When it comes to quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste. The APSS-2000 Parenteral Particle Counter 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.
Alongwith USP 788 for particulate matter in injections / parenterals, the APSS-2000 Pharmaceutical Parenteral 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.
The APSS-2000 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.
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.