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)

While I was at the Biocom Drug/Device Summit in December 2006, I attended a session that addressed the key players and issues at the intersection of Nanotech, Microelectronics and Regenerative Medicine.

Here’s a summary of the session’s highlights:

I recently attended the Biocom Drug/Device Summit in La Jolla, California. This summit brought together several players concentrating on developing next generation medical products and key investors interested in funding their growth and development.

Participating companies were small, start-up companies and larger, more established companies. Plenary sessions focused on defining the drug/device opportunity, combination products, key players and issues at the intersection of nanotech, microelectronics and regenerative medicine and how the FDA is addressing the new regulatory issues for in vitro diagnostics and combination products.

Over the next week or so, I will be posting the highlights of the plenary sessions I attended while at the summit.

The annual MD&M West tradeshow is coming up – February 12 – 15 in Anaheim, CA. DDL will be hosting a hospitality suite at the show and invites packaging professionals and manufacturers to join us for an evening of food, drink and music.

Tuesday, February 13, 2007
6 pm – 8.30 pm
Anaheim Marriott Hotel, Lobby Level

R.S.V.P and print your invitation.

We’re looking forward to seeing you in Anaheim!

DDL is kicking off 2007 with a brand new area to our blog. Various DDL experts will be making posts to this section about their industry insights and experiences.

In 2006, we were pleased to launch our Industry Standards Alert service to offer insight into changing industry standards. This was motivated by our involvement in the revisions to ISO 11607 and the depth of interest we received from industry professionals in receiving regular industry requirements updates. If you are still unclear about the ISO 11607 revisions, you can listen to our series of on-demand webinars.