Fungal and Bacterial Contamination Testing
Overview:
Fungal and Bacterial Contamination Testing is a vital microbiological procedure used to detect and quantify microbial contaminants—including bacteria, yeasts, and molds—in non-sterile pharmaceutical products. This test ensures compliance with regulatory microbiological quality standards and protects patient safety.
Test Description:
Samples are inoculated into or onto selective culture media and incubated under controlled conditions to encourage the growth of bacteria and fungi (yeasts and molds). The microbial counts are then assessed and compared to the permissible limits defined by pharmacopoeial guidelines.
Purpose & Benefits:
- Detect and quantify microbial contaminants to ensure product safety
- Identify contamination sources during manufacturing, packaging, or storage
- Verify that microbial levels are within acceptable regulatory limits
- Required for batch release, stability testing, and GMP compliance
Industries Served:
- Pharmaceuticals & Biotech
- Nutraceuticals & Cosmetics
- Herbal & Traditional Medicines
- Personal Care Products
- Dissolution Testing – Drug Release Profiling
- Shelf-Life Testing – Stability & Expiry Determination
- Assay of Residual Solvents – Volatile Impurity Analysis
- Sterility Testing – Assurance of Microbial Purity
- Potency Testing – Verifying Therapeutic Efficacy
- Disintegration Testing – Ensuring Effective Drug Release
- Heavy Metal Testing – Ensuring Product Safety & Regulatory Compliance
- pH Testing – Ensuring Product Stability, Safety, and Compliance
- Stability Testing of Biological Products
- Moisture Content Testing – Ensuring Stability, Efficacy, and Shelf-Life of Drug Products