JP5043035B2 - 生物学的処理用途における溶液の自動無菌移送のためのシングルユースマニホールドおよびセンサ - Google Patents
生物学的処理用途における溶液の自動無菌移送のためのシングルユースマニホールドおよびセンサ Download PDFInfo
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Description
充填プログラム実施例
クロマトグラフィプログラムの実施例
Claims (20)
- 生物工学用途のためのマニホールド装置であって、1回の使用に適合するように滅菌済みであり且つ使い捨てのマニホールドユニットを備えており、前記マニホールドユニットは、
(a)少なくとも1つの入口端部、少なくとも1つの出口端部、外側表面、および生物工学流体の通過のために滅菌された内側表面を有する少なくとも1つの配管部分と、
(b)主要アクセスポートを有する少なくとも1つのシングルユース袋と、
(c)前記シングルユース袋の前記主要アクセスポートに前記配管部分を作動的に接続するための無菌コネクタ手段と、
(d)一回の使用に適合する1つまたは複数の滅菌済み使い捨て導電率センサであって、前記使い捨て導電率センサが、マニホールド装置内のインラインセンサであり、前記使い捨て導電率センサが、(i)生物工学流体を案内するための導管であって、少なくとも1つの前記配管部分に接続可能な導管と、(ii)前記生物工学流体の導電率を検知するように配置された検知部分と、(iii)前記導電率センサに固有の較正情報を保存するメモリ部品と、を備え、前記導電率センサのメモリ部品に保存された較正情報が、導電率定数及び前記導電率センサのオフセット温度を有する導電率センサと、
(e)前記導電率センサの導管を通過する生物工学流体の実際の導電率を計算する制御ロジックを有するマニホールドコントローラと、を備え、
前記制御ロジックの計算が、(i)前記導電率定数を前記導電率センサの検知部分により測定された前記生物工学流体の導電率と比較して導電率の情報を発生すること、(ii)前記導電率センサにより測定された温度を前記生物工学流体の実際の測定温度と比較して前記導電率センサのオフセット温度を適用し温度の情報を発生すること、及び(iii)前記導電率の情報及び前記温度の情報を使用して前記導管における生物工学流体の実際の導電率を計算することを含む、前記マニホールド装置。 - 前記装置が、自動化された無菌流体移送に用いられ、さらに、複数の前記シングルユース袋を備えており、前記シングルユース袋の各々が主要なアクセスポートを有しており、前記無菌コネクタ手段が、前記シングルユース袋のうち少なくとも1つの前記主要アクセスポートに、前記配管部分を作動的に接続し、前記配管部分の前記出口端部が、前記シングルユース袋との作動的な接続のための前記無菌コネクタ手段の1つを有する連続的に配置された複数の出口通路を有する、請求項1に記載のマニホールド装置。
- 前記制御ロジックを有するユーザインターフェースユニットをさらに含み、前記使い捨て導電率センサが前記ユーザインターフェースユニットに電気的に接続される、請求項1又は2に記載のマニホールド装置。
- 少なくとも1つの配管部分の前記外側表面と係合するポンプユニットをさらに備え、前記ポンプユニットのポンプ速度が前記制御ロジックにより制御される、請求項1又は2に記載のマニホールド装置。
- 1つまたは複数のピンチ弁をさらに備え、前記ピンチ弁のうち少なくとも1つが遠隔操作可能であり、前記制御ロジックが前記遠隔操作可能なピンチ弁の開閉のタイミングを制御または命令する、請求項1乃至4のいずれかに記載のマニホールド装置。
- 前記制御ロジックが、前記導電率センサを通過する前記生物工学流体の導電率に応答して、前記マニホールド装置の外部操作を制御する、請求項1乃至5のいずれかに記載のマニホールド装置。
- 前記ユーザインターフェースユニットが、前記導電率センサの検知部分を通って電流を駆動することによって、前記導管を通過する前記生物工学流体の導電率を測定する、請求項1乃至6のいずれかに記載のマニホールド装置。
- 使い捨て圧力センサであって、前記生物工学流体が前記出口端部より上流側の位置において前記圧力センサを通って流れるように前記配管に沿って位置決めされる使い捨て圧力センサ、をさらに含む、請求項1または2に記載のマニホールド装置。
- 前記装置が自動分取クロマトグラフィに用いられ、
(a)前記配管が、クロマトグラフィ供給区分およびクロマトグラフィ済み流体区分を含む少なくとも2つの区分にあり
(b)前記クロマトグラフィ供給区分が、出口と、前記シングルユース袋との作動的な接続のための前記無菌コネクタ手段の1つを有する連続的に配置された複数の入口通路と、を有し、
(c)前記クロマトグラフィ済み流体区分が、入口と、前記シングルユース袋との作動的な接続のための前記無菌コネクタ手段の1つを有する連続的に配置された複数の出口通路を有する前記配管の前記出口端部と、を有し、
さらに、前記クロマトグラフィ供給区分と前記クロマトグラフィ済み流体区分との間にクロマトグラフィカラムを備える、請求項1または2に記載のマニホールド装置。 - 前記使い捨て導電率センサのうち少なくとも1つが、前記クロマトグラフィカラムより下流側に配置される、請求項9に記載のマニホールド装置。
- 前記使い捨て導電率センサのうち少なくとも1つが、前記クロマトグラフィカラムより上流側に配置される、請求項9に記載のマニホールド装置。
- ユーザインターフェースユニットをさらに含み、前記1つまたは複数の使い捨て導電率センサが、前記ユーザインターフェースユニットに電気的に接続される、請求項9に記載のマニホールド装置。
- 前記ユーザインターフェースユニットが、前記導電率センサを通過する前記生物工学流体の導電率に応答して、前記マニホールド装置の外部操作を制御する、請求項12に記載のマニホールド装置。
- 少なくとも1つの配管部分の前記外側表面と係合するポンプユニットをさらに備え、前記ポンプユニットが、少なくとも部分的に前記ユーザインターフェースユニットによって制御され、これにより、前記ユーザインターフェースユニットが、前記ポンプユニットに係合するまたは前記ポンプユニットを停止することによって、前記マニホールド装置の外部操作を行う、請求項13に記載のマニホールド装置。
- 1つまたは複数のピンチ弁をさらに備え、前記ピンチ弁のうち少なくとも1つが遠隔操作可能であり、前記ユーザインターフェースユニットが前記ピンチ弁の操作を制御し、前記ユーザインターフェースユニットが、前記遠隔操作可能なピンチ弁の開閉のタイミングを制御または命令する制御ロジックを有し、これにより、前記ユーザインターフェースユニットが外部操作を行う、請求項13に記載のマニホールド装置。
- 前記装置が接線流濾過に用いられ、
1つの前記シングルユース袋がプロセス溶液袋であり、もう1つのシングルユース袋が透過収集袋であり、
前記配管が、濾過通液区分および濾過済流体区分を含む少なくとも2つの区分内にあり、前記濾過通液区分が前記プロセス溶液袋を含み、
前記濾過済流体区分が、前記配管部分を前記シングルユース袋と作動的に接続するための前記無菌コネクタ手段を利用する前記透過収集袋を含み、
さらに、前記濾過通液区分と前記濾過済流体区分との間に使い捨てフィルタを備え、これにより、前記プロセス溶液袋からの流体が、前記使い捨てフィルタを通って濾過され、前記透過収集袋に収集される、請求項1または2に記載のマニホールド装置。 - ユーザインターフェースユニットをさらに含み、前記使い捨て導電率センサが前記ユーザインターフェースユニットに電気的に接続され、前記ユーザインターフェースユニットが、前記導電率センサから信号を受け取り且つ解釈する制御ロジックを含む、請求項16に記載のマニホールド装置。
- 前記使い捨て導電率センサのうち1つが前記使い捨てフィルタより下流側の位置に沿って位置決めされ、前記導電率センサが前記ユーザインターフェースユニットに接続され、これにより、前記ユーザインターフェースユニットが前記配管内の前記流体の導電率を監視する、請求項17に記載のマニホールド装置。
- 1つまたは複数のピンチ弁をさらに備え、前記ピンチ弁のうち少なくとも1つが遠隔操作可能であり、前記ユーザインターフェースユニットが前記ピンチ弁の操作を制御し、前記ユーザインターフェースユニットが、前記遠隔操作可能なピンチ弁の開閉のタイミングを制御または命令する制御ロジックを有し、これにより、前記ユーザインターフェースユニットが外部操作を行う、請求項17に記載のマニホールド装置。
- 前記ユーザインターフェースユニットが、前記マニホールド装置の外部操作を、少なくとも部分的に命令または制御する制御ロジックを含む、請求項17に記載のマニホールド装置。
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Application Number | Priority Date | Filing Date | Title |
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US11/294,297 | 2005-12-05 | ||
US11/294,297 US9283521B2 (en) | 2002-06-14 | 2005-12-05 | Single-use manifold and sensors for automated, aseptic transfer of solutions in bioprocessing applications |
PCT/US2006/061565 WO2007067882A2 (en) | 2005-12-05 | 2006-12-04 | Single-use manifold for automated, aseptic transfer of solutionspin bioprocessing applications comprising at least one conductivity sensor applications |
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US20060118472A1 (en) | 2006-06-08 |
JP2009519440A (ja) | 2009-05-14 |
US20130161245A1 (en) | 2013-06-27 |
WO2007067882A3 (en) | 2007-07-26 |
WO2007067882A2 (en) | 2007-06-14 |
US9283521B2 (en) | 2016-03-15 |
US9700844B2 (en) | 2017-07-11 |
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