Microbiology

Services to the medical device industry include microbiological testing. We provide consulting, design protocols and perform all testing for radiation, ethylene oxide and steam sterilization validations. We offer testing for product release and quarterly audits.

Our facilities are registered with the FDA. We conduct our studies per current Good Manufacturing Practices and, when requested, Good Laboratory Practice guidelines.

Sterilization Validation (AAMI and USP) Bacteriostasis/Fungistasis Bioburden Testing Bioburden Validation Biological Indicator Testing Bacterial Endotoxin Testing (LAL) Gel Clot Turbidimetric Chromogenic Environmental Monitoring Microorganism Identification Mycoplasma Direct cultivation method DNA-Fluorochrome Staining Method PCR Packaging Challenge/Integrity Particulate Analysis Spore Strip Population Verification Product Inoculation Sterility Testing (AAMI and USP)

For a written price quotation please email us at info@bioscreen.com or call 310-214-0043.