2. Properly size packaging components.
Loss of sterile integrity, one of the most common types of packaging failure, is often the result of improperly sized packaging elements in relation to the device. These packaging elements include the backer card or tray to retain the device, the pouch or lid, the shelf carton, and finally the corrugated master shipping container. If any one of these elements is improperly designed or sized in relation to the other, unnecessary movement will likely create complications during transportation and result in failure of your sterile barrier system.
For example, if the backer card is too large, constant pressure will be placed on the pouch seals. If it is too small, excessive motion within the pouch will create friction and abrasive forces. A pouch or tray lid within a shelf box that is too large will need to be folded or creased; one that is too small will be subject to repeated contact against the inner box, all of which cause stress and fatigue leading to pinholes and pouch failure.
Individual shelf cartons need to fit snugly around their contents to prevent movement during transportation, while the master shipping container must maintain sufficient rigidity and wall strength to protect the inner cartons consistent with the distribution environment of the device. All of these elements must be customized to the device, and they must work in tandem to reduce the risk of failure and successfully deliver your device to market.