Integrated In-Situ SEM and Raman Analysis
Product Overview
The RA802 Pharmaceutical Analyser is a specialized high-speed Raman imaging system designed to meet the complex demands of pharmaceutical development and quality control. Combining advanced LiveTrack and StreamLine technologies, it delivers rapid, high-resolution chemical imaging with no need for sample preparation.
The RA802 provides unique insights into component distribution, polymorphism, and batch uniformity, helping scientists and manufacturers optimize formulations, ensure product consistency, and troubleshoot manufacturing issues—all with non-destructive analysis.
Key Features
- High-Speed Raman Imaging: Generate complete chemical maps of samples in as little as five minutes.
- StreamLine and LiveTrack Technologies: Enables higher laser power for fast acquisition without damaging samples and maintains continuous focus on uneven surfaces.
- High Specificity: Detects and differentiates between APIs, excipients, salts, hydrates, polymorphs, and contaminants.
- Quantitative Particle Analysis: Provides morphology, uniformity, agglomeration, and particle size distribution data.
- Non-Destructive Testing: Analyze entire samples without destroying them, ideal for both development and QA/QC environments.
- Easy-to-Use Interface: User-friendly Renishaw WiRE™ software with automated method development and 21 CFR Part 11 compliance.
- Small Footprint: Compact system size suitable for laboratory and production environments.
- Built-in Standards: Internal reference standards ensure system performance and data traceability.
Specifications
| Specification | Details |
|---|---|
| Laser Wavelength | 785 nm |
| Laser Power at Sample | >150 mW (optimized with StreamLine to prevent damage) |
| Spectral Range | 100 cm⁻¹ to 3250 cm⁻¹ |
| Spectral Dispersion | 2 cm⁻¹ per pixel |
| Minimum Pixel Size | 1 µm |
| Field of View | Macro: ~21 mm × 16 mm; Micro: ~330 µm × 250 µm |
| Focusing Methods | Macro: Manual or Pre-Defined; Micro: LiveTrack™ Auto-Focus |
| Data Collection Speed | Over 1500 spectra per second |
| Maximum Sample Size | ~110 mm × 90 mm × 25 mm (fits 96-well plates) |
| Power Requirements | 100–240 VAC ± 10%, 50/60Hz, 100W maximum |
| Dimensions (W × H × D) | 720 mm × 502 mm × 535 mm |
| System Mass | 54 kg (excluding computer) |
| Software | Renishaw WiRE with CFR21 Part 11 compliance, particle statistics analysis |
| Qualification | Full IQ/OQ/PQ options available |
| Laser Class | Class 1 laser product (complies with IEC60825-1) |
Applications
Pharmaceutical Industry
- Formulation Development: Analyze API distribution, excipient compatibility, and batch uniformity.
- Quality Assurance (QA/QC): Ensure batch-to-batch consistency, detect contaminants, and validate formulation homogeneity.
- Counterfeit Drug Detection: Identify differences in genuine vs. counterfeit products quickly and non-destructively.
- Polymorph Analysis: Distinguish between different polymorphic and amorphous forms within tablets.
Academia & Research Institutions
- Advanced Material Studies: Investigate crystalline structures, hydrates, and salt forms in pharmaceutical and biological samples.
- Teaching and Method Development: Provide hands-on training in chemical imaging and spectroscopy techniques.
Materials Science
- Composite Analysis: Understand the distribution of different phases in complex material systems.
- Surface Chemistry Research: Map surface composition without sample preparation.
Life Sciences
- Biomaterials and Drug Delivery Systems: Investigate the dispersion of active ingredients in microcapsules and delivery matrices.
- Medical Device Coatings: Analyze the distribution of coatings and drug-eluting layers on implants.
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