IP Library Granted Patent US 12,504,546
Granted Patent B2
US 12,504,546 · App. 18/268,431 · Granted Dec 23, 2025

Method of measuring irradiation dose at a product level

Inventors: Samin Akbari (Winchester, MA); Magali Barbaroux (La Destrousse, FR); Samuel Dorey (Le Beausset, FR); David Pollard (South Boston, MA)
Assignee: Sartorius Stedim FMT
G01T1/02A61L2/081A61L2/082A61L2/087A61L2/26A61L2202/14A61L2202/23
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Quick Facts
Patent No.
US 12,504,546
App. No.
18/268,431
Granted
Dec 23, 2025
Kind
B2
Abstract

A method of measuring a radiation dosage during irradiation includes disposing a first sensor in a first package with a first biocontainer and disposing a second sensor in a second package with a second biocontainer. The method further includes placing the first package and the second package in a container and irradiation the container including the first package and the second package. During or after irradiation, a first radiation dosage associated with the first biocontainer is measured with the first sensor and a second radiation dosage associated with the second biocontainer is measured with the second sensor.

Claims (43)

1 . A method of measuring a radiation dosage, the method comprising:

disposing a first sensor in a first package with a first empty biocontainer;

disposing a second sensor in a second package with a second empty biocontainer;

placing the first package and the second package in a container;

irradiating the container including the first package and the second package; and

measuring a first radiation dosage associated with the first empty biocontainer with the first sensor and a second radiation dosage associated with the second empty biocontainer with the second sensor.

2 . The method according to claim 1 , wherein measuring the first radiation dosage and the second radiation dosage includes the first radiation dosage being different from the second radiation dosage.

3 . The method according to claim 1 , wherein disposing the first sensor in a first package includes disposing the first sensor in the first package with the first empty biocontainer and a third empty biocontainer such that the first sensor is associated with the first empty biocontainer and the third empty biocontainer.

4 . The method according to claim 1 , wherein placing the first package and the second package in a container includes placing the first package and the second package on a pallet.

5 . The method according to claim 1 , wherein irradiating the container including the first package and the second package comprises exposing the container to a first cycle of radiation and a second cycle of radiation, and wherein measuring the first radiation dosage occurs between the first cycle of radiation and the second cycle of radiation.

6 . The method according to claim 1 , further comprising filling the second empty biocontainer with a product after an ageing time at least partially based on the second radiation dosage.

7 . The method according to claim 6 , further comprising calculating the ageing time based at least partially on the second radiation dosage after measuring the second radiation dosage and before filling the second empty biocontainer.

8 . The method according to claim 1 , wherein disposing the first sensor in the first package includes the first sensor having:

a first electrode having a plurality of first fingers;

a second electrode having a plurality of second fingers, the plurality of first fingers extending from the first electrode towards the second electrode, the plurality of second fingers extending from the second electrode towards the first electrode such that the first fingers are interdigitated with the second fingers with gaps defined between the first and second fingers; and

a film coating the plurality of first fingers and the plurality of second fingers such that the film is disposed within the gaps, the film formed of a second material similar to the first material forming the first empty biocontainer.

9 . A method of measuring a radiation dosage, the method comprising:

placing a plurality of packages in a container with each package of the plurality of packages including a sensor associated with an empty biocontainer disposed within the package;

irradiating the container including the plurality of packages; and

measuring a radiation dosage of each package with the sensor associated with the empty biocontainer disposed within the respective package.

10 . The method according to claim 9 , wherein placing the plurality of packages in the container includes placing the plurality of packages on a pallet.

11 . The method according to claim 9 , wherein placing the plurality of packages in the container including the sensor associated with the empty biocontainer includes at least one package of the plurality of packages comprising a first sensor associated with a first empty biocontainer and a second sensor associated with a second empty biocontainer.

12 . The method according to claim 9 , wherein placing the plurality of packages in the container including the sensor associated with the empty biocontainer includes at least one package of the plurality of packages including the sensor associated with a first empty biocontainer and a second empty biocontainer disposed within the at least one package.

13 . The method according to claim 9 , wherein irradiating the container including the plurality of packages comprises exposing the container to a first cycle of radiation and a second cycle of radiation, and wherein measuring the radiation dosage occurs between the first cycle of radiation and the second cycle of radiation.

14 . The method according to claim 9 , further comprising filling the empty biocontainer with a product after an ageing time at least partially based on the radiation dosage.

15 . The method according to claim 14 , further comprising calculating the ageing time based at least partially on the radiation dosage after measuring the radiation dosage and before filling the empty biocontainer.

16 . The method according to claim 9 , wherein placing the plurality of packages in the container includes the first sensor having:

a first electrode having a plurality of first fingers;

a second electrode having a plurality of second fingers, the plurality of first fingers extending from the first electrode towards the second electrode, the plurality of second fingers extending from the second electrode towards the first electrode such that the first fingers are interdigitated with the second fingers with gaps defined between the first and second fingers; and

a film coating the plurality of first fingers and the plurality of second fingers such that the film is disposed within the gaps, the film formed of a second material similar to the first material forming the first empty biocontainer.

17 . The method according to claim 16 , wherein measuring the radiation dosage of each package with the sensor includes measuring an electrical property through the film.

18 . A method of measuring a radiation dosage, the method comprising:

disposing a first sensor in a first package with a first empty biocontainer;

disposing a second sensor in a second package with a second empty biocontainer;

placing the first package and the second package in a container;

irradiating the container including the first package and the second package;

measuring a first radiation dosage associated with the first empty biocontainer with the first sensor and a second radiation dosage associated with the second empty biocontainer with the second sensor; and

filling the first empty biocontainer with a product after an ageing time at least partially based on the first radiation dosage.

19 . The method according to claim 18 , further comprising calculating the ageing time based at least partially on the first radiation dosage after measuring the first radiation dosage and before filling the first empty biocontainer.

20 . The method according to claim 19 , wherein disposing the first sensor in the first package includes the first sensor having:

a first electrode having a plurality of first fingers;

a second electrode having a plurality of second fingers, the plurality of first fingers extending from the first electrode towards the second electrode, the plurality of second fingers extending from the second electrode towards the first electrode such that the first fingers are interdigitated with the second fingers with gaps defined between the first and second fingers; and

a film coating the plurality of first fingers and the plurality of second fingers such that the film is disposed within the gaps, the film formed of a second material similar to the first material forming the first empty biocontainer.

Assignments (2)
CHANGE OF NAME Recorded Oct 1, 2024
From: SARTORIUS STEDIM FMT SAS
To: SARTORIUS STEDIM FMT
Reel/Frame 069084/0133 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 11, 2023
From: AKBARI, SAMIN; BARBAROUX, MAGALI; DOREY, SAMUEL; POLLARD, DAVID
To: SARTORIUS STEDIM FMT S.A.S.
Reel/Frame 065183/0194 →
Continuity (2)
Provisional Application 63128389 · Dec 21, 2020
Related Publication 20240310532A1 · Sep 19, 2024
References Cited (60)
US 6157028A · Purtle · 2000 [cited by examiner]
US 6376845B1 · Purtle · 2002 [cited by applicant]
US 20020040968A1 · Black et al. · 2002 [cited by applicant]
US 20090278685A1 · Potyrailo et al. · 2009 [cited by applicant]
US 20100175393A1 · Burke et al. · 2010 [cited by applicant]
US 20110003279A1 · Patel · 2011 [cited by applicant]
US 20170030768A1 · Dardona et al. · 2017 [cited by applicant]
US 20240307568A1 · Akbari · 2024 [cited by examiner]
US 20240310533A1 · Akbari · 2024 [cited by examiner]
CN 102426378A · 2012 [cited by applicant]
DE 102015116617A1 · 2017 [cited by applicant]
WO 1995011459A1 · 1995 [cited by applicant]
WO 1997017595A1 · 1997 [cited by applicant]
WO 2000037966A1 · 2000 [cited by applicant]
WO 2004027417A1 · 2004 [cited by applicant]
WO 2004095062A2 · 2004 [cited by applicant]
WO 2005089402A2 · 2005 [cited by applicant]
WO 2007018749A2 · 2007 [cited by applicant]
WO 2009100192A1 · 2009 [cited by applicant]
WO 2011126725A1 · 2011 [cited by applicant]
WO 2012036570A1 · 2012 [cited by applicant]
WO 2014086675A2 · 2014 [cited by applicant]
WO 2016035060A1 · 2016 [cited by applicant]
WO 2019034093A1 · 2019 [cited by applicant]
WO 2020006377A1 · 2020 [cited by applicant]
WO 2020009930A1 · 2020 [cited by applicant]
WO 2020258282A1 · 2020 [cited by applicant]
O. M. Sanusi, F. A. Ghaffar, A. Shamim, M. Vaseem, Y. Wang and L. Roy, “Development of a 2.45 GHz Antenna for Flexible Compact Radiation Dosimeter Tags,” in IEEE Transactions on Antennas and Propagation, vol. 67, No. 8,… [cited by examiner]
European Office Action for EP Application No. 21847602.6 issued Apr. 8, 2024, 10 pages. [cited by applicant]
Sanusi, O. M. et al., Development of a 2.45 GHz Antenna for Flexible Compact Radiation Dosimeter Tags, IEE Transactions of Antennas and Propagation, Aug. 2019, pp. 5063-5072, vol. 67, No. 8, 10 pages. [cited by applicant]
Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharaceutical Sector, Pharmaceutical Technology, May 1, 2012, vol. 2012 Supplement, Issue 3, 12 pages. [cited by applicant]
McHale, B. P., Low-Cost, Disposable Mems Radiation Detectors Using Gamma-Sensitive Polymers, Calhoun Institutional Archieve of the Naval Postgraduate School, Jun. 2020, pp. 1-100, 100 pages. [cited by applicant]
Mittal, A. et al., Diacetylene-Based Colorimetric Radiation Sensors for the Detection and Measurement of g Radiation during Blood Irradiation, ACS Omega, 2021, pp. 9482-9491, vol. 6, 10 pages. [cited by applicant]
Gaston et al., FTIR study of ageing of g-irradiated biopharmaceutical EVA based film, Polymer Degradation and Stability, Apr. 1, 2016, pp. 19-25, vol. 129, 7 pages. [cited by applicant]
Gaston et al., One year monitoring by FTIR of g-irradiated multilayer film PE/EVOH/PE, Radiation Physics and Chemistry, Mar. 26, 2016, pp. 115-121, vol. 125, 7 pages. [cited by applicant]
Gaston et al., Impact of g-irradiation, ageing and their interactions on multilayer films followed by AComDim, Analytica Chimica Acta, Jun. 2, 2017, pp. 11-23, vol. 981, 13 pages. [cited by applicant]
Dorey et al., XPS analysis of PE and EVA samples irradiated at different g-doses, Applied Surface Science, Sep. 21, 2017, pp. 966-972, vol. 427, 7 pages. [cited by applicant]
Audran et al., Degradation of g-irradiated polyethylene-ethylene vinyl alcoholpolyethylene multilayer films: An ESR study, Polymer Degradation and Stability, Nov. 2, 2015, pp. 169-179, vol. 122, 11 pages. [cited by applicant]
Dorey et al., Reconciliation of pH, conductivity, total organic carbon with carboxylic acids detected by ion chromatography in solution after contact with multilayer films after g-irradiation, European Journal of Pharma… [cited by applicant]
Dorey et al., Generation of 02?Permeation Barrier during the Gamma-Irradiation of Polyethylene/Ethylene-Vinyl Alcohol/Polyethylene Multilayer Film, Industrial & Engineering Chemistry Research, Jul. 16, 2019, pp. 14115-1… [cited by applicant]
Dorey et al., Effect of gamma irradiation on the oxygen barrier properties of ethylene vinyl alcohol in ethyl-vinyl acetate/ethylene-vinyl alcohol/ ethyl-vinyl acetate multilayer film, Journal of Applied Polymer Science… [cited by applicant]
Gaston et al., Evaluation of multilayer film stability by Raman spectroscopy after gamma-irradiation sterilization process, Vibrational Spectroscopy, Mar. 5, 2018, pp. 52-59, vol. 96, 8 pages. [cited by applicant]
Gaston et al., Monitoring of the discoloration on g-irradiated PE and EVA films to evaluate antioxidant stability, Journal of Applied Polymer Science, 2018, 8 pages. [cited by applicant]
Girard-Perier et al., Mapping the scientific research on the gamma irradiated polymers degradation (1975-2018), Radiation Physics and Chemistry, Nov. 12, 2019, vol. 168, 9 pages. [cited by applicant]
Harris et al., A Thin Plastic Radiation Dosimeter, International Journal of Applied Radiation and Isotopes, 1961, pp. 114-122, vol. 11, 9 pages. [cited by applicant]
Kojima et al., The Gamma-ray Response of Clear Polymethylmethacrylate Dosimeter Radix RN15. Applied Radiation and Isotopes, Mar. 23, 1992, pp. 1197-1202, vol. 43, 6 pages. [cited by applicant]
Dorey et al., Theoretical and Practical Considerations When Selecting Solvents for Use in Extractables Studies of Polymeric Contact Materials in Single-Use Systems Applied in the Production of Biopharmaceuticals, Indust… [cited by applicant]
Pahl et al. Development of a Standardized Extractables Approach for Single-Use Components, BioProcess International, Oct. 2018, pp. 3-11, 9 pages. [cited by applicant]
Judeikis et al., Free Radical Yields in Polytetrafluoroethylene as the Basis for a Radiation Dosimeter, Space and Missile System Organization Air Force System Command, Los Angeles Air Force Station, Feb. 1968, 41 pages. [cited by applicant]
Nguyen et al., The Ubiquitous Issue of Cross-Mass Transfer: Applications to Single-Use Systems, Molecules, 2019, vol. 24, 31 pages. [cited by applicant]
Dorey et al., Identification of chemical species created during g-irradiation of antioxidant used in polyethylene and polyethylene-co-vinyl acetate multilayer film, Journal of Applied Polymer Science, May 25, 2020, 20 p… [cited by applicant]
Wormuth et al., Visible Particulate Matter in Single-Use Bags from Measurement to Prevention, BioProcess International, Apr. 2019, pp. 50-53, vol. 17, 4 pages. [cited by applicant]
Industrial Sterilization Process Optimization and Modality Changes, Association for the Advancement of Medical Instrumentation, 2020, 92 pages. [cited by applicant]
International Preliminary Report on Patentability for PCT/US2021/064557 issued Jun. 13, 2023, 10 pages. [cited by applicant]
Arshak et al., Portable Real-Time Gamma Radiation Dosimetry System Using MgO and CeO2 Thick Film Capacitors, University of Limerick, Jan. 1, 2015, pp. 137-142, 7 pages. [cited by applicant]
Pending U.S. Appl. No. 18/268,430, filed Jun. 20, 2023. [cited by applicant]
Pending U.S. Appl. No. 18/268,428, filed Jun. 20, 2023. [cited by applicant]
Sandle et al., Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector, Pharmaceutical Technology, May 1, 2012, vol. 36, 12 pages. [cited by applicant]
International Preliminary Report on Patentability for PCT/US2021/064558, issued Jun. 13, 2023, 12 pages. [cited by applicant]
International Preliminary Report on Patentability for PCT/US2021/064559, issued Jun. 13, 2023, 8 pages. [cited by applicant]