TruScan
TruScan™ is a rugged, handheld, lightweight Raman system for rapid raw material verification. Non-destructive point-and-shoot operation enables verification through sealed packaging to minimize risk of exposure and contamination. TruScan’s embedded analysis software delivers a PASS/FAIL decision verifying the identity of a sample typically within 30 seconds.
Standard Operating Procedure (SOP) templates are now available.
Contact us for details.
TruScan offers an unparalleled solution for rapid, accurate raw material inspection. Key benefits include:
- Handheld, rugged unit weighing less than 4 pounds (<1.8 kg) that can be used directly on the loading dock or wherever rapid material verification is required
- Rechargeable battery which can operate continuously for up to five hours
- On-the-spot identification test results delivered in seconds on raw materials including solids, powders, and liquids
- Greatly reduces costs per analysis and overhead overall
- Independent trials indicate that majority of pharmaceutical products can readily be tested with an extremely high degree of accuracy
- Easily operated by non-technical staff; managed workflow minimizes potential errors
- Non-contact analysis greatly eliminates potential staff exposure to hazardous chemicals and highly potent active pharmaceutical ingredients (APIs) during inspection
- Readily interpretable results enable user independence and require no secondary interpretation
- Non-contact analysis through plastic bags, glass containers, blister packs, and clear gel caps
- Fast method development requires only a single pure reference sample and can typically be accomplished in less than an hour
- Fleet management through proprietary software and data management system
- Remote administration capabilities over the web enables management of multiple units from a single location
- TruScan is fully 21 CFR part 11 compliant
- Currently used by nine of the top ten global pharmaceutical companies, as well as numerous regulatory agencies worldwide
- Classified as an intrinsically safe device Class I, Division 1, Group A-D, T3C
- CE and MET certified instrument
- 24/7/365 live customer support
- Extended service, support and warranty programs available
| Raman Spectral Range | 250 cm- 1 to 2875 cm- 1 |
|---|---|
| Spectral Resolution | 7 to 10.5 cm- 1 (FWHM) across range |
| Laser (excitation wavelength) | 785 nm +/- 0.5 nm, 2 cm- 1 linewidth |
| Laser Output Power | Auto-adjusted, 300 mW or lower |
| Collection Optics | NA = 0.33; 18 mm working distance; 0.2 mm to 2.5 mm spot size |
| Exposure | Automatic (100 ms minimum) |
| Battery | Rechargeable 7.4 V Internal Lithium Ion Battery; >5 hours at 25 °C |
| External Power Supply | Wall plug transformer 100-240 V AC 50/60 Hz |
| Weight | < 4 lbs. (<1.8 kg) |
| Size | 12" x 6" x 3" (30 cm x 15 cm x 7.6 cm) |
| Operating Temperature | -20 °C to +40 °C |
Ahura Scientific and ProPharma Group can assist with TruScan deployments into good manufacturing practice (GMP) environments while complying with regulatory requirements. Through our preferred partnership with ProPharma Group, the deployment of your TruScan can be accelerated significantly.
ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical device and related industries. Client speed to market, aggressive deadlines, and a challenging and changing regulatory environment are factors with which experienced ProPharma Group personnel can assist your organization to further increase your organization’s competitive advantage.
ProPharma Group can help in all aspects of the TruScan validation cycle including:
- Method development
- Development and execution of validation protocols for raw material identifications (change control, Comparability Protocols, and so forth)
- Development of Standard Operating Procedures (SOPs)
- Assistance with regulatory filings
ProPharma Group validation engineers are carefully selected and appropriately trained on all functions of TruScan. They regularly attend refreshers on GMP, U.S. Pharmacopeia, and Food and Drug Administration regulatory requirements.
Read more about TruScan Deployment Support through our preferred partnership with ProPharma.
For more information about Qualification and Validation services, contact Ahura Scientific at truscan@ahurascientific.com or contact ProPharma Group directly at +1.888.242.0559 (toll free) or through their online form.