Portable Pharmaceutical QA/QC and Manufacturing Solutions
Identify and quantify raw materials, intermediates and finished products on site in seconds
Achieve maximum quality coverage while minimizing time-consuming laboratory sampling tests. With Thermo Scientific handheld Raman and NIR spectrometers, pharmaceutical and biotechnology manufacturers can obtain fast, accurate material verification in less than 30 seconds anywhere in the plant, or in the field to combat the spread of falsified medicines.
Designed for compliance with current good manufacturing practices (cGMP) and 21 CFR Part 11, the TruScan and microPHAZIR analyzers can help you achieve high quality pharmaceutical analysis and verification.
Raw material testing and identity verification are critical steps in the quality control process with tremendous impact on customer safety as well as speed and cost of production. The TruScan and microPHAZIR handheld analyzers can be used directly on the warehouse floor and at any inspection point throughout the manufacturing process to increase inspection intervals, improve inventory management and reduce global supply chain risk.
Go beyond simple material ID and discriminate varying components in a mixture and quantify components in a material with the TruTools chemometrics functionality embedded in the TruScan RM analyzer. TruTools enables users to build custom qualitative and quantitative methods for complex material analysis problems – anywhere in the plant.
Make more informed decisions at the point of need, increasing productivity and efficiency. Use the TruScan RM with TruTools for at-line process monitoring. Applications include endpoint determination of distillations, reaction monitoring and component quantification of powder blended mixtures.
Falsified and substandard medicines are increasingly entering the supply chain, representing a deadly and growing worldwide health risk for patients and a costly violation of intellectual property rights for pharmaceutical manufacturers. These drugs at best will not deliver the therapy they promise and at worst can endanger patients’ lives.
Our handheld Raman and NIR analyzers for pharmaceutical analysis can authenticate medication directly through sealed packaging, wherever pharmaceuticals are distributed. These easy-to-use tools enable a higher level of screening, reducing the backlogs associated with lab testing.
By law, pharmaceutical manufacturers must identify and verify all incoming materials. Current Good Manufacturing Processes (cGMP) require that not only incoming raw materials but all in-process materials be tested for identity, strength, quality, and purity throughout the manufacturing process.
Make sure your QA/QC program is compliant. Download the free eBook, What You Need to Know About Field-Based Material Identification and Authentication for Pharmaceuticals.
From raw material verification to chemical dispensing and secondary operations through to finished product inspection, Thermo Scientific handheld analyzers provide manufacturers with a portable solution to achieve quality standards at the point of need.
Featured white papers
The TruScan handheld Raman analyzers meet the rigorous sampling demands of PIC/S Annex 8 and other pharmaceutical validation requirements with unique uncertainty modeling—without lengthy calibrations or expert interpretation. Read Probabilistic Approach for Material Verification and Identification in Pharmaceutical Application to see study results evaluating the performance of the TruScan RM.
Although several analytical methodologies are available for pharmaceutical material identification, the Thermo Scientific probabilistic approach is specifically designed for high accuracy in field-based testing. Read Analytical Methods for Field-Based Identification and Verification to see a comparison between the probabilistic approach and the hit quality index (HQI).
Thermo Scientific portable Raman and NIR spectrometers can detect even the most cleverly concealed falsified medicines. Read Handheld Analyzers for the Rapid and Accurate Screening of Counterfeit Pharmaceuticals to learn why national regulatory agencies rely on this advanced approach to pharmaceutical anti-counterfeiting.