Biocontamination Hazard Assessment

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 affect the required performance.

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 the 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.

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