About DDL: Testing Services Protocol Design Documentation Quality Assurance Pricing & Terms Contact DDL DDL In The News May 2006 "Common Mistakes in Validating Package Systems " May 2006 "What ISO 11607 Revisions Mean To You" May 2006 "Design Notes - Packaging Compliance Website" April 2006 "Industry Watch - ASTM   D-10 Committee Chairman Elected"

DDL has expanded into a second environmental testing laboratory.  The new facility allows DDL to take on 25% more environmental testing projects per year and also frees up space in the main laboratory for additional package, product and material testing. The new ISO 11607-01 standard has finally been published. Packaging professionals and medical device manufacturers should be aware that packaging requirements have changed for the distribution of medical devices. To learn more about new compliance requirements for packaging, attend Patrick Nolan's series of 3 webinars on the ISO 11607 Revisions. Listen to the first two webinars on-demand at your convenience Webinar #1 - The New Revised ISO 11607-01 Standard Webinar #2 - ISO 11607 Revisions - Understanding Clause 6 You can also register for the final webinar in this series "Implementing Clause 6", which will take place on the following dates: - August 15, 12 pm CST (1 pm EST; 10 am PST) - August 18, 2 pm CST (3 pm EST; 12 pm PST) - August 23, 1 pm CST (2 pm EST; 11 am PST) Finally, DDL would like to thank all of you that have attended an ISO 11607 Revisions Webinar. The response has been phenomenal and we encourage you to keep sending us your questions.  View PackAdvice below for answers to ISO 11607 questions we have received so far. 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 11607-01 Is Published The new ISO 11607-01 standard has been published. Clause 6 is the most revised section of ISO 11607.  Packaging requirements for the distribution of medical devices have changed in terms of the following:        •  Test methods        •  Sampling plans        •  Materials & performed sterile barrier systems        •  Storage & transport regulations        •  Closure/seal evaluation        •  Accelerated aging protocols Read Patrick Nolan's article "What Do ISO 11607 Revisions Mean To You?" Register here for an ISO 11607 Revisions on-demand webinar.

PackAdvice

ISO 11607 Revisions - FAQ                                         Following Patrick Nolan's first two webinars in the ISO 11607 Revisions series, the following questions were submitted by packaging professionals and manufacturers. 1)   During the webinar you mentioned that testing should be conducted on products produced at       "worst case" parameters not at nominal - is this a recommendation or a requirement? 2)   Is it necessary to re-do previous validations to comply with the new standard? 3)   Why is testing performed at every step of packaging?  Current practice usually combines                   processes and only tests at certain points. 4)   Why do you recommend the accelerated aging test separate from the distribution simulation test? 5)   Can DDL perform a visual inspection on the boxes, shelf cartons and sealed pouches after the       distribution simulation but before the leak/peel tests according to our protocol? 6)   Why is yellowing after sterilization a potential problem? Read the answers to these questions here.