HealthPack Archives

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.

DDL recently participated in the annual HealthPack Conference and ISTA TransPack Forum. Following is a recap of the highlights and issues that were discussed during this year’s conferences.

Beginning our adventure in Denver, CO, the turnout at HealthPack 2017 was even greater than in the past, with over 300 attendees. Some of the highlights from this year’s HealthPack include:

Jan Gates, Principal Packaging Engineer at PackWise Consulting, went over some of the upcoming changes happening with standards in her session on “Standards Updates.” The key updates include ASTM D4149, ISO TC 122, WG14, WG05 and WG09. ASTM D4169 is being revised for current practices and data. The truck vibration was recently updated in order to show various vibration profiles and comparison to original vibration profile. The next change being looked into for ASTM D4169 is for plane vibration, as the preliminary data shows the air vibration is not as current in the standard.
Laura Bix, Professor and Associate Director, School of Packaging of Michigan State University, discussed, “Objective Evaluation of Label Design”. For those who are on the outside of the industry looking in they would never realize how much goes into the thought process of labels and packaging. While listening to Bix’s session about the challenges with critical information that must be quickly identified and readable in the field for nurses as well as the end user was very interesting. For example, a few of the many that she went through is the need for transparent packaging to allow quick identification of contents, diagrams, color coding systems that would need to be consistent and universal, to have the important information together and highlight the critical information. There was also discussion on the expiration date, latex free and sterility (secondary packaging present).
One of the most popular sessions at HealthPack is the Nurses Panel. This is a great opportunity to ask the nurses and technicians what is important to them in packaging and labeling. It was great to hear what they are looking for in packaging in their field. Many things were brought up but some of the main characteristics were:
Display a clear Lot#/ Reference # and date of expiration.
Shape of packaging, easy for any size person to open.
Making sure that the sterility of a product stays sterile through the opening process to the end user.

Other sessions at HealthPack included:

Split Personalities: Development and Compliance
Guiding Material Selection through Function and Value
Sterility Assurance: An End to End Supply Chain Approach
The Next Generation of ISO11607\Objective Evaluation of Label Design for Healthcare Products
Applying Human Factors to Optimize the Usability of Packaging

Following the HealthPack tradeshow DDL headed to the ISTA TransPack Forum in sunny Orlando, Florida. DDL’s Packaging Project Managers Matt Doornink and Jacob Heffernan attended this year’s sessions, workshops and the volleyball tournament. Here’s a recap of the highlights and what they learned:

ISTA TransPack Forum is a good opportunity to better learn how DDL’s customers are attempting to further their understanding of the distribution environment, as the packaging profession is continually challenged by the continually evolving distribution environment.
A few presentations addressed the changing distribution environment, such as how retail has moved to e-commerce and is now beginning to test drone deliveries. A presentation by Clemson University demonstrated some of the patents Amazon has on the future of shipping including underground tunnels and floating distribution centers where drones would collect products and then deliver them.
Another presentation that stood out was Bernard McGarvey’s and Bryan Cardis’s from Eli Lilly and Company discussion on the performance and creating of profiles for thermal shipping containers. In their presentation, McGarvey and Cardis showed the relationships between the pre- usage temperature exposure and the duration to the final performance of the container to its destination, creating a performance curve to find the optimal usage for time and temperature.
In addition to the many great sessions and workshops there was also the annual volleyball tournament, which DDL has sponsored for the past several years. The volleyball tournament is always a great way to get to know industry peers and network with other companies. “This year we participated in the fun games, although we were not successful going 0-2, but each game went down to the wire. I am confident we are one year away from being one of the top teams in the tournament” said Doornink.

In addition to many informative sessions, a great part about attending conferences such as HealthPack and ISTA TransPack Forum is it provides an opportunity for members of the medical device packaging industry to reconnect with old colleagues, as well as interact with customers and meet new contacts.DDL looks forward to participating in next year’s HealthPack being held March 6-8, 2018 in Kansas City, MO, and the ISTA Transpack Forum being held March 20-23, 2018 in San Diego, CA.