The ISTA and IoPP sponsored Dimensions ’07 conference last month was a huge success, as over 300 packaging professionals assembled in Orlando.

The conference content was outstanding, as usual, and significant technical information regarding transport packaging, logistics, materials, and systems was exchanged.

The highlight for me is always the reunion of many packaging professionals and friends at this annual forum. This forum has become the foremost venue for the industry and should be considered THE annual packaging industry event. There is nothing else like it!

The 18th Annual HBA Woman of the Year luncheon will be held on Thursday May 3, at the New York Hilton.

HBA will be honoring the 2007 Woman of the Year recipient - Meryl Zausner, Vice President and Chief Financial Officer, Novartis Oncology, is a pioneer and an inspiration to those around her. She has exemplified her stellar leadership as a business woman, cultivator of internal talent and champion of diversity and inclusion. She was the founding member of Novartis Oncology global business unit in 2000, helping to make it one of the world’s top Oncology companies. One of her many contributions to the advancement of women includes her role in developing Novartis’ Annual Female Leadership Forum.

If you believe package engineering is not a science, a technology or a multi-billion dollar global business force, then you need to attend Dimensions.08.  Dimensions is a broad scope packaging forum covering all aspects of the technology and management of transport packaging.

Dimensions.07 covered issues of packaging sustainability as presented by Sams Club, IBM Corporation, Rochester Institute of Technology, Herman Miller and Lansmont Corporation.  These companies are setting the new standards for the total packaging lifecycle and challenged packaging professionals with their original research, corporate metrics programs and their forecasts for continuous improvement on preserving and conserving our world’s resources towards the development of packaging materials and systems.

The team at DDL stepped forward to answer the call for aid in rebuilding the city of Gulfport, after the devastations of Hurricane Katrina.

Ozzie Echols, Patrick Ayinde, Corey Hensel, and Pat Nolan have all lent a hand as part of a 24 member team organized by Faith Presbyterian Church, working on various projects aimed to rebuild the Gulfport/ Biloxi area.

The cost of the trip was covered by the DDL team who were delighted at the opportunity to take part in the renovation of the Mississippi community.

View Pictures From the Trip

DDL understands that time to market is critical for manufacturers.  This is why DDL has developed the 12 Steps to Market, a step-by-step guide to help manufacturers deliver their product to market on-time and intact.

1.  Packaging Design Requirements
2.  Packaging System Hazard Analysis
3.  Labeling Requirements
4.  Evaluation of Similar or Competing Devices
5.  Understanding the Clinical Application of a Medical Device
6.  Distribution, Storage & Handling of the Product
7.  Prototyping the Packaging System
8.  Stability Testing, Accelerated & Real Time Aging of Sterile Barrier System
9.  Sterilization Effects on Biocompatibility & Sterilization Validation, Device & Package
10. Integrity of the Sterile Barrier System & Packaging System Performance Testing
11. Packaging Equipment Qualification, IQ and OQ
12. Packaging Process Development & Performance Qualification (PQ)

I am also pleased to announce that I will be speaking at HealthPack 2007 on “Offshore Packaging - An Insider’s View”. Join me on March 9 at 2.15 pm.

Don’t forget to stop by the DDL Table #21 to find out how you can reduce time to market for your medical device or product.

I have been asked to speak at this year’s HealthPack trade show in New Orleans, March 8 - 10.

Please join me for “Standards Update - ASTM International Committee D10 Packaging” on March 9 at 10.45 am.

Many companies find value in combining their package and product testing to ensure that their product is delivered to market in a timely fashion.

1) Eliminate Re-Testing
Knowing the product’s response to environmental forces and informing the Package Engineer of them early on can eliminate the need to re-test or conduct a second round of testing.  The engineer can use product data collected to make educated packaging design decisions with confidence.

2) Reduce Time to Market
Combining package testing and product testing from the start streamlines process and reduces the overall time to market.

I recently met with the Technical Committee 122 to discuss the proposed changes to ISO 4180 - “Packaging-Complete, filled transport packages-General rules for the compilation of performance test schedules.”

The objective of this meeting was to review the draft document developed from discussions during the first meeting in June 2005.

In the previous meeting, the Working Group had agreed on the structure of combining the two parts of the current standard into a single document.

The ensuing discussion revolved around the proposed 2nd draft of the revised standard. Some of the highlights of the proposed draft are presented below and revolved around the Test Schedule Tables.

Another interesting session that I was able to attend at the Biocom Drug/Device Summit was about regulatory issues for new in vitro diagnostics and combination products.

Here is a summary of the session’s highlights:

• Combination products can be drug-device, device-biologic, drug-biologic, drug-device-biologic, but not drug-drug.
• Also defined that if a manufacturer co-packages any of the above in a kit then the package is defined as a combination product.
• The FDA has 3 medical products centers:
• CBER (center for biologics evaluation and research)
• CDER (center for drug evaluation and research)
• CDRH (center for devices and radiological health)