Ruggedized NIR Spectrometers: Pharmaceuticals/Neutraceuticals/Food/Ag/PAT

February 1, 2009

Application Notebook

Application Notebook, Application Notebook-02-01-2009, Volume 0, Issue 0

Confirming the water content of pharmaceuticals and food during processing is critical for GmP results. The ability to measure water content until recently has been a difficult challenge until now. As a result of developments in the telecom industry, NIR spectrometers offer highly repeatable, cost effective solutions.

Assuring Water Content During Blending and Mixing Results with NIR Spectrometer

Confirming the water content of pharmaceuticals and food during processing is critical for GmP results. The ability to measure water content until recently has been a difficult challenge until now. As a result of developments in the telecom industry, NIR spectrometers offer highly repeatable, cost effective solutions.

Figure 1

It has been well documented that NIR spectroscopy is an excellent method to measure water in powder mixtures. However, absorption curves are different for each given process and are developed for a given manufacturer's process. Once completed, the understanding and control of the blending process has significant benefits and typically pays for the metrology in time savings, waste reduction, faster time to market, reduced maintenance on machinery, and faster process certification.

Better process control and process understanding has intangible benefits as well. With subtle problems sometimes knowing where not to look can have great value.

Figure 2

Blend Uniformity Measurement

The same instrument that can measure your water during process has the ability to assure blend uniformity. In 2004 the FDA published a guidance document for PAT. The real intent of the document is to get manufacturers to fully understand their product completely during the production cycle. This has many benefits, not the least of which is if the FDA has confidence that the manufacturer understands his processes thoroughly, they are more willing to allow changes to the production process. The manufacturer knowing his product better knows where economies can be improved without adversely affecting product.

Benefits of real time in-situ NIR Spectroscopy are:

  • Greater control of the process

  • Reduced waste

  • Improved yield

  • Shorter time to market

  • Optimized process times

  • Better process understanding

  • Real-time feedback

  • Reduced maintenance

  • Minimal operator involvement

  • Optimizes equipment utilization

  • Improved process documentation

  • Reduced manufacturing costs

  • Better lot-to-lot uniformity

BaySpec, Inc.

101 Hammond Avenue • Fremont, CA 94539 USA

Tel. (510) 661-2008, Fax (510) 661-2009

info@bayspec.com, www.bayspec.com