By: Alison Payton, Sales Support Specialist, DDL
DDL once again was a sponsor and attendee of the annual HealthPack conference. This year’s conference was held in Kansas City, MO. In addition to enjoying all the great BBQ, we heard from several leaders in the industry regarding Smart Packaging & Industry 4.0, upcoming changes to ISO 11607, insights from the FDA, and of course, the ever popular Nurses Panel.
Following is a recap of the highlights, industry changes and topics discussed at HealthPack 2018:
- Ed Dunn, Head of Global Supply Chain, Packaging Center of Excellence at Johnson & Johnson, opened up the conference with a Keynote discussion on “Industry 4.0” and what this means for Packaging and Healthcare. Dan Burgess, Principal Packaging Engineer & Manager at Boston Scientific, enlightened us about Smart Packaging and how these various new technologies, such as RFID technology, add value to our operations and provide more data about the transit and storage environments through tracking and remote sensing.
- Scott Levy, Packaging Engineer at DDL, participated in HealthPack’s Preconference Roundtable regarding the new clause in upcoming revisions to ISO 11607-1. Michael Scholla, Global Director, Regulatory Standards at DuPont and Thierry Wagner, Regulatory Affairs Director EMEA at DuPont Medical and Pharmaceutical Protection, discussed these vital revisions in detail during their presentation at the main conference session. Here are the key points from their presentation:
- New language will be added that encompasses the concepts of sterile package ‘maintaining sterility up to the point of use’, design allows for ‘easy and safe handling’ and the package ‘integrity bring evident’ to the final user.
- In addition, the revisions include requirements on demonstrating the usability and aseptic presentation of the sterile package.
- New requirements will need to be supplied on the package that indicate the Sterile Barrier System, the month and year of manufacture, and instructions on what to do if the sterile packaging is damaged or unintentionally opened before use. The Sterile Barrier Association is working on proposed symbols to fulfill this requirement.
- Lastly, a new section with requirements for validation and changes will be added that describes that packaging systems that meet the requirements of design, usability, performance testing and stability testing shall be considered validation and revalidation will occur if there are changes to the design, contents, materials or shipping configurations.
- Scott also participated in the “Systemic Approach to Seal Strength” Panel Discussion alongside Rod Patch, Director, Packaging Center of Excellence, Medical Devices at Johnson & Johnson, Goeff Pavey, Technology Manager at Oliver Healthcare Packaging, Thomas McNabb, Principal Project Engineer at Medtronic Neurovascular, and Nick Layman, Staff Franchise Packaging Development Engineer at Ethicon. The panel discussion engaged the audience by addressing several industry concerns regarding minimum seal strength (Note: there is no industry standard for minimum seal strength!) and defining your seal strength values based on the characteristics of your device and shipping configurations. Nick Layman of Ethicon pointed out, “Seal strength is product specific! It has to relate to your product and its weight. Consider how your customer is going to be handing it.” Scott discussed that highs and lows for seal strength values need to be scientifically justified and rationalized as to why they were picked, which will ultimately be dependent on your equipment and package design
Other sessions at HealthPack included:
- The FDA perspective: Voluntary Recalls and Deficiencies for Package Processes presented by Patrick Weixel, Acting Deputy Office Director of Patient Safety and Product Quality at the FDA
- Six Steps to Successful Remediation, presented by David DiVaccaro, Principal at DiVaccaro Consulting Group
- Live Audience Interactive Polling Session
- Sample Size Strategic Planning and Optimization, presented by Jennifer Van Mullekom, Associate Professor of Statistical Practice and Director of Laboratory for Interdisciplinary Statistical Analysis at Virginia Tech
- Material Selection in Flexible Packaging, presented by Dhuanne Dodrill, President at Rollprint Packaging Products
- Let’s Make SBS Seal Strength Testing Really Easy! presented by Sameer Upadhyaya, Head of Technology at Genentech
In summary, HealthPack 2018 was engaging and enlightening and a great way to network with many people in the healthcare packaging industry.
HealthPack 2019 will be held at the Hilton Portland Downtown Portland, OR. March 5-7, 2019. For more information on HealthPack, please visit https://www.healthpack.net.