RT Journal Article
SR Electronic
T1 Visible Particle Limits in Small Volume Parenterals
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 167
OP 174
VO 34
IS 3
A1 Nilsuwan Leelarasamee
A1 Stephen A. Howard
A1 H. John Baldwin
YR 1980
UL http://journal.pda.org/content/34/3/167.abstract
AB The purpose of this study was to quantify for the first time the size and concentration of particles that can be detected by visual inspection. Five-milliliter ampuls with known concentrations and sizes of polystyrene beads from 5 to 40 μm suspended in electrolyte solution were inspected by trained student inspectors using 15-sec pacing. Particle size was the most significant variable in the ability to detect particle contamination. A 50% probability exists for the inspectors to reject 20-μm particles. It was concluded that such a rejection rate be achieved with 20-μm particles in order for inspectors to qualify for in-line inspection.