A:  Pharmaceutical manufacturers use TruScan RM for raw material analysis in the manufacturing of pharmaceutical products. A non-expert operator can use a handheld TruScan RM to accurately verify materials quickly. The efficient use of TruScan RM 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.

A: Falsified or substandard medicines are a growing problem worldwide. To protect patients and brand integrity, pharmaceutical manufacturers use TruScan RM to identify counterfeits. The TruScan RM 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 examines all the components of a pharmaceutical dosage form: 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.

A. TruScan RM 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 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 occupies 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. Using non-destructive, no-contact Raman handheld analyzers like TruScan RM, pharmaceutical manufacturers avoid all these costs.

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 TruScan RM analysis reduces contamination risks and production uncertainties.

A:  TruScan RM is a handheld Raman analyzer. 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, where you will find basic Raman tutorials, advanced Raman webinars on sample applications, and a helpful instrument guide.

The TruScan RM 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 has TruTools, an optional embedded chemometrics software package, 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, non-expert operators can run advanced chemometric analyses anywhere in the plant.

A:  The laser is a class 3B laser output of 250 mW +/-25 mW. The laser (excitation wavelength) is 785 nm.

A. The Spectrum Range is 250 to 2875 Raman Shift (cm-1). The Spectral Resolution is 8 to 10.5 cm-1 (FWHM) across the spectral range.

A:  The TruScan RM weighs less than 2 pounds (0.9kg)  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 analyzer can be powered by a rechargeable lithium ion battery that provides about 3.5 hours power with normal use. 

A. Yes, the TruScan RM 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.

Yes, the TruScan RM 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.

A. The TruScan RM is rugged, fully sealed, and has an IP65 (Ingress Protection) rating – meaning that it’s 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, wipe them with a soft cloth moistened with water, isopropyl alcohol, or a 5% solution of bleach (sodium hydrochloride). 

A. TruScan RM is sturdy – built to Military Specification (MIL-SPEC) 810G meaning it will survive a 1 meter drop. The screen is shatterproof.

A: No. TruScan RM 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). 

A: Yes, the TruScan RM 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
  Thermo Scientific TruScan RM Support for 21 CFR Part 11 Compliance.

A: Yes, the TruScan RM analyzer laser is 21 CFR part 1040 compliant and is certified to CE standards.

A: cGMP 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 PIC/S, Annex 8 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 meets cGMP requirements and the rigorous sampling demands of PIC/S Annex 8. TruScan RM 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 handheld Raman analyzers’ rapid verification of chemical compounds makes possible efficient and regulatory compliant 100% material inspection.

A:  Yes, the TruScan RM can scan through plastic bags, glass containers, blister packs and clear gel caps. TruScan RM’s point-and-shoot sampling is non-contact and non-destructive which minimizes the risk of cross-contamination and operator exposure.

A: Thermo Scientific TruTools is an embedded chemometrics software package that runs on the TruScan RM 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. 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.

A:  The TruScan RM Handheld Raman analyzer non-destructive point-and-shoot sampling principle facilitates rapid verification of a broad range of chemical compounds, including cellulose-based products.

A:  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 include essential oils of natural origin. The TruScan Analyzer used in the study obtained 100 percent specificity on the raw materials tested. Further, TruScan instrumentation also allows a 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.

 

Spectroscopic material verification is a critically important analytical application within the pharmaceutical industry. Analytical devices employed in the pharmaceutical environment require performance characterization. In applications for material verification and identification, strict rules must be defined for robust, repeatable operation of these devices by non-expert users. Traditional analytical methods of measuring qualitative performance are unsuitable for characterizing identification of unknowns. Read about the probabilistic approach of verifying a material’s chemical identity.

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