Sizes and counts suspended particulate matter in a wide range of liquids, including parenterals, to meet all current U.S., European and Japanese Pharmacopoeia standards.
The APSS-2000 from Particle Measuring Systems is a fully contained syringe sampling liquid particle counting system. It provides user flexibility from the many liquid sampling configurations to the comprehensive Sampler Sight software that allows the user to collect, analyze and report data from one simple platform. The entire system is validatable and 21CFR11 compliant. Learn more from this expert demonstration.
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-1000 syringe sampler, a LiQuilaz® E Series light obscuration spectrometer, and SamplerSight-Pharma software, allowing reports to meet 21 CFR 11 “Electronic Records and Signatures” rulings.
Adapters for small volume injectables (SVI) and bag testing for intravenous (IV) solutions
Automated particle counter sensor calibration
Particle measurements reported per ml or per container values
Available with various custom report formats
SamplerSight Pharma complies with FDA 21 CFR 11
Automated full calibration or routine verification functions
Benefits
Greater accuracy with 100% sample volume
Precise sampling within 0.1 ml to produce repeatable results
Comprehensive software development documentation and full instrument qualification (IQ), operations qualification (OQ) and performance qualification (PQ) protocols
Reduced operator error and increased process accuracy with recipes for repeat sample processing
Alarm levels for pass/fail criteria to ensure quality control
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)
