ePAT Update 2010 #2

Key attributes for a robust PAT implementation are the right sensor (e.g. spectrometer) coupled with compliant, plant appropriate software and well designed engineering to provide a small "footprint", low maintenance installation

This latest ePAT update #2, reports on Expo’s most recent innovations in these three areas essential to complete a fully documented in-process installation to support your PAT strategy.

Spectroscopy - Engineering - Software

Spectroscopy: The system suitability unit can now be implemented into our high performance spectrometers. It provides up to the moment confirmation that the hardware is fit for purpose. The integrated system suitability device automatically performs a periodic suitability test ensuring that the instrument is ready for use. Such tests are typically performed on a daily basis and include a check of wavelength accuracy and photometric accuracy. A report is generated each time the suitability test is run. In addition, NovaPAC© software automatically archives the spectral data associated with the suitability test. When coupled with NovaPAC’s automated reference checking feature it provides clear, complete and traceable functionality testing.

Engineering 1: Overcome probe fouling. The NIR Diffuse Reflectance probe used for such applications as Dryer or Granulation Monitoring incorporates a specially heated window to prevent sample build up. Successfully implemented in a number of companies, the sample build up on the window is eliminated and the analysis of a continuously refreshed sample is possible.
Engineering 2: Small scale blending The eBlend is a development scale blender with built in spectroscopic window enabling blend uniformity analysis on most laboratory NIR spectrometers. The eBlend has a total volume of 150 ml, and with a recommend fill volume of 75-100 ml, it is the perfect solution for calibration development and model building. The convenient two piece design with threaded cap and o-ring seal allows samples to be loaded in the cone section and the eBlend closed for measurements.

The open design and flush mounted window allow the eBlend to be cleaned easily. Custom options for larger blender volumes and alternative bin and window materials are available. The eBlend also works exceptionally well with Expo’s range of NIR blend monitoring Spectrometers, the ePAT601 and ePAT602, as well as the new ePAT801 fluorescence Spectrometer (eBlend version with optional UV window). Calibrations can be developed in the laboratory on these units and transferred with the ePAT solution to the process or manufacturing area.

Software: NovaPAC© is emerging as an industry standard. The most recent functionality to be added includes:

• Automated reference validation, compares the current reference spectrum to a stored reference and alerts operator to possible problems.
• Expanded batch report printout capabilities.
• Administrator configurable lamp warm up period.

The connectivity network of instruments and manufacturers grows and includes: a range of UV, VIS, NIR spectrometers with diode array, scanning and MEMS devices all implemented Zeiss, Foss, Ocean Optics, Axsun ......with ABB currently in beta test version.

These instrument specific versions include all of the standard NovaPAC© and NovaMath© functionality, such as full performance testing and calibration conformance, together with a full featured OPC server. The benefit is a Common User Interface, with an industry standard data format covering a wide range of instruments to give operators transferable knowledge.

Call Expo Technologies to discuss interfacing your instrument or to obtain a fully featured trial version of the software.

Further information on these new products and all of Expo's PAT solution is available from any of the Expo offices, or by visiting our website.

PAT Development Centre
Expo Technologies LLC
4041 Forest Park Avenue
St. Louis, MO 63108
USA
Tel: +1 314 615 6362
Fax: +1 314 615 6364
Email: e-mail pharma@expoforpat.com

European Sales and Support
Expo Technologies LLC
P.O. Box 1163
Bottisham
Cambridge, UK
CB25 9WD
Tel: +44 1223 812323
Mob: +44 7784 511001
Email: e-mail pharma@expoforpat.com

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