In the manufacturing of today’s pharmaceuticals, the introduction of Raman spectroscopy has created a paradigm shift in how quality inspection is performed. Once considered a new and unproven technology, Raman instruments have since evolved into the handheld, battery operated analyzers now in use around the globe, in high-volume, for a variety of material analysis applications. As word spreads about the efficiency gains achieved with the use of handheld and portable Raman, pharmaceutical companies are no longer wondering ‘if’ they should implement Raman instrumentation, but instead are determining which Raman instrument is best-suited for their unique production environment.
The Uses and Applications of Raman
With its high degree of specificity and selectivity, Raman is suited for a number of applications throughout the manufacturing process. Now available in a range of form factors, the addition of handheld and portable Raman has uncovered even more benefits as companies learn to unlock the power that Raman can bring to their businesses. Some popular application areas we see today include:
- Quality assurance/Quality control – Raman spectroscopy provides manufacturers with the ability to perform non-destructive material verification directly through sealed packaging at the point of receipt, or at any point in the manufacturing process, enabling streamlined quality inspection and increased throughput.
- R&D – Raman devices are being used more and more in R&D to discover new chemistry, monitor chemical reactions and speed up the drug discovery process.
- Product release – Product release is an important stage of the manufacturing process. Portable Raman analysis can be deployed throughout the manufacturing process to ensure product quality at each step and the specificity of Raman analysis makes it an excellent choice as a product release tool.
- Product inspection – Field product inspection must be fast, reliable and easy-to-use. Portable Raman instruments fulfill all of these requirements to help ensure product safety and quality assurance.
- Formulation – Testing new formulations is critical to product development. Raman’s chemical specificity allows manufactures to investigate small differences during the chemical formulation stage, which helps develop or improve products.
- Packaging identification – As drug counterfeiting is a growing worldwide concern, many pharmaceutical companies have developed product-specific packaging to support product quality and brand security. Raman is an easy-to-use, field-deployable tool that can quickly determine if a particular package is counterfeit by identifying the unique packaging materials including inks and plastics.
- Process monitoring – The use of Raman for real-time process monitoring is an ideal choice to better understand chemical reactions and ensure product quality throughout the manufacturing process.
Choosing the Right Raman Device
In order to ensure the right instrument is chosen to complement each unique production environment, a thorough evaluation process is required. Users need to understand what they really need from their Raman instrument and take a number of factors into consideration, such as:
- Are my materials Raman-active?
- Where else in the process can I use a new Raman instrument?
- Will this instrument integrate with existing equipment?
- Will I need to change my existing processes to implement this new technology?
There are several points to consider during the decision-making process.
Raman is not just for Material Identification
There are many areas where the right portable or handheld Raman spectrometer can provide better workfl ow efficiency in addition to streamlined raw material identification. For example, choosing an instrument with an open architecture off ers additional capabilities. Users are able to closely monitor spectral peaks and reactions, overlay spectra to better identify contaminants and impurities, and/or perform both qualitative and quantitative analysis so that more data can be ascertained from spectral results, providing a stronger return on the investment.
Get the Best and Broadest Materials 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 has become known for accurate performance when analyzing both solids and liquids through sealed packaging; however a thorough evaluation of your incoming materials may raise issues of fl uorescence when Raman spectroscopy is utilized which will interfere with achieving accurate results. The common laser wavelength options for Raman analysis has generally been 785nm (nanometer) and 1064nm, however, many manufacturers today are simply turning to 1064nm-only devices as these instruments have proven to perform accurate analysis on the broadest range of materials commonlyused in the production of pharmaceuticals.
Reliability, Accuracy and Optimal Sensitivity
Optimizing and monitoring instrument performance is key to ensuring reliable data. Two important 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 refl ective-ruled gratings are very popular, holographic volume phase gratings provide a more uniform spectral response across the wavelength range and higher diff ractive efficiency. Volume Phase Gratings (VPGs) are designed to provide up to 99 percent 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.
Conclusion
The evolution of Raman instruments has certainly changed the landscape of the pharmaceutical manufacturing industry. Just under a decade ago, skeptics questioned the viability of miniaturized spectroscopy and Raman was practically unheard of; nowadays, the technology experiences widespread adoption and acceptance by global regulatory enforcement agencies. Raman continues to grow as the technology of choice and is used by most of the world’s largest pharmaceutical manufacturers. These global manufacturers are using Raman in its most progressive form factor to improve workflow efficiencies while maintaining high quality and inspection standards. As with any cuttingedge technology, Raman spectroscopy delivers advantages that the industry cannot afford to go without.
The reality is – we are just scratching the surface with Raman’s capabilities. Not only are the uses of Raman expanding at a rapid pace, but instruments are also being further developed to include innovative features and workfl ow advancements, enabling broader application support to meet the needs of today’s manufacturer. In the next five years, we will see Raman devices reach beyond traditional markets and move into exciting new areas, including the medical fi eld, where Raman lasers are currently being developed to help detect cancer during surgery. The possibilities are endless for Raman spectroscopy and the future is exciting.