In the medical device industry, the use of vibration testing is critical since it is this hidden damage from vibration that can cause significant repercussions in the healthcare industry. On the one extreme, if the product reaches its intended use with visible damage to the shipping container, the product may be rejected and returned to the manufacturer. Or if the sterile barrier system is picked from the shelf for a surgical procedure and has sustained visible damage, a new product will have to be retrieved, perhaps at a critical time in the surgery. In a worst case scenario, if the sterile barrier system is picked for a procedure but the damage is not readily visible and has a small pinhole due to fatigue or abrasion damage, the product may become non-sterile and put the health and safety of the patient at risk. So it is critical in the package development and design process to assess the ability of the sterile barrier system to resist the vibratory forces in the transport environment to ensure that there is a very high probability that the product reaches its intended use in the condition for which it was designed.
Package validation or package performance testing is based on the accepted fact that sterile medical device packages do not typically lose their sterility simply by being stored on a shelf. Package failures are a result of environmental extremes and dynamic events which may have occurred during the manufacturing process, during shipping and handling to the sterilization facility, or during distribution or transit to the point of end use. All of these processes may subject the finished package to forces involving handling shocks, vibration, and, high and low temperature and humidity extremes. The GMP for Medical Devices Part 820.130 states that “the device package and any shipping container for a device shall be designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution”. Therefore it is generally accepted practice to perform simulated distribution testing in a laboratory setting to fulfill this requirement of the ISO 11607 standard. The vibration testing element of the package performance assessment is a key component of the package evaluation process. (370 words)