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Regular assessment is essential to detect contamination early and take corrective actions.
1) Microbial Limit Tests
Purpose
Determine the number and types of microorganisms present in non-sterile products.
Methods
A) Total Viable Count (TVC)
Aerobic Plate Count: Determines the total number of aerobic bacteria.
Yeast and Mold Count: Uses selective media to count fungi.
B) Specified Microorganisms Testing
Indicator Organisms: Testing for E. coli, S. aureus, P. aeruginosa, and C. albicans.
Method: Enrichment and selective plating to detect presence.
Standards
Set by pharmacopeias (USP, BP, EP) with acceptable limits.
2) Preservative Efficacy Testing (PET)
Purpose
Evaluate the effectiveness of antimicrobial preservatives in the product.
Procedure
Inoculation: Introduce a known quantity of test microorganisms into the product.
Incubation: Store samples under specified conditions.
Sampling: At intervals (e.g., 7, 14, 28 days), measure microbial counts.
Acceptance Criteria
Reduction in microbial counts as per pharmacopeial standards.
3) Visual Inspection
Observation
Physical Signs: Discoloration, turbidity, gas formation, mold growth.
Containers: Swelling, leakage, or corrosion indicating microbial activity.
Limitations
May not detect microbial contamination in early stages.
4) Chemical Tests
Detection of Metabolic By-products
pH Changes: Microbial metabolism can alter pH.
Gas Production: Measurement of gas in sealed containers.
Analytical Methods
High-Performance Liquid Chromatography (HPLC): Detect degradation products.
Spectrophotometry: Measure changes in absorbance due to microbial metabolites.
5) Rapid Microbiological Methods (RMM)
Purpose
Provide faster results compared to traditional culture methods.
Techniques
ATP Bioluminescence: Detects microbial ATP as an indicator of viability.
Flow Cytometry: Counts and analyzes microbial cells using fluorescent dyes.
PCR (Polymerase Chain Reaction): Detects microbial DNA or RNA.
Advantages
Faster turnaround times; increased sensitivity.
6) Environmental Monitoring
A) Air Sampling
Settle Plates: Expose agar plates to the environment to collect airborne microbes.
Active Air Samplers: Draw air through a filter or onto a culture medium.
B) Surface Sampling
Swabs: Wipe surfaces and culture swabs.
Contact Plates: Press agar surfaces onto equipment or facility surfaces.
C) Personnel Monitoring
Finger Dabs: Test gloves or hands of operators.
Gowning Evaluation: Check for contamination on protective clothing.
7) Endotoxin Testing
Purpose
Detect endotoxins (lipopolysaccharides) from Gram-negative bacteria.
Method
Limulus Amebocyte Lysate (LAL) Test: Uses blood cells from horseshoe crabs to detect endotoxins.
Application
Important for injectables and ophthalmic products.
These are all the Assessment of Microbial Contamination and Spoilage
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