Abstract: A new technology is established by the present invention to assist in the development of more reliable human method for the inspection of pharmaceutical and critical products. The present invention provides the industry with a standardized illumination environment in which the illumination conditions remain constant over extended periods of time. Furthermore, the invention provides the environment in an ergonomic package that is easily adjusted to match physical requirements of individual users without the use of any special tools. The optimized manual inspection environment implements the state of the art control techniques to maintain a constant luminous intensity within an expanded inspection volume. The large inspection volume minimizes the effects of variation in product positions while inspectors perform the operations.

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: The generation of a desired non-linear resonance in the toroidal flow of liquid in a cylindrical injectable product is described. The resulting liquid flow pattern generated with an approximately smooth meniscus is down at the walls, across to the center of rotation, up on the center of rotation, across the meniscus to complete the pattern. The controlled flow pattern results in a predictable location for particle of varying mass and hydraulic shape. This predictability of location transforms the problem of particle detection from a chance occurrence to a deterministic task. The deterministic location of particle position is a contributor to the demonstrated capability to measure the size of visible particle range in a range from 33 ?m to 1,000 ?m with a median deviation of 1% and a maximum deviation from NIST dimensional accuracy of 3%.