The LyoCheck Solution

Materials can be tested by simply placing vials over the sampling window on the Antaris FT-NIR analyzer.  Samples can also be analyzed by loading a carousel for high-throughput sampling with the Autosampler RS accessory.

Near-infrared offers many advantages:

• Analyze materials for both chemical ａnd physical properties in situ
• Scan ａnd verify non-destructively by analyzing directly through glass serum vials
• Scans take only a few seconds ａnd provide fast results
• Provides higher precision ａnd more predictable results than with titrations or other methods

RESULT Operation SoftwareThe key to the system＇s ease of use is RESULT^TM Operation software.  This software interface runs entire SOP＇s with a single click.  Operators cannot deviate from the SOP, ａnd predefined workflows control data collection, trait prediction, report generation, ａnd data archival automatically.  Compatibility with barcode information ａnd LIMS protocols allows RESULT software to integrate seamlessly with your QC data system.

Regulatory ComplianceThe LyoCheck system is based on the award-winning Antaris FT-NIR platform.  This FT-NIR analyzer family was developed for use in pharmaceutical manufacturing ａnd provides unprecendented depth in qualification ａnd validation tools.  The ValPro^TM qualification system includes traceable reference standards, United States Pharmacopoeial performance testing （USP General Chapter 1119）, qualification services, ａnd a design traceability protocol based on the FDA＇s quality system regulation.  RESULT software provides essential functionality for electronic record ａnd signature management compliant with 21 CFR Part 11.

Complete SolutionThe LyoCheck package is a complete solution for QC testing of lyophilized products.  This powerful testing tool has been developed to improve ａnd streamline processes for years to come.  To ensure success, we will perform feasibility analysis to determine which quality parameters are appropriate for near-infrared testing ａnd ensure acceptable performance.  At the time of installation, a member of our applications scientists staff will come on site to help qualify, configure, ａnd calibrate your system specifically to your product.

The LyoCheck Solution package includes:

• Antaris FT-NIR analyzer
• RESULT Software Suite
• SOP guidance for use
• RESULT Software Workflows for lyophilized product testing
• Lyophilized product methodology
• ValPro System Qualification Package
• Installation Qualification Service
• 2 days of onsite calibration ａnd training
• Voucher for Antaris Operations training course
• 1 second year annual System Qualification service
• 2 year warranty
• 1 spare NIR source