AutologousCellLabelingReleaseChecker

Autologous Cell Labeling Release Checker

medical-devices radiopharmaceuticals nuclear-medicine labelled-cells platelets in-111 tc-99m cell-viability
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Autologous Cell Labeling Release Checker

Autologous Cell Labeling Release Checker

ℹ️  Utility performs:
    • Final review of patient identity, viability, labelling efficiency, free activity, aggregates, sterility and endotoxins.
    • input.csv structure and numeric-value validation
    • LabWare-compatible output.json generation
    • Deterministic PASS / FAIL / ERROR status

⚠️  CRITICAL: Any nonconformity shall be reviewed by qualified personnel before the result is used in an operational workflow.

Usage:
  AutologousCellLabelingReleaseChecker.exe                            → demonstration mode (console output)
  AutologousCellLabelingReleaseChecker.exe input.csv output.json      → evaluate user data

Input format:
BatchNumber,PatientIdentityConfirmedFlag,CellViabilityPercent,LabelingEfficiencyPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToAdministrationMin

Example:
  AUTO-CELL-001,1,98,85,8,1,0,20,30

— WHY IS THIS NEEDED?
Final review of patient identity, viability, labelling efficiency, free activity, aggregates, sterility and endotoxins.
The utility belongs to “RPH Labelled Blood Cells QC Suite” and can be used as a standalone check or as part of a wider nuclear-medicine workflow.

⚠️  CRITICAL:
• PatientIdentity: =1
• CellViability: >=95
• LabelingEfficiency: >=70
• FreeActivity: <=20
• Aggregates: <=5
• Sterility: =0
• Endotoxins: <=175
• TimeToAdministration: <=180

Key features:
• One .NET 6 executable and one Program.cs
• Complete input.csv example with passing, boundary and failing records
• LabWare-compatible JSON: Header, Samples, Results, Status, StatusCode, ErrorMessage, Description and DescriptionEN
• CultureInfo.InvariantCulture for numeric values
• Explicit result for every parameter and empty ErrorMessage for PASS

Critical parameters:
• PatientIdentity: =1
• CellViability: >=95
• LabelingEfficiency: >=70
• FreeActivity: <=20
• Aggregates: <=5
• Sterility: =0
• Endotoxins: <=175
• TimeToAdministration: <=180

💡 Usage tips:
1. Before operational use, reconcile limits with the approved specification, product information, local SOP and equipment configuration.
2. Retain the source input.csv together with output.json and the executable version.
3. For clinical calculations, use only verified source data and an approved protocol profile.
4. FAIL requires review and is not an automatic medical decision.
5. Limit changes require change control and renewed verification.

⚠️ Note: The utility implements a deterministic CSV-to-LabWare-compatible-JSON workflow and does not replace an approved method, specification, SOP or medical judgement.

The reference limits in this version are a conservative FUZKK project starting profile. They shall be confirmed by the process owner before OQ/PQ and production use.

input.csv

BatchNumber,PatientIdentityConfirmedFlag,CellViabilityPercent,LabelingEfficiencyPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToAdministrationMin
AUTO-CELL-001,1,98,85,8,1,0,20,30
AUTO-CELL-002,1,95,70,20,5,0,150,120
AUTO-CELL-003,0,70,30,50,20,1,300,300

URS & FS — user requirements and functional specification

URS — User Requirements Specification

  • The utility shall run without arguments in demonstration mode and with two arguments: input.csv output.json.
  • Mandatory CSV header: BatchNumber,PatientIdentityConfirmedFlag,CellViabilityPercent,LabelingEfficiencyPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToAdministrationMin.
  • Numeric values shall be parsed with CultureInfo.InvariantCulture.
  • Each row shall create a separate Samples object in LabWare-compatible JSON.
  • Status shall be PASS, FAIL or ERROR; ErrorMessage shall be empty for PASS.
  • The utility shall apply workflow-specific rules and return a result for every parameter.
  • Repeated execution with the same data and version shall produce an identical result.
  • An invalid header, column count or value type shall produce ERROR, never PASS.

Complete input.csv example

BatchNumber,PatientIdentityConfirmedFlag,CellViabilityPercent,LabelingEfficiencyPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToAdministrationMin
AUTO-CELL-001,1,98,85,8,1,0,20,30
AUTO-CELL-002,1,95,70,20,5,0,150,120
AUTO-CELL-003,0,70,30,50,20,1,300,300

FS — Functional Specification

  1. Main() selects demonstration or file mode.
  2. LoadData() validates the exact header and converts each row into Record.
  3. Evaluate() returns a named tuple containing batch number, product, parameters, overall result and RU/EN recommendations.
  4. AddCheck() creates Results items with measured value, unit, limit and IsWithinSpec.
  5. RunWithFiles() builds Header/Samples and serializes the result with Newtonsoft.Json.
  6. A global exception becomes a SampleResult with ERROR status and code -1.

Implemented rules

  • PatientIdentity: =1
  • CellViability: >=95
  • LabelingEfficiency: >=70
  • FreeActivity: <=20
  • Aggregates: <=5
  • Sterility: =0
  • Endotoxins: <=175
  • TimeToAdministration: <=180

Complete input.csv example

BatchNumber,PatientIdentityConfirmedFlag,CellViabilityPercent,LabelingEfficiencyPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToAdministrationMin
AUTO-CELL-001,1,98,85,8,1,0,20,30
AUTO-CELL-002,1,95,70,20,5,0,150,120
AUTO-CELL-003,0,70,30,50,20,1,300,300

Minimum OQ scenarios

  • PASS for the first row.
  • Boundary-record processing for the second row.
  • FAIL for the third row.
  • ERROR for an altered header.
  • ERROR for a non-numeric value.
  • Identical JSON result on repeated execution.

Included in packages

PetRad QC Suite

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

Open

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.

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: labelled cells and blood

In-111 and Cr-51 for labelled cells, blood volume, RBC/WBC and survival workflows.

Open

RPH isotope family: Tc-99m

Tc-99m radiopharmaceuticals, kit preparation, generator control, SPECT workflows and calculation utilities.

Open

RPH Labelled Blood Cells QC Suite

In-111 and Tc-99m platelet labelling, cell recovery, autologous-cell release and cell-viability control.

Open

RPH organ/system: blood, cells and marrow

WBC/RBC/platelet labelling, blood volume, survival, blood-pool and cellular release workflows.

Open

RPH use case: labelled cells and blood-pool workflows

Leukocytes, red blood cells, platelets and autologous cell workflows: labeling efficiency, viability, free activity, recovery and release before reinjection.

Open

RPH workflow: product release QC

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

Open

RPH workflow: synthesis, labelling and kit reconstitution

Radiolabelling, synthesis, chelation, reducing agent, pH/stoichiometry and kit preparation.

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