PT  - JOURNAL ARTICLE
AU  - Nilsuwan Leelarasamee
AU  - Stephen A. Howard
AU  - H. John Baldwin
TI  - Visible Particle Limits in Small Volume Parenterals
DP  - 1980 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 167--174
VI  - 34
IP  - 3
4099  - http://journal.pda.org/content/34/3/167.short
4100  - http://journal.pda.org/content/34/3/167.full
SO  - PDA J Pharm Sci Technol1980 May 01; 34
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.