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Greetings, DDL would like to welcome Kelley Newman as a new Project Manager at its Minnesota facility.  Kelley joins DDL from Spalding Corporation where she served as a Package Engineer, and will bring valuable quality assurance experience to the company. 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 CEO, John Hart, will be delivering a presentation on the new ISO 11607-01 standard at the upcoming MD&M Minneapolis event, October 24 - 26, 2006.  Register here to attend. Patrick Nolan is attending an ISO 4168 committee meeting in Italy this month.  The next DDL newsletter will include an update on planned revisions to ISO 4168. Please pass this newsletter onto a colleague who may benefit from quarterly medical device packaging industry updates.

Sincerely, Patrick Nolan COO, DDL

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John E. Hart CEO, DDL

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.