The biocontamination hazard assessment identifies any gaps to current manufacturing practices that individually or combined may lead to unacceptable biocontamination of the diagnostic device and thus affecting the required performance.

ISO 13485 -6.4.2 Contamination Control.
“As appropriate, the organization shall plan and document arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel, or product.
For sterile medical devices, the organization shall document requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging process”

For sterile medical devices, the manufacturers shall implement solid controls to ensure processes remain in a state of control. It is required to consider the sterility of the final product, the design of the cleanroom, disinfection procedures, the media fill procedures, and a comprehensive root cause investigation to arrive at the cause of product contamination and prevent recurrence of failures.

Inspection trends and common problems investigators are seeing in auditing manufacturing facilities are related to media fill operations, sterility testing and environmental monitoring.

Investigating media fill failures: Even if you are not able to pinpoint the exact root cause it is essential to identify areas for improvements to prevent recurrence of failures.