It is critical to comply with regulations, while decreasing waste, when dealing with quality control for liquid drug manufacturers. The APSS-2000 Liquid Particle Counter sizes and counts suspended particulate matter in an extensive range of liquids to comply with all existing U.S., European, and Japanese Pharmacopoeia standards.
Together with USP 788 for particulate matter in injections, the APSS-2000 Pharmaceutical Liquid Particle Counter has recipe operations that allow it to adapt to future regulatory modifications, and its small sample volume reduces the waste of costly product.
The APSS-2000 System includes: a LiQuilaz® eSeries Light Obscuration Spectrometer, an SLS-1000 Syringe Sampler, and SamplerSight Pharma Software, allowing reports to comply with 21 CFR 11 regulations for electronic records and signatures.
SamplerSight Pharma Software allows users to handle sampling requirements for batch-based operations and provides a comprehensive view of the batch data with time plot, histogram, and tabular data, offered in an easy-to-use format that is effortlessly reported. SamplerSight Pharma features user-friendly, validatable, Windows-based software, with context-sensitive help.
The main features of the APSS-2000 Liquid Particle Counter are listed below:
- Sizing capability from 1.5 to 125 µm
- Automated sensor calibration
- Sample volumes from 0.2 ml to 1L
- Particle measurements reported per ml or per container values
- SamplerSight Pharma complies with FDA 21 CFR 11
- Adapters for small volume injectibles (SVI) and bag testing for intravenous (IV) solutions
- Automated full calibration or routine verification functions
- Available with a variety of custom report formats
The main benefits of the APSS-2000 Liquid Particle Counter are given below:
- Better accuracy with 100% sample volume
- Precise sampling within 0.1 ml to generate repeatable results
- Minimal operator error and increased process accuracy, with recipes for repeat sample processing
- Complete software development documentation and full instrument qualification (IQ), operations qualification (OQ) and performance qualification (PQ) protocols
- Alarm levels for pass/fail criteria to guarantee quality control
The APSS-2000 Liquid Particle Counter is used in the following applications:
- Filter efficiency testing
- Parts/medical device cleanliness testing
- Pharmaceutical parenteral monitoring to U.S., JP, EP, and FDA standards
- Laboratory water sampling for purified water testing and water for injection (WFI)