Thulium170QualityChecker
Thulium-170
Utility description: Thulium-170
Thulium-170 Quality Checker — Thulium-170 for Synovitis Therapy and Palliative Care
ℹ️ Utility checks critical parameters of Thulium-170:
• Radionuclidic purity (≥99.5%)
• Thulium-171 impurity (≤0.1%) — CRITICAL!
• Ytterbium-175 impurity (≤0.5%)
• Radiochemical purity (≥95%)
• Free thulium (≤5%)
• pH, endotoxins, sterility, heavy metals
⚠️ CRITICAL: Thulium-171 (T½=1.9 years) creates long-term waste issues.
Tm-170 is mainly used as colloids for synovectomy.
Usage:
Thulium170QualityChecker.exe → demo mode (console output)
Thulium170QualityChecker.exe input.csv output.json → evaluate your data
Input format:
BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Thulium171ImpurityPercent,Ytterbium175ImpurityPercent,RadiochemicalPurityPercent,FreeThuliumPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
Example (sterility: 0=sterile, 1=contaminated):
TM170-COL-2026-001,100.0,99.8,0.05,0.1,98.0,2.0,6.5,20.0,0,2,ColloidSynovectomy
Supported product types:
• ColloidSynovectomy — radiosynovectomy
• CitrateSolution — solutions for interstitial therapy
— WHY IS THIS NEEDED?
Thulium-170 (T½=128.6 days) is a beta-emitter with soft energy (E_max=0.968 MeV):
• Ideal for radiosynovectomy (treatment of synovial membrane inflammation) due to short beta-particle range in tissues (~1-2 mm)
• Also used as citrate or other complexes for palliative therapy or interstitial administration
• Produced by neutron irradiation of enriched Yb-169 or Yb-170 followed by decay to Tm-170 (or direct Tm irradiation)
⚠️ CRITICAL:
• Radionuclidic purity ≥99.5% — presence of other isotopes is unacceptable.
• Thulium-171 (T½=1.92 years) impurity ≤0.1% — CRITICAL PARAMETER. Long-lived isotope that makes radioactive waste hazardous for many years. Even trace amounts are strictly regulated.
• Ytterbium-175 (T½=4.18 days) impurity ≤0.5% — Parent isotope. If not removed or cooling time not observed, it increases patient radiation dose without therapeutic benefit.
• Radiochemical purity ≥95% — For synovectomy, thulium must be in the form of a stable colloid with specific particle size. For other applications — in the form of a soluble complex (citrate).
• Free thulium ≤5% — Ionic thulium accumulates in bones (as a lanthanide), which is undesirable in local joint therapy.
• pH 4.0–7.5, Endotoxins ≤175 EU/vial, Sterility — standard safety requirements.
• Heavy metals ≤10 ppm — Precursor purity control.
Key features:
• Strict control of long-lived Tm-171 impurity
• Assessment of suitability for local therapy (synovectomy)
• Control of free thulium content
Critical parameters:
• Radionuclidic purity: ≥99.5%
• Tm-171 impurity: ≤0.1% (CRITICAL!)
• Yb-175 impurity: ≤0.5%
• Radiochemical purity: ≥95.0%
• Free thulium: ≤5.0%
• Heavy metals: ≤10 ppm
• pH: 4.0–7.5
• Endotoxins: ≤175 EU/vial
• Sterility: no microbial growth
💡 Usage tips:
1. Production of Tm-170 often involves separation from ytterbium target. Separation quality determines Yb and Tm-171 impurity levels.
2. For synovectomy, colloid particle size must be strictly controlled (similar to P-32 or Y-90) to avoid leakage to lymph nodes.
3. Half-life of 128 days is convenient for logistics, but decay correction is required for dose calculation.
4. Tm-170 also emits low-energy gamma quanta (84 keV), allowing imaging of drug distribution.
⚠️ Note: Thulium-170 is an alternative to Y-90 and P-32 for synovectomy of small joints (hand, foot) due to softer beta energy, reducing risk of damage to surrounding healthy tissues. However, the problem of long-lived Tm-171 impurity is the main limitation for its widespread adoption.input.csv
BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Thulium171ImpurityPercent,Ytterbium175ImpurityPercent,RadiochemicalPurityPercent,FreeThuliumPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType TM170-COL-2026-001,100.0,99.8,0.05,0.1,98.0,2.0,6.5,20.0,0,2,ColloidSynovectomy TM170-CIT-2026-002,150.0,99.5,0.1,0.4,96.0,4.0,6.0,30.0,0,3,CitrateSolution TM170-FAIL-2026-003,120.0,98.0,0.5,1.0,90.0,10.0,5.5,200.0,0,15,ColloidSynovectomy
URS & FS — User Requirements and Functional Specification
This document describes the controlled interface and behaviour of Thulium170QualityChecker for Thulium-170.
Domain limits and critical parameters
- ℹ️ Utility checks critical parameters of Thulium-170:
- • Radionuclidic purity (≥99.5%)
- • Thulium-171 impurity (≤0.1%) — CRITICAL!
- • Ytterbium-175 impurity (≤0.5%)
- • Radiochemical purity (≥95%)
- • Free thulium (≤5%)
- • pH, endotoxins, sterility, heavy metals
- ⚠️ CRITICAL: Thulium-171 (T½=1.9 years) creates long-term waste issues.
- BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Thulium171ImpurityPercent,Ytterbium175ImpurityPercent,RadiochemicalPurityPercent,FreeThuliumPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
- Example (sterility: 0=sterile, 1=contaminated):
- ⚠️ CRITICAL:
- • Radionuclidic purity ≥99.5% — presence of other isotopes is unacceptable.
- • Thulium-171 (T½=1.92 years) impurity ≤0.1% — CRITICAL PARAMETER. Long-lived isotope that makes radioactive waste hazardous for many years. Even trace amounts are strictly regulated.
- • Ytterbium-175 (T½=4.18 days) impurity ≤0.5% — Parent isotope. If not removed or cooling time not observed, it increases patient radiation dose without therapeutic benefit.
URS — User Requirements Specification
| ID | Requirement | Criticality | Acceptance criterion |
|---|---|---|---|
| URS-001 | The utility shall accept an input.csv file with the exact headers defined in the data contract. | High | The file is processed without manual header editing. |
| URS-002 | The utility shall perform deterministic QC evaluation for Thulium-170 using input values, approved limits and domain rules. | High | Each input row receives a PASS / WARNING / FAIL status. |
| URS-003 | The utility shall validate mandatory fields, data types, numeric ranges, units and pharmaceutical/radiochemical plausibility. | High | Schema and conversion errors are explicitly reported. |
| URS-004 | The utility shall identify critical deviations related to radionuclidic purity, radiochemical purity, free radionuclide, impurities, pH, endotoxins and sterility when such fields are present. | High | A critical deviation causes FAIL or a separate critical finding. |
| URS-005 | The utility shall generate output.json with machine-readable results, source values, warnings and failures. | High | JSON is suitable for LIMS/ELN/MES integration and QA/QC review. |
| URS-006 | The utility shall not use machine learning to decide conformance. | Medium | The result is based on explicit rules, thresholds and input values. |
| URS-007 | The utility shall preserve traceability between batch number, input values, applied rules and final status. | High | The output contains the batch identifier and the list of checked parameters. |
| URS-008 | The documentation shall support IQ/OQ preparation and inspection discussion with FDA/EMA/Roszdravnadzor or local regulators. | Medium | URS & FS, input.csv/output.json contract and test scenarios are supplied with the utility. |
input.csv contract
| # | Field | Type | Sample | Purpose |
|---|---|---|---|---|
| 1 | BatchNumber | string | TM170-COL-2026-001 | Batch or lot identifier used for traceability. |
| 2 | TotalActivityMBq | decimal | 100.0 | Radioactivity value used for release, decay or dose-related assessment. |
| 3 | RadionuclidicPurityPercent | string | 99.8 | Radionuclidic purity; a critical radiation-safety and impurity parameter. |
| 4 | Thulium171ImpurityPercent | string | 0.05 | Controlled impurity or residual material. |
| 5 | Ytterbium175ImpurityPercent | string | 0.1 | Controlled impurity or residual material. |
| 6 | RadiochemicalPurityPercent | string | 98.0 | Radiochemical purity; confirms the labelled chemical form and binding quality. |
| 7 | FreeThuliumPercent | decimal | 2.0 | Free radionuclide / unbound species; important for non-target uptake and toxicity. |
| 8 | pH | decimal | 6.5 | Solution pH; relevant for stability, compatibility and administration. |
| 9 | EndotoxinsEU | decimal | 20.0 | Bacterial endotoxins; critical for parenteral administration. |
| 10 | SterilityTest | flag / boolean | 0 | Sterility result; critical release parameter. |
| 11 | HeavyMetalsPPM | decimal | 2 | Elemental impurity / metal residue parameter. |
| 12 | ProductType | string | ColloidSynovectomy | Controlled input parameter used by the deterministic QC rules. |
BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Thulium171ImpurityPercent,Ytterbium175ImpurityPercent,RadiochemicalPurityPercent,FreeThuliumPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType TM170-COL-2026-001,100.0,99.8,0.05,0.1,98.0,2.0,6.5,20.0,0,2,ColloidSynovectomy TM170-CIT-2026-002,150.0,99.5,0.1,0.4,96.0,4.0,6.0,30.0,0,3,CitrateSolution TM170-FAIL-2026-003,120.0,98.0,0.5,1.0,90.0,10.0,5.5,200.0,0,15,ColloidSynovectomy
FS — Functional Specification
| ID | Function | Implementation |
|---|---|---|
| FS-001 | CSV import | Read input.csv in UTF-8/CSV-compatible format and validate the header and expected columns. |
| FS-002 | Schema validation | Check mandatory fields and column count; report unknown or missing key fields. |
| FS-003 | Type conversion | Convert numeric, flag and text values; invalid formats are recorded as row-level errors. |
| FS-004 | Domain rule engine | Apply domain rules for Thulium-170, including critical limits from the utility description and approved specification. |
| FS-005 | Status aggregation | Produce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance. |
| FS-006 | JSON export | Write output.json with detailed checks, source values, warnings, failures and critical findings. |
| FS-007 | Audit support | Keep the result structure suitable for review, deviation investigation, calculation reproduction and IQ/OQ preparation. |
| FS-008 | Integration contract | Support the production scenario: LIMS/ELN/MES creates input.csv, the utility returns output.json, the portal displays description and documentation. |
Example output.json
{
"utilityId": "thulium170-quality-checker",
"api": "Thulium-170",
"overallStatus": "PASS|WARNING|FAIL",
"sourceFile": "input.csv",
"checks": [
{
"parameter": "BatchNumber",
"value": "TM170-COL-2026-001",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "TotalActivityMBq",
"value": "100.0",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "RadionuclidicPurityPercent",
"value": "99.8",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "Thulium171ImpurityPercent",
"value": "0.05",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "Ytterbium175ImpurityPercent",
"value": "0.1",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "RadiochemicalPurityPercent",
"value": "98.0",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "FreeThuliumPercent",
"value": "2.0",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "pH",
"value": "6.5",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
}
],
"criticalFindings": []
}
OQ/PQ test scenarios
| ID | Scenario | Expected result |
|---|---|---|
| OQ-001 | Valid sample row | PASS or acceptable WARNING according to the rules. |
| OQ-002 | Mandatory column missing | Schema error or FAIL. |
| OQ-003 | Non-numeric value in numeric field | Type-conversion error. |
| OQ-004 | Critical parameter outside limit | FAIL and critical finding. |
| PQ-001 | User real batch/lot | Reviewed result with input.csv and output.json retained. |
QA/QC and change control
- Do not rename columns without updating the validator and test set.
- Retain
input.csv,output.json, executable version and checksum. - Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
- Critical radiopharmaceutical limits must be verified against the approved specification and local SOPs.
Included in packages
PetRad3: expanded PET/SPECT and radiopharmaceutical QC package
A curated suite for PET/SPECT radiopharmaceuticals, generator and cyclotron radionuclides, labelled compounds, radiochemical purity, breakthrough, sterility and endotoxin control.
OpenRadiology QC Suite
QC package for radiology and diagnostic imaging: radiopharmaceuticals, PET/SPECT, contrast media, iodinated and gadolinium products, plus particle, sterility and endotoxin checks.
OpenRPH organ/system: bone and musculoskeletal
Bone scintigraphy, MDP/PYP, marrow, bone-pain palliation, skeletal metastases and radiosynovectomy.
OpenRPH organ/system: lymphatic, infection and inflammation
Sentinel node, lymphoscintigraphy, nanocolloid, labelled leukocytes, granulocyte and inflammatory imaging.
OpenRPH use case: generators, isotope purity and starting radionuclides
Control of generator eluate, breakthrough, radionuclidic purity, isotope mix, carrier/free radionuclides and starting radionuclides before labeling.
OpenRPH workflow: generators and isotope purity
Generator eluate, breakthrough, radionuclidic purity, isotope mix and starting radionuclides.
OpenRPH workflow: imaging QC and quantitative interpretation
Acquisition, uptake, clearance, perfusion, transit, ejection fraction, segmentation and quantitative imaging.
OpenRPH workflow: product release QC
Assay, purity, sterility, endotoxins, pH, impurities, appearance and batch-release checks.
OpenRPH workflow: stability, storage, decay and waste
Kinetic stability, shelf life, decay correction, expiry, storage, trend and radioactive waste.
OpenRPH: combined radiopharmaceutical QC package
RPH combines PetRad, PetRad2 and PetRad3 into one umbrella package for PET/SPECT, therapeutic radionuclides, generators, labelled compounds, decay calculations, sterility, endotoxins and radiochemical/radionuclidic purity.
Open