RT Journal Article
SR Electronic
T1 Particulate Inspection of Parenteral Products: An Assessment
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 176
OP 185
VO 35
IS 4
A1 Knapp, Julius Z.
A1 Kushner, Harold K.
A1 Abramson, Lee R.
YR 1981
UL http://journal.pda.org/content/35/4/176.abstract
AB The international drive to achieve higher quality and improved cost effectiveness in parenteral products has achieved an apparent concensus concerning the utility and desirability of automated particulate inspection systems. Any perspective on widespread inspection automation must commence with the establishment of realistic objective standards based on sound scientific principles. Economically acceptable methodology must also be available to achieve validation for new procedures and devices. Standards, techniques, and sampling schemes applicable to evaluation and validation of particulate inspections are discussed.