With all eyes on the successful production and sales of your the medical device packaging process too often falls into the “kick the can” category. Yet, without regulatory approved packaging, you can’t get that medical device to market.
The earlier you bring a packaging partner on board, the more time and money you can save. Yet, bringing on an expert at any point is possible—and will be a valuable step in keeping your launch on track.
Where are you in what we see our five-step process? We can pick up the challenge at any point along the way.
Just as early detection of disease can save lives, working with a packaging engineer while your medical device is still being perfected can save launches. This step helps you identify risks early to avoid surprises later. It can also significantly reduce packaging costs, allowing more time to test materials and compare sources. If you are in the planning stage, here are some ways we can help:
If you are at this point, your device is ready to be produced in the manufacturing environment. There are many items necessary at this stage in order to satisfy ISO 11607 Part 2 requirements. We can guide you to success from a variety of angles, including:
Transit testing provides you the reassurance that your sterile product will reach the hospital environment safely. These validations also help satisfy ISO 11607 Part 1 performance requirements. Below are some areas that PCL can confirm your distribution readiness:
The final step for satisfying ISO 11607 Part 1 performance requirements is to prove that your packaging can maintain sterility over the course of time. This can be achieved through a combination of both accelerated and real-time aging. To prove how your packaging system will perform over time, PCL offers:
Now that you have successfully launched your sterile product with a rock-solid packaging validation, it is time to keep it that way, and avoid future remediation efforts. PCL can partner with you several ways to ensure regulatory success going forward, including: