RT Journal Article
SR Electronic
T1 Visual Ampul Inspection by Experienced and Non-Experienced Inspectors
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 148
OP 151
VO 35
IS 4
A1 Baldwin, H. John
A1 Howard, Stephen A.
A1 Leelarasamee, Nilsuwan
YR 1981
UL http://journal.pda.org/content/35/4/148.abstract
AB Earlier work found individual differences between inspectors performing ampul inspections. This research sought to confirm or disaffirm those findings under controlled conditions. The experimental design had the following three factors: inspectors, particle size, and particle concentration. Five-milliliter ampuls, salted with particles of various sizes and concentrations, were inspected using a standard parenteral inspection technique (black/white background with incandescent lighting, 15-sec pacing). With seventeen pharmacy students as volunteer inspectors, analysis of variance found all main effects and interactions (except size X concentration) to be significant. Using identical ampuls and experienced parenteral inspectors employed by a pharmaceutical manufacturer, the inspectors themselves and the interaction between inspectors and particle size were found to be the significant factors. Essentially untrained inspectors differed from experienced inspectors, but, unlike the research by Graham et al., experienced inspectors had a larger rejection rate then inexperienced inspectors. In an actual work setting, the percent of unacceptable samples in an ampul lot appears to affect the inspection results in that experienced inspectors apparently tend to over-reject if a subjectively perceived “high” level of unacceptable ampuls are present. It is possible that experienced inspectors may see particles which inexperienced inspectors do not.