sapphire - interphex presentation

Inline Analytical System and Radiographic Method

for Determining the Mass of Single and Multi-Dose Powders

Kevin DrummSapphire Technologies USA, Inc.

Interphex Powder Inspection Abstract

Radiographic Analysis is established as a method

to verify a material’s net mass.

US Patent 6385284 described a Radiographic apparatus and assembly for, and associated method of, monitoring a

physical property of a material.

Transmission of Xray photons through a material is dependent on the

physical properties of the material.

This can be characterized as:

Historical Applications

Weight Control of Cigarettes

Mass of Blister Pack Contents

Fat Content of Meat Products

X-ray PhotonsIo

Ib

2t

X-ray PhotonsIo

Ia

t

Approximate relationship between the thickness of a material and the signal received by the Xray detector.

Radiographic Mass Analysis

Is it theoretically possible?

Yes.

Some potential issues to consider

Acceleration Voltage Beam Current Temperature Scan Interval Silicon Diode Response Apparent Dimensions

Improved accuracy requires utilization of purpose designed references

to account for variables in a given system.

Example Reference Piece

Quadratic Regression Y= aX2 + bX + C

900

925

950

975

1000

0 3 6 9 12

Number Missing

Y = -7.0615 X + 993.58R2 = 0.9983

RSD = 0.4 % (0.4 Tablets)

Example Mass Analysis

Radiographic Mass Analysis

Is it theoretically possible?

Is it accurate for large products?Yes.

Relative Signal at DetectorTr

ansm

issi

on

keV

Xray energy used for analysis of vitamin bottle

Relative Signal at Detector

10-50% Xray transmissionTr

ansm

issi

on

keV

Relative Signal at Detector

Maintain 10-50% transmission for capsuleTr

ansm

issi

on

keV

Relative Signal at DetectorTr

ansm

issi

on

keV

Thus, capsules require a low 10-15 keV

Tran

smis

sion

keV

Radiographic Mass Analysis

Is it theoretically possible?

Is it accurate for large products?

Yes.

Very low energy required for powders?

Designing an Xray System for Analysis of Powders

System Design – Xray Tube

Target Material

Focal Spot Size

Filtering

System Design – Detector

Detector Type

Linear Array Large Diode Area Sensor

Scintillator Material

Photo Credit: PerkinElmer

System Design – Layout

Orientation Focal Distance Magnification Material Handling

Analysis of Capsule Fill

Analysis of Capsule Fill

High Reference

Low Reference5 mg fill

Analysis of Powder Fill

Previously Evaluated over 2-10 mg fill range

Over 20,000 passes for 5 mg Capsule Test

Measurement Standard Deviation of 0.096 mg

Analysis of Powder Fill

Analysis of Powder Fill

Net Fill (mg)

Det

ecto

r Si

gnal

15 20105

100

80

60

40

R2 = 0.998

RSD = 0.77% Approx. 0.1 mg

Summary

1. Radiographic Mass Analysis of Powders 2. Capsules, Blister Strips and Disks 3. Fill weight ranged from 4-20 mg 4. Typical Standard Deviation of 0.1 mg 5. Continuous, Real-time, Inline Measurement

Kevin Drumm Sapphire Technologies USA, Inc. 1544 Sawdust Rd. #304 The Woodlands, TX 77380 +1 713 955 5995 sales@sapphirexray.com

Sapphire Technologies USA Inc. (#3717)

Cheyney Design & Development Co. Ltd.

Thank You for your Attention!

Interphex Powder Inspection Abstract