Medical devices play a key role in the diagnosis and treatment of many conditions and life saving treatments. To insure patient safety, the effectiveness of such medical devices should be carefully evaluated. Package integrity testing of medical devices is a crucial part of the manufacturing process.
Medical device package testing methods offered by PTI
1. Airborne Ultrasound technology
PTI’s Airborne Ultrasound technology (ABUS) is a seal quality inspection test method, capable of non-destructively examining packaging seal quality for defects, primarily flexible packaging seals. Under this method, ultrasound waves are passed through the pouch seal, creating a reflection of sound waves. The signal strength variations are analyzed to identify the presence of seal defects. Airborne Ultrasound technology creates a quick analysis of the seal area without tampering with the packaging to identify many common seal defects, such as incomplete or missing seals, wrinkles, and channel defects. The technology is in high demand due to its applicability across several industries, specifically the medical device industry. “Ultrasound is the only technology capable of identifying what the quality of that physical bonded nature of the seal materials are,” comments Tyler Harris, applications engineer at PTI- Packaging Technologies & Inspection. Medical device packaging including TYVEK® pouches is a very common application for ABUS technology.
PTI's Seal Scan (Offline) and Seal-Sensor (Inline) technology have further redefined pouch seal integrity testing. Both these technologies utilize non-contact airborne ultrasonic testing technology. With these advancements, Airborne Ultrasound technology has positioned itself to be the most sensitive method for non-destructive seal quality testing, in both the laboratory and in automated 100% inline testing production lines. ABUS is an ASTM Test Method F3004, recognized by the FDA as a standard for seal quality inspection and also referenced in the USP 1207 chapter guidelines.
2. Vacuum Decay technology
For several decades, Vacuum Decay has been proven to be the most practical and sensitive leak detection method for medical device and pharmaceutical packaging. It is a Container Closure Integrity Test (CCIT) capable of evaluating a wide range of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Vacuum Decay, being a non-destructive test method, does not cause any damage to the package being tested. This reduces significant waste and allows operators to have a thorough understanding of package integrity and package quality.
PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating a wide range of high-risk package applications. To conduct this test, packages are first placed in a well-fitted evacuation test chamber, which has an internal or external vacuum source. The test operator continuously monitors the vacuum levels to identify variations from a pre-determined targeted vacuum level. In the presence of a defect, air escapes from the package into the test chamber. Packages without any defect retain the air, maintaining a constant chamber vacuum level. It is an ideal solution for medical device manufacturers to assure that the product meets regulatory standards. Based on the packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.
ccit, vacuum decay, airborne ultrasound, package integrity testing, medical device package testing