In the context of current good manufacturing practice (cGMP), a number of pharmaceutical manufacturers are incorporating Process Analytical Technologies (PAT), Quality by Design (QbD), or Process Validation (PV) into their methods to facilitate continuous process verification and analysis.
Analytical instruments can speed up the analytical process and enable more flexibility as they can now facilitate in-situ sample monitoring. The technology is compact enough, meaning that it can be used directly online and in-process.
To discover more about end-to-end process monitoring in the biopharmaceutical industry, from raw materials to finished products, download the full article here.
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About Thermo Fisher Scientific – Portable and Handheld Raman Spectroscopy
Thermo Fisher Scientific offers innovative solutions that help our customers solve complex analytical challenges, accelerate life sciences manufacturing, deliver medicines to market, and increase laboratory productivity. Our Thermo Scientific portable and handheld process Raman analyzers enable accurate, real-time results for process monitoring.
The Thermo Scientific™ MarqMetrix™ All-In-One Process Raman Analyzer is an all-in-one system purpose-built for rapid deployment, ease of use, and scalability in markets where time-to-results is critical. The MarqMetrix All-In-One Process Raman Analyzer is designed for:
- Analysis without sample preparation, delivering Raman spectral results in real-time
- Easy setup and deployment by non–Raman spectroscopists
- Non-destructive workflows to protect precious samples
- Non-invasive handling to minimize contamination of samples
- Small footprint for convenient deployment
- Factory calibration for hardware stability and portability
Our Thermo Scientific TruScan™ Handheld Raman Analyzers includes state-of-the-art optics paired with a patented multivariate residual analysis that offers an effective chemometric solution for material identification, with two spectral pre-processing options. The non-destructive point-and-shoot sampling principle facilitates rapid verification of a broad range of chemical compounds, including cellulose-based products.
The TruScan™ G3 Handheld Raman Analyzer continues the evolution of raw material ID testing for pharmaceutical and biotechnology manufacturing quality control processes with:
- Incoming raw material identification (RMID)
- Dispensing of materials during API manufacture
- Finished product inspection
- Identification of falsified (counterfeit) medicines
- Enables non-technical operators to rapidly perform raw material ID testing without the need of a lab
The TruScan™ RM Handheld Raman Analyzer takes pharmaceutical manufacturing QA/QC to the next level with:
- Enhanced 21 CFR Part 11 and cGMP compliance with biometric login, complex password options, and full audit trail features
- Non-contact analysis through plastic bags, glass containers, blister packs and clear gel caps
- Intuitive workflow adapted to production environment through PDF batch reports and ease of data input using barcode scanners
- Easy fleet management feature that enables cloning of instruments and identification methods
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