Mark Cabell, Global Market Manager, Pharma Chem at Thermo Fisher Scientific talks to AZoM about the improved efficiency the TruScan family of products offers.
What changes in the spectroscopy discipline have you noticed recently?
The role of portable spectroscopy in pharmaceutical manufacturing has increased substantially over the past five years. Expanding requirements for 100% inspection, lean initiatives (restricting waste) and a growing focus on quality monitoring throughout the manufacturing process necessitate a fresh approach.
The proven benefit of Raman spectrometry to identify solid and liquid materials through glass and plastic packaging offers significant time savings with respect to physical sampling from containers.
We pioneered the probabilistic approach to material authentication and selectivity testing for the development of highly specific and robust Raman-based spectroscopic methods. The embedded algorithms within the TruScan family of products effectively removed the operator’s burden of subjective pass or fail decisions from pharmaceutical ID testing.
Can you describe this probabilistic approach to pass or fail decisions in more detail?
TruScan analysers not only acquire the Raman spectrum but also take into account the instrument-specific parameters and testing environment to improve the reliability of the material ID. TruScan poses and answers: “is the measurement of the test material statistically consistent with the measurement of the reference material?”
TruScan is not only portable but also adaptive to the testing environment as it exists during the actual sample measurement.
TruScan analysers adjust data-collection parameters automatically to ensure the appropriate signal-to-noise ratio has been achieved for each measurement so that the claim of pass or fail can be substantiated.
What were the challenges in implementing this?
Embedding this probabilistic approach within the TruScan analyser required the development of robust hardware and software platforms and their full characterisation to understand performance within specified operation ranges. Proving that our solution provided equal or greater specificity than required by current testing protocols for material ID was vital to most customers.
Are there other benefits to this design?
The simplicity of TruScan method development and validation has been touted as a major benefit by pharmaceutical quality professionals.
There is no user-dependent chemometric modelling or necessity for threshold determination involved with our efficient approach to method development. A single reference spectrum of a fully tested retain sample typically suffices for bulk materials.
Our standard operating procedures systematically document every step required to develop and extensively validate the method library to achieve superior specificity and robustness.
How do more common approaches compare?
One approach used regularly is hit quality index (HQI), which calculates a list of correlation coefficients between a sample and a library of reference spectra. While HQI is well-suited for laboratory use by spectroscopy experts, probabilistic analysis is specifically designed for field-based decision making with very high accuracy.
Are there any recent case studies which demonstrate the quality assurance benefits the TruScan RM range offers the pharmaceutical market?
We see new customers adopting this technology, specifically our instruments, every month. The benefits for risk management and compliance are clear to the pharmaceutical market.
How do you see this sector progressing over the coming years given the increased role portable spectroscopy is playing?
The requirements of pharmaceutical industry customers are changing quickly and portable spectroscopy is well positioned to provide an effective solution. The TruScan RM offers benchtop-quality, portable spectrometry that empowers users with high quality data for superior RMID and is equally effective in other areas including finished goods release, foreign body identification and product quality attributes.
How is Thermo Fisher Scientific going to be a part of this?
Innovation of our core optical platforms continues as will the applications served. Once focused solely upon cGMP incoming raw material inspection we are now monitoring the quality of the final product itself.
Our current efforts in anti-counterfeiting open the possibility of removing fake medicines from the global supply chain through statistically impactful screening. Increased tracking of the counterfeit epidemic through more effective and frequent surveys leads to greater access to safe medicines. Our analyzers are easily deployed tools for field-based efforts in an efficient, multi-layered approach to authentication of medicines for public health and patient safety.
Where can our readers learn more?
For more information on Raman Technology and the benefits of each wavelength go here.... http://www.thermoscientific.com/en/about-us/general-landing-page/raman-technology.html
Other great resources for Raw Material ID are the EP and USP Raman Chapters
More information on Brand security and patient safety… http://www.thermoscientific.com/en/about-us/general-landing-page/pharmaceutical-manufacturing.html
About Mark Cabell
Mark joined Thermo Scientific, Portable Analytical Instruments in 2009 and led the commercial deployment of TruScan Handheld Raman instruments into the pharmaceutical sector. He currently manages business development and applications on a global scale.
Mark has 15+ years of commercial experience for industry leading molecular spectroscopy tools from Ahura Scientific, Mettler Toledo and Malvern instruments. In addition, Mark is a graduate of Purdue University School of Chemistry and worked in the research of new enzyme catalysis as a research scientist in the Biotech industry.
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