Medical device packaging validation helps ensure that a medical device cleared for commercialization will arrive to the end-user in an uncompromised, sterile state, and non-sterile product remains uncompromised during its journey to the user. Here are five important best practices to packaging validation testing, according to the ISO 11607 standard.
Your medical device has finally been approved, and packed for shipping to the shelves. But what happens when the package drops in distribution or temperatures spike in transit? Will it still be safe for use by the time it makes it to patients or healthcare providers?
That’s what medical device packaging validation testing aims to find out. Quality and compliant packaging ensures a medical device arrives as intended to the end-user. To validate that the packaging is just that – quality and compliant – manufacturers are required to conduct a series of tests:
- Simulated distribution/transportation (“shake, rattle, and roll”) testing: evaluates the ability of the package and shipper to protect the product through handling, shipping, and distribution environments, which may result in damage such as puncture, abrasion, and seal failure.
- Shelf-life determination testing: serves as key interim data to support product shelf-life dating until real-time data are available.
- Package integrity testing: evaluates the integrity of packaging to be maintained during the production, shipping, and life of the product.
- Seal integrity testing: assesses how users interact with the packaging system, including seals, to determine its functionality, ease of use, and potential risks.
Each category of testing has several sub-test methods. Medical device manufacturers refer to ISO 11607 to develop an appropriate test plan.
Packaging Validation Testing Best Practices Guided by ISO 11607
ISO 11607 packaging for terminally sterilized medical devices is the principal standard for medical device packaging validation testing. It is broken up into two parts:
- ISO 11607-1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2: Validation requirements for forming, sealing and assembly processes
All in all, ISO 11607 stands as a globally acknowledged standard, cited by regulatory bodies worldwide. Both the US FDA and the EU MDR incorporate this standard into their evaluations. It ensures adherence to integrity, usability, and sterile barrier requirements, while also addressing risk mitigation for device packaging.
Missteps and retesting can be costly and cause market delays, so it’s important to get these final steps right. To help, we summarized five important best practices that every medical device manufacturer should know.
5 Medical Device Packaging Validation Testing Best Practices
#1. Build Packaging Around the Device
Successful packaging validation starts with how well you design your medical device’s packaging in the first place. In other words, you shouldn’t be putting your device in a package that already exists and hope it works. While it may be more efficient to reuse configurations, you risk over- or under-estimating packaging needs (like bubble wrap or cardboard layers) and ultimately put the device in jeopardy.
Instead, plan your medical device packaging design and materials by evaluating the:
- Nature of your medical device
- Planned sterilization methods
- Intended use
- Expiration date
- Transport circumstances
- Storage environment
Successful packaging – and a successful validation – will be informed by these parameters. It’s critical to know, for example, your various shipping modes and design packaging that can withstand that type of environment and test it accordingly.
While it takes more time on the front end, the time and money saved from retesting or failure will be well worth it. This is all about starting with the end in mind.
#2. Prioritize Protecting Sterile Barriers
For sterile products, sterilization commonly constitutes the final stage in the medical device manufacturing process. But it’s not the medical device’s last stop.
From there, it must remain sterile until the moment it’s needed for use. This sterility directly impacts the medical device’s safety, effectiveness, and usability. If the sterile barrier is compromised, there’s no way to prove if the contents are sterile or not, putting end-users at risk (or forcing them to discard a perfectly usable device). This means your packaging needs to protect sterile barriers above all else.
By conducting rigorous usability evaluations, you can address any usability issues that may compromise the seal integrity. For example, burst strength testing according to ASTM F1140 determines a package’s ability to resist internal pressure and measures the strength of the package seals.
Ultimately, usability evaluation contributes to the development of reliable and user-friendly packaging solutions that uphold the integrity and sterility of medical devices.
#3. Don’t Neglect Usability & Aesthetics
ISO 11607 places an emphasis on usability evaluations as a part of packaging validation testing. These evaluations demonstrate that the sterile contents can be aseptically removed from the sterile barrier system. According to section 7 of ISO 11607, usability evaluations should assess how well the instructions:
- Identify a clear location on the package to begin opening it.
- Describe the opening technique that doesn’t contaminate or damage the contents.
- Describe how to aseptically present the product into the sterile field.
These usability instructions are critical to patient safety – and so is making sure that these instructions and other labels stay legible during routine storage and use. In addition to usability, this has a lot to do with aesthetics. What will the packaging look like after distribution or long time on the shelf? Wrinkled, damaged, or illegible labels are an aesthetic problem with usability implications. Don’t neglect this!
#4. Document Everything
Your medical device packaging validation testing is only as good as it is documented. Keep a paper trail of everything, including:
- How the packaging has been designed.
- The test plan.
- Results of the tests.
As regulatory expectations evolve, having the right documentation will be helpful in case repackaging or revalidation is needed.
#5. Work with a Trustworthy Testing Partner
While it’s possible to conduct medical device packaging validation testing in-house, most medical device manufacturers work with testing labs to help them get the job done. However, it’s important to be critical about who you partner with. Make sure your partner checks, at least, these three boxes:
- Real-time and accelerated aging capabilities
Waiting for real-time aging data can delay your product’s go-to-market. Accelerated aging studies (ASTM F1980) serve as key interim data to support product shelf-life dating until that real-time data are available. This means it’s critical to have reliable results from these studies.
When vetting a partner, make sure they can perform these tests in a variety of settings to ensure all package types and materials are compatible with the temperature and humidity exposure limits.
- Environmental conditioning capabilities
Environmental conditioning testing (ISTA Series and ASTM D4332) exposes medical device packaging to freezing and tropical temperatures for impact assessment, supporting the package system’s ability to withstand worst-case scenarios. This helps ensure the product’s stability during and after distribution.
When vetting a testing lab, make sure they can do these studies. (Not all can!)
- True complete in-house testing
Some labs don’t have the resources or equipment needed to handle simulated distribution/transportation testing – a pinnacle of medical device packaging validation. In that case, they outsource the “shake, rattle, and roll” test to yet another lab, subjecting your packaging and product to additional handling and environmental conditions it wouldn’t normally encounter (and leaving room for error).
Unnecessary shipping and handling during validation creates room for error. Avoid this entirely by working with a testing partner that can handle this testing in-house.
Medical device packaging validation testing is an important final step. You have worked hard to design, develop, and clear your medical device product for commercialization – now make sure it stays that way with the best packaging, validated with these best practices in mind.
WuXi AppTec is an experienced preclinical testing partner for device manufacturers. We offer everything from validation of the packaging/seal integrity, simulated distribution/transportation testing to shelf-life determination.
Talk to an expert about your upcoming project to see how we can help.
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