RT Journal Article SR Electronic T1 Inventory and Measurement of Particulates in Sealed Sterile Containers JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 170 OP 179 VO 37 IS 5 A1 Julius Z. Knapp A1 John C. Zeiss A1 Brian J. Thompson A1 Joe S. Crane A1 Paul Dunn YR 1983 UL http://journal.pda.org/content/37/5/170.abstract AB 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.