JP2009149378A - デバイスに物質を供給し且つ充填する方法 - Google Patents
デバイスに物質を供給し且つ充填する方法 Download PDFInfo
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- JP2009149378A JP2009149378A JP2009070988A JP2009070988A JP2009149378A JP 2009149378 A JP2009149378 A JP 2009149378A JP 2009070988 A JP2009070988 A JP 2009070988A JP 2009070988 A JP2009070988 A JP 2009070988A JP 2009149378 A JP2009149378 A JP 2009149378A
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- Prior art keywords
- needle
- vial
- filling
- stopper
- resealable
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
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- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
- B29C65/16—Laser beams
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
- B29C65/16—Laser beams
- B29C65/1629—Laser beams characterised by the way of heating the interface
- B29C65/1654—Laser beams characterised by the way of heating the interface scanning at least one of the parts to be joined
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
- B29C65/16—Laser beams
- B29C65/1677—Laser beams making use of an absorber or impact modifier
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- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
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- B29C66/001—Joining in special atmospheres
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
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- B29C66/05—Particular design of joint configurations
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- B29C66/122—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section
- B29C66/1222—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a lapped joint-segment
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C66/01—General aspects dealing with the joint area or with the area to be joined
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- B29C66/1224—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a butt joint-segment
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
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- B29C66/124—Tongue and groove joints
- B29C66/1246—Tongue and groove joints characterised by the female part, i.e. the part comprising the groove
- B29C66/12461—Tongue and groove joints characterised by the female part, i.e. the part comprising the groove being rounded, i.e. U-shaped or C-shaped
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- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/01—General aspects dealing with the joint area or with the area to be joined
- B29C66/05—Particular design of joint configurations
- B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
- B29C66/13—Single flanged joints; Fin-type joints; Single hem joints; Edge joints; Interpenetrating fingered joints; Other specific particular designs of joint cross-sections not provided for in groups B29C66/11 - B29C66/12
- B29C66/131—Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
- B29C66/1312—Single flange to flange joints, the parts to be joined being rigid
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- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/01—General aspects dealing with the joint area or with the area to be joined
- B29C66/342—Preventing air-inclusions
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
- B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
- B29C66/53—Joining single elements to tubular articles, hollow articles or bars
- B29C66/534—Joining single elements to open ends of tubular or hollow articles or to the ends of bars
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
- B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
- B29C66/53—Joining single elements to tubular articles, hollow articles or bars
- B29C66/534—Joining single elements to open ends of tubular or hollow articles or to the ends of bars
- B29C66/5344—Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
- B29C66/61—Joining from or joining on the inside
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- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
- B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
- B29C66/73—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
- B29C66/737—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined
- B29C66/7375—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined uncured, partially cured or fully cured
- B29C66/73755—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined uncured, partially cured or fully cured the to-be-joined area of at least one of the parts to be joined being fully cured, i.e. fully cross-linked, fully vulcanized
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- B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
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- B65D51/00—Closures not otherwise provided for
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Abstract
【解決手段】実質的な層流の下でチャンバのボディをモールディングし、ボディのモールディングと互いに近接して実質的な層流の下で熱可塑性部をモールディングし、熱可塑性部とボディとを室温に冷却する前に、熱可塑性部とボディとを組み立てて常温で無菌シールされるデバイスを形成し、充填部材がデバイスのチャンバと流体連通するように熱可塑性部の貫通領域を充填部材で貫通させ、充填部材を通してデバイスのチャンバに物質を導入し、充填部材を熱可塑性部から引き抜き、所定の波長及びパワーでレーザ照射を熱可塑性部の貫通領域に形成された穿孔の上に伝達し、穿孔を約2秒より短い時間期間で気密シールする。
【選択図】図14
Description
参考例の一つの局面は、加硫ゴム又は既知の同様の材料から形成されバイアル内に収納された薬剤に対して安定した環境を提供するベース部と、ベース部に重なっている再シール可能部とを備える薬剤バイアルのための再シール可能なキャップに関している。再シール可能部は、低密度ポリエチレンのような再シール可能なポリマ材料からできていて、薬剤をバイアルの内部に分配するために針又は同様の注入部材で穴を開けられることができる。針の引き抜き時には、再シール可能部の穿孔された領域は熱シールされて、薬剤を収納しているチャンバを気密シールされた状態に維持する。
参考例の他の局面は、再シール可能なバイアルを所定の薬剤で充填する装置及び方法に関している。この方法は、バイアルを提供するステップと、熱エネルギーの印加に対して実質的に溶解しないベース部を含み、再シール可能部が、薬剤への露出及びバイアル内の薬剤のシールのために所定の薬剤と適合する再シール可能キャップと、ベース部に重なり熱エネルギーの印加に対して溶融する再シール可能部と、キャップ及びバイアルと係合してキャップをバイアルに固定するロック部材と、を含む。バイアルの薬剤での充填の前に、再シール可能キャップとロック部材とがバイアルに固定されて、それによって実質的に気体を通さないシールがキャップとバイアルとの間に形成される。それから、組み立てられたキャップ、バイアル、及びロック部材は、ベータ又はガンマ線照射への露出によってのようにして無菌化される。針又は同様の注射部材がそれから再シール可能キャップを通じて挿入され、所定の薬剤が針を通ってバイアルの内部に導入される。参考例の一つの実施形態では、針は「二重管腔」針であり、所定の薬剤のそこを通ってバイアル内への導入のためのコア通路と、バイアル内部からの置換された空気又はその他の気体あるいは蒸気の排出のために真空源と流体連通的に結合された環状通路とを規定している。バイアルの薬剤による充填時には、針がキャップから引き抜かれて、十分な熱エネルギーがキャップの再シール可能部の貫通された領域に印加されて、貫通された領域を溶融し、貫通された領域とバイアルの内部との間に実質的に気体を通さないシールを形成する。好ましくは、再シール可能部材の貫通可能領域は、直接熱焼灼あるいはレーザ又はその他の照射焼灼によってのようにして、キャップを通した針の導入に先立って焼灼され、アセンブリ及び充填プロセスを通じた無菌状態を更に確実にする。
参考例の他の局面は、再シール可能なストッパ及び前記再シール可能なストッパを含むアセンブリに関しており、これは、コンテナと、所定の物質をコンテナ内にシールする再シール可能ストッパと、ストッパをコンテナに固定するロック部材とを備える。再シール可能なストッパは、その軸方向に所定の壁厚を規定するボディと、針で貫通可能で針開口をそこに形成し且つ熱で再シール可能でレーザ源からの所定の波長及びパワーでのレーザ照射の印加によって針開口を気密シールする針貫通領域とを含む。針貫通領域は所定の色及び不透明度を規定し、(i)所定の波長のレーザ照射を実質的に吸収し且つ照射の所定の壁厚の通過を妨げ、(ii)所定の波長及びパワーのレーザ照射がその針貫通領域に形成された針開口を所定の時間期間で気密シールさせる。アセンブリはさらに、再シール可能なストッパを貫通して物質をストッパを通ってコンテナ内に導入する針と、針に流体連通的に結合されて物質を針を通ってコンテナ内に導入する物質源と、再シール可能なストッパと熱連通的に接続可能で所定の波長及びパワーでレーザ照射を印加するレーザ源と、を含む。
参考例の他の局面は、針で貫通可能で針開口をそこに形成し且つ熱で再シール可能で所定の波長及びパワーのレーザ照射の印加によって前記針開口を気密シールする針貫通領域を規定する熱可塑性ストッパに関する。このストッパは、その軸方向に所定の壁厚を規定する熱可塑性ボディを備え、この熱可塑性ボディが、(i)スチレンブロックコポリマと、(ii)オレフィンと、(iii)ボディが所定の波長でレーザ照射を実質的に吸収し且つその所定の壁厚を照射が通過することを実質的に妨げて、約2秒より短い所定の時間期間で針貫通領域に形成された針開口を気密シールすることを可能にする所定の量の顔料と、(iv)針の貫通の間に針とボディとの界面における摩擦力を低減する所定の量の潤滑剤と、を含む。
参考例の他の局面は、針で貫通可能で針開口をそこに形成し且つ熱で再シール可能で所定の波長及びパワーのレーザ照射の印加によって前記針開口を気密シールする針貫通領域を規定する熱可塑性ストッパに関する。このストッパは、その軸方向に所定の壁厚を規定する熱可塑性ボディを備え、この熱可塑性ボディが、(i)約80重量%から約97重量%の範囲内の量で且つ第1の伸びを規定する第1のポリマ材料と、(ii)約3重量%から約20重量%の範囲内の量で且つ第1の材料の第1の伸びよりも小さい第2の伸びを規定する第2のポリマ材料と、(iii)ボディが所定の波長でレーザ照射を実質的に吸収し且つその所定の壁厚を照射が通過することを実質的に妨げて、約2秒より短い所定の時間期間でその針貫通領域に形成された針開口を気密シールすることを可能にする量の顔料と、(iv)針の貫通の間に針とボディとの界面における摩擦力を低減する量の潤滑剤と、を含む。
参考例の他の局面は、バイアルに所定の薬剤を供給し且つ充填する方法に関しており、この方法は、
(i)針で貫通可能で針開口をそこに形成し且つ熱で再シール可能で所定の波長及びパワーのレーザ照射の印加によって針開口を気密シールする針貫通領域を規定する熱可塑性ストッパを提供するステップであって、ストッパがさらに、その軸方向に所定の壁厚を規定する熱可塑性ボディを備え且つスチレンブロックコポリマとオレフィンとを含む、ステップと、
(ii)熱可塑性ストッパに、ボディが所定の波長でレーザ照射を実質的に吸収し且つその所定の壁厚を照射が通過することを実質的に妨げる所定の量の顔料を提供するステップと、
(iii)ストッパをバイアルの開放端に接続し、ストッパとバイアルとの間にシールされたチャンバを規定するステップと、
(iv)非芯の円錐状先端と、先端に隣接して位置し且つ所定の薬剤のソースと流体連通的に接続可能な少なくとも一つの流れ開口とを規定する針を準備するステップと、
(v)針の流れ開口がバイアルのチャンバと流体連通するように、ストッパの針貫通領域を針の円錐状先端で貫通するステップと、
(vi)針とストッパとの界面に潤滑剤を提供して、それらの間の摩擦力を低減するステップと、
(vii)所定の薬剤を針を通してバイアルのチャンバに導入し、且つ針をストッパから引き抜くステップと、
(viii)所定の波長及びパワーでレーザ照射をストッパの針貫通領域に伝達し、その針貫通領域に形成された針開口を約2秒より短い時間期間で気密シールするステップと、
を包含する。
(1)針で貫通可能で針開口をそこに形成し且つ熱で再シール可能で所定の波長及びパワーのレーザ照射の印加によって前記針開口を気密シールする針貫通領域を規定する熱可塑性ストッパであって、前記ストッパが熱可塑性ボディを備え、この熱可塑性ボディが、その軸方向に所定の壁厚を規定し、且つ、(i)スチレンブロックコポリマと、(ii)オレフィンと、(iii)前記ボディが前記所定の波長でレーザ照射を実質的に吸収し且つその前記所定の壁厚を照射が通過することを実質的に妨げて、約2秒より短い所定の時間期間でその前記針貫通領域に形成された針開口を気密シールすることを可能にする所定の量の顔料と、(iv)針の貫通の間に前記針とボディとの界面における摩擦力を低減する所定の量の潤滑剤と、を含む、ストッパ。
(2)前記スチレンブロックコポリマが約80重量%から約97重量%の範囲内である、(1)記載のストッパ。
(3)前記オレフィンが約3重量%から約20重量%の範囲内である、(1)に記載のストッパ。
(4)前記ボディが約90重量%のスチレンブロックコポリマと約5重量%のオレフィンとを含む、(1)に記載のストッパ。
(5)前記スチレンブロックコポリマの前記オレフィンに対する比が、重量比で約50:50から重量比で約90:5の範囲内である、(1)に記載のストッパ。
(6)前記所定の波長が約980nmである、(1)に記載のストッパ。
(7)前記所定のパワーが約30ワットよりも少ない、(1)に記載のストッパ。
(8)前記所定のパワーが約10ワットよりも少ないか又は等しい、(7)に記載のストッパ。
(9)前記顔料がグレーである、(1)に記載のストッパ。
(10)前記顔料の量が約0.3重量%から約0.6重量%の範囲内である、(8)に記載のストッパ。
(11)前記所定の時間期間が約1.5秒よりも短い、(1)に記載のストッパ。
(12)前記ストッパがバイアルストッパである、(1)に記載のストッパ。
(13)前記ストッパがシリンジブランジャの形態である、(1)に記載のストッパ。
(14)前記潤滑剤が、シリコーン、鉱油、及びシリコーンオイルを含むグループから選択される、(1)に記載のストッパ。
(15)前記潤滑剤がシリコーンオイルであり、前記潤滑剤の量が約0.4重量%から約0.6重量%の範囲内である、(1)に記載のストッパ。
(16)前記ストッパを貫通する針と組み合わされ、前記針が、約15度から約25度の範囲内の内角を規定する非芯の円錐状先端を含む、(1)に記載のストッパ。
(17)前記針が、その貫通の間に前記針とストッパとの間の摩擦力を低減するための低摩擦コーティングを含む、(16)に記載のストッパ。
(18)前記低摩擦コーティングが、タングステンカーバイド及びチタンを含むグループから選択される、(17)に記載のストッパ。
(19)針で貫通可能で針開口をそこに形成し且つ熱で再シール可能で所定の波長及びパワーのレーザ照射の印加によって前記針開口を気密シールする針貫通領域を規定する熱可塑性ストッパであって、前記ストッパが熱可塑性ボディを備え、この熱可塑性ボディが、その軸方向に所定の壁厚を規定し、且つ、(i)約80重量%から約97重量%の範囲内の量で且つ第1の伸びを規定する第1のポリマ材料と、(ii)約3重量%から約20重量%の範囲内の量で且つ第1の材料の第1の伸びよりも小さい第2の伸びを規定する第2のポリマ材料と、(iii)前記ボディが前記所定の波長でレーザ照射を実質的に吸収し且つその前記所定の壁厚を照射が通過することを実質的に妨げて、約2秒より短い所定の時間期間でその前記針貫通領域に形成された針開口を気密シールすることを可能にする量の顔料と、(iv)針の貫通の間に前記針とボディとの界面における摩擦力を低減する量の潤滑剤と、を含む、ストッパ。
(20)前記第1の材料が前記第2の材料よりも高い溶融温度を規定する、(19)に記載のストッパ。
(21)前記第1の材料がスチレンブロックコポリマであり、前記第2の材料がオレフィンである、(20)に記載のストッパ。
(22)前記第1の材料が約10ポンドの力で少なくとも約75%の第1の伸びを規定する、(19)に記載のストッパ。
(23)前記第1の材料が約10ポンドの力で約85%から少なくとも約90%の範囲内の第1の伸びを規定する、(22)に記載のストッパ。
(24)前記第2の材料が約10ポンドの力で少なくとも約5%の第2の伸びを規定する、(19)に記載のストッパ。
(25)前記第2の材料が約10ポンドの力で約15%から約25%の範囲内の第2の伸びを規定する、(24)に記載のストッパ。
(26)前記第1の材料がスチレンブロックコポリマである、(19)に記載のストッパ。
(27)前記第2の材料がオレフィンである、(19)に記載のストッパ。
(28)前記第1の材料がスチレンブロックコポリマであり、前記第2の材料がオレフィンであり、前記ボディが約90重量%のスチレンブロックコポリマと約5重量%のオレフィンとを含む、(1)に記載のストッパ。
(29)前記第1の材料がスチレンブロックコポリマであり、前記第2の材料がオレフィンであり、前記スチレンブロックコポリマの前記オレフィンに対する比が重量比で約90:5である、(19)に記載のストッパ。
(30)前記所定の波長が約980nmである、(19)に記載のストッパ。
(31)前記所定のパワーが約30ワットよりも少ない、(19)に記載のストッパ。
(32)前記所定のパワーが約10ワットよりも少ないか又は等しい、(31)に記載のストッパ。
(33)前記顔料がグレーである、(19)に記載のストッパ。
(34)前記顔料の量が約0.3重量%から約0.6重量%の範囲内である、(33)に記載のストッパ。
(35)前記所定の時間期間が約1秒よりも短い、(19)に記載のストッパ。
(36)前記潤滑剤が、シリコーン、鉱油、及びシリコーンオイルを含むグループから選択される、(19)に記載のストッパ。
(37)前記潤滑剤がシリコーンオイルであり、前記潤滑剤の量が約0.4重量%から約0.6重量%の範囲内である、(19)に記載のストッパ。
(38)前記ストッパを貫通する針と組み合わされ、前記針が、約15度から約25度の範囲内の内角を規定する非芯の円錐状先端を含む、(19)に記載のストッパ。
(39)前記針が、その貫通の間に前記針とストッパとの間の摩擦力を低減するための低摩擦外部表面を含む、(38)に記載のストッパ。
(40)前記低摩擦表面が、タングステンカーバイド表面、電解研磨されたステンレス鋼表面、及びチタン表面を含むグループから選択される、(17)に記載のストッパ。
(41)バイアルに所定の薬剤を供給し且つ充填する方法で、
針で貫通可能で針開口をそこに形成し且つ熱で再シール可能で所定の波長及びパワーのレーザ照射の印加によって前記針開口を気密シールする針貫通領域を規定する熱可塑性ストッパを提供するステップであって、前記ストッパがさらに、その軸方向に所定の壁厚を規定する熱可塑性ボディを備え且つスチレンブロックコポリマとオレフィンとを含む、ステップと、
前記熱可塑性ストッパに、前記ボディが前記所定の波長でレーザ照射を実質的に吸収し且つその前記所定の壁厚を照射が通過することを実質的に妨げる所定の量の顔料を提供するステップと、
前記ストッパをバイアルの開放端に接続し、前記ストッパとバイアルとの間にシールされたチャンバを規定するステップと、
非芯の円錐状先端と、前記先端に隣接して位置し前記所定の薬剤の源と流体連通的に接続可能な少なくとも一つの流れ開口とを規定する針を準備するステップと、
前記針の前記流れ開口が前記バイアルの前記チャンバと流体連通するように、ストッパの前記針貫通領域を前記針の円錐状先端で貫通するステップと、
前記針とストッパとの界面に潤滑剤を提供して、それらの間の摩擦力を低減するステップと、
前記所定の薬剤を前記針を通して前記バイアルの前記チャンバに導入し、前記針を前記ストッパから引き抜くステップと、
所定の波長及びパワーでレーザ照射を前記ストッパの前記針貫通領域に伝達し、その前記針貫通領域に形成された前記針開口を約2秒より短い時間期間で気密シールするステップと、
を包含する、方法。
(42)前記潤滑剤を提供するステップが、前記ストッパボディ内に、前記針とボディとの界面における摩擦力を低減する所定の量の潤滑剤を提供するステップを含む、(41に記載の方法。
(43)前記ストッパとバイアルボディとを実質的な層流の元でプラスチックからモールドするステップと、前記ストッパとバイアルボディとを周囲温度まで冷却させる前に前記ストッパとバイアルボディとを組み合わせて、それらの間にシールされた無菌で発熱源を含まないチャンバを形成するステップと、をさらに包含する、(41)に記載の方法。
(44)前記針の表面に、前記ストッパをそれで貫通するステップの前に電子ビーム照射を伝達するステップをさらに包含する、(41)に記載の方法。
(45)前記ストッパに、そのレーザシールの間に電子ビーム照射を伝達するステップをさらに包含する、(41)に記載の方法。
Claims (4)
- 次のステップを含むデバイスに物質を供給し且つ充填する方法であって、
実質的な層流の下でチャンバのボディをモールディングするステップと、
前記ボディのモールディングと互いに近接して実質的な層流の下で、充填部材によって貫通できる貫通領域を備え貫通領域は所定の波長及びパワーでレーザ照射によってそのなかの穿孔を熱で再気密シール可能である熱可塑性部をモールディングするステップと、
前記熱可塑性部と前記ボディとを室温に冷却する前に、前記熱可塑性部と前記ボディとを組み立てて常温で無菌シールされるデバイスを形成するステップと、
充填部材が前記デバイスの前記チャンバと流体連通するように前記熱可塑性部の前記貫通領域を前記充填部材で貫通させるステップと、
前記充填部材を通して前記デバイスの前記チャンバに物質を導入するステップと、
前記充填部材を熱可塑性部から引き抜くステップと、
所定の波長及びパワーでレーザ照射を前記熱可塑性部の前記貫通領域に形成された前記穿孔の上に伝達し、前記穿孔を約2秒より短い時間期間で気密シールするステップと、
を含む方法。 - 請求項1に記載の方法であって、
組み立てステップは、前記ボディと前記熱可塑性部とを殺菌温度で組み立てる方法。 - 請求項1に記載された方法であって、
組み立てステップは、組み立て治具を用いて複数の前記熱可塑性部を複数の前記ボディに組み合わせるか、複数の複数の前記ボディを前記熱可塑性部に組み合わせる方法。 - 請求項1に記載された方法であって、
物質は少なくとも食品、化粧品、医薬品の内の1つである方法。
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CA2514569C (en) | 2010-05-11 |
CN102145774A (zh) | 2011-08-10 |
EP1594749A4 (en) | 2009-10-28 |
JP5123237B2 (ja) | 2013-01-23 |
US20040256026A1 (en) | 2004-12-23 |
CA2514569A1 (en) | 2004-08-26 |
JP2006516906A (ja) | 2006-07-13 |
WO2004071878A3 (en) | 2005-01-20 |
WO2004071878A2 (en) | 2004-08-26 |
RU2009126823A (ru) | 2011-01-20 |
EP1594749B1 (en) | 2013-05-29 |
HK1139635A1 (en) | 2010-09-24 |
CN1745019A (zh) | 2006-03-08 |
US7032631B2 (en) | 2006-04-25 |
CN101596962A (zh) | 2009-12-09 |
CN100526165C (zh) | 2009-08-12 |
RU2376220C2 (ru) | 2009-12-20 |
HK1160827A1 (en) | 2012-08-17 |
CN101596962B (zh) | 2011-03-23 |
JP4401355B2 (ja) | 2010-01-20 |
EP1594749A2 (en) | 2005-11-16 |
MXPA05008098A (es) | 2006-02-08 |
RU2005123708A (ru) | 2006-06-10 |
BRPI0407067A (pt) | 2006-01-17 |
RU2504357C2 (ru) | 2014-01-20 |
CN102145774B (zh) | 2013-08-21 |
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