Methods and apparati for nondestructive detection of undissolved particles in a fluid
AssigneeAmgen Inc.
InventorsGraham F. Milne, Erwin Freund, Ryan L. Smith
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Abstract
The apparati, methods, and computer program products disclosed herein can be used to nondestructively detect undissolved particles, such as glass flakes and/or protein aggregates, in a fluid in a vessel, such as, but not limited to, a fluid that contains a drug.
Claims12
A method of nondestructive counting and sizing of undissolved particles in a vessel that is at least partially filled with a fluid, the method comprising:
- capturing, via an imager, at least one image of the particles in the vessel that has been imaged under specified imaging conditions;
- storing, via a processor coupled to a memory, the at least one image in the memory;
- analyzing, via the processor, the at least one image to detect the particles and to calculate information indicative of the apparent size of the detected particles in the at least one image;
- calculating, via the processor, apparent particle size population information indicative of a distribution of varying apparent particle sizes of the detected particles in the at least one image;
- and
- calculating, via the processor, actual particle size population information indicative of a distribution of varying actual particle sizes of the detected particles in the at least one image based on a comparison between:
- (i) the apparent particle size population information;
- and
- (ii) calibration population information indicative of a distribution of varying apparent particle sizes of one or more sets of standard sized particles imaged under conditions corresponding to the specified imaging conditions.
An apparatus for counting and sizing undissolved particles in a vessel that is at least partially filled with a fluid, the apparatus comprising at least one processor configured to:
- store at least one image of the particles in the vessel in a memory that is coupled to the at least one processor, the at least one image of the particles being imaged via an imager under specified imaging conditions;
- analyze the at least one image to detect the particles and to calculate information indicative of the apparent size of the detected particles in the image;
- calculate apparent particle size population information indicative of a distribution of varying apparent particle sizes of the detected particles in the at least one image;
- and
- calculate actual particle size population information indicative of a distribution of varying apparent particle sizes of the detected particles based on a comparison between:
- (i) the apparent particle size population information, and
- (ii) calibration population information indicative of a distribution of varying apparent particle sizes of one or more sets of standard sized particles imaged under conditions corresponding to the specified imaging conditions.
A computer program product for nondestructive counting and sizing of undissolved particles in a vessel that is at least partially filled with a fluid, the computer program product comprising nonvolatile, machine-readable instructions stored on a non-transitory computer readable media, which, when executed by a processor, cause the processor to:
- store at least one image of the particles in the vessel in a memory that is coupled to the processor, the at least one image of the particles being imaged via an imager under specified imaging conditions;
- analyze the at least one image to detect the particles and to calculate information indicative of the apparent size of the detected particles in the image;
- calculate apparent particle size population information indicative of a distribution of varying apparent particle sizes of the detected particles;
- and
- calculate actual particle size population information indicative of the actual particle size distribution of the detected particles based on a comparison between:
- (i) the apparent particle size population information;
- and
- (ii) calibration population information indicative of a distribution of varying apparent particle sizes of one or more sets of standard sized particles imaged under conditions corresponding to the specified imaging conditions.
Dependencies are inferred from the claim text.