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.