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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® E20P particle counter, and SamplerSight-Pharma software, allowing reports to meet 21 CFR Part 11 "Electronic Records and Signatures" rulings.
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Parenteral Particle Counter: The APSS-2000 measures particles in small or large injectable solutions. It is a compact particle counter consisting of a syringe sampler, LiQuilaz particle counter and software. 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 1.5-125 microns.
Particle data is communicated to the personal computer for comparative analysis of the test solutions. The computer operates in a Windows XP 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-2000 parenteral particle counting system meets and exceeds USP, EP, and JP requirements and offers the flexibility to accommodate future regulatory changes.
This particle counter is CE certified.