Medical Product Outsourcing

Article Summary

The threat of offshore outsourcing may have concerned some contract service providers in recent years, but not so much for companies who perform medical device testing. In fact, these businesses are busier than ever as the next generation of products with complex designs and newer materials makes testing more complicated. While some manufacturing operations have shipped overseas, the tangled regulatory web only has served to strengthen the desire for outside expertise in the testing realm.

Pharmaceutical Commerce

Article Summary

Shipping pharmaceuticals is not the easiest of international trade activities. The need for cold-chain management of temperature-sensitive materials makes the process harder. And the need for meeting newly standardized rules for “biohazard” materials, such as vaccines, tissue samples, clinical materials and some blood products, can be the perfect storm of shipping difficulty. Layered over all of this is the concern with bioterrorism.

Medical Product Manufacturing News

Article Summary

Specializing in package testing and validation, a company has launched a service that sends subscribers updates about changing standards and compliance requirements. The free Industry Standards Alert service provided by DDL Inc. (Eden Prairie, MN) is accessible through the company’s Web site. Beneficial to medical device packaging and design engineers, the service consists of e-mail notifications from the firm detailing modifications or revisions to industry standards

European Medical Device Manufacturer

Article Summary

Specializing in package testing and validation, a company has launched a service that sends subscribers updates about changing standards and compliance requirements. The free Industry Standards Alert service provided by DDL Inc. (Eden Prairie, MN, USA) is accessible through the company’s Web site. The service consists of e-mail notifications from the firm detailing modifications or revisions to industry standards.

Pharmaceutical & Medical Packaging News

Article Summary

Specializing in package testing and validation, a company has launched a service that sends subscribers updates about changing standards and compliance requirements. The free Industry Standards Alert service provided by DDL Inc.

Pharmaceutical & Medical Packaging News

Article Summary

At ASTM’s October 2006 meeting, ASTM subcommittees approved changes to standards covering tests for distribution simulation and package accelerated aging, and balloted physical testing methods for measuring the integrity of porous packages and materials.

Pharmaceutical & Medical Packaging News

Article Summary

Early three years after FDA waged war on counterfeiting and diversion, some pharmaceutical firms and their supply-chain partners are in the thick of it, responding to threats on a number of fronts. But others are just now suiting up for battle.

Pharmaceutical & Medical Packaging News

Article Summary

ASTM Subcommittee F2.50 is clarifying the use of relative humidity levels in package accelerated-aging protocols to ensure more-realistic testing results. After three rounds of balloting on a revision to standard F1980-02, a fourth draft is being prepared that will be submitted to the subcommittee and full committee (F02) for concurrent voting, says Pat Nolan, chief operating officer, DDL (Eden Prairie, MN).

Pharmaceutical & Medical Packaging News

Article Summary

Last spring, in the wake of Hurricane Katrina, organizers of the HealthPack conference were forced to relocate the event to Dallas. But after struggling through a difficult recovery, The Big Easy is ready to welcome back the 17th annual conference for medical device professionals.

Pharmaceutical & Medical Packaging News

Article Summary

Experts say that a robust package that will hold up under the worst conditions can be designed. But is it possible to protect them against all distribution uncertainties? Could monitoring that package as it travels along the cold chain give you the ultimate peace of mind?