The APSS-2000 Liquid Particle Counter for USP 788 measures and counts suspended particle matter in a variety of liquids, particularly parenteral, to satisfy all current US, European and Japanese Pharmacopoeia requirements. It is critical to follow requirements while limiting waste when it relates to particle monitoring quality control for liquid medication producers.
The APSS-2000 Particle Counter features recipe functions to help it adjust to future policy measures, as well as USP 788 for particles in liquids, and its tiny sample capacity reduces the waste of valuable products.
The APSS-2000 Liquid Particle Counter, part of Particle Measuring Systems (PMS) comprehensive liquid particle counter series, contains an SLS-1000 Syringe Sampler, SamplerSight Pharma Software, and a LiQuilaz® eSeries Light Obscuration Spectrometer, which allows reports to fulfill 21 CFR 11 standards for electronic records and signatures.
SamplerSight Pharma Software enables operators to handle sample needs for batch-based procedures and gives a perfect overview of batch information, including a histogram, tabular data and time plot, all displayed in an easy-to-use manner that can be simply reported. SamplerSight Pharma has a Windows-based program that is validatable and user-friendly, with context-sensitive support.
The APSS-2000 Liquid Particle Counter for USP 788 is an entirely enclosed liquid particle counting instrument for syringe sampling.
From the several liquid sampling setups to the extensive Sampler Sight software, which allows the user to gather, examine and export data from a single platform, it gives the user flexibility. The software is 21CFR11 compatible and validatable. The below video tutorial reveals more.
APSS-2000 Syringe Sampler - Liquid Particle Counter Demo
Video Credit: Particle Measuring Systems
Features
- Sample sizes range from 0.2 mL to 1 L
- Various custom report formats are available
- Bag testing for intravenous (IV) solutions and adapters for small volume injectibles (SVI)
- Full calibration or regular verification functions that are automated
- Particle counts in liquids are given per mL or container values
- Capacity for particle size ranging from 1.5–125 µm
- Sensor calibration for a liquid particle counter that is automated
- FDA 21 CFR Part 11 is followed by SamplerSight Pharma
Benefits
- To get reliable findings, precise sampling within 0.1 ml is used
- To provide quality control, alarm levels for pass/fail criteria is available
- Complete Instrument Qualification (IQ), operations qualification (OQ), and performance qualification (PQ) procedures are all included in the software development documents
- With a 100% sample volume, accuracy is improved
- Recipes for repeat sample processing reduced operator error and improved process accuracy
Applications
- Cleaning of parts and medical devices
- USP 788, EP, JP and FDA guidelines for pharmaceutical parenteral particle monitoring
- Testing the effectiveness of filters
- Water samples were taken at the laboratory for purified water testing and water for injection (WFI)
Available Accessories
Pharmaceutical Calibration Kit
With the Pharmaceutical Calibration Kit for Extinction Sensors, users can make sure that the particle counter is working before taking a sample. One size/count standard at 15 µm is included, as well as seven NIST-traceable particle size standards at 2, 5, 10, 15, 20, 25, and 30 µm. Packs of six are available.
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Sample Extender Tubing
Pack of ten extension tubes featuring male and female Luer fittings on opposite ends for sampling from IV bags or containers taller than 6′′ tall. 18-gauge, 2.7′′ length.
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Spare Syringe (1 ml-25 ml)
Spare syringe for LS-200 revisions D and above, as well as LS-50 revisions C and above.
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IV Bag Holder
This two-horn IV bag holder clips directly to the sample stage post to store 1 L IV bags adjacent to the sampler for rapid, uncomplicated particle detection, with no additional bench space required. A ten-pack of 20′′ sample tube extensions is included, as well as a six-pack of coring needles to penetrate the IV bag’s septum for precise particle data.
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Magnetic Stirrer with Cable
In syringe sampling, a magnetic stirrer with a cable is used to stir samples.
Image Credit: Particle Measuring Systems