Tc99mTilmanoceptQualityChecker
Tc-99m Tilmanocept Quality Checker
Tc-99m Tilmanocept Quality Checker
Tc-99m Tilmanocept Quality Checker
ℹ️ Utility performs:
• Control of labelling yield, radiochemical purity, free Tc-99m, pH, activity and use time of tilmanocept.
• 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:
Tc99mTilmanoceptQualityChecker.exe → demonstration mode (console output)
Tc99mTilmanoceptQualityChecker.exe input.csv output.json → evaluate user data
Input format:
BatchNumber,LabelingYieldPercent,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,ActivityMBq,TimeSincePreparationMin,EndotoxinsEUPerVial,SterilityTest
Example:
TILM-001,99,98,1,6.5,20,30,20,0
— WHY IS THIS NEEDED?
Control of labelling yield, radiochemical purity, free Tc-99m, pH, activity and use time of tilmanocept.
The utility belongs to “RPH Lymphoscintigraphy and Sentinel Node QC Suite” and can be used as a standalone check or as part of a wider nuclear-medicine workflow.
⚠️ CRITICAL:
• LabelingYield: >=95
• RadiochemicalPurity: >=95
• FreePertechnetate: <=5
• pH: 4-8
• Activity: >0
• UseTime: <=360
• Endotoxins: <=175
• Sterility: =0
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:
• LabelingYield: >=95
• RadiochemicalPurity: >=95
• FreePertechnetate: <=5
• pH: 4-8
• Activity: >0
• UseTime: <=360
• Endotoxins: <=175
• Sterility: =0
💡 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,LabelingYieldPercent,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,ActivityMBq,TimeSincePreparationMin,EndotoxinsEUPerVial,SterilityTest TILM-001,99,98,1,6.5,20,30,20,0 TILM-002,96,95,4,5,5,240,150,0 TILM-003,80,82,15,3,0,500,300,1
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,LabelingYieldPercent,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,ActivityMBq,TimeSincePreparationMin,EndotoxinsEUPerVial,SterilityTest. - 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,LabelingYieldPercent,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,ActivityMBq,TimeSincePreparationMin,EndotoxinsEUPerVial,SterilityTest TILM-001,99,98,1,6.5,20,30,20,0 TILM-002,96,95,4,5,5,240,150,0 TILM-003,80,82,15,3,0,500,300,1
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
LabelingYield: >=95RadiochemicalPurity: >=95FreePertechnetate: <=5pH: 4-8Activity: >0UseTime: <=360Endotoxins: <=175Sterility: =0
Complete input.csv example
BatchNumber,LabelingYieldPercent,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,ActivityMBq,TimeSincePreparationMin,EndotoxinsEUPerVial,SterilityTest TILM-001,99,98,1,6.5,20,30,20,0 TILM-002,96,95,4,5,5,240,150,0 TILM-003,80,82,15,3,0,500,300,1
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 isotope family: Tc-99m
Tc-99m radiopharmaceuticals, kit preparation, generator control, SPECT workflows and calculation utilities.
OpenRPH Lymphoscintigraphy and Sentinel Node QC Suite
Tc-99m nanocolloid and tilmanocept control, injection review, acquisition QC, node-detection threshold and shine-through assessment.
OpenRPH organ/system: hepatobiliary and GI
HIDA, mebrofenin, gallbladder, gastric emptying, GI transit, bleeding and liver/spleen imaging.
OpenRPH organ/system: lymphatic, infection and inflammation
Sentinel node, lymphoscintigraphy, nanocolloid, labelled leukocytes, granulocyte and inflammatory imaging.
OpenRPH use case: HIDA, hepatobiliary and GI nuclear medicine
Hepatobiliary tracers, pertechnetate for Meckel/gastric mucosa, gastric emptying, GI transit, RBC bleeding and liver/spleen sulfur colloid.
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.
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