Image courtesy of Packaging Compliance Labs.
A recent study about recalls of foot and ankle implants included a portion that likely drew less attention than the headline. Some of these implants were recalled because they arrived at the hospital in an unsterile condition, and the authors said faulty packaging may have been the cause.
Poor packaging can cause a host of problems for medical device companies and their customers. A package that holds a sterile medical device not only has to arrive at the hospital or clinic free of holes, tears and broken seals, it also has to withstand sitting on a shelf, possibly for years, without breaking down.
Improperly designed and validated packaging can even derail a product launch in the 11th hour, according to a couple of medical device packaging experts who shared their insights into what device-makers should know about packaging.
Manufacturers like to use the smallest possible containers for shipping, which can compromise package integrity, according to David Furchak, launch architect with Keystone Solutions Group, an engineering, product development and medical device manufacturing company in Kalamazoo, Mich.
“Specifically, it’s a concern with sterile, which is what we almost exclusively deal with,” Furchak said.
Keystone works closely with Kentwood, Mich.-based Packaging Compliance Labs (PCL), which validates sterile medical device packaging according to FDA-recognized standard ISO 11607. The standard has three main pillars, according to Ryan Erickson, a packaging engineer at PCL:
1. A manufacturer must be able to consistently form and seal a package, meeting requirements for the strength and seal of the bond after heat-sealing, the seal’s visual aesthetics and the ability to open the package. If the end user in an ambulance, hospital or clinic has trouble opening a package, it may rip or tear, exposing the device inside to contamination and rendering it unusable.
2. The package design must be sufficiently robust to withstand shipping through all types of climates and a variety of physical hazards. PCL simulates different types of hazards that packages might encounter, exposing them to sub-zero, desert and tropical conditions, dropping, compression, vibration, impacts and altitude simulations.
3. A package must be able to maintain its integrity over time. For a sterile, disposable device package, that’s usually two years, Furchak noted. PCL uses real-time aging in a controlled environment as well as accelerated aging, which requires baking the package. “Forty days in the oven is equivalent to one year sitting on the shelf,” Erickson said. If the material hasn’t weakened too much and the heat seals remain secure, a company can officially market the device with the validated expiration date claim.
Many other considerations come into play. A package can neither be too small nor too large. Labeling must be easily understood and well-placed. Raw materials used in sterile medical device packaging must be traceable, safe and effective in creating a microbial barrier. Package manufacturing machinery must be set up and maintained in a validated state and produce a result that can be measured and monitored over time for performance to specification. The resulting packages must pass a variety of quality assurance checks.
PCL likes to receive two to five prototypes of package designs to compare their relative defect rates, understand the modes of failure and make a plan to fix them, according to Erickson. The company recently performed its own study of packaging systems that came through its lab as saleable goods, representing products as they would be presented to a hospital or clinic. One in three failed validation.
“If companies were more focused on doing engineering feasibility trials prior to undertaking a validation study, a lot of these issues could have been worked out,” Erickson said. “The very first time you test something, there’s a very good chance of something going wrong.”
Packaging problems can be averted if the customer gives contract manufacturers such as Keystone the ability to change the design after validation testing, Erickson said.
Sending prototype devices that are the same size and weight of the proposed finished product can also avert disaster. PCL once received a 3D-printed hip replacement implant prototype in packaging that passed all the tests. When testing the same packaging containing the actual, much heavier implant months later, packages were cracking, lids were popping off and the implant’s rough coating was rubbing off and shredding, Erickson said.
“I’m glad we caught it in development,” he added. “A lot goes into making a good package. It’s not easy, certainly.”
|
Speak Your Mind