Particle Counter for Injectables: APSS-200 for USP 788

The APSS-200 syringe sampling system is designed to size and count suspended particles in a wide range of liquids. This system meets and exceeds all current USP 788 requirements and is engineered to adapt to future regulatory changes. The APSS-200 system consists of an LS-200 syringe sampler, a LiQuilaz® particle counter, and SamplerSight-Pharma software, which meets FDA 21 CFR Part 11 "Electronic Records and Signatures" rulings.
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Particle Counter for Injectables APSS-200

APSS 200 Particle Counter (274.8 KB)

BENEFITS
  • Defect Reduction
  • 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, providing software development documentation.
  • SamplerSight-Pharma was designed to comply with the FDA 21-CFR-11 rulings.
  • User-Friendly
  • Reduce operator error and ensure process accuracy with recipes, containing 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
  • Comprehensive System
  • Easy-to-use, pull-down menus have context sensitive help
  • Security password maintains system integrity
  • Particle measurements are reported as differential or cumulative counts
  • Small sample volume minimizes waste of expensive product
  • Various report formats are available
  • Small footprint for easy transport from one sample point to another
APPLICATIONS
  • Pharmaceutical injectables monitoring to USP 788, BP, and FDA standards
  • Parts/medical device cleanliness testing
  • Laboratory water sampling
  • Filter efficiency testing

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Parenteral Particle Counter: The APSS-200 measures particles in small or large injectable solutions. It is a compact particle counter consisting of a syringe sampler, LiQuilaz particle counter and a personal computer. The system is capable of sampling volumes from 1 milliliter to 1 liter and supports a variety of syringe sizes. To calibrate the instrument, thresholds of 2, 5, 10, 15, 20, 25 and 30 microns are used to establish the individual channels of the sensor over a wide range from 2-125 microns.

Particle data is communicated to the personal computer for comparative analysis of the test solutions. The computer operates in a Windows 98, NT4, and 2000 environment using software from Particle Measuring Systems, SamplerSight-Pharma. This advanced package enables the operator to adjust thresholds, perform calibration and utilize on-line help screens. The program comes with a software validation information notebook, which provides testing documentation generated during system development.

The APSS-200 parenteral particle counting system meets and exceeds USP 788 requirements and offers the flexibility to accommodate future regulatory changes.

This particle counter is CE certified.

Without Measurement There Is No Control
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