JP2016501742A - 検査試料容器を無菌でブロー、充填及び密封する製造方法、関連システム並びに容器 - Google Patents
検査試料容器を無菌でブロー、充填及び密封する製造方法、関連システム並びに容器 Download PDFInfo
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
- B29D22/00—Producing hollow articles
- B29D22/003—Containers for packaging, storing or transporting, e.g. bottles, jars, cans, barrels, tanks
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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
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
- B29C49/04—Extrusion blow-moulding
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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
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
- B29C49/06—Injection blow-moulding
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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
- B29C49/20—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor of articles having inserts or reinforcements ; Handling of inserts or reinforcements
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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
- B29C49/46—Component parts, details or accessories; Auxiliary operations characterised by using particular environment or blow fluids other than air
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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
- B29C49/78—Measuring, controlling or regulating
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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
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
- B29C2049/023—Combined blow-moulding and manufacture of the preform or the parison using inherent heat of the preform, i.e. 1 step blow moulding
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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
- B29C49/20—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor of articles having inserts or reinforcements ; Handling of inserts or reinforcements
- B29C2049/2008—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor of articles having inserts or reinforcements ; Handling of inserts or reinforcements inside the article
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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
- B29C49/46—Component parts, details or accessories; Auxiliary operations characterised by using particular environment or blow fluids other than air
- B29C2049/4602—Blowing fluids
- B29C2049/4635—Blowing fluids being sterile
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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
- B29C49/46—Component parts, details or accessories; Auxiliary operations characterised by using particular environment or blow fluids other than air
- B29C2049/4673—Environments
- B29C2049/4679—Sterile gas to surround or flush parts of the blow-moulding apparatus, e.g. blowing means, preforms or parisons
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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
- B29C49/46—Component parts, details or accessories; Auxiliary operations characterised by using particular environment or blow fluids other than air
- B29C2049/4673—Environments
- B29C2049/4697—Clean room
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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
- B29C2949/00—Indexing scheme relating to blow-moulding
- B29C2949/30—Preforms or parisons made of several components
- B29C2949/3064—Preforms or parisons made of several components having at least one components being applied using techniques not covered by B29C2949/3032 - B29C2949/3062
- B29C2949/3074—Preforms or parisons made of several components having at least one components being applied using techniques not covered by B29C2949/3032 - B29C2949/3062 said at least one component obtained by coating
- B29C2949/3076—Preforms or parisons made of several components having at least one components being applied using techniques not covered by B29C2949/3032 - B29C2949/3062 said at least one component obtained by coating on the inside
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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
- 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
- B29C49/42808—Filling the article
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/02—Form or structure of the vessel
- C12M23/08—Flask, bottle or test tube
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Abstract
Description
この出願は、2012年10月31日に出願した米国特許仮出願第61/720,531号の利益及び優先権を主張し、仮出願の全内容を参照により本明細書に援用するものとする。
Claims (22)
- パリソンを形成する形成ステップと、
前記パリソンに流動可能な滅菌センサ材料を導入するセンサ材料導入ステップと、
前記センサ材料導入ステップの前、間又は後に、前記パリソンを容器の本体へとブロー成形するブロー成形ステップと、
前記センサ材料を硬化させて、前記センサ材料を前記容器の本体の内面に付着させる硬化ステップと、
前記容器を密封して、オートクレーブが不要な滅菌容器を形成する密封ステップと、
を含む培養容器の無菌製造方法。 - 前記センサ材料導入ステップを、前記ブロー成形ステップの前、かつ前記培養容器がブローフィルシール機械に保持されている間に実施する、請求項1に記載の方法。
- 前記センサ材料導入ステップを、前記ブロー成形ステップ後の、前記パリソンから形成される前記容器の本体の温度が高められた間、かつ前記容器の本体が滅菌環境内のブローフィルシール機械に保持されている間に実施する、請求項1に記載の方法。
- 前記センサ材料は滅菌比色センサ材料であり、
前記方法は、温度が室温よりも高められた間に、ブロー成形した前記容器の本体の上部を締め付けて閉じる締付ステップを更に含み、
前記形成ステップ、前記センサ材料導入ステップ、前記硬化ステップ、及び前記締付ステップの全てを、滅菌環境内のブローフィルシール機械を用いて実施する、請求項1に記載の方法。 - 前記流動可能なセンサ材料を前記パリソンに導入するときに、前記パリソンの温度は約25℃から約150℃の間である、請求項1に記載の方法。
- 前記センサ材料導入ステップの後、かつ前記密封ステップの前に、滅菌された増殖培地を流動させる流動ステップを更に含む、請求項1に記載の方法。
- 前記硬化ステップを、熱エネルギによって、及び/又は硬化剤をブロー成形した前記容器の本体に導入することによって実施し、それによって、前記容器の本体がブローフィルシール機械に保持されている間に、前記センサ材料を前記内面に接着させる、請求項1に記載の方法。
- 前記センサ材料が液状エマルジョンシリコーンを含む、請求項1に記載の方法。
- 滅菌ストッパを前記容器の本体の上部に電気機械的に取付ける取付ステップと、
その後、前記ストッパが前記容器の本体の前記上部に取付けられたまま、滅菌ニードル及び/又は滅菌チューブを、前記ストッパを通して電気機械的に挿入する挿入ステップと、
前記ニードル又は前記チューブを用いて、前記容器の本体の内部容積に電気機械的に真空処理を施す真空処理ステップと、
を更に含む、請求項1に記載の方法。 - 前記取付ステップの前に、滅菌された増殖培地を前記容器の本体に導入する増殖培地導入ステップを更に含む、請求項9に記載の方法。
- 前記取付ステップの後に、前記容器の本体内に真空処理を施して加圧された規定の滅菌ガス又はガス混合物を入れることを更に含む、請求項9に記載の方法。
- 前記形成ステップと、前記センサ材料導入ステップと、前記ブロー成形ステップと、前記硬化ステップと、前記密封ステップとの全てを、前記容器の本体が滅菌環境内のブローフィルシール機械に保持されている間に実施する、請求項1に記載の方法。
- 前記容器の本体内に滅菌微生物増殖培地を添加する増殖培地添加ステップと、
前記増殖培地添加ステップの後に、滅菌ストッパを前記容器の本体の上部に電気機械的に取付ける取付ステップと、
ブロー成形した前記容器の本体の上部を電気機械的に密封して滅菌環境を包囲する包囲ステップと、
前記容器の本体の上部を電気機械的にトリムするトリムステップと、
エラストマーの前記ストッパが前記容器の本体の前記上部に取付けられたまま、前記容器の本体内に真空状態を電気機械的に生み出す真空状態生成ステップと、
前記ストッパを覆う外部キャップを、前記容器の本体の上部に電気機械的に追加する外部キャップ追加ステップと、
を更に含む方法であり、
電気機械的な前記増殖培地添加ステップ、及び前記取付ステップを滅菌環境で、前記ブロー成形ステップに用いるブローフィルシール機械に保持されている間、又は前記ブローフィルシール機械内に存在する間に実施し、
前記トリムステップ及び前記外部キャップ追加ステップを、前記ブローフィルシール機械外の滅菌環境で実施する、請求項1に記載の方法。 - 前記パリソンは、オートクレーブ処理のオートクレーブ温度よりも低い温度定格を有するポリマー材料を含むことができる、請求項1に記載の方法。
- ブロー成形した密封後の前記容器の本体が、透光性である、請求項13に記載の方法。
- 少なくとも1つのブローピン、及び容器の本体の形状を画定する型キャビティを設けた型をそれぞれ備える複数のブロー成形ステーションを有する、少なくとも1つのブロー成形機と、
前記ブロー成形ステーションと流体連通する、少なくとも1つの滅菌パリソン成形材料の供給源と、
前記ブロー成形ステーションと流体連通する少なくとも1つの流体通路を有する、少なくとも1つの流動可能な滅菌センサ材料の供給源と、
(i)前記少なくとも1つのブロー成形機に、前記滅菌パリソン成形材料からパリソンを形成させ、(ii)前記パリソンが熱い間に、前記流動可能な滅菌のセンサ材料に前記流体通路内をそれぞれの前記ブロー成形ステーションまで流動させて、前記流動可能な滅菌センサ材料を前記パリソンに入れ、(iii)前記ブロー成形機に、前記パリソンを前記型キャビティでブロー成形させる、ように構成される、少なくとも1つのコントローラと、
を備える、培養試料容器を大量生産するためのシステムであり、
前記ブロー成形機は滅菌環境に存在する、システム。 - 前記コントローラは、前記パリソンをブロー成形する前に、前記センサ材料を前記パリソンに入れて、前記パリソンをブロー成形している間、前記センサ材料は前記パリソン内に存在する、請求項16に記載のシステム。
- 前記コントローラは、前記パリソンがブロー成形されている間又はブロー成形された後に、前記センサ材料を前記パリソンに入れる、請求項16に記載のシステム。
- それぞれの成形ステーションまで延びる少なくとも1つの流体通路を有する、少なくとも1つの滅菌有機体増殖培地の供給源と、
それぞれのストッパを、前記ブロー成形ステーションの1つに保持されるそれぞれの容器の本体の上部へ送り込む電気機械的運搬システムを有する、少なくとも1つの滅菌のエラストマーストッパの供給源と、
を更に備える、請求項16に記載のシステム。 - 滅菌ニードルに対応する流体通路を有する、少なくとも1つの真空源を更に備え、前記滅菌ニードルは、前記ブロー成形ステーションが容器の本体を保持している間に、前記ブローピンを通って下方に移動し、前記容器の本体に取付けられたそれぞれのストッパを通って延び、それによって前記容器の本体の内部容積を真空吸引するように構成される、請求項19に記載のシステム。
- それぞれの成形ステーションまで延びて、滅菌ガスを、前記成形ステーションが保持する前記容器の本体の内部容積に流すように構成される流体通路を有する、加圧された前記滅菌ガス源を更に備える、請求項16に記載のシステム。
- 底部と、内面を持ち上方へ延びる側面とを有する、ブロー成形された無菌の容器の本体を含む培養容器であり、
前記容器の本体は、前記容器の本体の前記底部と前記上方へ延びる側面とに付着する比色センサ材料の内部層を有し、前記比色センサ材料は前記底部の前記内面に付着する薄い層であり、
前記容器の本体は、137℃のオートクレーブ温度に15分間さらされた場合に、(i)半透明若しくは不透明になり、(ii)透過的になり、又は(iii)構造的な剛性が低下し、その結果、視覚的に透光性の培養容器として使用するのに適さなくなる、培養容器。
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Application Number | Priority Date | Filing Date | Title |
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US201261720531P | 2012-10-31 | 2012-10-31 | |
US61/720,531 | 2012-10-31 | ||
US13/790,244 | 2013-03-08 | ||
US13/790,244 US9358738B2 (en) | 2012-10-31 | 2013-03-08 | Aseptic blow, fill and seal methods of fabricating test sample containers and associated systems and containers |
PCT/US2013/066060 WO2014070514A1 (en) | 2012-10-31 | 2013-10-22 | Aseptic blow, fill and seal methods of fabricating test sample containers and associated systems and containers |
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JP2016501742A true JP2016501742A (ja) | 2016-01-21 |
JP6353844B2 JP6353844B2 (ja) | 2018-07-04 |
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US (1) | US9358738B2 (ja) |
EP (1) | EP2917018B1 (ja) |
JP (1) | JP6353844B2 (ja) |
CN (1) | CN104837602B (ja) |
AU (1) | AU2013338302B2 (ja) |
CA (1) | CA2888375A1 (ja) |
IN (1) | IN2015DN04012A (ja) |
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Also Published As
Publication number | Publication date |
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IN2015DN04012A (ja) | 2015-10-02 |
AU2013338302B2 (en) | 2018-03-08 |
EP2917018B1 (en) | 2017-02-01 |
CA2888375A1 (en) | 2014-05-08 |
JP6353844B2 (ja) | 2018-07-04 |
WO2014070514A1 (en) | 2014-05-08 |
AU2013338302A1 (en) | 2015-05-07 |
US9358738B2 (en) | 2016-06-07 |
US20140120606A1 (en) | 2014-05-01 |
CN104837602B (zh) | 2017-03-08 |
CN104837602A (zh) | 2015-08-12 |
EP2917018A1 (en) | 2015-09-16 |
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