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The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Patent No.:

US 12383638 B1

PDFFull Text
Date of Patent:
Aug. 12, 2025

Filed:

Apr. 21, 2022

Method for sterilizing an assembly comprising at least one single-use device for biopharmaceutical fluid

Applicant:

Sartorius Stedim Fmt Sas, Aubagne, FR;

Inventors:

Samuel Dorey, Le Beausset, FR;

Marie-Christine Menier, La Ciotat, FR;

Lara Nascimento-Brooks, Hitchin, GB;

Assignee:

SARTORIUS STEDIM FMT SAS, Aubagne, FR;

Attorney:

Heslin Rothenberg Farley & Mesiti P.C.

Primary Examiner:

Regina M Yoo

Int. Cl.
CPC ...
A61L 2/08 (2006.01); A61L 2/28 (2006.01); B01F 23/233 (2022.01); B01F 23/237 (2022.01); B01F 27/113 (2022.01); B01F 27/191 (2022.01); B01F 27/906 (2022.01); B01F 35/513 (2022.01); C12M 1/00 (2006.01); C12M 1/06 (2006.01); C12M 1/12 (2006.01); B01F 101/22 (2022.01);
U.S. Cl.
CPC ...
A61L 2/082 (2013.01); A61L 2/28 (2013.01); B01F 23/23313 (2022.01); B01F 23/23362 (2022.01); B01F 23/23761 (2022.01); B01F 27/113 (2022.01); B01F 27/191 (2022.01); B01F 27/906 (2022.01); B01F 35/513 (2022.01); C12M 23/14 (2013.01); C12M 23/28 (2013.01); C12M 27/02 (2013.01); C12M 37/00 (2013.01); A61L 2202/14 (2013.01); A61L 2202/181 (2013.01); A61L 2202/25 (2013.01); B01F 2101/22 (2022.01);
Abstract

A method for sterilizing by X-rays an assembly containing a single-use device intended to receive a biopharmaceutical fluid, comprising: placing a plurality of dosimeters, repeatedly passing the assembly in front of the X-ray radiation window, according to a first face then according to a second face of the assembly, at several irradiation power-time pairs (PTi), followed by mapping the radiation dose; and —determining an optimum power-time pair (PTopt) for which the mapping reveals that all dosimeters have recorded a radiation dose above a minimum sterility dose (Dmin), and for which the dosimeter associated with a fragile element of the single-use device records a radiation dose below a maximum dose (Dmax) defined as being the dose from which the X-ray irradiation deteriorates the fragile element.

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