--- title: "Stay in the Right Lane: Smarter Packaging Validation Starts with Better Questions" description: Discover key strategies for effective medical packaging validation, ensuring compliance and efficiency while avoiding common pitfalls in the testing process. image: https://www.oliverhcp.com/hubfs/blog%20for%20April%2029th.jpg --- [Skip to Main Content](https://www.oliverhcp.com/news-and-resources/packtalk/stay-in-the-right-lane-smarter-packaging-validation-starts-with-better-questions#main-content) Language ![](https://www.oliverhcp.com/hubfs/down_arrow.svg) English ESPAÑOL DEUTSCH FRANÇAIS 日本語 한국어 中文 - [PackTalk ](https://www.oliverhcp.com/packtalk/) - [ISO Certifications & Product Documents ](https://www.oliverhcp.com/iso-certifications-and-product-documents) [![Oliver_Logo_4clr_RGB_NoTag 1](https://www.oliverhcp.com/hubfs/Oliver_Logo_4clr_RGB_NoTag%201.svg "Oliver_Logo_4clr_RGB_NoTag 1")](https://oliverhcp.com) Toggle Menu Search Site Search Site Search [ Contact Us ](https://www.oliverhcp.com/contact) Phone Close **Website Settings** - No Animations [![](https://www.oliverhcp.com/hubfs/Oliver-logo-half.svg) ](https://www.oliverhcp.com/) [![](https://www.oliverhcp.com/hubfs/phone.svg) 833.465.4837](tel:833.465.4837) Language ![](https://www.oliverhcp.com/hubfs/down_arrow.svg) ENGLISH 中文 ESPAÑOL DEUTSCH FRANÇAIS 日本語 한국어 [PackTalk](https://www.oliverhcp.com/packtalk/) SEARCH![](https://www.oliverhcp.com/hubfs/icon-search.svg) #### Expanded Stock Pouch Program ![](https://www.oliverhcp.com/hubfs/43.png) Expedited shipping from a partner you trust, now with more pouch options in a variety of sizes and materials. 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[Learn More](https://www.oliverhcp.com/stockpouchprogram) [![logo-pack-talk-2](https://www.oliverhcp.com/hubfs/logo-pack-talk-2.svg) ](https://www.oliverhcp.com/packtalk/) # Stay in the Right Lane: Smarter Packaging Validation Starts with Better Questions [ Ryan Ott | Packaging Compliance Labs | VP, Quality ](https://www.linkedin.com/in/ryan-ott-a0601518/) Published on: 04/29/2026 Share:  [![](https://www.oliverhcp.com/hubfs/LinkedIn%20Icon.svg)](https://www.linkedin.com/sharing/share-offsite/?url=https://www.oliverhcp.com/news-and-resources/packtalk/stay-in-the-right-lane-smarter-packaging-validation-starts-with-better-questions) [![](https://www.oliverhcp.com/hubfs/FB%20Icon.svg)](https://www.facebook.com/sharer/sharer.php?u=https://www.oliverhcp.com/news-and-resources/packtalk/stay-in-the-right-lane-smarter-packaging-validation-starts-with-better-questions) [![](https://www.oliverhcp.com/hubfs/Email%20Icon.svg)](mailto:?subject=I%20wanted%20to%20share%20this%20great%20article&body=The%20article%20I%20wanted%20to%20share%20-%20https://www.oliverhcp.com/news-and-resources/packtalk/stay-in-the-right-lane-smarter-packaging-validation-starts-with-better-questions) When I think about medical packaging and the testing we do in our lab here, there’s a simple analogy I come back to often: driving on the highway. When you’re in the right lane, going the speed limit and moving with traffic, you’re unlikely to get pulled over. But if you’re in the left lane going 95 miles an hour and weaving in and out of traffic, you’re going to attract attention and not the kind you want. Packaging validation works the same way. We want all our customers in the right lane. When your approach aligns with industry expectations and standards like [ISO 11607](https://www.oliverhcp.com/news-and-resources/packtalk/packaging-101-iso-11607), things move smoothly. When it doesn’t, you risk delays, scrutiny, and costly rework. After working across a wide range of packaging validations, I tend to see the same questions and pitfalls come up again and again. So, here are 5 ways for you to stay in the “right lane.” 1 ## Determine a Minimum Spec Development The first validation you are going to run when developing a packaging system is your sealing validation. Seal strength is something that should be unique to your packaging system and should be developed statistically. For a long time, there was an industry standard of a 1 lb. minimum seal strength requirement. This number has floated around the industry for years, but it’s not grounded in science or standards. Today, I’m seeing more and more teams moving away from it and instead establishing their own, which is good thing. So, when, where, and how do you determine a minimum seal strength? Seal strength should be: - Specific to your packaging system - Developed statistically - Defined before validation begins A strong approach is to run a Design of Experiments (DOE): - Start with low sealing parameters (where seals fail or are inconsistent) - Increase until seals become overly strong or destructive - Identify the optimal window in between From there, you can: - Calculate a mean seal strength - Apply statistical methods - Establish a meaningful lower specification limit It’s important to have a seal strength value that makes sense as it is commonly used in manufacturing for startup or in-process testing. 2 ## Select the Right Integrity Tests to Use During Validation Another common issue is that customers are unsure of what test to run or ask for ones that are not necessary. Not all tests serve the same purpose, and the scope of testing should shift based on the device and packaging needs. During Sealing Validation (OQ/PQ), you’re focused on the seal itself, so tests like dye penetration ([ASTM F1929](https://store.astm.org/f1929-23.html)) and seal strength are important. But post transit and aging testing you’re now evaluating the entire sterile barrier system under real-world conditions, which is better evaluated via a whole package integrity test such as [bubble leak testing.](https://store.astm.org/f2096-11r19.html?_gl=1*lzztiw*_gcl_au*MTQzOTg2Njg5Ny4xNzcxMzQ2MTYz) At this stage, you’re no longer just asking, *“Is the seal good?”. *You’re asking, *“Does the entire system hold up?”*. This shift in perspective is critical, and selecting the wrong method can lead to issues with a submission and possible retesting.   3 ## Avoid Combining Transit and Aging On paper, combining transit and aging makes sense. Real products are shipped *and* stored, so why not test them together? First, with these tests we’re looking for different types of failures. Transit failures are event-based (drops, vibration, compression) where aging failures are time-based (material degradation, brittleness). If a failure occurs, and you have combined these tests, you lose clarity on where that failure took place. Did it happen during transit? Or overtime? If you can’t answer this, you can’t course correct. Separating these studies gives you: - Clear root cause identification - Faster troubleshooting - Stronger justification in regulatory review ISO 11607 supports this distinction by treating performance and stability as separate evaluations. 4 ## Don’t Assume Worst Case is Heaviest & Biggest It’s very rare that when we are running packaging validations there are enough devices to test. So, we often use simulated products to test packaging. But when creating your worst-case configurations, it’s important to not just default to the biggest & heaviest device. In some cases, larger products are more stable in the packaging, and the risk is with the smaller items that can move, shift, and cause abrasion. I’ve seen smaller components create more damage during transit. Therefore, I tell customers, instead of assuming heaviest/biggest, ask yourself: - What will move the most? - What creates the most stress? - Do you need to take configuration into account? - What challenges the packaging system the most? Usually, you can clearly choose the best path forward. But if it’s not clear, I recommend a bookend approach. Test both the smallest and the largest to be able to help bracket your risk. 5 ## Faster Isn’t Always Better [ASTM F1980](https://store.astm.org/f1980-21.html) is the standard that we follow to run accelerated aging. It looks at heightened temperatures as simulating a faster passage of time. [Accelerating aging](https://pkgcompliance.com/resource/accelerated-aging-calculator/) is an extremely powerful tool, but it is easy to misuse. A common temptation is to crank up the temperature to save time, but the problem with this approach is there is a point where instead of simulating time, you’re just damaging the materials. While I wouldn’t recommend it, if you are set on running a test at a higher temperature, consider running parallel studies, one at a higher temp (faster, riskier) and one at a moderate temp (slower, safer). In recent years, guidance has also encouraged considering humidity, not just temperature. Most commonly I see a 50% humidity approach. With this gaining prevalence in industry, even if you don’t include it, you should document your rationale. If there’s one takeaway I’d emphasize, it’s don’t over test**. **Engineers are naturally curious, me included. We want more data, more insight, and more validation. But every additional test introduces more complexity, more acceptance criteria, and more opportunities to fail. Every failed test, even if just for informational purposes, requires justification. My recommended approach is test what’s required and label any exploratory data as non-acceptance criteria. When it comes to over testing, more data can create risk. Validation isn’t about doing everything, it’s about doing the right things. If you do that, you’ll keep moving with the flow of industry and will easily stay in the “right lane”. >  Conversation Starters > > If you liked this article, consider these conversation starters: > > *“In the topic of process capability, do you use PPK or CPK?"* > > *"How do you determine your LSL for seal strength testing?"* > > *"What's the highest aging temp that you've successfully tested?"* > > *"What's the worst-case device or configuration you've used that defies the typical largest/heaviest logic?"* Share:  [![](https://www.oliverhcp.com/hubfs/LinkedIn%20Icon.svg)](https://www.linkedin.com/sharing/share-offsite/?url=https://www.oliverhcp.com/news-and-resources/packtalk/stay-in-the-right-lane-smarter-packaging-validation-starts-with-better-questions) [![](https://www.oliverhcp.com/hubfs/FB%20Icon.svg)](https://www.facebook.com/sharer/sharer.php?u=https://www.oliverhcp.com/news-and-resources/packtalk/stay-in-the-right-lane-smarter-packaging-validation-starts-with-better-questions) [![](https://www.oliverhcp.com/hubfs/Email%20Icon.svg)](mailto:?subject=I%20wanted%20to%20share%20this%20great%20article&body=The%20article%20I%20wanted%20to%20share%20-%20https://www.oliverhcp.com/news-and-resources/packtalk/stay-in-the-right-lane-smarter-packaging-validation-starts-with-better-questions) ## Stay up to date with PackTalk! 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