Sterile Medical Package Inspection

Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection methods. A variety of inspection methods exist for medical package inspection that require a thorough understanding to ensure quality.

The predominant inspection method for medical device packaging has been manual visual inspection. While this approach is covered by an ASTM method (ASTM F1886), it may not be appropriate for certain applications and is limited in capability. Manual visual inspection has the capability to detect a 75-micron channel defect, but even the ASTM method F1886 outlines that the probability of detection ranges from 60% to 100%. This wide range of uncertainty does not provide the confidence needed for higher risk medical device packaging