EP2034263A1 - Chambre de lyophilisation avec antenne externe - Google Patents

Chambre de lyophilisation avec antenne externe Download PDF

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Publication number
EP2034263A1
EP2034263A1 EP07075765A EP07075765A EP2034263A1 EP 2034263 A1 EP2034263 A1 EP 2034263A1 EP 07075765 A EP07075765 A EP 07075765A EP 07075765 A EP07075765 A EP 07075765A EP 2034263 A1 EP2034263 A1 EP 2034263A1
Authority
EP
European Patent Office
Prior art keywords
antenna
opening
controller
drying chamber
drying
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP07075765A
Other languages
German (de)
English (en)
Inventor
Antonius Lucien Adrianus Maria Kemmeren
Vincent Bons
Johannes Van Veen
Alexander Clemens Henricus Josef Schaepman
Jozef Antonius Willem Maria Corver
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
IMA Life SRL
Original Assignee
IMA Life SRL
BOC Edwards Pharmaceutical Systems BV
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 IMA Life SRL, BOC Edwards Pharmaceutical Systems BV filed Critical IMA Life SRL
Priority to EP07075765A priority Critical patent/EP2034263A1/fr
Priority to PCT/EP2008/061802 priority patent/WO2009030760A1/fr
Publication of EP2034263A1 publication Critical patent/EP2034263A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Definitions

  • the invention relates to device for treatment of materials by freeze drying, comprising a housing having walls that define a drying chamber that is equipped for the accommodation of the material for drying and intended for carrying out the drying process, and a controller assembly for the monitoring and evaluation of process parameters during the freeze drying process.
  • An example of such known device comprises an electronic controller having an antenna inside the housing for wireless communication with measuring transponders that are placed into some sample vials.
  • the antenna may form a surface for the accumulation of contamination, whereby special attention is needed during cleaning to comply with the very high sterility standards for the drying chamber.
  • the cleaning and sterilisation process may require the use of aggressive sterilants and high temperatures which may damage the antenna.
  • the antenna may not be optimised for the communication with the measuring transponders.
  • the invention provides a device for treatment of materials by freeze drying, comprising a housing having first walls that define a drying chamber that is equipped for the accommodation of the material for drying and intended for carrying out the freeze drying process, and a controller assembly for the monitoring and evaluation of process parameters during the freeze drying process, wherein the controller assembly includes a controller antenna for high frequency electromagnetic wireless communication with measuring transponders arranged within the drying chamber, which controller antenna is located outside of the drying chamber.
  • the antenna of the controller assembly is located outside of the drying chamber, whereby accumulation of contamination on the antenna does not affect the inside sterility of the drying chamber.
  • the device with this controller assembly can therefore comply with high sterility standards.
  • the controller antenna can be protected against mechanical harm if the housing has second walls that define an antenna chamber in which the controller antenna is confined.
  • Interference by surrounding electromagnetic sources can be reduced if the drying chamber is screened off electromagnetically to the greatest possible extent from an outer area of the device, wherein at least one first wall of the housing comprises an opening near the controller antenna for pass-through of the high frequency electromagnetic wireless communication between the controller antenna and the transponders.
  • the antenna chamber at the side facing away from the drying chamber is screened off electromagnetically to the greatest possible extent from an outer area of the device.
  • the controller antenna is arranged in front of the opening in order to enable wireless communication with the measuring transponders over a relatively short distance, preferably when the antenna and the transponders are arranged substantially face to face or in line sight.
  • the antenna chamber is adjacent to the first wall with the opening.
  • the drying chamber can be fully closed off from its environment if the device comprises a cover for the opening, which cover enables or permits the high frequency electromagnetic radiation used for the wireless communication to pass through it. In this manner the cover can form part of the first walls, and be sterilized together therewith.
  • the cover particularly enables the pass-though of high frequency wireless communication if the cover is made of glass or borosilicate. Other materials can be used for the cover, provided that the electrical conductance is low and that the (ferro) magnetic properties can be neglected.
  • the cover comprises a plate that extends parallel to the opening.
  • the cover can easily be replaced if the device comprises a holder that confines the cover around the opening, wherein the holder preferably comprises a ring-shaped flexible gasket made of a chemically inert, non-toxic and stable material, that is press fitted between the cover and the first wall.
  • the ring-shaped flexible gasket is made of a silicone rubber. Silicone rubber is suitable to be applied in a sterile environment, as it withstands high temperatures that are applied during the sterilization. Moreover, the chemical inertness is a prerequisite to achieve the sterile process conditions required for freeze drying pharmaceutical substances.
  • the high frequency electromagnetic radiation can pass through the opening with acceptable loss of signal if the opening has a main diameter that is typically substantially at least half of the wavelength of the applicable electromagnetic high frequency wireless communication.
  • the antenna is designed for wireless communication using frequencies of approximately 2.4 GHz, wherein the opening has a main diameter of typically at least 0.062 m.
  • a freeze dryer 1 includes a drying housing 2 having walls 9, 15 that define a drying chamber 3.
  • the front wall of the drying housing 2 comprises a slot that can be closed by a slot door (both not shown) to enable vials 10 to be loaded on and unloaded from a horizontally extending shelf 4 within the drying chamber 3.
  • the vials 10 contain sterile pharmaceutical liquids to be dried by freeze drying.
  • Each vial 10 is provided with a ventilating closure 24 that allows ventilation of its content during the drying process, and is pushed downwards into the vial 10 after the drying process is completed to fully close the vial 10.
  • the drying chamber 3 includes a number of shelves 4, each of which can be raised and lowered within the drying chamber 3 using a loading mechanism 14, which is known from the art.
  • a loading mechanism 14 To load the shelves 4 with rows of vials 10, the shelves 4 are initially collapsed in the lower portion of the drying chamber 3 and the uppermost shelf is first moved into a loading position. After this shelf 4 has been loaded, the loading mechanism 14 automatically raises the loaded shelf 4 to enable the next shelf 4 to be moved to the loading position. This moving sequence continues until the drying chamber 3 loading has been completed. To unload the drying chamber 3, the loading sequence is reversed, with the lowermost shelf 4 being unloaded first.
  • one side wall 15 of the drying housing 2 has a hole 8 which is fully covered with a plate 51 of borosilicate glass.
  • the circumferential edge of the plate 51 is confined between a holder 50 and the side wall 15.
  • a sealing ring or gasket 52, made of a material such as silicone rubber has been press fitted between the plate 51 and the side wall 15.
  • the freeze dryer 1 is provided with an electronic controller 40 with an antenna 41 disposed on the outside of the drying housing 2.
  • the controller 40 and the antenna 41 are confined within an antenna housing 7 defining an antenna chamber 12 adjacent to the drying chamber 3.
  • the electronic controller 40 is configured for wireless communication with measuring transponders 23 that are placed in some sample vials 20 within the drying chamber 3.
  • the sample vials 20 contain the same pharmaceutical liquids as the other vials 20, but are disposed off after the drying process.
  • the communication with the measuring transponders 23 in the sample vials 20 enable accurate real time measurement of process parameters during the freeze drying process.
  • the measuring transponders 23 are non-mains borne, and do not have an internal energy supply such as a battery.
  • the energy to operate the measuring transponders 23 is provided by electromagnetic waves radiated to the transponders 23 by the controller 40 via the controller antenna 41.
  • the measuring transponders 23 each have their own exclusive operative band width, and the individual operative band widths are cascaded into a frequency band.
  • the measuring transponders 23 comprise a sensor 22, for example a bimetallic element, having well specified electric properties related to a physical parameter to be measured, such as temperature or humidity.
  • the sensor 22 is connected to an antenna 21 that may extend through the closure 24 as illustrated in this exemplary embodiment.
  • each transponder 23 When the electronic controller 40 emits an amount of electromagnetic energy via the controller antenna 41, the electromagnetic signal is transmitted through the opening 8 to a measuring transponder 23. In response, each transponder 23 generates an internal resonance frequency within its exclusive small operative band width, which resonance frequency is picked up by the antenna 41. As will be understood, the measured physical parameter can be derived from this resonance frequency.
  • the transponders 23 operate on frequencies in the order of 2.4 GHz.
  • the drying housing 2 is supported by a condenser housing 5 having walls 15 that define a condenser chamber 6.
  • a condenser unit 13 has been arranged within the condenser chamber 6.
  • the drying chamber 3 opens to the condenser chamber 6.
  • the combined condenser chamber 6 and drying chamber 5 can be closed off in an airtight manner from the outer area of the freeze dryer 1.
  • the walls 9, 15 of the drying housing 2 and the condenser housing 5 are made of stainless steel in order to comply with the very high hygienic and anti toxic standards for processing pharmaceutical substances.
  • the antenna housing 7 is also made of stainless steel, whereby the drying chamber 3, the condenser chamber 6 and the antenna chamber form a Faraday cage that is screened off electromagnetically to the greatest possible extent from its surrounding area 80.
  • the wavelength is 0.125 m, whereby the diameter of the opening 8 is at least 0.062 m.
  • the controller 40 emits electromagnetic waves to the measuring transponders 23.
  • a frequency sweep is executed, whereby the frequency of the electromagnetic waves is increased while different resonance frequencies of the measuring transponders are picked up. These resonance frequencies are converted to the process parameters measured in the sample vials 20 at different locations within the drying chamber 3.
  • the controller antenna 41 is placed outside the drying chamber 3, it does not affect the freeze drying process inside the drying chamber 3.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Drying Of Solid Materials (AREA)
EP07075765A 2007-09-06 2007-09-06 Chambre de lyophilisation avec antenne externe Withdrawn EP2034263A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP07075765A EP2034263A1 (fr) 2007-09-06 2007-09-06 Chambre de lyophilisation avec antenne externe
PCT/EP2008/061802 WO2009030760A1 (fr) 2007-09-06 2008-09-05 Chambre de lyophilisation dotée d'une antenne externe

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP07075765A EP2034263A1 (fr) 2007-09-06 2007-09-06 Chambre de lyophilisation avec antenne externe

Publications (1)

Publication Number Publication Date
EP2034263A1 true EP2034263A1 (fr) 2009-03-11

Family

ID=39156400

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07075765A Withdrawn EP2034263A1 (fr) 2007-09-06 2007-09-06 Chambre de lyophilisation avec antenne externe

Country Status (2)

Country Link
EP (1) EP2034263A1 (fr)
WO (1) WO2009030760A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011021966A1 (fr) * 2009-08-21 2011-02-24 Закрытое Акционерное Общество "Твин Трейдинг Компани" Procédé et dispositif de séchage de matériaux capillaires et poreux pulvérulents
RU2458300C1 (ru) * 2011-04-01 2012-08-10 Государственное образовательное учреждение высшего профессионального образования Воронежская государственная технологическая академия (ГОУ ВПО ВГТА) Криогенная вакуум-сублимационная установка с комплексным использованием инертного газа
CN104092592A (zh) * 2014-07-25 2014-10-08 上海共和真空技术有限公司 用于冻干机的网络通讯系统
US10641661B2 (en) 2015-01-28 2020-05-05 Ima Life North America Inc. Process control using non-invasive printed product sensors
US11609587B2 (en) 2015-01-28 2023-03-21 Ima Life North America Inc. Process monitoring and control using battery-free multipoint wireless product condition sensing

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3502604B1 (fr) 2017-12-21 2023-07-12 Martin Christ Gefriertrocknungsanlagen GmbH Utilisation d'un capteur de produit, utilisation d'un ensemble de capteurs de produit, récipient de séchage et procédé de fonctionnement d'un capteur de produit

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4475024A (en) * 1978-04-10 1984-10-02 Sharp Kabushiki Kaisha Wireless food temperature-sensing assembly
JPS6484088A (en) * 1987-09-28 1989-03-29 Ulvac Corp Freeze drier
EP0687866A1 (fr) * 1994-06-18 1995-12-20 Wiesheu-Wiwa GmbH Four pour le traitement avec chaleur des aliments solides
DE102004007526A1 (de) * 2004-02-17 2005-09-01 Oetjen, Georg-Wilhelm, Dr. Verfahren und Einrichtung zur Gefriertrocknung von Produkten
DE102005018015B3 (de) * 2005-04-18 2006-04-27 Miele & Cie. Kg Haushaltsgerät, insbesondere Gargerät, mit einer Messeinrichtung zur Messung einer physikalischen Größe
WO2006092885A1 (fr) * 2005-03-03 2006-09-08 Advansense Corporation Systeme de sterilisation continue d’un contenant pour medicaments
DE102006019641A1 (de) * 2005-04-28 2006-11-02 Martin Christ Gefriertrocknungsanlagen Gmbh Gefriertrocknungsanlage

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITTO20060270A1 (it) * 2006-04-11 2007-10-12 Torino Politecnico Ottimazione e controllo del processo di liofilizzazione di prodotti farmaceutici

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4475024A (en) * 1978-04-10 1984-10-02 Sharp Kabushiki Kaisha Wireless food temperature-sensing assembly
JPS6484088A (en) * 1987-09-28 1989-03-29 Ulvac Corp Freeze drier
EP0687866A1 (fr) * 1994-06-18 1995-12-20 Wiesheu-Wiwa GmbH Four pour le traitement avec chaleur des aliments solides
DE102004007526A1 (de) * 2004-02-17 2005-09-01 Oetjen, Georg-Wilhelm, Dr. Verfahren und Einrichtung zur Gefriertrocknung von Produkten
WO2006092885A1 (fr) * 2005-03-03 2006-09-08 Advansense Corporation Systeme de sterilisation continue d’un contenant pour medicaments
DE102005018015B3 (de) * 2005-04-18 2006-04-27 Miele & Cie. Kg Haushaltsgerät, insbesondere Gargerät, mit einer Messeinrichtung zur Messung einer physikalischen Größe
DE102006019641A1 (de) * 2005-04-28 2006-11-02 Martin Christ Gefriertrocknungsanlagen Gmbh Gefriertrocknungsanlage

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011021966A1 (fr) * 2009-08-21 2011-02-24 Закрытое Акционерное Общество "Твин Трейдинг Компани" Procédé et dispositif de séchage de matériaux capillaires et poreux pulvérulents
US8713815B2 (en) 2009-08-21 2014-05-06 Twin Trading Company Method and device for drying bulk capillary-porous materials
RU2458300C1 (ru) * 2011-04-01 2012-08-10 Государственное образовательное учреждение высшего профессионального образования Воронежская государственная технологическая академия (ГОУ ВПО ВГТА) Криогенная вакуум-сублимационная установка с комплексным использованием инертного газа
CN104092592A (zh) * 2014-07-25 2014-10-08 上海共和真空技术有限公司 用于冻干机的网络通讯系统
US10641661B2 (en) 2015-01-28 2020-05-05 Ima Life North America Inc. Process control using non-invasive printed product sensors
US11609587B2 (en) 2015-01-28 2023-03-21 Ima Life North America Inc. Process monitoring and control using battery-free multipoint wireless product condition sensing
US11762403B2 (en) 2015-01-28 2023-09-19 Ima Life North America Inc. Process monitoring and control using battery-free multipoint wireless product condition sensing

Also Published As

Publication number Publication date
WO2009030760A1 (fr) 2009-03-12

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