APSS-2000
2Pages

Automated Parenteral Sampling System Sizes and counts suspended particulate matter in a wide range of liquids to meet regulation standards BENEFITS The APSS-2000 syringe sampling system sizes and counts suspended particulate matter in a wide range of liquids and meets or exceeds all current USP, EP, and JP requirements. Recipe functions allow the APSS-2000 to adapt to future regulatory changes. The APSS-2000 system consists of an SLS-2000 syringe sampler, a LiQuilaz® II E Series light obscuration spectrometer, and SamplerSight Pharma software, allowing reports to meet 21 CFR Part 11 regulations. 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 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 A P P L I C AT I O N S • Pharmaceutical parenteral monitoring to USP, EP, JP and FDA • • • • standards Parts/medical device cleanliness testing Laboratory water sampling Water for Injection (WFI) and Pu

Automated Parenteral Sampling System Liquid Sensor Size Range Size Channels Flow Rates Volume Sampled Maximum Concentration Sample Temperature Zero-count Level Capillary Size Maximum Pressure Maximum Sample Viscosity Laser Source Laser diode Wetted Surface Materials 1 Fused Silica, Black Quartz, Teflon, Kel-F®, Kalrez® Greater than 90% accuracy (less than 10% coincidence loss) at maximum recommended concentration. Liquid Sampler Syringe Size Sampling Mode Minimum Sample Volume Wetted Surface Materials Glass, Teflon 17.1 x 9 x 15 in (43.4 x 22.9 x 38.1 cm) Including particle counter Weight...