Accelerated Sterility Testing with Celsis®
Rapid microbial detection using Celsis® ATP bioluminescence. Sterility results in just 4–5 days versus the traditional 14 — reducing production delays while maintaining USP compliance.
Our Testing
Services
USP-compliant microbiological and analytical testing — engineered for speed, accuracy, and regulatory rigor.
Microbiological Tests
Microbial Enumeration Tests (USP 61)
Total Aerobic Microbial Count (TAMC) and Total Yeast & Mold Count (TYMC) to quantify contamination in non-sterile pharmaceutical, cosmetic, and personal-care products.
Tests for Specified Microorganisms (USP 62)
Screens for E. coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans to confirm the absence of objectionable pathogens.
Endotoxin Challenge Vials (ECV)
High-quality ECVs to support depyrogenation validation for pharmaceutical, biotech, and laboratory facilities, verifying sterilization cycle effectiveness.
Sterility Testing (USP 71)
ATP Bioluminescence sterility testing for compounded sterile preparations — rapid, reliable, and compendial-compliant options available.
Endotoxin Testing (USP 85)
Detection and quantification of bacterial endotoxins (LPS) from gram-negative bacterial cell walls, ensuring product pyrogen safety.
Method Suitability Testing
Per-client method suitability performed for each new compound we receive, eliminating false negatives caused by antimicrobial interference.
Antimicrobial Effectiveness (USP 51)
Evaluates preservative effectiveness in pharmaceuticals, cosmetics, and personal care products against bacteria, yeast, and mold over time.
Analytical Tests
Stability-Indicating Assay (SIA)
Evaluates potency and degradation of pharmaceutical products under storage conditions to confirm efficacy, safety, and regulatory compliance across shelf life.
HPLC Method Development & Analysis
High-performance liquid chromatography methods tailored to your product — impurity profiling, content uniformity, and stability studies.
FTIR Analysis
Fourier Transform Infrared Spectroscopy for functional-group identification and chemical composition verification. Non-destructive, precise, and compliant.
Potency Testing
Quantifies active pharmaceutical ingredient (API) concentration to confirm product strength and specification compliance.
pH Measurement
Critical for stability and compatibility across pharmaceutical formulations, cosmetics, and personal care products.
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