Mark Francis
Pat Nolan5 Questions to Ask a Medical Device Packaging Engineer
As a medical device manufacturer, one of the most important steps in the FDA approval process for a device is evaluate each package’s ability to protect the product inside throughout the handling, distribution, and storage environment.
The manufacturer must demonstrate that, under the rigors of distribution, storage, handling, and aging, the sterile package integrity is maintained at least for the claimed shelf life of the medical device or product.
There are many important questions you should be asking your packaging engineers internally, if you do your own testing, or that you should be asking of a third party testing laboratory. Here are 5 questions to ask a medical packaging engineer before you conduct your next package testing project.
- Which technical standards does your testing laboratory comply with?
- Are the standards that we are currently using or about to utilize in compliance with ISO 11607?
- What are the material characteristics in the package design?
- How is the device sterilized?
- What is the worst case packaging configuration to use for a final package performance validation?
As a medical device manufacturer, what other questions do you make sure to ask of your packaging engineers in house, or of your preferred testing laboratory?
