Analytical Spectral Devices introduces near infrared analyzer for in-line pharmaceutical quality control
Analytical Spectral Devices, Inc. (ASD), manufacturer of analytical instruments for the pharmaceutical and nutraceutical industries, announces the availability of the QualitySpec TI near-infrared (NIR) analyzer, the world's only validated on-line NIR technology for blister packaging. The QualitySpec TI's patent pending technology accurately and reliably verifies the chemical composition and concentration of tablets, rejects foreign tablets, and alerts if no tablet is present at all. The instrument provides 100% in-line screening and is non-destructive, making no physical contact with the package or the product.
In this system, each tablet is exposed to an internal light source. The light reflects off the tablet and is transmitted through a fiber optic probe back to the NIR analyzer. This reflected light contains the "chemical fingerprint" of the tablet. The analyzer verifies that tablet is supposed to be in that blister, providing 100% assurance that the correct product is sealed in the correct package and eliminates the need for time consuming and destructive testing afterward.
Sanofi-Synthelabo Research recently validated the QualitySpec TI on its production line after rigorous beta testing at the company's Malvern, Pennsylvania clinical packaging facility. The particular application was a clinical trial run, where the Quality Spec TI could distinguish between active and placebo tablets.
"Existing pharmaceutical blister packaging equipment utilize vision systems that identify tablets by their size, shape and color as verification that they are packaged correctly," said John Enterline, director of sales and marketing at ASD. "The QualitySpec TI allows pharmaceutical manufacturers to distinguish between tablets that have the same physical appearance yet different chemical composition, ensuring that the correct product has been put into the correct package."
The QualitySpec TI features an evaluation speed of 90 cycles/minute/head that can easily accommodate up to 24 tablets per blister with up to 4 products for multifill applications, giving it the ability to scan 2,160 tablets per minute. The system was designed for Klöckner Medipak's EAS blister packaging machine; however, the QualitySpec TI is easy to integrate into any low volume pharmaceutical blister packaging system. The QualitySpec TI also features an easy-to-use learn mode and a user-friendly touch-screen interface for use by production operators and non-technical people. QualitySpec TI is a Good Manufacturing Practices (GMP) compliant instrument.
The QualitySpec TI is the first of a family of products for low to high volume blister packaging machines. ASD plans to introduce another QualitySpec TI that will accommodate higher volume production blister packaging machines by the end of 2002.
At the heart of the QualitySpec TI is ASD's field-proven spectrometer. This highly accurate instrument measures reflectance, transmittance and transflectance and features a spectral range of 350 nm – 2500 nm with a wavelength accuracy of ± 0.8 nm and wavelength repeatability of ± 0.02 nm. Photometric range is 5 Au and noise is 60 µ Au.
Founded in 1990, Analytical Spectral Devices is the only manufacturer of truly portable, laboratory-quality UV/Vis/NIR spectrometers, spectroradiometers, spectrophotometers and corresponding software. ASD's instruments perform well in a range of environmental conditions, in and outside of the laboratory, and have applications in pharmaceutical, nutraceutical, analytical chemistry, remote sensing, petrochemical, grain, mining, food and dairy, and pulp and paper industries. For more information, please contact John Enterline, Analytical Spectral Devices, 5335 Sterling Dr., Suite A, Boulder, CO, 80301; 303/444-6522, 303/444-6825 (fax); www.asdi.com
Source: Analytical Spectral Devices