Sterile Medical Packaging

DuPont Medical Packaging Educational Seminars

Experts from DuPont address questions from its latest Webcasts.

In a special global packaging online community, PMP News and DuPont Medical Packaging presented “Current Events in Healthcare Packaging,” and “Microbial Barrier Properties of Porous Sterile Barrier Systems: Does Selection of the Packaging Material Matter?” John Bamberger of DuPont Medical and Pharmaceutical Protection received several questions during the events. He provides written responses below.

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PMP News Celebrates 20th Anniversary

Celebrating 20 years in Healthcare Product Packaging—A Look Back In Time… With Eyes on the Future (1993–2013)





PMP News, March 1999

Thanks to ISO 11607 and other milestones, medical device packaging has gained definite stature over the last two decades.

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Waste-Reducing Die-Cut Card Wins FPA Honors

One package is making quite an impact, for lessening its environmental impact. The CardioFocus HeartLight Cardiac Ablation System Balloon Catheter Die-Cut Tray manufactured by Beacon Converters Inc. has been honored with two awards from the Flexible Packaging Association during its annual meeting and awards ceremony held in Naples, FL, on February 26, 2013. The die-cut tray has received FPA's Gold Award for Environmental and Sustainability Achievement and its Gold Award for Technical Innovation.

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Addressing 20 Years of Medical Device Packaging Challenges—And Preparing Customers for the Next 20 Years

Oliver-Tolas Healthcare Packaging is a leading global producer of sterile-grade medical device and pharmaceutical packaging.

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AmeriStar Awards Competition Now Accepting Entries

Don't miss submitting your best work to the 2013 AmeriStar Package Awards Competition! AmeriStar showcases the most ground-breaking, innovative packages of the year.

AmeriStar winners in 2012 included the following medical device packages: 

Looking Back over 20 Years of Sterile Medical Packaging

Thanks to ISO 11607 and other milestones, medical device packaging has gained definite stature over the last two decades.

In 1993, medical device manufacturers sought packages that would maintain sterile product safety and efficacy, reduce hospital and supply chain waste, and offer cost efficiencies to prepare for healthcare reform.

Twenty years later, the goals are pretty much the same. But the means and methods have definitely changed. “The whole process of developing and testing packaging has become more scientific,” observes Dhuanne Dodrill, president of Rollprint Packaging Products Inc. “Validation is a way of life.”

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17 Years Ago, FDA Clarified Packaging’s Importance

In my look back at 20 years of sterile medical device packaging to kick off our 20th anniversary celebration, I heard some industry members talk about experiencing increased scrutiny from FDA. What has transpired?

There is no question that the 1996 publication of the Quality System Regulation (QS Regulation) clarified medical device manufacturers’ responsibilities when it came to package development and validation. I write “clarify,” though, because the responsibility to ensure that medical device packaging is adequate has been in place since the 1978 regulation that promulgated Good Manufacturing Practices for the manufacture, packing, storage, and installation of medical devices.

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Medical Device Companies Prepare To Implement Unique Device Identification

With a final rule from FDA for UDI expected this year, device makers have accelerated development of a UDI system. As a first step, “labelers” need to adopt a system for issuing UDIs from an issuing agency accredited by FDA. Support continues to grow in the supply chain for the GS1 System of Standards, embraced by early innovators pushing for a global standard for device identification and tracking.
In an interview with PMPN, Siobhan O’Bara, senior vice president, industry engagement, GS1 US discusses issues raised by manufacturers in comments on the proposed rule, and the advantages of using GS1’s system.
[Editor’s note: Siobhan O’Bara will join Jay Crowley, senior advisor patient safety, FDA, and panelists from Medtronic, GHX, and Premier speaking on Creating a Roadmap For UDI Compliance at the upcoming MD&M West trade show and conference, Feb. 11-14 in Anaheim, CA.]

Update on International Standards, Regulations at HealthPack Europe

EN ISO 11607, Packaging for Terminally Sterilized Medical Devices, continues to be the international standard for sterile medical device packaging, but proposed new medical device regulations in Europe could potentially impact packaging, reports Thierry Wagner, DuPont Medical Packaging’s regulatory affairs director. Wagner spoke at HealthPack Europe 2012, which was held in Dublin, Ireland, on December 3-4. The event marked HealthPack’s debut in Europe.

Steripax Offers Zone Coating For Medical Packaging

Design Coat from Steripax, Inc is a proprietary process in zone coating for medical packaging. The perimeter applied adhesive provides precision placement of the sealing bars and can be configured for almost any pattern or design.
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