JP2022507155A - バイオ容器用強化フィルム - Google Patents
バイオ容器用強化フィルム Download PDFInfo
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- JP2022507155A JP2022507155A JP2021525588A JP2021525588A JP2022507155A JP 2022507155 A JP2022507155 A JP 2022507155A JP 2021525588 A JP2021525588 A JP 2021525588A JP 2021525588 A JP2021525588 A JP 2021525588A JP 2022507155 A JP2022507155 A JP 2022507155A
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- B32B2262/0276—Polyester fibres
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- B32B2307/70—Other properties
- B32B2307/724—Permeability to gases, adsorption
- B32B2307/7242—Non-permeable
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Abstract
Description
本願は、2018年11月15日に出願した米国仮出願第62/767,946号の優先権の利益を主張するものであり、これはその全体が参照により本明細書に援用される。
本開示は、強化フィルムに関する。より詳細には、この開示内に提示されたフィルムの実施形態は、バイオ容器に使用するためのフィルムの亀裂又はしわを防止するための強化フィルムに関する。
医薬品及びバイオ医薬品業界では、使い捨てのバッグ及び他のバイオ容器の利用が高まっている。多くのフィルムで構成されるこれらのバッグは、原料、中間体及び完成品などの液体及び固体の加工及び輸送のためのステンレスタンク、トート及びビンに代わるものである。
フィルムに対する本体を形成する2つ以上の層から形成されるフィルムであって、内側及び外側を有するフィルム、及びフィルムの本体に組み込まれた基材であって、繊維状物質で形成される基材を含むバイオ容器用材料であって、該2つ以上の層のうち少なくとも1つの各々がエチレン-酢酸ビニルポリマー樹脂を含む、バイオ容器用材料。
図1Aは、本開示による強化されたバイオ容器フィルム2の第1の実施形態の断面を示す。フィルム2は、内側接触帯4を有する。内側接触帯4は、第1の面4kを含み、これは、フィルム2から形成されるバイオ容器(本明細書に記載)の内部容積内の液体と接触している。内側接触帯4は、フィルムと接触する可能性がある液体に対して不活性であり、かつフィルム2の内側接触帯4又は第1の前面4kと接触する液体中に入る可能性のある抽出物が少ない材料の1つ以上の層で形成され得る。このような材料には、ポリエチレンなどの様々なポリオレフィンが含まれるが、これらに限定されるものではない。いくつかの実施形態は、低密度ポリエチレン、線状低密度ポリエチレン、超低密度ポリエチレン、中密度ポリエチレンなどを含む。
レイクのPolyone Corp.のColormatrix(商標) Ultimate(商標)又はColormatrix(商標) Lactra(商標)又はOncap(商標)製品などの様々な供給源から入手することができる。
バイオ容器フィルムを、Gelbo Flex ASTM F392規格に従う本開示に従って作製した複合フィルム2と比較した。以下に述べるPureflex(商標)フィルムは、内側接触帯、中間酸素障壁帯及びプラスチックのみで形成された外側保護帯を有する多層積層フィルムであった。このフィルムの厚さは約0.020インチ(0.50mm)であった。いくつかの実施形態において、PureFlex(登録商標)フィルムは、エチレン-アルファ-オレフィン樹脂を含む接触層を有する。例えば、いくつかの例示的なエチレン-アルファ-オレフィン樹脂は、米国ミシガン州ミッドランドのDow Corp.により商標AFFINITY(登録商標)の下で市販されている。
Claims (21)
- フィルムに対する本体を形成する2つ以上の層から形成されたフィルムであって、内側及び外側を有するフィルム、及びフィルムの本体に組み込まれた基材を含むバイオ容器用材料であって、該基材は繊維状物質で形成され、該2つ以上の層のうちの少なくとも1つの各々がエチレン-酢酸ビニル樹脂を含む、バイオ容器用材料。
- 前記基材が、前記基材をフィルムに付着させるためのポリマー裏打ちで形成される、請求項1に記載の材料。
- 前記基材が、織布繊維状物質及び不織布繊維状物質からなる群から選択される材料で形成される、請求項1に記載の材料。
- 前記基材が、ナイロン、ポリエステル、アラミド、炭素、金属、ガラス及びポリオレフィンからなる群から形成される、請求項1に記載の材料。
- 前記基材が、ポリマー繊維、金属繊維、炭素繊維及びガラス繊維からなる群から選択される織布材料である、請求項1に記載の材料。
- 前記基材が、ナイロン、ポリエステル、アラミド、炭素、金属、ガラス及びポリオレフィンからなる群から選択される不織布繊維状物質から形成される、請求項1に記載の材料。
- 前記フィルムが、1つ以上の接触層及びガス不透過層の1つ以上の層を有する多層フィルムで形成され、前記基材が、前記1つ以上の接触層と前記ガス不透過層1つ以上の層の間でフィルムに組み込まれる、請求項1に記載の材料。
- 前記フィルムが、内側接触帯を形成する1つ以上の層から形成される第1の内側層、ガス不透過帯の1つ以上の層、及び外側強度帯を形成する、該ガス不透過帯の外側のポリマーの1つ以上の層を有する多層フィルムで形成され、前記基材が前記接触帯と前記ガス不透過帯との間で前記フィルムに組み込まれる、請求項1~7のいずれか一項に記載の材料。
- 前記基材がエチレン-酢酸ビニル樹脂に埋め込まれる、請求項1~8のいずれか一項に記載の材料。
- 前記基材が、観察窓及びポートからなる群から選択されるデバイスを提供するために、基材中に形成された1つ以上の開口部を有する、請求項1~9のいずれか一項に記載の材料。
- 少なくとも2つの壁、及び該少なくとも2つの壁によって規定される内部容積を有するバイオ容器であって、内側接触帯を形成する1つ以上の層から形成される第1の内側層、ガス不透過帯の1つ以上の層、及び外側強度帯を形成する、該ガス不透過帯の外側のポリマーの1つ以上の層を有するフィルム材料、及び該接触帯と該ガス不透過帯との間で該フィルムに組み込まれる基材で形成され、該基材が繊維状物質で形成される、バイオ容器。
- 前記基材が、織布繊維状物質及び不織布繊維状物質からなる群から選択される材料で形成される、請求項11に記載のバイオ容器。
- 前記基材が、織布材料及び不織布材料からなる群から選択される形態の繊維状物質からなる群から選択される材料で形成され、該繊維状物質が、ナイロン、ポリエステル、アラミド、炭素、金属及びポリオレフィンからなる群から選択される材料で作製される、請求項11に記載のバイオ容器。
- 前記フィルムが、第1内側帯、ガス不透過帯、及び外側強度帯を形成する、ガス不透過帯の外側の強度帯を有する多層フィルムと、該接触帯と該ガス不透過帯との間で前記フィルムに組み込まれる基材とから形成され、前記基材が繊維状物質で形成される、請求項11~13のいずれか一項に記載のバイオ容器。
- 前記基材が、観察窓及びポートからなる群から選択されるデバイスを提供するために、基材中に形成された1つ以上の開口部を有する、請求項11~14のいずれか一項に記載のバイオ容器。
- 前記基材が、前記バイオ容器の内部への観察窓を提供するために、基材中に形成された1つ以上の細長い開口部を有する、請求項11~15のいずれか一項に記載のバイオ容器。
- 前記基材が、ポリマー、金属繊維、炭素繊維及びガラス繊維からなる群から選択される材料で形成される、請求項11~16のいずれか一項に記載のバイオ容器。
- バイオ容器の入口にガス圧力源を取り付け、前記バイオ容器内のその他の入口又は出口を閉鎖し、前記バイオ容器又は圧力源に圧力計を取り付けて前記バイオ容器内の圧力を読み取り、前記バイオ容器を満杯になるまで所望の圧力で膨張させ、圧力を経時的に監視して、何らかの圧力減衰が起こるか否かを決定することを含む、請求項11に記載のバイオ容器の試験方法。
- 所望の容量の液体で満たされた請求項11に記載のバイオ容器と、圧力計を有する圧力源を前記バイオ容器に取り付け、弁を前記バイオ容器の出口に取り付け、前記バイオ容器を所望の圧力に膨張させ、前記弁を選択的に開閉して液体を分配することを含む分配方法。
- 前記バイオ容器が1回加圧される、請求項11に記載の方法。
- 分配中に前記バイオ容器が閾値最小値に達したときに、前記バイオ容器に追加のガス圧力を加えることをさらに含む、請求項11に記載の方法。
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JP2004351859A (ja) * | 2003-05-30 | 2004-12-16 | Nippon Petrochemicals Co Ltd | 引裂き性に優れる包装材料 |
US20050037162A1 (en) * | 2003-08-11 | 2005-02-17 | Adams John Peter | Paperboard laminate for food packaging applications |
JP6418158B2 (ja) * | 2013-07-25 | 2018-11-07 | 凸版印刷株式会社 | シート材及びそれを用いたバリア性包装容器並びにシート材の製造方法 |
JP6754754B2 (ja) * | 2014-10-17 | 2020-09-16 | テトラ ラバル ホールディングス アンド ファイナンス エス エイ | 積層包装材料のための方法 |
EP3212132A4 (en) * | 2014-10-29 | 2018-07-04 | 3M Innovative Properties Company | Inflatable medical articles |
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US5891541A (en) * | 1996-06-18 | 1999-04-06 | Reef Industries, Inc. | Forming a continuous reinforced composite material |
JP2002506144A (ja) * | 1998-03-10 | 2002-02-26 | テトラ ラバル ホールデイングス エ フイナンス ソシエテ アノニム | 積層包装材料および該材料から製造された包装容器 |
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WO2020101848A1 (en) | 2020-05-22 |
US20210347156A1 (en) | 2021-11-11 |
JP2024016119A (ja) | 2024-02-06 |
CA3116896A1 (en) | 2020-05-22 |
KR20230074616A (ko) | 2023-05-30 |
EP3880469A1 (en) | 2021-09-22 |
JP7379482B2 (ja) | 2023-11-14 |
CN113039073B (zh) | 2023-06-27 |
KR102534593B1 (ko) | 2023-05-26 |
CN113039073A (zh) | 2021-06-25 |
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