TruScan RM and next generation TruScan G3 Handheld Raman Analyzers

Significance of the topic

The reliable transfer of analytical identification methods between instrument generations is critical in regulated pharmaceutical environments. Seamless method portability reduces downtime, avoids repetitive method development and validation, and preserves data integrity and regulatory compliance when upgrading handheld vibrational spectroscopy tools used for incoming material verification and rapid identification at point of receipt.

Objectives and overview of the study

This technical brief evaluates the method transferability from legacy Thermo Scientific TruScan RM handheld Raman analyzers to the next-generation TruScan G3 Handheld Raman Analyzer. The primary goal was to determine whether identification Methods created on TruScan RM devices can be transferred to TruScan G3 units without loss of identification performance, across a representative set of chemicals spanning strong to weak Raman scatterers.

Methodology

The study design included:

• Creation of 29 identification Methods on each of three TruScan RM units (denoted A, B, C).
• Transfer of those Methods to three TruScan G3 analyzers (three recipient devices: G3-401, G3-402, G3-403), generating nine RM-to-G3 combinations.
• Evaluation of transferred Methods by analyzing the corresponding 29 test chemicals on the G3 devices, producing in total 261 data points (29 chemicals × 9 transfer combinations).
• Selection of test chemicals to cover a spectrum of Raman scattering behavior (examples include acetaminophen, alpha-lactose monohydrate, titanium dioxide, and various excipients and solvents).
• Use of the instrument’s proprietary p-value decision algorithm for spectral matching. The statistical decision rule applied: p-value < 0.05 indicates FAIL (no match), while p-value ≥ 0.05 indicates PASS (match). First-derivative spectral processing was applied for the results shown.

Used instrumentation

The brief describes two generations of Thermo Fisher handheld Raman analyzers:

• TruScan RM (legacy devices) — existing user-installed instruments used to create reference Methods.
• TruScan G3 Handheld Raman Analyzer (next-generation) — features include a detachable probe for direct scanning through bags or bottles, a capacitive touch screen operable with gloves, wireless data transfer or USB-C network adapter, and 21 CFR Part 11–relevant capabilities such as timestamping and user data integrity. The G3 continues to use Thermo Fisher’s p-value statistical decision algorithm for identification.

Main results and discussion

Key findings from the Method transfer experiments:

• All 261 method-transfer analyses yielded p-values greater than the defined 0.05 threshold, resulting in 100% PASS across the nine RM-to-G3 combinations and the 29 test chemicals.
• Successful transfer spanned chemicals exhibiting a wide range of Raman scattering intensities, demonstrating robustness of transferred Methods across sample types.
• The results indicate that spectral libraries and identification Methods created on TruScan RM units can be directly used on TruScan G3 instruments without performance degradation, when using the proprietary p-value algorithm and typical first-derivative processing.

Discussion points and technical implications:

• The data support that method portability is practical between these specific instrument generations, minimizing the need for recreation or revalidation of Methods when migrating to G3 hardware.
• Because the study used a representative set of chemistries (excipients, APIs, solvents, inorganic powders), users can be reasonably confident the finding will generalize to routine pharmaceutical incoming identity workflows; however, site-specific verification may still be advisable for unique or atypical matrices.
• The p-value thresholding approach is central to decision-making; understanding the algorithm’s behavior and pre-processing choices (e.g., first-derivative) remains important for local method control.

Benefits and practical applications

Practical advantages highlighted by the study:

• Reduced operational burden: eliminates the need to recreate Methods on new instruments, saving time and reducing resource expenditure for instrument upgrades.
• Regulatory continuity: retention of method performance supports compliance and consistent identity testing across instrument fleets.
• Enhanced workflow flexibility: the G3 hardware improvements (detachable probe, touchscreen usability with gloves, wireless/USB-C transfer) facilitate point-of-receipt screening and streamline sample handling.

Future trends and potential applications

Potential directions and broader utility arising from this capability:

• Standardized library management across instrument generations to enable centralized method governance and streamlined regulatory documentation.
• Expansion of transferability testing to more complex matrices (mixtures, low-concentration components) and to alternative preprocessing/algorithm settings to define limits of transfer robustness.
• Integration with laboratory information management systems (LIMS) and cloud-based spectral libraries for fleet-wide method distribution and audit-ready recordkeeping.
• Application beyond pharmaceutical receipt testing into manufacturing in-process checks, raw material quarantine screening, and field-based verification where handheld Raman is advantageous.

Conclusion

The TruScan G3 Handheld Raman Analyzer demonstrates reliable method transfer from legacy TruScan RM instruments. In the presented dataset (29 representative chemicals, three RM donors, three G3 recipients, 261 tests), transferred Methods maintained identification performance with 100% PASS according to the instrument’s p-value decision criterion. This capability reduces effort associated with instrument upgrades and supports continued use of established spectral Methods within regulated pharmaceutical workflows.

References

Thermo Fisher Scientific. TruScan G3 and TruScan RM Method Transfer Technical Brief. TS-TN-TRNSFRG3RM-0723, 2023.