New Trutools Quantization Tool for TruScan RM!

17 June 2019 ─  /  Analytical Sciences  by Lea Blanchard

Present on more than 3,000 GMP plants around the world, TruScan RM has become a key solution in the identification of raw materials and the fight against counterfeit medicines. Associated with the software package TruTools it allows to carry out both qualitative and quantitative analyzes for the analysis of complex materials in the production stages (control of mixtures, quality control in biotech production and protein compounds, control semi-finished and finished products …).

 

The TruScan RM is a portable Raman spectrometer weighing less than 0.9 kg that is resistant to moisture, dust and temperature fluctuations. It has several advantageous features:

 

  • Reliability and speed: able to identify an element in just a few seconds
  • Compliance: GMP compliant, 21 CRF Part 11 and Data Integrity
  • Robustness: the device is designed for the pharmaceutical field environment (resistance to chemicals, to falls)
  • Calibration ease: the laser is temperature stabilized and with no need of calibration 

 

The TruScan RM analyzer is composed of a state-of-the-art optical system combined with a patented multivariable residue analysis. It thus offers an effective chemometric solution for material identification with spectral pretreatment options. The device is also the only portable spectrometer with a selectivity tool. In addition, the analysis is done without contact through plastic bags, glass containers, blisters and clear gel caps.

 

Today, the Truscan RM has a quantization tool : the Trutools. TruTools operates the Solo chemometrics software package, developed by Eigenvector Research Inc., and enables users to develop quantitative and qualitative models. This combination enables Truscan RM to position itself in new markets: the identification of complex materials (for example multi-active ingredients), analytical process technology (PAT) and biotech production with cell cultures. Multi-use, it is now part of the entire pharmaceutical production chain.

 

The new applications of TruScan RM / TruTools in the field of QA / QC include improved identification of raw materials for similar compounds (eg polysorbate 20 and 40), identification of several components, different isomers (for example povidone and crospovidone), opadry pigments, solvents as well as identification and quantification of finished products. Applications for Analytical Process Technology (APT) include end-point production determination for distillations, reaction monitoring, and powder mixing operations. Trutools technology is also becoming a real opportunity for cell culture. Indeed, the device performs identification tests for dry powders (chemically defined media), identifies segregated media or hydrates and takes less than 2 minutes of scanning to correctly classify the support.

 

TruTools, combined with TruScan, enables faster analysis and a better return on investment (the analysis time is divided by 10). A seminar presenting the new TruScan applications will take place on October 14 in Paris. Do not hesitate to contact us for more information!

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