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US 11,971,374 B2Granted
In situ, real-time in-line detection of filling errors in pharmaceutical product manufacturing using water proton NMR
AssigneeUniversity of Maryland, Baltimore
InventorsYihua (Bruce) Yu, Marc B. Taraban
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Abstract
A method of using the transverse relaxation time (T2) of solvent NMR signal to detect filling errors of an alum-containing product in real-time and in-line during manufacturing, for example during a fill-finish unit operation. This method can be used for quality control in vaccine manufacturing to ensure the delivery of the correct concentration of alum-containing product to the product container such as a vial or pre-filled syringe.
Claims13
A method of detecting a filling error of an alum-containing product in real-time and in-line during a fill-finish unit operation, said method comprising:
- introducing the alum-containing product into a filling conduit, wherein the filling conduit directs the alum-containing product into a vial, and wherein the filling conduit is arranged to pass through a magnet of a nuclear magnetic resonance (NMR) spectrometer prior to reaching the vial;
- measuring a transverse relaxation time of water T2,m in the alum-containing product passing through the filling conduit;
- and
- comparing the measured T2,m to a reference transverse relaxation time of water T2,r, wherein T2,r, is a range which is considered an acceptable flow rate or concentration of aluminum particles in the alum-containing product,
- wherein when the measured T2,m is within the range of the reference T2,r, there is no filling error.
2 more elements
Dependencies are inferred from the claim text.