Purpose

Define user requirements for a standalone FUZKK utility that accepts laboratory CSV data, evaluates the records using limits embedded in code, and produces LabWare-compatible JSON.

Scope

The utility is intended for preliminary QC/QA review, integration testing, LIMS/LabWare flow and evidence-trail preparation. Final release decisions remain under the laboratory's validated procedure and responsible personnel.

Users

QC analyst, QA reviewer, CSV/validation engineer, LIMS/LabWare integration engineer, responsible laboratory specialist.

User requirements

1. The utility shall run without arguments and print its self-description, a built-in input.csv example from GetDemoData(), and demo evaluation for the embedded records.
2. The utility shall run with two arguments: input.csv output.json.
3. The utility shall not read input.csv and shall not write output.json when started without arguments.
4. CSV numeric values shall be parsed using CultureInfo.InvariantCulture.
5. Output shall be generated as LabWare-compatible JSON with Header, Samples, Results, Status, StatusCode, ErrorMessage, Description and DescriptionEN.
6. For PASS records, ErrorMessage shall be an empty string.
7. Embedded limits shall follow this priority: Ph. Eur. → British Pharmacopoeia / UK implementation → EAEU / regional requirements → EMA/ICH/EU guidance → USP fallback.
8. If an exact monograph is not known, strict standard API limits are used where applicable: assay 98–102%, total impurities ≤1.0%, individual impurity ≤0.5%.
9. For biologics and mAb-like products, aggregation, sterility and endotoxin checks shall be included where relevant to the utility purpose.
10. If a parameter may arrive in different units, the unit shall be represented as a separate input field or explicitly reflected in the input.csv field name.

Input CSV

BatchNumber,ProductName,DeviceType,DeliveredDose_Percent,ShotWeight_mg,GlideForce_N,InjectionTime_sec,Particles_ge10um_per_ml,Particles_ge25um_per_ml,SterilityTest,Endotoxins_EU_ml,SubVisibleParticles_Count
PEN-REL-2026-001,Semaglutide 2.4mg Pen,Pre-filled Pen,98.5,150.0,8.5,10.0,150.0,20.0,0,0.1,50
PEN-REL-2026-002,Liraglutide 6mg Pen,Pre-filled Pen,95.0,120.0,12.0,12.0,200.0,30.0,0,0.2,60
PEN-REL-2026-003,Tirzepatide Auto-inj,Auto-injector,102.0,80.0,6.0,5.0,100.0,10.0,0,0.05,40

input.csv fields

Utility description

Peptide Device & Injectable Release QC — Peptide Device and Injectable Form Quality Control

Peptide Device & Injectable Release QC — Peptide Device and Injectable Form Quality Control

ℹ️ Utility checks delivery device and solution parameters:
• Dose accuracy (90-110%)
• Glide force (≤15 N)
• Particulate matter (USP <788>)
• Sterility and endotoxins

⚠️ CRITICAL: High injection force reduces treatment compliance!
Particles in solution can clog needle or cause reaction.

Usage:
PeptideDeviceInjectableReleaseQC.exe → demo mode (console output)
PeptideDeviceInjectableReleaseQC.exe input.csv output.json → evaluate your data

Input format:
BatchNumber,ProductName,DeviceType,DeliveredDose_Percent,ShotWeight_mg,GlideForce_N,InjectionTime_sec,Particles_ge10um_per_ml,Particles_ge25um_per_ml,SterilityTest,Endotoxins_EU_ml,SubVisibleParticles_Count

Example:
PEN-REL-2026-001,Semaglutide 2.4mg Pen,Pre-filled Pen,98.5,150.0,8.5,10.0,150.0,20.0,0,0.1,50

— WHY IS THIS NEEDED?
Delivery device control is critical for peptide drugs (Novo Nordisk, Eli Lilly):
• Most GLP-1 agonists are delivered via complex devices (pens, auto-injectors)
• Dose accuracy must be maintained from first to last injection
• Glide force affects patient usability and comfort
• Peptide solutions are sensitive to particle formation upon contact with device materials
• Sterility and low endotoxin levels are mandatory for parenteral administration

⚠️ CRITICAL:
• Dose accuracy 90-110% — guarantees therapeutic effect
• Glide force ≤15 N — ensures comfortable injection
• Particles ≥10 μm ≤6000/mL and ≥25 μm ≤600/mL — USP <788> compliance
• Sterility — absolute requirement
• Endotoxins ≤0.5 EU/mL — patient safety

Key features:
• Combined device mechanics and solution quality control
• Usability assessment via injection force
• Solution cleanliness monitoring (particles)
• Safety check (sterility, endotoxins)

Critical parameters:
• Dose accuracy: 90–110%
• Glide force: ≤15 N
• Particles ≥10 μm: ≤6000 particles/mL
• Particles ≥25 μm: ≤600 particles/mL
• Sterility: Negative
• Endotoxins: ≤0.5 EU/mL

💡 Usage tips:
1. Perform tests on full devices (not just cartridges)
2. Measure glide force at different injection speeds
3. Control solution compatibility with device materials (needle siliconization)
4. For auto-injectors, additionally check injection time and click sound
5. If high particle level observed, check filtration and filling process

⚠️ Note: Unlike simple vials, pen devices contain many moving parts. Seal wear or uneven siliconization can lead to changes in injection force and dosing inaccuracy. The utility helps identify such issues at the release stage.

Traceability and limitations

• The URS is used as the source document for functional specification, CSV review and later validation work.
• This document does not replace an approved pharmacopoeial monograph, validated analytical method or internal product specification.
• For product-specific limits, the approved customer specification takes priority.

The functional specification describes the behaviour of the standalone FUZKK console utility, input-data format, evaluation algorithm and output JSON structure.

Functional flow

1. Main() checks the number of arguments.
2. If no arguments are provided: PrintHello() prints the description and built-in input.csv example, then RunDemoEvaluation() executes Evaluate() over GetDemoData() and prints demo JSON.
3. If two arguments are provided: RunWithFiles(input.csv, output.json) reads CSV, evaluates each record and writes LabWare-compatible JSON.
4. LoadData() uses CultureInfo.InvariantCulture and shall not be called in no-arguments mode.
5. Evaluate() returns a named tuple with BatchNumber, ProductName, Parameters, CriticalFailCount, WarningCount, Recommendation and RecommendationEN.
6. GetIssues() builds messages for ErrorMessage in WARNING/FAIL cases.

Evaluation rules

• PASS: CriticalFailCount = 0 and WarningCount = 0.
• WARNING: CriticalFailCount = 0 and WarningCount > 0.
• FAIL: CriticalFailCount > 0.
• ERROR: exception during reading or processing.
• ErrorMessage remains empty for PASS.
• Limits are embedded in Program.cs; no external limit configuration is required.

Input and fields

BatchNumber,ProductName,DeviceType,DeliveredDose_Percent,ShotWeight_mg,GlideForce_N,InjectionTime_sec,Particles_ge10um_per_ml,Particles_ge25um_per_ml,SterilityTest,Endotoxins_EU_ml,SubVisibleParticles_Count
PEN-REL-2026-001,Semaglutide 2.4mg Pen,Pre-filled Pen,98.5,150.0,8.5,10.0,150.0,20.0,0,0.1,50
PEN-REL-2026-002,Liraglutide 6mg Pen,Pre-filled Pen,95.0,120.0,12.0,12.0,200.0,30.0,0,0.2,60
PEN-REL-2026-003,Tirzepatide Auto-inj,Auto-injector,102.0,80.0,6.0,5.0,100.0,10.0,0,0.05,40

Output JSON

{
  "Header": {
    "UtilityName": "Peptide_DeviceInjectable_Release_QC",
    "Version": "1.0.0",
    "Timestamp": "UTC",
    "InstrumentID": "FUZKK-QC-WORKSTATION",
    "OperatorID": "Admin"
  },
  "Samples": [
    {
      "SampleID": "from BatchNumber",
      "BatchNumber": "from CSV",
      "ProductName": "from CSV",
      "TestName": "utility-specific test",
      "AnalysisCode": "utility-specific code",
      "Status": "PASS | WARNING | FAIL | ERROR",
      "StatusCode": "1 | 2 | 0 | -1",
      "ErrorMessage": "",
      "Description": "Russian recommendation",
      "DescriptionEN": "English recommendation",
      "Results": [
        {
          "ParameterName": "parameter",
          "ResultValue": 0.0,
          "UnitOfMeasure": "unit",
          "SpecificationLimit": "limit",
          "IsWithinSpec": true
        }
      ]
    }
  ]
}