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What are the advantages of using spectroscopy as an analytical tool over other techniques?
application benefits: GR:
1. Portability often makes it easier, simpler, faster, and cheaper to bring the instrument to the sample or sampling point, rather than bringing the sample to the instrument. Samples may be too large, delicate, dangerous, sensitive, or may be changed if surrounding conditions change, to bring them to the laboratory.
2. Materials can be measured in hostile conditions (hot, cold, wet, etc.) since the instrument does not have to be in those conditions itself.
3. Samples can be measured in sterile conditions, obviating the need to break the sterile seal to make the measurement.
Other advantages include speed, the ability to handle irregular sample types, and so on.
MS:
Spectroscopic measurements have a higher degree of specificity for subtle changes in chemical structure and
physical form than many other analytical techniques. Spectroscopy often requires little or no sample preparation and is, therefore, fast and non-destructive. Because spectroscopic techniques are non- contact, many types of samples can be analyzed directly through a container or other packaging, thus preserving sample integrity. The non-destructive, non-contact nature of spectroscopy also makes it adaptable for on-line measurements and many important applications have been demonstrated for monitoring continuous processes. Another important advantage of spectroscopy is that spatial images can be obtained to quantify the compositional uniformity of blends and the distributions of components in solid dosage forms.
BM:
There are many advantages to a spectroscopic solution over other traditional analytical approaches. As a prelude
to my arguments for spectroscopic solutions, I make the assumption that both the spectroscopic and traditional solutions are equal in their performance. The primary differentiator in most cases is the cost and labor associated with traditional analytical systems like chromatography. A typical process spectroscopic solution has very low cost of ownership after installation. For example, the typical service for a process Raman instrument is laser replacement after two years. In comparison, an HPLC requires consumables that consist of solvents and columns as well as an operator to collect and inject samples or fill vials for an auto sampler. An argument can be made that a Raman instrument costs three times what a typical HPLC costs. However, when you look at the cost of ownership for operating a Raman solution vs. an HPLC solution over two years, it has been shown that the process spectroscopy solution costs less in the long term. Beyond the cost savings of a spectroscopic solution, there are other advantages in both accuracy and reproducibility that result from not having to physically collect and inject samples for analysis.
26 | | November/December 2013
Probably the single greatest advantage is the capability for non-contact measurement, which provides several
What does the future hold for spectroscopic tools in pharmaceutical processing?
GR:
We are now in the age of Big Data. These tools have evolved to a point that allows data to be gathered at a faster and
cheaper rate without losing the quality of information coming out of that data. It is crucial for the end user to remain vigilant when asking the two key questions that, throughout the evolution of regulations of the food and drug industries, have not changed even as regulations have undergone continual improvement. These questions are: “What is it that I want to know about the system being measured?” and “When do I want to know it?” The way in which the answers are obtained has the potential to change the outcome. Spectroscopic tools have the ability to obtain those answers throughout the development and manufacturing lifecycle of the drug and drug product so that timing is always a big challenge for users of these tools. And because some of the uses of these tools may require multivariate analysis (MVA) for designing experiments, data measurement and control, data archival and retrieval, and data analysis, the increased application of statistical tools will have an impact on how Big Data coming out of pharmaceutical manufacturing will complement evolving regulatory requirements for defining product quality. In essence, now that we can make measurements anywhere in the lifecycle of the product, measurements must be made so that the quality being surveyed really measures an attribute with both adequate impact on the product and the customer, as well as meaningful impact so that the value to the customer can be measured, not just monitored or predicted. Thus, the future will focus on redefining and linking Big Data in pharmaceutical manufacturing to final product quality attribute and determining what that value-added quality metric will be to the customer.
MS:
There is a wealth of experience in deploying vibrational spectroscopy tools such as NIR and Raman in
pharmaceutical processing and many of the challenges of integrating analytical instrumentation into control systems and managing big data have commercial solutions from a number of sources. One new area of interest on the horizon is spectroscopy in the terahertz frequency range with commercial systems operating from 5-150 cm-1. Terahertz waves have a higher depth of penetration into many pharmaceutical materials than NIR which provides more representative sampling for bulk analysis and the ability to do depth profiling of multilayered tablets and coatings. Terahertz spectroscopy can be used to measure the densities of solid compacts and is uniquely sensitive to changes in crystallinity and crystalline form due to polymorphism and hydration.
BM:
The future will show that high information content spectroscopic tools will continue to capture market share
from more traditional analytical technologies. These changes will be driven by improved performance, less cost of ownership, reduction in skilled operator labor required, and the ability to effectively incorporate spectroscopy online for improved process control that will lead to improved product quality. I feel that with effective process spectroscopy solutions, we can design quality into pharmaceutical products and not have to test quality out as we have in the past with traditional methods.
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