GeneratorElutionPredictor
Generator Elution Predictor
Generator Elution Predictor — Generator elution activity predictor
ℹ️ Utility calculates PREDICTED daughter nuclide activity in generator eluate:
• Accounts for parent nuclide decay since calibration
• Accounts for daughter nuclide ingrowth between elutions
• Applies elution efficiency to calculate activity in eluate
• Estimates number of possible patient doses
⚠️ IMPORTANT: Result is a PREDICTION and does NOT replace activity measurement
before clinical use. Used for production planning and assessment of activity
sufficiency for scheduled studies.
Usage:
GeneratorElutionPredictor.exe → demo mode (console output)
GeneratorElutionPredictor.exe input.csv output.json → calculate with your data
Input format:
BatchNumber,GeneratorType,GeneratorCalibrationActivityMBq,CalibrationDateTime,LastElutionDateTime,NextElutionDateTime,ElutionEfficiencyPercent,DosePerPatientMBq
Examples:
TC99M-GEN-2026-001,Mo99-Tc99m,30000.0,2026-03-17T08:00:00,2026-03-18T08:00:00,2026-03-19T08:00:00,80.0,750.0
GA68-GEN-2026-001,Ge68-Ga68,1850.0,2026-03-01T08:00:00,2026-03-18T08:00:00,2026-03-18T14:00:00,60.0,200.0
RB82-GEN-2026-001,Sr82-Rb82,3700.0,2026-03-10T08:00:00,2026-03-18T08:00:00,2026-03-18T09:00:00,90.0,1500.0
— WHY IS THIS NEEDED?
Generator elution planning is critical in radiopharmacy:
• For diagnostic generators (Mo-99/Tc-99m) — ensuring sufficient activity for all
scheduled studies during the day
• For therapeutic/PET generators (Ge-68/Ga-68, Sr-82/Rb-82) — optimizing elution timing
for maximum activity with minimal losses
• For inventory management — deciding when to order a new generator
• For documentation — activity prediction for reporting and audits
⚠️ CRITICAL:
• Utility uses PHYSICAL decay model accounting for transient equilibrium
• Formula: A_d(t) = A_p(0) × [λ_d / (λ_d - λ_p)] × [1 - e^(-(λ_d - λ_p)×t)] × e^(-λ_p×t)
• Requires knowledge of PARENT nuclide activity at generator calibration
(provided in generator certificate by manufacturer)
• Elution efficiency varies by generator type and method:
— Mo-99/Tc-99m: 70-90% (typically 80%)
— Ge-68/Ga-68: 50-70% (typically 60%)
— Sr-82/Rb-82: 85-95% (typically 90%)
• Result is a PREDICTION — actual activity must be measured with dose calibrator
before clinical use!
Key features:
• Support for 3 major generator types with accurate half-lives
• Automatic daughter nuclide ingrowth time calculation
• Parent nuclide decay since calibration accounted for
• Patient dose count calculation
• Result categorization: EXCELLENT / ADEQUATE / MARGINAL / INSUFFICIENT
• Optional parameters with reasonable defaults
• Demo mode with clinically relevant examples for all generator types
Supported generators:
• Mo-99/Tc-99m: T½(Mo-99)=66 h, T½(Tc-99m)=6.01 h, efficiency=80%, dose=750 MBq
Use: bone, cardiac, renal scintigraphy
• Ge-68/Ga-68: T½(Ge-68)=6480 h (271 days), T½(Ga-68)=1.13 h, efficiency=60%, dose=200 MBq
Use: NET, prostate cancer PET
• Sr-82/Rb-82: T½(Sr-82)=605 h (25.2 days), T½(Rb-82)=0.0212 h (1.27 min), efficiency=90%, dose=1500 MBq
Use: cardiac PET perfusion
💡 Usage tips:
1. Always use PARENT nuclide activity from generator certificate
(do not confuse with activity in first eluate!)
2. For Mo-99/Tc-99m optimal time between elutions is 24 hours
3. For Ge-68/Ga-68 maximum activity reached 10-12 hours after elution
4. For Sr-82/Rb-82 elution possible every 10 minutes (short daughter half-life)
5. For INSUFFICIENT prediction — increase ingrowth time or order new generator
6. Document prediction before elution for audits
⚠️ Limitations:
• Does not account for column aging (decreasing efficiency over time)
• Does not account for generator storage temperature conditions
• Does not replace activity measurement before clinical use
• Assumes ideal elution (real-world variations ±10% possible)
Data sources:
• IAEA Technical Reports Series No. 466 (2009) — Radiopharmaceuticals for Positron Emission Tomography
• USP General Chapter <825> — Radiopharmaceuticals for Positron Emission Tomography
• Manufacturer specifications for commercial generators (Curium, IThemba LABS, etc.)
• Journal of Nuclear Medicine Technology — Generator elution efficiency studiesinput.csv
BatchNumber,GeneratorType,GeneratorCalibrationActivityMBq,CalibrationDateTime,LastElutionDateTime,NextElutionDateTime,ElutionEfficiencyPercent,DosePerPatientMBq TC99M-GEN-2026-001,Mo99-Tc99m,30000.0,2026-03-17T08:00:00,2026-03-18T08:00:00,2026-03-19T08:00:00,80.0,750.0 GA68-GEN-2026-001,Ge68-Ga68,1850.0,2026-03-01T08:00:00,2026-03-18T08:00:00,2026-03-18T14:00:00,60.0,200.0 RB82-GEN-2026-001,Sr82-Rb82,3700.0,2026-03-10T08:00:00,2026-03-18T08:00:00,2026-03-18T09:00:00,90.0,1500.0
URS & FS — user requirements and functional specification
This document defines user requirements and functional specification for the quality-control utility. It supports deployment discussion, IQ/OQ preparation and QC workflow integration.
1. Scope
The Generator Elution Predictor utility is used for Generator Elution Predictor. The actual input.csv is the source of truth for the input structure; control criteria are defined by the executable and the domain description.
The utility does not use machine learning; decisions are produced by deterministic rules.
Categories: Radiopharmaceuticals
Tags: decay correction, endotoxins, PET, radionuclide purity, radiopharma, SPECT, sterility
2. Execution modes
GeneratorElutionPredictor.exe → demo mode (console output) GeneratorElutionPredictor.exe input.csv output.json → calculate with your data
3. Key controlled areas
- purity and impurities
- microbiology and pathogens
- pH and physicochemical parameters
- activity, decay and radiochemical purity
4. Domain limits and critical parameters
- ⚠️ IMPORTANT: Result is a PREDICTION and does NOT replace activity measurement
- ⚠️ CRITICAL:
- Utility uses PHYSICAL decay model accounting for transient equilibrium
- Formula: A_d(t) = A_p(0) × [λ_d / (λ_d - λ_p)] × [1 - e^(-(λ_d - λ_p)×t)] × e^(-λ_p×t)
- Requires knowledge of PARENT nuclide activity at generator calibration
- Elution efficiency varies by generator type and method:
- — Mo-99/Tc-99m: 70-90% (typically 80%)
- — Ge-68/Ga-68: 50-70% (typically 60%)
- — Sr-82/Rb-82: 85-95% (typically 90%)
- Result is a PREDICTION — actual activity must be measured with dose calibrator
- Support for 3 major generator types with accurate half-lives
- Automatic daughter nuclide ingrowth time calculation
- Parent nuclide decay since calibration accounted for
- Patient dose count calculation
- Result categorization: EXCELLENT / ADEQUATE / MARGINAL / INSUFFICIENT
- Optional parameters with reasonable defaults
- Demo mode with clinically relevant examples for all generator types
- Mo-99/Tc-99m: T½(Mo-99)=66 h, T½(Tc-99m)=6.01 h, efficiency=80%, dose=750 MBq
- Ge-68/Ga-68: T½(Ge-68)=6480 h (271 days), T½(Ga-68)=1.13 h, efficiency=60%, dose=200 MBq
- Sr-82/Rb-82: T½(Sr-82)=605 h (25.2 days), T½(Rb-82)=0.0212 h (1.27 min), efficiency=90%, dose=1500 MBq
- 1. Always use PARENT nuclide activity from generator certificate
- 2. For Mo-99/Tc-99m optimal time between elutions is 24 hours
- 3. For Ge-68/Ga-68 maximum activity reached 10-12 hours after elution
- 4. For Sr-82/Rb-82 elution possible every 10 minutes (short daughter half-life)
5. URS — user requirements
| ID | Requirement | Criticality | Acceptance criterion |
|---|---|---|---|
| URS-001 | The system shall accept an input.csv file for Generator Elution Predictor with the exact columns listed in the “Input data contract” section. | High | A file with the correct header is processed without manual editing; missing mandatory columns produce FAIL/import error. |
| URS-002 | The system shall support execution without arguments in demo mode and execution with input.csv output.json for user data. | Medium | Both execution scenarios produce a predictable result or clear diagnostic error. |
| URS-003 | The system shall perform rule-based controls for: purity and impurities, microbiology and pathogens, pH and physicochemical parameters, activity, decay and radiochemical purity. | High | Each controlled parameter receives a status and message; the result does not depend on hidden Excel formulas or ML. |
| URS-004 | The system shall preserve traceability between batch/lot, source values, applied rules and final verdict. | High | Output includes batch identifier, source values, parameter statuses and critical findings. |
| URS-005 | The system shall generate machine-readable output.json for LIMS/ELN/MES, batch record and QA/QC review. | High | JSON contains overall status, check array, warnings, failures and source-file reference. |
| URS-006 | The system shall support use in the client validation package: URS/FS, IQ/OQ preparation, installation and operational scenario checks. | High | The document, test scenarios and reproducible CSV/JSON flow are suitable for audit and internal approval. |
| URS-007 | The system shall clearly separate technical data errors from specification nonconformities. | Medium | Schema/type errors are not mixed with pharmacopoeial deviations and are reported separately. |
6. input.csv data contract
The source of truth for the input schema is the actual input.csv header. Column names are technical identifiers and are not translated.
| # | Column | Type | Unit | Description | Sample | Control rule |
|---|---|---|---|---|---|---|
| 1 | BatchNumber | identifier | as specified | Batch Number | TC99M-GEN-2026-001 | mandatory field; used for batch/lot traceability |
| 2 | GeneratorType | text | as specified | Generator Type | Mo99-Tc99m | mandatory value; format and acceptability are checked by the utility |
| 3 | GeneratorCalibrationActivityMBq | decimal | MBq | Generator Calibration Activity MBq | 30000.0 | mandatory numeric value; rule comparison is performed by the utility |
| 4 | CalibrationDateTime | date/time | as specified | Calibration Date Time | 2026-03-17T08:00:00 | mandatory value; format and acceptability are checked by the utility |
| 5 | LastElutionDateTime | date/time | as specified | Last Elution Date Time | 2026-03-18T08:00:00 | mandatory value; format and acceptability are checked by the utility |
| 6 | NextElutionDateTime | date/time | as specified | Next Elution Date Time | 2026-03-19T08:00:00 | mandatory value; format and acceptability are checked by the utility |
| 7 | ElutionEfficiencyPercent | decimal | % | Elution Efficiency % | 80.0 | mandatory numeric value; rule comparison is performed by the utility |
| 8 | DosePerPatientMBq | decimal | MBq | Dose per Patient MBq | 750.0 | mandatory numeric value; rule comparison is performed by the utility |
CSV example
BatchNumber,GeneratorType,GeneratorCalibrationActivityMBq,CalibrationDateTime,LastElutionDateTime,NextElutionDateTime,ElutionEfficiencyPercent,DosePerPatientMBq TC99M-GEN-2026-001,Mo99-Tc99m,30000.0,2026-03-17T08:00:00,2026-03-18T08:00:00,2026-03-19T08:00:00,80.0,750.0
7. FS — functional specification
| ID | Function | Implementation description |
|---|---|---|
| FS-001 | CLI entry point | The executable GeneratorElutionPredictor.exe supports demo mode and input.csv output.json processing mode. |
| FS-002 | CSV parser | The import module reads CSV, validates header, column presence/order, value count and encoding. Decimal values are expected with a dot separator. |
| FS-003 | Field conversion | Each column is converted to the expected type: identifier, text, decimal number, date/time or boolean flag. |
| FS-004 | Domain rule engine | For Generator Elution Predictor, explicit rules are applied: range, minimum, maximum, absence of prohibited flag, data completeness or calculation-based check. |
| FS-005 | Criticality handling | Critical violations produce FAIL; non-critical deviations and incomplete data produce WARNING; full conformance produces PASS. |
| FS-006 | JSON writer | output.json stores overall status, per-parameter results, source values, warnings, failures and diagnostic messages. |
| FS-007 | Integration contract | The CSV → JSON format is stable for invocation from LIMS/ELN/MES, scheduled task or wrapper service. |
| FS-008 | Error handling | Schema error, missing file, non-numeric value or JSON write failure returns diagnosable error without silent PASS. |
8. output.json contract
The output file must be suitable for automated processing, audit review and correlation with the source input.csv row.
{
"utility": "GeneratorElutionPredictor",
"api": "Generator Elution Predictor",
"batchNumber": "TC99M-GEN-2026-001",
"overallStatus": "PASS|WARNING|FAIL",
"checkedAtUtc": "2026-05-18T00:00:00Z",
"checks": [
{
"parameter": "BatchNumber",
"value": "TC99M-GEN-2026-001",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "GeneratorType",
"value": "Mo99-Tc99m",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "GeneratorCalibrationActivityMBq",
"value": "30000.0",
"unit": "MBq",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "CalibrationDateTime",
"value": "2026-03-17T08:00:00",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "LastElutionDateTime",
"value": "2026-03-18T08:00:00",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "NextElutionDateTime",
"value": "2026-03-19T08:00:00",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "ElutionEfficiencyPercent",
"value": "80.0",
"unit": "%",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "DosePerPatientMBq",
"value": "750.0",
"unit": "MBq",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
}
],
"criticalFindings": [],
"sourceFile": "input.csv"
}9. OQ/PQ test scenarios
| ID | Scenario | Expected result |
|---|---|---|
| TC-001 | Valid CSV with expected header and sample row | All rows are processed; output contains PASS/WARNING/FAIL and parameter-level detail. |
| TC-002 | A mandatory input.csv column is missing | Import is rejected or the row receives FAIL with schema reference. |
| TC-003 | A numeric field contains text or a blank value | Type conversion error is recorded; the result is not hidden as PASS. |
| TC-004 | A parameter is outside specification or critical limit | Critical parameters produce FAIL; non-critical deviations produce WARNING according to the rule. |
| TC-008 | Incorrect activity, reference time or radiochemical purity | FAIL/WARNING is produced with calculation traceability. |
10. QA/QC, CSV and change control
- Before production use, the client records executable version, checksum, specification/monograph version, test CSV, expected JSON and IQ/OQ results.
- Column names must not be changed without updating the validator and test scenarios.
- The source CSV, output.json and utility version should be stored together as an evidence package.
- Any change in control rules must go through change control and repeated OQ scenario verification.
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