Ethylene Oxide Residuals An Alternative Testing Method
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Ethylene Oxide Residuals An Alternative Testing Method
Ethylene Oxide Residuals. An Alternative Testing. Method. Presented to: U.S.
Technical Advisory. Group for ISO/TC 198. April 24, 2007. 0 .01 .02 .03 .04 .05.
Ethylene Oxide Residuals An Alternative Testing Method .05
Presented to: U.S. Technical Advisory Group for ISO/TC 198
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April 24, 2007
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Drivers for Alternative Methods Meet new standard requirements for 10993-7 & 10993-18 Research alternative methodologies for Chemical Characterization Determine compliant, cost effective “One Shot Analysis” Seek method that minimizes product consumption
Review Equipment is Qualified Validating test method for the analysis of EO/ECH/EG Publishing in scientific journal this year Evaluate & develop other applications Currently validating a method for the analysis of water content in polymers to assist with establishing manufacturing specifications
Absorption of Infrared Radiation
FTIR Technologies .1
Gas Phase FTIR .05
Typical Bench Top FTIR 0 3000
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Absorbance / Wavenumber (cm-1) File # 2 : 71_4H2O Water in G.5 N2, Cosameter 74.57 ppm -3.16 ppm BG= 71.41 ppm, 10m,0.981 atm, 121C,Avg files 34-36 BAL
Beer’s Law Summary Ai = ai * b * ci Ai = Absorption at a given frequency o the ith sample component ai = Absorption coefficient (absorptivity) of the ith sample component b = Pathlength of cell ci = Concentration of ith sample
A = log10 (1/T) = -log10 T A = Absorbance T= Transmittance
Absorption Coefficient & Pathlength Certified gases are used to generate single component reference standards The absorption coefficient is a property of a material and it defines the extent to which a material absorbs energy Affected by Temperature Affected by Pressure Path length is fixed and calibrated
Innovative New Alternative to Existing Technologies ….
Detection of Acids, Bases, and Volatiles Identification and Quantitation Fast collection and analysis time – Get Product to Market Faster Provides Low Limits of Detection required by Guidelines
Static Headspace FTIR
FTIR Static Headspace (SHS): Outgassing Profile FTIR Static HS Gas Cell IR Source
Total Cumulative Outgassing vs Time
SAMPLE
Absorbance Units
FITR Spectra
Concentration
IR Detector
Time
FTIR Static Headspace (SHS): Outgassing Profile FTIR Static HS Gas Cell IR Source
Total Cumulative Outgassing vs Time
SAMPLE
Absorbance Units
FITR Spectra
Concentration
IR Detector
Time
FTIR Static Headspace (SHS): Outgassing Profile FTIR Static HS Gas Cell IR Source
Total Cumulative Outgassing vs Time
SAMPLE
Absorbance Units
FITR Spectra
Concentration
IR Detector
Time
FTIR Static Headspace (SHS): Outgassing Profile FTIR Static HS Gas Cell IR Source
Total Cumulative Outgassing vs Time
SAMPLE
Absorbance Units
FITR Spectra
Concentration
IR Detector
Time
FTIR Static Headspace (SHS): Outgassing Profile FTIR Static HS Gas Cell IR Source
Total Cumulative Outgassing vs Time
SAMPLE
Absorbance Units
FITR Spectra
Concentration
IR Detector
Time
Multiple Regions for Analysis .05
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Ethylene Oxide Reference Spectrum
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.015
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980 960 940 920 900 880 860 840
Reference Spectra of EO/ECH/EG .0025
EO Reference Spectrum
.002
.0015
.001
50E-05
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Paged Z-Zoom CURSOR
40E-05
ECH Reference Spectrum
30E-05
20E-05
10E-05
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Pag ed Z-Zoom CU RSOR
40E-05
EG Reference Spectrum
30E-05
20E-05
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Calibration Reference Spectra (Prediction Model)
Filename
Actual Predicted SEC Conc (ppm) Conc (ppm) (ppm)
Prediction %Error (ppm)
5EO_HSPC
5.27
5.383
0.012
2.143
8EO_H
8.01
8.676
0.012
8.316
14EO_H
14.34
13.701
0.012
-4.455
26EO_H
26.29
26.29
0
0
55EO_H
54.77
53.526
0.03
-2.272
Predicted Concentration (PPMv)
CLS Prediction Model Linearity Linearity of EO at 121 oC
60 y = 0.9821x R2 = 0.9993
50 40 30 20 10 0 0
10
20
30
40
Actual Concentration (PPMv)
50
60
Analysis Reference spectra Prepared on the instrument used for analysis but can be transferred to other instruments Recorded at the experimental temperature / conditions Concentration is measured using second technique or certified standard Multiple concentrations are prepared to bracket the experiment range Reference spectra are implemented into a Classical Least Squares (CLS) fit routine Sample Spectra are quantified by comparison to Single Component Reference spectra using CLS Multiple Species can be quantified simultaneously Analysis regions can be chosen to avoid interferences Multiple regions can be chosen to circumvent saturated absorbance bands that may deviate from Beer’s Law
EO Matrix Spike on Outgassing Medical Device Simulated Use EO Release @ 37o C 25.0
24 Hour outgas = 4.8 ppmv
PPMv EO
20.0
EO Spike 114% Recovery
= 38 ug EO
15.0
EO
10.0
EO Spike 103% Recovery
5.0 0.0 0.00
20.00
40.00
60.00
Elapsed Time (Hours)
80.00
100.00
Recovery of EO Matrix Spikes at 121 oC Spike
Average Prepared PPM
Average Indicated PPM
Average Recovery (%)
1
7.71
7.79
101
2
10.95
11.46
105
3
13.42
14.83
110
4
4.03
4.59
109
5
4.05
4.43
109
6
4.03
4.44
110
7
5.38
5.55
103
8
2.70
2.86
106
Average Spike
107
Percent RSD
3%
Method Advantages Real-time data collection allows calculation of release rates, formation of compounds, & outgassing endpoints FTIR method allows simultaneous data collection for materials characterization (ISO 10993-18 )
Method Advantages FTIR is additive, interferences can be subtracted Multiple compounds can be detected in a single test using fewer devices for testing Limits of Detection can be lower than GC methods
Method Advantages Broad range of selectivity for detection of compounds (organic and inorganic) Multiple spectral regions can be used to quantify compounds Recent ASTM, NIOSH & EPA approvals -Methods have been validated
