WO2009059645A1 - Electrode de ph-métrie en verre pour récipient jetable - Google Patents

Electrode de ph-métrie en verre pour récipient jetable Download PDF

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Publication number
WO2009059645A1
WO2009059645A1 PCT/EP2007/062130 EP2007062130W WO2009059645A1 WO 2009059645 A1 WO2009059645 A1 WO 2009059645A1 EP 2007062130 W EP2007062130 W EP 2007062130W WO 2009059645 A1 WO2009059645 A1 WO 2009059645A1
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WO
WIPO (PCT)
Prior art keywords
glass electrode
storage solution
storage
potential
electrode according
Prior art date
Application number
PCT/EP2007/062130
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English (en)
Inventor
Martin Heule
Christian Boeck
Original Assignee
Metroglas Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Metroglas Ag filed Critical Metroglas Ag
Priority to PCT/EP2007/062130 priority Critical patent/WO2009059645A1/fr
Publication of WO2009059645A1 publication Critical patent/WO2009059645A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/36—Glass electrodes

Definitions

  • the present invention relates to the technical field of pH glass electrodes especially for disposable containers such as biopro- cess bags, and methods for testing and calibration of such pH glass electrodes.
  • Irradiation by gamma rays is the most abundantly used procedure for sterilisation in the field of disposable bioprocess equipment.
  • the standard procedure in the case of bioprocess bags is to fabricate the bags in a clean room environment, to package the bags ready for use and then to subject the whole package to gamma sterilisation to obtain sterility inside. The sterilised bags are then shipped to the bioprocessing site.
  • a sensor into the bag system after this sterilisation procedure is cumbersome. It requires sensor sterilisation, a sterile environment and an expert person to perform the mounting of the sensor.
  • the sensor is preferably mounted earlier during the manufacturing process of the bag and sterilised together with the packaged bag.
  • the sensor is not accessible anymore after sterilisation without the risk to break sterility. Therefore, the sensor cannot be taken out of the installation for calibration. This is a severe problem for sensors requiring calibration before use, especially for pH glass electrodes that are calibrated using dedicated buffer solutions. These issues apply to any prepackaged assembly that contain a potentiometric pH electrode.
  • the plastic materials used for manufacturing the bioprocess disposables often is optically transparent. This allows for reading out the optical properties of a chemically sensitive material on the inside of a disposable system without endangering sterility.
  • the chemically sensitive material has typically a very low mass and is often provided as a small adhesive patch that can be easily fixed on the inside.
  • Sensing materials that withstand the gamma sterilisation process have been found and are in use today. Their optical properties are often stable enough so that calibration data obtained during the manufacturing of the sensing material is still valid for measurement months and years later. Therefore, such a system is perceived as "calibration-free" by the final user in biotechnology.
  • pH glass electrodes are still the most robust and selective pH sensors available. For many applications such as media and buffer preparation in biotechnology, it would definitively be an advantage to use glass electrodes for pH measure ⁇ ment.
  • pH glass electrodes are very well known and well accepted in standard biotechnology equipment such as steel tank fermenta ⁇ tion etc. pH glass electrodes are abundantly used the heavily regulated field of biopharmaceutical production and fulfil cur ⁇ rent regulatory, quality and safety requirements such as GMP, cGMP and other regulatory systems. Sterilisation in those classic systems is usually done by autoclaving the electrodes mounted to the tank or bioreactor.
  • Ap- pliflex a fermentation system with disposable bags called "Ap- pliflex” was marketed by Applikon Biotechnology BV (Schiedam, The Netherlands) , including the option to mount a single use sensor module consisting of a pH glass electrode, Clark-type dO sensor and a temperature sensor.
  • the sensor module was sterilized by gamma irradiation, but had to be mounted under sterile conditions into a threaded port on the bag. The calibration had to be performed using external calibration solutions. Furthermore, the module could only be mounted on the top of the system with sensors pointing downwards due to the liquid-filled sensors .
  • a pH glass electrode in a storage com ⁇ partment according to the independent claim 1, and related independent claims, i.e. the use of a buffered solution as a storage solution for a pH glass electrode, a method of testing a pH glass electrode, a method of calibrating a pH glass electrode, and a method of putting a pH glass electrode into operation.
  • a pH glass electrode (for use in a disposable container or a component of a disposable container) is stored in a storage compartment.
  • This storage compartment is filled with a sufficient amount of a buffered storage solution so as to cover at least the pH sensitive mem ⁇ brane (s) of the glass electrode during storage of the pH glass electrode in the storage compartment.
  • said storage so ⁇ lution is selected such as to provide for a stable pH upon expo ⁇ sure of the storage solution to gamma rays.
  • storage shall mean to keeping of at least the pH sensitive glass of the electrode in a liquid milieu while no actual use of the electrode for pH measurement is being intended at that time.
  • a "disposable container” preferably is a disposable bioprocess- ing bag (cf. overview in BioProcess International, May 2007, p 44-51), but the invention is not limited to such bags.
  • the pH glass electrode according to the invention could also be mounted in another piece of disposable equipment such as a transfer tubing setup or other disposable component in contact with a bio- process fluid whose pH is of interest.
  • a “storage compartment” is a housing that seals the pH sensitive glass membrane of the electrode leakproof from the environment.
  • a storage compartment has an inner volume of no more than 50 cm 3 , preferably no more than 10 cm 3 , most preferably no more than 2 cm 3 .
  • a very simple storage compartment is e.g. a flexible plastic cap that fits the pH glass electrode. Thus, the cap can be filled with the storage solution and is then pressed onto the pH electrode. After checking and calibrating, the cap is removed for measurement into the disposable container.
  • the pH glass electrode can be integrated in a disposable con ⁇ tainer such as a bioprocess bag system during the bag production process. Subsequently, the pH glass electrode undergoes gamma sterilisation with the fully packaged bag. The final user only has to attach the sensor cable to the pH meter to take the pH sensor into operation. Since the electrode is stored in a solution suited for a one-point calibration (as will be outlined be ⁇ low in more detail) , there is no need to bring the electrode in contact with additional calibration solutions. The electrode will remain in its original storage compartment throughout the testing and/or calibration procedures, thereby maintaining sterility.
  • the liquid compartment in which the electrode and its storage solution are kept is very small and can be opened after calibration towards the inside of a bioprocess bag in order to get the pH electrode into contact with the whole bag volume. It should be unproblematic that the small amount of storage solu ⁇ tion in the order of a few millilitres quantity is being dis ⁇ solved in the media on the order of 100 to 1000 litres. This is especially the case with e.g. phosphate buffers which are con ⁇ tained in many buffer and media compositions, anyhow. Alternatively, the remainders of the storage solution may of course be flushed out with the first quantity of process solution from the interior of the container. Another alternative would be to provide a storage compartment with fill and drain tubing.
  • This tubing could be used to drain and dry the compartment before bringing the container's contents into contact with the sensor.
  • the exact choice of procedure will evidently depend on the specific application, on the phase of the biotechnological production (upstream/downstream, etc.) and finally on the user and his specific regulatory requirements.
  • the object of the present invention is solved by storing the sensor in a small amount of buffered solution that substantially maintains its pH throughout the sterilisation process by gamma irradiation.
  • the suggested process is not entirely calibration-free, it can be simplified by automatic means to a point where the user only has to connect the electrode to the pH measuring equipment and to enter (or automatically read out) two values only, i.e. the slope from an electrode certificate and the pH of the storage solution. For a valid calibration, an electrode slope value and the offset potential value are required.
  • the slope of a pH glass electrode remains sufficiently stable within a small error margin throughout the sterilisation process at 25 - 50 kGy and during storage time in the order of several months to a few years.
  • the offset potentials may exhibit a significant change of several mV with time.
  • knowing the well-defined pH of the storage solution allows to determine the current value of the offset potential of the electrode.
  • the combined pH glass electrode according to the invention has electrolyte gels in both the reference electrode and the measuring electrode; these gels do not flow. This allows for mounting and operating the electrode in any orientation, including the electrode pointing upwards.
  • Such electrodes can be integrated at any location of the container. It is preferred to mount the electrodes at the bottom of the containers such that the electrode can be used to measure already during the first filling process as soon as both diaphragm and pH sensitive glass are immersed. This may be important in media and buffer preparation steps.
  • a pH glass electrode according to the invention comprises buffered storage solution, preferably containing: i) a first compound or combination of compounds that buffer (s) the storage solution at a substantially constant pH, despite irradiation with gamma rays; and ii) a second compound or combinations of compound that func ⁇ tion (s) to adjust the ionic strength of the storage solution .
  • the compound (s) of lit. i) constitute a buffer system selected from the group consisting of phosphate buffers, carbonate buff ⁇ ers, borate buffers.
  • a buffer system selected from the group consisting of phosphate buffers, carbonate buff ⁇ ers, borate buffers.
  • inorganic buffers are generally more stable than organic buffers; phosphate buffers are currently preferred.
  • Phosphates do not ex ⁇ hibit any measurable shift in pH up to a gamma irradiation dose of 49 kGy.
  • a very commonly used dose for biopro- cess equipment is 25 kGy.
  • the buffer system is adjusted to a pH of ⁇ 6.5, preferably 6.5; or > 7.5, preferably 7.5.
  • ⁇ cause a pH in the above ranges results in an electrode potential different from 0 mV when the electrode is fully functional; however, a broken or otherwise short-circuited pH electrode could exhibit a potential of 0 mV, as well as an "ideal" electrode at pH 7. In that case, a false positive would occur, i.e. the user would take a container with a defective electrode into operation. To prevent this, the following procedure is applied.
  • the compound(s) of lit. ii) (above) comprise an alkali metal salt, preferably potassium chloride, wherein the concentration of the alkali metal salt in the storage solution substantially equals the concentration of the alkali metal salt in the reference electrolyte of the pH glass electrode.
  • the storage solution is either saturated with the alkali metal salt, preferably potassium chloride; or contains the alkali metal salt, preferably potassium chloride, at a concentration of about 3 mol/1.
  • potassium chloride in the reference electrolyte is prevented from leaching out of the electrode by diffusion and the inner potential at the silver/silver chloride electrode is kept stable.
  • the buffer solution pH is therefore adjusted to match the hydrogen activity to the target pH of the buffer solution .
  • a further aspect of the present invention relates to a disposable container or a component of a disposable container, equipped with a pH glass electrode as described above.
  • the buffered storage solution preferably contains: i) a first compound or combination of compounds that buffer (s) the storage solution at a substantially constant pH, despite irradiation with gamma rays; and ii) a second compound or combinations of compound that function (s) to adjust the ionic strength of the storage solution .
  • the invention concerns a method of testing a pH glass electrode as described above, comprising the step of determining the potential of the pH glass electrode in the storage solution prior to opening the storage compartment.
  • the electrode according to the present invention may be checked for good measuring condition by measuring the potential in its storage solution. This procedure will prevent the accidental use of a bag with a defective sensor.
  • Yet a further aspect of the invention concerns a method of calibrating a pH glass electrode as described above, comprising the steps of: i) Measuring the potential of the pH glass electrode in the buffered storage solution of defined pH, at a time ti, prior to opening the storage compartment; ii) Determining an expected reference potential of the pH glass electrode in the buffered storage solution of defined pH, said expected potential being either a) calculated theoretically, based on the Nernst equation; and/or b) deduced from a suitable pre-determined data set corre ⁇ lating at least one measured potential at time to ⁇ ti to a defined pH of a calibration standard; iii) Calculating a current offset potential from the results of steps i) and ii) , compensating for the shift of the poten ⁇ tial from to to ti; and iv) Linear offsetting (a) slope (s) of (a) pre-determined cali ⁇ bration plot(s) by the offset potential determined in
  • ti is typically a point in time at the end-user's site, after sterilization by gamma irradiation and installation into a disposable container.
  • the offset potential U O ff U m - U' N * (7.0 - pH sts ) ; wherein U m is the measured potential according to step i) , U' N is the slope of the predetermined calibration plot at to and pH sts is the hydrogen ion activity of the storage solution (notation according to Galster, pH Measurement, VCH, Weinheim (DE), 1991 (p. 157; included herein by reference) .
  • Choosing pH 7 as the zero potential point is a common convention for the construction of pH Electrodes, e.g. according to DIN 19263:2006.
  • the pre-determined calibration plot or suitable pre-determined data set allowing for generation of such a plot is derived from a two or three-point calibration, e.g. at pHs 4.0, 7.0 and 9.0.
  • the above aspects of the invention can be combined in a method of putting a pH electrode into opera ⁇ tion, i.e. by a method comprising the steps of: i) Testing the pH glass electrode according to a method of testing as outlined above; and, ii) Calibrating the pH glass electrode according to a method of calibrating as outlined above, wherein steps i) and ii) are performed prior to opening the storage compartment, i.e. still under sterile conditions and with the pH glass electrode being stored in the storage solution in the storage compartment.
  • Fig. 2 Graphical representation of a calibration process according to the present invention.
  • Fig. 1 a represents a conventional pH glass electrode 1, here a combined pH glass electrode with an inner electrode 2 and an outer electrode 3; both electrodes are to be connected to a pH meter.
  • the pH glass electrode according to the invention is stored in a storing solution 4 as outlined above, in a storage compartment 5 as outlined above.
  • the pH glass electrode of Fig. 1 a) is installed in a disposable container 6, as shown in Fig. 1 b) , the storage compartment 5 still being sealed leakproof from the interior of the container 6. In this configuration, sterilization of the whole container assembly is performed, as well as (optional testing and) one- point calibration of the pH glass electrode 1 in the storage so ⁇ lution 4.
  • the storage compartment 5 can be opened towards the interior of the container 6, as is shown in Fig. 1 c) , thereby enabling pH measurements in the container 6 with the glass electrode 1. Opening of the storage compartment 5 has to be suffi ⁇ ciently wide in order to provide for substantially free fluid transport from the inside of the bioreactor 6 towards the electrode 1.
  • enabled fluid communication between storage compartment 5 and the interior of the bioreactor 6 is illustrated schematically by the long-dashed line at the bottom of the storage compartment 5.
  • the following buffer system in the storage compartment of the pH glass electrode has been used in the subsequent examples: 4.565 g KH 2 PO 4 and 2.979 g Na 2 HPO 4 were added to 500 ml of Milli- pore ® grade water, resulting in a pH of 6.51. To this mixture, 111.8 g KCl were added. The pH was shifted to 5.81 due to the higher ionic strength. The pH was then readjusted to 6.50 by adding 9.57 ml of 1 M NaOH solution by means of an automated titration .
  • the resulting difference in the offset potential after Gamma treatment has been determined.
  • Gamma treatment was performed by a specialist service provider (Studer Hard AG, Daeniken, Switzerland) with a total dose of 46-49 kGy.
  • Fig. 2 is a graphical representation of a calibration process according to the present invention.
  • the inclined dotted line represents the pH dependent potential of an ideal pH glass electrode, calculated with the Nernst equation.
  • a calibration data set is generated, indicated "original slope"; this calibration can be easily performed with standard solutions of well defined pH, e.g. a three-point cali ⁇ bration at pHs 4.0, 7.0 and 9.0 at the manufacturer's site.
  • the same calibration was carried out after Gamma sterilization. As can be seen from Fig.

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Abstract

La présente invention a trait à une électrode de pH-métrie en verre équipant un compartiment de conservation et utilisable dans un récipient jetable ou dans un composant d'un récipient jetable, ledit compartiment de conservation étant rempli d'une quantité suffisante d'une solution de conservation tamponnée pour recouvrir au moins la ou les membranes sensibles au pH de l'électrode de verre durant la conservation de l'électrode de pH-métrie en verre dans le compartiment de conservation, et ladite solution de conservation étant choisie de façon à assurer un pH stable suite à l'exposition de ladite solution de conservation à des rayons gamma. Un étalonnage à un point de l'électrode est possible du fait de la solution de conservation choisie et du fait qu'une pente a été prédéterminée pour le potentiel de l'électrode dans les installations du fabricant.
PCT/EP2007/062130 2007-11-09 2007-11-09 Electrode de ph-métrie en verre pour récipient jetable WO2009059645A1 (fr)

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Cited By (9)

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DE102010001779A1 (de) 2010-02-10 2011-08-11 Hamilton Bonaduz Ag Kalibrierbare Sensoreinheit für Reaktionsbehälter
WO2012000818A1 (fr) * 2010-07-02 2012-01-05 Endress+Hauser Conducta Gesellschaft Für Mess- Und Regeltechnik Mbh+Co. Kg Sonde potentiométrique servant à mesurer une grandeur d'un milieu à mesurer contenu dans un récipient
DE102010063033A1 (de) * 2010-12-14 2012-06-14 Endress + Hauser Conducta Gesellschaft für Mess- und Regeltechnik mbH + Co. KG Verfahren zur Inbetriebnahme eines Messgeräts
DE102013101735A1 (de) 2012-04-17 2013-10-17 Endress + Hauser Conducta Gesellschaft für Mess- und Regeltechnik mbH + Co. KG Potentiometrische Sensorvorrichtung
JP2013242277A (ja) * 2012-05-23 2013-12-05 Nihon Medi Physics Co Ltd ｐＨ測定技術
US8678638B2 (en) 2010-03-09 2014-03-25 Emd Millipore Corporation Process bag container with sensors
JP2016121992A (ja) * 2014-12-19 2016-07-07 スティヒティング・イメック・ネーデルラントＳｔｉｃｈｔｉｎｇ ＩＭＥＣ Ｎｅｄｅｒｌａｎｄ ドリフト補償されたイオンセンサ
WO2017040618A1 (fr) * 2015-09-01 2017-03-09 Rosemount Analytical Inc. Solution de stockage de capteur de ph à usage unique
US11046927B2 (en) 2018-02-28 2021-06-29 Rosemount Inc. Single-use pH sensor for bioreactor applications

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WO2004059286A2 (fr) * 2002-12-20 2004-07-15 Terumo Cardiovascular Systems Corporation Electrode miniature pour detecter le ph interstitiel de tissus
WO2005104706A2 (fr) * 2004-04-27 2005-11-10 Baxter International Inc. Systeme de reacteur a reservoir a agitation
EP1615023A1 (fr) * 2004-07-08 2006-01-11 Metroglas AG Solution de stockage pour électrode de verre pour pH
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WO2004059286A2 (fr) * 2002-12-20 2004-07-15 Terumo Cardiovascular Systems Corporation Electrode miniature pour detecter le ph interstitiel de tissus
WO2005104706A2 (fr) * 2004-04-27 2005-11-10 Baxter International Inc. Systeme de reacteur a reservoir a agitation
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Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8673624B2 (en) 2010-02-10 2014-03-18 Hamilton Bonaduz Ag Calibratable sensor unit for reaction vessels
EP2363704A1 (fr) 2010-02-10 2011-09-07 Hamilton Bonaduz AG Unité de détection pouvant être calibrée pour récipients de réaction
US9046501B2 (en) 2010-02-10 2015-06-02 Hamilton Bonaduz Ag Calibratable sensor unit for reaction vessels
US9034572B2 (en) 2010-02-10 2015-05-19 Hamilton Bonaduz Ag Calibratable sensor unit for reaction vessels
DE102010001779A1 (de) 2010-02-10 2011-08-11 Hamilton Bonaduz Ag Kalibrierbare Sensoreinheit für Reaktionsbehälter
US8678638B2 (en) 2010-03-09 2014-03-25 Emd Millipore Corporation Process bag container with sensors
WO2012000818A1 (fr) * 2010-07-02 2012-01-05 Endress+Hauser Conducta Gesellschaft Für Mess- Und Regeltechnik Mbh+Co. Kg Sonde potentiométrique servant à mesurer une grandeur d'un milieu à mesurer contenu dans un récipient
US9506893B2 (en) 2010-07-02 2016-11-29 Endress+l lauser Conducta GmbH+Co. KG Potentiometric probe for measuring a measured variable of a medium in a container
DE102010063033B4 (de) * 2010-12-14 2013-10-24 Endress + Hauser Conducta Gesellschaft für Mess- und Regeltechnik mbH + Co. KG Verfahren zur Inbetriebnahme eines Messgeräts
CN102590532A (zh) * 2010-12-14 2012-07-18 恩德莱斯和豪瑟尔测量及调节技术分析仪表两合公司 用于测量装置启动的方法
DE102010063033A1 (de) * 2010-12-14 2012-06-14 Endress + Hauser Conducta Gesellschaft für Mess- und Regeltechnik mbH + Co. KG Verfahren zur Inbetriebnahme eines Messgeräts
US8978438B2 (en) 2010-12-14 2015-03-17 Endress + Hauser Conducta Gesellschaft für Mess-und Regeltechnik mbH + Co. KG Method for start-up of a measuring device
DE102013101735A1 (de) 2012-04-17 2013-10-17 Endress + Hauser Conducta Gesellschaft für Mess- und Regeltechnik mbH + Co. KG Potentiometrische Sensorvorrichtung
CN103376285A (zh) * 2012-04-17 2013-10-30 恩德莱斯和豪瑟尔测量及调节技术分析仪表两合公司 电位传感器设备
US10267764B2 (en) 2012-04-17 2019-04-23 Endress + Hauser Conducta Gmbh + Co. Kg Potentiometric sensor apparatus
JP2013242277A (ja) * 2012-05-23 2013-12-05 Nihon Medi Physics Co Ltd ｐＨ測定技術
JP2016121992A (ja) * 2014-12-19 2016-07-07 スティヒティング・イメック・ネーデルラントＳｔｉｃｈｔｉｎｇ ＩＭＥＣ Ｎｅｄｅｒｌａｎｄ ドリフト補償されたイオンセンサ
JP2019219407A (ja) * 2014-12-19 2019-12-26 スティヒティング・イメック・ネーデルラントＳｔｉｃｈｔｉｎｇ ＩＭＥＣ Ｎｅｄｅｒｌａｎｄ ドリフト補償されたイオンセンサ
WO2017040618A1 (fr) * 2015-09-01 2017-03-09 Rosemount Analytical Inc. Solution de stockage de capteur de ph à usage unique
CN107949786A (zh) * 2015-09-01 2018-04-20 罗斯蒙特分析公司 一次性pH值传感器存储溶液
JP2018527591A (ja) * 2015-09-01 2018-09-20 ローズマウント・アナリティカル・インコーポレーテッドＲｏｓｅｍｏｕｎｔ Ａｎａｌｙｔｉｃａｌ Ｉｎｃ． 単回使用ｐＨセンサ保存液
US11046927B2 (en) 2018-02-28 2021-06-29 Rosemount Inc. Single-use pH sensor for bioreactor applications
RU2752474C1 (ru) * 2018-02-28 2021-07-28 Роузмаунт Инк. Ph-датчик одноразового использования для применений биореактора
US11667880B2 (en) 2018-02-28 2023-06-06 Rosemount Inc. Single-use pH sensor for bioreactor applications

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