Patients\u2019 safety is dependent on the sterility of medical device packaging, which starts at the packaging and sealing stages of the packaging process before shipment. Any failed sterile seal leads to a repackaging or total scrapping. A medical device with a broken sterility seal can significantly affect a patient\u2019s life. Therefore, the manufacturers usually pull samples of units from every batch at the end of every production line to ensure quality control. Here is more about boosting sterile packaging reliability.<\/p>\n\n\n\n
The Manufacturer\u2019s Test<\/strong><\/p>\n\n\n\n Before the packages strike, medical devices leave the were houses for shipment. The manufacturers first do their tests to ascertain everything is done correctly, and all the devices are safe for transport and use. First, they will get samples from all the batch units of the production line. Then, once they have all the batches, they use two simple tests.<\/p>\n\n\n\n One, they measure the force used to open the package. If the force is too little, it means the packaging is poor. Second, they insert a visual microscopic inspection inside the packed device and look for bubbles or if there are any breaches in the seal.<\/p>\n\n\n\n If there is any issue, the whole batch is quarantined for further evaluation and testing. Unfortunately, this may also trigger the regulatory protocol, significantly affecting production and slowing it down by two to three weeks. This is pretty costly on the manufacturer\u2019s side.<\/p>\n\n\n\n