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US 2021/0010962 A1Published application
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 rate (R2) of solvent NMR signal to detect filling errors of an alum-containing product in real-time in-line during manufacturing, for example during a fill-finish unit operation. This technique 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 in-line during a fill-finish unit operation, said method comprising:
- flowing 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 flow through a magnet and a probe of nuclear magnetic resonance (NMR) spectrometer prior to the vial;
- measuring the transverse relaxation rate of solvent R2,m in the alum-containing product flowing through the filling conduit;
- and
- comparing the measured R2,m to a reference transverse relaxation rate of solvent R2,r, wherein the reference R2,r represents an acceptable flow rate or concentration of aluminum particles in the alum-containing product,
- wherein when the measured R2,m is inside a range of the reference R2,r, there is no filling error.
2 more elements
Dependencies are inferred from the claim text.