TY - JOUR T1 - Inventory and Measurement of Particulates in Sealed Sterile Containers JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 170 LP - 179 VL - 37 IS - 5 AU - Julius Z. Knapp AU - John C. Zeiss AU - Brian J. Thompson AU - Joe S. Crane AU - Paul Dunn Y1 - 1983/09/01 UR - http://journal.pda.org/content/37/5/170.abstract N2 - 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. ER -