About DDL West: Testing Services Protocol Design Documentation Quality Assurance Pricing & Terms Contact DDL West DDL In The News April 2006 "Updated ISO Packaging Standard Nears Publication" March 2006 "Contract Package Testing & Inspection" March 2006 "Free Webinar Series: ISO 11607 Revisions"

DDL West is pleased to announce the launch of its new website as an educational resource for manufacturers and packaging professionals. DDL West has added advanced features to its website to help you keep on top of the latest industry standards and compliance requirements. New features include:   -  On-demand webinars   -  Industry standards search capability   -  Articles download DDL West is urging medical device manufacturers and package professionals to take note of the imminent changes to the ISO 11607 standard - "Packaging for Terminally Sterilized Medical Devices." While the medical device industry in California continues to thrive, DDL West Package Testing experts warn that the imminent ISO 11607 revisions will impact the way manufacturers package their medical devices and the compliance requirements they must fulfill for the validation of their packaging. How will ISO 11607 revisions affect you? Attend DDL's series of three webinars on the impact of the new ISO 11607-01 standard. Click here to attend the first webinar "ISO 11607 Revisions" on-demand at your convenience. You can also register for the second webinar "Understanding Clause 6", which will take place on the following dates:   May 17, 2006, 12 PM CST (1 EST, 10 PST)   May 23, 2006, 1 PM CST (2 EST, 11 PST)   May 25, 2006, 2 PM CST (3 EST, 12 PST) Please pass this newsletter to a packaging professional whom you think can benefit from quarterly packaging industry updates. Sincerely, Michael B. Foster Package Engineer DDL West

Industry News

ISO 11607 Is Being Revised! The ISO 11607 standard, the foremost guidance document for validating packaging for terminally sterilized medical devices is now being revised to incorporate the provisions of the EN 868-1 standard. As a result, the new ISO 11607-01 will be compromised of two parts: Part 1 - Materials & Designs Part 2 - Processes For more information on the ISO 11607 Revisions and how they will affect you, click here to register for a DDL webinar.

PackAdvice

The Cost of Package Integrity By Michael B. Foster Many medical device manufacturers struggle to satisfy and maintain package integrity requirements while remaining cost-efficient. Such companies can save themselves time, money, and unnecessary headaches by examining key issues prior to developing their packaging. Although manufacturers may still come upon engineering and logistical problems along the way, these issues will more than likely be relatively small and manageable. In the long run, those firms that address the potential pitfalls discussed in this article will be well positioned to meet package integrity requirements. Request a copy of the full article here.