About DDL West: Testing Services Protocol Design Documentation Quality Assurance Pricing & Terms Contact DDL West DDL In The News Nov/Dec 2006 "The Proof Is In The  Pudding" Oct 2006 "ISO 11607 FAQ" Oct 2006 "ISO Packaging Standard Revised" Sept 2006 "Newsmakers - Karen Greene " Sept 2006 "Web Sightings"

Greetings, 2006 has been a great year for DDL West.  Thank you to all of our customers, employees and partners for contributing to our company's success. Technical Director, Karen Greene, joined the DDL West team in August 2006. Greene, who is a tenured packaging professional, has already secured a speaking slot at next year's HealthPack and was quoted in Medical Product Outsourcing on process validation. This year, important revisions were made to ISO 11607, the foremost guidance document for validating packaging for terminally sterilized medical devices.  Thank you to everyone who attended DDL's series of webinars on the ISO 11607 Revisions.  If you missed them, you can still attend the webinars on-demand on the DDL website. You can also check out the 7 Tests Vital to Package Validation to watch videos of testing in progress. More industry standard revisions lie ahead in 2007.  In September, Patrick Nolan attended an ISO 4168 committee meeting in Italy to discuss the planned revisions to the standard for the ‘general rules for compilation of performance test schedules.’ DDL is helping industry professionals stay on-top of changes to standards with its new "Industry Standards Alert" service.  Sign up to receive notifications by email or RSS feed when an industry standard is updated. Please pass this newsletter onto a colleague who may benefit from quarterly medical device packaging industry updates. Sincerely, Michael B. Foster    &     Karen K. Greene Package Engineer            Technical Director

Industry News

Planned Revisions to ISO 4168 The Technical Committee 122/Subcommittee 3/Working Group 10 met on September 25, 2006 in Milan, Italy, to discuss the proposed revisions to ISO 4168.  The objective of the meeting was to review the draft document developed from discussions during the first meeting in June 2005. Click here to read the minutes from this meeting.

PackAdvice

7 Tests Vital to Packaging Validation The package validation process includes a number of tests designed to ensure that the package has the strength and integrity to survive the hazards inherent in the distribution, handling and storage environments. There are 7 tests vital to the package validation process: 1. Seal Peel Testing 2. Bubble Leak Testing 3. Leak Testing by Dye Penetration 4. Drop Testing 5. Compression Testing 6. Repetitive Shock Testing 7. Random Vibration Testing Read more