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Presentation at Interphex 2016

1/8/2016
Measurement of Powder Fill with Xray
 
Please join Sapphire on April 27th at Interphex where we will present an overview of mass measurement of pharmaceutical powders using xray.  The Presentation will be at Technical Conference Stage 4, Booth 1477 in the Exhibit Hall at 1:15pm. 

TITLE: Automatic Powder Inhaler Inspection Using Xrays: An Inline Analytical System and Radiographic Method for Determining the Mass of Single- and Multi-Dose Powders

ABSTRACT: Inline Xray systems have been established as a means for verification of the net mass of a package contents.   Accurate measurement of powder dose fill, at levels of 10 mg or less, has not been previously described.  The method described herein utilizes a low energy generator operating at 13 kVp or below, with customised large area detectors.  Special reference pieces were deployed to maintain accuracy and validate performance, by establishing the relationship between thickness and transmissivity.    Samples of powder were analyzed, with varying net fill levels,and the results applied to a regression analysis to determine the optimum calibration parameters. R&R techniques were applied to determine the underlying accuracy of the measurement technique.   The self-calibrating concept took into account variations in the measurement device electronics, radiographic performance and positioning due to the material handling system.  The accuracy of the equipment and the method were found to be within the required limits.  Based upon measured results, accuracy for the real-time system achieved a standard deviation of 0.1 mg for powder fills between 5 and 20 mg.  This radiographic method is effective for determination of the mass of powder dose formulations by Inline Analytical System and for real time verification of powder fill in a single or multi-cell packages.  

CLICK HERE FOR PRESENTATION 


Presentation at Interphex 2016

1/8/2016


Please join Sapphire on April 27th at Interphex where we will present an overview of mass measurement of pharmaceutical powders using xray.  The Presentation will be at Technical Conference Stage 4, Booth 1477 in the Exhibit Hall at 1:15pm. 

TITLE: Automatic Powder Inhaler Inspection Using Xrays: An Inline Analytical System and Radiographic Method for Determining the Mass of Single- and Multi-Dose Powders

ABSTRACT: Inline Xray systems have been established as a means for verification of the net mass of a package contents.   Accurate measurement of powder dose fill, at levels of 10 mg or less, has not been previously described.  The method described herein utilizes a low energy generator operating at 13 kVp or below, with customised large area detectors.  Special reference pieces were deployed to maintain accuracy and validate performance, by establishing the relationship between thickness and transmissivity.    Samples of powder were analyzed, with varying net fill levels,and the results applied to a regression analysis to determine the optimum calibration parameters. R&R techniques were applied to determine the underlying accuracy of the measurement technique.   The self-calibrating concept took into account variations in the measurement device electronics, radiographic performance and positioning due to the material handling system.  The accuracy of the equipment and the method were found to be within the required limits.  Based upon measured results, accuracy for the real-time system achieved a standard deviation of 0.1 mg for powder fills between 5 and 20 mg.  This radiographic method is effective for determination of the mass of powder dose formulations by Inline Analytical System and for real time verification of powder fill in a single or multi-cell packages.  

CLICK HERE FOR PRESENTATION 




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