When it comes to quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste. The APSS-2000 Liquid Particle Counter sizes and counts suspended particulate matter in a wide range of liquids to meet all current U.S., European and Japanese Pharmacopoeia standards.

Alongwith USP 788 for particulate matter in injections, the APSS-2000 Pharmaceutical Liquid 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 System 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.

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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

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

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

Supporting Materials

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