In general terms, what is NIR spectroscopy and how does it help pharmaceutical manufacturers meet their quality control/quality assurance goals?
NIR spectroscopy is predominantly a way to measure molecular vibrational overtone bands and is widely used in the pharmaceutical industry as a rapid method to ensure a product or ingredient is what it is supposed to be. Measurements can be qualitative or quantitative, but qualitative ID confirmation is probably most common. NIR has an advantage over mid-IR techniques in offering the ability to measure samples in their original form, either by direct reflectance or in favorable cases, transmission. No sample contact is necessary for the measurement, and no solvents are required for sample preparation. In addition, by using NIR techniques one can use fiber optics systems over extended distances if necessary to measure the sample more conveniently.
Spectroscopy techniques have seen significant advancements in recent years. What do you feel are some of the most important improvements in this technology in recent years, and what have these improvements offered pharma companies in terms of quality, efficiency, and time to market?
Spectroscopy techniques have benefitted from improvements in both detector and filter technology over the last decade and from miniaturization of hardware in general. Exciting developments in detector arrays and filters for NIR have resulted in new, smaller devices that enable measurements which once were confined to research labs to be performed in the production environments, and even in the field. In the lab and on-line, NIR imaging developments have also enabled scientists to get insights into chemical distribution of ingredients in final products and powder blends.
What can a company like PerkinElmer offer in terms of NIR spectroscopy solutions and expertise? Please tell us about some of your most advanced spectroscopy products/solutions and what advantages they offer your clients?
PerkinElmer has been at the forefront for mid-IR spectroscopy for pharmaceutical labs for many years, and we have extended our portfolio recently with the introduction of high-performance yet transportable FT-NIR systems for QA/QC testing [Spectrum Two N™]. In addition, we have developed some unique capabilities for NIR microsampling and imaging. These systems combine our developments and expertise in IR microspectroscopy with some recent NIR detector array advances as mentioned above. These systems have been helping customers understand ingredient distribution in their solid dosage forms and powder blends, in addition to measuring samples in the form of micro-pellets.
Software for data collection, analysis, and regulatory compliance is a large part of any instrument’s features and benefits. Can you tell us about the software used in your instruments and how it provides an added level of quality control for material identification and analysis?
With our emphasis on QA/QC and analytical operation, PerkinElmer has invested in software design for less experienced operators operating in a regulatory-controlled environment. In our Spectrum 10 and Touch Enhanced Security™ (ES) options, operators can incorporate protocols with clear simple-to-use interfaces where all instrument fit-for-purpose tests are as automated as possible and fully recorded for audit trailing. We use a comprehensive SQL database with our software which records operations so qualified personnel with suitable access control can assess previously collected data and reports.
Looking ahead, how will PerkinElmer continue to help its customers meet the demands of raw material identification?
PerkinElmer continues to develop spectroscopic instrumentation with direct relevance to pharmaceutical IR and NIR applications, including both hardware and software. Our breadth and depth of support for the pharmaceutical industry, extending from application/method development, validation and instrument maintenance to relocation services is extremely important to our business and continues to be an area of investment and growth for PerkinElmer.