Redefining the Global QC & Material Inspections Process

Not all Raman analyzers are alike — here’s some advice on how to tell them apart

By Bree Allen, Vice President, Rigaku Raman Technologies

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The widespread proliferation of Raman analyzers in the pharmaceutical industry is creating a paradigm shift in the way quality control and raw materials inspection are being handled. Over the years, Raman has become a proven technique for a variety of unknown material identification and verification applications. Pharmaceutical manufacturing companies are increasingly relying on portable and handheld instruments to help streamline their inspection process and create workflow efficiencies within their operations.

Given the widespread adoption of portable and handheld instruments and the acceptance of Raman spectroscopy as a viable technique for trusted results, it’s important to evaluate what a company’s true needs are when selecting a portable Raman instrument. There are many options to consider when evaluating one analyzer against another. Gone are the days when companies looked at Raman as a cool, new (but risky) technology. It’s no longer a question of “Why do I need Raman,” but rather a question of “What do I need to get out of my Raman instrument?”

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THE GLOBAL INSPECTIONS MARKET

Quality control is a top priority for every pharmaceutical manufacturer, but as the supply chain continues to expand globally there is a greater risk for vulnerability. This puts more emphasis on the QA/QC process to ensure effective and efficient material verification before and possibly during the manufacturing process. Strong regulatory enforcement and the implementation of 100% inspection are on the rise and driving a change in the way materials inspection is being performed. The question becomes: How to increase the rate of inspection without raising costs and disrupting current workflow? This is where handheld, portable Raman instruments provide options to seamlessly modernize inspection procedures without disruptive action. These instruments allow for point-of-receipt material inspection or support traditional laboratory testing efforts to increase material throughput with ease and accuracy.

WORKFLOW EFFICIENCY IS KEY
There is no doubt that Raman analyzers can create significant efficiencies for organizations. However, there are many ways to do this and it does not require a substantial change or re-investment in technology. Some companies may opt to take their Raman instrument directly onto the loading dock and bypass the lab inside to create efficiencies. Other companies, however, are more comfortable with their in-house laboratory testing facilities and can create the same efficiencies by bringing portable Raman instruments into the lab. Not only does this free up existing testing equipment in the lab to perform other critical data analyses, but portable instruments can also be shared among groups and departments involved in material testing. This creates a whole new set of operational efficiencies by enabling a seamless sharing of information throughout the entire organization.

Whatever route a company decides to take with a Raman instrument, one thing is clear: Portable and handheld Raman instruments are impacting pharmaceutical manufacturers around the globe. How one chooses to implement a Raman analyzer is unique to the individual’s company, and it will take careful analysis and consideration to make sure the instrument purchased is one with the functionality that meets the company’s specific needs.

WHAT TO LOOK FOR
When evaluating Raman instruments, there are several things to look for. At the end of the day, it comes down to efficiency, workflow improvements, product support and confidence that the instrument one’s selected will integrate seamlessly and easily with existing equipment, providing the required level of quality control and inspections customers and others have come to expect.

There are many spectroscopic instruments on the market with similar attributes including portability, rapid results, ease-of-use, easy-to-interpret results and reporting functionality. However, when contemplating a Raman instrument, there are some additional considerations.

THINK BEYOND IDENTIFICATION
There are many areas where a portable or handheld Raman spectrometer can provide workflow efficiency. A best choice when specifying a Raman instrument is choosing one that allows users to:
• Closely monitor spectral peaks and reactions;
• Overlay spectra to better identify contaminants and impurities;
• Perform both qualitative and quantitative analysis, and
• Allow users to ascertain more data from spectral results.

ENSURE BROAD MATERIAL COVERAGE
Each manufacturer has a unique production environment and must analyze a variety of pharmaceutical materials, often in bulk and from various suppliers from around the world. Raman is known for accurate performance when analyzing both solids and liquids through sealed packaging, however, a thorough evaluation of a drug maker’s unique material list and incoming packaging could reveal that fluorescence issues may interfere, and therefore, a unique combination of laser wavelength options is required to achieve reliable results at an efficient pace.

Raman provides that expanded materials identification capability. The common laser wavelength options for pharmaceutical analysis are 785nm (nanometer) and 1064nm. The selection of which option depends on the particular needs of the manufacturer. Some companies may only need to test a defined set of non-fluorescent samples, needing high sensitivity, and may opt for a 785nm configuration. However, for those customers that handle materials that fluoresce under 785nm excitation, particularly those utilized in the biopharmaceutical industry, a 1064nm configuration is necessary. In many cases, the use of both wavelength options can provide the greatest compound coverage possible. In this case, an instrument that provides both wavelengths is the best option.

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RELIABILITY, ACCURACY, OPTIMAL SENSITIVITY
Optimizing and monitoring instrument performance is essential to ensuring reliable data. Two key components of a portable or handheld Raman instrument are the Grating and the Detector. The instrument grating contributes to the overall optical resolution and signal efficiency over a given spectral range. While reflective ruled gratings are very popular, holographic volume phase gratings provide a more uniform spectral response across the wavelength range and higher diffractive efficiency. Volume Phase Gratings (VPGs) are designed to provide up to 99% diffracting efficiency and a large angular dispersion to maximize optical resolution. Choosing the right detector can help maximize signal-to-noise, while also maximizing resolution. A cooled InGaAs array detector reduces dark noise while enhancing the instrument’s dynamic operating range for long-term stability and reproducible results.

BUYER BE AWARE
The broad adoption of handheld and portable Raman instruments has indeed played a critical role in helping organizations streamline their material identification processes while maintaining a core focus on product quality. As companies, including Rigaku Raman Technologies, continue to introduce innovative spectroscopic solutions, pharmaceutical companies will continue to reap the rewards the technology can offer. As many companies have already discovered, Raman analyzers can deliver significant operational efficiencies that make them more competitive, while enabling them to maintain their focus on quality. And while the benefits of Raman are clear and understood by most companies today, the more important issue being tackled now is identifying what Raman product meets a specific company’s needs. There are many options to consider and, like buying any product or technology, the “buyer” must know what to look for and understand what they really need.

Published in the October 2013 edition of Pharmaceutical Manufacturing magazine

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