JP6042633B2 - Article carrying method and package for carrying article - Google Patents

Article carrying method and package for carrying article Download PDF

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JP6042633B2
JP6042633B2 JP2012109393A JP2012109393A JP6042633B2 JP 6042633 B2 JP6042633 B2 JP 6042633B2 JP 2012109393 A JP2012109393 A JP 2012109393A JP 2012109393 A JP2012109393 A JP 2012109393A JP 6042633 B2 JP6042633 B2 JP 6042633B2
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package
decontamination gas
packaging material
bag
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JP2013237452A (en
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和仁 谷本
和仁 谷本
慧 松井
慧 松井
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Shibuya Corp
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Description

本発明は、アイソレータ等の無菌環境へ物品を搬入する物品搬入方法および物品搬入用の包装体に関するものである。   The present invention relates to an article carrying method for carrying an article into an aseptic environment such as an isolator and a package for carrying the article.

アイソレータ等の無菌環境内に、滅菌処理済みの物品を搬入する際に、この物品を包装材により包装し、包装材の外面を滅菌した後、無菌環境内で包装を除去するようにした発明が従来から知られている（例えば、特許文献１または特許文献２参照）。   An invention in which when a sterilized article is carried into an aseptic environment such as an isolator, the article is packaged with a packaging material, the outer surface of the packaging material is sterilized, and then the packaging is removed in the aseptic environment. Conventionally known (see, for example, Patent Document 1 or Patent Document 2).

特許文献１に記載された発明では、包装対象物を三重に滅菌袋によって包装し、電子線照射、ガンマ線照射等により滅菌してから、最も外側の滅菌袋を破ってその中身の二重の滅菌袋を取り出して即座にパスボックス内に入れ、蓋を閉めて二重滅菌袋の外側への菌の付着およびクリーンルームへの雑菌の進入を防止している。次に、よりクリーン度の高いクリーンルーム側からパスボックスの蓋を開け、二重滅菌包装物をクリーンルーム内に搬入する。続いて、二重滅菌包装物の外側の滅菌袋を破いてその中身の一重滅菌包装物を取り出して、即座にグローブボックス内に収容する。   In the invention described in Patent Document 1, the packaging object is wrapped in three sterilization bags, sterilized by electron beam irradiation, gamma ray irradiation, etc., and then the outermost sterilization bag is broken to double sterilize the contents. The bag is taken out and immediately put in the pass box, and the lid is closed to prevent the bacteria from adhering to the outside of the double sterilized bag and entering the clean room. Next, the lid of the pass box is opened from the clean room side with a higher degree of cleanliness, and the double sterilized package is carried into the clean room. Subsequently, the sterilization bag on the outer side of the double sterilized package is torn and the single sterilized package is taken out and immediately stored in the glove box.

また、特許文献２に記載された発明では、予め滅菌処理された物品を梱包材によって包装して滅菌装置内に収容し、滅菌装置内で包装の外面を過酸化水素蒸気等の除染ガスによって滅菌処理した後、無菌空間内に搬入して前記包装を剥離して除去する。   Moreover, in the invention described in Patent Document 2, an article that has been sterilized in advance is packaged with a packing material and accommodated in a sterilizer, and the outer surface of the package is decontaminated in the sterilizer using a decontamination gas such as hydrogen peroxide vapor. After sterilization, it is carried into an aseptic space and the package is peeled off and removed.

特開２００８−２３９１６８号公報JP 2008-239168 A 特許第３５０３２８４号公報Japanese Patent No. 3503284

無菌環境に搬入する物品が除染ガス成分を取り除きにくい場合や、除染ガスの影響を受けやすい場合には、包装用の袋に入れて内部を電子線やガンマ線で滅菌し、外部を除染ガスによって除染して搬入する。このように包装体の外部を除染するために科学的な除染ガスを使用した場合には、少なからず除染ガス成分が包装体を透過してしまう。特に、物品を収容した包装体の外面の滅菌を十分に行おうとすると、透過する除染ガスの量が多くなってしまう。除染ガス成分が大量に透過した場合には、その後の除染ガス成分を取り除くエアレーションに要する時間が長くかかるという問題が発生するとともに、除去が不十分な場合には除染ガス成分が包装体から無菌環境に再放出されてしまう。また、透過した除染ガスが少量であっても、その影響を受けやすい物品の場合には問題が発生する。   If it is difficult to remove the decontamination gas components from the articles brought into the aseptic environment, or if they are easily affected by the decontamination gas, sterilize the inside with an electron beam or gamma ray and decontaminate the outside. Decontamination with gas and carry in. Thus, when scientific decontamination gas is used to decontaminate the outside of the package, not a few decontamination gas components permeate the package. In particular, if sufficient sterilization is performed on the outer surface of the package containing the articles, the amount of the decontamination gas that permeates increases. If a large amount of the decontamination gas component permeates, there will be a problem that it takes a long time to aerate to remove the decontamination gas component thereafter. Will be released again into a sterile environment. In addition, even if a small amount of decontamination gas permeates, there is a problem in the case of an article that is susceptible to the influence.

本発明は、前記課題を解決するためになされたもので、物品を包装体に収容し、この包装体の外面を除染ガスで除染した後、無菌環境で包装体から物品を取り出す無菌環境への物品搬入方法において、前記包装体の外側を前記除染ガスが透過する材質の包装材で形成するとともに、内側を前記外側の包装材よりも除染ガスが吸着しやすい材質の包装材で形成し、前記外側の包装材の外面を除染し、外側の包装材を透過してきた除染ガスを内側の包装材に吸着させることを特徴とするものである。   The present invention has been made in order to solve the above-described problems. An aseptic environment in which an article is accommodated in a package, and the outer surface of the package is decontaminated with a decontamination gas, and then the article is removed from the package in an aseptic environment. In the article carrying-in method, the outer side of the packaging body is formed of a packaging material made of a material through which the decontamination gas permeates, and the inner side is made of a packaging material made of a material that is easier to adsorb the decontamination gas than the outer packaging material. Forming, decontaminating the outer surface of the outer packaging material, and adsorbing the decontamination gas that has permeated the outer packaging material to the inner packaging material.

また、第２の発明は、前記第１の発明において、前記包装体が、内部に物品を収容する内側包装体と、この内側包装体を内部に収容する外側包装体から構成されることを特徴とするものである。   According to a second aspect of the present invention, in the first aspect, the package is composed of an inner package that houses an article inside and an outer package that houses the inner package inside. It is what.

さらに、第３の発明は、前記第１の発明において、前記包装体が、内側の除染ガスが吸着しやすい材質の包装材と、外側の除染ガスを透過する材質の包装材を重ね合わせて形成されていることを特徴とするものである。   Furthermore, in a third aspect of the present invention according to the first aspect of the present invention, the packaging body includes a packaging material made of a material that easily absorbs the inner decontamination gas and a packaging material made of a material that allows the outer decontamination gas to pass through. It is characterized by being formed.

また、第４の発明は、物品を包装する包装体であって、外面を過酸化水素またはエチレンオキサイドまたはホルムアルデヒドからなる除染ガスで除染した後、無菌環境内で物品を取り出す物品搬入用の包装体において、外側を上記除染に用いる除染ガスが透過する材質の包装材で形成するとともに、内側を外側の包装材よりも上記除染に用いる除染ガスが吸着しやすい材質の包装材で形成したことを特徴とするものである。

Further, the fourth invention is a package for packaging an article for carrying an article in which the outer surface is decontaminated with a decontamination gas comprising hydrogen peroxide, ethylene oxide or formaldehyde , and then the article is taken out in an aseptic environment. In the packaging body, the outer side is formed of a packaging material made of a material through which the decontamination gas used for the decontamination is permeated, and the inner side is made of a material that is easier to adsorb the decontamination gas used for the decontamination than the outer packaging material It is characterized by being formed by.

本発明の物品搬入方法では、物品を収容する包装体の外側を除染ガスが透過する材質の包装材で形成するとともに、内側を外側の包装材よりも除染ガスが吸収しやすい材質の包装材から形成したので、物品を収容した包装体の外面側は十分除染することができ、また、内側の包装材によって外側の包装材を透過してきた除染ガスを吸着するので、物品を収容している包装体の内部には除染ガスが浸透することがなく、除染ガス成分の再放出を防止するとともに、包装体の外面側は短時間のエアレーションで除染ガス成分を除去することができるという効果を奏する。また、物品搬入用の包装体の発明でも同様の効果を奏することができる。   In the article carrying-in method of the present invention, the outer side of the packaging body that houses the article is formed of a packaging material made of a material that allows the decontamination gas to permeate, and the inner side is made of a material that absorbs the decontamination gas more easily than the outer packaging material. Since the outer surface of the package containing the article can be sufficiently decontaminated, and the inner packaging material absorbs the decontamination gas that has permeated through the outer packaging material. The decontamination gas does not permeate the inside of the package, and the decontamination gas component is prevented from being released again, and the decontamination gas component is removed from the outer surface of the package by short-time aeration. There is an effect that can be. Moreover, the same effect can be achieved by the invention of the package for carrying in articles.

図１は二重袋内に物品を収容した状態を示す図である。（実施例１）FIG. 1 is a view showing a state in which an article is accommodated in a double bag. Example 1 図２は図１に示す二重袋をアイソレータ内に収容して除染する状態を示す図である。FIG. 2 is a view showing a state in which the double bag shown in FIG. 1 is housed in an isolator and decontaminated. 図３は二層の袋内に物品を収容した状態を示す図である。（実施例２）FIG. 3 is a view showing a state in which an article is accommodated in a two-layer bag. (Example 2) 図４は二層袋の材質を示す図である。FIG. 4 is a view showing the material of the two-layer bag.

物品を収容する内側の包装体（内袋）は、除染ガスを吸着しやすい材質の包装材から形成され、この内袋を収容する外側の包装体（外袋）は除染ガスを透過する材質の包装材から形成されており、これら２重の袋によって物品を包装して電子線やガンマ線により内部を除染し、アイソレータ内に収容して除染ガスにより除染を行う。除染ガスは外袋を透過して外袋の内部に入り、その際に外袋の外面を完全に除染する。また、外袋の内部に浸透した除染ガスは、内袋に吸着されて、内袋の内部には浸透しない。従って、内袋の内部に収容した物品は除染ガスの影響を受けず、また、除染ガスは内袋に吸着されるので再放出されることを防止でき、さらに、エアレーションを短時間で済ませることができる。   The inner package (inner bag) that accommodates the article is formed from a packaging material that easily adsorbs the decontamination gas, and the outer package (outer bag) that accommodates the inner bag permeates the decontamination gas. It is made of a packaging material, and the articles are packaged with these double bags, the inside is decontaminated with an electron beam or gamma rays, and the decontamination is performed with a decontamination gas in an isolator. The decontamination gas permeates the outer bag and enters the outer bag, and at that time, the outer surface of the outer bag is completely decontaminated. In addition, the decontamination gas that has penetrated into the outer bag is adsorbed by the inner bag and does not penetrate into the inner bag. Therefore, the articles contained in the inner bag are not affected by the decontamination gas, and the decontamination gas is adsorbed by the inner bag, so that it can be prevented from being released again, and aeration can be completed in a short time. be able to.

以下、図面に示す実施例により本発明を説明する。物品２が内側の包装体（内袋４）内に収容され、開口部４ａがヒートシールされて密封されている。この内袋４が、サイズの大きい外側の包装体（外袋６）内に収容され、開口部６ａがヒートシールされて密封されている。前記内袋４は、前記外袋６よりも除染ガスが吸着しやすいガス吸着性や水蒸気吸着性の高い材質の包装材で形成されている。具体的には、ナイロンや活性炭を原材料とした繊維、不織布、フィルム、シートからなる包装材を袋やバッグ状に形成したものである。また、外袋６は除染ガスが透過する材質の包装材で形成されており、具体的には、一般的に袋やバッグとして成形される樹脂材料であり、比較的ガスバリア性や水蒸気バリア性の低い（ガス透過性や水蒸気透過性の高い）、ＰＥ（ポリエチレン）、ＰＰ（ポリプロピレン）、ＰＳ（ポリスチレン）、ＰＥＴ（ポリエチレンテレフタレート）等が挙げられる。   Hereinafter, the present invention will be described with reference to embodiments shown in the drawings. The article 2 is accommodated in an inner package (inner bag 4), and the opening 4a is heat-sealed and sealed. The inner bag 4 is accommodated in a large outer package (outer bag 6), and the opening 6a is heat-sealed and sealed. The inner bag 4 is formed of a packaging material made of a material having a higher gas adsorbing property and water vapor adsorbing property that allows the decontamination gas to adsorb more easily than the outer bag 6. Specifically, a packaging material composed of fibers, nonwoven fabrics, films, and sheets made from nylon or activated carbon is formed into a bag or bag shape. Moreover, the outer bag 6 is formed of a packaging material made of a material that allows the decontamination gas to permeate. Specifically, the outer bag 6 is a resin material that is generally molded as a bag or a bag, and has relatively gas barrier properties and water vapor barrier properties. Of PE (polyethylene), PP (polypropylene), PS (polystyrene), PET (polyethylene terephthalate), and the like.

前記のように二重の包装体（内袋４と外袋６）の内袋４に物品２を収容した状態で、外袋６の外側から電子線やガンマ線等を照射することにより、外袋６の内面、内袋４の内外面および物品２の表面を除染してアイソレータ８に搬入する。このアイソレータ８には除染ガス発生装置１０が接続されており、この除染ガス発生装置１０からアイソレータ８内に除染ガスが供給されてアイソレータ８の内部および物品２を収容した外側の包装体（外袋６）の外面が除染される。この実施例では、除染ガスは、３５％過酸化水素水溶液から成る過酸化水素蒸気であるが、他に、エチレンオキサイドガス（ＥＯＧ）、ホルムアルデヒドガス等を用いることができる。   By irradiating an electron beam, gamma rays, etc. from the outer side of the outer bag 6 in a state where the article 2 is accommodated in the inner bag 4 of the double package (the inner bag 4 and the outer bag 6) as described above, The inner surface of 6, the inner and outer surfaces of the inner bag 4, and the surface of the article 2 are decontaminated and carried into the isolator 8. A decontamination gas generator 10 is connected to the isolator 8, and a decontamination gas is supplied from the decontamination gas generator 10 into the isolator 8 so as to accommodate the inside of the isolator 8 and the article 2. The outer surface of the (outer bag 6) is decontaminated. In this embodiment, the decontamination gas is hydrogen peroxide vapor composed of a 35% hydrogen peroxide aqueous solution, but ethylene oxide gas (EOG), formaldehyde gas, or the like can also be used.

アイソレータ８内に除染ガスが供給されると、前記物品２を収容した２重の包装体（袋４、６）のうち外側の袋６は、除染ガスを透過するポリエチレン製であり、除染ガスが素材内に浸透することにより十分な除染が行われる。また、外側の袋６を透過して内部に入った除染ガスは、内側の袋４が除染ガスを吸着しやすい材質のナイロンであるため、この除染ガスを吸着し、この内側の袋４内に透過することは防止される。このように物品２を収容した包装材（袋）を材質の異なる２種類の袋（内袋４と外袋６）から構成したので、最も外側の面は確実に除染することができ、しかも、内側の袋４内には除染ガスが入り込まないので、この袋４内に収容されている物品２には除染ガスの悪影響が及ぶことはない。さらに、内袋４から物品２を取り出す際に、除染ガスを外部へ再放出することを防止できる。   When the decontamination gas is supplied into the isolator 8, the outer bag 6 of the double package (bags 4 and 6) containing the article 2 is made of polyethylene that passes the decontamination gas, and is removed. Sufficient decontamination is performed by the dye gas permeating into the material. Further, the decontamination gas that has passed through the outer bag 6 and entered the inside is nylon made of a material that allows the inner bag 4 to easily adsorb the decontamination gas. Permeation into 4 is prevented. Thus, since the packaging material (bag) which accommodated the articles | goods 2 was comprised from two types of bags (inner bag 4 and outer bag 6) from which materials differ, the outermost surface can be decontaminated reliably, and Since the decontamination gas does not enter the inner bag 4, the decontamination gas does not adversely affect the articles 2 accommodated in the bag 4. Furthermore, when taking out the article 2 from the inner bag 4, it is possible to prevent the decontamination gas from being re-released to the outside.

なお、この実施例では、物品２を収容した袋４、６をアイソレータ８内に搬入して、外面の除染をアイソレータ８の内部除染と同時に行っているが、例えば、除染パスボックスを備えている場合には、パスボックス内で除染をしてから無菌状態のアイソレータ８内に搬入するようにしても良い。また、この実施例では、除染ガスである過酸化水素蒸気を透過しやすい材質としてポリエチレンを、そして、過酸化水素蒸気を吸着しやすい材質としてナイロンを用いたが、除染ガスおよび包装体（袋）の材質は前記のものに限定されるものではなく、その他の除染ガスを用いることもでき、その用いるガスの特性に応じた透過する材質、吸着しやすい材質を選択することができる。   In this embodiment, the bags 4 and 6 containing the articles 2 are carried into the isolator 8 and the external surface is decontaminated simultaneously with the internal decontamination of the isolator 8. For example, a decontamination pass box is used. If it is provided, it may be decontaminated in the pass box and then carried into the aseptic isolator 8. In this embodiment, polyethylene is used as a material that easily permeates hydrogen peroxide vapor, which is a decontamination gas, and nylon is used as a material that easily absorbs hydrogen peroxide vapor. The material of the bag) is not limited to those described above, and other decontamination gases can be used, and a permeating material and a material that is easily adsorbed can be selected according to the characteristics of the gas used.

前記実施例では、除染ガスが透過する材質の包装材から成る外側の包装体（外袋６）と、除染ガスを吸着して内部側に透過させない材質の包装材からなる内側の包装体（内袋４）との二重の包装体４、６の内部に物品２を収容したが、必ずしも別の袋（内袋４と外袋６）を二重にして物品２を収容する構成に限るものではない。図３および図４に示す第２実施例は、一つの包装体（袋１２）で同様の効果を得られるようにしたものである。この実施例では、除染ガスを透過しやすいポリエチレン等の材質の包装材（シート１６）と、除染ガスを吸着しやすいナイロン等の材質の包装材（シート１４）を重ね合わせ（図４参照）、除染ガスを透過しやすい材質の包装材１６を外側にして包装体（二層袋１２）を形成する。なお、二層袋１２は、一方の材質の包装材を基材として、他方の材質の包装材をコーティングして形成してもよい。   In the above embodiment, the outer packaging body (outer bag 6) made of a packaging material that allows the decontamination gas to permeate, and the inner packaging body made of a packaging material that does not adsorb the decontamination gas and permeate the inner side. Although the article 2 is accommodated in the double packaging bodies 4 and 6 with the (inner bag 4), the article 2 is not necessarily stored in the double bag (the inner bag 4 and the outer bag 6). It is not limited. In the second embodiment shown in FIGS. 3 and 4, the same effect can be obtained with one package (bag 12). In this embodiment, a packaging material (sheet 16) made of a material such as polyethylene that easily permeates the decontamination gas and a packaging material (sheet 14) made of a material such as nylon that easily adsorbs the decontamination gas are overlapped (see FIG. 4). ), And the packaging body (two-layer bag 12) is formed with the packaging material 16 that is easy to permeate the decontamination gas outside. Note that the two-layer bag 12 may be formed by coating a packaging material of one material as a base material and coating a packaging material of the other material.

前記二層袋１２内に滅菌済みの物品２を収容し、ヒートシール１２ａにより内部を密封する。この２層構造の包装体（二層袋１２）に電子線やガンマ線等による放射線除染を施した後、前記図２の実施例１と同様にアイソレータ８内に搬入し、除染ガス発生装置１０からアイソレータ８内に除染ガス（過酸化水素蒸気）を供給する。過酸化水素蒸気は、二層袋１２の外面側から外側の包装材１６（ポリエチレン）の内部に浸透し外面側を完全に除染する。二層構造の内部側の包装材１４を構成するナイロンは、過酸化水素蒸気を吸着しやすい性質なので、過酸化水素蒸気が外側包装材１６を透過して内側包装材１４に到達すると、内側包装材１４に吸着されて蓄積されるため、物品２ａが収容されている内側包装材１４の内側には到達せず、また、外側包装材１６を透過して外部環境に再放出されることもない。なお、包装体の形態としては、袋やバッグ状に限らず箱や容器状であっても良く、また、材質の異なる内外の包装材で形態が異なっていても良い。   The sterilized article 2 is accommodated in the two-layer bag 12, and the inside is sealed with a heat seal 12a. The two-layer package (two-layer bag 12) is subjected to radiation decontamination using an electron beam, gamma rays, or the like, and then carried into the isolator 8 in the same manner as in Example 1 in FIG. A decontamination gas (hydrogen peroxide vapor) is supplied from 10 into the isolator 8. The hydrogen peroxide vapor penetrates into the outer packaging material 16 (polyethylene) from the outer surface side of the two-layer bag 12 and completely decontaminates the outer surface side. Nylon constituting the packaging material 14 on the inner side of the two-layer structure has a property of easily adsorbing hydrogen peroxide vapor. Therefore, when the hydrogen peroxide vapor passes through the outer packaging material 16 and reaches the inner packaging material 14, the inner packaging Since it is adsorbed and accumulated by the material 14, it does not reach the inside of the inner packaging material 14 in which the article 2a is accommodated, and does not pass through the outer packaging material 16 and is re-released to the external environment. . The form of the package is not limited to a bag or a bag, but may be a box or a container, and the form may be different depending on the inner and outer packaging materials of different materials.

２ 物品
４ 内側包装体（内袋）
６ 外側包装体（外袋） 2 Goods 4 Inner packaging (inner bag)
6 Outer package (outer bag)

Claims (4)

物品を包装体に収容し、この包装体の外面を除染ガスで除染した後、無菌環境で包装体から物品を取り出す無菌環境への物品搬入方法において、
前記包装体の外側を前記除染ガスが透過する材質の包装材で形成するとともに、内側を前記外側の包装材よりも除染ガスが吸着しやすい材質の包装材で形成し、
前記外側の包装材の外面を除染し、外側の包装材を透過してきた除染ガスを内側の包装材に吸着させることを特徴とする物品の搬入方法。 In a method for carrying an article into a sterile environment in which the article is stored in a package and the outer surface of the package is decontaminated with a decontamination gas, and then the article is removed from the package in a sterile environment.
The outside of the packaging body is formed with a packaging material made of a material through which the decontamination gas permeates, and the inside is formed with a packaging material made of a material that easily absorbs the decontamination gas than the outside packaging material,
A method for carrying in an article, wherein the outer surface of the outer packaging material is decontaminated, and the decontamination gas that has permeated through the outer packaging material is adsorbed to the inner packaging material. 前記包装体が、内部に物品を収容する内側包装体と、この内側包装体を内部に収容する外側包装体から構成されることを特徴とする請求項１に記載の物品の搬入方法。   The method for carrying in an article according to claim 1, wherein the packaging body is composed of an inner packaging body that accommodates the article therein and an outer packaging body that accommodates the inner packaging body therein. 前記包装体が、内側の除染ガスが吸着しやすい材質の包装材と、外側の除染ガスを透過する材質の包装材を重ね合わせて形成されていることを特徴とする請求項１に記載の物品の搬入方法。   The packaging body is formed by overlapping a packaging material made of a material that easily adsorbs an inner decontamination gas and a packaging material made of a material that transmits the outer decontamination gas. How to carry in goods. 物品を包装する包装体であって、
外面を過酸化水素またはエチレンオキサイドまたはホルムアルデヒドからなる除染ガスで除染した後、無菌環境内で物品を取り出す物品搬入用の包装体において、
外側を上記除染に用いる除染ガスが透過する材質の包装材で形成するとともに、内側を外側の包装材よりも上記除染に用いる除染ガスが吸着しやすい材質の包装材で形成したことを特徴とする物品搬入用の包装体。 A package for packaging an article,
In a package for carrying goods in, after the outer surface is decontaminated with a decontamination gas consisting of hydrogen peroxide, ethylene oxide or formaldehyde , the article is taken out in a sterile environment.
The outer side is made of a packaging material that allows the decontamination gas used for the decontamination to pass therethrough, and the inner side is made of a packaging material that is easier to adsorb the decontamination gas used for the decontamination than the outer packaging material. A package for carrying goods.
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