About DDL: Testing Services Protocol Design Documentation Quality Assurance Pricing & Terms Contact DDL 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 is pleased to announce the launch of its new website as an educational resource for manufacturers and packaging professionals. DDL 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 is pleased to announce that COO, Patrick Nolan, has been elected Chairman of the ASTM D-10 on Packaging Committee. Mr. Nolan has also been actively involved in the AAMI Committee responsible for drafting the Technical Information Report (TIR) for the revisions to the ISO 11607 standard. 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, Patrick Nolan COO, DDL

&

John E. Hart CEO, DDL

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

What Not To Do When Performing Package Validation There are some very common mistakes made when performing package validation. Here is your Top 10 checklist on what not to do: Do Not: #1   Compromise Sterility #2   Cut Corners #3   Skip Package-Product Compatibility Prequalification #4   Ignore Worst Case Scenario #5   Skip Protocol Development #6   Use Wrong Sample Size #7   Use Wrong Package Type/Material #8   Squeeze Oversized Pouches Into Cartons #9   Misread Tyvek Separation Results #10  Perform Accelerated Aging At High Test Temperature For more detail on each of these common mistakes, view Mr. Nolan's complete article on  "Top 10 Common Mistakes Made In Package Validation."