NanoRam: Sistemas

The NanoRam-1064 is a high-performance handheld Raman Spectrometer for nondestructive identification and verification of incoming raw materials, such as APIs, excipients, and intermediates, regardless of their color. 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 in the laboratory, minimizing quarantine areas and expediting materials through the manufacturing lifecycle. Utilizing Raman technology, the NanoRam-1064 minimizes fluorescence and can identify a large range of samples by distinguishing between different grades of cellulose, polysorbate and Opadry®. Rapid incoming material testing with the NanoRam-1064 can be performed through transparent containers, all the while maintaining sample volume and integrity. The unit also offers full onboard library and method validation, making a compliant workflow for methods and library development.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 <858>, European Pharmacopeia 2.2.48, Japanese Pharmacopeia 2.26, as well as the People’s Republic of China Pharmacopeia Directives on Raman Spectroscopy. Raman is a recognized method for complying with the PIC/S & GMP directives regarding 100% identity assurance for starting materials. A complete range of training courses and support services is available, including IQ/OQ/PQ/DQ implementation services, as well as method and/or new library development support.