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 Software
The key to the system's ease of use is RESULTTM 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 Compliance
The 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 ValProTM 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 Solution
The 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
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