Types of Medical Packaging Missteps to Avoid

Medical device packaging engineers often face tight deadlines and budgets. So when the members of the Flexible Packaging 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.

Misstep 1: Missing Some Stakeholders

One of the first missteps discussed in Medicine Packaging is not taking into account stakeholders “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. “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.

Misstep 2: Mismeasurements in Heat Sealing

 Mistakes in Medicine Packaging can also be made during heat-sealing processes. There are 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 temperatures 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?

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.

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.