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Archive for March, 2009

Convenience Should Not Preclude Safety

Monday, March 30th, 2009

Insulin pens offer dosing convenience, but I worry that recent misuse could scare off potential users--and perhaps even drug companies considering them for novel products. Innovations that promote convenience can help users increase safety and efficacy. Users shouldn't employ the systems to sidestep safety, however. FDA recently noted that "insulin pens ...

Investing in the Future

Friday, March 27th, 2009

The faltering economy hasn’t side-tracked the growth agenda at T.O. Plastics. The Clearwater, MN-based packaging manufacturer has added 60,000 sq ft of manufacturing space, in order to support an expanded focus on medical device packaging. The capacity resides in an Ostego facility that will house a new high-speed inline thermoformer, and ISO-certified ...

Interchangeability is Possible, But Do Your Homework, and Early

Friday, March 27th, 2009

A few material suppliers are faltering in today’s unstable economy, so you could be using a packaging material that may not be available later this year. Suppliers may be shutting down entirely, or they may be discontinuing certain less-profitable formulations. If a long-used material or component should suddenly be pulled from ...

Feeling the Need for Braille Standards

Thursday, March 26th, 2009

Braille requirements in the European Union are influencing packagers stateside. Two groups, the International Association of Diecutting and Diemaking (IADD) and the Braille Authority of North America (BANA), have come together to develop standards of repeating printed information in braille on prescription and over-the-counter packages. IADD Braille Task Force chair Stephen ...

New FDA Commissioner, New Push for Safety?

Friday, March 20th, 2009

I just sent the following inquiry to the White House: "I am editor of Pharmaceutical & Medical Packaging News and have been following President's Obama's interest in curbing medical errors. With the appointment of Dr. Margaret Hamburg as FDA Commissioner and given her past election to the Institute of Medicine, will ...

Going Green, But Only If It Is Cheaper

Thursday, March 19th, 2009

Pharmaceutical and medical device packaging professionals generally seem interested in sustainability, but only if the price is right. Respondents to two polls during PMP News’s exclusive Webcast, “Sustainability 101: Beyond Recycling—Sustainability in a Material World,” explained that some modifications to packaging components and projects will be made to achieve some ...

Court Case’s Impact on Packaging

Monday, March 16th, 2009

Repercussions from the decision in Wyeth v. Levine could be felt in the packaging world, but experts say the exact impact is still unknown. Greater concern has arisen for pharma manufacturers, however, particularly from law professionals experienced in product liability and commercial ligation. Stephanie M. Rippee, a shareholder in the law ...

Don’t Be Afraid to Reduce Risk and Redundancy

Wednesday, March 11th, 2009

“Standardization is our friend.” Beth Staub, vice president of quality and regulatory affairs of Stryker Corp., offered these words of advice at HealthPack during her opening keynote. Focusing her talk on “lessons learned,” Staub outlined Stryker’s ongoing companywide reorganization of its packaging functions and the importance of a common packaging ...

Plug-In Ports XML Content For Package Design

Tuesday, March 10th, 2009

Pharmaceutical companies have moved in varying degrees to the tagged-content XML format for managing content internally, submitting documents to FDA in Structured Product Labeling (SPL) format, and meeting Europe’s Product Information Management (PIM) standard. If package designers could access the labeling information included in these master files, many of the road bumps ...

Should Taxpayers Bear the Costs of Quality?

Friday, March 6th, 2009

Addressing the issue of salmonella-ridden peanut butter in his weekly message, Frank M. Torti, acting FDA commissioner, explained on March 2 that FDA and other government agencies are spending a lot of time looking for bad nuts. And probably money. "You should know that we at FDA as well as ...