Liquid Particle Counter for USP788: APSS-2000 Sampler Particle Measuring Systems

Listing description

APSS 2000 + software

Liquid particle counter for USP 788 sizes & counts suspended particles.
The APSS-2000 Liquid Particle Counter for USP 788 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. When it comes to quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste.

Along with USP 788 for particles in liquids, the APSS-2000 Particle Counter has recipe functions that allow it to adapt to future regulatory changes, and its small sample volume minimizes the waste of expensive product.

The APSS-2000 Liquid Particle Counter includes: an SLS-1000 Syringe Sampler, a LiQuilaz® eSeries Light Obscuration Spectrometer and SamplerSight Pharma Software, allowing reports to meet 21 CFR 11 regulations for electronic records and signatures.

SamplerSight Pharma Software allows operators to manage sampling requirements for batch-based operations and provides a comprehensive view of the batch information with histogram, time plot and tabular data presented in an easy-to-use format that is easily reported. SamplerSight Pharma features a validatable, user-friendly, Windows-based software with context-sensitive help.

Features
Sizing capability from 1.5 to 125 μm
Sample volumes from 0.2 ml to 1 L
Adapters for small volume injectibles (SVI) and bag testing for intravenous (IV) solutions
Automated liquid particle counter sensor calibration
Liquid particle counts reported per ml or per container values
Available with various custom report formats
SamplerSight Pharma complies with FDA 21 CFR Part 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. USP 788, 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

This equipment is located in DE