Inoculated Product Testing

Inoculated products consist of actual devices or materials that have been inoculated with a specified level of a liquid biological indicator (BI) suspension or a BI carrier strategically placed within the device. Inoculated products are used to validate and / or monitor certain sterilization processes.

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Before a new lot of BIs for sterilization load monitoring, the average population per unit should be independently confirmed per USP regulations. This may be conducted with suspension, composition of 4 BI carriers, or a composite per the manufacturer’s instructions.