MultidoseVialUsageAndVaccineWastage_QualityChecker

Multidose Vial Usage And Vaccine Wastage

Huvac human vaccines vaccination adjuvants mRNA vaccines sterility endotoxins cold chain

Utility description: Multidose Vial Usage And Vaccine Wastage

Multidose Vial Usage And Vaccine Wastage Quality Checker — Multidose Vial Usage Control

ℹ️ Utility performs analysis of multidose vial (MDV) usage efficiency and wastage monitoring according to WHO guidelines and healthcare logistics standards:
• Usage Efficiency: Calculation of percentage of actually administered doses vs total vial capacity.
• Time Control: Strict monitoring of time elapsed since first rubber stopper puncture.
• Dose Balance: Reconciliation of administered and discarded doses with declared vial volume.
• Wastage Analysis: Classification of disposal reasons (expiry, cold chain breach, breakage).

⚠️ IMPORTANT:
• After opening, multidose vial becomes a potential source of bacterial contamination.
• Adherence to time limit (e.g., 6 hours for some vaccines) is critical for patient safety.

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

Input format:
VialSerialNumber,BatchNumber,ProductName,TotalDosesInVial,DosesAdministered,DosesDiscarded,OpenedTime,DiscardTime,MaxHoursAfterOpen

Example:
MDV-001,BATCH-A,HepB,10,9,1,2026-01-01 09:00,2026-01-01 14:00,6

📍 Scope of Application (Usage Where):
• Vaccination Points: Daily accounting of vaccine consumption.
• Warehouse Management: Analysis of material write-off reasons.
• Epidemiological Surveillance: Optimization of procurement and logistics.
• Quality Audit: Verification of MDV handling protocol compliance.

— WHY IS THIS NEEDED?
High vaccine wastage leads to significant financial losses and drug shortages.
At the same time, attempting to use a vial longer than allowed creates serious health risks.
Utility helps find balance between economic efficiency and patient safety.

⚠️ CRITICAL:
• Time Limit: Exceeding time after opening requires immediate disposal of residue, even if doses remain.
• Cold Chain: If vial is out of fridge longer than allowed, it must be rejected.
• Balance Check: Discrepancy in dose balance may indicate accounting errors or theft.
• Sterility: Reusing needles for withdrawal from same vial is unacceptable.

Key features:
• Automatic Wastage Rate calculation
• Usage time window control
• Detection of dose balance anomalies
• Report generation for procurement optimization
• Compliance with WHO waste management guidelines

Critical parameters:
• Utilization Rate: Target indicator (>80%)
• Wastage Rate: Allowable limit (<20%)
• Time After Open: Strictly within SOP
• Dose Balance: Exact match

💡 Usage tips:
1. Planning: Group patients for simultaneous vaccination to minimize residues.
2. Labeling: Clearly indicate opening time on each vial.
3. Training: Staff must know exact time limits for each vaccine type.
4. Disposal: Use safety containers for residue and needle disposal.
5. Trend Analysis: Regularly review reports to identify systemic issues.

⚠️ Note: This utility is a management and quality control tool. It does not replace medical decision on necessity of vaccination for specific patient.

input.csv

VialSerialNumber,BatchNumber,ProductName,TotalDosesInVial,DosesAdministered,DosesDiscarded,OpenedTime,DiscardTime,MaxHoursAfterOpen
MDV-2026-001,BATCH-X-99,Hepatitis B Vaccine,10,9,1,2026-06-08 09:00:00,2026-06-08 14:00:00,6
MDV-2026-002,BATCH-Y-88,Measles Vaccine,10,2,8,2026-06-08 08:00:00,2026-06-08 15:00:00,6
MDV-2026-003,BATCH-Z-77,Influenza Vaccine,10,10,0,2026-06-08 10:00:00,2026-06-08 11:30:00,24

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of MultidoseVialUsageAndVaccineWastage_QualityChecker for Multidose Vial Usage And Vaccine Wastage Quality Checker.

Domain limits URS input.csv FS IQ/OQ/PQ

Domain limits and critical parameters

Key fragments from the source description are shown below. Before production use, limits must be verified against the approved specification, registration dossier and local SOPs.

ℹ️ Utility performs analysis of multidose vial (MDV) usage efficiency and wastage monitoring according to WHO guidelines and healthcare logistics standards:
• Adherence to time limit (e.g., 6 hours for some vaccines) is critical for patient safety.
⚠️ CRITICAL:
• Time Limit: Exceeding time after opening requires immediate disposal of residue, even if doses remain.
• Cold Chain: If vial is out of fridge longer than allowed, it must be rejected.
• Compliance with WHO waste management guidelines
Critical parameters:
• Utilization Rate: Target indicator (>80%)
• Wastage Rate: Allowable limit (<20%)
3. Training: Staff must know exact time limits for each vaccine type.

URS — User Requirements Specification

ID	Requirement	Criticality	Acceptance criterion
URS-001	The utility shall accept an input.csv file for Multidose Vial Usage And Vaccine Wastage Quality Checker with headers defined in the data contract.	High	The file is processed without manual header editing.
URS-002	The utility shall perform deterministic QC evaluation without machine learning and without probabilistic conformance decisions.	High	Identical input data, rule version and configuration produce reproducible results.
URS-003	The utility shall validate mandatory fields, data types, ranges, units and domain plausibility.	High	Schema, conversion and range errors are explicitly reported.
URS-004	The utility shall apply domain limits and rules from the description, approved specification, registration dossier and local SOPs.	High	Each check has PASS/WARNING/FAIL and a clear message.
URS-005	The utility shall generate output.json with machine-readable results, source values, warnings, failures and critical findings.	High	JSON is suitable for LIMS/ELN/MES integration and QA/QC review.
URS-006	The utility shall preserve traceability between batch/sample, input file, applied rules and final status.	High	Output contains identifiers, checked parameters and audit metadata.
URS-007	The documentation shall support IQ/OQ/PQ, CSV/CSA and review by internal QA or inspectors.	Medium	URS, FS, input/output contract and test scenarios are supplied with the utility.
URS-008	The utility shall be used as a QC decision-support tool and not as a substitute for approved specifications and QA/QP release decision.	Medium	Documentation states change control and limit-verification expectations.

input.csv contract

#	Field	Type	Sample	Purpose
1	`VialSerialNumber`	string / controlled vocabulary	`MDV-2026-001`	Controlled input parameter for deterministic QC rules.
2	`BatchNumber`	string / controlled vocabulary	`BATCH-X-99`	Batch or lot identifier used for traceability.
3	`ProductName`	string / controlled vocabulary	`Hepatitis B Vaccine`	Product or dosage-form name under evaluation.
4	`TotalDosesInVial`	decimal	`10`	Dose/dosage unit; release and safety parameter.
5	`DosesAdministered`	decimal	`9`	Dose/dosage unit; release and safety parameter.
6	`DosesDiscarded`	decimal	`1`	Dose/dosage unit; release and safety parameter.
7	`OpenedTime`	string / controlled vocabulary	`2026-06-08 09:00:00`	Time parameter for process, incubation, storage or analytical workflow.
8	`DiscardTime`	string / controlled vocabulary	`2026-06-08 14:00:00`	Time parameter for process, incubation, storage or analytical workflow.
9	`MaxHoursAfterOpen`	integer / decimal	`6`	Time parameter for process, incubation, storage or analytical workflow.

VialSerialNumber,BatchNumber,ProductName,TotalDosesInVial,DosesAdministered,DosesDiscarded,OpenedTime,DiscardTime,MaxHoursAfterOpen
MDV-2026-001,BATCH-X-99,Hepatitis B Vaccine,10,9,1,2026-06-08 09:00:00,2026-06-08 14:00:00,6
MDV-2026-002,BATCH-Y-88,Measles Vaccine,10,2,8,2026-06-08 08:00:00,2026-06-08 15:00:00,6
MDV-2026-003,BATCH-Z-77,Influenza Vaccine,10,10,0,2026-06-08 10:00:00,2026-06-08 11:30:00,24

Input validation rules

ID	Field	Rule	Criticality
VR-001	`VialSerialNumber`	The field shall match an approved dictionary or accepted string representation.	High
VR-002	`BatchNumber`	The field shall match an approved dictionary or accepted string representation.	High
VR-003	`ProductName`	The field shall match an approved dictionary or accepted string representation.	High
VR-004	`TotalDosesInVial`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-005	`DosesAdministered`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-006	`DosesDiscarded`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-007	`OpenedTime`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-008	`DiscardTime`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-009	`MaxHoursAfterOpen`	The field shall match an approved dictionary or accepted string representation.	Medium

FS — Functional Specification

ID	Function	Implementation
FS-001	CLI execution	Support execution modes: demo mode without arguments and production mode input.csv output.json.
FS-002	CSV import	Read input.csv in UTF-8/CSV-compatible format and validate header and expected columns.
FS-003	Schema validation	Check mandatory fields, column count, unknown key fields and empty mandatory values.
FS-004	Type conversion	Convert numeric, flag and text values; invalid format is recorded as a row-level error.
FS-005	Domain rule engine	Apply rules for Multidose Vial Usage And Vaccine Wastage Quality Checker, including critical limits from the description and approved specification.
FS-006	Status aggregation	Produce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance.
FS-007	JSON export	Write output.json with detailed checks, source values, warnings, failures and critical findings.
FS-008	Audit support	Keep result structure suitable for review, deviation investigation and calculation reproduction.
FS-009	Integration contract	Support the scenario LIMS/ELN/MES → input.csv → utility → output.json → portal/admin review.
FS-010	Error handling	Return explicit messages for missing file, empty CSV, invalid schema, output write failure and invalid format.

Example output.json

{
  "utilityId": "multidosevialusageandvaccinewastage-qualitychecker",
  "utilityFolder": "MultidoseVialUsageAndVaccineWastage_QualityChecker",
  "package": "huvac",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "VialSerialNumber",
      "value": "MDV-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "BatchNumber",
      "value": "BATCH-X-99",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "ProductName",
      "value": "Hepatitis B Vaccine",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "TotalDosesInVial",
      "value": "10",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "DosesAdministered",
      "value": "9",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "DosesDiscarded",
      "value": "1",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "OpenedTime",
      "value": "2026-06-08 09:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "DiscardTime",
      "value": "2026-06-08 14:00:00",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "MaxHoursAfterOpen",
      "value": "6",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "MultidoseVialUsageAndVaccineWastage_QualityChecker.documentation.html"
  }
}

Traceability matrix

URS	FS	Test	Evidence
URS-001	FS-001, FS-002	OQ-001	Verify execution and import of valid input.csv.
URS-002	FS-005, FS-006	OQ-004	Repeat the same dataset and compare output.json.
URS-003	FS-003, FS-004, FS-010	OQ-002, OQ-003	Verify missing columns and invalid types.
URS-004	FS-005, FS-006	OQ-004, PQ-001	Verify critical deviations on real/boundary data.
URS-005	FS-007, FS-009	OQ-005	Verify JSON schema and downstream-system suitability.
URS-006	FS-008	OQ-006	Verify identifiers and audit metadata.
URS-007	FS-008, FS-010	IQ-001, OQ-007	Verify documentation completeness and control evidence.
URS-008	FS-005, FS-008	PQ-002	Verify review workflow and no replacement of QA decision.

IQ/OQ/PQ test scenarios

ID	Scenario	Expected result
IQ-001	Verify executable, input.csv, documentation and checksum availability.	Delivery set is complete; version is recorded.
OQ-001	Valid sample row from input.csv.	PASS or acceptable WARNING according to rules.
OQ-002	Remove a mandatory CSV column.	Schema error or FAIL with missing-column reference.
OQ-003	Place a non-numeric value into a numeric field.	Type-conversion error with row/field reference.
OQ-004	Set a critical parameter outside the limit.	FAIL and critical finding.
OQ-005	Verify output.json structure.	All mandatory sections are present and JSON is valid.
OQ-006	Verify batch/sample traceability.	Input and result identifiers match.
PQ-001	Verify 3–5 real user batches/samples.	Result is confirmed by QC/QA review.
PQ-002	Verify deviation workflow and manual QA decision.	Utility supports review but does not replace approved decision.

QA/QC and change control

Do not rename columns without updating validator, documentation and test set.
Retain input.csv, output.json, executable version and checksum.
Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.

Included in packages

Huvac — Human Vaccine QC Utilities

Huvac contains QC utilities for human vaccines: adjuvants, antigen potency, sterility, endotoxins, cold chain, mRNA controls, container closure and stability checks.

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