Drug/device combination products are becoming a significant portion of the product mix that packaging engineers have to deal with, one of the major challenges is dealing with the temperature fragility attributes that many of these products have.
Edison, NJ (PRWEB) February 23, 2012
Cryopak, leader temperature controlled package design and manufacturing, will be represented at this year’s Healthpack Conference with a presentation conducted by Anthony Alleva, Cryopak’s Technical Services Manager. This presentation titled, Packaging challenges for drug/device combo products in the cold chain distribution system, will deal with packaging system design and testing issues that are affected by the cold chain distribution system. Pat Nolan, DDL’s President, will also report on recent business discussed at the last ASTM D-10 Committee meeting.
“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.
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.
DDL, Inc. is a third party testing facility that specializes in medical device package, product and packaging material testing and consulting. We’re industry leaders in medical device package validation (ISO 11607) and can help ensure that you comply with industry standards and regulations. DDL's three full-service testing laboratories will provide the expertise to validate the efficacy of package systems for sterile medical devices. We take pride in our excellent customer service, our technical expertise, quick turnaround time and our commitment to get your product to market faster!
Cryopak engineers cold chain shipping solutions and supplies thermal packaging products that help our customers safely transport their temperature sensitive products. The materials and manufacturing processes cover a full spectrum of products from insulated shippers to manufacturing phase change material, gel packs and temperature monitors.
About The TCP Family of Companies
The TCP Family of Companies is a complete packaging integrity solutions provider servicing life science industries. The TCP Family consists of Cryopak, the leading manufacturer of cold chain packaging and verification products, DDL, the leader in product, material and package validation testing for the medical device and biopharmaceutical industries, Escort Verification Technologies, the leading provider of cold chain compliance solutions and software for the life science industry and healthcare organizations. Escort also provides data logging systems that offer an extensive range of temperature and humidity for the cold chain monitoring and cold chain visibility. The TCP Family handles your packaging projects with the paramount goal of helping you get your product to market faster while maintaining the integrity of your products.