Sterility Assurance

The Bioburden test is used to test for the viable microbial load of a given product.

This test follows current AAMI method 1 guidelines to calculate the appropriate irradiation dose needed to sterilize any of a wide range of products. This test also includes a validation of the calculated irradiation dose that is delivered to the product. Quarterly Dose Audits (QDA) are established using this validation.

This test follows the most current USP guidelines that apply to your product type to validate the sterilization process.