NanoRam® 1064 – BWT-840000953

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-1064 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 unit also offers full onboard library and method validation, saving users time when activating new methods and library entries on the device.

The NanoRam-1064 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 <858>, 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.

Features:

• 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

Software

State-of-the-Art Identification Software
The NanoRam-1064 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 and validation, and data storage/transfer. The PC-based NID EX software for data and methods management in a secure database, allows 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 The NID EX and NOS-1064 software packages are 21CFR part 11 compliant with IQ/OQ/PQ documentation and services available.

Additionally, the NanoRam-1064 provides secure Wi-Fi and USB synchronization capabilities with network terminals in order to optimize time and resources. Analysis information can be centralized by using NID EX, and transferring data and reports to store libraries, methods and final reports in general servers.

The NanoRam-1064 provides robust algorithms for identification and verification of samples. The statistical p-value from a reduced variable multivariate method on the NanoRam-1064 provides the best way to verify materials with a pass/fail result. These robust methods are based on multiple sample spectra collected from representative samples/lots to include natural material variations. Mixture analysis is also available for identification of multiple components in a sample.

The NanoRam-1064 includes a library of 110 USP standard pharmaceutical materials for reference only.

Data Quality & Reproducibility

• Robust hardware provides high quality data with low noise, providing consistent and reliable results with fast measurement times. Even samples that have high fluorescence signal with most Raman systems can be identified with the NanoRam-1064 with its 1064nm laser excitation.
• User-definable methods and libraries to meet challenging analysis needs
• TE cooling allows for greater stability of the instrument in environments where temperatures are highly variable.
• Secure data transfer and database to ensure data integrity

Sampling Accessories

Easy Transition Between Sample Types

The NanoRam-1064 includes a variety of sampling accessories optimized for the measurement of various materials in the form of liquids, gels, powders, or solids under both a laboratory setting and demanding environmental conditions. The NanoRam-1064 is designed to facilitate fast and convenient transitions between sample adaptors.