The NanoRam is a state-of-the-art handheld Raman instrument for nondestructive identification and verification of incoming raw materials such as active pharmaceutical ingredients (API), excipients and intermediates.
Compact and agile, the NanoRam can be used by non-technical users to rapidly identify samples in the lab, warehouse, loading dock or field to help eliminate quarantine areas and expedite materials through the manufacturing lifecycle. Utilising Raman technology, indirect-contact analysis can be performed through transparent containers, all while maintaining the volume and integrity of the sample.
The NanoRam meets the requirements of Raman spectroscopy methods including the US Pharmacopeia General Chapter 1120, European Pharmacopeia 2.2.48 and the People’s Republic of China Pharmacopeia Guidelines on Raman Spectroscopy.
Raman is a well-recognised method for compliance with the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) and good manufacturing practice (GMP) guidelines regarding 100% identity assurance for starting materials.
The NanoRam is fully compliant with all governing regulations, including 21 CFR Part 11 and Part 1040.10, and can play an integral role in current good manufacturing practice (cGMP) compliant facilities.
B&W Tek offers a wide variety of services, including method and / or new library development support as well as installation qualification (IQ) / operational qualification (OQ) / performance qualification (PQ) / design qualification (DQ) implementation services.