Bioburden Validation

START 5 Bioburden Validation

1. Turnaround time: to be determined upon study parameters
2. Sample Requirements: at least 3 samples (sterile)

ISO 11737-1 & USP <61>

The scope of the study included determining the bioburden recovery factor of the test item according to ISO 11737-1:2018 Sterilization of healthcare products – Microbiological methods – Part 1: Determination of a population of microorganisms on products. The aim of the study is to determine the bioburden recovery factor of the test article.

Bioburden recovery factor of test article is assessed by inoculation of the test item and then removing microorganisms from it followed by their culturing and enumeration.