Liquid Particle Counter for USP 788: APSS-2000

Liquid Particle Counter for USP 788: APSS-2000

Liquid particle counter for USP 788 Sensitivity range: 1.5 – 125 μm

The 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 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.
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The APSS-2000 Liquid Particle Counter, within Particle Measuring Systems PMS comprehensive liquid particle counter line, includes: an SLS-1000 Syringe Sampler, a LiQuilaz® eSeries Light Obscuration Spectrometer and SamplerSight Pharma Software, allowing reports to meet 21 CFR 11 regulations for electronic records and signatures. SamplerSight Pharma Software allows operators to manage sampling requirements for batch-based operations and provides a comprehensive view of the batch information with histogram, time plot and tabular data presented in an easy-to-use format that is easily reported. SamplerSight Pharma features a validatable, user-friendly, Windows-based software with context-sensitive help. Find the best particle counter from Particle Measuring Systems PMS for your application.

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Features

  • 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

Supporting Materials

Available Accessories

Pharmaceutical Calibration Kit

Verify your particle counter works in advance of taking a sample with the Pharmaceutical Calibration Kit for extinction sensors. Contains one size/count standard at 15µm and seven NIST-traceable particle size standards: 2, 5, 10, 15, 20, 25 and 30µm. Available in packs of six.

Sample Extender Tubing

Pack of 10 extension tubes with male and female Luer fittings on opposite ends for sampling from IV bags or containers larger than 6″ tall. Specs: 18-gauge, 2.7″ long.

Spare Syringe (1ml-25ml)

Spare syringe for revision D and higher LS-200 and revision C and higher LS-50 samplers.

IV Bag Holder

Requiring no additional bench space, this two-horn IV bag holder clamps directly to the sample stage post to hold 1L IV bags next to the sampler for quick, easy particle testing. Includes a 10-pack of 20″ sample tube extensions and a six-pack of coring needles to pierce the IV bag’s septum for accurate particle data.

Magnetic Stirrer with Cable

Magnetic stirrer with cable for mixing samples during syringe sampling.