When it comes to quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste. The APSS-2000 Pharmaceutical System sizes and counts suspended particulate matter in a wide range of liquids to meets all current U.S., European and Japanese Pharmacopoeia standards. Along with USP 788 for particulate matter in injections, the APSS-2000 Pharmaceutical System has recipe functions that allow it to adapt to future regulatory changes, and its small sample volume minimizes the waste of expensive product. The APSS-2000 Pharmaceutical System 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.
Greater accuracy with 100% sample volume
Precise sampling within 0.1ml 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
Sizing capability from 1.5 to 125?m
Sample volumes from 0.2ml to 1L
Adaptors for small volume injectibles (SVI) and bag testing for intravenous (IV) solutions
Automated sensor calibration
Particle measurements reported per ml or per container values
Available with various custom report formats
SamplerSight Pharma complies with FDA 21 CFR 11
Automated full calibration or routine verification functions
Pharmaceutical parenteral monitoring to U.S., 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
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All available accessories
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.
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.
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.