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US 12,313,614 B2Granted
Method for identifying the quality of a liquid pharmaceutical product
OwnerLaura Rodríguez García, David Mainkainventors
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Abstract
A method and a system for identifying the quality of a liquid pharmaceutical product as described. The method comprises providing a liquid pharmaceutical product in a sealed container and arranging the sealed container such that the liquid pharmaceutical product forms a sample layer in a first portion of the sealed container. The method further comprises directing a light beam through the sample layer and measuring a spectrum of the sample layer. The spectrum is chosen from the group of a NIR spectrum or a Raman spectrum. The method further comprises identifying the quality of the liquid pharmaceutical product by comparing the spectrum with a reference spectrum corresponding to an expected pharmaceutical product.
Claims26
A method for identifying the quality of a liquid pharmaceutical product, comprising:
- providing a liquid pharmaceutical product in a sealed container;
- arranging the sealed container such that the liquid pharmaceutical product forms a sample layer in a first portion of the sealed container;
- directing a light beam through the sample layer;
- measuring a spectrum of the sample layer,
- wherein the spectrum is a NIR spectrum or a Raman spectrum;
- and
- identifying the quality of the liquid pharmaceutical product by comparing the spectrum with a reference spectrum corresponding to an expected pharmaceutical product;
- and
- wherein the sample layer comprises a gas-liquid interface and a container-liquid interface penetrated by the NIR light beam;
- wherein the sealed container is arranged such that the gas-liquid interface is inclined relative to the container-liquid interface.
7 more elements
A method for identifying the quality of a liquid pharmaceutical product, comprising:
- providing a liquid pharmaceutical product in a sealed container;
- arranging the sealed container such that the liquid pharmaceutical product forms a sample layer in a first portion of the sealed container;
- directing a light beam through the sample layer;
- measuring a spectrum of the sample layer,
- wherein the spectrum is a NIR spectrum or a Raman spectrum;
- and
- identifying the quality of the liquid pharmaceutical product by comparing the spectrum with a reference spectrum corresponding to an expected pharmaceutical product;
- wherein the sealed container is arranged such that the sample layer has a smaller thickness than a bulk area of the liquid pharmaceutical product;
- and
- wherein the sealed container is arranged such that a thickness of the liquid pharmaceutical product decreases continuously between the bulk area and the sample layer.
7 more elements
A method for identifying the quality of a liquid pharmaceutical product, comprising:
- providing a liquid pharmaceutical product in a sealed container;
- arranging the sealed container such that the liquid pharmaceutical product forms a sample layer in a first portion of the sealed container;
- directing a light beam through the sample layer;
- measuring a spectrum of the sample layer,
- wherein the spectrum is a NIR spectrum or a Raman spectrum;
- and
- identifying the quality of the liquid pharmaceutical product by comparing the spectrum with a reference spectrum corresponding to an expected pharmaceutical product;
- and
- wherein the sample layer comprises a gas-liquid interface and a container-liquid interface penetrated by the NIR light beam;
- wherein the sealed container is arranged such that the gas-liquid interface is inclined relative to the container-liquid interface;
- wherein the sealed container is arranged such that a thickness of the sample layer is not larger than 10 mm and not smaller than 0.1 mm.
8 more elements
A method for identifying the quality of a liquid pharmaceutical product, comprising:
- providing a liquid pharmaceutical product in a sealed container;
- arranging the sealed container such that the liquid pharmaceutical product forms a sample layer in a first portion of the sealed container;
- directing a light beam through the sample layer;
- measuring a spectrum of the sample layer,
- wherein the spectrum is a NIR spectrum or a Raman spectrum;
- and
- identifying the quality of the liquid pharmaceutical product by comparing the spectrum with a reference spectrum corresponding to an expected pharmaceutical product;
- wherein the sample layer comprises a gas-liquid interface and a container-liquid interface penetrated by the NIR light beam;
- and
- wherein the sealed container is arranged such that the gas-liquid interface is perpendicular to a gravitation axis and the container-liquid interface is non-perpendicular to the gravitation axis.
7 more elements
A method for identifying the quality of a liquid pharmaceutical product, comprising:
- providing a liquid pharmaceutical product in a sealed container;
- arranging the sealed container such that the liquid pharmaceutical product forms a sample layer in a first portion of the sealed container;
- directing a light beam through the sample layer;
- measuring a spectrum of the sample layer,
- wherein the spectrum is a NIR spectrum or a Raman spectrum;
- and
- identifying the quality of the liquid pharmaceutical product by comparing the spectrum with a reference spectrum corresponding to an expected pharmaceutical product;
- and
- wherein the sealed container is arranged such that a first interface of the sample layer is inclined relative to a second interface of the sample layer, wherein the second interface opposes the first interface.
6 more elements
A method for identifying the quality of a liquid pharmaceutical product, comprising:
- providing a liquid pharmaceutical product in a sealed container;
- arranging the sealed container such that the liquid pharmaceutical product forms a sample layer in a first portion of the sealed container;
- directing a light beam through the sample layer;
- measuring a spectrum of the sample layer,
- wherein the spectrum is a NIR spectrum or a Raman spectrum;
- and
- identifying the quality of the liquid pharmaceutical product by comparing the spectrum with a reference spectrum corresponding to an expected pharmaceutical product;
- and
- wherein the sample layer comprises a gas-liquid interface and a container-liquid interface penetrated by the NIR light beam;
- wherein the sealed container is arranged such that the gas-liquid interface is inclined relative to the container-liquid interface;
- reflecting the light beam after the light beam has penetrated the sample layer a first time such that the light beam penetrates the sample layer a second time.
8 more elements
A method for identifying the quality of a liquid pharmaceutical product, comprising:
- providing a liquid pharmaceutical product in a sealed container;
- arranging the sealed container such that the liquid pharmaceutical product forms a sample layer in a first portion of the sealed container;
- directing a light beam through the sample layer;
- measuring a spectrum of the sample layer,
- wherein the spectrum is a NIR spectrum or a Raman spectrum;
- and
- identifying the quality of the liquid pharmaceutical product by comparing the spectrum with a reference spectrum corresponding to an expected pharmaceutical product;
- and
- wherein the NIR light beam is directed through the sample layer such that the NIR light beam penetrates the gas-liquid interface non-perpendicularly.
6 more elements
A system for identifying the quality of a liquid pharmaceutical product, comprising:
- a sample holder configured to hold a sealed container such that a liquid pharmaceutical product contained in the sealed container forms a sample layer in a first portion of the sealed container;
- and
- a measurement unit comprising a light source and a detector,
- wherein the measurement unit is configured to direct a light beam through the sample layer, and
- wherein the measurement unit is configured to measure a spectrum of the sample layer,
- wherein the spectrum is a NIR spectrum or a Raman spectrum;
- and
- wherein the sample layer comprises a gas-liquid interface and a container-liquid interface penetrated by the NIR light beam,
- wherein the sealed container is arranged such that the gas-liquid interface is inclined relative to the container-liquid interface.
6 more elements
Dependencies are inferred from the claim text.