Your medical device product likely needs terminally sterile package design to deliver to market.
At this point, you’ve progressed through product development and likely developed a sterilization process. You’ve now arrived at performance testing the sterile barrier system. But you may have concerns about the best way to evaluate your packaging system.
Where do you begin? And how do you prevent the dreaded package design failure? It seems like an incredibly complex process involving many steps.
Medical Package Testing has made it easy for you with 3 ways to prevent ISO 11607 package design failures.
But first, make sure you’re up to date with the latest 2019 standards involving your packaging system:
ISO 11607-1:2019
ISO 11607-1:2019 is part one of two, and relates to “requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.”
ISO 11607-2:2019
ISO 11607-2:2019 is part two of two, and involves “validation requirements for forming, sealing and assembly process of preformed sterile barrier systems, sterile barrier systems, and packaging systems.”
To comply with ISO 11607, your product must remain sterile up to the point of use. That’s right – literally until the time it will be opened. This is especially critical when considering the risk involved in the distribution system from manufacturer to end user.
3 steps to avoid package design failure
The diagram below offers three key steps to set you on the right path for your medical device package design process. Do you have even more questions about medical package testing? We’re ready to help! View our website or request information.
