This approach helps OEMs improve the process of getting a product into a validated sterile barrier system.
Due to the complex requirements of the medical device industry, the internal resources of device OEMs are drawn primarily to the device R&D and regulatory arenas. However, once the device R&D is complete, there is still a major hurdle left to tackle: how to get a product into a validated sterile barrier system.
One approach that has been developed to improve this process is QSEAL® pre-validated medical packaging. This line of pre-validated packaging can be adapted for a wide range of medical devices as an alternative approach to custom medical package designs. QSEAL incorporates both tray- and pouch-based sterile barrier systems that have been designed, sourced, and validated per ISO 11607 and associated standards.
As required by ISO 11607, a sterile barrier system that undergoes a validated sterilization process must maintain the sterility of a medical device when placed on the market, and must remain sterile under documented storage and transport conditions until the sterile barrier system is opened by the end user. The validation of the sterile barrier system can be a time-consuming and expensive obstacle to getting a new medical device on the market. The typical validations for a sterile barrier system include the validation of the packaging process, packaging-system performance testing (distribution simulation studies), and stability testing (aging studies).
During the validation of the sterile barrier system, the integrity of the seal and overall package are examined in detail. These characteristics are affected by a wide range of variables such as the materials that are used, the equipment and associated parameters used for package sealing, and the sterilization method. By standardizing many of these variables, many of these tasks are already completed, thus increasing overall efficiencies. Many of the validation activities have been completed with PETG trays and Poly-Tyvek pouch options for thQSEAL offering, resulting in a five-year package shelf life. The solution has been tested following a worst-case gamma radiation dose of at least 40 kGy and following two EO sterilization exposures with parameters representative of most EO sterilization cycles. Rigid and flexible packaging choices are available, along with foam protection options, standard label stock, IFU paper stock, and SBS shelf boxes to provide a complete packaging system.
By offering QSEAL packaging solutions with sealing processes and a packaging shelf life that have already been validated, only distribution simulation studies and other product-specific testing need to be performed. In fact, this solution can reduce packaging development costs by over 30% and reduce development time by as much as 60%. This solution offers customers the assurance that their device packaging has been thoroughly tested and validated by a team of dedicated packaging professionals, all while allowing medical device manufacturers to bring new products to the market much faster and more costeffectively.