PT - JOURNAL ARTICLE AU - Knapp, Julius Z. AU - Zeiss, John C. AU - Thompson, Brian J. AU - Crane, Joe S. AU - Dunn, Paul TI - Inventory and Measurement of Particulates in Sealed Sterile Containers DP - 1983 Sep 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 170--179 VI - 37 IP - 5 4099 - http://journal.pda.org/content/37/5/170.short 4100 - http://journal.pda.org/content/37/5/170.full SO - PDA J Pharm Sci Technol1983 Sep 01; 37 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.