In 2011, DuPont announced its intention to transition Tyvek 1073B and 1059B medical-grade materials to the company's latest flash-spinning technology with the stated objective of ensuring greater continuity and flexibility of future supply.
"Although this is being managed and dealt with very comprehensively by DuPont, there will still be an element of validation work necessary at each packaging manufacturer and medical device manufacturer," according to Tony Paolino, president of SteriPack USA, which provides sterile packaging solutions and contract manufacturing services to the medical device industry. "It's the single biggest change in the industry for years."
To minimize the amount of testing that medical device manufacturers must perform for requalification as a result of the transition, however, DuPont's Medical Packaging Transition Project (MPTP) aims to prove that the transition protocol material is functionally equivalent to current Tyvek materials.
In a recent Medical Packaging Community Webinar titled, "The Results Are In--But What Can I Do With Them?" DuPont global technical director Bruce Yost presented pre- and poststerilization data for the transition protocol material. The effects of sterilization and one-year accelerated aging on the transition material demonstrated puncture strength that was approximately 10 to 15% better than current Tyvek while tensile strength was shown to be equivalent to or better than current Tyvek. Microbial barrier performance of the transition material was also improved, according to Yost.
Although DuPont is striving to minimize additional work by medical device manufacturers, there are still some tasks for medtech companies to do in order to prepare for the transition. During the Webinar, Leslie Love, MDM specialist for DuPont Protection Technologies, identified four key action items on manufacturers' to do lists:
- Complete change management and risk assessments
- Perform supply-chain assessment and documentation
- Implement risk assessment testing, if necessary
- Engage regulatory teams, as necessary
It's also important for manufacturers to accept the concept of interchangeability between the transition material and current Tyvek, according to Love. She noted that, for devices currently on the market, interchangeability allows the medical device manufacturer to use either current Tyvek or the transition material, if:
- The medical device manufacturer has considered this in its change control, risk management, and regulatory submission process
- The specifications for the device package do no restrict the use of current Tyvek or transition protocol materials
- There were no changes to the packaging or sterilization process conditions
- Any required regulatory submissions for the transition are structured and approved to allow both products to be used, if applicable
New device qualifications, Love added, can either employ current Tyvek, use the transition material via the controlled sales program, or use both current and transition Tyvek materials.
DuPont expects FDA affirmation of functional equivalence in Q3 of 2015. The company further stated during the Webinar that if everything goes as planned, full commercialization of the transition protocol material would begin September 2015. The complete transition will likely take between 12 and 18 months.
Shana Leonard is group editorial director of medical content at UBM Canon.