WBCReinjectionReleaseChecker
WBC Reinjection Release Checker
WBC Reinjection Release Checker
WBC Reinjection Release Checker
ℹ️ Utility performs:
• Final review of identity, labelling efficiency, viability, free activity, aggregates and time to reinjection.
• 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:
WBCReinjectionReleaseChecker.exe → demonstration mode (console output)
WBCReinjectionReleaseChecker.exe input.csv output.json → evaluate user data
Input format:
BatchNumber,PatientIdentityConfirmedFlag,LabelingEfficiencyPercent,ViabilityPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToReinjectionMin
Example:
WBC-REL-001,1,75,98,8,1,0,20,30
— WHY IS THIS NEEDED?
Final review of identity, labelling efficiency, viability, free activity, aggregates and time to reinjection.
The utility belongs to “RPH Labelled Leukocyte Preparation and Release QC Suite” and can be used as a standalone check or as part of a wider nuclear-medicine workflow.
⚠️ CRITICAL:
• PatientIdentity: =1
• LabelingEfficiency: >=40
• Viability: >=95
• FreeActivity: <=20
• Aggregates: <=5
• Sterility: =0
• Endotoxins: <=175
• TimeToReinjection: <=120
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
• LabelingEfficiency: >=40
• Viability: >=95
• FreeActivity: <=20
• Aggregates: <=5
• Sterility: =0
• Endotoxins: <=175
• TimeToReinjection: <=120
💡 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,LabelingEfficiencyPercent,ViabilityPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToReinjectionMin WBC-REL-001,1,75,98,8,1,0,20,30 WBC-REL-002,1,45,95,18,5,0,150,100 WBC-REL-003,0,20,75,40,20,1,300,240
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,LabelingEfficiencyPercent,ViabilityPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToReinjectionMin. - 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,LabelingEfficiencyPercent,ViabilityPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToReinjectionMin WBC-REL-001,1,75,98,8,1,0,20,30 WBC-REL-002,1,45,95,18,5,0,150,100 WBC-REL-003,0,20,75,40,20,1,300,240
FS — Functional Specification
Main()selects demonstration or file mode.LoadData()validates the exact header and converts each row intoRecord.Evaluate()returns a named tuple containing batch number, product, parameters, overall result and RU/EN recommendations.AddCheck()creates Results items with measured value, unit, limit and IsWithinSpec.RunWithFiles()builds Header/Samples and serializes the result with Newtonsoft.Json.- A global exception becomes a SampleResult with ERROR status and code -1.
Implemented rules
PatientIdentity: =1LabelingEfficiency: >=40Viability: >=95FreeActivity: <=20Aggregates: <=5Sterility: =0Endotoxins: <=175TimeToReinjection: <=120
Complete input.csv example
BatchNumber,PatientIdentityConfirmedFlag,LabelingEfficiencyPercent,ViabilityPercent,FreeActivityPercent,AggregatePercent,SterilityTest,EndotoxinsEUPerVial,TimeToReinjectionMin WBC-REL-001,1,75,98,8,1,0,20,30 WBC-REL-002,1,45,95,18,5,0,150,100 WBC-REL-003,0,20,75,40,20,1,300,240
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.
OpenPetRad3: 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 Infection and Inflammation Imaging QC Suite
Ga-67 citrate, Tc-99m sulesomab and Tc-99m besilesomab control, plus antigranulocyte imaging acquisition review.
OpenRPH isotope family: Tc-99m
Tc-99m radiopharmaceuticals, kit preparation, generator control, SPECT workflows and calculation utilities.
OpenRPH Labelled Blood Cells QC Suite
In-111 and Tc-99m platelet labelling, cell recovery, autologous-cell release and cell-viability control.
OpenRPH Labelled Leukocyte Preparation and Release QC Suite
Tc-99m HMPAO leukocyte labelling, labelling efficiency, cell viability and recovery, free activity, process time and temperature, and pre-reinjection release.
OpenRPH organ/system: blood, cells and marrow
WBC/RBC/platelet labelling, blood volume, survival, blood-pool and cellular release workflows.
OpenRPH organ/system: lymphatic, infection and inflammation
Sentinel node, lymphoscintigraphy, nanocolloid, labelled leukocytes, granulocyte and inflammatory imaging.
OpenRPH 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.
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: synthesis, labelling and kit reconstitution
Radiolabelling, synthesis, chelation, reducing agent, pH/stoichiometry and kit preparation.
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