JP2017528237A - 滅菌容器、滅菌方法及び滅菌装置 - Google Patents
滅菌容器、滅菌方法及び滅菌装置 Download PDFInfo
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Abstract
Description
a.蒸気滅菌中に1つ又は複数の対象物を収容し、滅菌後にその周囲から隔離するための空間を成す非多孔質材料の基部及び側壁と、
b.前記側壁から外方に向けて延在するリムと、
c.使用時に、蒸気滅菌剤が容器に導入され、前記蒸気滅菌剤及び凝縮液が導管を介して前記容器から取り出されるように構成及び配置された密閉可能な導管と、を備える容器を提供する。
a.滅菌する対象物を受け入れるための開口部と、容器から離れて伸びる容器の基部又はその近くに配置された密閉可能な導管とを有する剛性又は半剛性の容器を準備することと、
b.前記滅菌する対象物を前記空間内に載置することと、
c.前記開口部の上にカバーをつけることと、
d.流体を前記容器から取り除くことと、
e.導管を通して蒸気滅菌剤を前記容器内及び前記容器周辺に前記導管を通過して導入し必要な滅菌を行うことと、
f.前記導管を経由して前記容器内に流体を取り出すことと、
g.前記導管を密閉(シール)することと、を含む方法を提供する。
a.1つ以上の滅菌されるリム付き容器を受容できる空間寸法を有する滅菌チャンバと、
b.滅菌中に各リムに対して挟むように構成された1つ以上の天板と、
c.前記滅菌チャンバの内部から前記滅菌チャンバの外部まで流体経路を提供する1つ以上のポートと、
d.前記1つ以上のポートを介して前記チャンバから流体を取り出すための真空器と、
e.前記1つ以上のポートを介して蒸気滅菌剤を供給する蒸気源と、
f.前記容器の導管を密閉するための密閉装置と、を備える蒸気滅菌装置を提供する。
1回使い切り容器により、再利用容器に伴う性能問題及び保守問題を回避することができる。
パッケージにより、パッケージ内にある流体が排出可能となり、滅菌剤又は殺菌剤を導入してその内容物のすべての表面に行き渡らせる。
装置とパッケージの結合体により、圧力変化、高温、高湿のような滅菌工程中に起こる状態に耐えられるようになる。
滅菌容器/滅菌工程は、対象物の品質に影響を与えたり、滅菌対象物を使用する患者又は工程に危険を及ぼす可能性のある、いかなる方法によっても、その対象物に影響を与えることはない。また、処理される対象物は、滅菌温度及び圧力によって評価する。
密閉され真空パックされた滅菌装填物/対象物を装置から取り出した後も、使用するまでの取扱い中、輸送及び保管中も滅菌状態のままであり、パッケージ密閉の完全性は損なわれない。
対象物の滅菌前のパッケージの認証により、試験され承認されたフィルムから認証された有効な滅菌容器が確実に得られるようにし、滅菌工程、完全密閉性、取り扱い、輸送及び使用期限に関して最も適切な機能性を得やすくするのが望ましい。
装置及びパッケージは、望ましくは、個々の装填物/トレイを、RFIDタグ又は(装填物に取り付けられた)それと同等物に書き込まれた、各自の識別コードを組み込んだ各装填物/トレイ毎に処理することができ個々のパッケージに対するプロセスパラメータのデータログを容易とするために、またその個々の装填物のライフサイクル全体を通じて対象物の個々の負荷の完全な追跡とトレーサビリティを容易とするために、データベースに取り込まれる。
透明な密閉されたパッケージにより、滅菌工程の指標を視覚的に検証しやすくなる。
無菌開封と滅菌装填物への直接アクセスを容易にする密閉された真空パックの滅菌装填物/対象物を簡単に開封できる。
装填物の滅菌後に密閉されてパッケージを真空状態にすると、最終的に滅菌されたパッケージを通常通りの制御下で無菌開放する際に、密閉不完全、パッケージ完全性欠如又はパッケージ開封のいずれかによるパッケージの真空損失を即時に可視表示できるようになる。パッケージが何かの不具合の結果として真空を失った場合には、即座にパッケージは汚染されたとみなされ、もはや滅菌状態ではないと考える。
1.少なくとも115℃の温度の蒸気滅菌剤を容器の内部に少なくとも40分間供給する。
2.少なくとも121℃の温度の蒸気滅菌剤を容器の内部に少なくとも15分間供給する。
3.少なくとも134℃の温度の蒸気滅菌剤を容器の内部に少なくとも3.5分間供給する。
Claims (20)
- 1回使い切りの剛性又は半剛性の1回使い切り/使い捨て容器であって、
a.蒸気滅菌中に対象物を収容し、滅菌後にその周囲から隔離するための空間を成す基部及び側壁と、
b.前記側壁から外方に向けて延在するリムと、
c.断面が長手で、使用時に、蒸気滅菌剤が前記容器に導入でき、前記蒸気滅菌剤及び凝縮液が導管を介して前記容器から除去されるように構成及び配置された密閉可能な導管と、を備える容器。 - 前記長手の導管は、前記基部の近傍または内部に設けられて前記容器の排出を容易とすることを特徴とする請求項1に記載の容器。
- 前記長手の導管の前記断面のアスペクト比は2:1より大きい請求項1又は請求項2に記載の容器。
- 前記長手の導管が2つの対向する長さ50mmより大きく、前記長手の導管を密閉するように互いに密閉可能な前記側壁を含む請求項1乃至請求項3のいずれか1に記載の容器。
- 前記長手の導管の前記側壁の間の間隔が5mmから25mmの間である請求項4に記載の容器。
- 前記長手の導管の前記側壁が前記容器の前記本体から外方に5mm以上延在する請求項4又は請求項5に記載の容器。
- 前記長手の導管が前記容器の側壁の長さの半分以上に沿って延在する請求項1乃至請求項6のいずれか1に記載の容器。
- 少なくとも115℃の内部蒸気滅菌工程の温度に少なくとも40分間耐えることができる材料で形成された請求項1乃至請求項7のいずれか1に記載の容器。
- ポリプロピレン(PP)、直鎖状低密度ポリエチレン(LDPE)、高密度ポリエチレン(HDPE)及びBiaxナイロン(BOPA)、PET−AIOx/PP(Barrialoxのような酸化アルミニウム被覆PET)またはEVOHから選択された材料で形成された請求項1乃至請求項8のいずれか1に記載の容器。
- 熱成形可能な材料または非伸縮性のプラスチック材料で形成された前記容器の前記リムに融着されたカバーを含む、請求項1乃至請求項9のいずれか1に記載の容器。
- 蒸気滅菌方法であって、
a.滅菌する対象物を受け入れるための開口部と、容器から離れて伸びる前記容器の基部またはその近くに配置された、長手の断面を有する密閉可能な導管と、を有する剛性または半剛性の容器を設けることと、
b.前記滅菌する対象物を前記空間内に載置することと、
c.前記開口部の上にカバーをつけることと、
d.流体を前記容器から除去することと、
e.蒸気滅菌剤を前記長手の導管を通過して前記容器内及び前記容器周辺に導入し必要な滅菌を行うことと、
f.前記長手の導管を経由して前記容器から流体を取り出すことと、
g.前記長手の導管を密閉することと、
を含む方法。 - 前記長手の導管は、前記長手の導管の壁をともにヒートシールすることによって、または前記長手の導管の前記壁を一緒に接着することによって密閉される請求項11に記載の方法。
- 前記カバーをヒートシール、超音波溶接、マイクロウェーブ溶接またはレーザー溶接によって前記容器に固定する請求項11又は請求項12に記載の方法。
- 少なくとも115℃の温度の蒸気滅菌剤を前記容器の内部に少なくとも40分間供給する請求項11乃至請求項13のいずれか1に記載の方法。
- 蒸気滅菌装置であって、
a.1つ以上の滅菌されるリム付き容器を受容できる空間寸法を有する滅菌チャンバと、
b.滅菌中に各リムに対して挟むように構成された1つ以上の天板と、
c.前記滅菌チャンバの内部から前記滅菌チャンバの外部まで流体経路を提供する1つ以上のポートと、
d.前記1つ以上のポートを介して前記チャンバから流体を取り出すための真空器と、
e.前記1つ以上のポートを介して蒸気滅菌剤を容器の導管に供給する蒸気源と、
f.前記容器の前記導管を密閉するための密閉装置と、
を備える蒸気滅菌装置。 - 前記1つ以上のポートが、滅菌中に請求項1乃至請求項10のいずれか1に記載の前記容器の前記長手の導管と結合するように構成された長手のポートを含む、請求項15に記載の蒸気滅菌装置。
- 前記滅菌チャンバは、容器の出し入れを可能にするドアを両端部に備えた略管状のチャンバを形成する上部、底部及び側壁を有する請求項16に記載の蒸気滅菌装置。
- 前記チャンバ内の容器のリムを支持するための、各側壁に沿った下部に固定部材を有する請求項17に記載の蒸気滅菌装置。
- 前記アンビルの上に位置するシールユニットと、容器のリムにカバーを密閉するための1つ以上のスペーサとを含む、請求項16又は請求項17に記載の蒸気滅菌装置。
- 前記シールユニットが、ヒートシールユニット、超音波溶接機、またはクランプ機構である請求項19に記載の蒸気滅菌装置。
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