RT Journal Article
SR Electronic
T1 Particulate Inspection of Parenteral Products: From Biophysics to Automation
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 121
OP 127
VO 36
IS 3
A1 Knapp, Julius Z.
A1 Kushner, Harold K.
YR 1982
UL http://journal.pda.org/content/36/3/121.abstract
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.