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US 10,823,687 B2Granted
Metal analysis during pharmaceutical manufacturing
AssigneeUHV Technologies, Inc.
InventorsNalin Kumar, Manuel Gerardo Garcia, Jr.
Life of this patent
Estimating the term…
Abstract
A system and method for detecting, measuring, and analyzing for metallic impurities in pharmaceutical drugs and compounds utilizes an x-ray fluorescence system. The system and method may be co-located with a pharmaceutical manufacturing process for in-line continuous monitoring of metal impurities. The pharmaceutical products may be in a form selected from a powder, slurry, pill, tablet, and gel.
Claims19
A system for analyzing pharmaceutical products for a presence of metallic impurities, comprising:
- a conveyer system for conveying the pharmaceutical products;
- and
- an x-ray fluorescence (“XRF”) system positioned in proximity to the conveyor system so that an x-ray source irradiates the pharmaceutical products as they are conveyed past the XRF system, wherein the XRF system is configured to detect a presence of 5 ppm or less of a metallic element in the pharmaceutical products,
- wherein the XRF system comprises a wavelength dispersive XRF detector that includes:
- a first stationary crystal configured to separate XRF emissions from the pharmaceutical products into a first plurality of separate wavelengths each pertaining to a first plurality of different metallic elements;
- a second stationary crystal configured to separate XRF emissions from the pharmaceutical products into a second plurality of separate wavelengths each pertaining to a second plurality of different metallic elements;
- a first detector configured to detect the first plurality of different metallic elements;
- and
- a second detector configured to detect the second plurality of different metallic elements.
6 more elements
A system for analyzing pharmaceutical products for a presence of an element, the system comprising:
- a conveyor system for conveying the pharmaceutical products along a path;
- and
- a wavelength dispersive x-ray fluorescence (“WD-XRF”) system positioned in proximity to the conveyor system so that an x-ray source irradiates the pharmaceutical products as they are conveyed on the conveyor system, wherein the WD-XRF system is configured to detect a presence of the element in the pharmaceutical products, wherein the WD-XRF system includes one or more stationary crystals and one or more stationary detectors, wherein the one or more stationary crystals are each configured to separate XRF emissions from the pharmaceutical products into one or more separate wavelengths each pertaining to a different element, wherein the one or more stationary crystals includes:
- a first stationary crystal configured to separate XRF emissions from the pharmaceutical products into a first plurality of separate wavelengths each pertaining to a first plurality of different metallic elements;
- and
- a second stationary crystal configured to separate XRF emissions from the pharmaceutical products into a second plurality of separate wavelengths each pertaining to a second plurality of different metallic elements,
- wherein the one or more stationary detectors includes:
- a first detector configured to detect the first plurality of different metallic elements;
- and
- a second detector configured to detect the second plurality of different metallic elements.
7 more elements
A method for analyzing pharmaceutical products for a presence of one or more metallic elements, the method comprising:
- conveying the pharmaceutical products along a path of a conveyor system;
- irradiating the pharmaceutical products with an x-ray source;
- detecting x-ray fluorescence (“XRF”) emissions emanating from the irradiated pharmaceutical products;
- and
- analyzing the XRF emissions to determine if the pharmaceutical products contain one or more metallic elements,
- wherein the detecting of the XRF emissions further comprises:
- separating the XRF emissions into a first plurality of wavelengths using a first stationary crystal, wherein the first plurality of wavelengths each pertain to a first plurality of the one or more metallic elements;
- separating the XRF emissions into a second plurality of wavelengths using a second stationary crystal, wherein the second plurality of wavelengths each pertain to a second plurality of the one or more metallic elements;
- separately counting each of the first plurality of wavelengths using a first stationary detector;
- and
- separately counting each of the second plurality of wavelengths using a second stationary detector.
8 more elements
Dependencies are inferred from the claim text.