Laboratory Equipment & Services Information System by Centralized Laboratory Management Office (CeLMO)

BENEFITS Defect Reduction • 100% sample volume for greater accuracy • A precise sample volume within 0.4 ml is achieved with the syringe sampler, producing repeatable results • SamplerSight Pharma software comes with a Validation Information Notebook, providing comprehensive software development documentation and full IQ, OQ, and PQ protocols • SamplerSight Pharma complies with FDA 21 CFR 11 User-Friendly • Reduce operator error and ensure process accuracy with recipes for repeat sample processing to USP, EP, or JP standards • Automated particle counter calibration wizard for full calibration or routine verification • Alarm levels for pass/fail criteria ensure quality control • Automated backup scheduling ensures enhanced data integrity Comprehensive System • Easy-to-use pull-down menus • Active Directory security password maintains system integrity • Particle measurements are reported per ml or per container values • Small sample volume minimizes waste of expensive product • Various custom report formats are available • Electronic report approval FEATURES • Particle size capability from 1.5 to 125 µm • Fifteen user-selectable sizing channels • Meets and exceeds all USP, EP and JP requirements • Sample volumes from 0.4 ml to 1 liter • Adapters for SVI and IV bag testing • Automated sensor calibration • Plug and play ultrasonic bath and magnetic stirrer options available

APPLICATIONS • Pharmaceutical parenteral monitoring to U.S., EP, JP and FDA standards • Parts/medical device cleanliness testing • Laboratory water sampling for purified water testing and water for injection (WFI) • Filter efficiency testing