FDA’s Center for Devices and Radiological Health (CDRH) has affirmed the functional equivalence of transition Tyvek to current Tyvek for sterile medical packaging, DuPont Protection Technologies (DuPont) is reporting in a news release issued today.
Want to prepare yourself for some of the most common challenges in medical device packaging? In a Webcast now available on demand, members of the Flexible Packaging Association’s Sterilization Packaging Manufacturers Council present “Package Design Missteps: A Study of Common Medical Device Packaging Pitfalls.”
A sterile medical packaging converter is using flexographic printing to coat lidstock in a single pass.
SteriPax Inc. (www.steripax.com) is streamlining the adhesive-coating process for savings. The company has developed a single-pass process for coating zones with six layers of adhesive in a single pass, explains Jack Roten, business development manager. Launched about 3 years ago, the patent-pending process utilizes a flexographic printing press to “print” the six layers.
DuPont reports that it has reached significant milestones in regulatory submissions and industry summaries pertaining to the Tyvek Medical Packaging Transition Project (MPTP). The effort seeks to demonstrate that Tyvek 1073B and Tyvek 1059B manufactured with DuPont’s latest flash-spinning technology on production lines at its Richmond, VA, and Luxembourg facilities are functionally equivalent to Current Tyvek manufactured on the older production lines. The MPTP comprises three parts: the U.S.
Get ready for a pretty different ISO 11607.
Nick Fotis, global packaging director for Cardinal Health, tells PMP News that ISO 11607 Parts 1 and 2 have begun to go through the revision process. Fotis recently joined David Johnson from Halyard Health as co-chairs of AAMI Working Group 7 to succeed Jackie Daly Johnson, president of Beacon Converters. Additionally they will be on the U.S. delegation to the ISO Technical Committee (TC) 198/Working Group (WG) 7 Packaging when it meets in December.
Package testing for the DuPont Tyvek Medical Packaging Transition Project (MPTP) is progressing on schedule, and all results published to date support the functional equivalence of the transitional material to the current Tyvek. While testing continues, DuPont expects that the U.S. FDA will affirm functional equivalence by the third quarter 2015.
By Maureen Kingsley
PAC Machinery launched a high-speed medical device bagging system at Pharma Expo. Suitable for use in cleanrooms, the Rollbag Magnum HS Med can produce bags with chevron or straight seals from rollstock consisting of a polymer web and either Tyvek or paper as well as foil and metallized polyester.
More than 70,000 packages from 40 medical device manufacturers have been tested under the DuPont Medical Packaging Transition Project (MPTP), and results continue to indicate functional equivalence, reported members of the DuPont team during a Webcast on October 2.
When it comes to medical devices, packaging is sometimes an afterthought. While there are outstanding packages that win high-profile awards, some companies fail to recognize the importance of this factor until late in the game. In worst-case scenarios, this can impact the quality and safety of the device. More often, however, the result is financial, because companies neglect to take steps to reduce packaging costs.