Greetings,

In response to requests for streamlined ways to achieve UN/DOT certification, DDL has identified 5 key steps in the PackAdvice article below.

Will ISO 11607 and EN 868-1 documents be harmonized? Read for yourself in an update on the status of the most recent AAMI Sterilization Standards Committees recent meeting.

Register here to gain free admission (a $45 value) to attend the October 19-21, 2004 Medical Design & Manufacturing conference and exposition.

Please pass this newsletter to a packaging professional who you think can benefit from quarterly industry packaging updates.

Sincerely,
Patrick Nolan	&	John E. Hart
COO, DDL		CEO, DDL

5-Steps to Achieving UN/DOT Package Certification By: DDL Package Engineer Dick Strand and COO Patrick J. Nolan This article presents a 5-Step guide to completing the certification process using a TPA and remaining compliant thereafter. To read the complete "5 Steps" article click here.

Patrick J. Nolan, DDL COO, Reports on the AAMI Sterilization Standards Committees Recent Meeting

A Harmonized ISO 11607 Standard
The AAMI Sterilization Standards Committee/TAG for ISO /TG 198 Working group ST/WG 07, "Sterilization Packaging" currently co-chaired by Mr. John Spitzley and Mr. Nick Fotis met in Washington D.C. on May 12, 2004.

The objectives of the meeting were:

To review ballot results and US comments received on the draft industry standard (DIS) for the ISO DIS 11607-1, "Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packing" To review ballot results and US comments received on the draft industry standard (DIS) for the ISO DIS 11607-2, "Packaging for terminally sterilized medical devices Part 2: Validation and requirements for forming, sealing, and assembly processes." Determine the process and enlist volunteers for updating and revising the AAMI TIR 22. Develop US position and vote on the two ISO 11607 documents.

Click here for full article