ISO 11607 can be difficult to read, to say the least! Aside from being lengthy, the details can be very dry leading people to skim through and miss key details. This is the reason we have put together the 3 Pillars to Packaging Validation : Your Guide to Understanding ISO 11607. This guide is aimed to be a cliff notes version summarizing the key points and highlighting the often missed points within ISO 11607: 2006.
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With the help of this guide, you should have a general overview of ISO 11607:2006 and be on track to begin your medical device packaging validation. As you begin to formulate what your validation process looks like, it is important to start with the strong foundation. This involves ensuring you have met supplier, material, and design/development requirements to set your sterile packaging system up for success as it progresses through validation.
Once that solid foundation is built, you are ready to move to process validation, where you ensure that your equipment is working as intended and is reliable. After this is confirmed, your packaging can then go into transit testing where it will be subjected to the worst-case shipping simulations. Following transit testing the package system should be inspected for how it held up and maintain its integrity. Finally, your packaging should go through shelf life testing to demonstrate the packages ability to maintain a sterile barrier over time. This includes accelerated aging and real time aging testing to make shelf life claims.
After completing all the above your medical device packaging should be well on its way to market with confidence! Packaging Compliance Labs is an expert in this topic and is a reliable and readily available resource for you as you embark on packaging validation.
Any further questions or comments, please email Sarah Rosenblum at srosenblum@pkgcompliance.com.
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