Abstract
Transmission holography has been used to translate the Knapp and Kushner probabilistically defined “Reject Zone” for particulate contamination in parenteral products into physical measurements. Sample containers rejected with a probability of 70% (i.e., at the lower boundary of the “Reject Zone”) in a standard paced inspection using a three diopter lens and an intense diffuse light source were investigated with holography. The containers investigated showed a major relationship between the shape of a particulate and its detectability. The net effect of magnification on the relationship between particulate size and rejection probability was also investigated.
- Received April 21, 1983.
- Accepted June 6, 1983.
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