SpecifiedMicroorganismsQualityChecker

Specified Microorganisms Quality Checker — Control of Specified Microorganisms

ℹ️  Utility checks for the absence of pathogenic microorganisms in non-sterile pharmaceutical products according to Ph. Eur. 2.6.13 and USP <62>:
     • Escherichia coli — indicator of fecal contamination (must be absent in 1g/1ml)
     • Salmonella — pathogen causing intestinal infections (must be absent in 10g/10ml)
     • Pseudomonas aeruginosa — opportunistic pathogen (must be absent in 1g/1ml)
     • Staphylococcus aureus — cause of purulent infections (must be absent in 1g/1ml)
     • Candida albicans — yeast-like fungus (must be absent in 1g/1ml)
     • Clostridium — anaerobic spore-forming bacteria (must be absent in 10g/10ml)
     • Bile-Tolerant Gram-Negative Bacteria — limit <10^2 CFU/g or mL

⚠️  CRITICAL: Detection of any of the specific pathogens (E. coli, Salmonella, P. aeruginosa, S. aureus, C. albicans, Clostridium) leads to immediate batch rejection!
     This is a patient safety requirement.

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

Input format:
BatchNumber,ProductName,EscherichiaColi,Salmonella,PseudomonasAeruginosa,StaphylococcusAureus,CandidaAlbicans,Clostridium,BileTolerantGramNeg

Example (0=Absent, 1=Present, number for bile-tolerant):
  MICRO-2026-SPEC-001,Herbal Extract,0,0,0,0,0,0,50

— WHY IS THIS NEEDED?
Non-sterile pharmaceutical products (tablets, ointments, syrups, herbal raw materials) must not contain certain pathogenic microorganisms that may pose a risk to patient health, especially for immunocompromised individuals.
The test for specified microorganisms is a mandatory part of microbiological quality.

⚠️  CRITICAL:
• Escherichia coli — presence indicates unsatisfactory production hygiene or contaminated raw materials.
• Salmonella — highly toxic, even small amounts are dangerous.
• Pseudomonas aeruginosa — resistant to many antibiotics, dangerous for wounds and mucous membranes.
• Staphylococcus aureus — can produce toxins.
• Candida albicans — causes candidiasis.
• Clostridium — risk of gas gangrene and botulism (depending on species).
• Bile-Tolerant Gram-Negative Bacteria — their quantity is limited (<100 CFU/g) as they indicate general sanitary status.

Key features:
• Check of all main pathogens according to Pharmacopoeia
• Strict control of absence for dangerous species
• Quantitative control for bile-tolerant bacteria
• Generation of reports for regulatory authorities and LIMS LabWare
• Compliance with Ph. Eur. 2.6.13 and USP <62>

Critical parameters:
• Escherichia coli: Absent in 1g/1ml
• Salmonella: Absent in 10g/10ml
• Pseudomonas aeruginosa: Absent in 1g/1ml
• Staphylococcus aureus: Absent in 1g/1ml
• Candida albicans: Absent in 1g/1ml
• Clostridium: Absent in 10g/10ml
• Bile-Tolerant Gram-Negative Bacteria: < 10^2 CFU/g

💡 Usage tips:
1. Detection methods: Enrichment methods in selective media followed by identification (biochemical or molecular) are used.
2. Sampling: Must be representative. For solid forms, 10g or 1g is used depending on the test.
3. Neutralization of antimicrobial activity: If the product has preservative properties, neutralizers must be used in the medium.
4. Interpretation: A "Present" (1) result for any of the first six parameters automatically means FAIL.
5. Investigation: A positive result requires a thorough investigation of the source of contamination (raw materials, water, personnel, equipment).

⚠️ Note: The test for specified microorganisms differs from the Total Aerobic Microbial Count (TAMC/TYMC). TAMC counts all living cells, while this test looks for specific dangerous species that may be absent in the total count but be deadly.