Medical device packaging engineers often face tight deadlines and budgets. So when the members of the Flexible Packaging Association’s Sterilization Packaging Manufacturers Council (SPMC) were brainstorming recently on how to help package engineers, the group decided to focus on how they could help packaging engineers minimize cycle times, iterations, and costs during new package development.

That’s how the group came up with the topic of its recent Webcast, “Package Design Missteps: A Study of Common Medical Device Packaging Pitfalls,” says Henk Blom, Director of Technical Services at Rollprint Packaging Products. Blom was recently re-elected chair of the Technical Committee of the SPMC, and he led the Webcast, which featured SPMC members.

He told PMP News that the Webinar could help attendees “shorten flexible packaging development timelines and reduce cost by learning from some of the packaging missteps that others have made in the past.

“All of us in the room here from the SPMC have many years of experience, and we’ve seen and committed some of the mistakes we’re going to talk about today, so we are hopeful this will be of some benefit,” Blom explained during the Webinar.

Here are the missteps:

Misstep 1: Missing Some Stakeholders

One of the first missteps discussed is not taking into account stakeholders, explained Chris Osborn, Vice President of Research & Development for Bemis Healthcare Packaging. “There’s a growing emphasis on eliminating all defects in the packaging process, so the challenge is designing a defect-free package that accommodates all Critical to Quality (CTQ) [attributes] while meeting design constraints such as cost and manufacturing,” he said. “Avoiding missteps starts with making sure you include all your stakeholders in the design process. Stakeholders are both internal and external, and they all have their own CTQs that need to be considered.”

One example involves package dimensional tolerances. “We often see specifications that call out dimensional tolerances that may or may not be realistic,” Osborn says. “Make sure the specification you are calling out is something that your supplier can actually manufacture. It is an example of including your external stakeholder early in the design process.” Other mistakes involve neglecting critical dimensions. Osborn referenced several ASTM standards for assistance. 

Misstep 2: Mismeasurements in Heat Sealing

Mistakes can also be made during heat-sealing processes. Geoff Pavey, Technology Manager and Technical Fellow for Oliver-Tolas Healthcare, discussed several misconceptions when it comes to parameter measurements and machine set up. One is assuming “that setting and actual sealing conditions are the same,” he said. For instance, there can be differences between the temperature of the gauge versus the actual temperature of the platen surface, he said. Also, there can be differences in dwell-time measurements depending upon when the sealer activates the timer—is it when the platen begins to move or when it is closed and pressure begins?

Pavey also offered several root causes for other heat-sealing missteps.

Misstep 3: Misunderstanding Distribution's Effects

And missteps can also occur when distribution’s influence on package performance isn’t considered. One common misstep is to use a pouch that’s too large for a folding carton, explained Russell Darley, R&D Manager for Sealed Air Medical Applications. “To fit the pouch in the carton, the pouch must be folded several times; we call this creating a compound fold,” he said. “Multiple folds in a material can create material stress points, which during distribution events like vibration, impact, or free-fall drops can result in abrasion, flex cracking, pin holes, and material separation.” Using pouches and cartons that aren’t appropriately matched can be the outcome of programs that use a one-size-fits-all approach to packaging, he said.

In addition, MDMs don’t always fully understand their distribution channels, Darley said. As a result, they might not select the appropriate distribution simulation protocol and could see damage in the field, a poor product-to-packaging ratio, or experience other missteps. He offered a few key recommendations on how to better understand such channels. “Spend time out in the field following your distribution channel, map the process, talk to employees, and make observations,” he said.   

Blom, Osborn, Pavey, and Darley answered a few questions during the event on how to get packaging engineers involved in the design process; on seal strength, seal integrity, and sealing tools; on upcoming changes to ASTM D4169; and more. Please listen to the on-demand Webcast to hear these answers as well as complete discussions on the above-referenced missteps.

The Webinar was sponsored by members of FPA-SPMC: Amcor Flexibles, Beacon Converters Inc., Bemis Healthcare Packaging, Oliver-Tolas Healthcare, Printpack Medical, Rollprint Packaging Products Inc., Sealed Air Medical Applications, and Technipaq Inc. 

Register here to learn more about these pitfalls or contact the FPA-SPMC at [email protected].