Particle Measuring Systems

Dec. 2, 2004
Parenterals Sampling Tool Counts, Sizes Suspended Particulates
Particle Measuring Systems has introduced the APSS-200 syringe sampling system with SamplerSight software. The system is designed to size and count suspended particulate matter in a wide range of solutions. It meets and exceeds all current USP test XXV <788> requirements and is engineered to adapt to future regulatory changes. It also provides pharmaceutical injection monitoring to USP, BP, and EP standards. The APSS-200 package consists of an LS-200 syringe sampler, a LiQuilaz volumetric sampler, and SamplerSight software, which meets the current FDA 21CFR Part 11 “Electronic Records and Signatures" rulings. APSS-200 is used for small and large volume parenteral sampling. SamplerSight allows operators to manage the 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 can be simply reported.
  • 100% view volume means greater accuracy for tighter process control
  • A precise sample volume within 0.1 milliliter is achieved with the syringe sampler, producing repeatable results
  • SamplerSight Pharma software comes with the Validation Information Notebook, which provides software development documentation
  • Designed to comply with 21CFR11 rulings
  • Reduce operator error and ensure process accuracy with recipes which contain sample description, sample volume, flow rates, channel sizes, sample limits, report formats and storage options
  • Automated sensor calibration takes less than 30 minutes
  • Alarm levels for pass/fail criteria can be created to ensure quality control
  • Easy-to-use, pull-down menus with context sensitive help
  • Security password maintains system integrity
  • Small footprint for easy transport from one sample point to another
  • Particle measurements are reported as differential or cumulative counts
  • Small sample volume minimizes waste of expensive product
  • Various report formats are available
  • Pharmaceutical injection monitoring
    to USP, BP, and EP standards
  • Parts/medical device cleanliness testing
  • Laboratory water sampling
  • Filter efficiency testing
  • Sizing sensitivities from 2 to 125 microns
  • 15 user-selectable sizing channels available
  • Meets and exceeds all USP requirements
  • Sample volumes from 1 milliliter to 1 liter
  • Samples effervescent chemicals
  • Small footprint, compact system
  • Automated sensor calibration