[MICRO-07] Microbial Assays, Sterility Testing, Bacterial Endotoxin Test (LAL) & Microbial Limit Tests (MLT)

MICRO-07 • 7. Microbiology

Learning Objectives

Perform compendial Sterility Testing using Membrane Filtration (0.45 µm) vs Direct Inoculation in Fluid Thioglycollate Medium (FTM) and Soyabean Casein Digest Medium (SCDM).; Compare Cup-Plate (Cylinder-Plate) Diffusion vs Turbidimetric Microbiological Assays of antibiotics and vitamins with IP test organisms.; Execute Microbial Limit Tests (TAMC, TYMC, and absence of specified pathogens: E. coli, Salmonella, P. aeruginosa, S. aureus) for non-sterile products.

Chapter Overview & Core Explanation

Compendial microbiological quality control ensures that injectable drugs are 100% free of living microbes and fever-causing endotoxins, and that non-sterile syrups and tablets contain no harmful foodborne or skin pathogens.

Key Exam & Clinical Takeaways

• In IP Sterility Testing, Fluid Thioglycollate Medium (FTM) is incubated at 30–35°C for 14 days (primarily for anaerobes/aerobes) and Soyabean Casein Digest Medium (SCDM) at 20–25°C for 14 days (primarily for fungi/aerobes).
• The threshold pyrogenic endotoxin constant (K) is 5.0 EU/kg/hr for intravenous injections and 0.2 EU/kg/hr for intrathecal injections.

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