JP2017515513A - 液体製剤を処理する方法 - Google Patents
液体製剤を処理する方法 Download PDFInfo
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- JP2017515513A JP2017515513A JP2016522726A JP2016522726A JP2017515513A JP 2017515513 A JP2017515513 A JP 2017515513A JP 2016522726 A JP2016522726 A JP 2016522726A JP 2016522726 A JP2016522726 A JP 2016522726A JP 2017515513 A JP2017515513 A JP 2017515513A
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- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C2218/00—Methods for coating glass
- C03C2218/30—Aspects of methods for coating glass not covered above
- C03C2218/32—After-treatment
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Abstract
Description
1.粒子フリーのチューブに、3.9ミリリットルのろ過水を充填し、内部に3つのプランジャを置く(シリンジに対して、充填量は、各シリンジ当り1.3ミリリットルである)
2.アルミニウム箔でチューブを覆う。
3.EP(欧州薬局方)のオートクレーブサイクル
4.MFIを用いた測定の前に試料を洗浄
窒素 50sccm
酸素 150sccm
大気圧
50秒の予備蒸着
2分30秒の蒸着時間
Claims (19)
- 液体製剤を処理する方法であって、第一の主容器を設けるとともに、バリア層を用いて前記液体製剤に曝される前記第一の主容器の内面をコーティングして、前記第一の主容器の前記内面からの物質の任意の放出を防ぐ又は少なくとも制限する工程と、前記第一の主容器と異なる第二の主容器を設けるとともに、バリア層を用いて前記液体製剤に曝される前記第二の主容器の内面をコーティングして、前記第二の主容器の前記内面からの物質の任意の放出を防ぐ又は少なくとも制限する工程と、前記第二の主容器の前記内面をコーティングする前記バリア層は、前記第一の主容器の前記内面をコーティングする前記バリア層と同様の材料組成を有し、前記液体製剤が、前記第一の主容器との同様の相互作用を、前記第二の主容器で発揮するように、第一の処理段階で前記第一の主容器内に充填された前記液体製剤の処理から、それに続く処理段階で前記第二の主容器内に充填された前記液体製剤の処理への移行の工程と、を備える、液体製剤を処理する方法。
- 前記第一の主容器及び前記第二の主容器は、前記液体製剤に曝される内面が、同様の材料組成を有するバリア層を用いて被覆される各閉鎖要素を有する、請求項1に記載の液体製剤を処理する方法。
- 前記第一の主容器及び前記第二の主容器をコーティングする前記バリア層は、対応する閉鎖要素をコーティングする前記バリア層と異なるか、又は同様である、請求項2に記載の液体製剤を処理する方法。
- 前記第一の主容器及び前記第二の主容器は、ガラス製であり、前記対応する閉鎖要素は、ゴム製である、請求項2に記載の液体製剤を処理する方法。
- 前記第一の主容器は、前記第二の主容器と異なる形状を有する、請求項1に記載の液体製剤を処理する方法。
- 前記第一の主容器は、前記第二の主容器と異なる材料組成を有する、請求項1に記載の液体製剤を処理する方法。
- 前記バリア層は、前記主容器の前記内面上に、接着プライマの層を、次に、前記接着プライマの層上にシリコーンオイルの層を塗布することによって、それから、前記シリコーンオイル層の部分の架橋結合を達成するために、アルゴンプラズマを用いて、塗布された内面を処理することによって、適用される、請求項1に記載の液体製剤を処理する方法。
- 前記バリア層は、前記主容器の前記内面上に、接着プライマの層を、次に、ペルフルオロポリエーテルの層を塗布することによって、それから、前記ペルフルオロポリエーテル層の部分の架橋結合を達成するために、アルゴンプラズマを用いて、塗布された内面を処理することによって、適用される、請求項1に記載の液体製剤を処理する方法。
- 前記バリア層は、前記主容器の前記内面上に、化学蒸着(CVD)又は原子層堆積(ALD)によって適用される、請求項1に記載の液体製剤を処理する方法。
- 前記バリア層は、前記主容器の前記内面に、固体ライナ又はホイルとして適用される、請求項1に記載の液体製剤を処理する方法。
- 前記主容器の前記内面は、架橋結合されたシリコーン製のバリア層を備えるコーティングを有する、請求項1に記載の液体製剤を処理する方法。
- 前記主容器の前記内面は、架橋結合されたペルフルオロポリエーテル製のバリア層を備えるコーティングを有する、請求項1に記載の液体製剤を処理する方法。
- 前記主容器の前記内面は、二酸化ケイ素(SiO2)製のバリア層を備えるコーティングを有する、請求項1に記載の液体製剤を処理する方法。
- 前記主容器の前記内面は、アルミナ(Al2O3)製のバリア層を備えるコーティングを有する、請求項1に記載の液体製剤を処理する方法。
- 前記主容器の前記内面は、窒化チタン(TiN)製のバリア層を備えるコーティングを有する、請求項1に記載の液体製剤を処理する方法。
- 前記主容器の前記内面は、シリコーンのライナ又はホイル製のバリア層を備えるコーティングを有する、請求項1に記載の液体製剤を処理する方法。
- 前記主容器の前記内面は、テフロン様のポリマのライナ又はホイル製のバリア層を備えるコーティングを有する、請求項1に記載の液体製剤を処理する方法。
- 前記主容器の前記内面は、ポリテレフタレンポリマのライナ又はホイル製のバリア層を備えるコーティングを有する、請求項1に記載の液体製剤を処理する方法。
- 前記主容器の前記内面は、ポリビニルアルコールポリマのライナ又はホイル製のバリア層を備えるコーティングを有する、請求項1に記載の液体製剤を処理する方法。
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PCT/EP2015/055169 WO2015136037A1 (en) | 2014-03-13 | 2015-03-12 | Method of handling a liquid drug formulation |
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US11709156B2 (en) | 2017-09-18 | 2023-07-25 | Waters Technologies Corporation | Use of vapor deposition coated flow paths for improved analytical analysis |
US11918936B2 (en) | 2020-01-17 | 2024-03-05 | Waters Technologies Corporation | Performance and dynamic range for oligonucleotide bioanalysis through reduction of non specific binding |
IT202100007835A1 (it) | 2021-03-30 | 2022-09-30 | Nuova Ompi Srl | Metodo per la rilevazione di aldeidi residue rilasciabili da una siringa |
IT202100007832A1 (it) | 2021-03-30 | 2022-09-30 | Nuova Ompi Srl | Metodo per l’estrazione di aldeidi dall’adesivo di una siringa |
IT202100024574A1 (it) | 2021-09-24 | 2023-03-24 | Stevanato Group Spa | Metodo per la fabbricazione di un dispositivo medico per iniezione e dispositivo medico così ottenuto |
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JP6685897B2 (ja) | 2020-04-22 |
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IL244616A0 (en) | 2016-04-21 |
CN105745030A (zh) | 2016-07-06 |
EP3041803A1 (en) | 2016-07-13 |
BR112016010475B1 (pt) | 2021-07-20 |
IL244616B (en) | 2019-10-31 |
HUE047974T2 (hu) | 2020-05-28 |
BR112016010475A2 (pt) | 2020-03-10 |
CN105745030B (zh) | 2022-04-15 |
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