JPH0584281A - High-pressure steam sterilization method for medical treatment container - Google Patents
High-pressure steam sterilization method for medical treatment containerInfo
- Publication number
- JPH0584281A JPH0584281A JP3273057A JP27305791A JPH0584281A JP H0584281 A JPH0584281 A JP H0584281A JP 3273057 A JP3273057 A JP 3273057A JP 27305791 A JP27305791 A JP 27305791A JP H0584281 A JPH0584281 A JP H0584281A
- Authority
- JP
- Japan
- Prior art keywords
- packaging container
- container
- film
- upper chamber
- blood bag
- 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.)
- Pending
Links
- 230000001954 sterilising effect Effects 0.000 title claims abstract description 20
- 238000004659 sterilization and disinfection Methods 0.000 title claims abstract description 17
- 238000000034 method Methods 0.000 title claims description 7
- 238000004806 packaging method and process Methods 0.000 claims abstract description 34
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 16
- 238000001035 drying Methods 0.000 claims abstract description 7
- 238000007789 sealing Methods 0.000 claims abstract description 6
- 239000000463 material Substances 0.000 claims abstract description 4
- 239000008280 blood Substances 0.000 abstract description 24
- 210000004369 blood Anatomy 0.000 abstract description 24
- 239000007788 liquid Substances 0.000 abstract description 3
- 239000000126 substance Substances 0.000 abstract description 2
- 230000002265 prevention Effects 0.000 abstract 1
- 238000001291 vacuum drying Methods 0.000 abstract 1
- 239000004743 Polypropylene Substances 0.000 description 2
- -1 polypropylene Polymers 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 238000003303 reheating Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 229940123973 Oxygen scavenger Drugs 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は薬液容器、血液バッグ等
の医療容器のオートクレーブ滅菌方法の改良に関するも
ので、特に医療容器を包装した後オートクレーブ滅菌を
行いさらに乾燥処理する方法に関する。以下血液バッグ
の例について説明する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an improvement in a method for autoclave sterilization of medical containers such as a liquid medicine container and a blood bag, and more particularly to a method of packaging a medical container, sterilizing it in an autoclave and further drying it. An example of the blood bag will be described below.
【０００２】[0002]
【従来技術および発明が解決しようとする課題】従来血
液バッグのオートクレーブ滅菌処理は、血液バッグをオ
ートクレーブ滅菌処理後に冷却、乾燥した後に包装して
いた。これは包装してオートクレーブ滅菌を行うと血液
バッグの相互間の密着（ブロッキング）が生じ血液バッ
グとしての機能を損ねてしまうこと及び包装容器内部に
水蒸気が侵入し、冷却後凝縮して水滴となり血液バッグ
が塗れた状態になることがあげられる。2. Description of the Related Art Conventionally, in autoclave sterilization of blood bags, blood bags have been cooled, dried and then packaged after autoclave sterilization. This is because packing and autoclave sterilization causes the blood bags to adhere to each other (blocking), impairing the function as a blood bag, and water vapor invades the inside of the packaging container, condensing after cooling and forming water drops. The bag may be painted.
【０００３】本来は、血液バッグは包装した後に滅菌す
ることができれば、血液バッグの表面も滅菌され、最も
好ましいが上述の理由でオートクレーブ滅菌後、外気に
露して乾燥した後に包装されている。従って血液バッグ
の表面はもはや無菌状態ではなくなり、この状態で包装
するとカビの発生が生ずる。従ってこの問題を解決する
ために包装材料をガスバリヤー性として包装容器内に脱
酸素剤を封入し酸素を除去してカビの発生を防止するこ
とが提案されている。又、血液バッグを包装してから再
加熱して表面を殺菌する手法もとられている。Originally, if the blood bag can be sterilized after packaging, the surface of the blood bag is also sterilized, and most preferably, after sterilizing by autoclave, the blood bag is exposed to the outside air and dried before being packaged. Therefore, the surface of the blood bag is no longer in a sterile state, and if it is packaged in this state, mold is generated. Therefore, in order to solve this problem, it has been proposed that the packaging material has a gas barrier property and a deoxidizer is enclosed in the packaging container to remove oxygen to prevent the generation of mold. Another method is to sterilize the surface by packaging the blood bag and then reheating it.
【０００４】以上述べたように、包装してからオートク
レーブ滅菌を行えば、血液バッグは無菌状態を維持さ
れ、脱酸素剤の封入や再加熱による滅菌も不要となる。
この包装滅菌の課題は、オートクレーブ滅菌による水蒸
気が製品に触れ冷却後凝縮して水滴となることである。
従って水滴を包装の内部から速やかに除去でき、かつ薬
液容器の水分透過を防止できる包装形態が必要となる。
そこで本発明者は以上の課題を解決するために鋭意検討
を重ねた結果次の発明に到達した。As described above, if autoclave sterilization is performed after packaging, the blood bag is maintained in a sterile state, and sterilization by encapsulating an oxygen scavenger and reheating is unnecessary.
The problem of this packaging sterilization is that water vapor due to autoclave sterilization touches the product and is cooled and then condensed to form water droplets.
Therefore, there is a need for a packaging form in which water droplets can be promptly removed from the inside of the package and water permeation of the chemical solution container can be prevented.
Therefore, the present inventor has arrived at the next invention as a result of extensive studies to solve the above problems.
【０００５】[0005]
【課題を解決するための手段】本発明は次の各工程から
なる医療容器の高圧蒸気滅菌方法を提供するものであ
る。 （１）水蒸気難透過性の材質からなり、水蒸気易透過性
のフィルムにより内部空間を二つ室に仕切られた包装容
器の前記フィルムと一方の室の端部間を開口状態にし
て、他方の室に医療容器を封入する工程、 （２）前記（１）の包装容器のフィルムと一方の室の端
部間を開口状態にしたまま高圧蒸気滅菌処理を行う工
程、 （３）前記（２）の包装容器を乾燥処理する工程、 （４）前記（３）の包装容器の開口端部を密封する工
程、The present invention provides a method for high-pressure steam sterilization of a medical container, which comprises the following steps. (1) A film of a packaging container made of a material that is less permeable to water vapor and having an inner space partitioned by a water vapor permeable film into two chambers, and one end of the chamber is opened, and the other is opened. A step of enclosing a medical container in the chamber, (2) a step of performing high-pressure steam sterilization with the film of the packaging container of the above (1) and an end portion of one chamber left open, (3) the above (2) Drying the packaging container according to (4), (4) sealing the open end of the packaging container according to (3),
【０００６】[0006]
【実施例】図１は血液バッグ５の包装容器１の概略図
で、図２は図１の右側面図である。包装容器１は、たと
えばポリプロピレン（厚さ７０μ）／延伸ナイロン（厚
さ１５μ）等の耐熱性、水蒸気難透過性の材質からな
り、内部空間は例えばポリプロピレン含浸紙等からなる
耐熱性、水蒸気易透過性フィルム２により二つの室（上
室３と下室４）に仕切られている。1 is a schematic view of a packaging container 1 for a blood bag 5, and FIG. 2 is a right side view of FIG. The packaging container 1 is made of, for example, polypropylene (thickness 70 μ) / stretched nylon (thickness 15 μ), which is heat resistant and water vapor impermeable, and the internal space is made of polypropylene impregnated paper, etc. It is divided into two chambers (upper chamber 3 and lower chamber 4) by the permeable film 2.
【０００７】次に血液バッグ５を包装容器１に包装して
滅菌乾燥処理する方法について説明する。血液バッグ５
を包装容器１の上室３に封入して、包装容器１の上室３
側の端部とフィルム２の端部をヒートシールして密封す
る。他方の下室４側の端部とフィルム２の端部は開口状
態にされている（図中、６は開口部、７はシール部であ
る。）Next, a method of wrapping the blood bag 5 in the packaging container 1 and sterilizing and drying it will be described. Blood bag 5
Is enclosed in the upper chamber 3 of the packaging container 1, and the upper chamber 3 of the packaging container 1
The side end and the end of the film 2 are heat-sealed and hermetically sealed. The other end of the lower chamber 4 side and the end of the film 2 are in an open state (in the figure, 6 is an opening and 7 is a sealing part).
【０００８】この状態で包装容器１を高圧蒸気滅菌処理
（１２１℃、２０分間）すると蒸気は開口部６、フィル
ム２を経て上室３内に入り、血液バッグ５は滅菌され
る。続いて包装容器を、温度６０〜８０℃、圧力４００
ｍｍＨｇで減圧乾燥処理する。密封された上室３内の水
滴はフィルム２、開口端部６を経て揮散し、血液バッグ
５は表１に示す通り約３時間で乾燥させることができ
た。In this state, when the packaging container 1 is subjected to high-pressure steam sterilization (121 ° C., 20 minutes), steam enters the upper chamber 3 through the opening 6 and the film 2, and the blood bag 5 is sterilized. Subsequently, the packaging container is placed at a temperature of 60 to 80 ° C. and a pressure of 400.
Dry under reduced pressure at mmHg. Water droplets in the sealed upper chamber 3 were volatilized through the film 2 and the open end portion 6, and the blood bag 5 could be dried in about 3 hours as shown in Table 1.
【０００９】[0009]
【表１】 [Table 1]
【００１０】乾燥後、図４に示すように開口部６（フィ
ルム２の端部と包装容器１の下室４側の端部）をヒート
シールして血液バッグを完全に密封する（図中８はシー
ル部である）。After drying, the opening 6 (the end of the film 2 and the end on the lower chamber 4 side of the packaging container 1) is heat-sealed as shown in FIG. 4 to completely seal the blood bag (8 in the figure). Is the seal).
【００１１】[0011]
【発明の作用効果】以上説明したように本発明によれ
ば、包装容器の開口部６をシールにして密封する前は水
蒸気が開口部６、フィルム２を経て血液バッグ５を封入
した上室３内に容易に出入りすることができるので血液
バッグ５は完全に滅菌処理することができる。また高圧
蒸気滅菌処理後は無菌状態を保ちながら乾燥処理するこ
とができる。このため従来のように雑菌による汚染や水
滴の付着等に帰因するカビの発生等は全くなく、衛生的
で安心して治療に使用することができる。As described above, according to the present invention, the upper chamber 3 in which the blood bag 5 is enclosed by the water vapor through the opening 6 and the film 2 before the opening 6 of the packaging container is sealed and sealed. The blood bag 5 can be completely sterilized because it can be easily moved in and out. Further, after the high-pressure steam sterilization treatment, it is possible to perform a drying treatment while maintaining the sterility. For this reason, there is no generation of mold caused by contamination with various bacteria or adhesion of water drops as in the conventional case, and it can be used for treatment hygienically and with peace of mind.
【図１】 本発明に使用する包装容器の概略図FIG. 1 is a schematic view of a packaging container used in the present invention.
【図２】 図１の右側側面図FIG. 2 is a right side view of FIG.
【図３】 医療容器を封入したところの包装容器の概略
図FIG. 3 is a schematic view of a packaging container in which a medical container is enclosed.
【図４】 包装容器を密封したところの概略図FIG. 4 is a schematic view of a sealed packaging container.
１ 包装容器 ２ フィルム ３ 上室 ４ 下室 ５ 血液バッグ ６ 開口部 1 Packaging Container 2 Film 3 Upper Chamber 4 Lower Chamber 5 Blood Bag 6 Opening
Claims (1)
菌方法。 （１）水蒸気難透過性の材質からなり、水蒸気易透過性
のフィルムにより内部空間を二つ室に仕切られた包装容
器の前記フィルムと一方の室の端部間を開口状態にし
て、他方の室に医療容器を封入する工程、 （２）前記（１）の包装容器のフィルムと一方の室の端
部間を開口状態にしたまま高圧蒸気滅菌処理を行う工
程、 （３）前記（２）の包装容器を乾燥処理する工程、 （４）前記（３）の包装容器の開口端部を密封する工
程、1. A method for high-pressure steam sterilization of a medical container, which comprises the following steps. (1) A film of a packaging container made of a material that is less permeable to water vapor and having an inner space partitioned by a water vapor permeable film into two chambers, and one end of the chamber is opened, and the other is opened. A step of enclosing a medical container in the chamber, (2) a step of performing high-pressure steam sterilization treatment while leaving an open state between the film of the packaging container of the above (1) and the end of one chamber, (3) the above (2) Drying the packaging container according to (4), (4) sealing the open end of the packaging container according to (3),
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3273057A JPH0584281A (en) | 1991-09-25 | 1991-09-25 | High-pressure steam sterilization method for medical treatment container |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3273057A JPH0584281A (en) | 1991-09-25 | 1991-09-25 | High-pressure steam sterilization method for medical treatment container |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH0584281A true JPH0584281A (en) | 1993-04-06 |
Family
ID=17522553
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP3273057A Pending JPH0584281A (en) | 1991-09-25 | 1991-09-25 | High-pressure steam sterilization method for medical treatment container |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH0584281A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH08164190A (en) * | 1994-06-01 | 1996-06-25 | Ethicon Inc | Sterilization process |
| JPH11253896A (en) * | 1997-12-17 | 1999-09-21 | Ethicon Inc | Integrated cleaning and sterilizing method |
| JPH11277005A (en) * | 1997-12-17 | 1999-10-12 | Ethicon Inc | Unclosed circulation treatment apparatus for lumen device |
| WO2011157705A1 (en) | 2010-06-16 | 2011-12-22 | Dsm Ip Assets B.V. | A package comprising a sterilized content |
-
1991
- 1991-09-25 JP JP3273057A patent/JPH0584281A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH08164190A (en) * | 1994-06-01 | 1996-06-25 | Ethicon Inc | Sterilization process |
| JPH11253896A (en) * | 1997-12-17 | 1999-09-21 | Ethicon Inc | Integrated cleaning and sterilizing method |
| JPH11277005A (en) * | 1997-12-17 | 1999-10-12 | Ethicon Inc | Unclosed circulation treatment apparatus for lumen device |
| WO2011157705A1 (en) | 2010-06-16 | 2011-12-22 | Dsm Ip Assets B.V. | A package comprising a sterilized content |
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