Microbial and Sterility Testing Services
At SEP Analytical Labs, we provide comprehensive microbiological testing services to ensure the safety, efficacy, and compliance of pharmaceutical, cosmetic, and personal care products. Our lab adheres to United States Pharmacopeia (USP) standards, including USP 51, USP 71, USP 85, USP 61, and USP 62.
USP <51> Antimicrobial Effectiveness Testing (AET)
USP 51 evaluates the effectiveness of preservatives in pharmaceuticals, cosmetics, and personal care products. This test ensures that antimicrobial preservatives effectively inhibit the growth of bacteria, yeast, and mold over a specified period. The challenge test is conducted by inoculating the product with specified microorganisms and monitoring microbial reduction over time.
USP <71> Sterility Testing
Sterility testing is critical for injectable drugs, ophthalmic solutions, and other sterile pharmaceutical products. USP 71 determines whether a product is free from viable contaminating microorganisms. We perform both membrane filtration and direct inoculation methods to ensure compliance with regulatory requirements.
USP <85> Bacterial Endotoxin Testing (BET)
Bacterial endotoxins, primarily derived from Gram-negative bacteria, can cause severe reactions in patients. USP 85 testing detects endotoxins in injectable drugs, medical devices, and other parenteral products using the Limulus Amebocyte Lysate (LAL) test. We offer gel-clot, turbidimetric, and chromogenic LAL testing methods.
USP <61> Microbial Enumeration Tests
USP 61 assesses the total viable count of aerobic bacteria and fungi in non-sterile pharmaceutical products. This includes:
- Total Aerobic Microbial Count (TAMC)
- Total Yeast and Mold Count (TYMC)
These tests help determine microbial contamination levels and ensure compliance with microbial limits.
USP <62> Tests for Specified Microorganisms
USP 62 complements USP 61 by testing for specific objectionable microorganisms, including:
- Escherichia coli
- Salmonella species
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Candida albicans
These tests ensure that harmful pathogens are absent in non-sterile pharmaceutical and personal care products.
Why Choose SEP Analytical Labs?
- State-of-the-art facility equipped with advanced microbiological testing instruments for precise analysis.
- Regulatory compliance with all tests performed according to USP and FDA guidelines.
- Fast turnaround time with reliable results and efficient reporting.
- Comprehensive support with expert consultation for interpreting test results.
For more information or to request testing services, contact us todaay!