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PMS APSS-2000 Liquid Particle Counter for USP 788

Features

  • Particle 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
APSS-2000 Spec

Introduction Liquid particle counter for USP 788: APSS-2000

Sensitivity range: 1.5 – 125 μm

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 particle monitoring 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.

Liquid Particle Counter for USP 788: APSS-2000

Features APSS-2000

  • Particle 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 APSS-2000

  • 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 particle 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
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