Passing the test for 100 percent material ID
Thermo Fisher Scientific explains how its TruScan analyser helps to meet the challenge of 100 percent ID
The trend toward 100% material ID continues to gather momentum, with both the European Pharmacopeia and Pharmaceutical Inspection Co-operation Scheme (PIC/S) mandating 100 % inspection of raw materials. This demand forces manufacturers to re-evaluate their quality control procedures, and challenges them to exponentially increase inspection without dramatically increasing staff – and cost.
Many pharmaceutical manufacturers are turning to Raman spectroscopy to enable 100% inspection, leveraging handheld instruments like Thermo Scientific TruScan analysers to bring the analysis directly to the warehouse. But not all handheld Raman analysers are created equal, and it’s critical that users consider several factors as they evaluate potential solutions. Is the instrument fit for purpose? How difficult is validation and deployment? Who is the trusted partner with proven industry leadership?
Trusted Solutions
The TruScan family of products is designed to meet the stringent requirements of the pharmaceutical manufacturing environment. It is robust, chemically resistant and sealed for cleaning with solvents or bleach without complicated protocols for each surface. The TruScan software platform is built onboard the instrument and does not require a separate computer package to manage and build libraries. This should help with rapid deployment since there is no separate computer qualification requirement. It automatically creates secure PDF reports of run data, batch reports and audit trails during synchronisation, aiding in compliance and ease of use.
Fast validation
Deploying Raman as a replacement for the compendia ID that complies with USP/EP/PIC’s guidelines requires validation of a spectral library method while ensuring specificity. With the aid of ‘one-button validation,’ TruScan analysers achieve these requirements by directly testing a sample scan against methods for the material of interest as well as the entire user or factory library on the device (factory library includes 4,300+ common pharmaceutical materials). This eliminates the need to test each material one by one versus every material in the user library, greatly reducing the time required for validation.
Smart decision making
The TruScan analyser belongs to the next generation of analytical instrumentation called ‘reactive analysers.’ It uses a patented probability approach (p-value) based on fundamental understanding of measurement uncertainty. Thus, the p-value approach provides superior specificity and sensitivity than correlation methods like HQI, Euclidean distance and empirical modeling approach such as SIMCA, PLS, etc. As the analysers acquires the Raman spectrum for a test material, they determine in real-time the uncertainty of that measurement with consideration of sample characteristics, instrument telemetry, and testing environment over a wide range of potential sampling conditions.
This makes the product portable and also adaptive to the testing environment as it exists during the actual sample measurement. This is absolutely critical for a handheld device outside the well-controlled environment of a laboratory where benchtop instruments have the benefit of highly reproducible sampling interfaces.
Embedding this probabilistic approach within the analyser required the development of robust hardware and software platforms and their full characterization to understand performance within specified operation ranges. Our technological developments were scrutinised by pharmaceutical manufacturers, and we’ve proven that our solutions provide equal or greater specificity than required by current material ID testing protocols.
Customer driven solutions
To meet the challenge of 100 percent raw material ID, pharmaceutical manufacturers are increasingly turning to handheld Raman instruments to increase inspection intervals, improve inventory management and reduce global supply-chain risk.