Particle Counter for Injectables: APSS-2000

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BENEFITS

• Defect Reduction
• 100% sample volume for greater accuracy
• 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 comprehensive software development documentation and full IQ, OQ, and PQ protocols
• SamplerSight-Pharma complies with FDA 21CFR-11
• User-Friendly
• Reduce operator error and ensure process accuracy with recipes for repeat sample processing to USP, EP, or JP standards
• Automated particle counter calibration wizard for full calibration or routine verification
• Alarm levels for pass/fail criteria ensure quality control
• Comprehensive System
• Easy-to-use, pull-down menus
• Security password maintains system integrity
• Particle measurements are reported per mL or per container values
• Small sample volume minimizes waste of expensive product
• Various custom report formats are available

APPLICATIONS

• Pharmaceutical parenteral monitoring to USP, EP, JP, and FDA standards
• Parts/medical device cleanliness testing
• Laboratory water sampling
• WFI and Purified Water testing
• Filter efficiency testing

LINKS TO MORE INFORMATION:

• Basic Guide to Particle Counters and Particle Counting
• Particle Counters for Injectable Solutions, 2007 USP 788 Update
• Quick Steps to Meet USP 797 Compliance

FREQUENTLY ASKED QUESTIONS:

• Do I need cumulative or differential data to determine the number of particle per ml of the product?
• What are the environmental conditions and calibration parameters for particle counter APSS 200 liquid sampler?

Contact us if you need more information or have questions.

Learn more about our microcontamination monitoring services.

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.