JP6718879B2 - 無バッテリのマルチポイント無線製品条件(状態)感知を用いるプロセス監視と制御 - Google Patents
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Description
本願は、2015年1月28日出願の米国仮出願番号62/108,589号明細書、題名「無電池のマルチポイント無線温度感知を用いるプロセス監視および制御」、及び2015年6月9日提出の米国仮出願番号62/172,829号明細書、題名「無電池のマルチポイント無線温度感知を用いるプロセス監視および制御」の全内容が、ここに参考文献として援用される。
Claims (23)
- 無菌医薬品処理チャンバ内で処理される製品バイアルに含まれる製品の条件プロファイルを測定するための製品条件測定ユニットであって、
前記製品バイアルの開口内に位置決めするための支持構造と、
単一の伸長プローブであって、
前記支持構造によって支持され、前記単一の伸長プローブの構造成分を形成するプリント回路基板と、
前記支持構造からの増分距離を隔てて前記単一の伸長プローブに沿う線形アレイに於いて長手方向に離間し、前記プリント回路基板上に表面搭載される複数の表面搭載センサとを備える単一の伸長プローブと、
前記支持構造によって支持され、前記複数のセンサからの測定値を受信するように接続されたプロセッサとを備える製品条件測定ユニット。 - 受信した無線電力信号を使用してプロセッサに電力を供給するよう接続された無線周波数環境発電ボードをさらに備える、請求項1に記載の製品条件測定ユニット。
- 条件プロファイルは温度プロファイルを含む、請求項1および2のいずれか1項に記載の製品条件測定ユニット。
- 前記条件プロファイルが湿度プロファイルを含む、請求項1および2のいずれか1項に記載の製品条件測定ユニット。
- 前記測定値の各1つを、空間の単一場所における温度測定値および湿度測定値の双方に変換するよう構成された測定処理モジュールをさらに備える、請求項1および2のいずれか1項に記載の製品条件測定ユニット。
- 前記表面搭載センサは、セラミック表面搭載容量性センサを含む、請求項1および2のいずれか1項に記載の製品条件測定ユニット。
- プロセッサはプリント回路基板上に搭載される、請求項1および2のいずれか1項に記載の製品条件測定ユニット。
- ローカル無線ネットワークを介して測定データを送信するための無線送信機をさらに含む、請求項1および2のいずれか1項に記載の製品条件測定ユニット。
- 前記プロセッサは、前記ローカルのネットワークを介して前記製品条件測定ユニットの固有のIDコードを送信するように構成される、請求項8に記載の製品条件測定ユニット。
- 前記プロセッサに接続され、前記測定データを前記ローカル無線ネットワークを介して送信する通信アンテナをさらに備える、請求項8に記載の製品条件測定ユニット。
- 前記センサは、前記単一の伸長プローブに沿って隣接するセンサから2mm未満の間隔を置いて配置されている、請求項1および2のいずれか1項に記載の製品条件測定ユニット。
- 前記複数のセンサは、6つ以上のセンサを備える、請求項1および2のいずれか1項に記載の製品条件測定ユニット。
- 凍結溶媒を含有する製品で、バイアル開口部を有し凍結乾燥チャンバ内に配置される複数のバイアルに存する前記製品の凍結乾燥方法であって、
凍結した溶媒を昇華させるための条件を製品に施すこと、
製品がプロセス条件に供されている間に、複数のバイアルのひとつのバイアルに於いて、プロダクト内に延在する単一の伸長測定プローブに沿って配置された製品条件センサであり、プリント回路基板上に搭載された表面搭載センサを含む前記製品条件センサの、2mm未満のピッチを有する線形アレイを利用して、昇華最前部の位置を測定すること、及び
測定された昇華最前部の位置に基づいてプロセス条件を制御することを含み、
前記プリント回路基板は、前記単一の伸長測定プローブの構造成分を形成する、凍結乾燥方法。 - 製品を周囲条件に戻すこと、
バイアルに於いて、製品が周囲条件に供される間に、製品条件センサの線形アレイを利用して製品の湿度プロファイルを測定することをさらに含む請求項13に記載の方法。 - 複数の棚であって、各個別棚は前記棚から前記棚によって支持されたバイアルへ熱伝達する個々の調整可能熱伝達システムを有する、前記複数の棚上に前記複数の製品バイアルが配置され、
昇華最前部の測定位置に基づいてプロセス条件を制御することは、前記昇華最前部の測定位置に基づいてバイアルが配置される特定の棚の調節可能な熱伝達システムを調節することをさらに含む請求項13および14のいずれか1項に記載の方法。 - 無線の高周波数電力供給信号を使用して、バイアル上の製品条件測定ユニットに電力を供給することをさらに含む請求項13および14のいずれか1項に記載の方法。
- 前記バイアル上の無線通信送信機によって測定データを送信することをさらに含む、請求項13および14のいずれか1項に記載の方法。
- 製品条件センサは温度センサであり、前記方法は、前記製品の温度測定値に基づいて製品温度勾配を推定することによって前記昇華最前部の位置を決定することをさらに含む請求項13および14のいずれか1項に記載の方法。
- 反復測定に基づいて前記昇華最前部の伝播速度を推定することをさらに含む請求項13および14のいずれか1項に記載の方法。
- 筐体の内部を周囲雰囲気から無菌的に隔離するための無菌筐体と、
無菌筐体の内部の条件を制御するために接続された環境制御装置と、及び
無菌筐体の内部の温度と湿度を測定するように位置決めされ、かつ環境制御装置に測定値を提供するように接続された少なくとも1つの測定ユニットであって、空間内の単一位置で温度および湿度の双方を測定するための容量性センサ、コンピュータ可読媒体およびプロセッサを備える前記少なくとも1つの測定ユニットとを備え、
前記コンピュータ可読媒体は、前記容量性センサのための温度対容量曲線および湿度対容量曲線を含む較正情報を含み、
前記プロセッサは、空間内の前記単一位置で前記温度および前記湿度を測定して前記較正情報を利用するという命令を含む、無菌医薬品処理システム。 - 前記少なくとも1つの測定ユニットが、プリント回路基板上に配置された複数の容量性センサを含む請求項20に記載の無菌医薬品処理システム。
- 前記複数の容量性センサは、前記無菌筐体内で処理される製品内の温度と湿度のプロファイルを測定するように配置される請求項20および21のいずれか1項に記載の無菌医薬品処理システム。
- 前記複数の容量性センサは、前記複数のセンサからの測定値を平均することによって前記無菌筐体内の環境条件を測定するように配置される請求項21に記載の無菌医薬品処理システム。
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US201562108589P | 2015-01-28 | 2015-01-28 | |
US62/108,589 | 2015-01-28 | ||
US201562172829P | 2015-06-09 | 2015-06-09 | |
US62/172,829 | 2015-06-09 | ||
PCT/US2016/014849 WO2016123062A1 (en) | 2015-01-28 | 2016-01-26 | Process monitoring and control using battery-free multipoint wireless product condition sensing |
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US (3) | US20180011502A1 (ja) |
EP (1) | EP3250868B1 (ja) |
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CN (1) | CN107429969B (ja) |
BR (1) | BR112017016033B1 (ja) |
DK (1) | DK3250868T3 (ja) |
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BR112017016033B1 (pt) * | 2015-01-28 | 2022-05-10 | Ima Life North America Inc | Unidade de medição de condição de produto, método para secagem por congelamento de um produto que contém um solvente congelado e sistema de processamento farmacêutico asséptico |
US20160265984A1 (en) * | 2015-03-13 | 2016-09-15 | Purdue Research Foundation | Wireless sensors, systems, and methods thereof |
CN108120528B (zh) * | 2016-11-29 | 2022-07-22 | 蜂巢能源科技有限公司 | 载流体的温度检测装置及检测设备 |
WO2018179327A1 (ja) * | 2017-03-31 | 2018-10-04 | アズビル株式会社 | 無線センサ |
JP6968666B2 (ja) * | 2017-11-08 | 2021-11-17 | アズビル株式会社 | センサシステム及び電磁波照射装置 |
ES2958727T3 (es) * | 2017-12-21 | 2024-02-13 | Martin Christ Gefriertrocknungsanlagen Gmbh | Uso de un sensor de producto, uso de un conjunto de sensores de producto, recipiente de secado y procedimiento para el funcionamiento de un sensor de producto |
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US11340015B2 (en) * | 2019-05-21 | 2022-05-24 | Ellab A/S | Data collector for use in monitoring a lyophilisation process of a product in a test product container in a lyophilisation chamber, corresponding system comprising the data collector, and use of data collector |
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CN107429969A (zh) | 2017-12-01 |
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JP2018507478A (ja) | 2018-03-15 |
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US11762403B2 (en) | 2023-09-19 |
CN107429969B (zh) | 2019-08-27 |
EP3250868A4 (en) | 2018-11-21 |
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EP3250868B1 (en) | 2020-07-15 |
BR112017016033B1 (pt) | 2022-05-10 |
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EP3250868A1 (en) | 2017-12-06 |
DK3250868T3 (da) | 2020-10-19 |
BR112017016033A2 (pt) | 2018-12-11 |
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