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 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 NanoRam 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, 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.
Easy Operation for Non-Technical Users
Touch screen interface with simple 1-touch workflow
Easy single-handed operation
Batch mode for quick testing of multiple containers
Interface available in multiple languages
Robust sample identification and verification methods
On-board method and library validation
On-board instrument performance validation and calibration
Camera for quick method selection and product information entry
State-of-the-Art Identification Software
The NanoRam is operated using B&W Tek’s intuitive NOS-1064 embedded software. The touch screen interface allows for identification and verification, library and method development, method validation, and data storage/transfer. The NanoRamID EX (NID EX) software is designed for use on PCs for data and methods management in a secure database, allowing customers to review data, generate reports, export data, and integrate to their LIMS system. NID EX provides a complete audit trail for instrument operations and electronic report signing. The NanoRam ID EX and NanoRam OS EX software packages are 21CFR part 11 compliant with IQ/OQ/PQ/DQ documentation and services available.
The NanoRam provides robust algorithms for identification and verification of samples. The p-value from a multivariate classification method on the NanoRam is the best way to verify materials. These robust methods are based on multiple sample spectra, thus providing representative sampling of multiple samples/lots of material and the ability to include the natural material variation. It also includes mixture analysis capabilities to identify multiple components in a sample.
The NanoRam includes a library of 110 USP standard pharmaceutical materials.
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