The First Line of
Patient Defense.
Microbiological contamination is a critical risk to patient safety. Our dedicated microbiology suite is designed to detect sterility failures and bioburden risks before they reach the market.
Core Capabilities:
- Sterility Testing:
USP <71> compliance for sterile products. - Endotoxin Testing:
LAL Kinetic Chromogenic analysis (USP <85>). - Bioburden:
Total Aerobic Microbial Count (TAMC) and Total Combined Yeasts and Molds Count (TYMC) (USP <61>). - Pathogen Detection:
Screening for specified microorganisms (USP <62>) and Burkholderia species (USP <60>). - Antimicrobial Effectiveness Testing (AET/PET):
Preservative efficacy studies (USP <51>).
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