JP2009513381A - 無菌環境下でバイアルを製造する方法および装置 - Google Patents
無菌環境下でバイアルを製造する方法および装置 Download PDFInfo
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/0053—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor combined with a final operation, e.g. shaping
- B29C45/006—Joining parts moulded in separate cavities
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- 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
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/17—Component parts, details or accessories; Auxiliary operations
- B29C45/1701—Component parts, details or accessories; Auxiliary operations using a particular environment during moulding, e.g. moisture-free or dust-free
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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
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/56—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits
- B29C65/565—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits involving interference fits, e.g. force-fits or press-fits
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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
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/56—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits
- B29C65/567—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits using a tamping or a swaging operation, i.e. at least partially deforming the edge or the rim of a first part to be joined to clamp a second part to be joined
- B29C65/568—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits using a tamping or a swaging operation, i.e. at least partially deforming the edge or the rim of a first part to be joined to clamp a second part to be joined using a swaging operation, i.e. totally deforming the edge or the rim of a first part to be joined to clamp a second part to be joined
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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
- B29C66/001—Joining in special atmospheres
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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
- B29C66/01—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
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- B—PERFORMING OPERATIONS; TRANSPORTING
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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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- 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
- B29C66/54—Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
- B29C66/542—Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles joining hollow covers or hollow bottoms to open ends of container bodies
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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
- B29C66/80—General aspects of machine operations or constructions and parts thereof
- B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
- B29C66/832—Reciprocating joining or pressing tools
- B29C66/8322—Joining or pressing tools reciprocating along one axis
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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
- B29C66/80—General aspects of machine operations or constructions and parts thereof
- B29C66/84—Specific machine types or machines suitable for specific applications
- B29C66/843—Machines for making separate joints at the same time in different planes; Machines for making separate joints at the same time mounted in parallel or in series
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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
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/17—Component parts, details or accessories; Auxiliary operations
- B29C45/1769—Handling of moulded articles or runners, e.g. sorting, stacking, grinding of runners
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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
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/17—Component parts, details or accessories; Auxiliary operations
- B29C45/40—Removing or ejecting moulded articles
- B29C45/42—Removing or ejecting moulded articles using means movable from outside the mould between mould parts, e.g. robots
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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
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/4273—Auxiliary operations after the blow-moulding operation not otherwise provided for
- B29C49/428—Joining
- B29C49/42802—Joining a closure or a sealing foil to the article or pincing the opening
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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
- B29C66/70—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
-
- 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
- B29C66/70—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
- B29C66/712—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 the composition of one of the parts to be joined being different from the composition of the other part
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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
- B29C66/80—General aspects of machine operations or constructions and parts thereof
- B29C66/84—Specific machine types or machines suitable for specific applications
- B29C66/863—Robotised, e.g. mounted on a robot arm
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/712—Containers; Packaging elements or accessories, Packages
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/4998—Combined manufacture including applying or shaping of fluent material
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49998—Work holding
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
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- Y10T29/53313—Means to interrelatedly feed plural work parts from plural sources without manual intervention
- Y10T29/53322—Means to assemble container
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/53—Means to assemble or disassemble
- Y10T29/53443—Means to assemble or disassemble container and fluid component
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Abstract
【選択図】 図12
Description
(1)口部開口部を有する医薬バイアルの形状を画定する、内部に開放可能空洞部を有するバイアル鋳型を提供する段階;
(2)成形可能な医学的に許容されるポリマーを用いて、前記バイアル鋳型空洞部でバイアルを成形する段階;
(3)前記バイアル鋳型を開けて、前記で形成されたバイアルを露出させる段階;
(4)前記で形成されたバイアル本体を前記バイアル鋳型から取り出す段階;
(5)自動機械式取扱手段を用いて前記で形成されたバイアル本体の前記口部開口部に無菌の穿刺可能密閉部を自動的に挿入する段階
を有し;
少なくとも段階(3)〜(5)を無菌条件下で行う。
(1)口部開口部を有する医薬バイアルの形状を画定する、内部に開放可能空洞部を有するバイアル鋳型を提供する段階;
(2)成形可能な医学的に許容されるポリマーを用いて、前記バイアル鋳型空洞部でバイアルを成形する段階;
(3)前記バイアル鋳型を開けて、前記で形成されたバイアルを露出させる段階;
(4)前記で形成されたバイアルを前記バイアル鋳型から取り出す段階;
(6)前記医薬バイアルの前記口部開口部のための穿刺可能密閉部の形状を画定する、内部に開放可能空洞部を有する密閉部鋳型を提供する段階;
(7)成形可能な医学的に許容されるエラストマーポリマーを用いて、前記密閉部鋳型空洞部に穿刺可能密閉部を成形する段階;
(8)前記密閉部鋳型を開けて、前記で形成された穿刺可能密閉部を露出させる段階;
(9)前記で形成された穿刺可能密閉部を前記密閉部鋳型から取り出す段階;
(5)前記で形成されたバイアルの前記口部開口部に前記で形成された穿刺可能密閉部を自動的に挿入する段階
を有し;
少なくとも段階(3)、(4)、(5)、(8)および(9)を無菌条件下で行う。
(A)口部開口部を有する医薬バイアルの形状を画定する開放可能空洞部を内部に有し、成形可能な医学的に許容されるポリマーを用いてバイアルを成形することができ、開けることで内部で成形されたバイアルを露出させることができるバイアル鋳型;
(B)第1の鋳型で成形した場合に医薬バイアル用の密閉部の形状を画定する開放可能空洞部を内部に有し、成形可能な医学的に許容されるポリマーを用いて密閉部を成形することができ、開けることで内部に成形された密閉部を露出させることができる密閉部鋳型;
(C)前記バイアル鋳型で製造されたバイアルの前記口部開口部に前記密閉部鋳型で製造された穿刺可能密閉部を挿入するよう構成された自動機械式取扱手段;
(D)無菌環境下で、前記バイアルおよび密閉部鋳型を開けることができ、個々のバイアルおよび密閉部を前記個々のバイアルおよび密閉部鋳型から取り出すことができ、前記密閉部をバイアルに挿入するように、(A)、(B)および(C)に関して無菌環境を提供する手段
を有することができる。
11 開放端
12 口部開口部
13 フランジ
14 閉鎖端
15 外側底部表面の側面
20 エラストマー密閉部
21 下側栓部分
22 フランジ
23 上側ドーム状穿刺可能部
30 射出鋳型の一部
31、32 2個の鋳型ブロック
33 空洞部
34 分割線
35 射出口
36 心金
37 表面
40 射出鋳型
41、42 鋳型ブロック
43 空洞部
45 射出口
46 心金
47 表面
50 無菌領域
51 無菌領域の壁
52、53 射出成形機
54 サブ領域
55、56 自動取扱機構
57、58 ロボットアーム
59、510 真空取り扱い
511 真空口
512、513 エアロック
60 クランプ部分を嵌合させるためのさらなる処理ステーション
601、602 別の処理ステーション
61 クランプ部分
62 スナップ留め歯
63 スナップ留め溝
70 コンベア
Claims (24)
- 医薬バイアルの製造方法において、
(1)口部開口部を有する医薬バイアルの形状を画定する、内部に開放可能空洞部を有するバイアル鋳型を提供する段階;
(2)成形可能な医学的に許容されるポリマーを用いて、前記バイアル鋳型空洞部でバイアルを成形する段階;
(3)前記バイアル鋳型を開けて、前記で形成されたバイアルを露出させる段階;
(4)前記で形成されたバイアル本体を前記バイアル鋳型から取り出す段階;
(5)自動機械式取扱手段を用いて前記で形成されたバイアル本体の前記口部開口部に無菌の穿刺可能密閉部を自動的に挿入する段階
を有し;
少なくとも段階(3)〜(5)を無菌条件下で行うことを特徴とする方法。 - (1)口部開口部を有する医薬バイアルの形状を画定する、内部に開放可能空洞部を有するバイアル鋳型を提供する段階;
(2)成形可能な医学的に許容されるポリマーを用いて、前記バイアル鋳型空洞部でバイアルを成形する段階;
(3)前記バイアル鋳型を開けて、前記で形成されたバイアルを露出させる段階;
(4)前記で形成されたバイアルを前記バイアル鋳型から取り出す段階;
(6)前記医薬バイアルの前記口部開口部のための穿刺可能密閉部の形状を画定する、内部に開放可能空洞部を有する密閉部鋳型を提供する段階;
(7)成形可能な医学的に許容されるエラストマーポリマーを用いて、前記密閉部鋳型空洞部で穿刺可能密閉部を成形する段階;
(8)前記密閉部鋳型を開けて、前記で形成された穿刺可能密閉部を露出させる段階;
(9)前記で形成された穿刺可能密閉部を前記密閉部鋳型から取り出す段階;
(5)前記で形成されたバイアルの前記口部開口部に前記で形成された穿刺可能密閉部を自動的に挿入する段階
を有し;
少なくとも段階(3)、(4)、(5)、(8)および(9)を無菌条件下で行う請求項1に記載の方法。 - 前記バイアルおよび密閉部の一方または両方が射出成形によって作製され、その成形では最初に固体ポリマーを、代表的には螺旋スクリューによって加熱および加圧することで流動化し、次に前記鋳型空洞部中に加圧下で押し込む請求項1または2に記載の方法。
- 前記バイアル鋳型空洞部を、内部に円筒管形状を有し、口部開口部を画定する開放端と反対側の閉鎖端を持ち、前記口部開口部周囲の外部にフランジを有するバイアルを作製する形状とする請求項1、2または3に記載の方法。
- 前記バイアル鋳型空洞部を、自動機械式取扱手段との係合に適した係合部分を持った閉鎖端を有するバイアルを作製する形状とする請求項1〜4のいずれかに記載の方法。
- シクロオレフィン系熱可塑性ポリマーを用いてバイアルを作製する請求項1〜5のいずれかに記載の方法。
- 前記密閉部鋳型を、前記バイアル鋳型によって作製されるバイアルの数の倍数を作製するよう構成する請求項1〜6のいずれかに記載の方法。
- 段階(4)、(5)および(9)を、前記個々のバイアルおよび密閉部鋳型で形成される前記バイアルおよび密閉部と解除可能に係合し、前記形成されたバイアルおよび密閉部をそれらの鋳型から取り出し、バイアルと密閉部を合体させてバイアルを密閉部と係合させることができる自動取扱手段によって行う請求項1〜7のいずれかに記載の方法。
- 前記自動取扱手段が、複数のバイアルおよび密閉部と解除可能に係合され、複数のバイアルおよび密閉部をそれらの鋳型から取り出し、複数のバイアルおよび密閉部を合体させて複数のバイアルを複数の密閉部と同時に係合させるように構成されている請求項8に記載の方法。
- 前記自動取扱手段が前記バイアルの前記閉鎖端の外部と係合し、前記密閉部が所定位置にある時には前記バイアルの内部と接触しない前記密閉部の一部と係合する請求項8または9に記載の方法。
- 前記自動取扱手段が、前記バイアルまたは密閉部を引きつけて前記自動取扱手段の係合手段と接触させる吸引手段によって、前記バイアルまたは密閉部と解除可能に係合する請求項8、9または10に記載の方法。
- 密閉部と係合した前記取扱手段が、段階(5)でバイアル中に前記密閉部を導入し、その間に前記バイアルも取扱手段によって係合される請求項8〜11のいずれかに記載の方法。
- 前記取扱手段が前記バイアルを解除することで、前記係合したバイアルおよび密閉部が、前記密閉部と係合した前記取扱手段によって保持される請求項12に記載の方法。
- 段階(5)でのバイアルおよび密閉部の組み立ての後、その組立物を別の処理ステーションに自動的に移動させ、そこで前記組立物について1以上の別の処理を行う請求項1〜13のいずれかに記載の方法。
- 請求項1〜14のいずれかに記載の方法を行うための装置であって、
(A)口部開口部を有する医薬バイアルの形状を画定する開放可能空洞部を内部に有し、成形可能な医学的に許容されるポリマーを用いてバイアルを成形することができ、開けることで内部に成形されたバイアルを露出させることができるバイアル鋳型;
(B)第1の鋳型で成形した場合に医薬バイアル用の密閉部の形状を画定する開放可能空洞部を内部に有し、成形可能な医学的に許容されるポリマーを用いて密閉部を成形することができ、開けることで内部に成形された密閉部を露出させることができる密閉部鋳型;
(C)前記バイアル鋳型で製造されたバイアルの前記口部開口部に前記密閉部鋳型で製造された穿刺可能密閉部を挿入するよう作製された自動機械式取扱手段;
(D)無菌環境下で、前記バイアルおよび密閉部鋳型を開けることができ、個々のバイアルおよび密閉部を前記個々のバイアルおよび密閉部鋳型から取り出すことができ、前記密閉部をバイアルに挿入できるように、(A)、(B)および(C)に関して無菌環境を提供する手段
を有する装置。 - 前記バイアル鋳型および密閉部鋳型の一方または両方が射出鋳型であり、そこでは最初に固体ポリマーを、代表的には螺旋スクリューによって加熱および加圧することで流動化し、次に前記鋳型空洞部中に加圧下で押し込む請求項15に記載の装置。
- 前記バイアル鋳型空洞部が、自動機械式取扱手段との係合に適した係合部分を持つ閉鎖端を有するバイアルを作製する形状となっている請求項15または16に記載の装置。
- 前記密閉部鋳型が、前記バイアル鋳型によって作製されるバイアルの数の倍数を作製するよう構成されている請求項15、16または17に記載の装置。
- 段階(4)、(5)および(9)を行うために、前記個々のバイアルおよび密閉部鋳型で形成される前記バイアルおよび密閉部と解除可能に係合し、前記形成されたバイアルおよび密閉部をそれらの鋳型から取り出し、バイアルと密閉部を合体させてバイアルを密閉部と係合させることができる自動取扱手段が設けられた請求項15〜18のいずれかに記載の装置。
- 前記自動取扱手段が、複数のバイアルおよび密閉部と解除可能に係合され、複数のバイアルおよび密閉部をそれらの鋳型から取り出し、複数のバイアルおよび密閉部を合体させて複数のバイアルを複数の密閉部と同時に係合させるように構成されている請求項19に記載の装置。
- 前記自動取扱手段が、前記バイアルの前記閉鎖端の外部と係合し、前記密閉部が所定位置にある時には前記バイアルの内部と接触しない前記密閉部の一部と係合するよう構成されている請求項19または20に記載の装置。
- 前記自動取扱手段が、前記バイアルまたは密閉部を引きつけて前記自動取扱手段の係合手段と接触させる吸引手段によって、前記バイアルまたは密閉部と解除可能に係合するよう構成されている請求項19、20または21に記載の装置。
- 前記取扱手段が、段階(5)で前記取扱手段によって係合された密閉部をバイアル中に導入し、その間に前記バイアルも取扱手段によって係合されるよう構成されている請求項19〜22のいずれかに記載の装置。
- 前記取扱手段が、前記バイアルを解除することで、前記係合したバイアルおよび密閉部が、前記密閉部と係合した前記取扱手段によって保持されるよう構成されている請求項23に記載の装置。
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DK1646491T3 (da) | 2009-01-05 |
CA2531046A1 (en) | 2005-01-20 |
EP1646491B1 (en) | 2008-08-27 |
CA2531046C (en) | 2011-11-08 |
DE602004016164D1 (de) | 2008-10-09 |
JP4827732B2 (ja) | 2011-11-30 |
SI1646491T1 (sl) | 2009-02-28 |
ATE406252T1 (de) | 2008-09-15 |
WO2005005128A1 (en) | 2005-01-20 |
US7832078B2 (en) | 2010-11-16 |
US20060200968A1 (en) | 2006-09-14 |
EP1646491A1 (en) | 2006-04-19 |
ES2313024T3 (es) | 2009-03-01 |
GB0315953D0 (en) | 2003-08-13 |
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