CDI Pharma, Manufacturer of Blender Uniformity,Dryer Monitor and Raman Spectrometers

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Blend Evaluation Kit

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Advantages of NIR Diode Array Spectrometers

“Only array-based instruments can use variance as it is the only instrument capable of taking a snapshot of sample area. All wavelengths are interrogated simultaneously.”

· Real Time, On/In-Line

· NIR spectrum provides both chemical and physical information of all components of a sample, from which we can determine homogeneity of all blend types

· Direct non destructive method

· No sample prep

· Minimize assay time

· No sampling of the blend, thus no sample error due to sample thief

· Improved process understanding by optimizing process equipment

· Faster response times to customer demands

· Better productivity

· Lower (manufacturing) costs

· Total control of production process

· No operator intervention is needed; system is totally automated

BlendSpek^TM Software
Click here for BlendSpek^TM information

· For highly potent actives, “non-sampling” has become an important issue

· Obtain process information in real-time

· Multi-ingredient uniformity can be assessed better than by current technology (HPLC, UV)

· Materials blended to uniformity rather than an unchanging pre-set time

· Continuous monitoring of the process means more sample points can be taken

· Advanced control will give better batch-to-batch consistency, better (product) quality

· Should eliminate reworks/rejects (no OOS report to file)

BlendSpekTM is a software package written specifically for blending applications. This software package is easy to use and allows the user numerous qualitative and quantitative approaches to analyzing data.

· Constituent Concentration (RSD and Slope)

· Full Spectrum Quantitative Analysis with PLS Chemometric Model

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· Provides real time qualitative and quantitative Analysis of Blend Uniformity

· Statistical methods as well as quantitative methods supported

· Versatile tool allows post-processing of data to determine most suitable analysis method

· Real-time spectral data collection

· Real-time storage

· Real-time display

· Real-time on-line processing

Endpoint Detection Algorithms

· Full Spectrum Average (RSD and Slope)

· Absorbance at selected wavelengths (RSD and Slope)

· Endpoint Spectrum ID Score (RSD and Slope)

Sample Collection Modes

· Automatic triggering with optical proximity sensor

· Free-running for continuous collection

· Push-button control for complete manual operation

Graphical User Interface

· Post-processing of logged data

· Model development

· Fine tuning of algorithms

21CFR Part 11 Ready

· XML Data File Type

· Electronic Signature

· Multi-Level Access that is password

protected

· Cannot modify file

· Audit trail

Flexible Platform

Use the same instrument in the laboratory as well as in production.

With an available sample stand, use exactly the same sensor in a research environment, product development or production.

This approach gives reproducible results and makes scale up from development to production easy. The analyzer is easy to move and remove either from the sample stand or a blender.

Other Applications

Explosion-Proof Probe for In-Line Analysis of Film Coating in a Pan Coater

Probe in EP Housing for Fluid Bed Dryer

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CDI Pharma has solutions for:

On-Line Non-Destructive Determination of Tablet Content Uniformity Using NIRS

End-Point Detection of High Shear Granulation

Real-time determination of Content Uniformity, Moisture Content, Compact Density, Tensile Strength, Young’s Modulus of roller compacted powder blends

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Click here to download a PDF file of this product
Part Number: BM-1000

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Updated on: Tuesday July 08, 2008 Est

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CDI Pharma
2633 Foundation Drive
South Bend, IN 46628
Tel. (574)-288-7338 - Fax (574)-288-7339