Class III Med Device Application Notebook
Class III medical devices have a unique set of requirements and package characteristics that need the right inspection methods. A variety of inspection methods exist for medical package inspection that require a thorough understanding to ensure quality. An operator’s ability to detect defects mitigates as the time spent in inspecting packaging increases. An ideal test method must meet two fundamental criteria. The method must be capable of measuring or detecting the quality attribute, and the method must be reliable. PTI offers two primary technologies to inspect medical device packaging; vacuum decay and airborne ultrasound. Both technologies aim to offer quantitative and deterministic test results to evaluate the package quality. Vacuum decay is focused on package integrity and detection of leak paths. Airborne ultrasound is focused on seal inspection and seal quality.