Risk Assessment for Vial Depyrogenation Tunnel

At the very basic stage of design the Risk Assessment is carried out to verify that all features are taken into consideration to avoid the risk of failure of critical GMP and EHS parameter in the equipment.

During study, all GMP, EHS and operational parameters will be identified and assessed for the risk, appropriate mitigation will be proposed and verification point will be identified and defined.

The Risk Assessment report is produced to provide the documented evidence that design concepts or requirement are complete in considering all GMP, EHS and operational risks.