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View additional product information for TruScan™ RM Handheld Raman Analyzer - FAQs (TSRMTRUTOOLS, TRUTOOLS, TRUSCANRM)
29 product FAQs found
Although Raman spectroscopy is typically considered a non-destructive technique, conditions such as exposure time, laser power, and the nature of the sample may lead to sample degradation. The energy transmitted by the laser depends on the duration of exposure and the wavelength. It may change the physical state and may destroy the sample.
The TruScan RM Handheld Raman Analyzer uses Raman spectroscopy where an unknown sample of material is illuminated with monochromatic (single wavelength or single frequency) laser light. The danger of using high-powered lasers must be recognized, especially when their wavelengths are in the Near Infrared area of the spectrum and, therefore, not visible to the eye. Fiber optic probes should be used with caution and with reference to appropriate government regulations regarding lasers and laser classes.
The laser used in the TruScan RM Handheld Raman Analyzer is class IIIb under the FDA CDRH classification system. Never point the instrument at yourself or others. Never start the instrument unless there is a sample fully covering the laser aperture. Always terminate a measurement prior to removing the sample from the laser aperture. Country-specific regulations with which the analyzer's laser complies is available in the user manual.
The TruScan RM Handheld Raman Analyzer is compliant with EP Chapter <2.2.48> and USP Chapter <1120>. To learn more, read the following documents:
Thermo Scientific TruScan RM United States Pharmacopeia (USP) Chapter <1120> - Raman Spectroscopy Statement of Compliance (https://assets.thermofisher.com/TFS-Assets/CAD/Product-Bulletins/TSRM-USP-Compliance-Oct-2016-FINAL.pdf)
Thermo Scientific TruScan RM European Pharmacopeia (EP) Chapter <2.2.48> - Raman Spectroscopy Statement of Compliance (https://assets.thermofisher.com/TFS-Assets/CAD/Product-Bulletins/TSRM-EP-Compliance-Oct-2016-FINAL.pdf)
Magnesium stearate is a white powder that becomes solid at room temperature. In the pharmaceutical manufacturing process, magnesium stearate is the most commonly used lubricant for capsules and tablets, and is used to help prevent pharmaceutical ingredients from adhering to manufacturing equipment. Calcium stearate, and to a lesser extent, zinc stearate, are also used as pharmaceutical excipients in manufacturing, primarily for tablet and capsule lubrication.
Magnesium stearate, calcium stearate, and zinc stearate share a similar chemical compound structure and are more challenging to verify during the incoming raw material inspection process. While some pharmaceutical handheld Raman analyzers have built-in multivariate residual analysis decision engines to identify most materials, more complex materials analysis requires users to build custom, advanced methods. Those Raman analyzers that utilize embedded chemometrics such as the TruScan RM Handheld Raman Analyzer can enable users to create customized predictive applications including classification using semi-quantitative and quantitative methods, which allows developing models that can be deployed on the analyzer. Read more in the technical note: Stearates verification using a handheld Raman analyzer (https://assets.thermofisher.com/TFS-Assets/CAD/Technical-Notes/stearates-verification-handheld-raman.pdf).
Pharmaceutical companies that manufacture tablets, capsules and other solid dosage forms use a film coating on their products to differentiate visual appearance, to improve the ability to swallow and to mask objectionable tastes or odors. Film coatings also reduce tablet breakage and chipping as well as provide protection from light, moisture, and environmental gases. While the latest handheld Raman analyzers have a built-in multivariate residual analysis decision engine to identify most materials, more complex materials analysis requires users to build custom, advanced methods. Some handheld analyzers such as the TruScan RM Handheld Raman Analyzer utilize embedded chemometrics to enable users to create customized predictive applications including classification using semi-quantitative and quantitative methods, that result in Pass/Fail criteria to identify highly similar compounds such as tablet coatings. Read more in the technical note: Opadry verification using a handheld Raman analyzer (https://assets.thermofisher.com/TFS-Assets/CAD/Technical-Notes/opadry-verification-handheld-raman.pdf).
Some pharmaceutical handheld Raman analyzers are expressly designed for setup and use by non-experts. For example, the TruScan RM Handheld Raman Analyzer not only acquires the Raman spectrum of the material of interest but also, in real-time, determines the uncertainty of that measurement, given factors such as the sample characteristics, instrument telemetry, environment and testing environment. End users of field-material identification systems are not usually spectroscopy experts and, therefore, can rely on the instrument's built-in algorithm to convert instrument data to a qualitative result.
High-throughput screening (HTS) in the pharmaceutical industry involves testing collections of hundreds or thousands of samples and subsequent analysis, in order to quickly assay the biological or biochemical activity of a large number of drug-like compounds. HTS techniques are used to characterize polymers and medicines by being incorporated into manufacturing processes to provide real-time measurements. Due to the large number of samples, HTS requires a high degree of automatization and small sample preparation. Raman spectroscopy fills this need and is used extensively for automated HTS and assay measurements. Read this article published by the European Pharmaceutical Review for more information: Raman In-Depth Focus (https://assets.thermofisher.com/TFS-Assets/CAD/Application-Notes/Raman-IDF.pdf).
In pharmaceutical manufacturing, Raman spectroscopy is suitable for incoming raw material identity verification, dispensing of materials during API manufacture, and counterfeit identification.
Pharmaceutical manufacturers use Raman spectroscopy for raw material analysis in the manufacturing of pharmaceutical products. A non-expert operator can use a handheld Raman analyzer to accurately verify materials quickly.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S), Annex 8: PIC/S Annex 8 requires that individual samples be taken from all incoming containers and an identity test be performed on each sample. This is a major change from the traditional practice of allowing composite sampling of a statistical subset of the batch and identity testing of the single composited sample before releasing the batch to manufacturing. Individual container identity testing puts drastically higher demands on expert analysts' time. The efficient use of portable Raman analyzers streamlines material verification and makes 100% material inspection cost-effective while maintaining high quality standards.
Raman analyzer QA/QCapplications include enhanced raw material ID for similar compounds, multiple component ID, and identification and quantification of intermediate and finished products. In PAT, applications include at-line endpoint determination for distillations, reaction monitoring, and powder blending operations.
Falsified or substandard medicines are a growing problem worldwide. To protect patients and brand integrity, pharmaceutical manufacturers use portable Raman analyzers to identify counterfeits. Portable Raman analyzers allow users without chemistry training to conduct field-based screening of pharmaceutical samples and quickly and accurately identify falsified or substandard medicines. Because the spectrum generated by the TruScan RM Handheld Raman Analyzer examines all the components of a pharmaceutical dosage form including API, excipients, fillers, dyes, coatings, etc. to generate a spectrum representative of all components (and their relative concentrations) any slight deviation from the original formulation will lead to a detectable change in the resulting spectrum. This makes the TruScan RM analyzer the ideal tool for rapid detection of counterfeit pharmaceuticals in the field.
In Raman spectroscopy, an unknown sample of material is illuminated with monochromatic (single wavelength or single frequency) laser light, which can be absorbed, transmitted, reflected, or scattered by the sample. Light scattered from the sample is due to either elastic collisions of the light with the sample's molecules (Rayleigh scatter) or inelastic collisions (Raman scatter). Whereas Rayleigh scattered light has the same frequency (wavelength) of the incident laser light, Raman scattered light returns from the sample at different frequencies corresponding to the vibrational frequencies of the bonds of the molecules in the sample.
If you wish to learn more about Raman spectroscopy, visit our online Raman Spectroscopy Academy (https://www.thermofisher.com/us/en/home/industrial/spectroscopy-elemental-isotope-analysis/spectroscopy-elemental-isotope-analysis-learning-center/molecular-spectroscopy-information/raman-technology.html), where you will find basic Raman tutorials, advanced Raman webinars on sample applications, and a helpful instrument guide.
The TruScan Handheld Raman Analyzer has been shown to help the European cosmetics industry meet the challenge of GMP compliance. In one case study, the raw materials used in cosmetics manufacturing included essential oils of natural origin. The TruScan Analyzer used in the study obtained 100% specificity on the raw materials tested. Further, TruScan instrumentation also allowed the user to check the formulations at various stages in the manufacturing process. You can read details of the study here: European Cosmetics Industry Faces New Test in GMP Compliance (https://assets.thermofisher.com/TFS-Assets/CAD/Application-Notes/EU_Cosmetics_White_Paper_v13.pdf).
The TruScan RM Handheld Raman analyzer's non-destructive point-and-shoot sampling principle facilitates rapid verification of a broad range of chemical compounds, including cellulose-based products.
Thermo Scientific TruTools is an embedded chemometrics software package that runs on the TruScan RM Handheld Raman Analyzer. It lets users build custom qualitative and quantitative methods for complex material analysis problems.
TruTools leverages Solo, a chemometrics software package from Eigenvector Research, Inc. that allows users to develop models that can be deployed onto the TruScan RM analyzer. Once deployed, TruTools methods are selected through standard menus on the TruScan RM analyzer. No longer relying on a laboratory benchtop spectrometer, users can conduct advanced chemometric analyses anywhere in the plant.
Read about a TruTools method using a Principal Component Analysis (PCA) model to successfully identify similar chemical compounds such as magnesium stearate, calcium stearate, and zinc stearate in this technical note:
Stearates verification using a handheld Raman analyzer (https://assets.thermofisher.com/TFS-Assets/CAD/Technical-Notes/stearates-verification-handheld-raman.pdf).
Yes, the TruScan RM Handheld Raman Analyzer can scan through plastic bags, glass containers, blister packs, and clear gel caps. The TruScan RM analyzer's point-and-shoot sampling is non-contact and non-destructive which minimizes the risk of cross-contamination and operator exposure.
cGMP (https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps) requires instituting strong quality management systems, obtaining appropriate quality raw materials, establishing proper operating procedures, detecting and investigating any product quality issues, and maintaining reliable testing laboratories.
PIC/S, Annex 8 (https://www.picscheme.org/) requires that individual samples be taken from all incoming containers (100% material inspection) rather than the traditional practice of composite sampling of a statistical subset of the batch, and an identity test be performed on each sample.
The TruScan RM Handheld Raman Analyzer meets cGMP requirements and the rigorous sampling demands of PIC/S Annex 8. The TruScan RM analyzer allows non-expert users to identify and quantify raw materials, intermediates, and finished products on site in seconds. Replacing time-consuming, expensive laboratory sampling with the handheld Raman analyzers' rapid verification of chemical compounds makes it possible to perform efficient and regulatory compliant 100% material inspection.
Yes, the TruScan RM Handheld Raman Analyzer is compliant with EP Chapter <2.2.48> and USP Chapter <1120>. To learn more, read the following documents:
Thermo Scientific TruScan RM United States Pharmacopeia (USP) Chapter <1120> - Raman Spectroscopy Statement of Compliance (https://assets.thermofisher.com/TFS-Assets/CAD/Product-Bulletins/TSRM-USP-Compliance-Oct-2016-FINAL.pdf)
Thermo Scientific TruScan RM European Pharmacopeia (EP) Chapter <2.2.48> - Raman Spectroscopy Statement of Compliance (https://assets.thermofisher.com/TFS-Assets/CAD/Product-Bulletins/TSRM-EP-Compliance-Oct-2016-FINAL.pdf)
Yes, the TruScan RM Handheld Raman Analyzer laser is 21 CFR part 1040 compliant and is certified to CE standards.
Yes, the TruScan RM Handheld Raman Analyzer has enhanced 21 CFR part 11 compliance security features, such as user access restricted by user names and passwords or biometric log-in, password aging and complexity, and full audit trail features. For more information on 21 CFR part 11 compliance read this product bulletin (https://assets.thermofisher.com/TFS-Assets/CAD/Product-Bulletins/USP-Compliance-21CFR-ThermoScientific-SpecSheet-TruScanRM.pdf).
No. The TruScan RM Handheld Raman Analyzer is calibrated at the factory directly in accordance with ASTM E1840-96 (2002) and does not require user calibration. Cyclohexane, acetonitrile, toluene, and acetaminophen bands are used to determine the x-axis calibration of the system, and this calibration is verified with acetaminophen (4-acetomidophenol) and polystyrene. All four of these materials are recommended in ASTM E1840-96 (2002). The laser output is also calibrated during the factory calibration procedures.
A polystyrene check sample is provided with TruScan RM for use in system performance verification (self test).
The TruScan RM Handheld Raman Analyzer is sturdy. It is built to Military Specification (MIL-SPEC) 810G meaning that it will survive a 1 meter drop. The screen is shatterproof.
The TruScan RM Handheld Raman Analyzer is rugged, fully sealed, and has an IP65 (Ingress Protection) rating meaning that it is dust tight and able to withstand water projected in powerful jets against the enclosure from any direction without harmful effects. To remove nonhazardous contaminants from the instrument and the nose cone, we recommend wipe them with a soft cloth moistened with water, isopropyl alcohol, or a 5% solution of bleach (sodium hypochlorite).
Yes, the TruScan RM Handheld Raman Analyzer comes with a nose cone, vial holder, tablet holder, vials and polystyrene rod, and also a battery, battery charger, cables, power cable adapters, card read, memory card, and Ethernet dongle.
Yes, the TruScan RM Handheld Raman Analyzer has an available factory library with over 4,300 samples of organic/industrial solvents, toxic chemicals, pharmaceuticals, household chemicals, and more. Using the factory library provides additional information for materials that fail a method run.
The TruScan RM Handheld Raman Analyzer can be powered by a rechargeable lithium ion battery that provides about 3.5 hours power with normal use.
The TruScan RM Handheld Raman Analyzer weighs less than 2 pounds (0.9 kg) and is ergonomically designed to increase comfort and productivity during inspections. It measures 8.2 in x 4.2 in x 1.7 in (20.8 cm x 10.7 cm x 4.3 cm).
The TruScan RM Handheld Raman Analyzer has a spectrum range of 250 to 2875 Raman Shift (cm-1) and the spectral resolution is 8 to 10.5 cm-1 (FWHM) across the spectral range.
The TruScan RM Handheld Raman Analyzer has a class IIIB laser output of 250 mW ±25 mW and a laser excitation wavelength of 785 nm.
In Raman spectroscopy, an unknown sample of material is illuminated with monochromatic (single wavelength or single frequency) laser light, which can be absorbed, transmitted, reflected, or scattered by the sample. Light scattered from the sample is due to either elastic collisions of the light with the sample molecules (Rayleigh scatter) or inelastic collisions (Raman scatter). Whereas Rayleigh scattered light has the same frequency (wavelength) of the incident laser light, Raman scattered light returns from the sample at different frequencies corresponding to the vibrational frequencies of the bonds of the molecules in the sample.
If you wish to learn more about Raman spectroscopy, visit our online Raman Spectroscopy Academy (https://www.thermofisher.com/us/en/home/industrial/spectroscopy-elemental-isotope-analysis/spectroscopy-elemental-isotope-analysis-learning-center/molecular-spectroscopy-information/raman-technology.html), where you will find basic Raman tutorials, advanced Raman webinars on sample applications, and a helpful instrument guide.
The TruScan RM Handheld Raman Analyzer is built with a state-of-the-art optical platform paired with a field-proven embedded chemometrics engine. The patented, multivariate residual analysis offers the most effective chemometric solution for material identification, with two spectral pre-processing options (1st and 2nd derivative), that is easy to operate in challenging environments and sampling conditions.
In addition to Raman technology, the TruScan RM Handheld Raman Analyzer has TruTools, an optional embedded chemometrics software package (https://assets.thermofisher.com/TFS-Assets/CAD/Specification-Sheets/TSRM-TruTools-SpecSheet-2016-FINAL.pdf), with which users can build advanced, customized qualitative and quantitative methods for complex material analysis problems. TruTools models allow discrimination of multiple components, discrimination of raw materials with minimal spectral differences (such as ethanol and methylated spirits), and discrimination of low API dosage tablets from placebos. With TruTools deployed on a TruScan RM Handheld Raman Analyzer, non-expert operators can run advanced chemometric analyses anywhere in the plant.
The TruScan RM Handheld Raman Analyzer can save manufacturing resources. Each year, plant personnel spend hours moving materials into the sampling room, sampling them, documenting samples for tracking purposes and sending them to the lab, then moving materials into a quarantine area to await laboratory results. With the TruScan RM Handheld Raman Analyzer, incoming materials may be verified in the warehouse, by-passing all the traditional central laboratory testing steps, saving time and manufacturing resources such as personnel, plant space, and inventory costs.
QC laboratory testing is also resource intensive. Highly qualified lab personnel spend numerous hours preparing and analyzing samples, reviewing data, and documenting procedures and results. Identity testing uses up valuable instrument time that could be used for other analyses. Consumables like sample vials and reagents along with chemical disposal fees add to laboratory costs. Pharmaceutical manufacturers can avoid all these costs by using non-destructive, no-contact Raman handheld analyzers like the TruScan RM Handheld Raman Analyzer.
Traditional sampling and laboratory testing introduces production risks that have the potential to impact product quality, yield, and production schedule. Opening a container to extract a sample increases its chance of material contamination and rejection of the final product. Sampling and lab analysis adds variability to material release times. Samples may be accidentally contaminated, destroyed, lost, or mislabeled in a traditional central laboratory testing workflow. The variabilities of turnaround time for material inspection may impair the ability to forecast production equipment and personnel scheduling, a direct stress on plant productivity. Non-contact, non-destructive analysis using the TruScan RM Handheld Raman Analyzer reduces contamination risks and production uncertainties.
Falsified or substandard medicines are a growing problem worldwide. To protect patients and brand integrity, pharmaceutical manufacturers use the TruScan RM Handheld Raman Analyzer to identify counterfeits. The TruScan RM analyzer allows users without chemistry training to conduct field-based screening of pharmaceutical samples and quickly and accurately identify falsified or substandard medicines. Because the spectrum generated by the TruScan RM analyzer examines all the components of a pharmaceutical dosage form including API, excipients, fillers, dyes, coatings, etc. to generate a spectrum representative of all components (and their relative concentrations), any slight deviation from the original formulation will lead to a detectable change in the resulting spectrum, providing detection of counterfeit pharmaceuticals in the field.
Pharmaceutical manufacturers use the TruScan RM Handheld Raman Analyzer for raw material analysis in the manufacturing of pharmaceutical products. A non-expert operator can use the TruScan RM Handheld Raman Analyzer to accurately verify materials quickly. The efficient use of the TruScan RM analyzer streamlines material verification and makes 100% material inspection cost-effective while maintaining high quality standards.
TruScan RM QA/QC applications include enhanced raw material ID for similar compounds, multiple component ID, and identification and quantification of intermediate and finished products. In PAT, applications include at-line endpoint determination for distillations, reaction monitoring, and powder blending operations.
In addition, the TruScan RM analyzer is used by pharmaceutical manufacturers to identify counterfeits in order to protect patients and brand integrity.