Tc99mBesilesomabQualityChecker

Tc-99m Besilesomab Quality Checker

Tc-99m Besilesomab Quality Checker

ℹ️  Utility performs:
    • Control of labelling yield, RCP, free Tc-99m, aggregates and contraindication flags related to HAMA/previous exposure.
    • 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:
  Tc99mBesilesomabQualityChecker.exe                            → demonstration mode (console output)
  Tc99mBesilesomabQualityChecker.exe input.csv output.json      → evaluate user data

Input format:
BatchNumber,LabelingYieldPercent,RadiochemicalPurityPercent,FreePertechnetatePercent,AggregatePercent,HAMAContraindicationFlag,PreviousBesilesomabExposureFlag,pH,SterilityTest

Example:
  BESI-001,99,98,1,1,0,0,6.5,0

— WHY IS THIS NEEDED?
Control of labelling yield, RCP, free Tc-99m, aggregates and contraindication flags related to HAMA/previous exposure.
The utility belongs to “RPH Infection and Inflammation Imaging 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
• Aggregates: <=5
• HAMAContraindication: =0
• PreviousExposure: =0 for this reference profile
• pH: 4-8
• 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
• Aggregates: <=5
• HAMAContraindication: =0
• PreviousExposure: =0 for this reference profile
• pH: 4-8
• 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.