Medical Device Link .

In the medical arena, the goal is always to present a sterile, zero-defect product to the end user. Not only must the product itself be perfect, but the packaging must be free of defects that could compromise the integrity of the contents. To ensure package integrity, manufacturers may rely on both destructive and nondestructive test methods. In the past, nondestructive package testing methods tended to be time consuming, and the equipment was expensive and complicated to use. Today, suppliers are offering better solutions, and device manufacturers are taking heed. Traditional ultrasonic technology requires the test piece to be placed in contact with a wet physical coupling. Although very effective, moisture contact rules out the use of this technology for 90% of medical and pharmaceutical packaging. In response, PTI / Packaging Technologies and Inspection (Tuckahoe, NY, USA) has developed air-coupled ultrasonic testing. Air is the only coupling medium used, and no special package preparation is needed prior to testing. The technology is suited for seal-integrity testing on a full range of nonrigid packaging, such as heat-sealed pouches, sachets, and some blister packs, as well as porous packaging. In addition to basic package integrity testing for air, this technology will identify defects such as voids, delamination, foreign materials, inclusions in the seal and misaligned seals. In air-coupled ultrasonic testing, focussed high-frequency sound waves are fired in 200-Hz pulses through the seal area under inspection. A sensitive noncontact receiver detects and interprets the transmitted ultrasound signal and shows the results in a visual display. The company’s Seal Scan Airborne ultrasound inspection technology is capable of testing many types of packaging materials, including aluminium, foil, paper, Tyvek or any