WO2007116371A2 - Optimization and control of the freeze-drying process of pharmaceutical products - Google Patents

Optimization and control of the freeze-drying process of pharmaceutical products Download PDF

Info

Publication number
WO2007116371A2
WO2007116371A2 PCT/IB2007/051276 IB2007051276W WO2007116371A2 WO 2007116371 A2 WO2007116371 A2 WO 2007116371A2 IB 2007051276 W IB2007051276 W IB 2007051276W WO 2007116371 A2 WO2007116371 A2 WO 2007116371A2
Authority
WO
WIPO (PCT)
Prior art keywords
lyophilisation
container
freeze
optimization
control
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.)
Ceased
Application number
PCT/IB2007/051276
Other languages
French (fr)
Other versions
WO2007116371A3 (en
WO2007116371A8 (en
Inventor
Antonello Barresi
Giancarlo Baldi
Marco Parvis
Alberto Vallan
Salvatore Velardi
Hassan Hammouri
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.)
Universite Claude Bernard Lyon 1
Politecnico di Torino
Original Assignee
Universite Claude Bernard Lyon 1
Politecnico di Torino
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 Universite Claude Bernard Lyon 1, Politecnico di Torino filed Critical Universite Claude Bernard Lyon 1
Priority to US12/296,802 priority Critical patent/US8117005B2/en
Priority to EP07735443.9A priority patent/EP2010848B1/en
Publication of WO2007116371A2 publication Critical patent/WO2007116371A2/en
Publication of WO2007116371A8 publication Critical patent/WO2007116371A8/en
Publication of WO2007116371A3 publication Critical patent/WO2007116371A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01K—MEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR
    • G01K1/00—Details of thermometers not specially adapted for particular types of thermometer
    • G01K1/02—Means for indicating or recording specially adapted for thermometers
    • G01K1/024—Means for indicating or recording specially adapted for thermometers for remote indication
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility

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)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Drying Of Solid Materials (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

A system is described for monitoring the lyophilisation process of a product in containers (4, 4a, 4b) arranged inside a lyophilisation chamber, comprising a temperature measurement system (6) associated with each container housed inside (10) said lyophilisation chamber, capable of surveying local temperature data for each container. The system includes: a wireless communication system (8) for the surveyed temperature data; and a processing module (16) for said data, located externally to the lyophilisation chamber, programmed to determine at least one parameter indicative of the progress of the lyophilisation process not measured by the measurement system, by means of a predetermined representation model of the process, capable of correlating a local temperature value of the container with said parameter.
PCT/IB2007/051276 2006-04-11 2007-04-10 Optimization and control of the freeze-drying process of pharmaceutical products Ceased WO2007116371A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US12/296,802 US8117005B2 (en) 2006-04-11 2007-04-10 Optimization and control of the freeze-drying process of pharmaceutical products
EP07735443.9A EP2010848B1 (en) 2006-04-11 2007-04-10 Optimization and control of the freeze-drying process of pharmaceutical products

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000270A ITTO20060270A1 (en) 2006-04-11 2006-04-11 OPTIMATION AND CONTROL OF THE PHARMACEUTICALS PROCESS OF LIOFILIZATION
ITTO2006A000270 2006-04-11

Publications (3)

Publication Number Publication Date
WO2007116371A2 true WO2007116371A2 (en) 2007-10-18
WO2007116371A8 WO2007116371A8 (en) 2007-11-29
WO2007116371A3 WO2007116371A3 (en) 2008-02-21

Family

ID=38581469

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2007/051276 Ceased WO2007116371A2 (en) 2006-04-11 2007-04-10 Optimization and control of the freeze-drying process of pharmaceutical products

Country Status (4)

Country Link
US (1) US8117005B2 (en)
EP (1) EP2010848B1 (en)
IT (1) ITTO20060270A1 (en)
WO (1) WO2007116371A2 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009030760A1 (en) * 2007-09-06 2009-03-12 Ima Life S.R.L. Freeze drying chamber with external antenna
US20130006546A1 (en) * 2009-12-23 2013-01-03 Telstar Technologies, S.L. Method for monitoring primary drying of a freeze-drying process
US8434240B2 (en) 2011-01-31 2013-05-07 Millrock Technology, Inc. Freeze drying method
EP3014205A4 (en) * 2013-06-25 2017-06-21 Millrock Technology, Inc. Using surface heat flux measurement to monitor and control a freeze drying process

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2480299B (en) 2010-05-12 2016-08-10 Gea Pharma Systems Ltd A method for monitoring and/or controlling process parameters of a lyophilization process
US20150226617A1 (en) * 2014-02-12 2015-08-13 Millrock Technology, Inc Using in-process heat flow and developing transferable protocols for the monitoring, control and characerization of a freeze drying process
JP6718879B2 (en) * 2015-01-28 2020-07-08 アイエムエー ライフ ノース アメリカ インコーポレーテッド Process monitoring and control using battery-less multi-point wireless product condition sensing
DK3250869T3 (en) 2015-01-28 2019-07-29 Ima Life North America Inc PROCESS CONTROL USING NON-INVASIVE PRINTED PRODUCT SENSORS
US10605527B2 (en) 2015-09-22 2020-03-31 Millrock Technology, Inc. Apparatus and method for developing freeze drying protocols using small batches of product
US11828535B2 (en) * 2018-06-29 2023-11-28 Universiteit Gent Freezing, drying and/or freeze-drying of product dose units
CN110645077B (en) * 2019-10-15 2021-11-02 黄冈师范学院 Synchronous estimation method of ammonia injection rate and state for diesel engine Urea-SCR system
US11287185B1 (en) 2020-09-09 2022-03-29 Stay Fresh Technology, LLC Freeze drying with constant-pressure and constant-temperature phases
NL2026826B1 (en) * 2020-11-04 2022-06-24 Rheavita Bv Method and apparatus for freezing or thawing mixtures comprising water
WO2022103745A1 (en) * 2020-11-10 2022-05-19 Purdue Research Foundation System and method for measuring rapid decompression ice nucleation in lyophilization
US20260016226A1 (en) * 2024-07-14 2026-01-15 Frei Jonathan Advanced lyophilization control interfaces and techniques

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS54134479A (en) * 1978-04-10 1979-10-18 Sharp Corp Wireless temperature measuring device
KR20020064036A (en) * 2001-01-31 2002-08-07 만도공조 주식회사 Apparatus and method for controlling average temperature of kimchi chamber
US7520670B2 (en) * 2005-04-26 2009-04-21 John Jeffrey Schwegman Wireless temperature sensing system for lyophilization processes

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009030760A1 (en) * 2007-09-06 2009-03-12 Ima Life S.R.L. Freeze drying chamber with external antenna
US20130006546A1 (en) * 2009-12-23 2013-01-03 Telstar Technologies, S.L. Method for monitoring primary drying of a freeze-drying process
US9170049B2 (en) * 2009-12-23 2015-10-27 Azbil Telstar Technologies, S.L. Method for monitoring primary drying of a freeze-drying process
US8434240B2 (en) 2011-01-31 2013-05-07 Millrock Technology, Inc. Freeze drying method
EP3014205A4 (en) * 2013-06-25 2017-06-21 Millrock Technology, Inc. Using surface heat flux measurement to monitor and control a freeze drying process
EP3575718A1 (en) * 2013-06-25 2019-12-04 Millrock Technology, Inc. Using surface heat flux measurement to monitor and control a freeze drying process

Also Published As

Publication number Publication date
WO2007116371A3 (en) 2008-02-21
EP2010848A2 (en) 2009-01-07
WO2007116371A8 (en) 2007-11-29
EP2010848B1 (en) 2014-09-03
ITTO20060270A1 (en) 2007-10-12
US8117005B2 (en) 2012-02-14
US20090276179A1 (en) 2009-11-05

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