Sterility Assurance Labratories
SA Labs building

How we can help your business

SA Labs offers an array of microbiological and chemical services including EO, radiation and steam sterilization validations, sterility testing, quantitative bioburden and microbial assessments of medical devices, pharmaceutical preparations, water and fresh produce, also heterotrophic plate counts of water and other solutions for hemodialysis. SA Labs offers analytical services for sterile devices including EO Residuals and Endotoxin testing. SA Labs is ISO-17025:2017 accredited.

Bioburden

BioburdenBioburden testing to quantitatively determine the total number of viable organisms on or in a device prior to sterilization is a specialty of SA Labs. We offer a range of validated methods for the recovery of bioburden, including Shaking, Stomaching, Flushing and Ultrasonication.

All bioburden determinations are conducted in accordance with the procedures and practices of ANSI/AAMI/ISO 11737. Options for the determination of bioburden include aerobic bacteria, anaerobic bacteria, spores and fungi, or any combination thereof including all.

Microbial characterization of the bioburden via sequencing for recovered pure colonies is also available.

SA Labs is ISO-17025:2017 accredited for bioburden testing of medical devices.