Managing the timeline of a medical device packaging validation project can be challenging, especially with so many variables at play and the roadblocks that may pop up along the way. The key to reducing stress in the process is to plan as far ahead as possible, anticipate potential setbacks before they happen, and communicate effectively with your cross-functional team.
At PCL, we understand the complexities of the packaging validation process because we’ve been through it ourselves. So, we asked one of our experts, Anna Richards, to put together a step-by-step guide designed to make your next project more manageable. We’ve broken it down into six clear steps, complete with practical tips and insights to help you navigate the process with confidence.
Step One: Scope
This is a crucial initial step in the process. Here you’re going to dig deep into the minute details of your packaging configuration, product design, timeline, and budget to help yourself prepare for your upcoming project.
A common roadblock we see during this step is the lack of consideration for packaging. Packaging shouldn’t be an afterthought. Plan early and remember that packaging is considered part of the product. You can’t go to market without it!
Tip: Keep your project milestones in mind when planning your budget and procuring your funding. It’s important to be aware of when your budget will be taking hits.
Possible questions to ask yourself during this step include:
- Is this a new packaging design or a sustaining change?
- Are there any cleaning or sterilization processes required for the product or device?
- What packaging configuration do I want to use based on the design inputs?
- What’s my budget?
- What’s my regulatory timeline?
It’s important to leave no stone unturned during this step. This is the time to really dissect your project and become familiar with every little detail. Being an expert in your packaging design, product requirements, budget, and timeline restrictions will help you tremendously as you move forward.
Tip: Nothing is ever going to run smoothly. Plan in advance for delays and mishaps that are not in control of your own project (i.e. delays due to suppliers, sterilization processes, or shipping).
Step Two: Design
For a custom packaging design, you need to create a design concept. This design will be reviewed with your cross-functional team. The two big components of this step are understanding your prototype lead times and your production times and then building those into your overall timeline. At this stage you’re doing fit checks to see if it’s going to pass transit validation. You also want to take into consideration where the device will ultimately end up. For example, will this package be opened in an operating room or in a nursing home? Who is the intended user?
Process design goes hand in hand with packaging design. You’re also checking if you need any new equipment, or if any major modifications need to be made to your manufacturing process.
Tip: Is your device high-risk or high-volume? Source similar components within your packaging supply chain, or even dual source your process, to ensure supply chain redundancy is planned for early in the process.
Step Three: Early-Stage Testing
For this step you’ll be developing your sealing process and gathering early feasibility testing results. Early-stage testing is important for de-risking your validation execution. Testing your packaging design early with feasibility testing allows you to see if there are any blatant failures right off the bat. If you see passing results, you can proceed with more confidence that you will avoid failures when you get to formal V&V in Step Four.
Tip: Early errors lead to accelerated solutions! Discovering failures early in the process gives you the time to adjust and fix your trouble spots before you’re too deep into your validation. Roadblocks are never easy, but nothing is worse than a roadblock in the eleventh hour.
Step Four: Verification and Validation Strategy
Next is your V&V planning. Here you will detail the testing and sterilization processes that your packaging will go through. During this stage you should also be gearing up your production team so you can be ready for manufacturing when the time comes.
Tip: Determining if your device requires a cleaning validation process as early as possible, especially if you have a complex device. This process can tend to be a little high risk for the more complex devices so starting as early as possible is highly recommended.
PAUSE: Are you keeping everyone in the loop and communicating regularly with all parties involved? Are you keeping in touch with your Quality team? Production? It’s important to be in communication with everyone throughout the process so that there are no surprises when you try to move on to the next step.
We recommend using one project management software for the device and packaging sides of your project timeline. If your various teams are all using different software, it can make it harder to keep track of all the moving parts. We recommend layering your timelines within your full project schedule so you can clearly see the big picture.
Step Five: Verification and Validation Execution
Now it’s time to put the plan into action! During this step the packaging design will be put to the test through transit, aging, and usability testing. It will also go through the cleaning (if required), and it’s sterilization process.
Tip: You can run validation builds and testing in parallel, if you’re feeling confident with your risk profile and looking to pull in timelines. OQ + PQ are common to run in parallel, as well as the builds and sterilization processes required to run Transit (DV), Accelerated Aging, and Real Time Aging (RTA) in parallel.
With your production team on deck, you will wait to receive clearance or approval from a regulatory body. Once you have that, you’re good to move forward!
Step Six: Manufacturing Readiness/Design Transfer
The sixth and final step is to transfer that knowledge to the production team. With official clearance/approval from a regulatory body, production builds can be scheduled.
Key Takeaway
No two packaging validation timelines will ever look exactly the same. Because of this variability, it’s important to approach every validation with flexibility and a readiness to adapt. Ultimately, the success of your project will depend not only on your technical planning, but also on how effectively your team communicates, collaborates, and responds to challenges as they arise. Being proactive, organized, and prepared for setbacks is what will keep your project moving forward, even when things don’t go exactly as planned.
Is there a specific step that you would like more information about? Reach out to PCL and speak to one of our experts!
