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November 21, 2018

Be Thankful for Packaging Validation Strategies


Our engineers preach this every day, “The key to a faster market launch is a well-planned packaging validation strategy.” Packaging is typically the last piece in the puzzle to launching a medical device into the marketplace. We often hear the phrase, “can’t I just throw it in a box?” This belief is what prevents most companies from developing a proper packaging strategy. Instead of wishing for a perfect packaging configuration, this Thanksgiving, give thanks for these tips to help make your medical device packaging and validation project go more smoothly.


What are your goals for testing?

If ISO 11607 compliance is your goal, then you should look to simulate the actual transportation and storage environment that occurs during your supply chain. Other reasons to test, include root cause analysis. If you’ve seen a failure in the field and are looking to find the cause, the best way is to complete tests to duplicate the failure seen in the field. Understanding your goal outcomes is vital to choosing the correct path for your validation.

What defines passing results?

A critical factor in completing testing is defining what passing results look like for your packaging configuration. This is called acceptance criteria. Many standards offer guidance on accurately determining your acceptance criteria. Each packaging project is unique and should have a detailed description of what a failure looks like for its specific material, configuration, etc. Ultimately the key detector of a failure will occur during packaging integrity testing. If the integrity of the packaging is maintained and the sterile barrier is intact, then the packaging should be sufficient. It is also essential to define what packaging integrity tests are best suited for your project.
For help in this section, our engineers are always available to discuss the specific needs of your configuration. Contact us today.

Does lab selection matter?

The short answer is YES! It is vital to match the needs of your packaging project with a lab’s capabilities and expertise. It is essential to verify the credibility of a lab by looking at accreditations and certifications. This will build trust behind a lab ability to perform proper testing and uphold to a standard. Next, you’ll want to investigate a lab’s expertise. Many packaging labs go far beyond medical and pharmaceutical, including the food and automotive industries. Specialization in the medical category will ensure that the lab maintains a medical grade level of procedures and operations. This also leads to extra support if medical packaging expertise is needed. Finally, you’ll need to have a deep understanding of the lead times for your project timeline. Various labs have longer lead times or extra charges for expediting. To stay on your schedule and budget, you must calculate those factors into your packaging plan.

If timing is your highest priority – ask us about our FAST 24-hour lead times!


Are we on the same page?

Each test is backed by an ASTM, ISTA or another governing body standard, but this does not ensure that all are alike or run the same. For each method, there are various ways for it to be completed and acceptance criteria to consider. To ensure that you and your test lab are on the same page, you should clarify all the methods and procedures used for your testing. Miscommunication can be a timely and expensive mistake!

Ask about our Test Parameter Sheet (TPS) as an answer to this problem.

Stay in the know

Once your packaging enters testing, it can be a stressful time awaiting the results. Often critical decisions will be made following the outcomes of testing and having all the information is vital. During testing, it is essential to stay in the know with how each segment is going. A steady stream of communication should be upheld between you and your lab to ensure informed decisions. In the event of a failure, this communication is key to saving time and money. The fastest solutions are made when results are shared during the critical path and experts are on site to act.

Data is King

The entire project relies on accurate data to properly document all the details of testing. This is the data you are going to use to support your packaging selection and will be the vital piece in completing your project. Data can be recorded in various ways including template worksheets, Excel tables, laboratory notebooks and more. Ask a lab engineer about their data techniques and delivery methods to ensure it aligns with your understanding and expectations.

Final Test Report

At the conclusion of testing, you will receive a final test report. This is the documentation that provides the outcomes of the testing including pass / fail results, data behind those results, and details regarding the testing. Not only is timely delivery of this document essential to your timeline, but it also plays a role in your ability to act upon those results. Final test reports should be thorough, easy to understand and proof that the lab conducted proper procedures and quality controls.

This Thanksgiving instead of starting the vegetables before the Turkey let’s develop packaging validation strategies before we get to market launch stages.

Happy Thanksgiving to all our clients, friends, families and packaging engineers everywhere!

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