PMS - Model APSS-2000 -Liquid Particle Counter for USP 788

The APSS-2000 is engineered to safeguard product integrity and patient safety by delivering uncompromising accuracy and compliance in liquid particle monitoring.

Data Integrity & Compliance

• 21 CFR Part 11 Ready: Electronic records and signatures supported through SamplerSight Pharma software.
• Validation Built-In: IQ, OQ, and PQ protocols included for full system qualification.
• Secure Architecture: Active Directory integration and automated backup scheduling protect your data.

Operational Efficiency

• Recipe Functions: Standardize workflows to minimize operator error and ensure consistent compliance.
• Automated Calibration: Full calibration or routine verification at the touch of a button.
• Custom Reporting: Flexible formats for streamlined audits and quality reviews.

Precision Sampling:

• 100% Sample Volume Accuracy: Every drop counts—ensuring complete measurement for reliable results.
• Syringe-based control achieves repeatable volumes within 0.4 mL, reducing variability and risk.

Complete Reporting

• 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.

The APSS-2000 syringe sampling system sizes and counts suspended particulate matter in a wide range of liquids and meets or exceeds all current USP, EP, and JP requirements. Recipe functions allow the APSS-2000 to adapt to future regulatory changes.

The APSS-2000 system consists of an SLS-2000 syringe sampler, a LiQuilaz® II E Series light obscuration spectrometer, and SamplerSight Pharma software, allowing reports to meet 21 CFR Part 11 regulations.

Defect Reduction

• 100% sample volume for greater accuracy
• A precise sample volume within 0.4 ml is achieved with the syringe sampler, producing repeatable results
• SamplerSight Pharma software comes with a Validation Information Notebook, providing comprehensive software development
• documentation and full IQ, OQ, and PQ protocols
• SamplerSight Pharma complies with FDA 21 CFR 11

User-Friendly

• Reduce operator error and ensure process accuracy with recipes for repeat sample processing to USP, EP, or JP standards
• Automated particle counter calibration wizard for full calibration or routine verification
• Alarm levels for pass/fail criteria ensure quality control
• Automated backup scheduling ensures enhanced data integrity

Comprehensive System

• Easy-to-use pull-down menus
• Active Directory security password maintains system integrity
• Particle measurements are reported per ml or per container values
• Small sample volume minimizes waste of expensive product
• Various custom report formats are available
• Electronic report approval

• Particle size capability from 1.5 to 125 µm
• Fifteen user-selectable sizing channels
• Meets and exceeds all USP, EP and JP requirements
• Sample volumes from 0.4 ml to 1 liter
• Adapters for SVI and IV bag testing
• Automated sensor calibration
• Plug and play ultrasonic bath and magnetic stirrer options available

• 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