RT Journal Article
SR Electronic
T1 Automated Particulate Inspection Systems: Strategies and Implications
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 74
OP 107
VO 44
IS 2
A1 Julius Z. Knapp
A1 Lee R. Abramson
YR 1990
UL http://journal.pda.org/content/44/2/74.abstract
AB The 1980 human performance based validation procedure for automated particulate inspection systems described by Knapp and Kushner is extended to cover the major imported systems now in use. The original publications considered only inspection machine strategies in which the controlling probability in the determination of the inspection security attained was that of rejecting the “must reject” group of containers. For application to the widely used Japanese machines, this paper also considers machines in which the controlling probability in the determination of the inspection security attained is that of accepting the "must reject" container group. The difference in inspection strategy is traced to the inherent particle detection capability of each inspection system. The effect of inspection strategy on the true and false reject rate is also discussed.