SterilityMycoplasmaReviewUtility
Sterility & Mycoplasma Review
Vet veterinary veterinary vaccines animal health adjuvants aquaculture batch release CSV→JSON
Open selectionUtility description: Sterility & Mycoplasma Review
Sterility & Mycoplasma Review Utility — Review of Sterility and Mycoplasma Tests
ℹ️ Utility performs comprehensive verification of microbiological test results for biotechnological products according to Ph. Eur. 2.6.1 (Sterility) and Ph. Eur. 2.6.7 (Mycoplasma):
• Sterility: Check for absence of microbial growth in TSB (aerobes) and FTG (anaerobes) media.
• Mycoplasma: Check for absence of mycoplasma by culture method (including indicator cells) and PCR.
• Test Validity: Confirmation of control correctness and sufficiency of incubation time.
⚠️ CRITICAL:
• Detection of growth in any sterility test or positive mycoplasma result is grounds for immediate batch rejection.
• Mycoplasma is a frequent contaminant of cell cultures and may not cause medium turbidity, requiring specific detection methods.
• Invalid controls (e.g., no growth in sterility positive control) render the entire test unsuitable for assessment.
Usage:
SterilityMycoplasmaReviewUtility.exe → demo mode (console output)
SterilityMycoplasmaReviewUtility.exe input.csv output.json → evaluate your data
Input format:
BatchNumber,ProductName,Sterility_TSB_Growth,Sterility_FTG_Growth,Sterility_Incubation_Days,Mycoplasma_Culture_Result,Mycoplasma_Indicator_Cell_Result,Mycoplasma_PCR_Result,Mycoplasma_Incubation_Days,Sterility_PosControl_Valid,Sterility_NegControl_Valid,Mycoplasma_Control_Valid
Example (0=No Growth, 1=Growth):
SM-001,mAb Bulk,0,0,14,Negative,Negative,Negative,28,1,1,1
— WHY IS THIS NEEDED?
For biologics produced on cell lines, the risk of mycoplasma and bacterial contamination is one of the highest.
These tests are mandatory for Batch Release and require long incubation times (up to 28 days for mycoplasma).
Automation of review reduces the risk of human error in interpreting complex data.
⚠️ CRITICAL:
• Incubation Time: Sterility requires at least 14 days, mycoplasma — 28 days. Tests stopped earlier are invalid.
• PCR Method: Is a faster alternative method but is often used in combination with culture for maximum reliability.
• Indicator Cells: Used to detect mycoplasmas that grow poorly on artificial media.
• Investigation: Any positive result requires laboratory investigation to exclude false-positive results (operator error, lab contamination).
Key features:
• Combined check of sterility and mycoplasma
• Strict system validity control (controls and time)
• Automatic Pass/Fail decision making
• Generation of reports for microbiology and QA departments, and LIMS LabWare
• Compliance with Ph. Eur., USP, and GMP requirements
Critical parameters:
• Growth in TSB/FTG: 0 (Absent)
• Mycoplasma (Culture/PCR): Negative
• Control Validity: 1 (Valid)
• Incubation Days: ≥ 14 (Sterility), ≥ 28 (Mycoplasma)
💡 Usage tips:
1. LIMS Integration: Configure automatic transfer of "Negative/Positive" statuses from microbiological LIMS.
2. Alternative Methods: If Rapid Microbiology methods are used, ensure they are validated as equivalent to pharmacopoeial methods.
3. Quarantine: Batch must be in quarantine until final results of all tests are received.
4. Documentation: Save reports as part of the Batch Record package.
5. Trends: Track frequency of positive controls to assess overall laboratory hygiene.
⚠️ Note: Unlike chemical tests, microbiological tests are probabilistic in nature. Strict adherence to sampling protocol and asepsis is more critical than instrument accuracy.input.csv
BatchNumber,ProductName,Sterility_TSB_Growth,Sterility_FTG_Growth,Sterility_Incubation_Days,Mycoplasma_Culture_Result,Mycoplasma_Indicator_Cell_Result,Mycoplasma_PCR_Result,Mycoplasma_Incubation_Days,Sterility_PosControl_Valid,Sterility_NegControl_Valid,Mycoplasma_Control_Valid SM-REV-2026-001,Monoclonal Antibody Bulk,0,0,14,Negative,Negative,Negative,28,1,1,1 SM-REV-2026-002,Vaccine Harvest,0,0,14,Negative,Negative,Negative,28,1,1,1 SM-FAIL-2026-003,Cell Culture Supernatant,0,1,14,Negative,Negative,Negative,28,1,1,1
URS & FS — User Requirements and Functional Specification
This document describes the controlled interface and behaviour of SterilityMycoplasmaReviewUtility for Sterility & Mycoplasma Review Utility.
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 comprehensive verification of microbiological test results for biotechnological products according to Ph. Eur. 2.6.1 (Sterility) and Ph. Eur. 2.6.7 (Mycoplasma):
- ⚠️ CRITICAL:
- • Compliance with Ph. Eur., USP, and GMP requirements
- Critical parameters:
- • Incubation Days: ≥ 14 (Sterility), ≥ 28 (Mycoplasma)
- 3. Quarantine: Batch must be in quarantine until final results of all tests are received.
- ⚠️ Note: Unlike chemical tests, microbiological tests are probabilistic in nature. Strict adherence to sampling protocol and asepsis is more critical than instrument accuracy.
URS — User Requirements Specification
| ID | Requirement | Criticality | Acceptance criterion |
|---|---|---|---|
| URS-001 | The utility shall accept an input.csv file for Sterility & Mycoplasma Review Utility 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 | BatchNumber | string / controlled vocabulary | SM-REV-2026-001 | Batch or lot identifier used for traceability. |
| 2 | ProductName | string / controlled vocabulary | Monoclonal Antibody Bulk | Product or dosage-form name under evaluation. |
| 3 | Sterility_TSB_Growth | flag / boolean | 0 | Sterility or related absence-of-growth control. |
| 4 | Sterility_FTG_Growth | flag / boolean | 0 | Sterility or related absence-of-growth control. |
| 5 | Sterility_Incubation_Days | integer / decimal | 14 | Sterility or related absence-of-growth control. |
| 6 | Mycoplasma_Culture_Result | string / controlled vocabulary | Negative | Result/status used in final classification. |
| 7 | Mycoplasma_Indicator_Cell_Result | string / controlled vocabulary | Negative | Result/status used in final classification. |
| 8 | Mycoplasma_PCR_Result | string / controlled vocabulary | Negative | Result/status used in final classification. |
| 9 | Mycoplasma_Incubation_Days | integer / decimal | 28 | Time parameter for process, incubation, storage or analytical workflow. |
| 10 | Sterility_PosControl_Valid | string / controlled vocabulary | 1 | Sterility or related absence-of-growth control. |
| 11 | Sterility_NegControl_Valid | string / controlled vocabulary | 1 | Sterility or related absence-of-growth control. |
| 12 | Mycoplasma_Control_Valid | string / controlled vocabulary | 1 | Control point/control sample for assay run validity. |
BatchNumber,ProductName,Sterility_TSB_Growth,Sterility_FTG_Growth,Sterility_Incubation_Days,Mycoplasma_Culture_Result,Mycoplasma_Indicator_Cell_Result,Mycoplasma_PCR_Result,Mycoplasma_Incubation_Days,Sterility_PosControl_Valid,Sterility_NegControl_Valid,Mycoplasma_Control_Valid SM-REV-2026-001,Monoclonal Antibody Bulk,0,0,14,Negative,Negative,Negative,28,1,1,1 SM-REV-2026-002,Vaccine Harvest,0,0,14,Negative,Negative,Negative,28,1,1,1 SM-FAIL-2026-003,Cell Culture Supernatant,0,1,14,Negative,Negative,Negative,28,1,1,1
Input validation rules
| ID | Field | Rule | Criticality |
|---|---|---|---|
| VR-001 | BatchNumber | The field shall match an approved dictionary or accepted string representation. | High |
| VR-002 | ProductName | The field shall match an approved dictionary or accepted string representation. | High |
| VR-003 | Sterility_TSB_Growth | The field shall match an approved dictionary or accepted string representation. | High |
| VR-004 | Sterility_FTG_Growth | The field shall match an approved dictionary or accepted string representation. | Medium |
| VR-005 | Sterility_Incubation_Days | The field shall match an approved dictionary or accepted string representation. | Medium |
| VR-006 | Mycoplasma_Culture_Result | The field shall match an approved dictionary or accepted string representation. | Medium |
| VR-007 | Mycoplasma_Indicator_Cell_Result | The field shall match an approved dictionary or accepted string representation. | Medium |
| VR-008 | Mycoplasma_PCR_Result | The field shall match an approved dictionary or accepted string representation. | Medium |
| VR-009 | Mycoplasma_Incubation_Days | The field shall match an approved dictionary or accepted string representation. | Medium |
| VR-010 | Sterility_PosControl_Valid | The field shall match an approved dictionary or accepted string representation. | Medium |
| VR-011 | Sterility_NegControl_Valid | The field shall match an approved dictionary or accepted string representation. | Medium |
| VR-012 | Mycoplasma_Control_Valid | 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 Sterility & Mycoplasma Review Utility, 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": "sterilitymycoplasmareviewutility",
"utilityFolder": "SterilityMycoplasmaReviewUtility",
"package": "Vet",
"overallStatus": "PASS|WARNING|FAIL",
"sourceFile": "input.csv",
"processedAtUtc": "2026-06-10T00:00:00Z",
"checks": [
{
"parameter": "BatchNumber",
"value": "SM-REV-2026-001",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-001"
},
{
"parameter": "ProductName",
"value": "Monoclonal Antibody Bulk",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-002"
},
{
"parameter": "Sterility_TSB_Growth",
"value": "0",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-003"
},
{
"parameter": "Sterility_FTG_Growth",
"value": "0",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-004"
},
{
"parameter": "Sterility_Incubation_Days",
"value": "14",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-005"
},
{
"parameter": "Mycoplasma_Culture_Result",
"value": "Negative",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-006"
},
{
"parameter": "Mycoplasma_Indicator_Cell_Result",
"value": "Negative",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-007"
},
{
"parameter": "Mycoplasma_PCR_Result",
"value": "Negative",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-008"
},
{
"parameter": "Mycoplasma_Incubation_Days",
"value": "28",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-009"
},
{
"parameter": "Sterility_PosControl_Valid",
"value": "1",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-010"
},
{
"parameter": "Sterility_NegControl_Valid",
"value": "1",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-011"
},
{
"parameter": "Mycoplasma_Control_Valid",
"value": "1",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-012"
}
],
"criticalFindings": [],
"warnings": [],
"audit": {
"inputHash": "sha256:<calculated at runtime>",
"rulesVersion": "<utility executable version>",
"documentation": "SterilityMycoplasmaReviewUtility.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
Biopharmaceuticals Core QC Suite
Focused QC utility package for biologic products: HCP, mAbs, biosimilars, proteins/peptides, sterility, endotoxins and key release checks.
OpenBiopharmaceuticals Extended QC Suite
Extended QC utility coverage for mAbs, biosimilars, proteins, insulins, vaccines, mRNA/LNP, HCP, sterile release, microbiology, water, cleanroom and stability workflows.
OpenImmunology QC Suite
QC utility package for immunology: monoclonal antibodies, biosimilars, immunomodulators, immunosuppressants, ELISA/SPR, HCP, protein characterization, sterility and pyrogen/release checks.
OpenInfectious Diseases QC Suite
QC utility package for infectious diseases: antibacterial, antiviral, antifungal and antiparasitic products, microbiology, sterility, endotoxins, viral safety and vaccine release checks.
OpenVet — Veterinary QC Utilities
Vet is designed for veterinary pharmaceuticals and vaccines: adjuvants, antigens, autogenous vaccines, aquaculture, feed/premixes, antimicrobial and antiparasitic products, sterility and batch release.
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