JP4585013B2 - 柔軟な、多隔室の薬剤容器およびその製造および使用方法 - Google Patents
柔軟な、多隔室の薬剤容器およびその製造および使用方法 Download PDFInfo
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- JP4585013B2 JP4585013B2 JP2008125237A JP2008125237A JP4585013B2 JP 4585013 B2 JP4585013 B2 JP 4585013B2 JP 2008125237 A JP2008125237 A JP 2008125237A JP 2008125237 A JP2008125237 A JP 2008125237A JP 4585013 B2 JP4585013 B2 JP 4585013B2
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Description
本発明の追加の態様において、未充填の容器を輸送キャリヤーの中に入れ、次いでこのキャリヤーを環境の汚染に対してシールする。輸送キャリヤー、およびその中の容器を電子ビームで滅菌する。輸送キャリヤー、およびその中の容器を紫外線汚染除去トンネルを通してアイソレーターの中に導入し、これはアイソレーター内の無菌の環境の維持を保証する。
図3において断片的略断面図で描写されている、本発明の第1態様において、前面シート12は透明な、単一層の、熱可塑性ポリマーフィルム44から構成される。この態様において、透明フィルム44は約80重量%のポリプロピレン-ポリエチレンコポリマー(Fina Oil and Chemical Company,of Deerpark,Texas、から商業的表示Z9450で入手可能である)と、約20重量%のスチレンブタジエンエラストマーゴム(Shell Chemical Corporationから商品名KratonR および商業的表示G1652で入手可能である)とのブレンドからなる。実際に、フィルムはコポリマー樹脂および小片の形態のKratonR を80%/20%の重量比で高剪断ミキサー中で混合し、この混合物を溶融し、再ペレット化することによって製造される。
図5において略断面図で描写されている、本発明の第2の典型的な態様において、薬剤隔室をカバーする、透明な高バリヤーの中間ラミネートフィルム(図4の64)のための別の構成が提供される。
本発明の好ましい態様によれば、容器を折り重ねた状態で固定して、偶発的活性化に対してガードし、かつアルミニウム箔を含有する後面シートのみを周囲光に暴露することによって、容器の内容物を放射線の暴露から保護するための手段を設ける。
したがって、追加の剥離可能なシール25および緩衝剤隔室29は、薬剤隔室中の乾燥薬剤を湿気による劣化から保護する手段を提供することを理解することができる。
本発明の原理の実施に従い、容器10の1つの典型的な態様の前面シート12および後面シート14は80:20フィルム層により互いに接する。他の相接するフィルムは本発明の範囲および考えの中に入るが、前述の態様の各々において、前面シート12の内方に面する層は80:20フィルムからなり、このフィルムは背面または後面シート14の内方に面する80:20フィルム層と接触して配置されている。
特に、保持スロット(図1の27)および保持タブ(図1の28)を、それぞれ、シール延長部110eおよび110fの比較的に剛性の材料から切断できるために十分な幅を過大部分110eおよび110fは有する。
本発明の原理の実施に従い、図8aの容器10を製作する方法および装置を図9に関して説明する。容器充填装置の下記の説明から明らかになるように、単一層または多層のラミネートフィルムからなる前面シートおよび後面シートを有する医用容器の製作に適するように、装置および方法の双方を適合させる。さらに、下記の説明から明らかになるように、図8aの容器10の種々のシールの数、形状、構成および位置を、装置の構成部分のモジュール配置のために、容易変化させるか、あるいは省略することさえ可能である。
前述の製作プロセスの間に形成される剥離可能なシールは、薄い長方形を有する直線のシールである。剥離可能なシールは慣用の直線のシールに類似するように見えるが、この態様の剥離可能なシールは、製造ロットを通じていっそう予測可能な破壊を示す、すなわち、操作圧力に対して均一な抵抗特性を示すことにおいて、改良されている。
ここで図10を参照すると、全体的に150で示し、本明細書において「キャリヤー」と呼ぶ、取扱い容器は、系統的方法において、滅菌、輸送および無菌ゾーンの、空の容器の中へ導入のための輸送可能な含有アイソレーターとして機能する。キャリヤー150は3つの構成部分からなる;一般的に長方形の容器トレー152、シール可能なフィルムの蓋154、および多数の容器をトレー内に支持するレールカートリッジ162、これらを図11aおよび図11bに関して以下において詳細に説明する。
空の容器を含有する密閉されたキャリヤーをポリバッグの中に包装し、放射線滅菌設備に輸送され、ここでキャリヤーおよびその内容物は、例えば、電子ビーム滅菌法により無菌とされる。
前述のキャリヤーの装填および電子ビーム滅菌が完結した後、滅菌された医用容器を無菌的充填設備に輸送し、そして図13に描写されている典型的なプロセスのフローチャートおよび図14において半概略的平面図で描写された典型的な充填装置に関して説明するように、容器を本発明の1態様に従い無菌的に充填する。
完成された容器の使用は、使用された製造技術に対して実質的に独立である。3部分から成る容器10および混合システムは、図1および図2に示す完成された形状で、健康医療の従業員、典型的には病院の薬局に受け取られる。ここで図16を参照すると、容器を使用するために準備するとき、アルミニウム箔含有保護層55上のタブ62をつかみ、そして保護層を容器から剥離して、粉末状薬剤を含有する中間の隔室20を視的に検査できるようにすることによって、薬剤を検査することができる。薬剤が乾燥した通常の状態に見える場合、容器を操作して上の希釈剤隔室18の区域における前面シートおよび後面シートを圧縮することによって、図17に示すように溶液を混合する。
下記の詳細な説明、添付の請求の範囲および添付図面に関して考慮するとき、本発明のこれらおよび他の特徴、面および利点はいっそう完全に理解されるであろう。
Claims (29)
- 柔軟な後面シート;
共通の周囲へりに沿って後面シートに対してシールされた柔軟な前面シート;
前記共通の周囲へりの2つの側面の間を延びかつ前記前面シートおよび後面シートを分離可能に接合して、希釈剤を含有する隔室を形成する第1の剥離可能なシール;
前記共通の周囲へりの2つの側面の間を延びかつ前記前面シートおよび後面シートを分離可能に接合し、これにより出口隔室と、前記出口隔室および前記希釈剤隔室の中間に存在する薬剤を含有する隔室とを形成する第2の剥離可能なシール;
前記前面シートに対してシールされる透明な高バリヤーラミネートフィルム、この高バリヤーラミネートフィルムは前記薬剤隔室にわたって伸びる寸法を有し、前記フィルムは容器前面シートに隣接するポリプロピレン内層、ポリエステルを含んでなる外層、及び該内層と外層との間の透明な高湿分バリヤーを含んで成る;並びに
前記透明な高バリヤーラミネートフィルムに対して分離可能にシールされる不透明な高バリヤー保護フィルム;
を有し、
上記不透明な高バリヤー保護フィルムが、
前記ラミネートの内側に向く表面を含む改質エチレン酢酸ビニルポリマー層;
前記ラミネートの外側に向く表面を含む、前記改質エチレン酢酸ビニルポリマー層よりも高い溶融強度を有するポリエステルポリマー層;及び
前記改質エチレン酢酸ビニル層とポリエステルポリマー層との中間にあるアルミニウム箔層;
を有する、
薬剤および希釈剤の貯蔵および投与のための柔軟な容器。 - 前記透明な高バリヤーラミネートフィルムが、前記ポリプロピレン層および前記ポリエステル層の中間にある透明な高酸素バリヤーのフィルム層をさらに含む、請求項1に記載の柔軟な容器。
- 前記透明な高湿気バリヤーのフィルム層が、延伸高密度ポリエチレン、ポリクロロトリフルオロエチレン、およびシリカ沈着ポリエチレンテレフタレートから成る群より選択されるポリマーである、請求項2に記載の柔軟な容器。
- 前記透明な高酸素バリヤーのフィルム層が、エチレンビニルアルコール、ポリ塩化ビニリデンコーテッドポリエチレンテレフタレート、およびシリカ沈着ポリビニルアルコールから成る群より選択されるポリマーである、請求項2に記載の柔軟な容器。
- 前記前面シートが、ポリスチレン末端ブロックとゴム性ポリ(エチレン−ブチレン)中間ブロックからなる3ブロックコポリマーである熱可塑性ゴムによりブレンドされたポリプロピレン−ポリエチレンコポリマーを含んで成る、請求項1に記載の柔軟な貯蔵容器。
- 前記ポリプロピレン−ポリエチレンコポリマーが、ポリスチレン末端ブロックとゴム性ポリ(エチレン−ブチレン)中間ブロックからなる3ブロックコポリマーである熱可塑性ゴムにより、約80%/20%の割合でブレンドされる、請求項5に記載の柔軟な貯蔵容器。
- 前記後面シートが、
前記前面シートと隣接する、ポリスチレン末端ブロックとゴム性ポリ(エチレン−ブチレン)中間ブロックからなる3ブロックコポリマーである熱可塑性ゴムにより約80%/20%の割合でブレンドされるポリプロピレン−ポリエチレンコポリマーの内層;
アルミニウム箔の中間層;並びに
前記内層よりも高い融点を有する熱可塑性外層;
を含む多層ラミネートを含んで成る、請求項1に記載の柔軟な貯蔵容器。 - 前記不透明な高バリヤー保護フィルムが、前記透明な高バリヤーラミネートフィルム上に剥離可能に固定され、これにより前記不透明な高バリヤー保護フィルムが前記透明な高バリヤーラミネートフィルムの表面の一部とのみ接触し、前記不透明な高バリヤー保護フィルスの結合の強度が前記表面接触の区域と直接的に比例する、請求項1に記載の柔軟な貯蔵容器。
- 前記不透明な高バリヤー保護フィルムが、パターン化されたヒートシールヘッドにより前記透明な高バリヤーラミネートフィルム上に固定され、前記パターン化されたヒートシールヘッドが一般的に環状の非接触貯蔵区域の規則的なアレイを定義する、請求項8に記載の柔軟な貯蔵容器。
- 前記不透明な高バリヤー保護フィルムが、均等なヒートシールにより前記クリアーな高バリヤーラミネートフィルム上に固定される、請求項8に記載の柔軟な貯蔵容器。
- 前記不透明な高バリヤー保護フィルムが、剥離可能な周囲シールにより前記透明な高バリヤーラミネートフィルムに固定される、請求項8に記載の柔軟な貯蔵容器。
- 前記容器が、前記第1の剥離可能シールに隣接して折りたたまれ、その結果、前記折りたたまれた容器の外側に面する表面が前記多層ラミネート後面シートを含んで成り、前記柔軟な容器がさらに、折りたたまれた状態で前記容器を固定するための手段を含んで成る、請求項1に記載の柔軟な貯蔵容器。
- 折りたたまれた状態で前記容器を固定するための手段が、
前記容器の側面と共に一体的に形成され、そしてその側面から延長するロッキングタブ;並びに
前記タブと同じ容器の側面と共に一体的に形成され、そしてその側面から延長するスロット、前記タブ及びスロットは、前記容器が前記第1の剥離可能シールに隣接して折りたたまれる場合、主動的嵌合のための位置に移動され、それにより、前記容器が折りたたまれた状態で固定される;を含んで成る、請求項12に記載の柔軟な貯蔵容器。 - 前記剥離可能シールが、前記容器の操作により引き起こされるシールに対する液圧に対して均等な抵抗特性を提供するよう構成され、前記均等な抵抗特性が3〜5ポンド/in2の範囲の適用圧力でのシールの剥離を引き起こす、請求項1に記載の柔軟な貯蔵容器。
- 薬剤および希釈剤の貯蔵および投与のための柔軟な容器の製造方法において、
柔軟な後面シートを用意し;
柔軟な前面シートを用意し;
前記柔軟な後面シートと前記柔軟な前面シートを共通の周囲へりに沿って後面シートに対してシールし;
前記後面シート及び前面シートを第一の所定の領域において加熱し、それらのシートの隣り合う表面の加熱された部分を融着せしめ、これにより、共通の周囲へりの2つの側面の間を延び第1の剥離可能なシールを形成し、当該剥離可能なシールは前記前面シートおよび後面シートを分離可能に接合して、希釈剤を含有する隔室を形成し;
前記後面シート及び前面シートを第二の所定の領域において加熱し、それらのシートの隣り合う表面の加熱された部分を融着せしめ、これにより、共通の周囲へりの2つの側面の間を延び第2の剥離可能なシールを形成し、当該剥離可能なシールは前記前面シートおよび後面シートを分離可能に接合して、出口隔室と、当該出口隔室および前記希釈剤隔室の中間に存在する薬剤を含有する隔室とを形成し;
前記前面シートに対して透明な高バリヤーラミネートフィルムをシールし、この高バリヤーラミネートフィルムは前記薬剤隔室にわたって伸びる寸法を有し、この高バリヤーラミネートフィルムは容器前面シートに隣接するポリプロピレン内層、ポリエステルを含んでなる外層、及び該内層と外層との間の透明な高湿分バリヤーを含んで成り;そして
前記透明な高バリヤーラミネートフィルムに対して不透明な高バリヤー保護フィルムを分離可能にシールし、ここで、当該不透明な高バリヤー保護フィルムが、前記ラミネートの内側に向く表面を含む改質エチレン酢酸ビニルポリマー層、前記ラミネートの外側に向く表面を含む、前記改質エチレン酢酸ビニルポリマー層よりも高い溶融強度を有するポリエステルポリマー層、及び前記改質エチレン酢酸ビニル層とポリエステルポリマー層との中間にあるアルミニウム箔層を有する、
ことを特徴とする方法。 - 前記第1の剥離可能なシール及び第2の剥離可能なシールが、約1.5秒〜約2.5秒の範囲の時間にわたって約230psi〜約340psiの範囲の圧力をかけながら118.3℃〜129.4℃の範囲の熱溶着温度を維持することにより形成される、請求項15に記載の方法。
- 仕上がった容器を、希釈剤隔室と薬剤隔室との間の第1の剥離可能なシールの線に沿って折畳む、請求項15に記載の方法。
- 前記柔軟な前面シートが、スチレンエチレン−ブチレンスチレンエラストマーとブレンドされたポリプロピレン−ポリエチレン−コポリマーを含んで成る、請求項15に記載の方法。
- 前記ポリプロピレン−ポリエチレン−コポリマーがスチレンエチレン−ブチレンスチレンエラストマーと約80%/20%の割合でブレンドされる、請求項18に記載の方法。
- 前記後面シートが、
前記前面シートと隣接する、ポリスチレン末端ブロックとゴム性ポリ(エチレン−ブチレン)中間ブロックからなる3ブロックコポリマーである熱可塑性ゴムにより約80%/20%の割合でブレンドされるポリプロピレン−ポリエチレンコポリマーの内層;
アルミニウム箔の中間層;並びに
前記内層よりも高い融点を有する熱可塑性外層;
を含む多層ラミネートを含んで成る、請求項15に記載の方法。 - 前記透明な高バリヤーラミネートフィルムが、前記ポリプロピレン層および前記ポリエステル層の中間にある透明な高酸素バリヤーのフィルム層をさらに含む、請求項15に記載の方法。
- 前記透明な高湿気バリヤーのフィルム層が、延伸高密度ポリエチレン、ポリクロロトリフルオロエチレン、およびシリカ沈着ポリエチレンテレフタレートから成る群より選択されるポリマーである、請求項15に記載の方法。
- 前記透明な高酸素バリヤーのフィルム層が、エチレンビニルアルコール、ポリ塩化ビニリデンコーテッドポリエチレンテレフタレート、およびシリカ沈着ポリビニルアルコールから成る群より選択されるポリマーである、請求項15に記載の方法。
- 前記前面シートが、ポリスチレン末端ブロックとゴム性ポリ(エチレン−ブチレン)中間ブロックからなる3ブロックコポリマーである熱可塑性ゴムによりブレンドされたポリプロピレン−ポリエチレンコポリマーを含んで成る、請求項15に記載の方法。
- 前記不透明な高バリヤー保護フィルムが、パターン化されたヒートシールヘッドにより前記透明な高バリヤーラミネートフィルム上に固定され、前記パターン化されたヒートシールヘッドが一般的に環状の非接触貯蔵区域の規則的なアレイを定義する、請求項24に記載の方法。
- 前記不透明な高バリヤー保護フィルムが、均等なヒートシールにより前記透明な高バリヤーラミネートフィルム上に固定される、請求項24に記載の方法。
- 前記不透明な高バリヤー保護フィルムが、剥離可能な周囲シールにより前記透明な高バリヤーラミネートフィルムに固定される、請求項24に記載の方法。
- 前記容器が、前記第1の剥離可能シールに隣接して折りたたまれ、その結果、前記折りたたまれた容器の外側に面する表面が前記多層ラミネート後面シートを含んで成り、前記柔軟な容器がさらに、折りたたまれた状態で前記容器を固定するための手段を含んで成る、請求項15に記載の方法。
- 折りたたまれた状態で前記容器を固定するための手段が、
前記容器の側面と共に一体的に形成され、そしてその側面から延長するロッキングタブ;並びに
前記タブと同じ容器の側面と共に一体的に形成され、そしてその側面から延長するスロット、前記タブ及びスロットは、前記容器が前記第1の剥離可能シールに隣接して折りたたまれる場合、主動的嵌合のための位置に移動され、それにより、前記容器が折りたたまれた状態で固定される;を含んで成る、請求項28に記載の方法。
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