Xe127ProductionYieldAndPurityAnalyzer

Xe-127 Production Yield & Purity Analyzer

api Hyperpolarized Xenon RPH Xe-129 medical gases CSV→JSON URS & FS rule-based
Open selection

Utility description: Xe-127 Production Yield & Purity Analyzer

Xe-127 Production Yield & Purity Analyzer — Xe-127 Production Yield and Purity Analyzer

ℹ️  Utility controls cyclotron production process of Xe-127:
    • Specific yield (MBq/uAh)
    • Radionuclidic purity (% Xe-127)
    • Impurity levels (Xe-125, I-123)

⚠️  CRITICAL: Xe-125 has a long half-life!
    Its presence increases patient radiation dose without diagnostic benefit.

Usage:
  Xe127ProductionYieldAndPurityAnalyzer.exe                            → demo mode (console output)
  Xe127ProductionYieldAndPurityAnalyzer.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,ProductName,Iodine_Mass_g,Beam_uA,Time_h,Act_Xe127_MBq,Act_Xe125_MBq,Act_I123_MBq,Min_Yield,Max_Xe125_Percent

Example:
  XE127-PROD-2026-001,Xe-127,1.0,20,2,2200,10,5,50,1.0

— WHY IS THIS NEEDED?
Xe-127 production control is critical for nuclear medicine:
• Xe-127 is produced by irradiating iodine targets with protons on a cyclotron
• Process must be efficient (high yield) for economic viability
• Side reactions lead to formation of Xe-125 and I-123
• Xe-125 (T1/2 ~17 h) creates unwanted radiation burden
• Utility helps optimize irradiation parameters and control raw material quality

⚠️  CRITICAL:
• Specific yield ≥50 MBq/uAh (depends on beam energy)
• Radionuclidic purity ≥99%
• Xe-125 impurity ≤1%
• Beam energy control to minimize threshold reactions

Key features:
• Specific yield calculation based on beam parameters
• Radionuclidic purity assessment via gamma spectrometry
• Specific impurity monitoring (Xe-125)
• Support for various iodine target types

Critical parameters:
• Specific Yield: ≥50 MBq/uAh
• Purity: ≥99%
• Xe-125 Impurity: ≤1%

💡 Usage tips:
1. Use high-purity targets to reduce side isotope formation
2. Precisely calibrate beam current and irradiation time
3. Perform gamma-spectrometric analysis immediately after end of bombardment (EOB)
4. Account for decay of short-lived impurities before product release
5. Maintain yield log for each cyclotron energy setting

⚠️ Note: Unlike reactor production, cyclotron production allows carrier-free isotopes but requires strict beam energy control to avoid "hitting" adjacent nuclear levels. The utility helps maintain this balance.

input.csv

BatchNumber,ProductName,Iodine_Mass_g,Beam_uA,Time_h,Act_Xe127_MBq,Act_Xe125_MBq,Act_I123_MBq,Min_Yield,Max_Xe125_Percent
XE127-PROD-2026-001,Xe-127 (Cyclotron),1.0,20,2,2200,10,5,50,1.0
XE127-PROD-2026-002,Xe-127 (Low Yield),1.0,20,2,800,5,2,50,1.0
XE127-PROD-2026-003,Xe-127 (High Impurity),1.0,20,2,2000,50,5,50,1.0

URS & FS — user requirements and functional specification

URS & FS — User Requirements and Functional Specification

This document defines the controlled interface and behaviour of Xe127ProductionYieldAndPurityAnalyzer for “Xe-127 Production Yield & Purity Analyzer”. Limits from the source description are an initial configuration and shall be reconciled with the approved specification, study protocol, equipment instructions and local SOPs before production use.

Domain constraints and critical parameters

  • Specific Yield: ≥50 MBq/uAh
  • Purity: ≥99%
  • Xe-125 Impurity: ≤1%

URS — User Requirements Specification

IDRequirementCriticalityAcceptance criterion
URS-001The utility shall accept input.csv with the exact headers defined by the data contract.HighThe file is processed without manual header renaming.
URS-002The utility shall perform a deterministic assessment for “Xe-127 Production Yield & Purity Analyzer”.HighPASS / WARNING / FAIL is produced for each row.
URS-003Required fields, types, ranges, units and data consistency shall be validated before domain rules.HighSchema errors are separated from nonconformities.
URS-004Critical limits from the description and approved local configuration shall create a critical finding.HighA critical rule violation results in FAIL.
URS-005The result shall be written to machine-readable output.json.HighJSON contains source values, checks, warnings and failures.
URS-006The conformity decision shall not use machine learning.MediumThe result is reproducible from explicit rules and inputs.
URS-007Traceability of batch, source file, rule version and final status shall be retained.HighQA/QC can reproduce the decision.
URS-008The utility shall have exactly one primary portal tag: api.MediumThe other api / instrumental / medical_devices tags are absent.
URS-009Documentation shall support IQ/OQ/PQ or equivalent CSA/CSV verification.MediumThe contract, test scenarios and change-control rules are supplied with the utility.

input.csv data contract

#FieldTypeUnitSamplePurpose
1BatchNumberstringas specifiedXE127-PROD-2026-001Batch/lot identifier for traceability.
2ProductNamestringas specifiedXe-127 (Cyclotron)Name of the controlled product, gas, procedure or equipment.
3Iodine_Mass_gdecimalG1.0Controlled input.csv field: Iodine Mass g.
4Beam_uAdecimalas specified20Controlled input.csv field: Beam u A.
5Time_hdecimalh2Time parameter for processing, relaxation, pumping or examination.
6Act_Xe127_MBqdecimalMBq2200Xenon parameter: concentration, isotope fraction, activity, volume or purity depending on the field.
7Act_Xe125_MBqdecimalMBq10Xenon parameter: concentration, isotope fraction, activity, volume or purity depending on the field.
8Act_I123_MBqdecimalMBq5Controlled input.csv field: Act I123 MBq.
9Min_Yielddecimalas specified50Controlled input.csv field: Min Yield.
10Max_Xe125_Percentdecimal%1.0Xenon parameter: concentration, isotope fraction, activity, volume or purity depending on the field.
BatchNumber,ProductName,Iodine_Mass_g,Beam_uA,Time_h,Act_Xe127_MBq,Act_Xe125_MBq,Act_I123_MBq,Min_Yield,Max_Xe125_Percent
XE127-PROD-2026-001,Xe-127 (Cyclotron),1.0,20,2,2200,10,5,50,1.0
XE127-PROD-2026-002,Xe-127 (Low Yield),1.0,20,2,800,5,2,50,1.0
XE127-PROD-2026-003,Xe-127 (High Impurity),1.0,20,2,2000,50,5,50,1.0

FS — Functional Specification

IDFunctionImplementation
FS-001CLI executionXe127ProductionYieldAndPurityAnalyzer.exe supports demo mode and input.csv output.json mode.
FS-002CSV importRead UTF-8 CSV and validate header, column count and order.
FS-003Schema validationValidate required values, empties, types and basic plausibility.
FS-004Domain rule engineApply explicit rules for “Xe-127 Production Yield & Purity Analyzer” and locally approved limits.
FS-005Status aggregationFAIL for a critical finding; WARNING for a non-critical deviation; PASS for conformity.
FS-006JSON exportWrite source values, applied rules, statuses, warnings, failures and configuration version.
FS-007Audit supportRetain a result structure suitable for review, investigation, IQ/OQ and change control.
FS-008Integration contractLIMS/ELN/MES or an instrument wrapper creates CSV; the utility returns JSON.

output.json example

{
  "utilityId": "xe127-production-yield-and-purity-analyzer",
  "primaryTag": "api",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "XE127-PROD-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ProductName",
      "value": "Xe-127 (Cyclotron)",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Iodine_Mass_g",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Beam_uA",
      "value": "20",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Time_h",
      "value": "2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Act_Xe127_MBq",
      "value": "2200",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Act_Xe125_MBq",
      "value": "10",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Act_I123_MBq",
      "value": "5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "warnings": [],
  "criticalFindings": []
}

OQ/PQ test scenarios

IDScenarioExpected result
OQ-001Valid example rowPASS or an allowed WARNING under local rules.
OQ-002Required column missingSchema error; domain checks do not mask it.
OQ-003Non-numeric value in numeric fieldType-conversion error.
OQ-004Critical parameter outside its limitFAIL and a critical finding.
OQ-005Boundary valueThe result follows the configured ≤ / ≥ / < / > operator.
PQ-001Real site dataAgreed QA/QC review retaining CSV, JSON, version and checksum.

QA/QC and change control

  • Do not change column names without updating the validator, documentation and test set.
  • Retain input.csv, output.json, executable version, rule version and checksums.
  • Before production use, verify local limits and execute IQ/OQ/PQ or equivalent CSA.
  • Changes affecting patient safety, dosimetry, gas composition, polarization or equipment require documented impact assessment.

Included in packages

Rph Hyperpolarized Xenon Lifecycle QC Suite

29 utilities for the hyperpolarized xenon lifecycle: isotope composition and gas purity, SEOP and polarization, T1/storage/transport, safe blending and delivery, MRI/SPECT QC, dosimetry, scavenging, recovery and recycling.

Open

RPH isotope family: radioiodine

I-123, I-124, I-125 and I-131 for diagnostics, therapy, labelling and purity control.

Open

RPH isotope family: xenon and gas tracers

Xe-127, Xe-129 and Xe-133 for ventilation, hyperpolarized imaging, gas QC and safety.

Open

RPH organ/system: pulmonary and ventilation

Lung perfusion, MAA, V/Q, aerosol, xenon ventilation, shunt and pulmonary dosimetry.

Open

RPH use case: xenon, ventilation and medical gases

Xe-129, Xe-133, Xe-127, hyperpolarization, SEOP, T1, mixing, scavenging, transport, recovery and ventilation imaging.

Open

RPH workflow: generators and isotope purity

Generator eluate, breakthrough, radionuclidic purity, isotope mix and starting radionuclides.

Open

RPH workflow: product release QC

Assay, purity, sterility, endotoxins, pH, impurities, appearance and batch-release checks.

Open

RPH workflow: stability, storage, decay and waste

Kinetic stability, shelf life, decay correction, expiry, storage, trend and radioactive waste.

Open