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Standard, Sterile and Small: Packaging Trends Focus on Savings and Speed to Market

Previously, some orthopaedic manufacturers considered sterile barrier testing to be supplemental to visual inspection on sterile barrier package test samples. However, sterile barrier testing is a standard requirement for design and process validations. FDA and Notified Bodies have been active in auditing and highlighting gaps in orthopaedic manufacturers’ packaging in recent years, which has forced manufacturers to get smarter and comply with all elements within standards like ISO 11607— packaging and terminally sterilized medical devices.

Still, greater understanding of the sterile packaging process is demanded of OEMs that desire a smoother product launch. The one question Lucenti says he wishes customers would ask is, How long does each sterile packaging validation take to complete? “Many of our customers do not plan for adequate time to conduct all of the sterile packaging validations required—sealing validation, ultrasonic cleaning validation, sterilization validation, ship testing validation, label system validation, accelerated and real-time aging validation,” he says. “As a result, everyone is under tremendous pressure to meet product launch timelines. We often have to expedite the validations at every step.”

As more tests are required and packages are shipped longer distances, high barrier materials and designs are needed to pass processing and maintain integrity through transit.

Tyler says she has seen an increase in interest in specialized packages that protect from moisture loss and gas penetration.

“High barrier materials that can withstand deep freeze temperatures are in high demand,” she adds. “Many companies that deal with tissue based products need to package in materials that will protect the product from moisture loss and deterioration, and also be able to take the product in its package down to low temperatures. This is tricky from a packaging standpoint, so specialized materials are needed.”

Orthopaedic device manufacturers have also asked for packages to take up a smaller space.

“We have had several projects with a primary goal of taking a relatively large footprint package and making it much smaller. Some of these require moving out of a thermoformed tray into alternative packaging designs,” Tyler says.

The request to decrease size has extended to secondary and tertiary packaging, as well. Manufacturers face increased pressures to optimize their product and shipping cartons to minimize unused space and design precise packaging configurations, says Robin Hooker, Healthcare Marketing Director, UPS.

“Empty spaces in and between articles can drive cube size and transportation cost inefficiency,” he says. “The effect can be particularly acute in shipping pallets and parcel containers. Manufacturers that do not continually review, evaluate and update packaging best practices leave themselves open to product damage and gaps in cost efficiencies.”

As packaging engineers consider best practices to getting product into customers’ hands faster, outside influences should be considered. Regulatory agencies continue to evaluate manufacturing environmental guidelines, as well as the logistics environment.

“Manufacturers are being asked to align manufacturing and distribution practices in a manner that supports the product from an end-to-end perspective,” Hooker says. “This means proper identification and conditions of manufacturing storage and distribution will be more stringent in the future; the days of trunk stock implantable device inventory as ‘regulatory compliant’ healthcare space is a thing of the past. More robustpackaging may offer a degree of protection as a stop gap.”

Added to packaging engineers’ list of changes and challenges is UDI implementation and DuPont Tyvek transition, as well as business interruptions like mergers and acquisitions, supplier process changes and demands on global sourcing. Suppliers’ primary advice to manufacturers is to seek expertise before a regulatory body shows up and informs that you don’t have the right people or resources.

Carolyn LaWell is Content Manager at ORTHOWORLD. She can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

Looking for packaging solutions? The packaging capability in the Supplier & Service Provider Directory was recently updated with more than 40 companies offering services.

Ms. Tyler will present “Lessons from FDA Recalls: Design and
Develop the Best Package for Your Device
” at OMTEC 2015.

In preparation for the session, we asked what can be learned from recent packaging recalls.

“Some more common failures that we see that are realized in validations and commonly in ship testing include insufficient protective packaging and undersized secondary packaging. People often fold the sterile barrier to accommodate a shelf-carton size that is dictated by marketing or other requirements. This is a universally bad idea. Folding sterile barrier packaging will often lead to delamination of the Tyvek® or film—sometimes these internal delamination events visually appear as breaches in sterility. I have seen more than one occasion where a complex fold in a sterile barrier pouch has created a hole in the pouch through the action of abrasion at the points of multiple folds.”

Learn more about here session and and register for OMTEC at


 Photos courtesy of Millstone Medical Outsourcing.


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