PT  - JOURNAL ARTICLE
AU  - Knapp, Julius Z.
AU  - Kushner, Harold K.
TI  - Particulate Inspection of Parenteral Products: From Biophysics to Automation
DP  - 1982 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 121--127
VI  - 36
IP  - 3
4099  - http://journal.pda.org/content/36/3/121.short
4100  - http://journal.pda.org/content/36/3/121.full
SO  - PDA J Pharm Sci Technol1982 May 01; 36
AB  - To facilitate more rapid application of automated particulate inspection systems, biophysical foundations for the industry standard manual inspection have been traced. This theoretical support for the probabilistic inspection model described by Knapp and Kushner formally links an applied analysis to its theoretical roots. Ethical obligations and clinical requirements for parenteral products are reviewed. It is concluded that the small sample quantities employed in destructive testing of particulate contamination in production batches leads to results that are too variable to ensure adequate process control.