APSS – 2000 Parenteral Particle Counter.

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.

Download PDF SpecSheet

Description

Features

  • Sizing capability from 1.5 to 125 μm
  • Sample volumes from 0.2 ml to 1 L
  • 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)
  • Filter efficiency testing

Download PDF SpecSheet

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