In a special global packaging online community, PMP News and DuPont Medical Packaging presented “DuPont Medical Packaging Transition Project (MPTP)—Progress Report,” in September 2012. Roseann C. Salasin, global marketing director; Mike Scholla, global regulatory director; and Bruce Yost, global technical director, of DuPont Medical and Pharmaceutical Protection, spoke about progress in the transitioning of Tyvek 1073B and Tyvek 1059B to manufacturing lines that use its latest flash-spinning technology. The team received several questions during the event, and together they provide written responses.
Webcasts held so far in the community include “An Introduction to DuPont Tyvek,” “Fundamentals of Medical Package Engineering and Design,” “Current Events in Healthcare Packaging,” and “Microbial Barrier Properties of Porous Sterile Barrier Systems: Does Selection of the Packaging Material Matter?” To view these Webcasts, visit www.pmpnews.com/DuPontSeminars . Stay tuned for a full lineup of 2013 events.
Q: What type of sealer was used to create the pouch samples and the FFS blister pack samples shown on the sealing fingerprints?
A: The pouch samples, which were made of uncoated DuPont Tyvek 1073B and 100-gauge biaxial nylon with an HDPE sealant layer, were made on a commercial pouch line using a heated platen press. The FFS blister pack samples, which were made of uncoated DuPont Tyvek 1073B and 100-gauge multilayer nylon with a peelable sealant layer, were made on a Multivac machine.
Q: Can you provide more details about the ethylene oxide (EtO) sterilization parameters that are being used in the accelerated aging studies?
A: The 2X EtO sterilization exposure is as follows:
Sterilization set points
EtO gas concentration: 725 mg/L (100% EtO)
Relative humidity: 60%
Initial vacuum: 1.3 psia
EtO gas dwell time: 480 minutes
Steam dwell time: 60 minutes
Aeration set points
Temperature: 55 ±4ºC
Time: 24 hours (minimum)
Q: When do you expect to discontinue selling current Tyvek 1073B and Tyvek 1059B?
A: The material produced on the older manufacturing lines will be available for a limited time during commercialization of the material produced on the newer assets.
The full commercial launch of material produced on the newer assets will begin after regulatory affirmation of functional equivalence. This affirmation will occur at various times in different countries and regions. We expect the U.S. FDA to affirm functional equivalence in 3Q 2014.
Q: When will the Device Master File for Tyvek be updated?
A: The Device Master File for Tyvek will be updated when data from the Medical Packaging Transition Project (MPTP) becomes available.
Q: Is Tyvek 2FS part of this transition?
A: No. Tyvek 2FS and Tyvek Asuron were commercialized on manufacturing lines that already use our latest flash-spinning technology and, therefore, will not be part of the transition.
Q: Why is DuPont conducting the Phantom Protocol?
A: DuPont is conducting the Phantom Protocol to include additional testing of applications and technologies that are outside the scope of the Transition Protocol, but have been requested by the industry to support risk assessments.
Q: What value does Tyvek bring over other medical packaging material alternatives?
A: DuPont Tyvek delivers superior microbial barrier protection through its unique non-woven structure, mitigating the introduction of microorganisms into the package; it has long-standing global regulatory acceptance, which reduces time required to gain regulatory approval of devices; it helps lower total delivered systems costs through puncture and abrasion resistance, reducing product returns associated with shipping or transport damages; and it conforms with the Healthcare Packaging Recycling Council (HPRC) Design Guidelines for optimal hospital plastics recycling.