handheld raman spectrometer scanning raw material

Raw Material Identification

Raw material identification and verification is important for any industry, and a regulatory requirement for pharmaceutical manufacturers. Raman instruments provide a molecular fingerprint of samples measured and provide nondestructive identification and verification of materials such as active pharmaceutical ingredients (APIs), excipients, intermediates, and finished products. It is also a well-recognized method for compliance with the PIC/S GMP guide regarding 100% identity assurance for starting materials. Utilizing portable and handheld Raman instrumentation, non-contact analysis can be performed through transparent containers, all while maintaining the volume and integrity of the sample. The handheld NanoRam, purpose-built for material ID in the pharmaceutical industry, can be used by non-technical users to rapidly identify samples in the lab, warehouse, loading dock or field, helping to eliminate quarantine areas and expedite materials through the manufacturing lifecycle. Being able to take the instrument to the sample, wherever it is in the manufacturing environment, provides efficiencies in raw material, and final product acceptance without the need for material movement or sample preparation.

Products

NanoRam®

Handheld Raman Spectrometer

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i-Raman® Pro-ST

Portable Raman Analyzer for Rapid Analysis and Identification Through Opaque Barriers

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NanoLIBS®

Handheld LIBS Analyzer for the Pharmaceutical Industry

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Testimonials

The NanoRam was the most suitable Raman instrument on the global market, significantly reducing the time spent and as a result increasing the efficiency of our API control process.

— Pharmstandard

The NanoRam is so easy to use, and we are now able to get through hundreds of samples per day, allowing us to fulfill regulatory requirements of 100% identification testing of APIs

— Hetero

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Application Notes

Ever since the European Medicines Agency (EMA) recommended that all pharmaceutical companies test every raw material that passes through their manufacturing facilities, this practice has attracted great interest in the nutraceuticals, food manufacturing, cosmetics, and agricultural industries, pushing them to strive for more rigorous and technology-oriented quality control standards.
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In recent years, Raman Spectroscopy has gained a reputation in market segments that require the rapid identification of unknown compounds, such as the testing of chemicals, measurement of pharmaceutical ingredients and characterization of polymers. 
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Competition in the pharmaceutical industry is driving drug companies to spread their manufacturing operations around the globe. Unfortunately, production delocalization results in more testing of the incoming raw materials for quality assurance, product safety and regulatory purposes, which results in an increased cost of doing business. This application note discusses the economic costs and benefits of the implementation of handheld Raman in the warehouse.Read the full application note
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Historically, identification of complex compounds and binding/tableting materials have only been achievable using research-grade, laboratory systems, which offer high resolving power and better signal to noise capability. In this article we set out to demonstrate that the recent technological breakthroughs in the NanoRam are proving that high performance Raman spectroscopy can be combined with simplicity and ease of use in a compact design.
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Moving identity verification of incoming raw materials out of the laboratory and into the warehouse through the use of handheld spectrometers has become an accepted method for obtaining optimal efficiency for testing.  Since multiple sites within an organization often use the same raw materials, transferring identification methods and libraries between spectrometers at receiving sites can help to ensure consistency and reliability of the materials before they reach production, all while maintaining that efficiency.
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In this article, Dr. Bülent Üstün, a senior scientist at Merck Sharp & Dohme, reasons that the most efficient means for identity verification of incoming raw materials is to move it out of the laboratory and into the warehouse.   He discusses the various elements of spectroscopic techniques including Raman spectroscopy, the differences between spectral matching (e.g. “match/no match”) vs. identity verification (e.g. “pass/fail”) and how to utilize these tools to get the best possible results. 
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