JPH11193010A - Pasteurization method in medical pasteurization packaging - Google Patents

Pasteurization method in medical pasteurization packaging

Info

Publication number
JPH11193010A
JPH11193010A JP9367652A JP36765297A JPH11193010A JP H11193010 A JPH11193010 A JP H11193010A JP 9367652 A JP9367652 A JP 9367652A JP 36765297 A JP36765297 A JP 36765297A JP H11193010 A JPH11193010 A JP H11193010A
Authority
JP
Japan
Prior art keywords
hydrogen peroxide
peroxide gas
chamber
gas
container
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP9367652A
Other languages
Japanese (ja)
Other versions
JP3831505B2 (en
Inventor
Mitsuru Hasegawa
充 長谷川
Shuichi Maeda
秀一 前田
Tokuji Mitomi
得司 三富
Takeshi Kanaguchi
剛 金口
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Seikagaku Corp
Original Assignee
Seikagaku Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Seikagaku Corp filed Critical Seikagaku Corp
Priority to JP36765297A priority Critical patent/JP3831505B2/en
Priority to US09/197,614 priority patent/US6228324B1/en
Priority to DK98955938T priority patent/DK0971749T3/en
Priority to NZ336723A priority patent/NZ336723A/en
Priority to TW087119662A priority patent/TW486373B/en
Priority to KR10-1999-7006722A priority patent/KR100527151B1/en
Priority to ES98955938T priority patent/ES2224448T3/en
Priority to DE29825112U priority patent/DE29825112U1/en
Priority to PT98955938T priority patent/PT971749E/en
Priority to PCT/JP1998/005322 priority patent/WO1999027971A2/en
Priority to AU12605/99A priority patent/AU752610B2/en
Priority to CA002280941A priority patent/CA2280941C/en
Priority to RU99118767/12A priority patent/RU2225226C2/en
Priority to EP98955938A priority patent/EP0971749B1/en
Priority to AT98955938T priority patent/ATE271884T1/en
Priority to DE69825258T priority patent/DE69825258T2/en
Priority to IS5116A priority patent/IS2185B/en
Publication of JPH11193010A publication Critical patent/JPH11193010A/en
Priority to NO19993624A priority patent/NO312941B1/en
Priority to AT0022605U priority patent/AT9119U1/en
Application granted granted Critical
Publication of JP3831505B2 publication Critical patent/JP3831505B2/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps

Landscapes

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

Abstract

PROBLEM TO BE SOLVED: To enable medical pasteurization packaging which can surely prevent a residue of gas and is applicable to even to a packaging material made of a polyester resin, by subjecting a gas-barrier-property-having container to the process of pasteurization with hydrogen peroxide gas, and thereafter subjecting it to the process of degassing while increasing temperature. SOLUTION: Package containers each are loaded into a chamber together with a carriage (S1), a vacuum pump is started to exhaust air in it via a catalytic device (S2) and produce a vacuum in, and hydrogen peroxide gas is supplied and caused to diffuse in the chamber (S3) and allowed to permeate through pasteurizing paper, thereby effectively spreading the hydrogen peroxide gas into the package container (S4). These operations are repeated one to twelve times, the hydrogen peroxide gas is decomposed by the catalytic device and exhausted safely out of a system, thereby producing a vacuum in (S5), and the inside of the chamber is allowed to have atmospheric pressure (S6). Air increased in its temperature is caused to flow back and the inside of the package container is subjected to a degassing process (S7), and the processed package container is taken out (S8). Therefore, the container main body made of a polyester resin which is excellent in transparency and easy to dispose of can be used.

Description

【発明の詳細な説明】DETAILED DESCRIPTION OF THE INVENTION

【0001】[0001]

【発明の属する技術分野】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。
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for sterilizing medical sterile packaging, and more particularly, to a method for packaging a medical product, for example, a syringe containing a drug, packed in a packaging container with hydrogen peroxide gas as it is. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a sterilization method for performing a sterilization process, which can efficiently perform a process and reliably prevent a residual hydrogen peroxide gas.

【0002】[0002]

【従来の技術】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。
2. Description of the Related Art As with other disposable medical devices, it is preferable that a syringe containing a medicine be distributed in a sterilized medical package. The medical sterilization packaging uses a medical container made of a synthetic resin container body having a gas barrier property and a sterile paper as a lid material through which the sterilizing gas can pass and which can be welded to the container body. This is a form of packaging in which the product is sealed and then exposed to a sterilizing gas in a packaged state so that the inside is sterilized with a sterilizing gas that has passed through sterilized paper.

【0003】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、特公昭61−45
43号、特開平1−121057号などの公報に開示さ
れている。
[0003] In the above-mentioned medical sterile packaging, the use of hydrogen peroxide gas instead of ethylene oxide has been studied for various medical products due to the problem of the toxicity of the sterilizing gas. Regardless of the type of hydrogen gas used, post-treatment of removing sterilizing gas from the inside of the packaging container is indispensable in order to eliminate the harmfulness of the residual gas to the human body during the distribution process. The technology related to sterilization and sterilization using hydrogen peroxide is disclosed in JP-B-61-45.
No. 43, Japanese Patent Application Laid-Open No. 1-121057 and the like.

【0004】[0004]

【発明が解決しようとする課題】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
分の際に塩素がスが発生すると言う問題もある。
In medical sterilization packaging, however, it is necessary to leave the packaging container for a considerably long time to completely remove the sterilizing gas from the packaging container after the sterilization treatment. It is a factor that lowers. In addition, when a container made of polyester resin is used, the adsorption of sterilizing gas is high, and it becomes more difficult to remove the sterilizing gas. Therefore, in practice, containers mainly containing vinyl chloride are often used. I have. As a result, there is a problem in that visibility inside the packaging container is poor, and chlorine is generated during the disposal of vinyl chloride.

【0005】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 has as its object to provide, for example, a sterilization method for sterilizing a drug-containing syringe or the like with a hydrogen peroxide gas in a package without any treatment. It is an object of the present invention to provide a sterilization method for medical sterile packaging that can prevent hydrogen peroxide gas from remaining, and can be applied to a packaging material of a polyester resin.

【0006】[0006]

【課題を解決するための手段】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
バリヤー性を有する合成樹脂製の容器本体と、過酸化水
素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容器を使用すると共に、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を
特徴とする。
In order to solve the above-mentioned problems, a sterilization method in a medical sterilization package according to the present invention comprises:
A sterilization method for sterilizing a medical product enclosed in a packaging container with hydrogen peroxide gas, wherein the packaging container includes a container body made of a synthetic resin having a gas barrier property, and a container capable of transmitting hydrogen peroxide gas. After using a container composed of sterilized paper as a lid material that can be welded to the main body, and sterilizing with hydrogen peroxide gas, degas the hydrogen peroxide gas from the inside of the packaging container while heating. It is characterized by the following.

【0007】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を滅菌処
理した後、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。
[0007] In the above sterilization method, the medical product is sterilized with hydrogen peroxide gas that has passed through the sterilizing paper of the packaging container, and then heated to promote desorption of the hydrogen peroxide gas adsorbed on the container body. Then, the hydrogen peroxide gas remaining inside the packaging container is removed.

【0008】また、上記の滅菌方法においては、包装容
器に封入された医療品を滅菌装置としてのチャンバーに
収容して滅菌処理した後、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。
[0008] In the above sterilization method, the medical product enclosed in the packaging container is stored in a chamber as a sterilizer and sterilized, and then the circulated air is circulated while the heated air is circulated through the chamber. The hydrogen peroxide gas contained in the chamber is decomposed by a catalytic reaction, so that the concentration of hydrogen peroxide gas in the chamber is always maintained at a low level in the degassing process of the hydrogen peroxide gas, and the peroxide is efficiently and safely oxidized. Hydrogen gas can be degassed.

【0009】更に、上記の態様においては、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、滅菌処理において、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ことが出
来る。
Further, in the above embodiment, the operation of supplying the hydrogen peroxide gas to the depressurized chamber is repeated a plurality of times, so that the hydrogen peroxide gas permeates the inside of the packaging container quickly and reliably in the sterilization treatment. Can be done.

【0010】[0010]

【発明の実施の形態】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。
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS One embodiment of a method for sterilizing medical sterile packaging according to the present invention will be described with reference to the drawings.
FIG. 1 is a process chart 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 performing 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-containing syringe is sealed, 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 shows a packaging container (packaged product) in the chamber.
It is a perspective view which shows the handling method of.

【0011】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。
[0011] The sterilization method of the present invention is a sterilization method in a so-called medical sterilization package in which a medical product (including a medicine, a medical device, and the like) enclosed in a specific packaging container is sterilized by a hydrogen peroxide gas in a packaged state. It is. As a medical product suitable for sterile medical packaging, for example, a drug-containing syringe (4) as shown in FIG. 4 can be mentioned. As is well known, the drug-containing syringe (4) is a syringe which is pre-filled with a required drug and which can be used immediately with an injection needle attached thereto.
150868 and the like.

【0012】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(4
1)に充填された薬剤とから成る。また、注射筒(4
1)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-containing syringe (4) has a syringe barrel (41) in which a cap (42) is attached to the tip of a syringe needle mounting portion, and a syringe barrel (41) having a piston at the tip.
The piston rod (44) inserted into the
And 1) a drug filled therein. In addition, a syringe (4
An adapter (auxiliary tool) (47) for hooking a finger at the time of use is attached to the flange (43) of 1).
Such an adapter (47) also has a function of preventing the medicine-containing syringe (4) from swinging when housed in a packaging container described later. As the medicine to be filled into the medicine-containing syringe (4), a medicine unsuitable for heat sterilization, typically, a sodium hyaluronate solution or the like is suitable.

【0013】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 reference numeral (1) in FIG. 3, the packaging container has a container body (2) made of a synthetic resin having a gas barrier property and a container body (2) permeable to hydrogen peroxide gas. )) And sterilized paper (3) as a lid material that can be welded. The container body (2) is integrally formed in an elongated container shape with a transparent resin, and is opened.
Is sealed with sterile paper (3).

【0014】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 the resin material constituting the container body (2), any thermoplastic resin can be used as long as the material does not allow bacteria to permeate and the contents can be visually recognized. From the viewpoint, the container body (2)
Is preferably made of a polyester resin such as polyethylene terephthalate (PET) and polybutylene terephthalate. Specifically, the container body (2) is manufactured 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 main body (2) made of a PET film does not generate toxic gas such as chlorine at the time of disposal and is a preferable packaging material from the viewpoint of preventing pollution.

【0015】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(4
3)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)、(2
4)とを備えている。
As shown in FIGS. 3 and 4, the container main body (2) has a first bulging portion for accommodating the distal end side of the syringe barrel (41) of the medicine-containing syringe (4) when viewed from the outside. (21)
And a second housing for accommodating a substantially central portion of the entire length of the medicine-containing syringe (4) including the piston rod (44) inserted partway.
Bulge (22) and the flange (4) of the syringe barrel (41).
3) and a third bulged portion (23) for accommodating the pusher (extended diameter enlarged portion) (45) of the piston rod (44), and two constricted portions (24) for connecting these bulged portions. , (2
4).

【0016】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 relatively large spaces at both ends of the medicine-containing syringe (4). It functions to temporarily store the sterilizing gas that diffuses into details such as the gap between (41) and the piston rod (44), and the central second bulge (22) serves as a packaging container (1). Functioning as a bending fulcrum of the container body (2) for easily and hygienically removing the syringe (4) containing the medicine from the container.

【0017】一方、容器本体(2)の各くびれ部(2
4)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(2
1)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)に対するの接触面積
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 constricted portion (2) of the container body (2)
4) When many are stacked in the sterilization process described below,
A gap is formed between the upper and lower packaging containers (1) to improve the flow of hydrogen peroxide gas and air. Furthermore,
From such a viewpoint, the first bulging portion (2) of the container body (2) is used.
1) and the third bulge (23) are configured as support points for stacking, and the second bulge (22) is composed of the first bulge (21) and the third bulge. Preferably, it is formed at a height lower than (23). In a preferred embodiment, in order to reduce the contact area of the upper or lower packaging container (1) with the sterilizing paper (3), a saddle-shaped concave portion is provided at the center of the third bulging portion (23). (25) is formed.

【0018】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 is permeable to microorganisms such as bacteria and permeable to gas such as sterilizing gas and air, for example, known as "Tyvek 1073B" manufactured by DuPont. High density polyethylene sheet material is preferably used. Such a sterilized paper (3) is hermetically welded by an ultrasonic welding method or a heat welding method after accommodating the above-mentioned medicine-containing syringe (4) in the container body (2).

【0019】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。
In carrying out the sterilization method of the present invention, a chamber (5) as a sterilization apparatus as shown in FIG.
Is used. The chamber (5) is designed, for example, as an airtight horizontally-long pressure-resistant container, and is packaged (packaged product).
(1) The pallet on which (see FIG. 5) is loaded can be loaded from the door on one end face. Such a 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. A catalytic device (54) for decomposing hydrogen peroxide gas is interposed in the line (D).

【0020】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 above hydrogen peroxide gas supply line (A)
A hydrogen peroxide generator (51) comprising a mechanism for measuring and supplying a fixed amount of a hydrogen peroxide solution and a gas generating system for heating and gasifying the supplied solution; and a hydrogen peroxide generator ( 51) through a gate valve (61) and into a chamber (5) through a gate valve (61). At the tip of the pipe (71), a plurality of nozzles (81) are provided via branch pipes. Provided.

【0021】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 pressure reducing line (B) is connected to 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 a suction side of the vacuum pump (52), and a discharge side of the vacuum pump (52). Pipe (73), a gate valve (62), and a catalyst device (54) for rendering the hydrogen peroxide gas discharged from the chamber (5) harmless. On the exhaust side of the catalyst device (54), A gate valve (63) for releasing oxygen gas generated by the decomposition process is provided. Note that a dry pump is used as the vacuum pump (52) in order to avoid deterioration of the lubricating oil due to hydrogen peroxide gas.

【0022】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(6
4)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 branched from the pipe (71) and has a filter (6) at the open end.
4) and a pipe provided with a gate valve (65). That is, a hydrogen peroxide gas supply line (A)
When the gate valve (61) is closed, air is introduced into the chamber (5) by opening the gate valve (65).

【0023】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(6
6)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 constituted by sequentially connecting the above-described catalyst device (54), circulation fan (55) and heater (56). In the catalyst device (54), for example, a pipe (74) extending from a plurality of intake ports (83) provided on one side wall of the chamber (5) is a gate valve (6).
6). The circulation fan (55) is disposed downstream of the catalyst device (54), and a pipe (75) extending from the exhaust side of the circulation fan (55) is connected to the heater (56). A pipe (76) leading to a plurality of outlets (84) provided on the other side wall of the chamber (5) is connected to the outlet side of the heater (56). As described above, the catalyst device (54) is installed to decompose hydrogen peroxide gas in both the pressure reduction line (B) and the hot air circulation line (D), and the catalyst device (54) A known device containing a reducing agent such as platinum is used.

【0024】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(S9)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))。
In the sterilization method of the present invention using the chamber (5), as shown in FIG.
The operation is performed along the operation process of step (S9). First, a packaging container (packaged product) (1) to be sterilized is loaded on a truck and loaded into the chamber together with the truck. At that time, FIG.
As shown in (1), the packaging containers (1) are arranged in a large number of rows (only one row is illustrated for example) and loaded on a cart in a state of being vertically stacked in multiple stages (step (S1)) in order to increase processing efficiency. )).

【0025】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 pressure reducing line (B) are opened (the gate valve (66) of the hot air circulation line (D) is closed).
In addition, the vacuum pump (52) is started, and the internal air is exhausted through the suction port (82), the pipes (72) and (73), and the catalyst device (54), so that the inside of the chamber (5) is approximately 10 to 30 torr. Reduce the pressure. By such an operation, in the loaded packaging container (1), the internal air is exhausted through the sterilizing paper (3). (Step (S2))

【0026】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 of the chamber (5) is preferably high to some extent in order to sufficiently infiltrate the hydrogen peroxide gas into the inside of the packaging container (1), but is not so high. Then, if air is mixed into the medicine-containing syringe (4), the piston rod (44) may be unnecessarily popped out of the syringe barrel (41). Is preferred.

【0027】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(7
1)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 pressure reducing line (B) is stopped or switched to the idling operation, the gate valves (62) and (63) are closed, and then the hydrogen peroxide gas supply line (A) is connected. Supply hydrogen peroxide gas.
The hydrogen peroxide gas is supplied to the pipe (7) by opening the gate valve (61) and operating the hydrogen peroxide generator (51).
1) and diffused into the chamber (5) through the plurality of nozzles (81) (Step (S3)).

【0028】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 syringe (4) containing the medicine is sterilized. To process. Since the inside of the packaging container (1) has been pre-pressurized by the decompression operation in the step (S2), the sterilizing paper (3) is permeated and hydrogen peroxide gas is further diffused into the packaging container (1). It can be made to penetrate efficiently (step (S4)).

【0029】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(4
4)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。
When sterilizing a medical product having a simple shape, a single sterilization operation is sufficient, but the sterilization of the packaging container (1) in which the drug-containing syringe (4) as described above is enclosed is sterilized. In the case, the injection cylinder (41) and the piston rod (4
It is necessary to sterilize the details such as 4). Therefore, the above-described sterilization operation, that is, the operation of supplying hydrogen peroxide gas to the decompressed chamber (5) is repeated a plurality of times. Specifically, the operation from step (S2) to step (S4) is repeated 1 to 12 times. As a result, the hydrogen peroxide gas can be surely penetrated into the details of the medicine-containing syringe (4).

【0030】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(S
5))。
After 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 operated again, so that hydrogen peroxide is removed from the chamber (5). Exhaust gas. That is, the gate valve (61) of the hydrogen peroxide gas supply line (A) is closed, and the gate valves (62) and (63) of the pressure reducing line (B) are closed.
Is released and the vacuum pump (52) is operated to exhaust the hydrogen peroxide gas inside. At that time, the hydrogen peroxide gas
It is decomposed into oxygen and water by the catalyst device (54), is evacuated safely to the outside of the system, and the pressure in the chamber (5) is reduced to about 10 to 30 torr (step (S)
5)).

【0031】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 pressure reducing line (B) is closed, and the chamber (5) is passed through the air introducing line (C).
Introduce air into the In the air introducing operation, the gate (65) is opened to open the filter (64),
Air is introduced through the pipe (71) and the plurality of nozzles (81), and the pressure in the chamber (5) is restored to the atmospheric pressure.
Then, after the inside of the chamber (5) is set to the atmospheric pressure, the gate valve (65) is closed (step (S6)).

【0032】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、PE
T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. Removal of hydrogen peroxide gas
Although it can be removed to some extent only by exposure to air, it must be left for an extremely long time, and PE
Depending on the material of the container body of the packaging container such as the above-mentioned polyester resin such as T, there is a problem that the hydrogen peroxide gas cannot be completely removed due to a high adsorption force. Therefore,
In the present invention, the hydrogen peroxide gas is degassed from the packaging container (1) while heating. Thereby, desorption of the hydrogen peroxide gas from the container body (2) is promoted, the hydrogen peroxide gas can be degassed more quickly, and the residual hydrogen peroxide gas can be reliably prevented. As the above-mentioned heating method, a method of circulating the heated air to the chamber (5) is preferable.

【0033】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 generated by the catalyst device (54). Supplying the removed air to the heater (56) through a pipe (75);
Then, the air heated by the heater (56) is returned to the chamber (5) through the plurality of outlets (84) (Step (S7)).

【0034】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 above step (S7),
By setting the temperature in the chamber (5), that is, adjusting the heater (56), hydrogen peroxide gas is supplied from the inside of the packaging container (1) under a hot air condition of about 30 to 120 ° C, preferably 30 to 100 ° C. Degassing is important.
The reasons for defining the temperature conditions are as follows. That is,
When the temperature of the hot air is lower than 30 ° C., it is difficult to desorb hydrogen peroxide gas from the surface of the polyester resin film of the container body (2), so that the degassing efficiency is reduced.
If the temperature of the hot air is higher than 120 ° C., the drug filled in the drug-containing syringe (4) may have a temperature substantially higher than 100 ° C. and deteriorate.

【0035】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 process in step (S7) is usually
It is performed for about 30 to 120 minutes, and the hydrogen peroxide gas remaining inside the packaging container (1) is discharged through a sterilized paper (3),
The decomposition treatment is performed by the catalyst device (54) in the hot air circulation line (D). That is, the heated air is supplied to the chamber (5).
The hydrogen peroxide gas contained in the circulating air is decomposed by a catalytic reaction while being circulated with respect to the air, so that the concentration of the hydrogen peroxide gas in the chamber (5) is always kept at a low level, and efficiently and safely. Degas the hydrogen peroxide gas. After the hydrogen peroxide gas is degassed as described above, the hot air circulation line (D) is stopped, and the processed packaging container (1) is taken out of the chamber (5) (step (S8)). .

【0036】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 of the chamber (5) and the temperature of the packaging container (1) can be lowered, and handling of the subsequent process can be performed immediately. In addition, even if a small amount of hydrogen peroxide gas remains due to malfunction of the catalyst device (54) or the like, safety can be ensured by replacing the air in the refrigerator.

【0037】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 the container body (2) made of a specific material and the sterilized paper (3), and the container body (2) has the specific shape. Since the packaging container (1) provided with the packaging container (1) is used, even if the packaging container (1) is exposed to gas while being stacked in multiple stages, the contact area with the upper or lower packaging container (1) is small, and the sterilization paper ( The contact efficiency with the hydrogen peroxide gas and air in 3) can be increased, and rapid sterilization and degassing can be performed.

【0038】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 is degassed from the inside of the packaging container (1) under the condition of hot air at a predetermined temperature, so that the container body (2) Since the desorption of the hydrogen peroxide gas can be promoted, the degassing process can be performed efficiently, and the residual hydrogen peroxide gas can be reliably prevented. In addition, in the degassing treatment of the hydrogen peroxide gas, the hydrogen peroxide gas contained in the circulating air is decomposed by a catalytic reaction while circulating the heated air, so that the hydrogen peroxide gas in the chamber (5) is decomposed. Always keep the concentration lower than the inside of the packaging container (1),
Since the density difference allows the sterilized paper (3) to permeate, the hydrogen peroxide gas inside the packaging container (1) can be more efficiently degassed. Accordingly, it is possible to use a container body made of a polyester resin, which has excellent transparency and is easy to dispose of, as the container body (2).

【0039】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(S
7))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。
The container body made of PET film (2)
And a sterile paper (3) composed of the above-mentioned "Tyvek" to constitute a packaging container (1), and a drug-containing syringe (4) filled with sodium hyaluronate as a drug, and a packaging container (1).
Enclosed. Then, it is divided into two processing lots (a) and (b), and using the chamber (5) shown in FIG.
Each lot was sterilized with hydrogen peroxide gas. In this case, the lot (a) is sterilized by the sterilization method of the present invention, and the lot (b) is subjected to the operations of steps (S1) to (S6) in FIG. It was left in the air for degassing. As a result, in the lot (a), the degassing process (step (S
7)), the hydrogen peroxide gas could be completely removed, whereas in lot (b), about 100 ppm of hydrogen peroxide remained in the packaging container (1) even after 6 hours.

【0040】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 the circulation of the warm air as described above exerts remarkable effects from an industrial and environmental point of view. . That is, according to the above degassing operation, it is possible to significantly reduce the amount of air used for degassing, which may contain a small amount of hydrogen peroxide gas, to the outside of the system, and to produce hot air. The heat load required for performing this 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. In addition, hydrogen peroxide gas in the circulating air can be safely processed. In addition, since hydrogen peroxide gas is used as a sterilizing gas, it can be decomposed accurately to completely harmless components by catalytic decomposition, so it is extremely safe not only for sterilization but also for final discharge outside the system. Is secured.

【0041】[0041]

【発明の効果】以上説明した様に、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。
As described above, according to the sterilization method of the present invention, after sterilizing with a hydrogen peroxide gas, the hydrogen peroxide gas is degassed from the inside of the packaging container while heating. In addition, the desorption of the hydrogen peroxide gas adsorbed on the container body 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 surrounding hydrogen peroxide gas concentration is always kept lower than the inside of the packaging container, Since the sterilized paper is permeated at the concentration difference, the degassing process can be performed more efficiently, and the residual hydrogen peroxide gas can be reliably prevented. Therefore, also in medical sterilization packaging, as a container body,
It is also possible to use a container body made of a polyester resin which is excellent in transparency and easy to dispose. 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 significantly reduced. The catalyst can be completely decomposed into harmless components by catalytic decomposition, and extremely high safety is ensured not only in sterilization but also in final discharge outside the system.
It has significant environmental benefits.

【図面の簡単な説明】[Brief description of the drawings]

【図1】本発明に係る滅菌方法の各操作工程を示す工程
FIG. 1 is a process diagram showing each operation step of a sterilization method according to the present invention.

【図2】滅菌装置としてのチャンバーの概要を示す系統
FIG. 2 is a system diagram showing an outline of a chamber as a sterilizer.

【図3】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
FIG. 3 is an external perspective view showing one embodiment of a packaging container in which a medicine-containing syringe is enclosed.

【図4】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
4 is an exploded perspective view showing the packaging structure of the packaging container in FIG. 3 from the bottom side.

【図5】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
FIG. 5 is a perspective view showing a method of handling a packaging container (package) in the 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: drug-containing syringe 5: chamber 51: hydrogen peroxide gas generator 52: vacuum pump 54: catalyst device 55: circulation fan 56: heater 64: filter 81: nozzle 82: suction port 83: suction port 84: blow port

Claims (8)

【特許請求の範囲】[Claims] 【請求項1】 包装容器に封入された医療品を過酸化水
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する合成樹脂製の容器本
体と、過酸化水素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容器を使用
すると共に、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
処理することを特徴とする医療用滅菌包装における滅菌
方法。
1. A sterilization method for sterilizing a medical product sealed in a packaging container with hydrogen peroxide gas, wherein the packaging container includes a container body made of a synthetic resin having a gas barrier property, and a hydrogen peroxide gas. Using a container that is permeable and sterilized paper as a lid material that can be welded to the container body, and after sterilizing with hydrogen peroxide gas,
A method for sterilizing medical sterile packaging, comprising degassing hydrogen peroxide gas from the inside of a packaging container while heating.
【請求項2】 包装容器に封入された医療品を滅菌装置
としてのチャンバーに収容して滅菌処理した後、昇温し
た空気を前記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。
2. A method for sterilizing a medical product enclosed in a packaging container in a chamber as a sterilizing device, and circulating heated air to the chamber, while hydrogen peroxide contained in the circulating air. The sterilization method according to claim 1, wherein the hydrogen peroxide gas is degassed by decomposing the gas by a catalytic reaction.
【請求項3】 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。
3. The sterilization method according to claim 2, wherein after degassing, air is introduced into the chamber.
【請求項4】 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す
る請求項2又は3に記載の滅菌方法。
4. The sterilization method according to claim 2, wherein the sterilization treatment is performed by repeating an operation of supplying hydrogen peroxide gas to the decompressed chamber a plurality of times.
【請求項5】 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2〜4の何れかに
記載の滅菌方法。
5. A hydrogen peroxide gas supply line, a pressure reduction line, an air introduction line and a hot air circulation line are provided as a chamber, and the hydrogen peroxide gas is supplied to the pressure reduction line and the hot air circulation line. The sterilization method according to any one of claims 2 to 4, wherein a chamber provided with a catalyst device for decomposition is used.
【請求項6】 医療品が薬剤入り注射器である請求項1
〜5の何れかに記載の滅菌方法。
6. The medical product according to claim 1, wherein the medical product is a syringe containing a medicine.
The sterilization method according to any one of claims 1 to 5, wherein
【請求項7】 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6に記載の滅菌方
法。
7. The sterilization method according to claim 6, wherein the drug filled in the drug-containing syringe is a sodium hyaluronate solution.
【請求項8】 30〜120℃に加温する請求項7に記
載の滅菌方法。
8. The sterilization method according to claim 7, wherein the method is heated to 30 to 120 ° C.
JP36765297A 1997-11-28 1997-12-26 Sterilization method in medical sterilization packaging Expired - Lifetime JP3831505B2 (en)

Priority Applications (19)

Application Number Priority Date Filing Date Title
JP36765297A JP3831505B2 (en) 1997-12-26 1997-12-26 Sterilization method in medical sterilization packaging
US09/197,614 US6228324B1 (en) 1997-11-28 1998-11-23 Sterilizing method for medical sterilization packaging and injection pack
EP98955938A EP0971749B1 (en) 1997-11-28 1998-11-26 Sterilizing method for medical sterilization packaging
TW087119662A TW486373B (en) 1997-11-28 1998-11-26 Sterilizing method for medical sterilization packaging and injection pack
KR10-1999-7006722A KR100527151B1 (en) 1997-11-28 1998-11-26 Sterilizing method for medical sterilization packaging and injection pack
ES98955938T ES2224448T3 (en) 1997-11-28 1998-11-26 STERILIZATION METHOD FOR STERILE MEDICAL PACKAGING.
DE29825112U DE29825112U1 (en) 1997-11-28 1998-11-26 Sterilizing medical injector pre-filled with sodium hyaluronate solution
PT98955938T PT971749E (en) 1997-11-28 1998-11-26 METHOD OF STERILIZATION FOR MEDICAL STERILIZATION PACKAGING AND INJECTION ASSEMBLY
PCT/JP1998/005322 WO1999027971A2 (en) 1997-11-28 1998-11-26 Sterilizing method for medical sterilization packaging and injection pack
AU12605/99A AU752610B2 (en) 1997-11-28 1998-11-26 Sterilizing method for medical sterilization packaging and injection pack
DK98955938T DK0971749T3 (en) 1997-11-28 1998-11-26 Sterilization procedure for medical, sterile packaging
RU99118767/12A RU2225226C2 (en) 1997-11-28 1998-11-26 Method and injection instrument for sterilizing medical packages
NZ336723A NZ336723A (en) 1997-11-28 1998-11-26 Using hydrogen peroxide to sterilise medicine filled injectors or syringes
AT98955938T ATE271884T1 (en) 1997-11-28 1998-11-26 STERILIZATION PROCESS FOR MEDICAL STERILE PACKAGING
DE69825258T DE69825258T2 (en) 1997-11-28 1998-11-26 STERILIZATION PROCEDURE FOR MEDICAL-STERILE PACKAGING
CA002280941A CA2280941C (en) 1997-11-28 1998-11-26 Sterilizing method for medical sterilization packaging and injection pack
IS5116A IS2185B (en) 1997-11-28 1999-07-13 Disinfection method for medical disinfection packaging equipment
NO19993624A NO312941B1 (en) 1997-11-28 1999-07-26 Sterilization method for sterilizing a medical package as well as the obtained package
AT0022605U AT9119U1 (en) 1997-11-28 2005-04-12 MEDICAL STERILIZATION PACKAGING AND INJECTION PACKAGING

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP36765297A JP3831505B2 (en) 1997-12-26 1997-12-26 Sterilization method in medical sterilization packaging

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2006001454A Division JP3845110B2 (en) 2006-01-06 2006-01-06 Sterilization method in medical sterilization packaging

Publications (2)

Publication Number Publication Date
JPH11193010A true JPH11193010A (en) 1999-07-21
JP3831505B2 JP3831505B2 (en) 2006-10-11

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ID=18489857

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Country Status (1)

Country Link
JP (1) JP3831505B2 (en)

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JP2003052819A (en) * 2001-08-10 2003-02-25 Seikagaku Kogyo Co Ltd Drug filling syringe package and sterilization or bactericidal method for it
JP2003070884A (en) * 2001-07-13 2003-03-11 Ethicon Inc Surface treatment of aluminum alloy for improving compatibility in sterilization treatment
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JP2007510592A (en) * 2003-10-22 2007-04-26 イー・アイ・デュポン・ドウ・ヌムール・アンド・カンパニー Nanofiber porous fiber sheet
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CN107551296A (en) * 2016-06-30 2018-01-09 伊西康公司 For the apparatus and method to be sterilized to endoscope
JP2019172349A (en) * 2018-03-29 2019-10-10 大日本印刷株式会社 Method for sterilizing paper container for aseptic filling machine
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JP2012532715A (en) * 2009-07-14 2012-12-20 ノバルティス アーゲー Surface decontamination of pre-filled containers in secondary packaging
JP2011162267A (en) * 2011-03-14 2011-08-25 Terumo Corp Manufacturing method for packed pre-filled syringe
JP2022081491A (en) * 2012-06-01 2022-05-31 ノバルティス アーゲー Injection syringe
JP2016064854A (en) * 2014-09-25 2016-04-28 大日本印刷株式会社 Aseptic bag filling method and device
WO2016125810A1 (en) * 2015-02-03 2016-08-11 株式会社湯山製作所 Sterilization device and sterilization method
JP2017006462A (en) * 2015-06-24 2017-01-12 キヤノンマーケティングジャパン株式会社 Sterilization device and sterilization method
JP2017036055A (en) * 2015-08-07 2017-02-16 大日本印刷株式会社 Sterile bagging method and device
CN107551296A (en) * 2016-06-30 2018-01-09 伊西康公司 For the apparatus and method to be sterilized to endoscope
US11648327B2 (en) 2016-06-30 2023-05-16 Asp Global Manufacturing Gmbh Apparatus and method for sterilizing endoscope
US11696967B2 (en) 2016-06-30 2023-07-11 Asp Global Manufacturing Gmbh Apparatus and method for sterilizing endoscope
JP2021508558A (en) * 2017-12-27 2021-03-11 コッヒャー−プラスティック マシーネンバウ ゲゼルシャフト ミット ベシュレンクテル ハフツング How to reduce microbial contamination
JP2019172349A (en) * 2018-03-29 2019-10-10 大日本印刷株式会社 Method for sterilizing paper container for aseptic filling machine

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