Raman Spectrometer for Raw Materials - NanoRam®-1064

The NanoRam^®-1064 is a compact and agile handheld Raman instrument. It has been specifically designed for the nondestructive identification and verification of incoming raw materials, including active pharmaceutical ingredients (APIs), excipients and intermediates.

The NanoRam^®-1064 is a user-friendly device that can be used to quickly identify samples in a wide range of external environments such as the lab, warehouse, loading dock or field. The versatility of this device to function in different locations has eliminated the need for quarantined areas, while also reducing the overall time associated with the manufacturing lifecycle of the product.

The NanoRam^®-1064 can be used to analyze samples that are stored in transparent containers, without compromising on the accuracy of evaluating both the volume and integrity of the sample. The high-performance NanoRam^®-1064 minimizes fluorescence requirements, while also maintaining the ability to distinguish different grades of cellulose, polysorbate and Opadry^®.

The NanoRam^®-1064 is fully compliant with all governing regulations, of which includes 21 CFR Part 11 and Part 1040.10. As a result, the NanoRam^®-1064 often plays an integral role in cGMP-compliant facilities. Furthermore, this unique and compact device also meets the requirements of Raman spectroscopy methods that have been set by the United States Pharmacopeia, European Pharmacopeia 2.2.48, as well as the People’s Republic of China Pharmacopeia Guidelines on Raman Spectroscopy.

Raman spectroscopy is a well-recognized technique that is often used for compliance with the PIC/S & GMP guidelines regarding complete identity assurance for starting materials. B&W Tek offers a wide variety of services, which includes method and/or new library development support, as well as IQ/OQ/PQ/DQ implementation services.