Particle Counter for Injectables: APSS-200 for USP 788The 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. APSS 200 Particle Counter (274.8 KB) BENEFITS
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Contact us if you need more information or have questions. Learn more about our microcontamination monitoring services. 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. | |
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