ISO 11607 is the defining standard for medical package testing and validation. As the consensus standard for the Food & Drug Administration (FDA), no device can expect to find its way to market without an in-depth understanding of the standard and how to meet the requirements it spells out.
Lots of medical device manufacturers focus on accelerated aging and successfully establishing an estimated shelf life for medical devices. But another aging test often gets overlooked – real-time aging. Learn the right time to start real-time aging and some best practices for results that comply with ISO 11607.
Does your medical package testing project need a sterile barrier accelerated aging? Find out in our what, why, and how explanation of this process.
Medical device, pharmaceutical, and biotech companies must follow stringent medical device packaging validation processes to obtain what they need for an FDA or EU submission: The coveted validation report. Your terminally sterilized medical devices cannot [...]
How many medical package testing samples do you need? Read common processes testing providers use to make the determination!
Medical device distribution testing is an important part of delivering your product to market. Learn more about the “shake, rattle, and roll” medical package testing method.
Learn the difference between real time aging and accelerated aging for your medical device package testing project.
Design Terminally Sterile Packaging: 3 Ways to Prevent ISO 11607 Package Design Failure (Infographic)
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.
Dye penetration testing is a common method of checking for seal leaks in medical packaging such as pouches, trays, and blisters. The intent of this article is to review and clarify the recent developments in [...]
As a project leader for medical device manufacturing, there is one area in particular that I feel can really derail projects. When a project reaches me, often times the packaging has already been created and [...]