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Introduction APSS 2000 liquid particle counter for USP 788
Sensitivity range: 1.5 – 125 μm
The PMS APSS 2000 Liquid Particle Counter for USP 788 sizes and counts suspended particulate matter in a wide range of liquids, including parenterals, to meet all current U.S., European and Japanese Pharmacopoeia standards. When it comes to particle monitoring quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste.
Along with USP 788 for particles in liquids, the PMS APSS 2000 Particle Counter has recipe functions that allow it to adapt to future regulatory changes, and its small sample volume minimizes the waste of expensive product.
Features APSS 2000 liquid particle counter for USP 788
- Particle sizing capability from 1.5 to 125 μm
- Sample volumes from 0.2 ml to 1 L
- Adapters for small volume injectibles (SVI) and bag testing for intravenous (IV) solutions
- Automated liquid particle counter sensor calibration
- Liquid particle counts reported per ml or per container values
- Available with various custom report formats
- SamplerSight Pharma complies with FDA 21 CFR Part 11
- Automated full calibration or routine verification functions
Benefits
- Greater accuracy with 100% sample volume
- Precise sampling within 0.1 ml to produce repeatable results
- Comprehensive software development documentation and full instrument qualification (IQ), operations qualification (OQ) and performance qualification (PQ) protocols
- Reduced operator error and increased process accuracy with recipes for repeat sample processing
- Alarm levels for pass/fail criteria to ensure quality control
Applications
- Pharmaceutical parenteral particle monitoring to U.S. USP 788, EP, JP and FDA standards
- Parts/medical device cleanliness testing
- Laboratory water sampling for purified water testing and water for injection (WFI)
- Filter efficiency testing
Specifications
| Liquid Sensor | LiQuilaz® II E-20P | LiQuilaz® II E-15P |
| Size Range | 2 – 125 µm 1.5 – 125 µm | 1.5 – 125 µm |
| Location | Internal to SLS-2000 | |
| Size Channels | 15 | |
| Flow Rates | 20 ml/min | |
| Volume Sampled | 100% | |
| Maximum Concentration | 10,000 per ml¹ | |
| Sample Temperature | 50 – 122 °F (10 – 50 °C) | |
| Zero-count Level | < 1 count per 10 ml | |
| Capillary Size | 0.5 x 0.7 mm | |
| Maximum Pressure | 25 psi | |
| Maximum Sample Viscosity | 35 centipoise @ 20 ml/min | |
| Laser Source | Laser diode | |
| Wetted Surface Materials | Fused Silica, Black Quartz, Teflon, Kel-F®, Kalrez® 1 | |
| Liquid Sampler | SLS-2000 |
| Syringe Size | 1, 5, 10, and 25 ml (10 ml is standard and included) |
| Sampling Mode | Vacuum |
| Minimum Sample Volume | 0.4 ml @ 20 ml/min |
| Wetted Surface Materials | Glass, Teflon |
| Dimensions (H x W x L) | 17.1 x 9 x 15 in (43.4 x 22.9 x 38.1 cm) Including particle counter |
| Weight (Particle Counter) | 30 lb (13.6 kg) Including particle counter |
| Power | 100 – 240 V, 50 – 60 Hz |
| Environment Temperature | Temperature 50 – 86 °F (10 – 30 ºC) |
| Humidity | 0 – 98% non-condensing |
| Software | SamplerSight Pharma |
| Operating System | Windows® 10 |
| Developer | Particle Measuring Systems |
| Test Procedure Software | Validation Information Notebook |
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