CN101073732A - 具有存储器、通信和温度传感器的过滤器 - Google Patents
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Abstract
本发明描述了一种准确测量过滤元件的温度的系统和方法。温度变送器和通信器件耦合以便能在过滤元件处于使用中时测量并发送所述过滤元件的温度。此系统能包括集成有通信器件和温度变送器的单个组件。作为选择,所述系统能包括彼此相互通信的独立温度变送器和发送器组件。在又一实施例中,能把存储元件添加到该系统上,由此允许该器件存储一组温度值。该器件的使用对许多应用是有益的。例如,就地读取过滤器温度的能力允许改进的现场灭菌(SIP)协议相符合,这是由于能够直接测量实际过滤元件的温度,而不是像目前那样进行内插。
Description
发明背景
RFID标签的使用已经变得普遍起来,特别是在资产管理方面,尤其是与库存管理相关联的那些应用。例如,RFID标签的使用允许监视生产线以及通过供应链移动资产或组件。
为了进一步图示此原理,制造实体可以在组件进入生产设备时把RFID标签附着到它们上。这些组件接着被插入到生产流中,结合其它组件形成装配件,并且最终产生成品。RFID标签的使用允许制造实体内的工作人员在整个制造过程中跟踪具体组件的移动。它还允许所述实体能够标识包括任何特定配件或成品的具体组件。
另外,RFID标签的使用在药物和制药工业内也得到提倡。在2004年2月,美国联邦药物管理机构发布了提倡使用RFID标签来标记并监视药物的报告。这试图提供系谱并且限制伪造处方药物进入到市场及消费者。
自从RFID标签引入以来,RFID标签已经使用于许多应用中,例如用以标识过滤器产品中过程控制并为该过程控制提供信息。于1997年授予Den Dekker的美国专利5,674,381公开了结合过滤设备和可替换的过滤配件来使用“电子标记”。特别的是,该专利公开了具有电子标记的过滤器,所述过滤器具有读取/写入存储器和相关联的过滤设备,所述过滤设备具有响应于所述标记的读出装置。电子标记适合于计数并存储可替换过滤器的实际运转时间。该过滤设备适合于根据此实时数值来允许使用或拒绝该过滤器。该专利还公开了可以使用电子标记来存储关于可替换过滤器的标识信息。
于2005年公开的Baker等人的美国专利申请公开号为US2005/0205658的专利申请公开了一种处理设备跟踪系统。此系统包括结合处理设备来使用RFID标签。该RFID标签被描述为能够存储“至少一个可跟踪的事件”。这些可跟踪的事件被枚举为清理日期和批处理日期。该公开内容还公开了可连接到PC或因特网的RFID读取器,在所述PC或因特网中存在处理设备数据库。此数据库包含多个可跟踪的事件并且可以提供用于确定“基于累积数据的处理设备的使用寿命”的信息。该应用包括具有各种处理设备的此类系统的使用,所述处理设备诸如阀、泵、过滤器和紫外线灯。
于2004年公开的由Jornitz等人提交的美国专利申请公开号2004/0256328的另一专利申请公开了一种用于监视过滤设备完整性的设备和方法。此公布内容描述了结合过滤器外壳来包含板上存储器芯片和通信器件的过滤器的使用。该过滤器外壳安装有直接耦合到完整性测试仪器的通信读取器。(作为选择,读取器可以是手持式读取器,其具有自己的用于存储数据的存储器并且可以连接到独立的完整性测试仪器)。该申请还公开了用来确保在多个圆形(multi-round)外壳中所使用的过滤元件的完整性的一组步骤。这些步骤包括查询存储元件来验证正在使用的过滤器的类型、其限制数据及其生产发行数据。
尽管已经通过使用RFID标签进行了一些改进,但还有一些尚未得到满意解决的其他地方。例如,在诸如现场灭菌(sterilization-in-place,SIP)之类的许多应用中,在过滤元件处于使用中时所测量的过滤器温度是重要的考虑因素。当前,还不能够在实时灭菌处理期间在过滤器上可靠且准确地测量过滤器温度。为了解决这一问题,使用次佳的配置。例如,典型情况下温度传感器位于远离过滤元件的位置,并且从此传感器的读数来内插过滤器温度。虽然RFID标签提供了本发明的一个实施例,但还可以预见到利用有线通信的解决方案。
发明内容
本发明克服了现有技术的缺点,本发明描述了一种用于准确地测量过滤元件温度的系统和方法。在某些实施例中,温度变送器和通信器件耦合用以能够在过滤元件处于使用中时测量并发送所述过滤元件的温度。此系统可以包括集成有通信器件和温度变送器的单个组件。作为选择,该系统可以包括彼此通信的独立温度变送器和发送器组件。在又一实施例中,可以把存储元件添加到该系统,由此允许该器件存储一组温度值。在一个实施例中,该通信器件能够向用户无线发送信息。在第二实施例中,该通信器件经由有线连接向一般在外壳之外的点发送该信息。
此器件的使用对于许多应用来说是有益的。例如,就地读取过滤器温度的能力允许改进的现场灭菌(SIP)协议相配性,这是由于可以直接测量实际过滤元件的温度,而不是像目前那样进行内插。
附图说明
图1是本发明的代表性实施例。
具体实施方式
图1图示了依照本发明的代表性过滤系统。用外壳20来封闭过滤元件10。该过滤元件可以简单地是多孔材料,诸如褶纸或PVDF(Polyvinylidene fluoride聚偏氟乙烯)隔膜。作为选择,该过滤元件可以包括诸如塑料的框架和多孔材料。温度传感器30位于过滤元件10附近,并且优选嵌入到该过滤元件10中。此传感器30能够产生输出,该输出根据周围温度而变化。此输出可以采用模拟电压或电流的形式,或者可以是数字值。在优选实施例中,所述输出相对于温度线性变化,然而这并非是必要条件。可以使用与周围温度具有诸如对数或指数之类的已知关系的任何输出。在这种情况下,可以变换所述输出用以确定实际测量的温度。
在一个实施例中,温度传感器30被嵌入到过滤元件10的端盖中。在其它实施例中,温度传感器被贴到或嵌入到过滤元件中的不同点,优选在下游侧上。在一些应用中,该过滤元件的温度可能超过145℃,因此应当使用能够监视此温度的传感器。类似地,外壳20的温度可能是从较低温度到较高温度并且返回地循环,因此该温度传感器应当具有足以能够测量温度循环的响应时间。适当的传感器包括热敏电阻和变送器,所述热敏电阻是具有高温电阻系数的电阻,所述变送器是集成电路。该传感器还可以属于另一类型,包括但不限于二极管、RTD(电阻式温度检测器)或热电偶。
在一个实施例中,无线发送器40也位于温度传感器30附近或与之集成在一起。在优选实施例中,无线发送器40和温度传感器30被封装在单个集成组件中。作为选择,发送器40和传感器30可以被分离开,并且彼此之间诸如经由电信号来通信。各种类型的无线通信器件都是可以的,不过优选使用RFID标签。有源RFID标签允许与读取器进行有规律地通信,由此随时间推移而连续地获得温度分布图。作为选择,可以使用无源RFID标签,借此从由RFID读取器所发送的电磁场获得用于发送并感测温度的能量,由此在对应于RFID元件被所述读取器激活时的具体时间点获得所述温度。在一些应用中,该过滤元件的温度可能超过145℃多达一小时,因此应当使用能够经受得起此温度的发送器。类似地,外壳20的温度可能是从较低温度到较高温度并且返回的循环,因此该温度传感器应当能够经受得起温度循环。用于向外壳之外发送无线信号的机制已被公开。美国专利申请公开2004/0256328描述了使用天线来把在位于过滤器外壳上的发送应答器之间的信息中继到所述外壳之外的监视和测试部件。
作为选择,可以结合有线发送器来使用温度传感器。在此实施例中,使用一个或多个线路或其它适当的管道来把信息从该温度传感器发送到过滤器外壳之外的位置。
选择性地,可以结合无线发送器40和温度传感器30来使用存储元件50。可以使用此存储元件50来存储一组诸如可以借助传感器的有规律采样而产生的温度读数,所述存储元件50优选为随机存取存储器(RAM)、闪存(FLASH EPROM)或NVRAM器件。这允许无线发送器40发送数据所采用的速率不同于采样温度所采用的速率。例如,可以每秒采样温度10次,而每秒只发送数据一次。类似地,该存储元件必须能够经受得起145℃的温度达所延长的时段。
在使用无线发送器的实施例中,使用位于过滤器外壳20之外的无线接收器60来与所述发送器通信。在优选实施例中,使用RFID读取器或基站。该读取器可以被配置成使得它以有规律的间隔查询该发送器。作为选择,该读取器可以被手动操作,使得当设备操作者进行请求时进行读数。在另一实施例中,无线接收器60还包括存储元件。这降低了外壳内器件所需要的复杂性。在此实施例中,该无线接收器以优选有规律的间隔来查询该无线发送器/温度传感器。它从无线发送器接收在那时所确定的当前温度传感器测量。然后无线接收器60把此值存储在其存储元件中。该存储元件的容量可以改变,并且可以根据各种因素来确定。这些包括但不局限于接收测量的速率,处理所存储数据的速率,以及此存储元件与其外部环境通信的频率。
作为一个例子,考虑过滤元件具有与温度传感器30耦合的无线发送器40,诸如RFID标签。在此实施例中,RFID标签是无源的,即,它只在收到来自无线接收器或基站的查询时才发送数据。当收到该查询时,所述发送器发送当前可从温度传感器30获得的值。在一种方案中,被耦合到计算设备(诸如计算机)的无线接收器接着把这些温度值(选择性地连同相关联的时间戳一起)存储在诸如日志文件中。在不同的方案中,如果无线接收器与计算机相分离,那么该接收器将需要在内部存储多个温度测量,直到它连接到主计算和/或存储器件时为止。在这种情况下,存储元件需要与接收器集成在一起。
在已经定义了本发明的物理结构的情况下,在很多应用中本发明的物理结构都是有益的。下面打算图示那些应用中的一些,然而这并不意味着是所有这种应用的列举。
在一个实施例中,结合使用现场蒸汽灭菌(SIP)来使用本发明。SIP是FDA所命令的要求,用于依照cGMP来确保制造设备足够的清洁度。在此过程中,蒸汽被引入过滤器外壳中。此过程要求操作者保证灭菌温度至少达到最低温度。通常,为了确保符合这点,在外壳外面的“冷点”上监视温度,并且假定其中所包含的所有过滤元件的温度至少为该值。一旦此“冷点”到达所要求的最低温度,那么可以开始计时。典型情况下,灭菌周期大约持续30分钟。由于无法直接测量过滤元件的温度,所以此方法要求需要以超过所要求的温度来执行灭菌。可以在Millipore公司题目为“Steam-In-Place Method forMillipore Express SHF Filters”的技术摘要中找到此过程的完整描述,在此将其引入以供参考,在Jean-Marc Cappia的题目为“Principlesof Steam-In-Place”的技术读物中也可以找到此过程的完整描述,在此也将其引入以供参考。
通过使用本发明可以更准确且有效地执行使用现场蒸汽灭菌(SIP)。由塑料构成的过滤元件比不锈钢外壳加热更缓慢。因此,潜在地,过滤元件可能并不与所监视的冷点在同一时刻处于SIP温度。在这种情况下,可以使用直接安装到过滤器上或嵌入到其中的器件来测量各个过滤元件的温度,以使错误最小化。在一个实施例中,该温度传感器将测量过滤器端盖的温度,该温度代表过滤元件中塑料的温度。作为选择,该传感器可以位于隔膜和端盖的汇接处。可以在该温度和过滤器褶层内的温度之间获得相关性。取决于所使用温度传感器的类型,可以提供对该传感器的校准。给定用于测量在过滤元件处的温度的此能力,SIP协议的验证不再是必要的了。
得益于本发明的第二应用是在压力衰减完整性测试期间监视在邻近于过滤元件的过滤器外壳内的温度。在这些测试中,向外壳中泵入气体直到到达确定的压力。然后,随着气体通过过滤元件扩散,监视压力衰减。如果压力衰减太过迅速,那么假定气体流动不再经由扩散,而是经由对流。在完整性测试中确定此转变的发生点是关键的。
假定温度在整个测试过程中保持恒定或者在整个所述测试过程中是特定值或者以显著小于所测量的压力衰减的恒定速率而变化,来执行这些完整性测试。然而,这些假设一般是不真实的。依照被表示为(PV=nRT)的理想气体定律,当在外壳内向气体加压时,由于体积保持不变所以其温度必然增加。从而,由于温度在绝对值上从该假定值发生改变,或者如果温度随时间的改变可与压力随时间的改变相比,那么所获得的结果可能是错误的。在这些各个完整性测试期间监视并测量外壳内的温度、特别是温度随时间的瞬时改变的能力可以依照几种方式来缓解此问题。首先,它确保测试结果是有效的,这是由于它可以验证外壳内的温度是按照要求的。第二,利用理想气体定律的算法可以明确地说明温度和温度变化。因此,该算法可以从测量的判读去除温度影响以便获得校正的且更准确的测试结果估算。第三,由于可以测量实际温度,所以可以更迅速地执行测试,这是因为不必再等待预定时间量以使外壳内的温度稳定或衰减到确定值,这是当前能够在压力衰减完整性测试测量中消除温度影响所能执行的唯一动作。
在一个实施例中,利用塑料过滤器外壳,允许无线发送器在任何时间通过所述外壳发送压力数据。
Claims (19)
1.一种用于监视过滤元件的温度的设备,包括:
所述过滤元件,
接近于所述过滤元件的温度传感器,和
发送器,与所述温度传感器通信。
2.如权利要求1所述的设备,进一步包括与所述温度传感器通信的存储元件,适合于存储来自所述温度传感器的测量。
3.如权利要求1所述的设备,其中从由热敏电阻、热电偶、温度变送器、二极管和电阻热检测器所构成的组中选择所述温度传感器。
4.如权利要求1所述的设备,其中所述发送器包括无线发送器。
5.如权利要求4所述的设备,其中所述无线发送器包括RFID标签。
6.如权利要求1所述的设备,其中在单个机壳中提供所述温度传感器和所述发送器。
7.如权利要求4所述的设备,进一步包括无线接收器,适合于接收从所述无线发送器所发送的信号。
8.如权利要求1所述的设备,其中所述温度传感器被嵌入到所述过滤元件中。
9.如权利要求8所述的设备,其中所述过滤元件包括端盖,并且所述温度传感器被嵌入到所述端盖中。
10.如权利要求8所述的设备,其中所述温度被嵌入到所述过滤元件的下游侧中。
11.一种用于确保在过滤器外壳内的过滤元件上所执行的使用现场蒸汽灭菌过程的有效性的方法,包括:
邻近于所述过滤元件提供与发送器通信的温度传感器;
执行所述现场灭菌过程;
在所述过程期间监视所述过滤元件的温度;并且
验证所述被监视的过滤器温度高于预定义的最低温度。
12.如权利要求11所述的方法,其中以有规律的间隔执行所述监视步骤。
13.如权利要求11所述的方法,其中所述发送器包括无线发送器,并且所述方法进一步包括向位于所述外壳之外的接收器发送所述被监视温度的步骤。
14.如权利要求11所述的方法,其中所述温度传感器被嵌入到所述过滤元件中。
15.一种从利用加压气体对在过滤器外壳内的过滤元件做执行的完整性测试测量中去除温度变化的方法,包括:
邻近于所述过滤元件提供与发送器通信的温度传感器;
执行所述完整性测试过程;
在所述过程期间监视在所述外壳内气体的温度;并且
把所述监视的温度测量结合到所述完整性测试的判读中。
16.如权利要求15所述的方法,其中所述结合步骤包括如果所述监视的温度不在预定范围内,那么拒绝所述测试的结果。
17.如权利要求15所述的方法,其中所述结合步骤包括响应于所述监视的温度来调节所述测试的结果。
18.如权利要求15所述的方法,进一步包括监视所述气体的压力,并且根据所述被监视的温度来使所述被监视的压力正常化。
19.如权利要求15所述的方法,其中所述温度传感器被嵌入到所述过滤元件中。
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-
2007
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- 2007-03-28 EP EP13150656.0A patent/EP2586515A1/en not_active Withdrawn
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-
2009
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-
2010
- 2010-02-10 US US12/703,246 patent/US20110036782A1/en not_active Abandoned
- 2010-09-15 JP JP2010207093A patent/JP2011031241A/ja active Pending
- 2010-09-15 JP JP2010207091A patent/JP2011007812A/ja active Pending
- 2010-10-10 US US12/901,547 patent/US20110026560A1/en not_active Abandoned
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CN102016939A (zh) * | 2008-03-26 | 2011-04-13 | 米利波尔有限公司 | 用于工艺壳体的天线垫圈 |
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CN102016939B (zh) * | 2008-03-26 | 2015-01-28 | Emd密理博公司 | 用于工艺壳体的天线垫圈 |
CN107249648A (zh) * | 2015-02-12 | 2017-10-13 | 倍力曼股份公司 | 灭菌器 |
CN110168569A (zh) * | 2016-10-14 | 2019-08-23 | 哈恩席卡德应用研究协会 | 阈值检测设备 |
CN110168569B (zh) * | 2016-10-14 | 2024-01-12 | 哈恩席卡德应用研究协会 | 阈值检测设备 |
CN112823240A (zh) * | 2018-08-07 | 2021-05-18 | 唐纳森公司 | 具有数据传送特征的过滤器元件和系统 |
Also Published As
Publication number | Publication date |
---|---|
EP1844838A2 (en) | 2007-10-17 |
US20110026560A1 (en) | 2011-02-03 |
CN101073732B (zh) | 2012-02-15 |
EP2586515A1 (en) | 2013-05-01 |
JP2011007812A (ja) | 2011-01-13 |
JP2011031241A (ja) | 2011-02-17 |
JP2007286051A (ja) | 2007-11-01 |
US20110036782A1 (en) | 2011-02-17 |
EP1844838A3 (en) | 2012-09-12 |
SG136865A1 (en) | 2007-11-29 |
US20070240578A1 (en) | 2007-10-18 |
US20090225808A1 (en) | 2009-09-10 |
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