PT  - JOURNAL ARTICLE
AU  - Julius Z. Knapp
AU  - John C. Zeiss
AU  - Brian J. Thompson
AU  - Joe S. Crane
AU  - Paul Dunn
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.