"Drug/device combination products are becoming a significant portion of the product mix that packaging engineers have to deal with," Alleva said. "One of the major challenges is dealing with the temperature fragility attributes that many of these products have."

Alleva’s presentation will included a brief overview of thermal dynamics and the temperature control terminology commonly used within the industry. He will also address how to design a temperature controlled package.

"I am going to specifically address both the design iterations and qualifications," Alleva said.

The main thing to be aware of when it comes to drug/device combination products is to accurately identify what parts of package and product are actually temp sensitive and focus on those parts.

"It is best if you can design the package to separate out the temperature sensitive portions of the package from the non temperature sensitive products," Alleva said.

Another will also share case studies of projects in which the package was designed with multiple cavities to control difference parts of the product or materials at different temperature ranges.

Alleva will close out his presentation with common trends and issues that Cryopak has experienced in the past. One being the increase in controlled room temperature (CRT) products.
In addition to Alleva’s presentation, Pat Nolan, President of DDL, leader in package, product and material testing will talk about the ideas and data presented at the last ASTM D-10 committee meeting which focused on revisions to ASTM D-4169.
"We discussed major changes to the vibration schedules," Nolan said. We are currently in the process of developing the revision that we will ballot.

Nolan has volunteered to develop three different options for the vibration schedule to circulate for comments, and to begin the ballot process later this year.