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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Download the APSS 200 Particle Counter spec sheet... (274.8 KB)
- 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
- Pharmaceutical injectables monitoring to USP 788, BP, and FDA standards
- Parts/medical device cleanliness testing
- Laboratory water sampling
- Filter efficiency testing
Learn more about our complete pharmaceutical particle counting products and services.
- Basic Guide to Particle Counters and Particle Monitoring
- Particle Counters for Injectable Solutions, 2007 USP 788 Update
- Quick Steps to Meet USP 797 Compliance
- 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?
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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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