|Description|| With costs of poor quality running into billions of dollars worldwide, pharmaceutical manufacturing organizations are under increasing pressure to reduce expensive rework costs. In tablet production, the microscopic distribution of ingredients is known to impact important quality parameters such as dissolution, stability, bio-availability and hardness. However, to date there have been no convenient techniques to which can provide this information, which means that the blending and tabletting processes are often poorly controlled, adversely affecting product quality. |
In both formulation development areas and the process analytical support functions it is essential to be able to identify anomalous distribution of ingredients, and FT-NIR imaging is rapidly being implemented by major pharmaceutical companies to help solve these and many other manufacturing problems.
FT-NIR Imaging performance and productivity
The Spotlight 400N combines state-of-the art imaging technology and full automation, maximizing productivity and accelerating problem solving. The Near-IR spectral range is particularly convenient for rapid sample imaging and sample preparation is often unnecessary. Spectra are collected directly from the sample surface at a pixel size of either 6.25 x 6.25 um or 25 x 25 um over a user-definable sampling area. Samples are simply stepped below a linear detector array, building an image at a rate of up to 80 pixels per second - for example at 25 x 25 um pixel size, a 1 x 1 mm sample area can be imaged in less than 1 minute and a 5 x 5 mm sample area in around 7 minutes. Each pixel corresponds to a high-quality NIR spectrum and by using Spotlights built-in intelligent software routines, chemical differences between pixels are highlighted images that show the distribution of individual ingredients are quickly displayed.
- Seamless automation simplifies set-up and measurement, increasing productivity and reducing errors
- Two-in-one detector enables single-point microscopy as well as IR Imaging, allowing micro-contaminants in products and packaging to be identified in seconds
- Powerful built-in data processing routines automate data analysis and provide quick answers
- Superb visible image quality ensures accurate and easy sample inspection
- User-defined sampling area and aspect ratio allows you to match the image size to the sample size.
- Full range imaging from 7800 2200 cm-1 covers the most information-rich areas of the spectrum, maximising applications flexibility
There are many other application-areas where FTIR and FT-NIR imaging can troubleshoot problems leading to significant cost savings.
- Tablet stability studies
- Dry powder electrostatic coating analysis
- Counterfeit detection
- Contamination identification
- Packaging development
- Transdermal patches and related delivery systems