Andrew Fronk, packaging development consultant at Orchid Design, will be speaking during the Orthopaedic Packaging Trends session at OrthoTec 2011. Here’s a sneak peek into the issues that he plans to tackle.

 

OrthoTec: What challenges specific to package sealing and in-process testing in orthopaedics do manufacturers face?

Andrew Fronk: Sterile package integrity is the single most important element in orthopaedic packaging and the primary reason for the stringent regulations with FDA and regulatory authorities elsewhere. After a thorough sealing process validation, assuring that you're getting good seals (strength + integrity) on a daily basis [and]in production, are vital. Orthopaedic manufacturers face various challenges with regard to this in-process testing and quality control. Because equipment is expensive, often older sealing machines are used that are difficult to validate with confidence. This packaging requires 100% inspection for seal integrity and a set of human eyes is often the only tool to nondestructively test for integrity. Even those companies using newer sealing equipment and more advanced inspection technology face challenges because the results are often subjective.

 

ORT: What are the key elements that orthopaedic device manufacturers must consider regarding the packaging process?

Fronk: There are several [elements] and I will talk more about this in my presentation at OrthoTec. One of the big problems I've seen in my career is that packaging in the manufacturing environment is often overlooked at being one of the most important pieces of the finished sterile product. Newer, less-experienced employees often start out in packaging and don't have the proper training or experience to identify sealing problems or other issues that might affect sterile barrier integrity.

 

ORT: Are there factors that they tend to overlook? If so, what effect does it have?

Fronk: I think a thorough understanding of your equipment and the effect the process variables have on seal strength and integrity is very important. [These] are foundation pieces to the puzzle that some people tend to gloss over. When you have a good foundation, you can build on that to not only optimize the sealing parameters but to put the types of quality control in the right places to be effective.

 

ORT: What information do you hope attendees will gain from your presentation at OrthoTec 2011?

Fronk: I am hoping that they will gain some appreciation for the complexity of sterile packaging, if they're not very familiar with it, but to also learn some interesting things that might help them in their own situations. There are a myriad of different situations out there, but consistently having a good sterile barrier on the packaging—whether you do this yourself or contract with another company —is something many of us share. The field of medical device packaging is an interesting one and I've enjoyed working for various companies and learning much over the past couple of decades. Since the 1990s, there have been significant changes in the way FDA and other regulatory agencies look at sterile packaging and it's vital that companies understand these and make an investment in this piece of their product. I hope the overall discussion is able to shed some light on some of this and I really believe the attendees will find this field a lot more interesting than they ever thought before.