Pharmaceutical Manufacturing

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 for pharmaceutical identification, 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.

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Raw material testing
Identify and quantify materials

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 for pharmaceutical identification can be used directly on the warehouse floor and at any inspection point throughout the qc 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.

Ensure patient safety and brand integrity

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 identification and qc manufacturing 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.

counterfeit pharmaceuticals

Handheld Raman spectrometers have fundamentally changed how the pharmaceutical industry performs incoming raw material identification testing. The Thermo Scientific ™ TruScan™ RM Handheld Raman Analyzer continues to push the trend that it started with a new set of capabilities to improve quality testing initiatives for biopharmaceutical manufacturers. 

A quality specialist from a Johnson & Johnson company will also share his experience with the use of Thermo Scientific™ TruTools™ for the quantification of APIs in their syrup products.

In this webinar you’ll learn:

  1. What TruScan is and how it supports continuous improvement for biopharma manufacturers
  2. Applications using TruTools chemometric software to identify classically difficult materials and cell culture medias
  3. How to leverage TruTools to create quality testing algorithms for at-line PAT checks and perform protein product identification

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End-to-end solutions for pharma and biotech

End-to-End Solutions for Pharma and Biotech

Producing the highest quality pharmaceuticals is the common goal of all pharma and biotech manufacturers. This eBook offers guidance and best practices for the issues that concern the pharma and biotech manufacturing industry the most.

Download the free eBook, A Practical Guide to Improving Pharmaceutical and Biotech Manufacturing Processes and Production Methods.

Download eBook

Join us for this webinar to learn how the portable x-ray fluorescence (XRF) instrument, the Thermo Scientific™ IonicX™ improves salt testing, allowing quick results in the warehouse. IonicX replaces traditional time-consuming and resource-intensive wet chemistry and benchtop methods and allows sample results to be available in less than a minute.

The key objectives of this webinar are to help you:

  • Learn what materials can be identified using portable XRF
  • Understand how to measure ionic salts quickly with the IonicX
  • Be able to make the decision if portable technologies will help you.

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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.

Download eBook

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Achieve Quality Initiatives Throughout the Manufacturing Process

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 or pharmaceutical identification at the point of need.

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Support material verification with advanced analysis

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.

Perform field-based testing with high accuracy

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).

Don’t be fooled

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.

Improve pharma and biotech manufacturing processes and help ensure patient safety

Save time, improve processes, protect brand integrity, and ensure patient safety, from raw material identification through the pharmaceutical manufacturing process, to finished and packaged pharmaceutical product inspection.

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