Crystallization plays an important role in product quality as it influences particle size, purity, and product yield. Stringent crystallization process control is thus crucial across the pharmaceutical industries to ensure the desired specifications of active pharmaceutical ingredients (APIs) are achieved.
Crystallization quality also affects other process elements, such as drying, flowability, and scalability. For example, a wide particle size distribution due to the crystallization process can bring about inefficient drying and slow filtration, leading to bottlenecks during the manufacturing process.
This article describes how the Thermo Scientific™ MarqMetrix™ All-in-One Process Raman Analyzer, in combination with chemometric analysis, is a powerful in-line process analytical technology (PAT) tool for observing the crystallization process for an essential API.
After ensuring the analytical conditions were optimized and identifying peaks analogous to the API and solvent background, a Principal Component Analysis (PCA) model was designed to monitor the crystallization kinetics and establish a precise completion time for the process.
This in-line PAT tool provides users with real-time data to give confidence in the quality of the API crystallization process. By facilitating continuous monitoring and analysis, it enabled enhanced process control, optimization, and the manufacture of high-quality crystalline materials, improving product quality across various industries, including pharmaceuticals.
For insights into how these technologies enhance process efficiency and support regulatory initiatives, including those from the FDA, download the full article here.
Download the full application note
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
Sponsored Content Policy: News-Medical.net publishes articles and related content that may be derived from sources where we have existing commercial relationships, provided such content adds value to the core editorial ethos of News-Medical.Net which is to educate and inform site visitors interested in medical research, science, medical devices and treatments.