Gallium68LNPTrackerQualityChecker

Gallium68 LNP Tracker

decay correction endotoxins impurities PET radionuclide purity radiopharma SPECT sterility

⚠️ DEPRECATED UTILITY

This utility has been REPLACED by the universal version:

RadiolabeledNanoparticleQualityChecker.exe

Please use the universal utility instead:

RadiolabeledNanoparticleQualityChecker.exe input.csv output.json

Reasons for replacement:
• Universal utility supports 5 radionuclides (not just Ga-68 only)
• Automatic parameter adaptation for target organ
• More flexible and extensible architecture
• Less code duplication and easier maintenance

Remove this utility from the package:
• Gallium68LNPTrackerQualityChecker.exe
• Gallium68LNPTrackerQualityChecker.cs
• Gallium68LNPTrackerQualityChecker.description.txt
• input.csv (specific to this utility)

Use instead:
• RadiolabeledNanoparticleQualityChecker.exe
• RadiolabeledNanoparticleQualityChecker.cs
• RadiolabeledNanoparticleQualityChecker.description.txt

For backward compatibility:
If you have old scripts using Gallium68LNPTrackerQualityChecker.exe,
replace them with:

OLD:
Gallium68LNPTrackerQualityChecker.exe input_old.csv output.json

NEW:
RadiolabeledNanoparticleQualityChecker.exe input_new.csv output.json

Input file format has changed:

OLD FORMAT:
BatchNumber,SpecificActivityGBqPerUmol,RadiochemicalPurityPercent,Germanium68ImpurityPercent,FreeGallium68Percent,ParticleSizeNm,ParticleSizePDI,pH,EndotoxinsEU,SterilityTest,TargetOrgan

NEW FORMAT:
BatchNumber,Radionuclide,NanoparticleType,TargetOrgan,SpecificActivityMBqPerUmol,RadiochemicalPurityPercent,FreeRadionuclidePercent,ParentNuclideImpurityPercent,ParticleSizeNm,PolydispersityIndex,ZetaPotentialMv,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM

Conversion example:

OLD:
GA68-LNP-2026-001,45.0,94.5,0.0005,7.0,100.0,0.15,6.8,120.0,0,Lungs

NEW:
RN-2026-001,Ga-68,LNP,Lungs,45000.0,94.5,7.0,0.0005,100.0,0.15,-25.0,6.8,120.0,0,5.0

Note:
• Specific activity now in MBq/μmol (not GBq/μmol)
• New parameters added: NanoparticleType, ZetaPotentialMv, HeavyMetalsPPM
• ParentNuclideImpurityPercent can be blank for non-generator nuclides

For assistance:
Contact developer:
• Artem Nadobnykh (Russia / CIS / Asia)
• Sergey Mortikov (UK / EU / North America) — Telegram: @Serge_Mo

input.csv

BatchNumber,SpecificActivityGBqPerUmol,RadiochemicalPurityPercent,Germanium68ImpurityPercent,FreeGallium68Percent,ParticleSizeNm,ParticleSizePDI,pH,EndotoxinsEU,SterilityTest,TargetOrgan
GA68-LNP-2026-001,45.0,94.5,0.0005,7.0,100.0,0.15,6.8,120.0,0,Lungs

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: Gallium68LNPTrackerQualityCheckerAPI / object: Gallium68 LNP TrackerCategory: Radiopharmaceuticals

1. Scope

The Gallium68 LNP Tracker Quality Checker utility is used for Gallium68 LNP Tracker. 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, impurities, PET, radionuclide purity, radiopharma, SPECT, sterility

2. Execution modes

Gallium68LNPTrackerQualityChecker.exe
Gallium68LNPTrackerQualityChecker.exe input.csv output.json

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

⚠️ DEPRECATED UTILITY

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 Gallium68 LNP Tracker 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	`GA68-LNP-2026-001`	mandatory field; used for batch/lot traceability
2	`SpecificActivityGBqPerUmol`	decimal	GBq	Specific Activity GBq per Umol	`45.0`	mandatory numeric value; rule comparison is performed by the utility
3	`RadiochemicalPurityPercent`	decimal	%	Radiochemical Purity %	`94.5`	numeric value; compared with assay/purity limit from specification or method
4	`Germanium68ImpurityPercent`	decimal	%	Germanium68 Impurity %	`0.0005`	numeric value; compared with individual or total impurity limit
5	`FreeGallium68Percent`	decimal	%	Free Gallium68 %	`7.0`	mandatory numeric value; rule comparison is performed by the utility
6	`ParticleSizeNm`	decimal	µm	Particle Size Nm	`100.0`	mandatory numeric value; rule comparison is performed by the utility
7	`ParticleSizePDI`	decimal	µm	Particle Size PDI	`0.15`	mandatory numeric value; rule comparison is performed by the utility
8	`pH`	decimal	pH	p H	`6.8`	mandatory numeric value; rule comparison is performed by the utility
9	`EndotoxinsEU`	decimal	as specified	Endotoxins EU	`120.0`	numeric value; critical safety attribute compared with endotoxin limit
10	`SterilityTest`	boolean / flag	0/1	Sterility Test	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent
11	`TargetOrgan`	text	as specified	Target Organ	`Lungs`	mandatory value; format and acceptability are checked by the utility

CSV example

BatchNumber,SpecificActivityGBqPerUmol,RadiochemicalPurityPercent,Germanium68ImpurityPercent,FreeGallium68Percent,ParticleSizeNm,ParticleSizePDI,pH,EndotoxinsEU,SterilityTest,TargetOrgan
GA68-LNP-2026-001,45.0,94.5,0.0005,7.0,100.0,0.15,6.8,120.0,0,Lungs

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `Gallium68LNPTrackerQualityChecker.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 Gallium68 LNP Tracker, 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": "Gallium68LNPTrackerQualityChecker",
  "api": "Gallium68 LNP Tracker",
  "batchNumber": "GA68-LNP-2026-001",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "GA68-LNP-2026-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SpecificActivityGBqPerUmol",
      "value": "45.0",
      "unit": "GBq",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "94.5",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Germanium68ImpurityPercent",
      "value": "0.0005",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeGallium68Percent",
      "value": "7.0",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ParticleSizeNm",
      "value": "100.0",
      "unit": "µm",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ParticleSizePDI",
      "value": "0.15",
      "unit": "µm",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "6.8",
      "unit": "pH",
      "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-005	Positive pathogen/microbiological flag or microbiological limit excursion	Critical FAIL is produced with the offending parameter.
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 isotope family: Ga/Ge

Ga-67, Ga-68 and Ge-68: generator, radiolabelling, PET/SPECT and purity workflows.

Open

RPH organ/system: oncology and theranostics

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

Open

RPH organ/system: pulmonary and ventilation

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

Open

RPH use case: PET/SPECT oncology diagnostics and receptor imaging

F-18, Ga-68, Cu-64, Zr-89, In-111 and other diagnostic tracers: synthesis, purity, receptor targeting, immuno-PET and generator-based workflows.

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

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