Abstract: New methodology, realizable with both manual and new semi-automatic imaging technology, has transformed both the inspection and the batch release Attribute Sampling Inspection for contaminating visible particles in injectable solutions into statistically replicable procedures. In this new non-destructive inspection procedure, a calibration curve relates NIST traceable measurement of maximum particle size to the rejection probability of the particle. Data for this calibration curve is determined with a graduated set of single durable stainless steel and glass microspheres that are sized with NIST traceability. Use of the calibration curve transforms the probabilistic variability of visible particle inspection data described by Knapp into the ‘simply replicable form’ required by the Attribute Sampling Tables. The present invention uses cutting edge imaging technology to achieve 1% sizing accuracy within 10 ?m from 50 to 1,000 ?m.

Abstract: Essential prerequisites for any injectable product are its sterility, its freedom from pathogens and its freedom from visible particle contamination . . . . These requirements must be satisfied prior to the release of an injectable product batch for sale and use. A major difficulty in responding to these assay requirements is the need for a size sensitivity difference of 100 or greater in determining the presence of viable pathogenic organisms and of non-viable random particle contaminants. The wide dynamic testing range cannot be satisfied in current art with a single non-destructive testing station. The present invention uses a special agitation procedure to generate separate liquid volumes containing the small viable and larger non-viable particle contaminants. This separation makes possible the introduction of sensing systems that have been optimized for each size range and that can operate in parallel without interference.

Abstract: A method for the substantially complete detection and measurement of all particles, within a predetermined size, range, contained in an injectable solution comprising the steps of: a) rotation of the container causes substantially all of the particles in the injectable solution in the container to be set in motion; b) uniformly illuminating the background around the container with light; and c) detecting at least one of light scatter, light reflection and light extinction caused by said particles, with detectors having a depth of focus of detection in a specified volume of the container. Wherein the detectors are positioned, relative to the container whereby the optical path and field of view allows the sensor sufficient focus to view substantially all of the bottom interior surface of the container and substantially all of the solution volume within the container.

Abstract: The invention describes a method for the inspection of machining tools used in computational numerical control (CNC) machining centers. The invention will observe a machining tool immediately after use to determine if it has been damaged. The invention is based on a machine vision technology that uses one or more image sensors to acquire, locate and compare the tool to a good model. The inspection equipment is designed for implementation in the CNC automatic tool changing system and will alert the operator that tool has been damaged before the next operation. This immediate response of the invention will contain defect components and prevent damage to subsequent components. With the addition of an infrared image sensor the invention is capable of detecting worn or dull tools that may damage a component due to excessive heating.