RadionuclideMixChecker

Radionuclide Mix

decay correction endotoxins PET radionuclide purity radiopharma SPECT sterility

Radionuclide Mix Checker — Batch and radionuclide mix-up check during manual data entry

ℹ️ Utility performs CRITICAL data verification to prevent catastrophic errors:
• Batch number verification (entered vs expected)
• Radionuclide verification (entered vs expected)
• Activity deviation check from expected value (±20%)
• Activity plausibility check for given radionuclide
• Deviation analysis and risk assessment with specific recommendations

⚠️ CRITICAL: Designed to prevent errors like "administered wrong radiopharmaceutical to patient"!
Even single batch mix-up can lead to patient death or serious harm.
Real incident examples:
• Administered Lu-177 instead of F-18 → excessive radiation dose without diagnostic benefit
• Administered previous batch Ra-223 (expired) → reduced therapy efficacy
• Administered I-131 instead of Tc-99m → unintended therapeutic dose during diagnostics

Usage:
RadionuclideMixChecker.exe → demo mode (console output)
RadionuclideMixChecker.exe input.csv output.json → verification with your data

Input format:
RecordID,EnteredBatchNumber,ExpectedBatchNumber,EnteredNuclide,ExpectedNuclide,EnteredActivityMBq,MeasurementDateTime,TechnicianID,WorkstationID,ExpectedActivityMBq

Examples:
REC-001,F18-FDG-2026-03-18-A,F18-FDG-2026-03-18-A,F-18,F-18,3700.0,2026-03-18T09:00:00,TECH-001,WS-PET-01,3800.0
REC-002,LU177-PSMA-2026-03-18-B,LU177-PSMA-2026-03-18-B,F-18,Lu-177,6000.0,2026-03-18T10:30:00,TECH-002,WS-THERAPY-02,6200.0
REC-003,RA223-2026-03-17-X,RA223-2026-03-18-A,Ra-223,Ra-223,110.0,2026-03-18T11:00:00,TECH-003,WS-THERAPY-01,110.0

— WHY IS THIS NEEDED?
Batch and radionuclide mix-ups are among the most dangerous errors in radiopharmacy:
• Human factor: fatigue, distraction, similar batch number formats
• Systemic issues: inconvenient LIMS interface, lack of dual verification
• Consequences: wrong diagnosis, excessive radiation dose, fatalities
• Statistics: per IAEA, 15-20% of radiation incidents are related to identification errors

⚠️ CRITICAL:
• Utility does NOT replace dual verification by two technicians (GMP requirement)
• Utility IS a critical safety barrier BEFORE patient administration
• Integration into workflow: run AFTER data entry, BEFORE drug release to imaging suite
• All critical errors require IMMEDIATE process stop

Key features:
• Instant detection of batch number mismatches (even typos)
• Detection of radionuclide mix-ups (F-18 instead of Lu-177 etc.)
• Activity plausibility check (protection from unit errors: MBq vs GBq)
• Activity deviation analysis from expected value (±20%)
• Risk categorization: CRITICAL / WARNING / ACCEPTABLE
• Specific action recommendations for errors
• Audit trail (technician, workstation, check time)
• Summary report for all verified records (critical errors, warnings count)

Typical error detection scenarios:
1. Technician entered yesterday's generator batch instead of today's → UTILITY STOPS
2. Radionuclide selected as "F-18" instead of "Ga-68" in system → UTILITY STOPS
3. Activity entered as 37000 instead of 3700 (extra zero) → PLAUSIBILITY CHECK TRIGGERS
4. Activity 30% below expected (possible dose calibrator calibration error) → WARNING

💡 Implementation recommendations:
1. Integrate utility into workflow AFTER data entry in LIMS, BEFORE drug release
2. Configure automatic launch on dose calibrator data export
3. Mandatory use of "ExpectedBatchNumber" field (from production schedule)
4. For critical agents (therapeutic) set stricter tolerance (±10% instead of ±20%)
5. All critical errors should block further processing in system
6. Regularly update activity plausibility database for your specific products

⚠️ Limitations:
• Requires correct "ExpectedBatchNumber" field population (from schedule/LIMS)
• Does not replace visual verification of physical vial label
• Cannot detect errors if expected and entered values match by mistake
• For complete safety DUAL VERIFICATION BY TWO TECHNICIANS IS REQUIRED (human factor)

Data sources:
• IAEA Safety Standards Series No. SSG-46 (2016) — Radiation Protection and Safety in Medical Uses of Ionizing Radiation
• ISPN Guidelines on Prevention of Errors in Radiopharmacy (2021)
• FDA Guidance: Investigational New Drug Applications (INDs) for Radiopharmaceuticals
• Journal of Nuclear Medicine Technology — Analysis of Radiopharmacy Errors (2022)

input.csv

RecordID,EnteredBatchNumber,ExpectedBatchNumber,EnteredNuclide,ExpectedNuclide,EnteredActivityMBq,MeasurementDateTime,TechnicianID,WorkstationID,ExpectedActivityMBq
REC-001,F18-FDG-2026-03-18-A,F18-FDG-2026-03-18-A,F-18,F-18,3700.0,2026-03-18T09:00:00,TECH-001,WS-PET-01,3800.0
REC-002,LU177-PSMA-2026-03-18-B,LU177-PSMA-2026-03-18-B,F-18,Lu-177,6000.0,2026-03-18T10:30:00,TECH-002,WS-THERAPY-02,6200.0
REC-003,RA223-2026-03-17-X,RA223-2026-03-18-A,Ra-223,Ra-223,110.0,2026-03-18T11:00:00,TECH-003,WS-THERAPY-01,110.0
REC-004,TC99M-MDP-2026-03-18-C,TC99M-MDP-2026-03-18-C,Tc-99m,Tc-99m,15000.0,2026-03-18T08:30:00,TECH-001,WS-SPECT-01,20000.0

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.

Utility: RadionuclideMixCheckerAPI / object: Radionuclide MixCategory: Radiopharmaceuticals

1. Scope

The Radionuclide Mix Checker utility is used for Radionuclide Mix. 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

RadionuclideMixChecker.exe                            → demo mode (console output)
RadionuclideMixChecker.exe input.csv output.json      → verification 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

⚠️ CRITICAL: Designed to prevent errors like "administered wrong radiopharmaceutical to patient"!
Administered Lu-177 instead of F-18 → excessive radiation dose without diagnostic benefit
Administered previous batch Ra-223 (expired) → reduced therapy efficacy
Administered I-131 instead of Tc-99m → unintended therapeutic dose during diagnostics
⚠️ CRITICAL:
Utility does NOT replace dual verification by two technicians (GMP requirement)
Utility IS a critical safety barrier BEFORE patient administration
Integration into workflow: run AFTER data entry, BEFORE drug release to imaging suite
All critical errors require IMMEDIATE process stop
Instant detection of batch number mismatches (even typos)
Detection of radionuclide mix-ups (F-18 instead of Lu-177 etc.)
Activity plausibility check (protection from unit errors: MBq vs GBq)
Activity deviation analysis from expected value (±20%)
Risk categorization: CRITICAL / WARNING / ACCEPTABLE
Specific action recommendations for errors
Audit trail (technician, workstation, check time)
Summary report for all verified records (critical errors, warnings count)
1. Technician entered yesterday's generator batch instead of today's → UTILITY STOPS
2. Radionuclide selected as "F-18" instead of "Ga-68" in system → UTILITY STOPS
3. Activity entered as 37000 instead of 3700 (extra zero) → PLAUSIBILITY CHECK TRIGGERS
4. Activity 30% below expected (possible dose calibrator calibration error) → WARNING
1. Integrate utility into workflow AFTER data entry in LIMS, BEFORE drug release
2. Configure automatic launch on dose calibrator data export
3. Mandatory use of "ExpectedBatchNumber" field (from production schedule)

Limits stated in the description must be verified against the current approved specification, pharmacopoeial monograph and registration dossier before production use.

5. URS — user requirements

ID	Requirement	Criticality	Acceptance criterion
URS-001	The system shall accept an `input.csv` file for Radionuclide Mix 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	`RecordID`	text	as specified	Record ID	`REC-001`	mandatory value; format and acceptability are checked by the utility
2	`EnteredBatchNumber`	identifier	as specified	Entered Batch Number	`F18-FDG-2026-03-18-A`	mandatory field; used for batch/lot traceability
3	`ExpectedBatchNumber`	identifier	as specified	Expected Batch Number	`F18-FDG-2026-03-18-A`	mandatory field; used for batch/lot traceability
4	`EnteredNuclide`	text	as specified	Entered Nuclide	`F-18`	mandatory value; format and acceptability are checked by the utility
5	`ExpectedNuclide`	text	as specified	Expected Nuclide	`F-18`	mandatory value; format and acceptability are checked by the utility
6	`EnteredActivityMBq`	decimal	MBq	Entered Activity MBq	`3700.0`	mandatory numeric value; rule comparison is performed by the utility
7	`MeasurementDateTime`	date/time	as specified	Measurement Date Time	`2026-03-18T09:00:00`	mandatory value; format and acceptability are checked by the utility
8	`TechnicianID`	text	as specified	Technician ID	`TECH-001`	mandatory value; format and acceptability are checked by the utility
9	`WorkstationID`	text	as specified	Workstation ID	`WS-PET-01`	mandatory value; format and acceptability are checked by the utility
10	`ExpectedActivityMBq`	decimal	MBq	Expected Activity MBq	`3800.0`	mandatory numeric value; rule comparison is performed by the utility

CSV example

RecordID,EnteredBatchNumber,ExpectedBatchNumber,EnteredNuclide,ExpectedNuclide,EnteredActivityMBq,MeasurementDateTime,TechnicianID,WorkstationID,ExpectedActivityMBq
REC-001,F18-FDG-2026-03-18-A,F18-FDG-2026-03-18-A,F-18,F-18,3700.0,2026-03-18T09:00:00,TECH-001,WS-PET-01,3800.0

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `RadionuclideMixChecker.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 Radionuclide Mix, 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": "RadionuclideMixChecker",
  "api": "Radionuclide Mix",
  "batchNumber": "F18-FDG-2026-03-18-A",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "RecordID",
      "value": "REC-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EnteredBatchNumber",
      "value": "F18-FDG-2026-03-18-A",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ExpectedBatchNumber",
      "value": "F18-FDG-2026-03-18-A",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EnteredNuclide",
      "value": "F-18",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ExpectedNuclide",
      "value": "F-18",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EnteredActivityMBq",
      "value": "3700.0",
      "unit": "MBq",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "MeasurementDateTime",
      "value": "2026-03-18T09:00:00",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TechnicianID",
      "value": "TECH-001",
      "unit": "as specified",
      "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.

Included in packages

PetRad QC Suite

A specialised utility package for radiopharmaceutical quality control: PET, SPECT, therapeutic radionuclides, generators and decay calculations.

Open

Radiology QC Suite

QC package for radiology and diagnostic imaging: radiopharmaceuticals, PET/SPECT, contrast media, iodinated and gadolinium products, plus particle, sterility and endotoxin checks.

Open

RPH organ/system: oncology and theranostics

Tumour imaging, PSMA/FAPI/receptor tracers, immuno-PET, targeted radionuclide therapy and radioembolization.

Open

RPH 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.

Open

RPH workflow: generators and isotope purity

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

Open

RPH workflow: imaging QC and quantitative interpretation

Acquisition, uptake, clearance, perfusion, transit, ejection fraction, segmentation and quantitative imaging.

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

RPH: 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