sapphire - interphex presentation
TRANSCRIPT
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 [email protected]
Sapphire Technologies USA Inc. (#3717)
Cheyney Design & Development Co. Ltd.
Thank You for your Attention!
Interphex Powder Inspection Abstract