The most difficult process for a medical device package to survive is sterilization, explains Joyce Hansen, vice president of sterile process technology for Johnson & Johnson. Hansen spoke at HealthPack 2013, held in Louisville, KY, giving the keynote presentation to kick off this year’s packed opening day March 13.
To ensure success, medical device packaging professionals should work closely with their colleagues in sterile process technology, Hansen urged. “Sterility assurance and packaging professionals need to work together to make sure that the testing performed will provide a safe and effective package for current and future projects,” she explained. The challenges of those future projects will entail more complex products, such as kits and biomedical tissues, as well as materials sensitive to high temperatures and radiation, she added.
To ensure package/product designs survive sterilization, “expose your product to deeper, faster, quicker processes that would be the most difficult [such as] in excess of the maximum amount of the dose to be used in radiation sterilization,” she said. “Don’t think about routine sterilization parameters—think about the extreme!”
Hansen explained that the largest source of sterility related recalls is packaging failure. “Every time I look at recalls, it is about 80%.” Such recalls are associated with packaging design, packaging processes that are not validated, inappropriate sealing, and supplier quality issues, she explained. “It is surprising,” she said. “It should always be a huge part of what we do together.
Consistency is the key, she explained. In terms of packaging validation, for instance, Hansen asked the audience to examine whether efforts are consistent across multiple batches as well as their organizations.
Part of the challenge may be what Hansen characterized as a “reduced pool of technical population,” among others.
Interestingly, Michael Tokarski, a principal packaging engineer with KCI who spoke later in the day, offered one emerging source of support, calling it a “step in the right direction that Joyce was speaking about today.” Tokarski, through the Packaging Sterilization subcommittee of IoPP’s Medical Device Packaging Technical Committee, is building a database listing commonly used polymers and compatible sterilization methods. The HealthPack audience gave Tokarski some feedback about the database, which he called a “living document,” and he hopes to solicit more input for further peer review.
For more details on HealthPack, visit www.healthpack.net