Eurofins Medical Device Testing helps ensure Sterile Barrier System integrity for patient safety

by Sunny J. Modi, Ph.D., Director of Package Testing, Eurofins Medical Device Testing

Medical device and pharmaceutical companies across the globe are keenly focused on developing their product and often miss the critical requirements for creating a safe packaging system that will protect the product during manufacturing, transport, and storage. One of the areas that should be evaluated is how the sterile barrier is maintained to protect the patient and prevent the transmission of diseases from the manufacturing line to the surgical suite. The regulatory agencies across the globe recognise the critical nature of a Sterile Barrier System (SBS) by considering it as a component of a medical device or pharmaceutical product. One key function of an SBS is to maintain the safety of terminally sterilised products until the point of use in a healthcare setting. The sterile integrity of the final packaging design can be evaluated through a series of seal integrity and seal strength testing outlined in ISO 11607 - Packaging for Terminally Sterilised Medical Devices.

Seal integrity testing identifies any leaks for the area around the perimeter of your packaging system. Some of the commonly used standards for seal integrity are ASTMs F1886, F2096, F1929, and others. Seal integrity testing is followed by seal strength testing to evaluate the mechanical strength of your packaging system and the force needed to separate and open the seal. ASTMs F88 and F1140 are commonly used standards to measure the strength of the seal. A high force numerical value could indicate challenges in opening your packaging system by hand. A low force numerical value could indicate poor bonding of materials, which would result in a breach of sterile integrity. As Medical device and pharmaceutical companies continue to innovate across the globe, the Sterile Barrier System (SBS) should be evaluated not only at final design stage but also during the continuous manufacturing of the product.