HealthPack Attendees Updated on DuPont Tyvek Medical Packaging Transition Project
While testing of sterile packaging produced for the DuPont Tyvek Medical Packaging Transition Project (MPTP) continues, the first round of results for pre-sterile and post sterile (at T=0) evaluations for the packages represented in the FDA-accepted transition protocol are nearing completion. As Nelson Laboratories completes testing for the 78 different combinations (also called cells) included in protocol, the testing lab is providing data to DuPont for drafting summary reports to industry. The main report, which will include “a summary of all cells in the protocol tested for 1, 3 & 5 years accelerated and 1 year real time aging,” is expected to be completed and published by the third quarter of 2015, explained Karen Polkinghorne, DuPont’s packaging engineer and MDM specialist, before the audience at HealthPack 2014 in March.
Under the MPTP, DuPont is moving production of Tyvek 1073B and Tyvek 1059B to its latest flash-spinning technology and production lines at its Richmond, VA, and Luxembourg facilities. DuPont Tyvek 2FS and Tyvek Asuron are already produced using the new technology.
The MPTP also includes testing under the Phantom Protocol for evaluating the mechanical properties of sterilized transition material in sheet form, as well as testing related to biocompatibility, food contact, and pharmacopeia testing.
In a press release issued this week, DuPont Protection Technologies announced that it has issued a formal Change Notification letter for DuPont Tyvek 1073B and Tyvek 1059B to all customers who have a Change Notification Agreement in place with DuPont, providing industry with at least one year’s notice before beginning the full commercialization of Tyvek Transition Protocol material in 2015.
Prior to this formal notification, a significant amount of material testing had been completed and all results to date indicate that the Transition Protocol materials are functionally equivalent to current Tyvek, DuPont reported in the release. Extensive package testing is now in progress.
“All cells for the U.S. FDA Transition Protocol and the Phantom Protocol have been received at Nelson Laboratories and package testing is well under way,” said Bruce A. Yost, Ph.D., technical director, DuPont Medical and Pharmaceutical Protection, in the release. “We are pleased with the results we have seen to date and look forward to sharing data with the industry during our next transition project webinar on May 7, 2014.”
While most comparisons between current and transition materials have shown little variation, which Polkinghorne demonstrated with diagrams at HealthPack, the transition material is a bit thicker. “The structure is trending about 10% thicker than the current materials, by about 20 microns,” Polkinghorne said. However, DuPont has conducted sealing studies to confirm the slight increase in thickness does not have an effect on sealing individual packages.
In terms of regulatory developments, Polkinghorne explained that Japan has issued a minor change notification form for MDMs, which MDMs need to evaluate and assess if this information is required for their existing products sold in Japan. China’s SFDA—Jinan has also completed its functional equivalence study, and the testing results meet the criteria of functional equivalence and non-inferiority under the DuPont Validation Protocol. A summary of SFDA-Jinan’s report is available on DuPont’s web site.
Polkinghorne advised MDMs to continue conducting their own “risk assessments, using controlled sales materials to do additional testing to prepare for 3Q2015.”
She pointed out that companies qualifying new products need to do an assessment of the pros and cons of using Transition Material or Current Material. The MPTP study was designed to prove a “one-way hypothesis, which is that transition material is functionally equivalent to current material,” she explained. “Transition and Current material would be interchangeable for devices already on the market as long as the MDM has considered interchangeability in their change and risk management processes, the specification for the product does not restrict the use of current Tyvek or Transition Protocol material, the MDM did not make changes to their packaging and sterilization process conditions, and any regulatory submissions for the transition are structured and approved to allow both products to be used. ”
When asked when the last time MDMs could purchase current materials would be, Polkinghorne advised that the only way to guarantee receipt of current material is to procure and take delivery of that material prior to DuPont commercializing the Transition material. For planning purposes, any MDMs interested in ensuring a last-time buy of the current materials should begin these discussions with their direct supplier no later than “the end of this year, beginning of next.”
Once FDA affirms functional equivalence of the Transition Material, “DuPont would like to transition to the newer lines as quickly as possible,” she said.
Polkinghorne advised attendees to read more details under DuPont’s “Are You Ready?” campaign at www.Transition.Tyvek.com.
To register for the May 7 Webcast and to become a member of the DuPont sponsored Medical Packaging Community click here.
By Daphne Allen, Editor
Pharmaceutical & Medical Packaging News