The NanoRam-1064 is a state-of-the-art handheld Raman instrument for nondestructive identification and verification of incoming raw materials such as APIs, excipients, and intermediates. Compact and agile, the NanoRam-1064 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. Utilizing Raman technology, analysis can be performed through transparent containers, all while maintaining the volume and integrity of the sample. The high-performance NanoRam-1064 minimizes fluorescence, so can effectively identify many more materials, even those with color. The NanoRam-1064 can differentiate different types of cellulose, polysorbate and Opadry®. The unit also offers full onboard library and method validation, saving users time when activating new methods and library entries on the device.
The NanoRam-1064 is fully compliant with all governing regulations, including 21 CFR Part 11 and Part 1040.10, and plays 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 Pharmacopoeia 2.26, as well as the People’s Republic of China Pharmacopeia Guidelines on Raman Spectroscopy. Raman is a well-recognized technology for compliance with the PIC/S & GMP guidelines regarding 100% identity assurance for starting materials. B&W Tek offers a wide variety of services, including method and/or new library development support as well as IQ/OQ/PQ implementation services.