NanoRam 1064 Handheld Raman Spectrometer
BWT-840000953
The NanoRam-1064 is a high-performance handheld Raman Spectrometer for nondestructive identification and verification of incoming raw materials, including APIs, excipients, and intermediates, even when they are colored. Compact and agile, the NanoRam-1064 can be used by non-technical users to rapidly identify samples in the warehouse, on the loading ramp, in the field or lab, minimizing quarantine areas and expediting materials through the manufacturing lifecycle. Utilizing Raman technology, the NanoRam-1064 minimizes fluorescence, and can identify a larger range of samples, differentiating different grades of cellulose, polysorbate and Opadry®. Rapid incoming material testing with the NanoRam-1064 can be performed through transparent containers, all while maintaining sample volume and integrity. The NanoRam is fully compliant with the US FDA 21 CFR Part 11 and Part 1040.10, and can play an integral role in cGMP-compliant facilities. The NanoRam-1064 meets the requirements of Raman spectroscopy methods including the US Pharmacopeia <1120>, European Pharmacopeia 2.2.48, Japanese Pharmacopeia 2.26, as well as the People’s Republic of China Pharmacopeia Guidelines on Raman Spectroscopy. Raman is a well-recognized method for compliance with the PIC/S & GMP guidelines regarding 100% identity assurance for starting materials. Full training and support services are available, including IQ/OQ/PQ/DQ implementation services as well as method and/or new library development support.