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 Knapp, Julius Z.
A1 Zeiss, John C.
A1 Thompson, Brian J.
A1 Crane, Joe S.
A1 Dunn, Paul
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.