The next generation handheld Raman spectrometer: the Thermo Scientific TruScan RM

Thermo Fisher Scientific has a diverse portfolio of products, from analytical instruments and laboratory equipment to software, services, consumables and reagents. The company’s scientific and research products primarily serve pharmaceutical and biotechnology companies, as well as academia, research institutes, government agencies, OEMs, quality control and R&D laboratories. Created in 2006 by the merger of Thermo Electron and Fisher Scientific, Thermo Fisher Scientific has over 100 years of experience and insight in their products and services.

“The Thermo Scientific TruScan RM builds on the proven capability of the award-winning TruScan analyser, which is now installed in hundreds of pharmaceutical manufacturing sites worldwide,” explains Erica Hirsch, Product Manager at Thermo Fisher Scientific. “The TruScan RM analyser is our lightest, fastest and most portable analyser. The device weighs less than two pounds, which is 0.9 kilograms. It can deliver rapid results up to five times faster than traditional Raman platforms for quick release of raw materials to manufacturing. The TruScan RM is highly specific and uses Raman spectroscopy to perform rapid material verification at the point-of-need, delivering actionable Pass/Fail results within seconds.”

“We are dedicated to ensuring that we constantly listen to and incorporate customer feedback into TruScan RM product updates,” Hirsch says. “The TruScan RM delivers a stateof- the-art optical platform paired with a revolu tionary embedded analysis package. The analyser offers enhanced compliance features, as well as software and data manage – ment functions, designed to facilitate workflow and optimise efficiency in tightly regulated environments. As pharmaceutical manufacturers face mounting pressure to reduce costs, improve quality control and increase productivity, they need to perform even more tests to accomm – odate increased production volume and regulatory requirements as they move towards 100 per cent inspection of incoming raw materials. The portability of the TruScan RM makes it easier for customers to achieve these initiatives without any compromise to product quality. To facilitate the deployment and administration of a fleet of TruScan RM analysers in different locations, identification methods and system configuration files can be easily shared between instruments.”

It is important for medical and pharma – ceutical products to be compliant with 21 CFR Part 11 of the Code of Federal Regulations, as well as meet Good Manufacturing Practice procedures. Does TruScan RM meet these criteria? “Yes, the TruScan RM features enhanced 21 CFR Part 11 compliance features, such as a biometric log-in and optional password aging and complexity, allowing users to customise the analyser’s security settings to exceed regulatory requirements,” Hirsch confirms. “Period quali – fication of the analyser can be performed with annual performance checks executed remotely for faster and efficient requalification.”

According to Hirsch, the TruScan RM is trusted for use by 36 of the top 40 global pharmaceutical manufacturers. “It is used for the verification of incoming raw materials and inspection of finished products, as well as more than 15 regulatory enforcement agencies around the world for the screening of suspect counterfeit medicines in the field,” Hirsch says. “The TruScan RM can perform analysis directly through glass and plastic packaging to increase inspection rates and reduce the risk of con tamination and exposure. The instrument can obtain reliable identification of bulk Active Pharmaceutical Ingredients and/or excipients within seconds, virtually anywhere in the manufacturing plant.”

Developed with in-depth pharmaceutical industry experience, the TruScan RM contains built-in smart features, such as assisted signature acquisition and device qualification warnings to enable successful material identification and prevent user error. “Our unparalleled customer support encompasses everything from expert consultation for implementation strategies, project timelines and regulatory filings to prepared templates for IQ/OQ/PQ, SOPs, statements of compliance and supplier quality assessment documentation,” Hirsch explains. “We offer training that ranges from analyser administration to general operator usage, as well as focused analytical method development and validation consultation.”