LevonorgestrelIUSQualityChecker

Levonorgestrel IUS

assay contraceptives endotoxins fixed-dose combinations heavy metals hormones impurities microbiology

Levonorgestrel IUS Quality Checker — Levonorgestrel Intrauterine System (Mirena, Kyleena, Skyla) (Ph. Eur., ISO 13485)

ℹ️  The utility checks levonorgestrel content in IUS, release rate, reservoir physical properties (length, width, thickness, tensile strength), impurities, heavy metals, endotoxins, sterility, packaging integrity.
ℹ️  Does not use machine learning — rule-based logic only.
⚠️  CRITICAL for implantable IUS! Sterility and endotoxins are mandatory parameters. Reservoir strength prevents damage during insertion/removal!

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

Input format:
BatchNumber,LevonorgestrelContent,ReleaseRate,Length,Width,Thickness,TensileStrength,Impurity3Keto,ImpurityEpimer,TotalImpurities,HeavyMetals,Endotoxin,SterilityTest,PackagingIntegrityTest,EthanolPPM,AcetonePPM

Example (SterilityTest/PackagingIntegrityTest: 0=pass, 1=fail):
LNG-IUS-2026-001,52.0,20.0,32.0,32.0,2.0,10.0,0.2,0.1,0.4,5,0.3,0,0,800,500

— WHY IS THIS NEEDED?
Levonorgestrel intrauterine system (IUS) — highly effective long-acting contraceptive (3–7 years):
• Mirena (52 mg, 5 years), Kyleena (19.5 mg, 5 years), Skyla (13.5 mg, 3 years), Levosert (13.5 mg, 3 years)
• Polymer reservoir with levonorgestrel, inserted into uterine cavity
• Provides local hormone delivery with minimal systemic load
⚠️ CRITICAL:
• Release rate 15–25 mcg/day (initial for Mirena) — ensures contraceptive efficacy throughout service life
• Sterility — MANDATORY for implantable devices (USP <71> test)
• Endotoxins ≤0.5 EU/IUS — critical to prevent inflammatory reactions in uterus (LAL test per USP <85>)
• Reservoir strength ≥5.0 N — prevents damage during insertion/removal
• Packaging integrity — guarantees sterility until insertion
• 3-Keto impurity ≤0.5% — affects stability and release
⚠️ Special attention: IUS are sterile medical devices risk class III! Quality requirements stricter than oral forms. Release rate tested by diffusion cell method (in vitro) under conditions simulating uterine environment. Physical properties critical for applicator function and correct placement in uterus.
Critical parameters (Mirena example):
• Levonorgestrel content: 46.8–57.2 mg/IUS (52.0 ± 10%)
• Release rate: 15–25 mcg/day (initial)
• Reservoir length: 30–34 mm
• Reservoir width: 30–34 mm
• Reservoir thickness: 1.8–2.2 mm
• Tensile strength: ≥5.0 N
• 3-Keto impurity: ≤0.5%
• Epimer (13β/17α): ≤0.5%
• Total impurities: ≤1.0%
• Heavy metals: ≤10 ppm
• Endotoxins: ≤0.5 EU/IUS
• Sterility: no microbial growth
• Packaging integrity: no compromise
• Residual solvents: ethanol ≤5000 ppm, acetone ≤5000 ppm
⚠️ Note: IUS manufactured from medical-grade silicone or ethylene-vinyl acetate (EVA). Release rate control is critical — determines dose over 3–7 years! Sterility tested by direct inoculation or membrane filtration (USP <71>). Endotoxins — mandatory test for all implantable devices, especially IUS contacting uterine mucosa!

input.csv

BatchNumber,LevonorgestrelContent,ReleaseRate,Length,Width,Thickness,TensileStrength,Impurity3Keto,ImpurityEpimer,TotalImpurities,HeavyMetals,Endotoxin,SterilityTest,PackagingIntegrityTest,EthanolPPM,AcetonePPM
LNG-IUS-2026-001,52.0,20.0,32.0,32.0,2.0,10.0,0.2,0.1,0.4,5,0.3,0,0,800,500

URS & FS — user requirements and functional specification

This document defines user requirements and functional specification for the quality-control utility. It supports deployment discussion, IQ/OQ preparation and QC workflow integration.

Utility: LevonorgestrelIUSQualityCheckerAPI / object: Levonorgestrel IUSCategory: Contraceptives

1. Scope

The Levonorgestrel IUS Quality Checker utility is used for Levonorgestrel IUS. The actual input.csv is the source of truth for the input structure; control criteria are defined by the executable and the domain description.

The utility does not use machine learning; decisions are produced by deterministic rules.

Categories: Contraceptives

Tags: assay, contraceptives, endotoxins, fixed-dose combinations, heavy metals, hormones, impurities, microbiology, residual solvents, sterility

2. Execution modes

LevonorgestrelIUSQualityChecker.exe                            → demo mode (console output)
LevonorgestrelIUSQualityChecker.exe input.csv output.json      → evaluate your data

3. Key controlled areas

assay / content
purity and impurities
residual solvents
microbiology and pathogens
heavy metals / elemental impurities

4. Domain limits and critical parameters

⚠️ CRITICAL for implantable IUS! Sterility and endotoxins are mandatory parameters. Reservoir strength prevents damage during insertion/removal!
⚠️ CRITICAL:
Release rate 15–25 mcg/day (initial for Mirena) — ensures contraceptive efficacy throughout service life
Sterility — MANDATORY for implantable devices (USP <71> test)
Endotoxins ≤0.5 EU/IUS — critical to prevent inflammatory reactions in uterus (LAL test per USP <85>)
Reservoir strength ≥5.0 N — prevents damage during insertion/removal
Packaging integrity — guarantees sterility until insertion
3-Keto impurity ≤0.5% — affects stability and release
⚠️ Special attention: IUS are sterile medical devices risk class III! Quality requirements stricter than oral forms. Release rate tested by diffusion cell method (in vitro) under conditions simulating uterine environment. Physical properties critical for applicator function and correct placement in uterus.
Critical parameters (Mirena example):
Levonorgestrel content: 46.8–57.2 mg/IUS (52.0 ± 10%)
Release rate: 15–25 mcg/day (initial)
Reservoir length: 30–34 mm
Reservoir width: 30–34 mm
Reservoir thickness: 1.8–2.2 mm
Tensile strength: ≥5.0 N
3-Keto impurity: ≤0.5%
Epimer (13β/17α): ≤0.5%
Total impurities: ≤1.0%
Heavy metals: ≤10 ppm
Endotoxins: ≤0.5 EU/IUS
Sterility: no microbial growth
Packaging integrity: no compromise
Residual solvents: ethanol ≤5000 ppm, acetone ≤5000 ppm

Limits stated in the description must be verified against the current approved specification, pharmacopoeial monograph and registration dossier before production use.

5. URS — user requirements

ID	Requirement	Criticality	Acceptance criterion
URS-001	The system shall accept an `input.csv` file for Levonorgestrel IUS with the exact columns listed in the “Input data contract” section.	High	A file with the correct header is processed without manual editing; missing mandatory columns produce FAIL/import error.
URS-002	The system shall support execution without arguments in demo mode and execution with `input.csv output.json` for user data.	Medium	Both execution scenarios produce a predictable result or clear diagnostic error.
URS-003	The system shall perform rule-based controls for: assay / content, purity and impurities, residual solvents, microbiology and pathogens, heavy metals / elemental impurities.	High	Each controlled parameter receives a status and message; the result does not depend on hidden Excel formulas or ML.
URS-004	The system shall preserve traceability between batch/lot, source values, applied rules and final verdict.	High	Output includes batch identifier, source values, parameter statuses and critical findings.
URS-005	The system shall generate machine-readable `output.json` for LIMS/ELN/MES, batch record and QA/QC review.	High	JSON contains overall status, check array, warnings, failures and source-file reference.
URS-006	The system shall support use in the client validation package: URS/FS, IQ/OQ preparation, installation and operational scenario checks.	High	The document, test scenarios and reproducible CSV/JSON flow are suitable for audit and internal approval.
URS-007	The system shall clearly separate technical data errors from specification nonconformities.	Medium	Schema/type errors are not mixed with pharmacopoeial deviations and are reported separately.

6. input.csv data contract

The source of truth for the input schema is the actual input.csv header. Column names are technical identifiers and are not translated.

#	Column	Type	Unit	Description	Sample	Control rule
1	`BatchNumber`	identifier	as specified	Batch Number	`LNG-IUS-2026-001`	mandatory field; used for batch/lot traceability
2	`LevonorgestrelContent`	decimal	as specified	Levonorgestrel Content	`52.0`	numeric value; compared with assay/purity limit from specification or method
3	`ReleaseRate`	decimal	as specified	Release Rate	`20.0`	mandatory numeric value; rule comparison is performed by the utility
4	`Length`	decimal	as specified	Length	`32.0`	mandatory numeric value; rule comparison is performed by the utility
5	`Width`	decimal	as specified	Width	`32.0`	mandatory numeric value; rule comparison is performed by the utility
6	`Thickness`	decimal	as specified	Thickness	`2.0`	mandatory numeric value; rule comparison is performed by the utility
7	`TensileStrength`	decimal	as specified	Tensile Strength	`10.0`	mandatory numeric value; rule comparison is performed by the utility
8	`Impurity3Keto`	decimal	as specified	Impurity3 Keto	`0.2`	numeric value; compared with individual or total impurity limit
9	`ImpurityEpimer`	decimal	as specified	Impurity Epimer	`0.1`	numeric value; compared with individual or total impurity limit
10	`TotalImpurities`	decimal	as specified	Total Impurities	`0.4`	mandatory numeric value; rule comparison is performed by the utility
11	`HeavyMetals`	decimal	as specified	Heavy Metals	`5`	numeric value; checked as elemental/metal impurity
12	`Endotoxin`	decimal	as specified	Endotoxin	`0.3`	numeric value; critical safety attribute compared with endotoxin limit
13	`SterilityTest`	boolean / flag	0/1	Sterility Test	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent
14	`PackagingIntegrityTest`	decimal	as specified	Packaging Integrity Test	`0`	mandatory numeric value; rule comparison is performed by the utility
15	`EthanolPPM`	decimal	ppm	Ethanol PPM	`800`	numeric value; checked as residual solvent against the applicable limit
16	`AcetonePPM`	decimal	ppm	Acetone PPM	`500`	numeric value; checked as residual solvent against the applicable limit

CSV example

BatchNumber,LevonorgestrelContent,ReleaseRate,Length,Width,Thickness,TensileStrength,Impurity3Keto,ImpurityEpimer,TotalImpurities,HeavyMetals,Endotoxin,SterilityTest,PackagingIntegrityTest,EthanolPPM,AcetonePPM
LNG-IUS-2026-001,52.0,20.0,32.0,32.0,2.0,10.0,0.2,0.1,0.4,5,0.3,0,0,800,500

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `LevonorgestrelIUSQualityChecker.exe` supports demo mode and `input.csv output.json` processing mode.
FS-002	CSV parser	The import module reads CSV, validates header, column presence/order, value count and encoding. Decimal values are expected with a dot separator.
FS-003	Field conversion	Each column is converted to the expected type: identifier, text, decimal number, date/time or boolean flag.
FS-004	Domain rule engine	For Levonorgestrel IUS, explicit rules are applied: range, minimum, maximum, absence of prohibited flag, data completeness or calculation-based check.
FS-005	Criticality handling	Critical violations produce FAIL; non-critical deviations and incomplete data produce WARNING; full conformance produces PASS.
FS-006	JSON writer	`output.json` stores overall status, per-parameter results, source values, warnings, failures and diagnostic messages.
FS-007	Integration contract	The CSV → JSON format is stable for invocation from LIMS/ELN/MES, scheduled task or wrapper service.
FS-008	Error handling	Schema error, missing file, non-numeric value or JSON write failure returns diagnosable error without silent PASS.

8. output.json contract

The output file must be suitable for automated processing, audit review and correlation with the source input.csv row.

{
  "utility": "LevonorgestrelIUSQualityChecker",
  "api": "Levonorgestrel IUS",
  "batchNumber": "LNG-IUS-2026-001",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "LNG-IUS-2026-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "LevonorgestrelContent",
      "value": "52.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ReleaseRate",
      "value": "20.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Length",
      "value": "32.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Width",
      "value": "32.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Thickness",
      "value": "2.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TensileStrength",
      "value": "10.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Impurity3Keto",
      "value": "0.2",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "sourceFile": "input.csv"
}

9. OQ/PQ test scenarios

ID	Scenario	Expected result
TC-001	Valid CSV with expected header and sample row	All rows are processed; output contains PASS/WARNING/FAIL and parameter-level detail.
TC-002	A mandatory input.csv column is missing	Import is rejected or the row receives FAIL with schema reference.
TC-003	A numeric field contains text or a blank value	Type conversion error is recorded; the result is not hidden as PASS.
TC-004	A parameter is outside specification or critical limit	Critical parameters produce FAIL; non-critical deviations produce WARNING according to the rule.
TC-005	Positive pathogen/microbiological flag or microbiological limit excursion	Critical FAIL is produced with the offending parameter.
TC-007	Residual solvent above applicable limit	FAIL is produced with solvent name and measured value.

10. QA/QC, CSV and change control

Before production use, the client records executable version, checksum, specification/monograph version, test CSV, expected JSON and IQ/OQ results.
Column names must not be changed without updating the validator and test scenarios.
The source CSV, output.json and utility version should be stored together as an evidence package.
Any change in control rules must go through change control and repeated OQ scenario verification.

Included in packages

Algeria: national essential medicines QC package

QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.

LevonorgestrelIUSQualityChecker

input.csv

1. Scope

2. Execution modes

3. Key controlled areas

4. Domain limits and critical parameters

5. URS — user requirements

6. input.csv data contract

CSV example

7. FS — functional specification

8. output.json contract

9. OQ/PQ test scenarios

10. QA/QC, CSV and change control

Included in packages

Algeria: national essential medicines QC package

Argentina: national essential medicines QC package

Bangladesh: national essential medicines QC package

Colombia: national essential medicines QC package

Contraceptives QC Suite

Democratic Republic of the Congo: national essential medicines QC package

Egypt: national essential medicines QC package

Ethiopia: national essential medicines QC package

Gynecology QC Suite

Indonesia: national essential medicines QC package

Iran: national essential medicines QC package

Kenya: national essential medicines QC package

Mexico: national essential medicines QC package

Myanmar: national essential medicines QC package

Nigeria: national essential medicines QC package

Pakistan: national essential medicines QC package

Philippines: national essential medicines QC package

South Africa: national essential medicines QC package

Sudan: national essential medicines QC package

Tanzania: national essential medicines QC package

Turkey: national essential medicines QC package

Uganda: national essential medicines QC package