For the first time, the European Pharmacopoeia has established specific wavenumber accuracy requirements for handheld Raman spectrometers. Of particular note, the revised chapter (2.2.48: Raman spectroscopy) to the European Pharmacopoeia Supplement 8.7 includes separate acceptable Raman shift band position tolerances for benchtop and handheld Raman analysers for polystyrene, paracetamol and cyclohexane.
These new specifications give pharmaceutical manufacturers clear guidance on the requirements for use in GMP environments. Manufacturers will now have well-defined parameters without the need to justify analytical performance individually. Overall, these changes should streamline the deployment of handheld solutions for the release of raw materials.
Thermo Fisher Scientific TruScan analysers are for use in GMP raw materials identification (RMID) testing without the need for recalibration. Unlike other handheld analysers that require either factory recalibration or frequent user calibration, TruScan has a robust and stable engine which does not require any user calibration. The superior laser and spectrometer stability of TruScan analysers eliminates the need to update the analyser’s hardware or manufacturing operations to ensure compliance, the firm says.
In anticipation of the new requirements, Thermo Fisher Scientific has adjusted all validation procedures and acceptance criteria for initial instrument calibration as well as annual calibration re-certifications. The company is monitoring regulatory expectations to best meet customer requirements going forward.
There are more than 1,000 GMP installations worldwide of the Thermo Scientific TruScan family of instruments. TruScan handheld analysers are widely deployed at leading pharmaceutical companies to ensure the efficient release of raw materials and to screen for falsified or substandard medicines. TruScan’s patented chemometric algorithm, in conjunction with superior spectrometer stability, allows for sharing across large numbers of instruments without the need to establish a spectral library for each.