The NanoRam 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, indirect-contact analysis can be performed through transparent containers, all while maintaining the volume and integrity of the sample. The NanoRam plays an integral role in cGMP-compliant facilities. It meets the requirements of Raman spectroscopy methods including the US Pharmacopeia General Chapter 1120, European Pharmacopeia Raman Solution 2.2.48, as well as the People’s Republic of China Pharmacopeia Guidelines on Raman Spectroscopy. Raman is a well-recognized method for compliance with the PIC/S & 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. B&W Tek offers a wide variety of services, including method and/or new library development support as well as IQ/OQ/PQ/DQ implementation services. Data Quality & Reproducibility Versatility in Sampling • Robust hardware provides high quality data Easy Transition Between Sample Types with low noise providing consistent and reliable The NanoRam includes a variety of sampling accessories optimized results with fast measurement times. Even for the measurement of various materials in the form of liquids, gels, samples that have weak Raman signal can be powders, or solids under both a laboratory setting and under demanding identified with the NanoRam because of this environmental conditions. The NanoRam is designed to facilitate fast and high dynamic range system. convenient transitions between sample adaptors. • Broad spectral range as low as 176 cm-1 for more spectral data to improve identification The NanoRam has a unique immersion probe that comes standard with capabilities the instrument allowing for easy measurements of materials in bottles and drums beyond the surface. A disposable protective sleeve is available • Method and library transfer between devices for to prevent cross-contamination. We also have a shoulder bag to reduce company wide deployment stress on users when working long shifts, increasing portability. • User-definable methods and libraries to meet particular analysis needs Vial Holder Point and Shoot Bottle Adaptor • TE cooling allows for greater stability of the instrument in environments where temperatures are highly variable. Shoulder Bag Right Angle Adaptor Tablet Holder Immersion Probe Specifications Intuitive Software State-of-the-Art Identification Software Excitation Wavelength 785 nm Laser Output Power Up to 300 mW, software adjustable The NanoRam is operated using B&W Tek’s Spectral Range 176 cm-1 to 2900 cm-1 intuitive NanoRam OS (NOS) embedded software. The touch screen interface Spectral Resolution ~ 9 cm-1 @ 912 nm allows for identification and verification, Detector Type TE-cooled Linear CCD Array library and method development, and data storage/transfer. The NanoRam ID Display High Brightness & High Resolution OLED Touch Screen (NID) software is designed for use on PCs Barcode Reader Linear and 2D Standards for data and methods management in a Software NOS (Embedded), NID (PC) secure database, allowing customers to review data, generate reports, export data, Data Formats .txt, .csv, .spc, .pdf and integrate to their LIMS system. The Data Transfer Ethernet, Wi-Fi NanoRam ID and NanoRam OS software packages are 21CFR part 11 compliant with IQ/OQ/PQ/DQ Battery Rechargeable Li-ion, >5 hrs Continuous Operation documentation and services available. AC Adapter Output: DC 12V, 2A Minimum Weight ~2.5 lbs (~1.2 kg) Additionally, the NanoRam provides secure Wi-Fi and Ethernet synchronization capabilities with network terminals in order to Size 8.8 in x 3.9 in x 2.0 in (22 cm x 10 cm x 5 cm) optimize time and resources. NanoRam Operating Temperature -20°C to +45°C OS is capable of data and report transfers Storage Temperature -30°C to +60°C in order to centralize information (such as libraries, methods and final reports) in Rating IP64 general servers. Standard Accessories Point & Shoot, Vial Holder, Polystyrene Validation Cap, Immersion Probe, Large Bottle Adapter 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 Easy Operation for Non-Technical Users sample spectra, thus providing representative sampling of • Touch screen interface with simple 1 touch workflow multiple samples/lots of material and reflect the natural material variation. It also includes mixture analysis capabilities to identify • Easy single-handed operation multiple components in a sample. • Batch mode for quick testing of multiple containers The NanoRam includes a library of 110 USP standard • Interface available in multiple languages pharmaceutical materials. • Barcode scanner for quick method selection • Compatible with Labware LIMS Investigation Identification 19 Shea Way, Newark, DE 19713, USA • Tel: +1 (302) 368-7824 • Web: www.bwtek.com Copyright 2019 B&W Tek, LLC · Doc-Rev: 280001222-L (2019/04/09)