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Saturday, March 5, 2011

QUALITY CONTROL OF STERILE PRODUCTS (3)


Instruments for evaluation of particulate matter
System Working Principle Remarks
Visual Based Inspection
Autoskan Light Scattering Non-Destructive
Eisai Ampoule Inspection
(AIM) System
Light blockage (Shadow) Non-Destructive
Schering PDS/A-V System Light Scattering Non-Destructive
Electronic Particle Counters
Coulter Counter Change in Electric Resistance Destructive; Large errors in measuring flakes and fibers;
Not recommended by FDA for parenterals
HIAC (High Accuracy
Instruments)
Light Blockage Destructive; High Efficiency,
Easy calibration;
Recommended by USP;
Expensive
Met-One Climet Particle
Counter
Light Scattering Destructive; Measures 6 particles sizes at a time;
Excellent large particle detection
Climet Instrument Light Obstruction Non-destructive

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