The APSS 2000 liquid particle counting system sizes and counts particles in liquids, including parenterals. This solution meets all US, European and Japanese pharmacopoeia standards, including USP 788.
The APSS 2000 helps you meet regulations, such as USP 788, while using only a small sample size, which helps you minimise waste of expensive product.
While it is currently programmed for USP 788, the APSS-2000 Parenteral Particle Counter has recipe functions that allow it to adapt to future regulatory changes, helping you save money in the long-term while meeting requirements.
More than just a particle counter, the APSS-2000 System includes:
- An SLS-1000 syringe sampler
- LiQuilaz®eSeries light obscuration spectrometer
- SamplerSight Pharma Software, allowing reports to meet 21 Code of Federal Regulations (CFR) 11 regulations for electronic records and signatures.
SamplerSight Pharma Software enables you to manage sampling requirements for batch-based operations while providing 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.
Key features include:
- Sizing capability from 1.5μm to 125μm
- Sample volumes from 0.2ml to 1l
- Adapters for small volume injectibles (SVI) and bag testing for intravenous (IV) solutions
- Automated particle counter sensor calibration
- Particle measurements reported per ml or per container values
- Available with various custom report formats
- SamplerSight Pharma complies with US Food and Drug Administration (FDA) 21 CFR 11
- Automated full calibration or routine verification functions
Key benefits include:
- 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
Key applications include:
- Pharmaceutical parenteral monitoring to US, European Pharmacopoeia (EP), Japan Pharmacopoeia (JP) and FDA standards
- Parts/medical device cleanliness testing
- Laboratory water sampling for purified water testing and water for injection (WFI)
- Filter efficiency testing