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Greetings, DDL West would like to welcome Karen Greene as its new Technical Director.  Karen joins DDL West from Seltzer Nutritional Technologies, where she was Director of Package Engineering.  As Technical Director, Karen will focus on increasing DDL West's package testing business. Patrick Nolan, COO of DDL Inc., hosted the third and final Webinar in the ISO 11607 Revisions series in August.  All three Webinars are now available on-demand on the DDL website. Webinar #1: The Revised ISO 11607-01 Webinar #2: ISO 11607 Revisions - Understanding Clause 6 Webinar #3: ISO 11607 Revisions - Implementing Clause 6 Thank you to everyone who attended one or more of the Webinars.  We were also pleased to receive and answer your questions on the new ISO 11607-01 standard.  You can read an FAQ of questions posed below. DDL West is finding that many California-based manufacturers are not fully aware of what it takes to validate their packaging.  Defective packaging is often the number one reason for a medical device to be recalled.  Read our report on FDA medical device recalls. Please pass this newsletter onto a colleague who may benefit from quarterly medical device packaging industry updates. Sincerely, Michael B. Foster DDL West Package Engineer VP & Treasurer of IOPP Southern CA Chapter

Industry News

Defective Packaging Causes Medical Device Recalls Medical devices are used every day to save lives.  However, compromised medical devices are frequently released into the marketplace, jeopardizing the life of the end user. Defective packaging is a large reason for medical devices being recalled. DDL Inc. COO, Patrick Nolan, comments on the presence of many packaging-related recalls in the FDA's latest product recall report.  Click here to read more.

PackAdvice

ISO 11607-01 - FAQ DDL received a number of questions about the new ISO 11607-01standard following the third Webinar in the ISO 11607 Revisions series. 1)  Is Environmental Extremes Testing now a requirement of ISO 11607-01? 2)  What is the definition of "worst case" with regards to package design? 3)  How can you make sure that the pouch manufacturer is using the "worst case" pouches? 4)  Can microbiological challenges be eliminated from package validation?  If so, how can the results of physical testing be justified without correlation to microbiological data? 5)  Is it true that for small parcels, the final drop should be done in the most damage prone      orientation, not always the bottom? 6)  What is a reasonable rational for selection of sample size? 7)  Why do you need to include the IFU when testing? 8)  How do you validate a test method? 9)  How to companies have to modify their current tests to meet the new standards? 10)  Does the PQ testing for shelf life have to be done at the minimum and maximum setting for the heat sealer, or can it be the nominal? Read the answers to these questions here.