Enterobacteriaceae testing

Enterobacteriaceae are a family of Gram-negative bacteria used as key indicators of hygienic quality in pharmaceutical and dietary products. Their detection helps assess manufacturing cleanliness.

Tests We Offer

• Enterobacteriaceae Test — USP <2021>

Test Methodology (USP <2021>)

Testing is performed using a selective enumeration and confirmation-based culture method designed to detect and quantify Enterobacteriaceae in pharmaceutical products:

This method allows both detection and estimation of microbial load, making it useful for quality trend monitoring as well as compliance testing.

• Sample preparation and homogenization to ensure uniform microbial distribution
• Pre-enrichment in non-selective media to recover stressed organisms from complex matrices
• Selective enrichment using inhibitory media that suppresses non-Enterobacteriaceae flora
• Plating on selective/differential agar media to isolate characteristic colonies
• Enumeration of typical colonies based on growth morphology and reaction characteristics
• Confirmatory identification tests, including biochemical profiling and oxidase testing (Enterobacteriaceae are typically oxidase-negative)

Why It matters

• Serves as a key indicator of sanitary quality and process hygiene
• Detects contamination from raw materials, water systems, or handling practices
• Supports risk assessment for pathogenic Gram-negative bacteria.
• Ensures compliance with USP <2021> and global pharmacopeial standards
• Helps maintain robust GMP manufacturing and environmental control systems

How to Connect

Contact our lab team for Enterobacteriaceae testing services.