Bioburden Method Suitability: A Practical Solution to Screening for Inhibition.

ANSI/AAMI/ISO 11737-1:2018 addresses validation of the method for determination of bioburden. Clause 7 states that validation shall consist of four items, one of which is "assessment of test method suitability to demonstrate lack of inhibition of growth." Information must be provided, either through a rationale or via testing, showing that no inhibitory properties from the product exist in the specified bioburden test.

Sterility Assurance Across-Sectors-New Paradigms and Tools.

The sterility assurance community is facing significant challenges. A relatively recent challenge is the pressure on manufacturing supply chains resulting from the limited availability of capacity for terminal sterilization of healthcare products. The current challenge is finding solutions for innovative new products, especially biologics and combination products, that offer great promise for patients around the world.

Medical device SALs and surgical site infections: a mathematical model.

It is commonly accepted that terminally sterilized healthcare products are rarely the source of a hospital-acquired infection (HAI). The vast majority of HAIs arise from human-borne contamination from the workforce, the clinical environment, less-than-aseptic handling techniques, and the patients themselves. Nonetheless, the requirement for a maximal sterility assurance level (SAL) of a terminally sterilized product has remained at 10(-6), which is the probability of one in one million that a single viable microorganism will be on a product after sterilization.

Bacterial endotoxin testing: a report on the methods, background, data, and regulatory history of extraction recovery efficiency.

Since the mid-1970s the Limulus Amebocyte Lysate (LAL) assay has been used to test medical devices for bacterial endotoxins. The Association for the Advancement of Medical Instrumentation (AAMI) recently published a standard designated ANSI/AAMI ST 72: 2002, Bacterial Endotoxins--Test methodologies, routine monitoring, and alternatives to batch testing, which addresses LAL testing and associated issues. In order to perform the bacterial endotoxins test (BET), the test article must be extracted in an aqueous medium, with the extract being used as the test solution.