Tc99mHIDAQualityChecker

Tc-99m HIDA Quality Checker

api radiopharmaceuticals nuclear-medicine tc-99m hida hepatobiliary-imaging liver-function radiochemical-purity
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Tc-99m HIDA Quality Checker

Tc-99m HIDA Quality Checker

ℹ️  Utility performs:
    • Control of radiochemical purity, free pertechnetate, pH, sterility, endotoxins and use time for a HIDA preparation.
    • 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:
  Tc99mHIDAQualityChecker.exe                            → demonstration mode (console output)
  Tc99mHIDAQualityChecker.exe input.csv output.json      → evaluate user data

Input format:
BatchNumber,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,EndotoxinsEUPerVial,SterilityTest,TimeSincePreparationMin,ActivityMBq

Example:
  HIDA-001,98,1,6.5,40,0,30,180

— WHY IS THIS NEEDED?
Control of radiochemical purity, free pertechnetate, pH, sterility, endotoxins and use time for a HIDA preparation.
The utility belongs to “RPH Tc-99m Hepatobiliary and HIDA QC Suite” and can be used as a standalone check or as part of a wider nuclear-medicine workflow.

⚠️  CRITICAL:
• RadiochemicalPurity: >=95
• FreePertechnetate: <=5
• pH: 4-8
• Endotoxins: <=175
• Sterility: =0
• UseTime: <=360
• Activity: >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:
• RadiochemicalPurity: >=95
• FreePertechnetate: <=5
• pH: 4-8
• Endotoxins: <=175
• Sterility: =0
• UseTime: <=360
• Activity: >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,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,EndotoxinsEUPerVial,SterilityTest,TimeSincePreparationMin,ActivityMBq
HIDA-001,98,1,6.5,40,0,30,180
HIDA-002,95,4,5,150,0,240,100
HIDA-003,85,10,3,250,1,500,0

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,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,EndotoxinsEUPerVial,SterilityTest,TimeSincePreparationMin,ActivityMBq.
  • 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,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,EndotoxinsEUPerVial,SterilityTest,TimeSincePreparationMin,ActivityMBq
HIDA-001,98,1,6.5,40,0,30,180
HIDA-002,95,4,5,150,0,240,100
HIDA-003,85,10,3,250,1,500,0

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

  • RadiochemicalPurity: >=95
  • FreePertechnetate: <=5
  • pH: 4-8
  • Endotoxins: <=175
  • Sterility: =0
  • UseTime: <=360
  • Activity: >0

Complete input.csv example

BatchNumber,RadiochemicalPurityPercent,FreePertechnetatePercent,pH,EndotoxinsEUPerVial,SterilityTest,TimeSincePreparationMin,ActivityMBq
HIDA-001,98,1,6.5,40,0,30,180
HIDA-002,95,4,5,150,0,240,100
HIDA-003,85,10,3,250,1,500,0

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: Tc-99m

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

Open

RPH organ/system: hepatobiliary and GI

HIDA, mebrofenin, gallbladder, gastric emptying, GI transit, bleeding and liver/spleen imaging.

Open

RPH Tc-99m Hepatobiliary and HIDA QC Suite

Quality control of HIDA, mebrofenin and disofenin, hepatic extraction and gallbladder ejection calculations, and hepatobiliary transit review.

Open

RPH 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.

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: 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