PET Course KFSH&RC Calibration of QC Instruments for PET Radiopharmaceuticals Testing

1. Sonny Wahab
Senior Quality Control Chemist, QC Section
Cyclotron & Radiopharmaceuticals Department
King Faisal Specialist Hospital & Research Centre
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2. Origin – from the word caliber
– Earliest record comes from Egypt, Indus Valley
and Mesopotamia
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3.  In measurement technology and metrology – is the
comparison of measurement values delivered by a
device under test with those of a standard of known
accuracy.
 In instrument calibration- is the process of
evaluating and adjusting the precision and accuracy
of measurement equipment.
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4. Similar names – qualification, validation
Qualification means documented assurance that
equipment (or facilities, utilities, etc.) are suitable for
intended use.
Validation is objective evidence that a process or
procedure (including analytical methods) result in a
consistent output meeting quality specifications.
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5.  Qualification can be considered to be a part of the
validation process and forms as the initial basis of
calibration.
 Installation Qualification (IQ), Opérations
Qualification (OQ) and Performance Qualification
(PQ)
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6. Frequency:
 Installation (IQ, OQ, PQ)
 Periodic or routine
 After major repair or any questionable observation.
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7.  Accuracy
 Precision
 Reliability
 Confidence in result
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8.  – Using the wrong calibrator values
 - Calibrator formulation tolerance
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9.  Sample preparation technique
 Ambient temperature effects
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10.  SOP’s and forms for calibrations.
 Log file for instrument type, parts list, serial
numbers, maintenance history, supplies list,
parameters data trend
 Stickers- Instrument status
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11. 1. High Performance Liquid Chromatography (HPLC)- Annually
2. Gas Chromatograph – Annually
3. Gamma Spectroscopy System- Annually/Daily Verification
4. Radioactivity Imaging Scanner- Annually
5. Dose Calibrator- Annually/Weekly Verification
6. Osmometer- Every time out of calibration/Weekly Verification
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12. 1. High Performance Liquid Chromatography (HPLC)
a. Flow rate ± 3%
b. System Pressure Decay ± ≤ 0.15
c. Wavelength Accuracy 257 ± 2 nm
d. Detector Linearity Correlation Coefficient, γ ≥ 0.99
e. Retention Time Precision RSD ≤ 1.0%
f. Radioactive Area Precision RSD ≤ 3.0%
g. UV Area Precision RSD ≤ 1.0%
h. Radioactive Area Linearity Correlation Coefficient, γ ≥ 0.99
i. UV Area Linearity Correlation Coefficient, γ ≥ 0.99
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13. 2. Gas Chromatograph
a. System Check Pass
b. Column Flow Rate Check Report results; Correlation
Coefficient, γ ≥ 0.98
c. Precision, Retention Time RSD ≤ 5.0%
d. Precision, Peak Area Ratio RSD ≤ 5.0%
e. Linearity Correlation Coefficient, γ ≥ 0.98
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14. 3. Gamma Spectroscopy System
a. Background Check Pass
b. Energy Calibration Pass
c. Peak-to-Compton Ratio 30-50
d. Efficiency Calibration Pass
e. Reference Standard Check ± 5% of Standard Activity
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17. 4. Radioactivity Imaging Scanner
a. Positional Linearity ± 3 mm
b. Resolution > 80%
c. Normalization As per attached reference scan
d. Background Typically < 50 cpm
e. Detector Linearity Peaks 1+3 : 1.8-2.2% ,
Peak 2 : 97.8-98.2%
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18. 5. Dose Calibrator
Annually
a. Constancy ± 2%
b. Accuracy ± 5%
c. Linearity (By Decay Method) ≥ 0.99
d. Linearity (Using Calicheck Kit) ± 5%
Weekly
a. Self-test Pass
b. Background Check Pass
c. Accuracy Check ± 5% of Standard Activity
d. Constancy Check ± 2%
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19. 6. Osmometer
a. 290 Std. Check 290 ± 4
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