Benefits
Greater accuracy with 100% sample volume
Precise sampling within 0.1ml 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
Features & applications
Features
Sizing capability from 1.5 to 125μm
Sample volumes from 0.2ml to 1L
Adapters for small volume injectibles (SVI) and bag testing for intravenous (IV) solutions
Automated 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
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