JP2017529291A - 容器およびクロージャ - Google Patents
容器およびクロージャ Download PDFInfo
- Publication number
- JP2017529291A JP2017529291A JP2017532220A JP2017532220A JP2017529291A JP 2017529291 A JP2017529291 A JP 2017529291A JP 2017532220 A JP2017532220 A JP 2017532220A JP 2017532220 A JP2017532220 A JP 2017532220A JP 2017529291 A JP2017529291 A JP 2017529291A
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- JP
- Japan
- Prior art keywords
- closure
- container
- chamber
- wall
- active agents
- 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.)
- Ceased
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- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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Abstract
Description
Claims (49)
- 破壊可能壁を有する密閉されたまたは密閉可能なチャンバと、
ピストンガイドに摺動自在に取り付けられる中空ピストンと
を備え、
前記中空ピストンが外壁を備え、
前記外壁が前記チャンバ内の末端と少なくとも1つの通気開口とを有し、
前記末端が切断形態を有し、
前記中空ピストンが、前記少なくとも1つの通気開口が前記チャンバの通気を可能にする通気位置と、前記少なくとも1つの通気開口が前記チャンバの通気を阻止するように密閉される密閉位置と、前記切断形態が前記破壊可能壁の少なくとも一部を突き破った展開位置との間で前記ピストンガイドを摺動可能であり、
前記外壁が、前記通気位置と前記密閉位置と前記展開位置との間の前記中空ピストンの摺動に解放可能に抵抗する前記ピストンガイドと係合する保持形態を有する、
1つまたは複数の活性薬剤を容器に投入するためのクロージャ。 - 前記ピストンガイドが前記外壁の前記保持形態と係合可能な位置決め形態を備える、
請求項1に記載のクロージャ。 - 前記位置決め形態が、前記外壁の前記保持形態と係合可能な少なくとも1つのフランジ状端部を備える、
請求項2に記載のクロージャ。 - 隙間が前記切断形態に設けられる、
請求項1〜3のいずれか一項に記載のクロージャ。 - 前記切断形態の前記隙間が、前記少なくとも1つの通気開口によって形成される、
請求項4に記載のクロージャ。 - 前記中空ピストンが前記展開位置にあるとき、前記破壊可能壁が前記切断形態の隙間の近接領域で破壊されない、
請求項1〜5のいずれか一項に記載のクロージャ。 - 前記クロージャが前記容器の開口部内に保持され、前記クロージャが前記容器の前記開口部のためのシールを提供する、
容器および、1つまたは複数の活性薬剤を前記容器に投入するための請求項1〜6のいずれか一項に記載のクロージャ。 - 破壊可能壁を有する密閉されたまたは密閉可能なチャンバと、
ピストンガイドに摺動自在に取り付けられる中空ピストンと
を備え、
前記中空ピストンが外壁を備え、
前記外壁が前記チャンバにおいて前記破壊可能壁に面する末端を有し、
前記末端が切断形態と前記切断形態における隙間とを有する、
1つまたは複数の活性薬剤を容器に投入するためのクロージャ。 - 前記中空ピストンが前記チャンバ内のデフォルト位置から摺動可能であり、前記外壁の一部が前記破壊可能壁を通して延在するが前記切断形態の前記隙間に近接する前記破壊可能壁の領域では延在しないように、前記破壊可能壁を突き破る、
請求項8に記載のクロージャ。 - 前記破壊可能壁が、前記中空ピストンが前記破壊可能壁を突き破ると、前記クロージャにヒンジ式に取り付けられたままである、
請求項8または9に記載のクロージャ。 - 前記中空ピストンが、前記破壊可能壁を突き破るために、前記デフォルト位置から手動で摺動可能である、
請求項9または10に記載のクロージャ。 - 前記中空ピストンの前記外壁が、前記中空ピストンの長手方向軸と略平行に整列されてもよく、前記長手方向軸が前記破壊可能壁に略垂直である、
請求項8〜11のいずれか一項に記載のクロージャ。 - 前記切断形態の前記隙間が、前記ピストンの前記外壁の前記末端の凹部である、
請求項8〜12のいずれか一項に記載のクロージャ。 - 前記中空ピストンの前記外壁が、前記クロージャの頂面から延在する、
請求項8〜13のいずれか一項に記載のクロージャ。 - 前記中空ピストンが、前記クロージャの前記頂面を押し下げることによって、手動で摺動可能である、
請求項14に記載のクロージャ。 - 前記クロージャが前記容器の開口部内に保持される、1つまたは複数の活性薬剤を前記容器に投入するための請求項8〜15のいずれか一項に記載の容器およびクロージャ。
- 前記クロージャが、前記容器の前記開口部のためのシールを提供する、
請求項16に記載の容器およびクロージャ。 - 前記中空ピストンを摺動させて前記破壊可能壁の一部を突き破ることにより、前記容器の内部チャンバを前記クロージャの前記チャンバと流体連通させる、
請求項17に記載の容器およびクロージャ。 - 前記チャンバが密閉されて、1つまたは複数の活性薬剤を保持し、前記容器が液体希釈剤を保持する、
請求項16〜18のいずれか一項に記載の容器およびクロージャ。 - 前記バイアルが患者送達機構をさらに備える、
請求項19に記載の容器およびクロージャ。 - 前記患者送達機構がスポイトまたはスプレーノズルである、
請求項20に記載の容器およびクロージャ。 - 前記容器が希釈剤を保持するのに好適な静脈輸液バッグであり、前記静脈輸液バッグが入口を有し、
前記クロージャが1つまたは複数の活性薬剤を保持するのに好適な入口クロージャである、
請求項17〜21のいずれか一項に記載の容器およびクロージャ。 - 前記クロージャが密閉されたまたは密閉可能なチャンバと注入ポートとを備え、
前記クロージャが前記注入ポートの外面上に位置付けられる注入ポートカバーをさらに備える、
1つまたは複数の活性薬剤を容器に投入するためのクロージャ。 - 前記クロージャが、前記チャンバの壁を形成する破壊可能壁をさらに備える、
請求項23に記載のクロージャ。 - ピストンガイドに摺動自在に取り付けられる中空ピストンをさらに備える、
請求項23または24に記載のクロージャ。 - 前記注入ポートおよび前記破壊可能壁が、前記中空ピストンの長手方向軸と一直線に並ぶ、
請求項25に記載のクロージャ。 - 前記注入ポートが、前記チャンバ内にあり前記破壊可能壁に面する前記末端の反対側にある前記中空ピストンの前記末端に設けられ、前記注入ポートカバーが前記注入ポートを覆い、
前記クロージャが前記中空ピストンの前記反対側の末端を覆い、前記中空ピストンの手動押下を制限するように配置される着脱自在のキャップをさらに備える、
請求項25または26に記載のクロージャ。 - 前記注入ポートが前記チャンバの開口部内に保持される、または、前記チャンバの前記開口部全体にシールを形成する、
請求項23〜27のいずれか一項に記載のクロージャ。 - 前記注入ポートカバーが、粘着フィルムまたは粘着タブを備える、
請求項23〜28のいずれか一項に記載のクロージャ。 - 前記注入ポートカバーが無菌カバーである、
請求項23〜29のいずれか一項に記載のクロージャ。 - 前記クロージャが前記容器の開口部内に保持される、1つまたは複数の活性薬剤を前記容器に投入するための請求項23〜30のいずれか一項に記載の容器およびクロージャ。
- 前記チャンバが密閉されて、1つまたは複数の活性薬剤を保持し、
前記容器が前記クロージャによって密閉されて、液体希釈剤を保持する、
請求項31に記載の容器およびクロージャ。 - 容器本体、密閉可能なチャンバを有するクロージャ、注入ポートおよびピストンガイドで摺動可能な少なくとも1つの通気開口を有する中空ピストン、1つまたは複数の活性薬剤を含有する溶液、希釈剤、ならびに不活性ガスを提供するステップと、
前記1つまたは複数の活性薬剤を含有する溶液の一部を、前記注入ポートを通して前記チャンバに注入するステップと、
前記チャンバの前記溶液を凍結乾燥させるステップと、
前記少なくとも1つの通気開口を密閉することによって前記クロージャを密閉し、それによって、前記チャンバを密閉するステップと、
前記不活性ガスの一部を前記注入ポートを通して前記チャンバに注入するステップと、
前記希釈剤の一部を前記容器本体に加えて、前記容器本体を前記クロージャで密閉するステップと
を含む、
1つまたは複数の活性薬剤の投入に使用するための予め充填された容器を製造する方法。 - 前記希釈剤の一部を前記容器本体に加えて、前記容器本体を前記クロージャで密閉する前記ステップを、前記1つまたは複数の活性薬剤を含有する溶液の一部を前記チャンバに注入する前記ステップおよび/あるいは前記チャンバの前記溶液を凍結乾燥させる前記ステップおよび/あるいは前記不活性ガスの一部を前記チャンバに注入する前記ステップの前または後に行う、
請求項33に記載の方法。 - 前記容器本体、前記クロージャ、前記注入ポート、および前記中空ピストンが使用前に殺菌される、
請求項33または34に記載の方法。 - 前記1つまたは複数の活性薬剤が、凍結乾燥された活性薬剤のかたまりまたはタブレットの形態で提供される、
請求項33〜35のいずれか一項に記載の方法。 - 前記1つまたは複数の活性薬剤を含有する溶液が注射器内に提供される、
請求項33〜36のいずれか一項に記載の方法。 - 1つまたは複数の活性薬剤を含有する溶液の一部をチャンバに注入する前記ステップが、
最初に、前記クロージャの前記注入ポートに針で穴をあけるステップと、
次いで、1つまたは複数の活性薬剤を含有する前記溶液の一部を注射器から前記針を通して前記チャンバに注入するステップと
を含む、
請求項33〜37のいずれか一項に記載の方法。 - 前記不活性ガスの一部をチャンバに注入する前記ステップが、
最初に、前記クロージャの前記注入ポートに針で穴をあけるステップと、
次いで、前記不活性ガスの一部を前記針を通して前記チャンバに注入するステップと
を含む、
請求項33〜38のいずれか一項に記載の方法。 - 注入ポートの上に無菌カバーを設けるステップをさらに含む、
請求項33〜39のいずれか一項に記載の方法。 - 容器本体と、
請求項1〜6のいずれか一項に記載のクロージャ、または請求項8〜15のいずれか一項に記載のクロージャ、または請求項23〜30のいずれか一項に記載のクロージャと
を備える、
1つまたは複数の活性薬剤の投入に使用するための予め充填された容器。 - 前記容器本体が希釈剤の一部を保持し、前記クロージャが1つまたは複数の凍結乾燥された活性薬剤を保持し、
前記クロージャが前記容器本体の開口部全体で無菌のシールを形成する、
請求項33〜40のいずれか一項に記載の方法によって製造される予め充填された容器。 - 前記容器本体がバイアルであり、前記クロージャがバイアルキャップである、
請求項41または42に記載の予め充填された容器。 - 前記バイアルが患者送達機構をさらに備える、
請求項41または42に記載の予め充填された容器。 - 前記患者送達機構がスポイトまたはスプレーノズルである、
請求項44に記載の予め充填された容器。 - 前記容器が希釈剤を保持するのに好適な静脈輸液バッグであり、前記静脈輸液バッグが入口を有し、
前記クロージャが1つまたは複数の活性薬剤を保持するのに好適な入口クロージャである、
請求項44に記載の予め充填された容器。 - 前記中空ピストンを前記デフォルト位置から手動で摺動させて、前記破壊可能壁の一部を突き破るが、前記切断形態の前記隙間に近接する前記破壊可能壁の領域では突き破らないステップと、前記1つまたは複数の活性薬剤が前記希釈剤の一部と混ざり、それに溶解するように、前記予め充填された容器の前記内容物を揺動させるステップと
を含む、
請求項41〜46のいずれか一項に記載の予め充填された容器を使用して、1つまたは複数の活性薬剤を投入する方法。 - 前記注入ポートの外面からカバーを除去するステップと、
前記注入ポートを通して針を前記容器に挿入するステップと、
前記希釈剤の一部への前記1つまたは複数の活性薬剤の溶解から生じる溶液の一部を、前記容器から前記針を通して注射器に吸い込むステップと
をさらに含む、
請求項47に記載の方法。 - 前記溶液の一部を患者に投与するステップをさらに含む、
請求項48に記載の方法。
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- 2015-09-08 US US15/509,701 patent/US11246802B2/en active Active
- 2015-09-08 BR BR112017004566A patent/BR112017004566A2/pt not_active Application Discontinuation
- 2015-09-08 MX MX2017003044A patent/MX2017003044A/es unknown
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- 2015-09-08 EP EP15771229.0A patent/EP3191226B1/en active Active
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JPWO2019073846A1 (ja) * | 2017-10-10 | 2021-01-28 | 大日本印刷株式会社 | 薬剤収容容器、閉鎖部材、薬剤収容容器の製造方法、および微生物夾雑物検査方法、ならびに緩衝液調製用固形剤 |
JP7379158B2 (ja) | 2017-10-10 | 2023-11-14 | 大日本印刷株式会社 | 薬剤収容容器、閉鎖部材、薬剤収容容器の製造方法、および微生物夾雑物検査方法、ならびに緩衝液調製用固形剤 |
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US11246802B2 (en) | 2022-02-15 |
US20170258683A1 (en) | 2017-09-14 |
EP3191226A1 (en) | 2017-07-19 |
RU2017111656A (ru) | 2018-10-11 |
GB2544951A (en) | 2017-05-31 |
EP3191226B1 (en) | 2018-11-07 |
CN106999346A (zh) | 2017-08-01 |
GB201415869D0 (en) | 2014-10-22 |
WO2016038357A1 (en) | 2016-03-17 |
GB2544951B (en) | 2021-08-04 |
AU2015313975B2 (en) | 2020-09-24 |
GB201705560D0 (en) | 2017-05-24 |
MX2017003044A (es) | 2017-09-07 |
BR112017004566A2 (pt) | 2018-01-23 |
IL251006A0 (en) | 2017-04-30 |
AU2015313975A1 (en) | 2017-04-27 |
RU2017111656A3 (ja) | 2019-04-18 |
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