Sterile Medical Packaging

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.

Wrapping Up Cost Savings

These days, pharmaceutical and medical device manufacturers are looking for more cost-effective ways to package their products, reports Kevin Ryan, pharmaceutical/medical technical sales at Formost Fuji. He says that many are finding that flow-wrapped packages can provide flexible and cost-effective solutions.

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Oliver Products Acquired by Berwind Group

Oliver Products, the parent company of Oliver-Tolas Healthcare Packaging and Oliver Packaging and Equipment, has been acquired by an affiliate of the Berwind Corp., Oliver Products reported in a press release. Oliver-Tolas Healthcare Packaging  supplies sterile-grade die-cut lid, rollstock, and pouch products for medical and pharmaceutical applications.

Medical Packaging Converter Technipaq Redesigns Web Site

Technipaq Inc., an ISO 9001/ ISO 13485 certified manufacturer of flexible sterilizable packaging materials for the medical device, diagnostic, pharmaceutical, and other industries, has launched a new Web site. The site has been redesigned to enhance navigation and expand access to information about Technipaq’s product lines.

Nurses' Packaging Preferences Headlined HealthPack

As expected, HealthPack 2012 provided compelling end-user feedback with its Voice of the Customer survey and its lively nurses panel. This year’s survey results, organized by Jennifer Neid Benolken and Jennifer Blocher and presented by Blocher, reiterated many of the ongoing preferences nurses have expressed at past HealthPack events, such as for double-barrier packaging. And in the live panel moderated by Benolken, nurses expressed their opening concerns, which included avoiding tears and reducing waste. Benolken serves as senior packaging engineer for St.

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