SterilityTestMembraneFiltrationQualityChecker

Sterility Test Membrane Filtration Quality Checker — Sterility Testing (Membrane Filtration Method)

ℹ️  Utility checks sterility test results of medicinal products by membrane filtration method according to Ph. Eur. 2.6.1 and USP <71>:
     • Absence of microbial growth in TSB (Thioglycollate Medium) and FTG (Soybean-Casein Digest Medium)
     • Validity of negative controls (must be sterile)
     • Validity of positive controls (growth of test strains must be confirmed)
     • Compliance with incubation time (minimum 14 days)
     • Sufficient number of tested sample units

⚠️  CRITICAL: Any growth in test samples means NON-STERILITY of the batch!
     Growth in negative control or absence of growth in positive control makes the test INVALID.

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

Input format:
BatchNumber,ProductName,NumberOfUnitsTested,VolumePerUnit_ml,TSB_Growth,FTG_Growth,NegativeControl_TSB,NegativeControl_FTG,PositiveControl_TSB,PositiveControl_FTG,IncubationDays

Example (0=No Growth, 1=Growth):
  STER-MF-2026-001,WFI,20,100.0,0,0,0,0,1,1,14

— WHY IS THIS NEEDED?
Sterility testing is mandatory for all parenteral drugs, ophthalmic preparations, and other sterile forms.
The membrane filtration method is preferred as it allows filtering large volumes and washing away antimicrobial properties of the product.
The result of this test is critical for batch release.

⚠️  CRITICAL:
• TSB (Fluid Thioglycollate Medium) — supports growth of aerobic and anaerobic bacteria.
• FTG (Soybean-Casein Digest Medium) — supports growth of fungi and aerobic bacteria.
• Negative Control: Confirms sterility of media and technique. Growth = laboratory error.
• Positive Control: Confirms suitability of media and viability of test strains (S. aureus, P. aeruginosa, C. sporogenes, B. subtilis, C. albicans, A. brasiliensis). No growth = media/incubation error.
• Incubation: 14 days at 30-35°C (TSB) and 20-25°C (FTG).

Key features:
• Comprehensive check of sample results and all control types
• Automatic determination of test validity
• Incubation duration control
• Generation of reports for regulatory authorities and LIMS LabWare
• Compliance with GMP and Pharmacopoeia requirements

Critical parameters:
• Growth in TSB: 0 (Absent)
• Growth in FTG: 0 (Absent)
• Negative Control TSB: 0 (Absent)
• Negative Control FTG: 0 (Absent)
• Positive Control TSB: 1 (Present)
• Positive Control FTG: 1 (Present)
• Incubation Days: ≥ 14

💡 Usage tips:
1. Membranes: Use membranes with 0.45 µm pore size. Cellulose nitrate for aqueous solutions, PVDF/nylon for organic solvents.
2. Rinsing: After filtration, rinse the membrane with suitable diluent (usually 3 x 100 ml) to remove growth inhibitors.
3. Asepsis: The entire process must be performed in a Class A laminar flow hood.
4. Interpretation: If the test is invalid (controls failed), it may be repeated once. If invalid again or growth occurs upon repetition — batch is rejected.
5. Observation: Visual inspection of media is performed regularly throughout the 14 days.

⚠️ Note: Sterility testing is probabilistic. It does not guarantee absolute sterility of the entire batch, but confirms that microorganisms were not detected in the tested sample under specified conditions.