JP2002303618A - Indicator for plasma sterilization and packaging material for sterilization - Google Patents

Indicator for plasma sterilization and packaging material for sterilization

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Publication number
JP2002303618A
JP2002303618A JP2001106347A JP2001106347A JP2002303618A JP 2002303618 A JP2002303618 A JP 2002303618A JP 2001106347 A JP2001106347 A JP 2001106347A JP 2001106347 A JP2001106347 A JP 2001106347A JP 2002303618 A JP2002303618 A JP 2002303618A
Authority
JP
Japan
Prior art keywords
indicator
plasma sterilization
change
sterilization
compounds
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
JP2001106347A
Other languages
Japanese (ja)
Other versions
JP4574048B2 (en
Inventor
Sadako Sudou
禎子 須藤
Hiroko Sugiyama
裕子 杉山
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.)
Fujimori Kogyo Co Ltd
Original Assignee
Fujimori Kogyo Co Ltd
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Filing date
Publication date
Application filed by Fujimori Kogyo Co Ltd filed Critical Fujimori Kogyo Co Ltd
Priority to JP2001106347A priority Critical patent/JP4574048B2/en
Publication of JP2002303618A publication Critical patent/JP2002303618A/en
Application granted granted Critical
Publication of JP4574048B2 publication Critical patent/JP4574048B2/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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  • Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

PROBLEM TO BE SOLVED: To provide an indicator for plasma sterilization capable of obtaining effective discoloration without using a discoloration assistant for determining a plasma sterilization treatment on an object to be sterilized and a packaging material for sterilization in which a display using the indicator for plasma sterilization is formed. SOLUTION: A binder and a compound selected from compounds such as (1) a sulfophthalein-based compound, a naphtolphthalein-based compound, phenolphthalein-based compound, etc., which discolor by an ring-opening reaction, compounds such as (2) hematoxylin, lacmoid, an alizarin sulfonic acid, etc., which discolor by the reaction between an intramolecular hydroxyl group and a hydrogen peroxide in an atmosphere, and compounds such as (3) Nile blue, quinoline blue, resazurin, etc., which discolor by the opening of a double-bond of an intramolecular (-N=) structure. These compounds change in hue with changes in pH.

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、過酸化水素プラズ
マ殺菌処理に有用な化学指示薬による滅菌用インジケー
タ、および該滅菌用インジケータからなる表示部を形成
してなるプラズマ殺菌処理用の被処理物を収納するため
の滅菌用包装材料に関する。
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an indicator for sterilization using a chemical indicator useful for hydrogen peroxide plasma sterilization, and an object to be processed for plasma sterilization comprising a display section comprising the sterilization indicator. The present invention relates to a packaging material for sterilization for storage.

【0002】[0002]

【従来の技術】使い捨て可能、或いは再使用可能な医療
装置や食品容器などのに対して、種々の殺菌手段が用い
られてきており、代表的なものとしては、エチレンオキ
サイドガス(EOG)滅菌、オートクレーブによる高圧
高温蒸気滅菌、或いはプラズマ滅菌などが挙げられる。
例えば、病院などで実施される滅菌方法としては、メス
やシリンジなどの被滅菌物を、少なくともガス透過性で
あって細菌類が通過不能である領域を有する包装袋に入
れ、密封した後、前記したような方法により滅菌処理を
行い、滅菌後の器具は手術などに使用するまで、この包
装袋内に収納され、手術や治療に用いる際に開封して使
用される。この場合、包装材料に密封された器具に殺菌
処理が行われたかどうかを容易に判断する表示を付する
ことが事故防止などの観点から有用である。表示部の形
成は、滅菌処理を行うと非可逆的に変色する、指示機能
を有するインキを使用して行なわれる。
2. Description of the Related Art Various sterilization means have been used for disposable or reusable medical devices and food containers, and typical examples thereof include ethylene oxide gas (EOG) sterilization, High-pressure high-temperature steam sterilization using an autoclave, plasma sterilization, or the like can be given.
For example, as a sterilization method carried out in hospitals and the like, an object to be sterilized such as a scalpel or a syringe is placed in a packaging bag having an area that is at least gas permeable and does not allow bacteria to pass through, and after sealing, The sterilized device is sterilized by the method described above, and the sterilized instrument is stored in the packaging bag until it is used for surgery or the like, and is opened and used for surgery or treatment. In this case, it is useful from the viewpoint of preventing accidents and the like to attach a display for easily determining whether or not the sterilization process has been performed on the device sealed in the packaging material. The display portion is formed by using an ink having an indicating function, which changes color irreversibly when sterilization is performed.

【0003】これらの滅菌処理のうち、被滅菌物である
医療器具に影響を与える懸念が少ないことから、最近で
は、過酸化水素プラズマ殺菌方法とそのための装置が提
案され、また実際に使用されている(特公平2−622
61号および同7−22693号)。この殺菌方法は、
要約すると、被殺菌製品を気密容器中で減圧下に過酸化
水素蒸気に触れさせ、ついで過酸化水素プラズマを発生
させるものである。この方法は、高殺菌効率が得られる
だけでなく、過酸化水素が全く無害な水と酸素に転換さ
れるという点で、非常に有用と言える。
[0003] Among these sterilization treatments, there is little concern about affecting medical instruments which are to be sterilized. Therefore, recently, a hydrogen peroxide plasma sterilization method and an apparatus therefor have been proposed and actually used. Yes (Tokuhei 2-622
Nos. 61 and 7-22693). This sterilization method,
Briefly, the product to be sterilized is exposed to hydrogen peroxide vapor under reduced pressure in an airtight container, and then a hydrogen peroxide plasma is generated. This method is very useful in that not only high sterilization efficiency is obtained, but also hydrogen peroxide is converted into completely harmless water and oxygen.

【0004】但し、プラズマ滅菌処理は、前記EOG滅
菌よりも短時間で処理可能なため、従前にEOG滅菌に
使用していた表示用インクは使用し難いという問題があ
る。また、この滅菌処理は、処理中に過酸化水素を用い
ることから、親水性材料、例えば、セルロース系、再生
セルロース系、ポリビニルアルコール系、ポリアミド系
の繊維からなる不織布や紙、或いはこれらの材料からな
るフィルムなどは過酸化水素を吸着するため好ましくな
く、通常、ポリエステル系、ポリ塩化ビニル系、ポリエ
チレン系、ポリプロピレン系、フッ素系などの水分非吸
着性の材料を選択して用いる必要がある。このようなプ
ラズマ滅菌処理に適合する表示組成物としては、例え
ば、特開平11−178904号公報にはトリフェニル
メタン系色素、シアニン系色素と発色助剤との組合せ
が、また、特開平11−37988号公報にはpH指示
薬と有機アミン系の変色助剤とを用いる技術が、それぞ
れ提案されている。これらの表示成分は、プラズマ滅菌
に使用される酸化力の強いガスの酸化性により消色或い
は変色する色素とその変色を促進し、安定性を向上させ
るための変色助剤とを含有するが、変色速度が安定せ
ず、多量の被滅菌物を対象とするプラズマ滅菌処理によ
っては、十分な変色が得られない、或いは、アミン系、
メルカプト系の変色助剤を必須とするため、高コストと
なるなどの問題があり、改良が望まれていた。
[0004] However, plasma sterilization can be performed in a shorter time than the above-mentioned EOG sterilization, and thus there is a problem that it is difficult to use the display ink which has been used for EOG sterilization before. In addition, since this sterilization treatment uses hydrogen peroxide during the treatment, a hydrophilic material, for example, a nonwoven fabric or paper made of cellulose-based, regenerated cellulose-based, polyvinyl alcohol-based, polyamide-based fibers, or these materials is used. Such a film is not preferable because it adsorbs hydrogen peroxide, and usually, it is necessary to select and use a water-absorbing material such as polyester, polyvinyl chloride, polyethylene, polypropylene, and fluorine. As a display composition suitable for such a plasma sterilization treatment, for example, Japanese Patent Application Laid-Open No. H11-178904 discloses a combination of a triphenylmethane-based dye, a cyanine-based dye, and a color-forming auxiliary. Japanese Patent No. 37988 proposes a technique using a pH indicator and an organic amine-based discoloration aid. These display components contain a dye that is decolorized or discolored due to the oxidizing property of a gas having a strong oxidizing power used for plasma sterilization and a discoloration aid for promoting the discoloration and improving stability, The discoloration rate is not stable, and sufficient discoloration cannot be obtained by plasma sterilization for a large amount of objects to be sterilized, or amine-based,
Since a mercapto-based discoloration aid is essential, there are problems such as high cost, and improvement has been desired.

【0005】[0005]

【発明が解決しようとする課題】従って、本発明の目的
は、被殺菌物へのプラズマ殺菌処理が行われたかどうか
が明確に判定できる、変色助剤を用いなくとも、表示に
有効な変色が得られるプラズマ滅菌用インジケータ及び
該プラズマ滅菌用インジケータを用いた表示部を形成し
てなる滅菌用包装材料を提供することにある。
SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a method that can clearly determine whether or not plasma sterilization has been performed on an object to be sterilized. An object of the present invention is to provide an obtained indicator for plasma sterilization and a packaging material for sterilization comprising a display unit using the indicator for plasma sterilization.

【0006】[0006]

【課題を解決するための手段】本発明者らは、検討の結
果、pH指示薬として特定の変色機構を有する化合物を
選択することで、変色助剤を用いることなく有効な表示
が可能となることを見出し、本発明を完成した。
Means for Solving the Problems As a result of the study, the present inventors have found that by selecting a compound having a specific discoloration mechanism as a pH indicator, effective display can be performed without using a discoloration aid. And completed the present invention.

【0007】即ち、本発明のプラズマ滅菌用インジケー
タは、pHの変化に伴い色相が変化する化合物として、
(1)スルホフタレン系化合物、ナフトールフタレン系
化合物、フェノールフタレイン系化合物等のpHの変化
に伴い開環反応を生起することで色相が変化する化合
物、(2)ヘマトキシリン、ラクモイド、アリザリンス
ルホン酸ナトリウム等の分子内の水酸基と雰囲気内の過
酸化水素とが反応することで色相が変化する化合物、或
いは、(3)ナイルブルー、キノリンブルー、レザズリ
ン等の、分子内に二重結合と連結された窒素原子(−N
=)を有し、pHの変化に伴い該二重結合部分が開くこ
とで色相が変化する化合物から選択されるpHの変化に
伴い色相が変化する化合物とバインダーとを含有する。
That is, the indicator for plasma sterilization of the present invention is a compound whose hue changes with a change in pH.
(1) Sulfophthalene-based compounds, naphthol-phthalene-based compounds, phenolphthalein-based compounds, etc., whose hue changes by causing a ring-opening reaction with a change in pH, (2) hematoxylin, lacmoid, sodium alizarin sulfonate Compounds whose hue changes due to the reaction of hydroxyl groups in the molecule with hydrogen peroxide in the atmosphere, or (3) Nile blue, quinoline blue, resazurin, etc., linked to a double bond in the molecule Nitrogen atom (-N
=), And contains a binder selected from compounds whose hue changes when the double bond portion is opened with a change in pH, and a compound whose hue changes with a change in pH, and a binder.

【0008】また、請求項8に係る本発明の滅菌用包装
材料は、少なくとも一部がガス透過性の不織布により構
成され、プラズマ滅菌処理のための被滅菌物を収納しう
る滅菌用包装材料であって、前記本発明に係る特定のp
Hの変化に伴い色相が変化する化合物とバインダーとを
含有するプラズマ滅菌用インジケータからなる表示部が
形成されてなることを特徴とする。
[0008] The sterilization packaging material according to the present invention according to claim 8 is a sterilization packaging material that is at least partially formed of a gas-permeable nonwoven fabric and can store an object to be sterilized for plasma sterilization. The specific p according to the present invention
A display section comprising a plasma sterilization indicator containing a compound whose hue changes with a change in H and a binder is formed.

【0009】本発明のプラズマ滅菌インジケータは、p
Hの変化に伴い、特定の構造変化により色相が変化する
化合物(以下、適宜、pH指示薬と称する)を含むた
め、過酸化水素によるpHの変化やプラズマ処理の強い
酸化力には速やかに反応して変色或いは消色し、その変
色は非可逆的であるため、化学指示薬として好適であ
り、医療装置、食品容器等の非殺菌物が過酸化水素プラ
ズマ殺菌処理を受けてから一定の時間を経過した後で
も、そのような処理を経たか否かを明瞭に判定すること
ができる。
The plasma sterilization indicator of the present invention has a p
Since it contains a compound whose hue changes due to a specific structural change with a change in H (hereinafter, appropriately referred to as a pH indicator), it reacts quickly to a change in pH by hydrogen peroxide or a strong oxidizing power of plasma treatment. Discoloration or discoloration occurs.Since the discoloration is irreversible, it is suitable as a chemical indicator, and a certain period of time has passed since non-sterile substances such as medical devices and food containers were subjected to hydrogen peroxide plasma sterilization. Even after this, it is possible to clearly determine whether or not such processing has been performed.

【0010】[0010]

【発明の実施の形態】以下に本発明を詳細に説明する。
本発明のプラズマ滅菌用インジケータは、前記特定のp
H指示薬を用いることで、有機アミン系化合物などの変
色助剤を含有することなく、有効なインジケーターとし
て機能し得る。ここで用いられるpH指示薬の詳細を説
明する。前記pHの変化に伴い色相が変化する化合物の
第1の態様として、(1)pHの変化に伴い開環反応を
生起することで色相が変化する化合物が挙げられる。こ
の変色機構は以下のようなスキームで表される。
DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below in detail.
The indicator for plasma sterilization of the present invention includes the specific p
By using the H indicator, it can function as an effective indicator without containing a discoloration aid such as an organic amine compound. Details of the pH indicator used here will be described. The first embodiment of the compound whose hue changes with a change in the pH includes (1) a compound whose hue changes by causing a ring opening reaction with a change in the pH. This discoloration mechanism is represented by the following scheme.

【0011】[0011]

【化1】 Embedded image

【0012】このような化合物としては、スルホフタレ
ン、ナフトールフタレン、フェノールフタレン等が挙げ
られる。例えば、スルホフタレンは以下に示される構造
を有し、酸、アルカリにより開環して赤色に発色する。
Examples of such compounds include sulfophthalene, naphtholphthalene, phenolphthalene and the like. For example, sulfophthalene has the structure shown below, and develops a red color by ring opening with an acid or alkali.

【0013】[0013]

【化2】 Embedded image

【0014】この化合物の誘導体として、クレゾールレ
ッド、チモールブルー、ブロモフェノールレッド、ブロ
モクレゾールパープル、ブロモフェノールブルーなどが
代表的なものとして挙げられる。このような化合物は、
プラズマ滅菌用インジケータ中に固形分として、0.1
〜5.0重量%含有されることが好ましい。含有量が
0.1重量%未満であると色(色調)が薄く色の変化を
目視で明確に検知しにくくなり、5.0重量%を超える
とプラズマ滅菌器で滅菌処理した後も変色前の色相が残
るため、いずれも好ましくない。
Representative derivatives of this compound include cresol red, thymol blue, bromophenol red, bromocresol purple, bromophenol blue and the like. Such compounds are:
0.1 as solids in plasma sterilization indicator
It is preferably contained in an amount of up to 5.0% by weight. If the content is less than 0.1% by weight, the color (color tone) is thin and it is difficult to detect the change in color visually. If the content exceeds 5.0% by weight, the color is not changed after sterilization by a plasma sterilizer. Are not preferred, since the hue remains.

【0015】前記pHの変化に伴い色相が変化する化合
物の第2の態様として、(2)分子内の水酸基と雰囲気
内の過酸化水素とが反応することで色相が変化する化合
物が挙げられる。このような化合物としては、具体的に
は、ヘマトキシリン、ラクモイド、アリザリンスルホン
酸ナトリウム等が挙げられる。これらの化合物はその分
子内に水酸基をそれぞれ2〜5個有しており、発色性、
変色速度、耐光性のいずれにも優れていることから、本
発明に好適に用いることができる。
The second embodiment of the compound whose hue changes with a change in pH is (2) a compound whose hue changes when a hydroxyl group in a molecule reacts with hydrogen peroxide in an atmosphere. Specific examples of such a compound include hematoxylin, lacmoid, sodium alizarin sulfonate, and the like. These compounds each have 2 to 5 hydroxyl groups in the molecule,
Since it is excellent in both discoloration speed and light resistance, it can be suitably used in the present invention.

【0016】[0016]

【化3】 Embedded image

【0017】なかでも、ヘマトキシリンは後述するバイ
ンダーのうち、ポリアミド系の樹脂を主材とするもの
〔例えば、市販品としてセーフル(商品名)、ポリアミ
ド樹脂と硝化綿含有、(株)T&K TOKA社製〕と
組合せて用いることで、経時的な変色速度の安定化が向
上し、また、所望されない滅菌処理の中断が生じたと
き、そのインジケーターの発色状態を観察することで、
再度、滅菌処理を行うことが必要か否かを検知すること
ができるという利点をも有する。このような化合物は、
プラズマ滅菌用インジケータ中に固形分として、0.2
〜5.0重量%含有されることが好ましい。含有量が
0.2重量%未満であると色(色調)が薄く色の変化を
目視で明確に検知しにくくなり、5.0重量%を超える
とプラズマ滅菌器で滅菌処理した後も変色前の色相が残
るため、いずれも好ましくない。
Among them, hematoxylin is a binder mainly composed of a polyamide resin among binders described below [for example, commercially available Safull (trade name), containing polyamide resin and nitrified cotton, manufactured by T & K TOKA Co., Ltd.] By using in combination with, the stabilization of the discoloration rate over time is improved, and when an undesired interruption of the sterilization treatment occurs, by observing the color development state of the indicator,
Another advantage is that it is possible to detect whether it is necessary to perform the sterilization process again. Such compounds are:
0.2 as solids in the indicator for plasma sterilization
It is preferably contained in an amount of up to 5.0% by weight. If the content is less than 0.2% by weight, the color (color tone) is thin and it is difficult to detect the color change clearly by visual observation. If the content exceeds 5.0% by weight, before discoloration even after being sterilized by a plasma sterilizer. Are not preferred, since the hue remains.

【0018】前記pHの変化に伴い色相が変化する化合
物の第3の態様として、(3)分子内に二重結合と連結
された窒素原子(−N=)を有し、pHの変化に伴い該
二重結合部分が開くことで色相が変化する化合物が挙げ
られる。ここで、二重結合と連結された窒素原子(−N
=)は環構造を形成する化合物の官能基として導入され
ていてもよく、また、それ自体がヘテロ環構造を有する
ものであってもよい。このような化合物としては、例え
ば、ナイルブルー、キノリンブルー、レザズリンなどが
挙げられる。
As a third embodiment of the compound whose hue changes with a change in pH, (3) a compound having a nitrogen atom (-N =) linked to a double bond in a molecule, A compound whose hue changes when the double bond portion is opened is exemplified. Here, a nitrogen atom (-N
=) May be introduced as a functional group of a compound forming a ring structure, or may itself have a heterocyclic structure. Such compounds include, for example, Nile Blue, Quinoline Blue, Resazurin and the like.

【0019】[0019]

【化4】 Embedded image

【0020】このような化合物は、プラズマ滅菌用イン
ジケータ中に固形分として、0.05〜5.0重量%含
有されることが好ましい。含有量が0.05重量%未満
であると色(色調)が薄く色の変化を目視で明確に検知
しにくくなり、5.0重量%を超えるとプラズマ滅菌器
で滅菌処理した後も変色前の色相が残るため、いずれも
好ましくない。なお、これらのpH指示薬は1種のみを
用いてもよく、2種以上を組み合わせて使うこともでき
る。複数の化合物を組合せることで、インジケータとし
て所望の色相を実現することもできる。
Such a compound is preferably contained in the indicator for plasma sterilization as a solid content of 0.05 to 5.0% by weight. If the content is less than 0.05% by weight, the color (color tone) is thin and it is difficult to detect the change in color clearly by visual observation. If the content exceeds 5.0% by weight, before discoloration even after being sterilized by a plasma sterilizer. Are not preferred, since the hue remains. These pH indicators may be used alone or in combination of two or more. By combining a plurality of compounds, a desired hue can be achieved as an indicator.

【0021】次に本発明に用いられるバインダーについ
て説明する。本発明のインジケータに使用するバインダ
ーとしては、前記pH指示薬の発色機構に影響を与えな
い限りにおいて、公知のバインダーを特に制限なく使用
することができ、例えば、印刷用インキの調製に通常用
いられる合成樹脂などを適宜選択して用いることができ
る。バインダーは、インジケータを包装材料の表示部と
して用いる場合の担持体となる。先に述べたように、プ
ラズマ滅菌用の包装材料には、ポリエステル系、ポリ塩
化ビニル系、ポリエチレン系、ポリプロピレン系、フッ
素系などの水分非吸着性の材料を選択して用いる必要が
あり、これらに強固に付着することが好ましい。
Next, the binder used in the present invention will be described. As the binder used in the indicator of the present invention, a known binder can be used without any particular limitation as long as it does not affect the coloring mechanism of the pH indicator, for example, a synthetic binder usually used for preparing a printing ink. Resins and the like can be appropriately selected and used. The binder serves as a carrier when the indicator is used as a display unit of the packaging material. As described above, the packaging material for plasma sterilization must be selected from non-adsorbent materials such as polyester, polyvinyl chloride, polyethylene, polypropylene, and fluorine. It is preferable to adhere firmly to the surface.

【0022】本発明のインジケータは、組成物としての
安定性の観点からは、ポリアミドやエチルセルロース系
バインダーが好ましいが、他の添加物を調製することに
よりアルカリ成分からのダメージを防止することができ
るため、必ずしも耐アルカリ性である必要はない。従っ
て、色素の変色速度や安定性を考慮すれば、例えば、硝
化綿などもバインダーとして好適に用いることができ
る。バインダーの種類や添加量は、滅菌用インジケータ
としての特性、適用される包装材料や容器などの材質、
必要とされる耐久性などに応じて適宜選択すればよい
が、添加量としては、5〜30重量%程度が一般的であ
る。
The indicator of the present invention is preferably a polyamide or an ethylcellulose binder from the viewpoint of the stability of the composition, however, it is possible to prevent damage from an alkali component by preparing other additives. However, it is not always necessary to be alkali-resistant. Therefore, in consideration of the discoloration speed and stability of the dye, for example, nitrified cotton can be suitably used as the binder. The kind and amount of binder added are the characteristics of the indicator for sterilization, the material of the packaging material and container to be applied,
It may be appropriately selected according to the required durability and the like, but the addition amount is generally about 5 to 30% by weight.

【0023】本発明は前記構成としたため、従来から使
用されていた変色助剤を必ずしも必要としないが、例え
ば、ジエタノールアミン、トリエタノールアミンなどの
有機アミン化合物など、公知の変色助剤を添加してもよ
い。
Since the present invention has the above-mentioned constitution, a conventionally used discoloration aid is not necessarily required. For example, a known discoloration aid such as an organic amine compound such as diethanolamine or triethanolamine may be added. Is also good.

【0024】本発明のプラズマ滅菌用インジケータに
は、前記各成分に加えて、耐久性、ハンドリング性など
の向上のため、公知の可塑剤、分散剤、安定剤、増粘剤
等の添加剤を適宜含有することができる。とくに、耐光
性向上の観点から、本発明のプラズマ滅菌用インジケー
タには、紫外線吸収剤を含有することが好ましい。紫外
線吸収剤としては、この分野で通常使用されているもの
であれば、本発明の目的達成に悪影響を与えるものでな
い限り、どのような種類のものでも使用することができ
る。具体的には、例えば、トリアジン系化合物、ベンゾ
トリアゾール系化合物、ヒンダートアミン系化合物など
が好適なものとして挙げられる。紫外線遮断効果を有す
るこのような化合物は、市販品としては、チバガイギー
(Ciba-Geigy)社のチヌビン(Tinuvin)の商標で知ら
れている種種の化合物を挙げることができる。紫外線吸
収剤は単独でも、また二種類以上の化合物を組み合わせ
て使用することもできるが、異なる特性を有する紫外線
吸収剤を複数種用いることも効果的である。
The indicator for plasma sterilization of the present invention contains, in addition to the above components, known additives such as a plasticizer, a dispersant, a stabilizer, and a thickener in order to improve durability and handling properties. It can be appropriately contained. In particular, from the viewpoint of improving light resistance, the indicator for plasma sterilization of the present invention preferably contains an ultraviolet absorber. As the ultraviolet absorber, any types can be used as long as they are commonly used in this field, as long as they do not adversely affect the achievement of the object of the present invention. Specifically, for example, a triazine-based compound, a benzotriazole-based compound, a hindered amine-based compound, and the like are preferable. As such a compound having an ultraviolet ray blocking effect, commercially available products include various compounds known under the trademark Tinuvin of Ciba-Geigy. The ultraviolet absorbers can be used alone or in combination of two or more compounds, but it is also effective to use a plurality of ultraviolet absorbers having different properties.

【0025】本発明のプラズマ滅菌用インジケータはプ
ラズマ滅菌処理によって消色又は変色する組成物である
が、インジケータの消色後の視認性を確保するため、色
素主成分の色相を損なわず、且つ、滅菌処理により消色
或いは変色しない染料や顔料を添加してもよい。
The indicator for plasma sterilization of the present invention is a composition which is decolorized or discolored by the plasma sterilization treatment. However, in order to ensure the visibility of the indicator after decolorization, the hue of the pigment main component is not impaired, and A dye or pigment that does not lose or change color by sterilization may be added.

【0026】本発明のプラズマ滅菌用インジケータは、
前記各成分を好適な溶剤に溶解して、表示が必要な領域
に塗布、乾燥して使用することができる。溶剤は、前記
アントラキノン系色素や他の成分の溶解性を考慮して選
択されるが、バインダー樹脂の溶解性、色素の安定性及
び印刷時の乾燥の効率を考慮すれば、エタノール、メタ
ノール、酢酸エチル、イソプロパノール、n−プロパノ
ール、トルエン、シクロヘキサン、酢酸−n−プロピル
などが好ましい。
The indicator for plasma sterilization of the present invention comprises:
Each of the above components can be dissolved in a suitable solvent, applied to a region requiring display, dried, and used. The solvent is selected in consideration of the solubility of the anthraquinone dye and other components.However, in consideration of the solubility of the binder resin, the stability of the dye, and the drying efficiency during printing, ethanol, methanol, and acetic acid are used. Preferred are ethyl, isopropanol, n-propanol, toluene, cyclohexane, n-propyl acetate and the like.

【0027】次に、本発明の滅菌用包装材料について説
明する。この包装材料は、少なくとも一部がガス透過性
の不織布により構成される滅菌可能である領域を備え、
且つ、必要な強度を有する公知のシート状物を任意に選
択して構成することができる。滅菌可能である領域、即
ち、本発明に適用されるプラズマ滅菌処理に際して、有
効成分であるガス(気体)を透過させ、菌を透過させな
い範囲の透過度を有する不織布からなる領域を少なくと
も一部に有している必要がある。包装材料のすべてをこ
のような滅菌可能な材料で構成することもできるが、コ
スト、強度、内容物の視認性の観点から、一方にガス透
過性材料を用い、他方に透明の合成樹脂シートなどを用
いることも好ましい態様である。例えば、一方にガス透
過性のポリエチレン、又は、ポリプロピレン等の不織
布、他方に透明な合成樹脂シートと2枚のシートを組合
せて用いて、袋状に成形したものは、製造も容易であ
り、内容品の視認性、強度が確保される。
Next, the packaging material for sterilization of the present invention will be described. The packaging material comprises a sterilizable region at least partially composed of a gas permeable nonwoven fabric,
In addition, a known sheet material having a necessary strength can be arbitrarily selected and configured. At least a part of a region that can be sterilized, that is, a region made of a nonwoven fabric having a permeability in a range that allows a gas (gas) as an active ingredient to pass therethrough and does not allow bacteria to pass therethrough in the plasma sterilization treatment applied to the present invention. Must have. Although all of the packaging material can be made of such a sterilizable material, from the viewpoint of cost, strength, and visibility of the contents, a gas permeable material is used for one, and a transparent synthetic resin sheet is used for the other. Is also a preferred embodiment. For example, a nonwoven fabric such as gas-permeable polyethylene or polypropylene on one side and a transparent synthetic resin sheet combined with two sheets on the other side, and molded into a bag, are easy to manufacture, The visibility and strength of the product are secured.

【0028】本発明の滅菌用包装材料は、前記したよう
に、表裏二枚のシートを積層し、両側端近傍に剥離可能
な接着部を設け、少なくともいずれか一方のシートに前
記インジケータによる表示部を設けることにより形成さ
れる。この包装材料は、袋状、ロール状など、所望によ
り任意の形状に加工されて供給される。
As mentioned above, the packaging material for sterilization of the present invention is obtained by laminating two sheets on the front and back sides, providing peelable adhesive portions near both side edges, and displaying the indicator by the indicator on at least one of the sheets. Is formed. This packaging material is supplied after being processed into an arbitrary shape such as a bag shape or a roll shape as desired.

【0029】表示部の形成は、通常、包装材料を構成す
るシート上に少なくとも前記プラズマ滅菌用インジケー
タ組成物を適切な溶剤に溶解し、塗布、乾燥することで
行なわれる。このようにして形成された指示部には、指
示部を保護するための表面保護層を設けることもでき
る。表面保護層は、プラズマ滅菌処理に用いられる過酸
化水素蒸気、又は過酸化水素から誘導されるプラズマを
透過させ、かつ染料の色の変化を透視できるよう透明ま
たは半透明のものならば、どのような成分からも形成す
ることができる。なかでも、表示部との親和性の観点か
ら、前記指示部を形成する組成物を構成するバインダー
を皮膜形成成分として含み、紫外線吸収剤や耐水性付与
のための撥水性の成分、耐磨耗性の成分、具体的にはポ
リエチレンワックスなどのワックス成分などを含有する
組成物から形成されることが好ましい。このような表示
部の表面保護層も前記表示部の形成と同様に溶剤に溶解
して塗布することで実施することができる。
The formation of the display portion is usually performed by dissolving at least the indicator composition for plasma sterilization in a suitable solvent on a sheet constituting a packaging material, coating and drying. The indicator formed in this way may be provided with a surface protective layer for protecting the indicator. The surface protective layer is transparent or translucent so that the hydrogen peroxide vapor used in the plasma sterilization process or the plasma derived from the hydrogen peroxide can be transmitted and the color change of the dye can be seen. It can also be formed from various components. Among them, from the viewpoint of affinity with the display unit, the binder constituting the composition forming the indicator unit is included as a film-forming component, and an ultraviolet absorber, a water-repellent component for imparting water resistance, and abrasion resistance. It is preferably formed from a composition containing an acidic component, specifically, a wax component such as polyethylene wax. Such a surface protective layer of the display unit can be also implemented by dissolving in a solvent and applying the same as in the formation of the display unit.

【0030】滅菌包装材料の表示部は、通常、包装材料
の一部を構成するガス透過性の前記不織布の表面上に形
成される。包装材料の他の構成材料が内部を透視できる
透明なシートである場合には、指示部層は、ガス透過性
の前記不織布の内側あるいは透明な樹脂シートの内側
(すなわち包装材料が形成する袋体の内側)に形成する
ことができる。
The indicator of the sterile packaging material is usually formed on the surface of the gas permeable nonwoven fabric which forms part of the packaging material. In the case where the other constituent material of the packaging material is a transparent sheet through which the inside can be seen, the indicator portion layer is formed inside the gas permeable nonwoven fabric or inside the transparent resin sheet (that is, the bag formed by the packaging material) Inside).

【0031】インジケータを構成する前記組成物は、印
刷インキの調製に用いられているような公知の混練方法
を使って均質に混合され、次に、これを包装材料を構成
するシート状物の上に塗布して指示部を形成する。その
塗布方法としては、公知の印刷方法、例えば、オフセッ
ト印刷、フレキソ印刷あるいはグラビア印刷等に準じて
行なう方法が挙げられる。表示部上に表面保護層を形成
する場合にも、同様の方法をとることができる。表示部
の塗布量には特に制限はなく、表示が視認できる限り任
意に選択できるが、一般的には、0.2〜20g/m2
程度であり、好ましくは1〜10g/m2の範囲であ
る。塗布量が少なすぎると滅菌処理後の視認性に劣り、
多すぎると輸送や保管時における耐傷性が低下する傾向
がある。また、所望により設けられる表面保護層の塗布
量は、1〜10g/m2の範囲であることが好ましい。
なお、本発明のインジケーターは変色速度が早いため、
プラズマ滅菌処理に好適に使用し得るものであるが、そ
の変色の反応機構は、酸、アルカリの変化を検知するも
のであり、プラズマ滅菌処理の如き速度を必要としない
滅菌処理であっても、酸、アルカリが変化する滅菌処
理、例えば、EOG滅菌などのインジケーターとして有
用であることは言うまでもない。
The composition constituting the indicator is homogeneously mixed by using a known kneading method such as that used in the preparation of printing ink, and then is mixed with the sheet material constituting the packaging material. To form an indicator. Examples of the application method include a method according to a known printing method, for example, offset printing, flexographic printing, gravure printing, or the like. The same method can be used for forming a surface protective layer on the display unit. There is no particular limitation on the coating amount of the display unit can be selected arbitrarily as long as the display is visible, in general, 0.2 to 20 g / m 2
And preferably in the range of 1 to 10 g / m 2 . If the coating amount is too small, the visibility after the sterilization treatment is poor,
If the amount is too large, the scratch resistance during transportation and storage tends to decrease. The coating amount of the optional surface protective layer is preferably in the range of 1 to 10 g / m 2 .
Since the indicator of the present invention has a high discoloration speed,
Although it can be suitably used for plasma sterilization, its discoloration reaction mechanism is to detect changes in acid and alkali, and even in sterilization that does not require speed as in plasma sterilization, Needless to say, it is useful as an indicator for sterilization treatment in which acid and alkali are changed, for example, EOG sterilization.

【0032】[0032]

【実施例】以下に、本発明を具体的な実施例を用いて詳
細に説明するが、本発明はこれらに制限されるものでは
ない。なお、以下の実施例において、「%」は、他に断
らない限り「重量%」を示す。
The present invention will be described below in detail with reference to specific examples, but the present invention is not limited to these examples. In the following examples, “%” indicates “% by weight” unless otherwise specified.

【0033】(実施例1〜6)プラズマ滅菌用インジケ
ータを構成する下記表1に記載の各成分を混合、溶解
し、均質になるまでロールミルで練り合わせて、指示部
形成用の組成物を調製した。
(Examples 1 to 6) The components shown in Table 1 below which constitute the indicator for plasma sterilization were mixed, dissolved, and kneaded with a roll mill until homogeneous to prepare a composition for forming the indicator. .

【0034】[0034]

【表1】 [Table 1]

【0035】前記インジケータ組成物を、高密度ポリエ
チレン不織布のシート表面にグラビアロールを用いるグ
ラビア法で乾燥後の塗布量が10g/m2となるように
塗布し、表示部を形成した。表示部の色相を前記表1に
示す。
The indicator composition was applied to the sheet surface of a high-density polyethylene nonwoven fabric by a gravure method using a gravure roll so that the coating amount after drying was 10 g / m 2 to form a display portion. Table 1 shows the hues of the display section.

【0036】(プラズマ滅菌用インジケータの評価) 1.表示性能 前記不織布シートを低温プラズマ滅菌システム〔STE
RRAD−100(商標)ジョンソン・エンド・ジョン
ソンメディカル(株)製〕に入れて75分間滅菌処理を
行ない、表示部の色相の変化を観察した。結果を下記表
1に示す。 2.変色速度 前記不織布シートに表示部を形成した直後に、低温プラ
ズマ滅菌システム〔STERRAD−100(商標)ジ
ョンソン・エンド・ジョンソンメディカル(株)製〕に
入れて過酸化水素を注入後1分間で処理を中止し、目視
にて表示部の色相の変化を観察した。完全に変色してい
るものを○、目視にては変色を検知できなかったものを
×と評価した。 3.変色性 表示部を形成したのち、常温にて一週間放置し、表示性
能と同様の試験を行ない、経時後の変色性を評価した。
(Evaluation of Indicator for Plasma Sterilization) Display Performance The nonwoven fabric sheet is treated with a low-temperature plasma sterilization system [STE
RRAD-100 (trade name, manufactured by Johnson & Johnson Medical Co., Ltd.)], and subjected to a sterilization treatment for 75 minutes. The results are shown in Table 1 below. 2. Discoloration speed Immediately after the display portion is formed on the nonwoven fabric sheet, it is placed in a low-temperature plasma sterilization system [STERRAD-100 (trademark) manufactured by Johnson & Johnson Medical Co., Ltd.] and treated for 1 minute after hydrogen peroxide is injected. The operation was stopped, and the change in hue of the display portion was visually observed. A sample that completely discolored was evaluated as ○, and a sample whose coloration was not detected visually was evaluated as x. 3. Discoloration After forming the display part, it was left at normal temperature for one week, and the same test as the display performance was performed to evaluate the discoloration after lapse of time.

【0037】4.滅菌包装材料の滅菌性能及び表示性能 前記不織布シートを片面に用い、他方に透明のポリエス
テル/低密度ポリエチレン積層フィルムを用い、三方を
ヒートシールして滅菌包装袋を作成した。この滅菌袋の
中に生物学的インジケータ(BI)を入れて密閉し、低
温プラズマ滅菌システム〔STERRAD−100(商
標)ジョンソン・エンド・ジョンソンメディカル(株)
製〕に入れて75分間滅菌処理を行なった。滅菌後の表
示部の色相の変化を観察した。結果を下記表2に示す。
また、生物学的インジケータ(有芽胞菌:標準菌No.
ATC9372)を無菌的に取出し、滅菌済みTSB培
地に植え込み、35℃で7日間培養した後、菌の発育の
有無を目視により確認した。結果を下記表2に示す。
4. Sterilization performance and display performance of sterile packaging material The nonwoven fabric sheet was used on one side, and a transparent polyester / low-density polyethylene laminated film was used on the other side, and three sides were heat-sealed to produce a sterile packaging bag. A biological indicator (BI) is placed in the sterilization bag and sealed, and a low-temperature plasma sterilization system [STERAD-100 (trademark) Johnson & Johnson Medical Co., Ltd.]
And sterilized for 75 minutes. The change in the hue of the display after sterilization was observed. The results are shown in Table 2 below.
In addition, a biological indicator (spore-forming bacterium: standard bacterium No.
ATC9372) was aseptically taken out, inoculated in a sterilized TSB medium, cultured at 35 ° C. for 7 days, and the presence or absence of bacterial growth was visually checked. The results are shown in Table 2 below.

【0038】[0038]

【表2】 [Table 2]

【0039】表2に明らかなように本発明のプラズマ滅
菌用インジケータはプラズマ滅菌処理により速やかに変
色し、変色速度も速く、優れた表示機能を果たすことが
確認された。また、滅菌包装材料の形態をとった場合で
も、表示機能に問題はなく、また、プラズマ滅菌処理効
果にも問題がないことが確認された。
As is clear from Table 2, it was confirmed that the indicator for plasma sterilization of the present invention was quickly discolored by the plasma sterilization treatment, had a fast discoloration speed, and exhibited an excellent display function. It was also confirmed that there was no problem in the display function and no problem in the effect of the plasma sterilization treatment even when the sterilized packaging material was used.

【0040】[0040]

【発明の効果】本発明によれば、変色助剤を用いなくと
も、被殺菌物へのプラズマ殺菌処理が行われたかどうか
が明確に判定でき、安定性に優れ、表示にあたっての変
色速度が早いプラズマ滅菌用インジケータを提供しう
る。また、本発明の滅菌用包装材料は前記プラズマ滅菌
用インジケータを用いた表示部を形成してなるため、表
示部の安定性に優れ、被殺菌物へのプラズマ殺菌処理が
行われたかどうかが明確に判定できる。
According to the present invention, it is possible to clearly determine whether or not the object to be sterilized has been subjected to the plasma sterilization treatment without using a discoloration aid, and it is excellent in stability and has a high discoloration speed for displaying. An indicator for plasma sterilization may be provided. In addition, since the sterilization packaging material of the present invention is formed with a display unit using the plasma sterilization indicator, the display unit has excellent stability, and it is clear whether or not the object to be sterilized has been subjected to plasma sterilization. Can be determined.

───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.7 識別記号 FI テーマコート゛(参考) G01N 21/80 G01N 21/80 Fターム(参考) 2G042 FA12 FB05 2G054 AA04 AB10 BB20 CA03 CE01 EA06 GA03 GB04 GE10 JA04 4C058 AA06 AA12 BB06 KK06 ──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. 7 Identification symbol FI Theme coat ゛ (Reference) G01N 21/80 G01N 21/80 F-term (Reference) 2G042 FA12 FB05 2G054 AA04 AB10 BB20 CA03 CE01 EA06 GA03 GB04 GE10 JA04 4C058 AA06 AA12 BB06 KK06

Claims (8)

【特許請求の範囲】[Claims] 【請求項1】 pHの変化に伴い色相が変化する化合物
と、バインダーとを含有するプラズマ滅菌用インジケー
タ。
1. An indicator for plasma sterilization comprising a compound whose color changes with a change in pH and a binder.
【請求項2】 前記pHの変化に伴い色相が変化する化
合物が、pHの変化に伴い開環反応を生起することで色
相が変化する化合物である請求項1に記載のプラズマ滅
菌用インジケータ。
2. The indicator for plasma sterilization according to claim 1, wherein the compound whose hue changes with a change in pH is a compound whose hue changes by causing a ring opening reaction with a change in pH.
【請求項3】 前記pHの変化に伴い色相が変化する化
合物が、スルホフタレン系化合物、ナフトールフタレン
系化合物、フェノールフタレイン系化合物からなる群よ
り選択される1種又は2種以上の化合物であることを特
徴とする請求項2に記載のプラズマ滅菌用インジケー
タ。
3. The compound whose hue changes with a change in pH is one or more compounds selected from the group consisting of sulfophthalene compounds, naphtholphthalene compounds, and phenolphthalein compounds. The indicator for plasma sterilization according to claim 2, characterized in that:
【請求項4】 前記pHの変化に伴い色相が変化する化
合物が、分子内の水酸基と雰囲気内の過酸化水素とが反
応することで色相が変化する化合物である請求項1に記
載のプラズマ滅菌用インジケータ。
4. The plasma sterilization according to claim 1, wherein the compound whose hue changes with a change in pH is a compound whose hue changes when a hydroxyl group in a molecule reacts with hydrogen peroxide in an atmosphere. Indicator.
【請求項5】 前記pHの変化に伴い色相が変化する化
合物が、ヘマトキシリン、ラクモイド、アリザリンスル
ホン酸ナトリウムからなる群より選択される1種又は2
種以上の化合物であることを特徴とする請求項4に記載
のプラズマ滅菌用インジケータ。
5. The compound whose hue changes with a change in pH is one or two selected from the group consisting of hematoxylin, lacmoid, and sodium alizarin sulfonate.
The indicator for plasma sterilization according to claim 4, wherein the indicator is at least one kind of compound.
【請求項6】 前記pHの変化に伴い色相が変化する化
合物が、分子内に二重結合と連結された窒素原子(−N
=)を有し、pHの変化に伴い該二重結合部分が開くこ
とで色相が変化する化合物である請求項1に記載のプラ
ズマ滅菌用インジケータ。
6. A compound whose hue changes with a change in pH is a nitrogen atom (-N) linked to a double bond in the molecule.
2. The indicator for plasma sterilization according to claim 1, wherein the compound is a compound having the following formula: ## EQU2 ## and the hue changes when the double bond is opened with a change in pH.
【請求項7】 前記pHの変化に伴い色相が変化する化
合物が、ナイルブルー、キノリンブルー、レザズリンか
らなる群より選択される1種又は2種以上の化合物であ
ることを特徴とする請求項6に記載のプラズマ滅菌用イ
ンジケータ。
7. The compound whose hue changes with a change in pH is one or more compounds selected from the group consisting of Nile Blue, Quinoline Blue, and Resazurin. 5. The indicator for plasma sterilization according to 4.
【請求項8】 少なくとも一部がガス透過性不織布によ
り構成され、プラズマ滅菌処理のための被滅菌物を収納
しうる滅菌用包装材料であって、前記請求項1乃至請求
項7のいずれか1項に記載のプラズマ滅菌用インジケー
タからなる表示部が形成されてなることを特徴とする滅
菌用包装材料。
8. A sterilizing packaging material at least partially composed of a gas-permeable nonwoven fabric and capable of storing an object to be sterilized for plasma sterilization treatment, wherein the packaging material is one of the above-mentioned items 1 to 7. 14. A packaging material for sterilization, comprising: a display section comprising the indicator for plasma sterilization according to any one of the above items.
JP2001106347A 2001-04-04 2001-04-04 Plasma sterilization indicator and sterilization packaging material Expired - Fee Related JP4574048B2 (en)

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JP2007298315A (en) * 2006-04-28 2007-11-15 Powdertech Co Ltd Manufacturing method of oxygen detector
US8222327B2 (en) 2008-03-10 2012-07-17 Hogy Medical Co., Ltd. Plasma sterilization indicator
JP2013178922A (en) * 2012-02-28 2013-09-09 Nagoya Industries Promotion Corp Indicator, sheet for evaluation, and plasma processing evaluation method
JP2014126410A (en) * 2012-12-25 2014-07-07 Sakura Color Products Corp Ink composition for detection of hydrogen peroxide gas and hydrogen peroxide gas detection indicator
US20160141192A1 (en) 2013-08-22 2016-05-19 Sakura Color Products Corporation Indicator used in electronic device manufacturing apparatus and method for designing and/or managing the apparatus
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