Non-Phthalate Plasticizer As DEHP-Replacement For Medical Use

Non-phthalate Plasticizer as DEHP-replacement for medical use

08-Dec-16

BloodCenter of Wisconsin (BCW, part of Versiti) and Eastman Chemical Company have announced the results of a recent clinical trial evaluating a new plasticizer for blood bags.
di-2-ethylhexyl phthalate (DEHP) has provided the medical industry with a stable ortho-phthalate plasticizer for many years, regulatory trends and consumer demands will inevitably drive the industry to non-phthalate alternatives. The clinical trial results demonstrate that Eastman 168™ SG non-phthalate plasticizer, a sensitive-grade DEHT, is a viable alternative for medical applications.

Eastman 168™ SG is a non-phthalate plasticizer - It offers low extractables, low migration and a clean toxicological profile, It is an enhanced grade of Eastman 168 non-phthalate plasticizer.

Application/Uses

* Food contact

* Medical

* Toys/Child care

“Blood bags are one of the most challenging applications in the plastics market,” says Eastman Market Development Manager Mark Brucks. “BCW’s research is important because it demonstrates a viable alternative for those who have concerns around using DEHP in sensitive applications like blood bags, and it’s also a testament to the importance of material suppliers and institutions working together to find safer solutions.”

The clinical trial findings were presented at the 2016 AABB Annual Meeting in Orlando, Florida, on Oct. 24 by Sharon Graminske, manager of applied research laboratory at BloodCenter of Wisconsin. Entitled “In Vitro Evaluation of DEHT Plasticized PVC Blood Bags for Red Blood Cell Storage in AS-1 and PAGGSM Preservative Solutions,” Graminske’s presentation highlighted the trend driving the need for DEHP alternatives as well as the preliminary results supporting DEHP replacement with DEHT, a non-phthalate plasticizer.
“Our work with Eastman has provided valuable results that will benefit the blood banking industry,” said Kathleen Puca, M.D., BloodCenter medical director and principal investigator who oversaw the findings reported by Graminske. “The DEHT trial results offer new insight about a well-established plasticizer that has now been proven to have an even broader application within health care — providing safer blood products.”

Further work is being completed on plasma to validate performance. “Eastman 168 SG is a proven, tested, and toxicologically clean solution for the medical market,” says Brucks. “By working closely with BCW, we are able to extend the utility of Eastman 168 SG into this application, offering customers a cost-effective alternative that performs to standard so that they can confidently make the switch from DEHP when they are ready.”

BloodCenter of Wisconsin’s Clinical Trials and Cellular Therapy Services provide a full spectrum of services for clinical trials (preclinical and phases I–IV) in a wide range of therapeutic areas. BloodCenter of Wisconsin has assisted pharmaceutical and medical device companies with regulatory studies, laboratory testing, assay development and a variety of other research needs for more than 30 years.