hydrogen peroxide gas instead of ethylene oxide has been studied for various medical products due to the toxicity of sterilization gas. In any case, post-treatment for removing the sterilization gas from the inside of the packaging container is indispensable in order to eliminate the harmfulness of the residual gas to the human body in the distribution process. Techniques relating to sterilization and sterilization using hydrogen peroxide are disclosed in the following publications and the like.
Japanese Patent Publication No.61-4543 Japanese Patent Laid-Open No. 1-121057

ところで、医療用滅菌包装において、滅菌処理の後に包装容器から滅菌ガスを完全に除去するには相当に長い時間放置する必要があり、斯かる除去操作は製造効率を低下させる要因となっている。また、ポリエステル系樹脂製の容器を使用した場合には、滅菌ガスの吸着性が高く、滅菌ガスを一層除去し難くなるため、実際には、塩化ビニルを主成分とする容器が多く使用されている。その結果、包装容器の内部に対する視認性が悪く、しかも、塩化ビニルの廃棄処分の際に塩素ガスが発生すると言う問題もある。   By the way, in medical sterilization packaging, in order to completely remove the sterilization gas from the packaging container after the sterilization treatment, it is necessary to leave it for a considerably long time, and such a removal operation causes a reduction in manufacturing efficiency. In addition, when a polyester resin container is used, the sterilization gas adsorbability is high and it becomes difficult to remove the sterilization gas. Therefore, in reality, many containers mainly composed of vinyl chloride are used. Yes. As a result, the visibility of the inside of the packaging container is poor, and there is also a problem that chlorine gas is generated when vinyl chloride is disposed of.

本発明は、上記の実情に鑑みなされたものであり、その目的は、例えば、薬剤入り注射器などをパッケージのまま過酸化水素ガスで滅菌処理する滅菌方法であって、効率的に処理でき且つ過酸化水素ガスの残留を確実に防止でき、そして、ポリエステル系樹脂の包装材料にも適用可能な医療用滅菌包装における滅菌方法を提供することにある。   The present invention has been made in view of the above circumstances, and an object of the present invention is, for example, a sterilization method of sterilizing a medicine-filled syringe or the like with a hydrogen peroxide gas in a package, which can be efficiently processed and excessively processed. It is an object of the present invention to provide a sterilization method in medical sterilization packaging that can reliably prevent hydrogen oxide gas from remaining and can be applied to a packaging material of polyester resin.

上記の課題を解決するため、本発明に係る医療用滅菌包装における滅菌方法は、包装容器に封入された医療品としての薬剤入り注射器を過酸化水素ガスによって滅菌処理する滅菌方法であって、包装容器として、ガスバリヤー性を有し且つ底面全体が開放された合成樹脂製の一体成形された容器本体と、過酸化水素ガスを透過可能で且つ容器本体の底面全体に溶着可能な蓋材としての滅菌紙とから構成される包装容器を使用すると共に、包装容器に封入された薬剤入り注射器を滅菌装置としてのチャンバーに収容し、10〜30torrに減圧したチャンバーに過酸化水素ガスを供給する操作を複数回繰り返すことによって滅菌処理した後、加温しつつ包装容器の内部から過酸化水素ガスを脱ガス処理することを特徴とする。   In order to solve the above problems, the sterilization method in the medical sterilization packaging according to the present invention is a sterilization method in which a medicine-filled syringe as a medical product enclosed in a packaging container is sterilized with hydrogen peroxide gas. As a container, an integrally molded container body made of a synthetic resin that has gas barrier properties and the entire bottom surface is opened, and a lid material that can transmit hydrogen peroxide gas and can be welded to the entire bottom surface of the container body. Using a packaging container composed of sterilized paper, storing the medicine-filled syringe enclosed in the packaging container in a chamber as a sterilizer, and supplying hydrogen peroxide gas to the chamber decompressed to 10 to 30 torr After sterilization by repeating a plurality of times, hydrogen peroxide gas is degassed from the inside of the packaging container while heating.

上記の滅菌方法においては、包装容器の滅菌紙を透過した過酸化水素ガスによって医療品としての薬剤入り注射器を滅菌処理する。その際、減圧したチャンバーに過酸化水素ガスを供給する操作を複数回繰り返すことにより、包装容器の内部へ過酸化水素ガスを迅速に且つ確実に浸透させる。そして、上記の処理の後、加温することによって容器本体に吸着した過酸化水素ガスの脱着を促進し、包装容器の内部に残留した過酸化水素ガスを除去する。   In the sterilization method described above, the medicine-filled syringe as a medical product is sterilized with hydrogen peroxide gas that has passed through the sterilized paper in the packaging container. At that time, the operation of supplying the hydrogen peroxide gas to the decompressed chamber is repeated a plurality of times, so that the hydrogen peroxide gas penetrates quickly and reliably into the inside of the packaging container. Then, after the above treatment, heating is performed to promote desorption of the hydrogen peroxide gas adsorbed on the container body, and the hydrogen peroxide gas remaining inside the packaging container is removed.

また、上記の滅菌方法においては、滅菌処理した後、昇温した空気をチャンバーに対して循環させつつ、循環空気に含まれる過酸化水素ガスを触媒反応によって分解することにより、過酸化水素ガスの脱ガス処理において、チャンバー内の過酸化水素ガス濃度を常に低濃度に維持し、効率的に且つ安全に過酸化水素ガスを脱ガス処理できる。   Further, in the above sterilization method, after sterilization, the hydrogen peroxide gas contained in the circulation air is decomposed by a catalytic reaction while circulating the heated air to the chamber. In the degassing process, the hydrogen peroxide gas concentration in the chamber is always kept low, and the hydrogen peroxide gas can be degassed efficiently and safely.

本発明の滅菌方法によれば、過酸化水素ガスによって滅菌処理した後、加温しつつ包装容器の内部から過酸化水素ガスを脱ガス処理することにより、容器本体に吸着した過酸化水素ガスの脱着を促進できる。更に、昇温した空気を循環させつつ、循環空気に含まれる過酸化水素ガスを触媒反応によって分解することにより、周囲の過酸化水素ガス濃度を包装容器の内部よりも常に低濃度に維持し、その濃度差で滅菌紙を透過させるため、一層効率的に脱ガス処理でき且つ過酸化水素ガスの残留を確実に防止できる。従って、また、医療用滅菌包装において、容器本体として、透明性に優れ且つ廃棄処理が容易なポリエステル系樹脂製の容器本体を使用することも可能である。特に、温風の循環による包装容器からの過酸化水素ガスの脱ガス処理は、上記の様に効率的に脱ガス出来、かつ、温風を製造するための熱負荷も大幅に低減でき、しかも、触媒分解によって全く無害な成分に適確に分解処理でき、かつ、滅菌処理においては勿論、最終的な系外への排出においても極めて高い安全性が確保されるため、工業的、環境的に著しい効用を発揮する。   According to the sterilization method of the present invention, after sterilizing with hydrogen peroxide gas, the hydrogen peroxide gas adsorbed on the container body is removed by degassing the hydrogen peroxide gas from the inside of the packaging container while heating. Desorption can be promoted. Furthermore, while circulating the heated air, the hydrogen peroxide gas contained in the circulating air is decomposed by a catalytic reaction, so that the concentration of the surrounding hydrogen peroxide gas is always kept lower than the inside of the packaging container, Since the sterilized paper is permeated by the concentration difference, the degassing process can be performed more efficiently and the residual hydrogen peroxide gas can be surely prevented. Therefore, in a medical sterilization package, it is also possible to use a container body made of a polyester resin that is excellent in transparency and easy to dispose of as a container body. In particular, the degassing treatment of hydrogen peroxide gas from the packaging container by circulating hot air can be efficiently degassed as described above, and the heat load for producing hot air can be greatly reduced. Because it can be accurately decomposed into completely harmless components by catalytic decomposition, and extremely high safety is ensured not only in the sterilization process but also in the final discharge from the system. Demonstrates remarkable utility.

本発明に係る医療用滅菌包装における滅菌方法の一実施形態を図面に基づいて説明する。図1は、本発明に係る滅菌方法の各操作工程を示す工程図である。図2は、本発明に係る滅菌方法を実施するための滅菌装置としてのチャンバーの概要を示す系統図である。図3は、薬剤入り注射器が封入された包装容器の一形態を示す外観斜視図であり、図4は、図3における包装容器の包装構造を底面側から示す展開斜視図である。図5は、チャンバー内における包装容器(包装品)の取扱方法を示す斜視図である。   An embodiment of a sterilization method in a medical sterilization package according to the present invention will be described with reference to the drawings. FIG. 1 is a process diagram showing each operation process of the sterilization method according to the present invention. FIG. 2 is a system diagram showing an outline of a chamber as a sterilization apparatus for carrying out the sterilization method according to the present invention. FIG. 3 is an external perspective view showing an embodiment of a packaging container in which a medicine-filled syringe is enclosed, and FIG. 4 is an exploded perspective view showing the packaging structure of the packaging container in FIG. 3 from the bottom side. FIG. 5 is a perspective view illustrating a method of handling a packaging container (packaged product) in the chamber.

本発明の滅菌方法は、特定の包装容器に封入された医療品(医薬品、医療用具などを含む)を包装状態のまま過酸化水素ガスによって滅菌処理するいわゆる医療用滅菌包装における滅菌方法である。医療用滅菌包装に適した医療品としては、例えば、図4に示す様な薬剤入り注射器(4)が挙げられる。薬剤入り注射器(4)は、周知の通り、所要の薬剤が予め充填され、注射針を取り付けて直ちに使用できる形態の注射具であり、斯かる薬剤入り注射器に関する技術は、特開平4−150868号公報などに記載されている。   The sterilization method of the present invention is a sterilization method in so-called medical sterilization packaging in which medical products (including pharmaceuticals and medical devices) enclosed in a specific packaging container are sterilized with hydrogen peroxide gas in the packaged state. An example of a medical product suitable for medical sterilization packaging is a medicine-filled syringe (4) as shown in FIG. As is well known, the medicine-filled syringe (4) is an injection tool that is pre-filled with a required medicine and can be used immediately after the injection needle is attached. Japanese Patent Application Laid-Open No. 4-150868 discloses a technique related to such a medicine-filled syringe. It is described in gazettes.

すなわち、薬剤入り注射器(4)は、先端の注射針取付部にキャップ(42)が装着された注射筒(41)と、先端にピストンを有し且つ注射筒(41)に挿入されたピストンロッド(44)と、注射筒(41)に充填された薬剤とから成る。また、注射筒(41)のフランジ(43)には、使用時に指を引掛けるためのアダプター(補助具)(47)が装着されており、斯かるアダプター(47)は、後述の包装容器に収容した際、薬剤入り注射器(4)の揺動を防止する機能も有する。そして、薬剤入り注射器(4)に充填される薬剤としては、加熱滅菌に適さない薬剤、典型的には、ヒアルロン酸ナトリウム溶液などが好適である。   That is, the medicine-filled syringe (4) includes a syringe barrel (41) having a cap (42) attached to the tip needle mounting portion, and a piston rod having a piston at the tip and inserted into the syringe barrel (41). (44) and the medicine filled in the syringe barrel (41). Further, an adapter (auxiliary tool) (47) for hooking a finger during use is attached to the flange (43) of the syringe barrel (41), and the adapter (47) is attached to a packaging container to be described later. It also has a function of preventing the drug-containing syringe (4) from swinging when housed. And as a chemical | medical agent with which a syringe (4) containing a chemical | medical agent is filled, the chemical | medical agent which is not suitable for heat sterilization, typically a sodium hyaluronate solution etc. are suitable.

上記の包装容器は、図3に符号(1)で示す様に、ガスバリヤー性を有する合成樹脂製の容器本体(2)と、過酸化水素ガスを透過可能で且つ容器本体(2)に溶着可能な蓋材としての滅菌紙(3)とから構成される。容器本体(2)は、透明性の樹脂によって細長の略器状に一体成形され、開放された容器本体(2)の底面が滅菌紙(3)によって封止される。   As shown by the reference numeral (1) in FIG. 3, the packaging container described above is made of a synthetic resin container body (2) having gas barrier properties and is capable of permeating hydrogen peroxide gas and welded to the container body (2). It is composed of sterilized paper (3) as a possible lid. The container body (2) is integrally formed into a thin and substantially container shape with a transparent resin, and the bottom surface of the opened container body (2) is sealed with sterilized paper (3).

容器本体(2)を構成する樹脂材料としては、細菌を透過することがなく且つ内容物を目視できる材料であれば適宜の熱可塑性樹脂を使用できるが、ガスバリヤー性および透明性の観点から、容器本体(2)は、ポリエチレンテレフタレート(PET)、ポリブチレンテレフタレート等のポリエステル系樹脂によって構成されているのが好ましい。具体的には、容器本体(2)は、200〜600μmの厚さのPETフィルムを使用し、ブリスター成形、深絞り成形などの成形法によって作製される。特に、PETフィルムにて構成された容器本体(2)は、廃棄処分の際に塩化ビニルの様に塩素などの毒性ガスの発生がなく、公害防止の観点からも好ましい包装材である。   As a resin material constituting the container body (2), an appropriate thermoplastic resin can be used as long as it is a material that does not permeate bacteria and allows the contents to be visually observed. From the viewpoint of gas barrier properties and transparency, The container body (2) is preferably made of a polyester-based resin such as polyethylene terephthalate (PET) or polybutylene terephthalate. Specifically, the container body (2) is produced by a molding method such as blister molding or deep drawing using a PET film having a thickness of 200 to 600 μm. In particular, the container body (2) made of a PET film does not generate a toxic gas such as chlorine like vinyl chloride at the time of disposal, and is a preferable packaging material from the viewpoint of pollution prevention.

また、図3及び図4に示す様に、容器本体(2)は、外観視した場合、薬剤入り注射器(4)の注射筒(41)先端側を収容する第1の膨出部(21)と、途中まで挿入されたピストンロッド(44)を含む薬剤入り注射器(4)の全長の略中央部を収容する第2の膨出部(22)と、注射筒(41)のフランジ(43)及びピストンロッド(44)の押し子(終端の拡径部)(45)を収容する第3の膨出部(23)と、これらの膨出部を結合する2つのくびれ部(24)、(24)とを備えている。   As shown in FIGS. 3 and 4, the container main body (2) has a first bulging portion (21) that accommodates the distal end side of the syringe barrel (41) of the medicine-filled syringe (4) when viewed externally. A second bulging portion (22) that accommodates the substantially central portion of the entire length of the medicine-filled syringe (4) including the piston rod (44) inserted partway, and a flange (43) of the syringe barrel (41) And a third bulge portion (23) for accommodating the pusher (end diameter enlarged portion) (45) of the piston rod (44), and two constricted portions (24) for coupling these bulge portions ( 24).

容器本体(2)の第1の膨出部(21)及び第3の膨出部(23)は、薬剤入り注射器(4)の両端側に比較的大きな空間を形成し、注射筒(41)とピストンロッド(44)の隙間などの細部に拡散する滅菌ガスを一時的に貯留する様に機能し、そして、中央の第2の膨出部(22)は、包装容器(1)から薬剤入り注射器(4)を容易に且つ衛生的に取り出すための容器本体(2)の折り曲げ支点として機能する。   The first bulging portion (21) and the third bulging portion (23) of the container body (2) form a relatively large space on both ends of the medicine-filled syringe (4), and the syringe barrel (41) Functions as a temporary storage of sterilizing gas that diffuses into details such as the gap between the piston rod and the piston rod (44), and the second bulge (22) in the center is filled with drug from the packaging container (1). It functions as a folding fulcrum of the container body (2) for taking out the syringe (4) easily and hygienically.

一方、容器本体(2)の各くびれ部(24)は、後述する滅菌処理において多数積み重ねた際、上段または下段の包装容器(1)との間に隙間を形成し、過酸化水素ガスや空気の流れを良好にする。更に、斯かる観点からは、容器本体(2)の第1の膨出部(21)及び第3の膨出部(23)は、積み重ねる場合の支持点として構成され、第2の膨出部(22)は、第1の膨出部(21)及び第3の膨出部(23)よりも低い高さで形成されるのが好ましい。なお、好ましい態様において、第3の膨出部(23)の中央には、上段または下段の包装容器(1)の滅菌紙(3)に対する接触面積を低減するため、鞍部状の凹没部(25)が形成される。   On the other hand, each of the constricted portions (24) of the container body (2) forms a gap with the upper or lower packaging container (1) when many are stacked in a sterilization process to be described later. Make the flow better. Furthermore, from such a viewpoint, the first bulging portion (21) and the third bulging portion (23) of the container body (2) are configured as support points when stacked, and the second bulging portion (22) is preferably formed at a lower height than the first bulging portion (21) and the third bulging portion (23). In a preferred embodiment, the center of the third bulging portion (23) has a saddle-shaped depression (in the lower or upper packaging container (1) in order to reduce the contact area with the sterilized paper (3). 25) is formed.

滅菌紙(3)としては、細菌などの微生物を透過することなく且つ滅菌用ガスや空気などのガスを透過可能な材料、例えば、デュポン社製の商品名「タイベック 1073B」として知られる高密度ポリエチレンのシート材料が好適に使用される。斯かる滅菌紙(3)は、容器本体(2)に対して上記の様な薬剤入り注射器(4)を収容した後、超音波溶着法または加熱溶着法によって気密に溶着される。   As the sterilized paper (3), a material that does not permeate microorganisms such as bacteria and can permeate gas such as sterilization gas or air, for example, high-density polyethylene known as a trade name “Tyvek 1073B” manufactured by DuPont. These sheet materials are preferably used. Such sterilized paper (3) is hermetically welded by ultrasonic welding or heat welding after accommodating the above-mentioned syringe (4) containing the medicine in the container body (2).

また、本発明の滅菌方法を実施するにあたり、図2に示す様な滅菌装置としてのチャンバー(5)が使用される。チャンバー(5)は、例えば、気密可能な横長の耐圧容器として設計され、包装容器(包装品)(1)(図5参照)が積載されたパレットを一側端面の扉から装填可能に構成される。斯かるチャンバー(5)には、過酸化水素ガスの供給ライン(A)、減圧ライン(B)、空気の導入ライン(C)及び温風循環ライン(D)が付設され、かつ、減圧ライン(B)及び温風循環ライン(D)には、過酸化水素ガス分解用の触媒装置(54)が介装される。   Moreover, when implementing the sterilization method of this invention, the chamber (5) as a sterilizer as shown in FIG. 2 is used. The chamber (5) is designed, for example, as a horizontally-tight pressure-resistant container that can be hermetically sealed, and is configured such that a pallet on which a packaging container (packaged product) (1) (see FIG. 5) is loaded can be loaded from a door on one end face. The The chamber (5) is provided with a hydrogen peroxide gas supply line (A), a decompression line (B), an air introduction line (C) and a hot air circulation line (D), and a decompression line ( B) and a hot air circulation line (D) are provided with a catalyst device (54) for hydrogen peroxide gas decomposition.

上記の過酸化水素ガスの供給ライン(A)は、一定量の過酸化水素溶液を計量して定量供給する機構および供給された溶液を加熱してガス化するガス発生システムから成る過酸化水素発生器(51)と、過酸化水素発生器(51)から仕切弁(61)を介してチャンバー(5)内に伸長された配管(71)とから構成され、配管(71)の先端には、分岐管を介して複数のノズル(81)が設けられる。   The hydrogen peroxide gas supply line (A) includes a mechanism for metering and metering a fixed amount of hydrogen peroxide solution and a gas generation system for heating and gasifying the supplied solution. And a pipe (71) extended from the hydrogen peroxide generator (51) through the gate valve (61) into the chamber (5). At the tip of the pipe (71), A plurality of nozzles (81) are provided via the branch pipe.

減圧ライン(B)は、真空ポンプ(52)と、チャンバー(5)の他方の側端面に設けられた複数の吸引口(82)から真空ポンプ(52)の吸気側に至る配管(72)と、真空ポンプ(52)の排気側に接続された配管(73)及び仕切弁(62)と、チャンバー(5)から排出された過酸化水素ガスを無害化する触媒装置(54)とから構成され、触媒装置(54)の排気側には、分解処理して発生した酸素ガスを放出する仕切弁(63)が設けられる。なお、真空ポンプ(52)としては、過酸化水素ガスによる潤滑油の変質を回避するため、乾式のポンプが使用される。   The decompression line (B) includes a vacuum pump (52), and a pipe (72) extending from a plurality of suction ports (82) provided on the other side end surface of the chamber (5) to the suction side of the vacuum pump (52). The pipe (73) and the gate valve (62) connected to the exhaust side of the vacuum pump (52), and the catalyst device (54) for detoxifying the hydrogen peroxide gas discharged from the chamber (5). On the exhaust side of the catalyst device (54), a gate valve (63) for releasing oxygen gas generated by the decomposition treatment is provided. In addition, as a vacuum pump (52), in order to avoid the quality change of the lubricating oil by hydrogen peroxide gas, a dry pump is used.

空気の導入ライン(C)は、上記の配管(71)から分岐され且つ開放端側にフィルター(64)及び仕切弁(65)が設けられた配管によって構成される。すなわち、過酸化水素ガスの供給ライン(A)の仕切弁(61)が閉止された状態において、仕切弁(65)が開放されることによりチャンバー(5)に空気を導入する様になされている。   The air introduction line (C) is constituted by a pipe branched from the pipe (71) and provided with a filter (64) and a gate valve (65) on the open end side. That is, when the gate valve (61) of the hydrogen peroxide gas supply line (A) is closed, air is introduced into the chamber (5) by opening the gate valve (65). .

温風循環ライン(D)は、上記の触媒装置(54)、循環ファン(55)及びヒーター(56)を順次に接続して構成される。触媒装置(54)には、例えば、チャンバー(5)の一側壁に設けられた複数の吸気口(83)から伸長された配管(74)が仕切弁(66)を介して接続される。循環ファン(55)は、触媒装置(54)の後段に配置され、ヒーター(56)には、循環ファン(55)の排気側から伸長された配管(75)が接続される。そして、ヒーター(56)の出口側には、チャンバー(5)の他方の側壁に設けられた複数の吹出口(84)に至る配管(76)が接続される。なお、触媒装置(54)は、上記の様に、減圧ライン(B)及び温風循環ライン(D)の両ラインの過酸化水素ガスを分解するために設置され、斯かる触媒装置(54)としては、白金などの還元剤を収容して成る公知の装置が使用される。   The hot air circulation line (D) is configured by sequentially connecting the catalyst device (54), the circulation fan (55), and the heater (56). For example, piping (74) extended from a plurality of inlets (83) provided on one side wall of the chamber (5) is connected to the catalyst device (54) via a gate valve (66). The circulation fan (55) is disposed at the rear stage of the catalyst device (54), and a pipe (75) extended from the exhaust side of the circulation fan (55) is connected to the heater (56). And the piping (76) which reaches the some blower outlet (84) provided in the other side wall of the chamber (5) is connected to the exit side of a heater (56). As described above, the catalyst device (54) is installed to decompose the hydrogen peroxide gas in both the decompression line (B) and the hot air circulation line (D), and the catalyst device (54). As this, a known apparatus containing a reducing agent such as platinum is used.

上記チャンバー(5)を使用した本発明の滅菌処理方法は、図1に示す様に、ステップ(S1)〜ステップ(S8)の操作工程に沿って実施される。先ず、滅菌処理すべき包装容器(包装品)(1)を台車に積載して台車ごとチャンバーに装填する。その際、図5に示す様に、包装容器(1)は、処理効率を高めるため、多数列に配列され(例示的に1列のみ図示)且つ上下に多数段積み重ねた状態で台車に積載される(ステップ(S1))。   As shown in FIG. 1, the sterilization method of the present invention using the chamber (5) is carried out along the operation steps of Step (S1) to Step (S8). First, a packaging container (packaged product) (1) to be sterilized is loaded on a cart and the entire cart is loaded into a chamber. At that time, as shown in FIG. 5, the packaging containers (1) are arranged in a large number of rows (only one row is illustrated) and are loaded on a cart in a state where they are stacked in a number of stages in the vertical direction. (Step (S1)).

次いで、チャンバー(5)を閉鎖した後、減圧ライン(B)の仕切弁(62)及び(63)を開放し(温風循環ライン(D)の仕切弁(66)は閉止し)且つ真空ポンプ(52)を起動し、吸引口(82)、配管(72)、(73)及び触媒装置(54)を通じて内部の空気を排気することにより、チャンバー(5)内を凡そ10〜30torrに減圧する。斯かる操作により、装填された包装容器(1)においては、滅菌紙(3)を通じて内部の空気が排気される。(ステップ(S2))   Next, after closing the chamber (5), the gate valves (62) and (63) of the decompression line (B) are opened (the gate valve (66) of the hot air circulation line (D) is closed) and the vacuum pump (52) is started, and the inside of the chamber (5) is depressurized to about 10 to 30 torr by exhausting the internal air through the suction port (82), the pipes (72), (73) and the catalyst device (54). . By such an operation, in the loaded packaging container (1), the internal air is exhausted through the sterilized paper (3). (Step (S2))

上記ステップ(S2)の操作において、チャンバー(5)の真空度は、包装容器(1)の内部へ過酸化水素ガスを十分浸透させるためにある程度は高いほうがよいが、あまり高真空にすると、薬剤入り注射器(4)の内部に空気が混入している場合、ピストンロッド(44)が注射筒(41)から不要に飛び出す虞があるので上記の様な真空度の範囲に設定するのが好ましい。   In the operation of the above step (S2), the degree of vacuum in the chamber (5) should be high to some extent so that the hydrogen peroxide gas sufficiently penetrates into the packaging container (1). When air is mixed in the syringe (4), the piston rod (44) may jump out of the syringe barrel (41) unnecessarily, so it is preferable to set the vacuum level as described above.

続いて、減圧ライン(B)の真空ポンプ(52)を停止またはアイドリング運転に切り替え、仕切弁(62)及び(63)を閉止した後、過酸化水素ガスの供給ライン(A)から過酸化水素ガスを供給する。過酸化水素ガスは、仕切弁(61)を開放し、過酸化水素発生器(51)を作動させることにより、配管(71)及び複数のノズル(81)を通じてチャンバー(5)の内部に拡散される(ステップ(S3))。   Subsequently, the vacuum pump (52) of the decompression line (B) is stopped or switched to idling operation, the gate valves (62) and (63) are closed, and then hydrogen peroxide gas is supplied from the hydrogen peroxide gas supply line (A). Supply gas. The hydrogen peroxide gas is diffused into the chamber (5) through the pipe (71) and the plurality of nozzles (81) by opening the gate valve (61) and operating the hydrogen peroxide generator (51). (Step (S3)).

過酸化水素ガスを供給した後、斯かるガスがチャンバー(5)に充満した状態を1〜10分程度維持し、薬剤入り注射器(4)を含む包装容器(1)の内部を滅菌処理する。包装容器(1)の内部は、上記ステップ(S2)の減圧操作により予め負圧になっているため、滅菌紙(3)を透過させて包装容器(1)の内部に過酸化水素ガスを一層効率的に浸透させることが出来る(ステップ(S4))。   After supplying the hydrogen peroxide gas, the state in which the gas is filled in the chamber (5) is maintained for about 1 to 10 minutes, and the inside of the packaging container (1) including the medicine-filled syringe (4) is sterilized. Since the inside of the packaging container (1) is negative pressure in advance by the decompression operation in the above step (S2), the sterilized paper (3) is permeated and hydrogen peroxide gas is further injected into the packaging container (1). It can be efficiently penetrated (step (S4)).

ところで、単純な形状の医療品を滅菌する場合は1回の滅菌操作でも十分であるが、上述の様な薬剤入り注射器(4)などが封入された包装容器(1)を滅菌する場合、注射筒(41)とピストンロッド(44)の隙間などの細部に亙って滅菌処理する必要がある。そこで、上述の滅菌操作、すなわち、減圧したチャンバー(5)に過酸化水素ガスを供給する操作を複数回繰り返す。具体的には、ステップ(S2)からステップ(S4)の操作を1〜12回繰り返す。これにより、薬剤入り注射器(4)の細部にまで過酸化水素ガスを確実に浸透させることが出来る。   By the way, when sterilizing a medical product with a simple shape, a single sterilization operation is sufficient, but when sterilizing a packaging container (1) in which a syringe (4) containing a medicine as described above is sealed, an injection is performed. It is necessary to sterilize over details such as the gap between the cylinder (41) and the piston rod (44). Therefore, the above-described sterilization operation, that is, the operation of supplying the hydrogen peroxide gas to the decompressed chamber (5) is repeated a plurality of times. Specifically, the operations from step (S2) to step (S4) are repeated 1 to 12 times. Thereby, hydrogen peroxide gas can be made to osmose | permeate reliably to the detail of the syringe (4) containing a chemical | medical agent.

滅菌処理の操作を所定回数だけ終了したならば、過酸化水素ガスの供給ライン(A)を閉止し、再び減圧ライン(B)を作動させることにより、チャンバー(5)から過酸化水素ガスを排気する。すなわち、過酸化水素ガスの供給ライン(A)の仕切弁(61)を閉止し、減圧ライン(B)の仕切弁(62)及び(63)を開放し且つ真空ポンプ(52)を作動させて内部の過酸化水素ガスを排気する。その際、過酸化水素ガスは、触媒装置(54)によって酸素と水に分解され、系外に安全に排気され、そして、チャンバー(5)内は、凡そ10〜30torrに減圧される(ステップ(S5))。   When the sterilization operation has been completed a predetermined number of times, the hydrogen peroxide gas supply line (A) is closed and the decompression line (B) is activated again to exhaust the hydrogen peroxide gas from the chamber (5). To do. That is, the gate valve (61) of the hydrogen peroxide gas supply line (A) is closed, the gate valves (62) and (63) of the decompression line (B) are opened, and the vacuum pump (52) is operated. Exhaust the hydrogen peroxide gas inside. At that time, the hydrogen peroxide gas is decomposed into oxygen and water by the catalyst device (54), safely exhausted out of the system, and the inside of the chamber (5) is depressurized to about 10 to 30 torr (step ( S5)).

次いで、上記の減圧ライン(B)を閉止し、空気の導入ライン(C)を通じてチャンバー(5)に空気を導入する。空気の導入操作においては、仕切弁(65)を開放することにより、フィルター(64)、配管(71)及び複数のノズル(81)を通じて空気が導入され、チャンバー(5)内が大気圧に復圧される。そして、チャンバー(5)内を大気圧とした後、仕切弁(65)を閉止する(ステップ(S6))。   Next, the decompression line (B) is closed, and air is introduced into the chamber (5) through the air introduction line (C). In the air introduction operation, air is introduced through the filter (64), the pipe (71), and the plurality of nozzles (81) by opening the gate valve (65), and the inside of the chamber (5) is restored to atmospheric pressure. Pressed. And after making the inside of a chamber (5) atmospheric pressure, a gate valve (65) is closed (step (S6)).

続いて、包装容器(1)の内部に残留する過酸化水素ガスを除去する。過酸化水素ガスの除去は、空気に晒すだけでもある程度は除去できるが、極めて長時間放置しなければならないと言う問題、および、PET等の上記ポリエステル系樹脂などの包装容器の容器本体の材質によっては、過酸化水素ガスの高い吸着力によって完全に除去できないと言う問題が生じる。そこで、本発明においては、加温しつつ包装容器(1)から過酸化水素ガスを脱ガス処理する。これにより、容器本体(2)からの過酸化水素ガスの脱着を促進し、過酸化水素ガスを一層迅速に脱ガスでき、しかも、過酸化水素ガスの残留を確実に防止できる。そして、上記の加温方法としては、昇温した空気をチャンバー(5)に対して循環させる方法が好ましい。   Subsequently, the hydrogen peroxide gas remaining inside the packaging container (1) is removed. The removal of hydrogen peroxide gas can be removed to some extent by just exposing it to air, but depending on the problem that it must be left for a very long time, and the material of the container body of a packaging container such as the above-mentioned polyester resin such as PET Has a problem that it cannot be completely removed due to the high adsorption power of hydrogen peroxide gas. Therefore, in the present invention, the hydrogen peroxide gas is degassed from the packaging container (1) while heating. As a result, the desorption of the hydrogen peroxide gas from the container body (2) is promoted, the hydrogen peroxide gas can be degassed more quickly, and the remaining hydrogen peroxide gas can be reliably prevented. And as said heating method, the method of circulating the heated air with respect to a chamber (5) is preferable.

具体的には、温風循環ライン(D)の仕切弁(66)を開放し、循環ファン(55)及びヒーター(56)を稼働させる。循環ファン(55)は、複数の吸気口(83)から吸込んだチャンバー(5)内の空気を触媒装置(54)に配管(74)を通じて吸引し、触媒装置(54)によって過酸化水素ガスが除去された空気をヒーター(56)に配管(75)を通じて供給し、そして、ヒーター(56)によって昇温された空気をチャンバー(5)に複数の吹出口(84)を通じて返流する(ステップ(S7))。   Specifically, the gate valve (66) of the hot air circulation line (D) is opened, and the circulation fan (55) and the heater (56) are operated. The circulation fan (55) sucks the air in the chamber (5) sucked from the plurality of intake ports (83) into the catalyst device (54) through the pipe (74), and the hydrogen peroxide gas is absorbed by the catalyst device (54). The removed air is supplied to the heater (56) through the pipe (75), and the air heated by the heater (56) is returned to the chamber (5) through the plurality of outlets (84) (step ( S7)).

また、上記ステップ(S7)においては、チャンバー(5)内の温度設定、すなわち、ヒーター(56)の調整により、約30〜120℃、好ましくは30〜100℃の温風条件下で包装容器(1)の内部から過酸化水素ガスを脱ガス処理することが重要である。温度条件を規定する理由は次の通りである。すなわち、温風の温度が30℃よりも低い場合には、容器本体(2)のポリエステル系樹脂フィルム表面から過酸化水素ガスを脱着し難いために脱ガス効率が低下し、また、温風の温度が120℃よりも高い場合には、薬剤入り注射器(4)に充填された薬剤が実質的に100℃よりも高温になり変質する虞がある。   In the step (S7), the temperature of the chamber (5) is set, that is, the heater (56) is adjusted to adjust the temperature of the packaging container (30 to 120 ° C., preferably 30 to 100 ° C.). It is important to degas the hydrogen peroxide gas from the inside of 1). The reason for specifying the temperature condition is as follows. That is, when the temperature of the hot air is lower than 30 ° C., it is difficult to desorb the hydrogen peroxide gas from the surface of the polyester resin film of the container body (2), so that the degassing efficiency is lowered. When the temperature is higher than 120 ° C, the medicine filled in the medicine-filled syringe (4) is substantially higher than 100 ° C and may be deteriorated.

ステップ(S7)の脱ガス処理は、通常、30〜120分程度行い、包装容器(1)内部に残留する過酸化水素ガスを滅菌紙(3)を透過させて排出し、温風循環ライン(D)の触媒装置(54)によって分解処理する。すなわち、昇温した空気をチャンバー(5)に対して循環させつつ、循環空気に含まれる過酸化水素ガスを触媒反応によって分解することにより、チャンバー(5)内の過酸化水素ガス濃度を常に低い状態に維持し、効率的に且つ安全に過酸化水素ガスを脱ガス処理する。そして、上記の様に過酸化水素ガスを脱ガス処理した後は、温風循環ライン(D)を停止し、チャンバー(5)から処理済みの包装容器(1)を取り出す(ステップ(S8))。   The degassing treatment in step (S7) is usually performed for about 30 to 120 minutes, and the hydrogen peroxide gas remaining inside the packaging container (1) is discharged through the sterilized paper (3). Decomposition is performed by the catalyst device (54) of D). That is, the hydrogen peroxide gas concentration in the chamber (5) is constantly reduced by decomposing the hydrogen peroxide gas contained in the circulating air by catalytic reaction while circulating the heated air to the chamber (5). The hydrogen peroxide gas is degassed efficiently and safely while maintaining the state. And after degassing the hydrogen peroxide gas as described above, the hot air circulation line (D) is stopped and the treated packaging container (1) is taken out from the chamber (5) (step (S8)). .

なお、脱ガス処理した後、すなわち、ステップ(S7)の操作の後は、チャンバー(5)に一旦大気を導入してもよい。チャンバー(5)にフレッシュエアーを供給することにより、チャンバー(5)の庫内および包装容器(1)の温度を下げることが出来、直ちに後工程のハンドリングが可能になる。しかも、触媒装置(54)の不調などで仮に微量の過酸化水素ガスが残存した場合にも、庫内の空気を置換することによって安全を確保できる。   After the degassing process, that is, after the operation of step (S7), the atmosphere may be once introduced into the chamber (5). By supplying fresh air to the chamber (5), the temperature of the inside of the chamber (5) and the packaging container (1) can be lowered, and the subsequent process can be handled immediately. Moreover, even if a small amount of hydrogen peroxide gas remains due to malfunction of the catalyst device (54), safety can be ensured by replacing the air in the cabinet.

上記の様に、本発明の滅菌方法においては、包装容器として、特定の素材からなる容器本体(2)と滅菌紙(3)とから構成され且つ容器本体(2)が特定の形状を備えた包装容器(1)を使用するため、多数段積み重ねた状態でガスに晒しても、上段または下段の包装容器(1)との接触面積が少なく、包装容器(1)の滅菌紙(3)における過酸化水素ガス及び空気との接触効率を高めることができ、迅速な滅菌処理および脱ガス処理が可能である。   As described above, in the sterilization method of the present invention, the packaging container is composed of a container main body (2) made of a specific material and sterilized paper (3), and the container main body (2) has a specific shape. Since the packaging container (1) is used, even if it is exposed to gas in a stacked state, the contact area with the upper or lower packaging container (1) is small, and the sterilized paper (3) of the packaging container (1) Contact efficiency with hydrogen peroxide gas and air can be increased, and rapid sterilization and degassing can be performed.

そして、過酸化水素ガスによって滅菌処理した後、所定温度の温風条件下で包装容器(1)の内部から過酸化水素ガスを脱ガス処理することにより、容器本体(2)からの過酸化水素ガスの脱着を促進できるため、効率的に脱ガス処理でき且つ過酸化水素ガスの残留を確実に防止できる。しかも、過酸化水素ガスの脱ガス処理においては、昇温した空気を循環させつつ、循環空気に含まれる過酸化水素ガスを触媒反応によって分解することにより、チャンバー(5)内の過酸化水素ガス濃度を常に包装容器(1)の内部よりも低濃度に維持し、その濃度差で滅菌紙(3)を透過させるため、包装容器(1)内部の過酸化水素ガスを一層効率的に脱ガス処理できる。従って、また、容器本体(2)として、透明性に優れ且つ廃棄処理が容易なポリエステル系樹脂製の容器本体を使用することが可能である。   Then, after sterilizing with hydrogen peroxide gas, the hydrogen peroxide gas from the container body (2) is degassed from the inside of the packaging container (1) under hot air conditions of a predetermined temperature. Since the desorption of the gas can be promoted, the degassing process can be performed efficiently and the residual hydrogen peroxide gas can be reliably prevented. Moreover, in the degassing treatment of the hydrogen peroxide gas, the hydrogen peroxide gas in the chamber (5) is decomposed by catalytic reaction while the heated air is circulated and the hydrogen peroxide gas contained in the circulating air is decomposed. Since the concentration is always kept lower than the inside of the packaging container (1) and the sterilized paper (3) is permeated by the concentration difference, the hydrogen peroxide gas inside the packaging container (1) is more efficiently degassed. It can be processed. Therefore, it is also possible to use a polyester resin container body having excellent transparency and easy disposal as the container body (2).

因に、PETフィルム製の容器本体(2)と上記「タイベック」から成る滅菌紙(3)とから包装容器(1)を構成し、薬剤としてヒアルロン酸ナトリウムが充填された薬剤入り注射器(4)を包装容器(1)に封入した。そして、2つの処理ロット(a)及び(b)に分け、図2に示すチャンバー(5)を使用し、過酸化水素ガスによって各ロットを滅菌処理した。その場合、ロット(a)は、本発明の滅菌方法によって滅菌処理し、ロット(b)は、比較例として、図1のステップ(S1)〜ステップ(S6)の操作を行った後、常温の大気中に放置して脱ガス処理した。その結果、ロット(a)においては、2時間の脱ガス処理(ステップ(S7))により過酸化水素ガスを完全に除去できたのに対し、ロット(b)においては、6時間後も包装容器(1)から約100ppmの過酸化水素の残留が確認された。   In this connection, a medicine-filled syringe (4) comprising a container body (2) made of PET film and a sterilized paper (3) made of the above-mentioned “Tyvek” and comprising a packaging container (1) and filled with sodium hyaluronate as a medicine. Was enclosed in a packaging container (1). Then, it was divided into two treatment lots (a) and (b), and each lot was sterilized with hydrogen peroxide gas using the chamber (5) shown in FIG. In that case, the lot (a) is sterilized by the sterilization method of the present invention, and the lot (b) is subjected to steps (S1) to (S6) in FIG. It was left in the air and degassed. As a result, in lot (a), the hydrogen peroxide gas could be completely removed by the degassing treatment (step (S7)) for 2 hours, whereas in lot (b), the packaging container after 6 hours. From (1), it was confirmed that about 100 ppm of hydrogen peroxide remained.

本発明において、特に、上記の様な温風の循環による包装容器(1)からの過酸化水素ガスの脱ガス操作は、工業的、環境的な観点からして著しい効用を発揮する。すなわち、上記の脱ガス操作によれば、脱ガス処理に使用されて微量ながらも過酸化水素ガスを含む可能性のある空気の系外への排出量を大幅に削減できると共に、温風を製造するための熱負荷も大幅に低減できる。そして、脱ガス効果をより促進するには、チャンバーに返流される空気中の過酸化水素ガス濃度を極力低くするのが望ましいが、触媒の使用により、更には循環空気の昇温により、確実かつ安全に循環空気中の過酸化水素ガスを処理できる。しかも、滅菌ガスとして過酸化水素ガスを使用するため、触媒分解によって全く無害な成分に適確に分解処理できるため、滅菌処理においては勿論、最終的な系外への排出においても極めて高い安全性が確保される。   In the present invention, in particular, the degassing operation of the hydrogen peroxide gas from the packaging container (1) by circulating hot air as described above exhibits a remarkable effect from the industrial and environmental viewpoints. That is, according to the above degassing operation, it is possible to greatly reduce the amount of air that is used in the degassing process and that may contain hydrogen peroxide gas but may contain hydrogen peroxide gas, and to produce hot air. The heat load for doing so can be greatly reduced. In order to further promote the degassing effect, it is desirable to reduce the concentration of hydrogen peroxide gas in the air returned to the chamber as much as possible. However, by using a catalyst and further raising the temperature of the circulating air, it is ensured. And hydrogen peroxide gas in circulating air can be processed safely. In addition, since hydrogen peroxide gas is used as the sterilization gas, it can be accurately decomposed into completely harmless components by catalytic decomposition, so it is extremely safe not only for sterilization but also for final discharge to the outside of the system. Is secured.

本発明に係る滅菌方法の各操作工程を示す工程図である。It is process drawing which shows each operation process of the sterilization method which concerns on this invention. 滅菌装置としてのチャンバーの概要を示す系統図である。It is a systematic diagram which shows the outline | summary of the chamber as a sterilizer. 薬剤入り注射器が封入された包装容器の一形態を示す外観斜視図である。It is an external appearance perspective view which shows one form of the packaging container with which the injection syringe containing a chemical | medical agent was enclosed. 図3における包装容器の包装構造を底面側から示す展開斜視図である。It is an expansion | deployment perspective view which shows the packaging structure of the packaging container in FIG. 3 from the bottom face side. チャンバー内における包装容器(包装品)の取扱方法を示す斜視図である。It is a perspective view which shows the handling method of the packaging container (packaged product) in a chamber.

符号の説明Explanation of symbols

1 :包装容器
2 :容器本体
3 :滅菌紙
4 :薬剤入り注射器
5 :チャンバー
51:過酸化水素ガスの発生器
52:真空ポンプ
54:触媒装置
55:循環ファン
56:ヒーター
64:フィルター
81:ノズル
82:吸引口
83:吸気口
84:吹出口
1: Packaging container 2: Container body 3: Sterilized paper 4: Syringe containing medicine 5: Chamber 51: Hydrogen peroxide gas generator 52: Vacuum pump 54: Catalytic device 55: Circulation fan 56: Heater 64: Filter 81: Nozzle 82: Suction port 83: Air intake port 84: Air outlet

Claims (7)

包装容器に封入された医療品としての薬剤入り注射器を過酸化水素ガスによって滅菌処理する滅菌方法であって、包装容器として、ガスバリヤー性を有し且つ底面全体が開放された合成樹脂製の一体成形された容器本体と、過酸化水素ガスを透過可能で且つ容器本体の底面全体に溶着可能な蓋材としての滅菌紙とから構成される包装容器を使用すると共に、包装容器に封入された薬剤入り注射器を滅菌装置としてのチャンバーに収容し、10〜30torrに減圧したチャンバーに過酸化水素ガスを供給する操作を複数回繰り返すことによって滅菌処理した後、加温しつつ包装容器の内部から過酸化水素ガスを脱ガス処理することを特徴とする医療用滅菌包装における滅菌方法。   A sterilization method for sterilizing a syringe containing a medicine as a medical product enclosed in a packaging container with hydrogen peroxide gas, and as a packaging container, an integrated unit made of a synthetic resin having gas barrier properties and having the entire bottom surface opened Uses a packaging container composed of a molded container body and sterilized paper as a lid material that is permeable to hydrogen peroxide gas and can be welded to the entire bottom surface of the container body, and a medicine enclosed in the packaging container The syringe was placed in a chamber as a sterilizer and sterilized by repeating the operation of supplying hydrogen peroxide gas to the chamber depressurized to 10 to 30 torr, and then was oxidized from the inside of the packaging container while heating. A method for sterilization in medical sterilization packaging, characterized by degassing hydrogen gas. 昇温した空気をチャンバーに対して循環させつつ、循環空気に含まれる過酸化水素ガスを触媒反応によって分解することにより、過酸化水素ガスを脱ガス処理する請求項1に記載の滅菌方法。   The sterilization method according to claim 1, wherein the hydrogen peroxide gas is degassed by decomposing the hydrogen peroxide gas contained in the circulating air by a catalytic reaction while circulating the heated air to the chamber. 脱ガス処理した後、チャンバーに大気を導入する請求項2に記載の滅菌方法。   The sterilization method according to claim 2, wherein the atmosphere is introduced into the chamber after the degassing treatment. チャンバーとして、過酸化水素ガスの供給ライン、減圧ライン、空気の導入ライン及び温風循環ラインが付設され、かつ、前記の減圧ライン及び前記の温風循環ラインに過酸化水素ガス分解用の触媒装置が介装されたチャンバーを使用する請求項1〜3の何れかに記載の滅菌方法。   As a chamber, a hydrogen peroxide gas supply line, a decompression line, an air introduction line, and a hot air circulation line are attached, and a catalyst device for decomposing hydrogen peroxide gas in the decompression line and the hot air circulation line. The sterilization method according to any one of claims 1 to 3, wherein a chamber in which is installed is used. 薬剤入り注射器に充填された薬剤がヒアルロン酸ナトリウム溶液である請求項1〜4の何れかに記載の滅菌方法。   The sterilization method according to any one of claims 1 to 4, wherein the medicine filled in the medicine-filled syringe is a sodium hyaluronate solution. 滅菌処理した後、30〜120℃に加温する請求項1〜5の何れかに記載の滅菌方法。   The sterilization method according to any one of claims 1 to 5, wherein the sterilization treatment is followed by heating to 30 to 120 ° C. 容器本体は、多数積み重ねた際に上段または下段の包装容器との間に隙間を形成するくびれ部を備えている請求項1〜6の何れかに記載の滅菌方法。   The sterilization method according to any one of claims 1 to 6, wherein the container body includes a constricted portion that forms a gap with the upper or lower packaging container when a large number of the container bodies are stacked.
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