handheld raman spectrometer scanning raw material

Raw Material Identification

Raw material identification and verification is important for any industry, and a regulatory requirement for pharmaceutical manufacturers. Raman instruments provide a molecular fingerprint of samples measured and provide nondestructive identification and verification of materials such as active pharmaceutical ingredients (APIs), excipients, intermediates, and finished products. It is also a well-recognized method for compliance with the PIC/S GMP guide regarding 100% identity assurance for starting materials. Utilizing portable and handheld Raman instrumentation, non-contact analysis can be performed through transparent containers, all while maintaining the volume and integrity of the sample. The handheld NanoRam is specialized for material ID in the pharmaceutical industry and, 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. Having the ease to identify samples wherever in the manufacturing environment provides efficiencies in raw material, and final product acceptance without the need for material movement or sample preparation.

Products

NanoRam® 1064 – BWT-840000953

Handheld Raman Spectrometer

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

STRam^®

Portable Raman Analyzer for Rapid Analysis and Identification Through Opaque Barriers

STRam^®

The award-winning STRam^® portable Raman system delivers rapid material identification capabilities through a variety of barrier layers and packaging previously impenetrable with Raman. The system design unites a high throughput spectrometer, specialized sampling optics and advanced algorithms in a compact Raman system with embedded tablet computer. The STRam and STRam-1064, operating with 785 and 1064-nm Raman excitation respectively, can identify materials through multiple layers of packaging to meet your application needs.

With our patented technology, you can use the STRam to identify samples inside opaque packages. The STRam collects Raman signal generated underneath diffusive top layers so you can identify material inside visually opaque barriers such as white plastic bottles, paper envelopes, tablet coatings, and highly fluorescent Kraft paper. This removes the need to open containers and have any direct exposure with the material, thus maintaining package and sample integrity, and increasing operator safety.

The STRam design features a large sampling area and sampling depth and minimized power density, so you can measure samples that can be challenging for conventional focused Raman spectroscopy.

Click here to download our portable Raman product compatibility chart

Applications:

Through-Package Material Inspection
Customs and Logistics Package Inspection
Pharmaceutical Raw Material Identification
Narcotics Detection
Art and Archaeological Study
Bioscience and Medical Analysis
Forensic Analysis
Geological and Mineralogical Research
Material Science Research

SENSITIVE:

The system design enhances the signal at a greater depth so that samples inside opaque containers can be identified without the signature of the top layers overwhelming the sample signature. The system combines a high-throughput spectrometer, a high sensitivity and low noise detector, a specialized sample probe, and advanced identification algorithms.

VERSATILE:

The system provides versatility for see-though measurements through barriers and across a large sampling area while allowing low power density in measuring sensitive samples. Specialized adaptors can easily be attached for focused measurement directly on a sample. The STRam can be used for Raman analysis of samples ranging from those in packages to sensitive energetics or biological samples, and its large spot size gives greater reproducibility of heterogeneous sample measurements.

TOUCH SCREEN INTERFACE:

The STRam is a fully integrated system with a tablet computer running 21CFR part 11 compliant software for through-barrier-layer material identification. With optional battery operation for easy portability, the system provides research-grade, high-sensitivity Raman capabilities wherever needed.

NanoRam^® – BWT-840000341

Handheld Raman Spectrometer

NanoRam^® – BWT-840000341

The NanoRam is a state-of-the-art handheld Raman instrument for nondestructive identification and verification of materials such as APIs, excipients, intermediates, & finished products. 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, non-contact analysis can be performed through transparent containers, all while maintaining the volume and integrity of the sample.

The NanoRam handheld Raman spectrometer facilitates fast and convenient transitions between sampling accessories for raw material identification through a variety of packaging. The NanoRam comes standard with the point and shoot, vial holder, bottle adaptor, and immersion probe accessories for optimal identification of different sample forms. These accessories allow you to measure through plastic and glass containers, take in situ measurements of liquids and powders, and measure larger containers only accessible from the top. Additionally, right angle, and tablet holder accessories are available to facilitate hands-free sampling . The NanoRam is operated with easy to follow, touch screen NanoRam OS (NOS) embedded software, which allows for identification and verification and library and method development. The NanoRam ID (NID) PC software provides a secure database for data and methods management, allowing customers to export data, generate and e-sign reports and transfer methods and libraries to other NanoRam units.

Raman spectroscopy is an approved method by the U.S. and European Pharmacopoeia, as well as the Pharmacopoeia of the People’s Republic of China. It is also a well-recognized method for compliance with the PIC/S GMP guide regarding 100% identity assurance for starting materials. NanoRam has performance validation tests to ensure system performance to the standards of the USP<858>, EP 2.2.48 and JP 2.26. 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 cGMP compliant facilities. B&W Tek offers a wide variety of services, including assistance with method and/or new library development as well as support with IQ/OQ/PQ implementation.

Intuitive Software – a user-friendly interface for both technical & non-technical users to make their job easier
Versatility – measure a variety of samples in a variety of environments and packaging with just one unit
Data Reproducibility – superior hardware ensures that results are consistent and reliable
Performance – robust multivariate algorithms guarantee accuracy when testing and identifying materials

2012 Laboratory Equipment Readers' Choice Winner Pharmaceutical Manufacturing Innovations 2012 Honoree

Features:

High-Brightness Touch Screen Display
Embedded 1 & 2 Dimensional Barcode Scanner
IP-64 Dust Tight and Splash Proof Rated Housing
Sampling Accessories for Almost Any Environment
Batch Scanning Option for Large Volume Operation
Intuitive Software for Technical & Non-technical Users
Wi-Fi & Ethernet Communication for Data Sync & Management

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
Barcode scanner for quick method selection
Compatible with Labware LIMS

Testimonials

The NanoRam was the most suitable Raman instrument on the global market, significantly reducing the time spent and as a result increasing the efficiency of our API control process.

— Pharmstandard

The NanoRam is so easy to use, and we are now able to get through hundreds of samples per day, allowing us to fulfill regulatory requirements of 100% identification testing of APIs

— Hetero

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Application Notes

Using Raman to Identify Excipients for Food and Drug Formulations.

Ever since the European Medicines Agency (EMA) recommended that all pharmaceutical companies test every raw material that passes through their manufacturing facilities, this practice has attracted great interest in the nutraceuticals, food manufacturing, cosmetics, and agricultural industries, pushing them to strive for more rigorous and technology-oriented quality control standards.
Read the full application note

Handheld Raman for Inspection of Raw Materials

In recent years, Raman Spectroscopy has gained a reputation in market segments that require the rapid identification of unknown compounds, such as the testing of chemicals, measurement of pharmaceutical ingredients and characterization of polymers.
Read the full application note

Cost Benefits of Handheld Raman for Quality Control Testing in the Pharmaceutical Industry

Competition in the pharmaceutical industry is driving drug companies to spread their manufacturing operations around the globe. Unfortunately, production delocalization results in more testing of the incoming raw materials for quality assurance, product safety and regulatory purposes, which results in an increased cost of doing business. This application note discusses the economic costs and benefits of the implementation of handheld Raman in the warehouse.
Read the full application note

New Study Validates Identification of Complex Compounds with Handheld Raman

Historically, identification of complex compounds and binding/tableting materials have only been achievable using research-grade, laboratory systems, which offer high resolving power and better signal to noise capability. In this article we set out to demonstrate that the recent technological breakthroughs in the NanoRam are proving that high performance Raman spectroscopy can be combined with simplicity and ease of use in a compact design.
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Making Raw Material Inspection Easier for Companies with Numerous Receiving Facilities

Moving identity verification of incoming raw materials out of the laboratory and into the warehouse through the use of handheld spectrometers has become an accepted method for obtaining optimal efficiency for testing. Since multiple sites within an organization often use the same raw materials, transferring identification methods and libraries between spectrometers at receiving sites can help to ensure consistency and reliability of the materials before they reach production, all while maintaining that efficiency.
Read the full application note

Raw Material Identity Verification in the Pharma Industry

In this article, Dr. Bülent Üstün, a senior scientist at Merck Sharp & Dohme, reasons that the most efficient means for identity verification of incoming raw materials is to move it out of the laboratory and into the warehouse. He discusses the various elements of spectroscopic techniques including Raman spectroscopy, the differences between spectral matching (e.g. “match/no match”) vs. identity verification (e.g. “pass/fail”) and how to utilize these tools to get the best possible results.
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Sampling Guidelines for Handheld Raman Measurements; What You Need To Know

When it comes to rapid material identification, there is a large variety of sampling requirements and sample forms that are specific to each situation, so flexibility in measuring samples with minimal sample preparation and handling is becoming ever more important. A handheld Raman spectrometer provides the ability to sample a material directly in its original package, or to take a small sample for testing in or close to the receiving area, providing a high ROI without introducing complexity to the raw material receiving process. This application note discusses a series of accessories for handheld Raman spectrometers that addresses these issues for a cost effective solution to rapid material identification.
Read the full application note

Raw Material Identification through Multiple Polyethylene Bags

Raman technology is known for its fast speed and convenience for material identification and verification since Raman measurements can be conducted through transparent containers without any sample preparation. This technical note showcases the NanoRam handheld Raman spectrometer for raw material identification through multiple polyethylene (PE) bags.
Read the full application note

Using Handheld Raman Spectroscopy To Reduce Risks In Materials Used For Manufacturing

This article presents the discussion on minimizing risks in quality of pharmaceutical manufacturing using Raman spectroscopy, which provides a rapid, reliable means of testing in many different environments in manufacturing, including the loading dock.
Read the full application note

Webinar: Raw Material Control Strategy New Technologies for Rapid, Robust Release Methods

In this webinar, we’ll discuss new handheld Raman technologies including the NanoRam-1064 and its effectiveness for efficient and accurate raw material control in pharmaceutical manufacturing settings.
Watch the Webinar

Material ID through Dark Brown PV Bag

This technical note is to demonstrate the ability of the NanoRam® (785 nm laser excitation) for material identification through dark brown plastic bags. Tests have been done for material identification test directly from outside dark brown polyvinyl bag using NanoRam.
Read the full application note

Raw Material Verification of Cellulose and its Derivatives

This app note demonstrates how the NanoRam-1064 accurately identifies and verifies cellulose materials used frequently in raw material pharmaceutical settings by minimizing fluorescence.
Read the full application note

NanoRam®-1064 Fast Facts: Botanical Verification

This app note demonstrates the effectiveness of utilizing the NanoRam-1064 for analyzing and identifying botanical ingredients while minimizing fluorescence to provide accurate results.
Read the full application note