Sterile packaging of medical devices is critical for patient health and safety. Whether it’s packaging for a surgical instrument, joint prosthesis or a heart valve, broken packaging seals can cause product contamination. Other sealing applications, including food and military supplies, also rely on intact hermetic seals. The common link between these applications is that failure of a seal can have serious consequences, such as infection or even loss of life.
“It goes without saying that Class II and III medical device and supply manufacturers can ill afford the risk of sterile product contamination,” said John Fouts, senior controls software engineer at DWFritz, in Vision Systems Design Magazine.
And yet, FDA recalls show that current approaches to package sealing are inadequate. Sterility issues caused 89.4% of recalled medical device units in the third quarter of 2017, according to the Stericycle Recall Index. One failed package can cause a recall of the entire lot and even close down the manufacturing line, increasing product costs and potentially limiting supplies of critical devices. Lawsuits can further raise the costs associated with failed seals.
Many package seals are inspected by hand, but the time available for this inspection is limited: defects must be detected within 10 seconds.
“Manual inspection of package seals tends to be time consuming and error prone,” said Fouts. “After all, contaminants such as hair and hidden particles in the seal can be extremely challenging for people to see, leading to mistakes or oversights.”
Low-cost automated 100% inspection of seals improves the dependability of shipped packages, dramatically lowering the risk of delivering contaminated materials.